Kalcijev karbonat Krka may be available in the countries listed below.
Calcium Carbonate is reported as an ingredient of Kalcijev karbonat Krka in the following countries:
International Drug Name Search
Kaoke may be available in the countries listed below.
Calcitonin is reported as an ingredient of Kaoke in the following countries:
International Drug Name Search
Flagemed may be available in the countries listed below.
Metronidazole is reported as an ingredient of Flagemed in the following countries:
International Drug Name Search
Ondansetron BFN may be available in the countries listed below.
Ondansetron hydrochloride (a derivative of Ondansetron) is reported as an ingredient of Ondansetron BFN in the following countries:
International Drug Name Search
In the US, Nitisinone (nitisinone systemic) is a member of the drug class miscellaneous metabolic agents.
US matches:
Rec.INN
A16AX04
0104206-65-7
C14-H10-F3-N-O5
329
Enzyme inhibitor
Herbicide
1,3-Cyclohexanedione, 2-(2-nitro-4-(trifluoromethyl)benzoyl)-
2-(alpha,alpha,alpha-Trifluoro-2-nitro-p-toluoyl)-1,3-cyclohexanedione (WHO)
2-[2-Nitro-4-(trifluormethyl)benzoyl)cyclohexan-1,3-dion (IUPAC)
International Drug Name Search
Glossary
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
| WHO | World Health Organization |
Triptyl may be available in the countries listed below.
Amitriptyline hydrochloride (a derivative of Amitriptyline) is reported as an ingredient of Triptyl in the following countries:
International Drug Name Search
Cerureg may be available in the countries listed below.
Metoclopramide is reported as an ingredient of Cerureg in the following countries:
International Drug Name Search
Metronidazol Fresenius may be available in the countries listed below.
Metronidazole is reported as an ingredient of Metronidazol Fresenius in the following countries:
International Drug Name Search
Presteron may be available in the countries listed below.
Epidihydrocholesterin is reported as an ingredient of Presteron in the following countries:
International Drug Name Search
Trisulin 80/420 may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Sulfadiazine sodium (a derivative of Sulfadiazine) is reported as an ingredient of Trisulin 80/420 in the following countries:
Trimethoprim is reported as an ingredient of Trisulin 80/420 in the following countries:
International Drug Name Search
Bifradin may be available in the countries listed below.
Cefradine is reported as an ingredient of Bifradin in the following countries:
International Drug Name Search
Loxipronal may be available in the countries listed below.
Loxoprofen sodium salt (a derivative of Loxoprofen) is reported as an ingredient of Loxipronal in the following countries:
International Drug Name Search
Bioplak may be available in the countries listed below.
Acetylsalicylic Acid is reported as an ingredient of Bioplak in the following countries:
International Drug Name Search
In the US, Antivert (meclizine systemic) is a member of the drug class anticholinergic antiemetics and is used to treat Motion Sickness, Nausea/Vomiting and Vertigo.
US matches:
Meclozine dihydrochloride (a derivative of Meclozine) is reported as an ingredient of Antivert in the following countries:
International Drug Name Search
Hexazin may be available in the countries listed below.
Inositol Nicotinate is reported as an ingredient of Hexazin in the following countries:
International Drug Name Search
Rec.INN
A14AA04
0000153-00-4
C20-H30-O2
302
Anabolic
Androst-1-en-3-one, 17-hydroxy-1-methyl-, (5α,17ß)-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Kratium may be available in the countries listed below.
Diazepam is reported as an ingredient of Kratium in the following countries:
International Drug Name Search
Terbinafina Kern Pharma may be available in the countries listed below.
Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Terbinafina Kern Pharma in the following countries:
International Drug Name Search
Angiprin may be available in the countries listed below.
Acetylsalicylic Acid is reported as an ingredient of Angiprin in the following countries:
International Drug Name Search
Viscotirs may be available in the countries listed below.
Carbomer is reported as an ingredient of Viscotirs in the following countries:
International Drug Name Search
Risperidona Mepha may be available in the countries listed below.
Risperidone is reported as an ingredient of Risperidona Mepha in the following countries:
International Drug Name Search
Yadim may be available in the countries listed below.
Ceftazidime pentahydrate (a derivative of Ceftazidime) is reported as an ingredient of Yadim in the following countries:
International Drug Name Search
Hevert-Enzym comp. may be available in the countries listed below.
Dimeticone is reported as an ingredient of Hevert-Enzym comp. in the following countries:
Pancreatin is reported as an ingredient of Hevert-Enzym comp. in the following countries:
International Drug Name Search
Rec.INN
0004696-76-8
C18-H37-N5-O10
483
Antibacterial: Aminoglycoside
D-Streptamine, O-3-amino-3-deoxy-α-D-glucopyranosyl-(1-6)-O-[2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl-(1-4)]-2-deoxy-
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| WHO | World Health Organization |
Ophtagram may be available in the countries listed below.
Gentamicin is reported as an ingredient of Ophtagram in the following countries:
Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Ophtagram in the following countries:
International Drug Name Search
Xylometazoline HCl CF may be available in the countries listed below.
Xylometazoline hydrochloride (a derivative of Xylometazoline) is reported as an ingredient of Xylometazoline HCl CF in the following countries:
International Drug Name Search
Trenxy may be available in the countries listed below.
Pentoxifylline is reported as an ingredient of Trenxy in the following countries:
International Drug Name Search
Calcium-D-Sandoz may be available in the countries listed below.
Calcium Carbonate is reported as an ingredient of Calcium-D-Sandoz in the following countries:
Colecalciferol is reported as an ingredient of Calcium-D-Sandoz in the following countries:
International Drug Name Search
Oraspor may be available in the countries listed below.
Cefroxadine is reported as an ingredient of Oraspor in the following countries:
International Drug Name Search
Amilostad HCT may be available in the countries listed below.
Amiloride hydrochloride dihydrate (a derivative of Amiloride) is reported as an ingredient of Amilostad HCT in the following countries:
Hydrochlorothiazide is reported as an ingredient of Amilostad HCT in the following countries:
International Drug Name Search
Tilker may be available in the countries listed below.
Diltiazem hydrochloride (a derivative of Diltiazem) is reported as an ingredient of Tilker in the following countries:
International Drug Name Search
Ketoconazolo may be available in the countries listed below.
Ketoconazolo (DCIT) is known as Ketoconazole in the US.
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
Melobax may be available in the countries listed below.
Meloxicam is reported as an ingredient of Melobax in the following countries:
International Drug Name Search
Kocefan may be available in the countries listed below.
Ceftriaxone disodium salt (a derivative of Ceftriaxone) is reported as an ingredient of Kocefan in the following countries:
International Drug Name Search
Alyprost may be available in the countries listed below.
Alprostadil is reported as an ingredient of Alyprost in the following countries:
International Drug Name Search
Thiamine Chloride may be available in the countries listed below.
Thiamine hydrochloride (a derivative of Thiamine) is reported as an ingredient of Thiamine Chloride in the following countries:
International Drug Name Search
Ova-mit may be available in the countries listed below.
Clomifene citrate (a derivative of Clomifene) is reported as an ingredient of Ova-mit in the following countries:
International Drug Name Search
boe-SEN-tan
Use of bosentan may result in serious liver injury or liver failure. Measure serum aminotransferase levels prior to initiation of treatment and then monthly. Stop treatment if liver aminotransferase elevations are accompanied by clinical symptoms of liver injury or increases in bilirubin greater than or equal to 2 times ULN occur. Use of bosentan is very likely to produce major birth defects if used by pregnant women. Exclude pregnancy before initiation of therapy and prevent pregnancy thereafter by the use of two forms of reliable contraception for the duration of treatment and for one month after stopping bosentan. Monthly pregnancy tests should be obtained. Bosentan may be prescribed only through the TRACLEER(R) Access Program by calling 1-866-228-3546 .
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antihypertensive
Pharmacologic Class: Endothelin Receptor Antagonist
Bosentan is used to treat the symptoms of pulmonary arterial hypertension. This is the high blood pressure that occurs in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When the smaller blood vessels in the lungs become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs. Bosentan works by blocking a hormone (a naturally occurring substance), that is found in the blood and lungs in large quantities of the people with pulmonary arterial hypertension. Bosentan helps by increasing the supply of blood to the lungs and reducing the workload of the heart.
bosentan is available only under a special restricted distribution program called the Tracleer Access Program (T.A.P.).
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For bosentan, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to bosentan or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of bosentan in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bosentan in the elderly. However, elderly patients are more likely to have age-related heart, liver, or kidney problems, which may require caution in patients receiving bosentan.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | X | Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking bosentan, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using bosentan with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using bosentan with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using bosentan with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
The presence of other medical problems may affect the use of bosentan. Make sure you tell your doctor if you have any other medical problems, especially:
Take bosentan exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not change the dose or stop using bosentan without checking first with your doctor.
It is very important that you understand the requirements of the Tracleer® access program, and become familiar with the Tracleer® educational materials and Patient Medication Guide. Direct any questions to your doctor or pharmacist before starting bosentan therapy.
You may take bosentan with or without food.
The dose of bosentan will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of bosentan. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of bosentan, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check your progress at regular visits to make sure bosentan is working properly and to check for unwanted effects.
It is also important that your doctor does a blood test to check your liver function before you start bosentan and each month after that.
Using bosentan while you are pregnant can cause very serious birth defects. Use two forms of effective birth control to keep from getting pregnant while you are using bosentan (even if the medicine is temporarily stopped), and for at least one month after you stop taking the medicine. The most effective forms of birth control are hormone birth control pills, patches, shots, vaginal rings, or implants, an IUD, or a vasectomy (for men). One of these forms of birth control should be combined with a condom, a diaphragm, or a cervical cap. If a woman has had a tubal ligation, she does not need to use a second form of birth control. If you think you have become pregnant while using bosentan, tell your doctor right away.
You must have a negative pregnancy test before you will be allowed to take bosentan. You will also be required to have a pregnancy test every month during your treatment. If you miss a period while you are using bosentan, tell your doctor right away.
Liver problems may occur while you are using bosentan. Stop using bosentan and check with your doctor right away if you are having more than one of these symptoms: dark urine, fever with or without chills, light colored stools, loss of appetite, nausea and vomiting, skin rash, stomach pain, unusual tiredness, or yellow eyes or skin.
Bosentan may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using bosentan.
bosentan may cause fluid retention (edema) in some patients. Check with your doctor right away if you are gaining weight rapidly; have swelling in your hands, ankles, feet, or all over the body; or if you have trouble with breathing while you are using bosentan.
Pulmonary edema may occur while using bosentan. Stop using bosentan and check with your doctor right away if you have chest pain; difficult, fast, noisy breathing, sometimes with wheezing; blue lips and fingernails; pale skin; increased sweating; coughing that sometimes produces a pink frothy sputum; or shortness of breath.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: bosentan side effects (in more detail)
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
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In the US, Maxalt (rizatriptan systemic) is a member of the drug class antimigraine agents and is used to treat Migraine.
US matches:
UK matches:
Rizatriptan is reported as an ingredient of Maxalt in the following countries:
Rizatriptan benzoate (a derivative of Rizatriptan) is reported as an ingredient of Maxalt in the following countries:
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Kardopal may be available in the countries listed below.
Carbidopa monohydrate (a derivative of Carbidopa) is reported as an ingredient of Kardopal in the following countries:
Levodopa is reported as an ingredient of Kardopal in the following countries:
International Drug Name Search
Sicorten Plus may be available in the countries listed below.
Halometasone monohydrate (a derivative of Halometasone) is reported as an ingredient of Sicorten Plus in the following countries:
Triclosan is reported as an ingredient of Sicorten Plus in the following countries:
International Drug Name Search
Ketrodol may be available in the countries listed below.
Ketorolac tromethamine (a derivative of Ketorolac) is reported as an ingredient of Ketrodol in the following countries:
International Drug Name Search
Luminity may be available in the countries listed below.
Perflutren is reported as an ingredient of Luminity in the following countries:
International Drug Name Search
Loperamid-1A Pharma may be available in the countries listed below.
Loperamide hydrochloride (a derivative of Loperamide) is reported as an ingredient of Loperamid-1A Pharma in the following countries:
International Drug Name Search
Kenzoflex may be available in the countries listed below.
Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Kenzoflex in the following countries:
International Drug Name Search
Torasemid AAA Pharma may be available in the countries listed below.
Torasemide is reported as an ingredient of Torasemid AAA Pharma in the following countries:
International Drug Name Search
Nor-Fluozol may be available in the countries listed below.
Fluconazole is reported as an ingredient of Nor-Fluozol in the following countries:
International Drug Name Search
Tamiram may be available in the countries listed below.
Levofloxacin hemihydrate (a derivative of Levofloxacin) is reported as an ingredient of Tamiram in the following countries:
International Drug Name Search
CabergoLek may be available in the countries listed below.
Cabergoline is reported as an ingredient of CabergoLek in the following countries:
International Drug Name Search
Fluoxetinã may be available in the countries listed below.
Fluoxetine is reported as an ingredient of Fluoxetinã in the following countries:
International Drug Name Search
ACC Hexal may be available in the countries listed below.
Acetylcysteine is reported as an ingredient of ACC Hexal in the following countries:
International Drug Name Search
Valpro TAD may be available in the countries listed below.
Valproic Acid sodium (a derivative of Valproic Acid) is reported as an ingredient of Valpro TAD in the following countries:
International Drug Name Search
Modustatine may be available in the countries listed below.
Somatostatin x acetate (a derivative of Somatostatin) is reported as an ingredient of Modustatine in the following countries:
International Drug Name Search
Karbox may be available in the countries listed below.
Oxcarbazepine is reported as an ingredient of Karbox in the following countries:
International Drug Name Search
Glucadol may be available in the countries listed below.
Glucosamine sulfate (a derivative of Glucosamine) is reported as an ingredient of Glucadol in the following countries:
International Drug Name Search
In the US, Selsun (pyrithione zinc topical) is a member of the drug class miscellaneous topical agents and is used to treat Seborrheic Dermatitis and Tinea Versicolor.
US matches:
Selenium Sulfide is reported as an ingredient of Selsun in the following countries:
International Drug Name Search
Asoben may be available in the countries listed below.
Ascorbic Acid is reported as an ingredient of Asoben in the following countries:
International Drug Name Search
Bacterix may be available in the countries listed below.
Nifuroxazide is reported as an ingredient of Bacterix in the following countries:
International Drug Name Search
Biotin Hexal may be available in the countries listed below.
Biotin is reported as an ingredient of Biotin Hexal in the following countries:
International Drug Name Search
Oranex may be available in the countries listed below.
Azithromycin dihydrate (a derivative of Azithromycin) is reported as an ingredient of Oranex in the following countries:
International Drug Name Search
Serozil may be available in the countries listed below.
Cefprozil is reported as an ingredient of Serozil in the following countries:
International Drug Name Search
Benzododécinium may be available in the countries listed below.
Benzododécinium (DCF) is also known as Benzododecinium (DCF)
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
MCP Tropfen-1A Pharma may be available in the countries listed below.
Metoclopramide hydrochloride (a derivative of Metoclopramide) is reported as an ingredient of MCP Tropfen-1A Pharma in the following countries:
International Drug Name Search
Krisxon may be available in the countries listed below.
Trimebutine is reported as an ingredient of Krisxon in the following countries:
International Drug Name Search
Calcium may be available in the countries listed below.
Calcium Carbonate is reported as an ingredient of Calcium in the following countries:
Calcium Gluconate is reported as an ingredient of Calcium in the following countries:
International Drug Name Search
Definition of Ischemic Heart Disease: Ischemia is a condition in which the blood flow (and thus oxygen) is restricted to a part of the body. Cardiac ischemia (Ischemic Heard Disease) is the name for lack of blood flow and oxygen to the heart muscle.
Micromedex Care Notes:
Medical Encyclopedia:
Vancomycin-Teva may be available in the countries listed below.
Vancomycin is reported as an ingredient of Vancomycin-Teva in the following countries:
International Drug Name Search
Generic Name: oxaprozin (Oral route)
ox-a-PROE-zin
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Oxaprozin is contraindicated for the treatment of perioperative pain in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .
In the U.S.
Available Dosage Forms:
Therapeutic Class: Analgesic
Pharmacologic Class: NSAID
Chemical Class: Propionic Acid (class)
Oxaprozin is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it .
This medicine is available only with your doctor's prescription .
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of oxaprozin in children 6 to 16 years of age. Safety and efficacy have not been established in children below 6 years of age .
Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of oxaprozin in the elderly. However, elderly patients may be more sensitive to the effects of oxaprozin than younger adults, and are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving oxaprozin .
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients .
When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects .
This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk .
This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid or a blood thinner) .
Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, white spots in mouth or on lips, or unusual tiredness or weakness .
Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; unusual bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs .
This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once .
Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away .
This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds .
Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure .
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Daypro side effects (in more detail)
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Lipoicin may be available in the countries listed below.
Thioctic Acid is reported as an ingredient of Lipoicin in the following countries:
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Gabapentin is reported as an ingredient of Gabapentina Edigen in the following countries:
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Do not use Revlimid during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or death to a developing baby. In women of childbearing potential, obtain 2 negative pregnancy tests before starting Revlimid® treatment. Women of childbearing potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after Revlimid treatment [see Warnings and Precautions (5.1), and Medication Guide (17)]. To avoid fetal exposure to lenalidomide, Revlimid is only available under a restricted distribution program called “RevAssist®” (5.2).
Information about the RevAssist program is available at www.Revlimid.com or by calling the manufacturer’s toll-free number 1-888-423-5436.
Hematologic Toxicity (Neutropenia and Thrombocytopenia)
Revlimid can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q myelodysplastic syndromes had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q myelodysplastic syndromes should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors [see Dosage and Administration (2.2)].
Deep Vein Thrombosis and Pulmonary Embolism
Revlimid has demonstrated an increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients with multiple myeloma who were treated with Revlimid and dexamethasone therapy. Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism. Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. It is not known whether prophylactic anticoagulation or antiplatelet therapy prescribed in conjunction with Revlimid may lessen the potential for venous thromboembolic events. The decision to take prophylactic measures should be done carefully after an assessment of an individual patient’s underlying risk factors.
FULL PRESCRIBING INFORMATION
Revlimid in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma (MM) who have received at least one prior therapy.
Revlimid is indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
Revlimid should be taken orally at about the same time each day, either with or without food. Revlimid capsules should be swallowed whole with water. The capsules should not be opened, broken, or chewed.
The recommended starting dose of Revlimid is 25 mg once daily on Days 1-21 of repeated 28-day cycles. The recommended dose of dexamethasone is 40 mg once daily on Days 1-4, 9-12, and 17-20 of each 28-day cycle for the first 4 cycles of therapy and then 40 mg once daily orally on Days 1-4 every 28 days. Treatment is continued or modified based upon clinical and laboratory findings.
Dose Adjustments for Hematologic Toxicities During Multiple Myeloma Treatment
Dose modification guidelines, as summarized below, are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to lenalidomide.
Platelet counts
Thrombocytopenia in MM
| When Platelets | Recommended Course |
|---|---|
| Fall to <30,000/mcL | Interrupt Revlimid treatment, follow CBC weekly |
| Return to ≥30,000/mcL | Restart Revlimid at 15 mg daily |
| For each subsequent drop <30,000/mcL | Interrupt Revlimid treatment |
| Return to ≥30,000/mcL | Resume Revlimid at 5 mg less than the previous dose. Do not dose below 5 mg daily |
Absolute Neutrophil counts (ANC)
Neutropenia in MM
| When Neutrophils | Recommended Course |
|---|---|
| Fall to <1000/mcL | Interrupt Revlimid treatment, add G-CSF, follow CBC weekly |
| Return to ≥1,000/mcL and neutropenia is the only toxicity | Resume Revlimid at 25 mg daily |
| Return to ≥1,000/mcL and if other toxicity | Resume Revlimid at 15 mg daily |
| For each subsequent drop <1,000/mcL | Interrupt Revlimid treatment |
| Return to ≥1,000/mcL | Resume Revlimid at 5 mg less than the previous dose. Do not dose below 5 mg daily |
Other Grade 3 / 4 Toxicities in MM
For other Grade 3/4 toxicities judged to be related to Revlimid, hold treatment and restart at next lower dose level when toxicity has resolved to ≤ Grade 2.
Starting Dose Adjustment for Renal Impairment in MM
Since REVLIMD is primarily excreted unchanged by the kidney, adjustments to the starting dose of Revlimid are recommended to provide appropriate drug exposure in patients with moderate or severe renal impairment and in patients on dialysis. Based on a pharmacokinetic study in patients with renal impairment due to nonmalignant conditions, Revlimid starting dose adjustment is recommended for patients with CLcr < 60 mL/min. Non-dialysis patients with creatinine clearances less than 11 mL/min and dialysis patients with creatinine clearances less than 7 mL/min have not been studied. The recommendations for initial starting doses for patients with multiple myeloma (MM) are as follows:
| Category | Renal Function (Cockcroft-Gault) | Dose |
|---|---|---|
| Moderate Renal Impairment | CLcr 30-60 mL/min | 10 mg Every 24 hours |
| Severe Renal Impairment | CLcr < 30 mL/min (not requiring dialysis) | 15 mg Every 48 hours |
| End Stage Renal Disease | CLcr < 30 mL/min (requiring dialysis) | 5 mg Once daily. On dialysis days, administer the dose following dialysis. |
After initiation of Revlimid therapy, subsequent Revlimid dose modification should be based on individual patient treatment tolerance, as described elsewhere in this section.
The recommended starting dose of Revlimid is 10 mg daily. Treatment is continued or modified based upon clinical and laboratory findings.
Dose Adjustments for Hematologic Toxicities During MDS Treatment
Patients who are dosed initially at 10 mg and who experience thrombocytopenia should have their dosage adjusted as follows:
Platelet counts
If thrombocytopenia develops WITHIN 4 weeks of starting treatment at 10 mg daily in MDS
| If baseline ≥100,000/mcL | |
|---|---|
| When Platelets | Recommended Course |
| Fall to <50,000/mcL | Interrupt Revlimid treatment |
| Return to ≥50,000/mcL | Resume Revlimid at 5 mg daily |
| If baseline <100,000/mcL | |
| When Platelets | Recommended Course |
| Fall to 50% of the baseline value | Interrupt Revlimid treatment |
| If baseline ≥60,000/mcL and returns to ≥50,000/mcL | Resume Revlimid at 5 mg daily |
| If baseline <60,000/mcL and returns to ≥30,000/mcL | Resume Revlimid at 5 mg daily |
If thrombocytopenia develops AFTER 4 weeks of starting treatment at 10 mg daily in MDS
| When Platelets | Recommended Course |
|---|---|
| <30,000/mcL or <50,000/mcL with platelet transfusions | Interrupt Revlimid treatment |
| Return to ≥30,000/mcL (without hemostatic failure) | Resume Revlimid at 5 mg daily |
Patients who experience thrombocytopenia at 5 mg daily should have their dosage adjusted as follows:
If thrombocytopenia develops during treatment at 5 mg daily in MDS
| When Platelets | Recommended Course |
|---|---|
| <30,000/mcL or <50,000/mcL with platelet transfusions | Interrupt Revlimid treatment |
| Return to ≥30,000/mcL (without hemostatic failure) | Resume Revlimid at 2.5 mg every other day |
Patients who are dosed initially at 10 mg and experience neutropenia should have their dosage adjusted as follows:
Absolute Neutrophil counts (ANC)
If neutropenia develops WITHIN 4 weeks of starting treatment at 10 mg daily in MDS
| If baseline ANC ≥1,000/mcL | |
|---|---|
| When Neutrophils | Recommended Course |
| Fall to <750/mcL | Interrupt Revlimid treatment |
| Return to ≥1,000/mcL | Resume Revlimid at 5 mg daily |
| If baseline ANC <1,000/mcL | |
| When Neutrophils | Recommended Course |
| Fall to <500/mcL | Interrupt Revlimid treatment |
| Return to ≥500/mcL | Resume Revlimid at 5 mg daily |
If neutropenia develops AFTER 4 weeks of starting treatment at 10 mg daily in MDS
| When Neutrophils | Recommended Course |
|---|---|
| <500/mcL for ≥7 days or <500/mcL associated with fever (≥38.5°C) | Interrupt Revlimid treatment |
| Return to ≥500/mcL | Resume Revlimid at 5 mg daily |
Patients who experience neutropenia at 5 mg daily should have their dosage adjusted as follows:
If neutropenia develops during treatment at 5 mg daily in MDS
| When Neutrophils | Recommended Course |
|---|---|
| <500/mcL for ≥7 days or <500/mcL associated with fever (≥38.5°C) | Interrupt Revlimid treatment |
| Return to ≥500/mcL | Resume Revlimid at 2.5 mg every other day |
Other Grade 3 / 4 Toxicities in MDS
For other Grade 3/4 toxicities judged to be related to Revlimid, hold treatment and restart at next lower dose level when toxicity has resolved to ≤ Grade 2.
Starting Dose Adjustment for Renal Impairment in MDS:
Since Revlimid is primarily excreted unchanged by the kidney, adjustments to the starting dose of Revlimid are recommended to provide appropriate drug exposure in patients with moderate or severe renal impairment and in patients on dialysis. Based on a pharmacokinetic study in patients with renal impairment due to nonmalignant conditions, Revlimid starting dose adjustment is recommended for patients with CLcr < 60 mL/min. Non-dialysis patients with creatinine clearances less than 11 mL/min and dialysis patients with creatinine clearances less than 7 mL/min have not been studied. The recommendations for initial starting doses for patients with myelodysplastic syndromes (MDS) are as follows:
| Category | Renal Function (Cockcroft-Gault) | Dose |
|---|---|---|
| Moderate Renal Impairment | CLcr 30-60 mL/min | 5 mg Every 24 hours |
| Severe Renal Impairment | CLcr < 30 mL/min (not requiring dialysis) | 2.5 mg Every 24 hours |
| End Stage Renal Disease | CLcr < 30 mL/min (requiring dialysis) | 2.5 mg once daily. On dialysis days, administer the dose following dialysis. |
After initiation of Revlimid therapy, subsequent Revlimid dose modification should be based on individual patient treatment tolerance, as described elsewhere in this section.
Revlimid 2.5 mg, 5 mg, 10 mg, 15 mg and 25 mg capsules will be supplied through the RevAssist program
Revlimid is available in the following capsule strengths:
2.5 mg: White and blue-green opaque hard capsules imprinted “REV” on one half and “2.5 mg” on the other half in black ink
5 mg: White opaque capsules imprinted “REV” on one half and “5 mg” on the other half in black ink
10 mg: Blue/green and pale yellow opaque capsules imprinted “REV” on one half and “10 mg” on the other half in black ink
15 mg: Powder blue and white opaque capsules imprinted “REV” on one half and “15 mg” on the other half in black ink
25 mg: White opaque capsules imprinted “REV” on one half and “25 mg” on the other half in black ink
Revlimid may cause fetal harm when administered to a pregnant woman. Limb abnormalities were seen in the offspring of monkeys that were dosed with lenalidomide during organogenesis. This effect was seen at all doses tested. Due to the results of this developmental monkey study, and lenalidomide’s structural similarities to thalidomide, a known human teratogen, lenalidomide is contraindicated in pregnant women and women capable of becoming pregnant [see Boxed Warning]. Females of childbearing potential may be treated with lenalidomide provided adequate precautions are taken to avoid pregnancy. Females must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control, including at least one highly effective method (e.g., hormonal contraception, tubal ligation, IUD or partner’s vasectomy) and one additional effective method (e.g., latex condom, diaphragm, or cervical cap), beginning 4 weeks prior to initiating treatment with Revlimid, during therapy, during dose interruptions , and continuing for 4 weeks following discontinuation of Revlimid therapy. If hormonal or IUD contraception is medically contraindicated, two other effective or highly effective methods may be used.
Females of childbearing potential being treated with Revlimid must have pregnancy testing (sensitivity of at least 50 mIU/mL). The first test should be performed within 10-14 days and the second test within 24 hours prior to beginning Revlimid therapy and then weekly during the first month, then monthly thereafter in women with regular menstrual cycles or every 2 weeks in women with irregular menstrual cycles. Pregnancy testing and counseling must be performed if a patient misses her period or if there is any abnormality in menstrual bleeding. If pregnancy occurs, Revlimid must be immediately discontinued. Under these conditions, the patient should be referred to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling.
Revlimid is contraindicated in patients who have demonstrated hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide [see Warnings and precautions (5.5)}.
Revlimid is a thalidomide analogue. Thalidomide is a known human teratogen that causes life-threatening human birth defects. An embryofetal development study in non-human primates indicates that lenalidomide produced malformations in the offspring of female monkeys who received the drug during pregnancy, similar to birth defects observed in humans following exposure to thalidomide during pregnancy. If Revlimid is used during pregnancy, it may cause birth defects or death to a developing baby. Females of childbearing potential must be advised to avoid pregnancy while on Revlimid. Two effective contraceptive methods should be used during therapy, during dose interruptions and for at least 4 weeks after completing therapy.
There are no adequate and well-controlled studies in pregnant females.
Because of this potential toxicity and to avoid fetal exposure, Revlimid is only available under a special restricted distribution program called "RevAssist". Prescribers and pharmacists registered with the program can prescribe and dispense the product to patients who are registered and meet all the conditions of the RevAssist program.
Please see the following information for prescribers, female patients, and male patients about this restricted distribution program.
RevAssist Program Description
Prescribers
Revlimid can be prescribed only by licensed prescribers who are registered in the RevAssist program and understand the potential risk of teratogenicity if lenalidomide is used during pregnancy.
Effective contraception must be used by female patients of childbearing potential for at least 4 weeks before beginning Revlimid therapy, during therapy, during dose interruptions and for 4 weeks following discontinuation of Revlimid therapy. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or because the patient has been postmenopausal naturally for at least 24 consecutive months. Females of childbearing potential should be referred to a qualified provider of contraceptive methods, if needed. Sexually mature females who have not undergone a hysterectomy, have not had a bilateral oophorectomy or who have not been postmenopausal naturally for at least 24 consecutive months (i.e., who have had menses at some time in the preceding 24 consecutive months) are considered to be females of childbearing potential. Two reliable forms of contraception must be used simultaneously unless continuous abstinence from heterosexual sexual contact is the chosen method.
Females of childbearing potential must have 2 negative pregnancy tests (sensitivity of at least 50 mIU/mL). The first test should be performed within 10-14 days, and the second test within 24 hours prior to prescribing Revlimid. A prescription for Revlimid for a female of childbearing potential must not be issued by the prescriber until negative pregnancy tests have been verified by the prescriber.
Male Patients: Clinical data has demonstrated the presence of lenalidomide in human semen. Male patients taking Revlimid should not donate sperm.
Males receiving Revlimid must always use a latex condom during any sexual contact with females of childbearing potential even if they have undergone a successful vasectomy.
Once treatment has started and during dose interruptions, pregnancy testing for females of childbearing potential should occur weekly during the first 4 weeks of use, then pregnancy testing should be repeated every 4 weeks in females with regular menstrual cycles. If menstrual cycles are irregular, the pregnancy testing should occur every 2 weeks. Pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in her pregnancy test or in her menstrual bleeding. Revlimid treatment must be discontinued during this evaluation.
Pregnancy test results should be verified by the prescriber and the pharmacist prior to dispensing any prescription.
If pregnancy does occur during treatment, Revlimid must be discontinued immediately.
Any suspected fetal exposure to Revlimid must be reported to the FDA via the MedWatch number at 1-800-332-1088 and also to Celgene Corporation at 1-888-423-5436. The patient should be referred to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling.
Female Patients
Revlimid may be used in females of childbearing potential only when the PATIENT MEETS ALL OF THE FOLLOWING CONDITIONS (i.e., she is unable to become pregnant while on Revlimid therapy):
Male Patients
Revlimid may be used in sexually active males when the PATIENT MEETS ALL OF THE FOLLOWING CONDITIONS:
Revlimid can cause significant neutropenia and thrombocytopenia. Patients taking Revlimid for MDS should have their complete blood counts monitored weekly for the first 8 weeks and at least monthly thereafter. Patients taking Revlimid for MM should have their complete blood counts monitored every 2 weeks for the first 12 weeks and then monthly thereafter. Patients may require dose interruption and/or dose reduction [see Dosage and Administration (2.1)].
Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the MDS study. In the 48% of patients who developed Grade 3 or 4 neutropenia, the median time to onset was 42 days (range, 14-411 days), and the median time to documented recovery was 17 days (range, 2-170 days). In the 54% of patients who developed Grade 3 or 4 thrombocytopenia, the median time to onset was 28 days (range, 8-290 days), and the median time to documented recovery was 22 days (range, 5-224 days [see Boxed Warning and Dosage and Administration (2.2)].
In the pooled multiple myeloma studies Grade 3 and 4 hematologic toxicities were more frequent in patients treated with the combination of Revlimid and dexamethasone than in patients treated with dexamethasone alone [see Adverse Reactions (6.1)].
Venous thromboembolic events (predominantly deep venous thrombosis and pulmonary embolism) have occurred in patients with multiple myeloma treated with lenalidomide combination therapy [see Boxed Warning] and patients with MDS treated with lenalidomide monotherapy. A significantly increased risk of DVT and PE was observed in patients with multiple myeloma who were treated with Revlimid and dexamethasone therapy in a clinical trial [see Boxed Warning]. It is not known whether prophylactic anticoagulation or antiplatelet therapy prescribed in conjunction with Revlimid may lessen the potential for venous thromboembolic events. The decision to take prophylactic measures should be done carefully after an assessment of an individual patient’s underlying risk factors.
Angioedema and serious dermatologic reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive Revlimid. Revlimid interruption or discontinuation should be considered for Grade 2-3 skin rash. Revlimid must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS or TEN is suspected and should not be resumed following discontinuation for these reactions.
Revlimid capsules contain lactose. Risk-benefit of Revlimid treatment should be evaluated in patients with lactose intolerance.
Fatal instances of tumor lysis syndrome have been reported during treatment with lenalidomide. The patients at risk of tumor lysis syndrome are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken.
Tumor flare reaction has occurred during investigational use of lenalidomide for CLL and lymphoma, and is characterized by tender lymph node swelling, low grade fever, pain and rash. Treatment of CLL or lymphoma with lenalidomide outside of a well-monitored clinical trial is discouraged.
Cases of transient liver laboratory abnormalities (predominantly transaminases) were reported in patients treated with lenalidomide. Treatment with lenalidomide should be interrupted and restarted once the levels return to baseline. Successful re-challenge without recurrence of liver laboratory elevation was reported in some patients.
The following adverse reactions are described in detail in other labeling sections:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Data were evaluated from 703 patients in two studies who received at least one dose of Revlimid/dexamethasone (353 patients) or placebo/dexamethasone (350 patients).
In the Revlimid/dexamethasone treatment group, 269 patients (76%) underwent at least one dose interruption with or without a dose reduction of Revlimid compared to 199 patients (57%) in the placebo/dexamethasone treatment group. Of these patients who had one dose interruption with or without a dose reduction, 50% in the Revlimid/dexamethasone treatment group underwent at least one additional dose interruption with or without a dose reduction compared to 21% in the placebo/dexamethasone treatment group. Most adverse events and Grade 3/4 adverse events were more frequent in patients who received the combination of Revlimid/dexamethasone compared to placebo/dexamethasone.
Tables 3, 4, and 5 summarize the adverse reactions reported for Revlimid/dexamethasone and placebo/dexamethasone groups.
| System Organ Class/ Preferred Term | Revlimid/Dex* (n=353) n (%) | Placebo/Dex * (n=350) n (%) |
|---|---|---|
| Blood and lymphatic system disorders | ||
| Neutropenia % | 149 (42.2) | 22 (6.3) |
| Anemia @ | 111 (31.4) | 83 (23.7) |
| Thrombocytopenia @ | 76 (21.5) | 37 (10.6) |
| Leukopenia | 28 (7.9) | 4 (1.1) |
| Lymphopenia | 19 (5.4) | 5 (1.4) |
| General disorders and administration site conditions | ||
| Fatigue | 155 (43.9) | 146 (41.7) |
| Pyrexia | 97 (27.5) | 82 (23.4) |
| Peripheral edema | 93 (26.3) | 74 (21.1) |
| Chest Pain | 29 ( 8.2) | 20 (5.7) |
| Lethargy | 24 ( 6.8) | 8 (2.3) |
| Gastrointestinal disorders | ||
| Constipation | 143 (40.5) | 74 (21.1) |
| Diarrhea@ | 136 (38.5) | 96 (27.4) |
| Nausea @ | 92 (26.1) | 75 (21.4) |
| Vomiting @ | 43 (12.2) | 33 (9.4) |
| Abdominal Pain @ | 35 (9.9) | 22 (6.3) |
| Dry Mouth | 25 (7.1) | 13 (3.7) |
| Musculoskeletal and connective tissue disorders | ||
| Muscle cramp | 118 (33.4) | 74 (21.1) |
| Back pain | 91 (25.8) | 65 (18.6) |
| Bone Pain | 48 (13.6) | 39 (11.1) |
| Pain in Limb | 42 (11.9) | 32 (9.1) |
| Nervous system disorders | ||
| Dizziness | 82 (23.2) | 59 (16.9) |
| Tremor | 75 (21.2) | 26 (7.4) |
| Dysgeusia | 54 (15.3) | 34 (9.7) |
| Hypoaesthesia | 36 (10.2) | 25 (7.1) |
| Neuropathy a | 23 (6.5) | 13 (3.7) |
| Respiratory, Thoracic and Mediastinal Disorders | ||
| Dyspnea | 83 (23.5) | 60 (17.1) |
| Nasopharyngitis | 62 (17.6) | 31 (8.9) |
| Pharyngitis | 48 (13.6) | 33 (9.4) |
| Bronchitis | 40 (11.3) | 30 (8.6) |
| Infectionsb and infestations | ||
| Upper respiratory tract infection | 87 (24.6) | 55 (15.7) |
| Pneumonia @ | 48 (13.6) | 29 (8.3) |
| Urinary Tract Infection | 30 (8.5) | 19 (5.4) |
| Sinusitis | 26 (7.4) | 16 (4.6) |
| Skin and subcutaneous system disorders | ||
| Rash c | 75 (21.2) | 33 (9.4) |
| Sweating Increased | 35 (9.9) | 25 (7.1) |
| Dry Skin | 33 (9.3) | 14 (4.0) |
| Pruritus | 27 (7.6) | 18 (5.1) |
| Metabolism and nutrition disorders | ||
| Anorexia | 55 (15.6) | 34 (9.7) |
| Hypokalemia | 48 (13.6) | 21 (6.0) |
| Hypocalcemia | 31 (8.8) | 10 (2.9) |
| Appetite Decreased | 24 (6.8) | 14 (4.0) |
| Dehydration | 23 (6.5) | 15 (4.3) |
| Hypomagnesaemia | 24 (6.8) | 10 (2.9) |
| Investigations | ||
| Weight Decreased | 69 (19.5) | 52 (14.9) |
| Eye disorders | ||
| Blurred vision | 61 (17.3) | 40 (11.4) |
| Vascular disorders | ||
| Deep vein thrombosis % | 33 (9.3) | 15 (4.3) |
| Hypertension | 28 (7.9) | 20 (5.7) |
| Hypotension | 25 (7.1) | 15 (4.3) |
| System Organ Class/ Preferred Term | Revlimid/Dex# (n=353) n (%) | Placebo/Dex# (n=350) n (%) |
|---|---|---|
| Blood and lymphatic system disorders | ||
| Neutropenia % | 118 (33.4) | 12 (3.4) |
| Thrombocytopenia @ | 43 (12.2) | 22 (6.3) |
| Anemia @ | 35 (9.9) | 20 (5.7) |
| Leukopenia | 14 (4.0) | 1 (0.3) |
| Lymphopenia | 10 (2.8) | 4 (1.1) |
| Febrile Neutropenia % | 8 (2.3) | 0 (0.0) |
| General disorders and administration site conditions | ||
| Fatigue | 23 (6.5) | 17 (4.9) |
| Vascular disorders | ||
| Deep vein thrombosis % | 29 (8.2) | 12 (3.4) |
| Infectionsb and infestations | ||
| Pneumonia @ | 30 (8.5) | 19 (5.4) |
| Urinary Tract Infection | 5 (1.4) | 1 (0.3) |
| Metabolism and nutrition disorders | ||
| Hypokalemia | 17 (4.8) | 5 (1.4) |
| Hypocalcemia | 13 (3.7) | 6 (1.7) |
| Hypophosphatemia | 9 (2.5) | 0 (0.0) |
| Respiratory, thoracic and mediastinal disorders | ||
| Pulmonary embolism@ | 14 (4.0) | 3 (0.9) |
| Respiratory Distress @ | 4 (1.1) | 0 (0.0) |
| Musculoskeletal and connective tissue disorders | ||
| Muscle weakness | 20 (5.7) | 10 (2.9) |
| Gastrointestinal disorders | ||
| Diarrhea @ | 11 (3.1) | 4 (1.1) |
| Constipation | 7 (2.0) | 1 (0.3) |
| Nausea @ | 6 (1.7) | 2 (0.6) |
| Cardiac disorders | ||
| Atrial fibrillation @ | 13 (3.7) | 4 (1.1) |
| Tachycardia | 6 (1.7) | 1 (0.3) |
| Cardiac Failure Congestive @ | 5 (1.4) | 1 (0.3) |
| Nervous System disorders | ||
| Syncope | 10 (2.8) | 3 (0.9) |
| Dizziness | 7 (2.0) | 3 (0.9) |
| Eye Disorders | ||
| Cataract | 6 (1.7) | 1 (0.3) |
| Cataract Unilateral | 5 (1.4) | 0 (0.0) |
| Psychiatric Disorder | ||
| Depression | 10 (2.8) | 6 (1.7) |
| For all tables above: n – Number of Patients * - All Treatment Emergent AEs with ≥5% of Patients in Revlimid/ Dex and at Least 2% Difference in Proportion between the Two Arms - (Safety population) # - All Treatment Emergent Grades 3 and 4 AEs with ≥1% Patients in Revlimid/ Dex and at Least 1% Difference in Proportion between the Two Arms - (Safety population) & - All Treatment Emergent Serious AEs with ≥1% Patients in Revlimid/ Dex and at Least 1% Difference in Proportion between the Two Arms - (Safety population) @ - ADRs with Death as an outcome % - ADRs which were considered to be life threatening (if the outcome of the event was death, it is included with death cases) a - All PTs under the MedDRA SMQ of Neuropathy of a peripheral sensory nature will be considered listed b - All PTs under SOC of Infections except for rare infections of Public Health interest will be considered listed c- All PTs under HLT of Rash will be considered listed Dex=dexamethasone Median duration of exposure among patients treated with Revlimid/dexamethasone was 44 weeks while median duration of exposure among patients treated with placebo/dexamethasone was 23 weeks. This should be taken into consideration when comparing frequency of adverse events between two treatment groups Revlimid/dexamethasone vs. placebo/dexamethasone. | ||
| System Organ Class/ Preferred Term | Revlimid/Dex& (n=353) n (%) | Placebo/Dex& (n=350) n (%) |
|---|---|---|
| Blood and lymphatic system disorders | ||
| Febrile Neutropenia% | 6 (1.7) | 0 (0.0) |
| Vascular disorders | ||
| Deep vein thrombosis% | 26 (7.4) | 11 (3.1) |
| Infectionsb and infestations | ||
| Pneumonia @ | 33 (9.3) | 21 (6.0) |
| Respiratory, thoracic, and mediastinal disorders | ||
| Pulmonary embolism@ | 13 (3.7) | 3 (0.9) |
| Cardiac disorders | ||
| Atrial fibrillation @ | 11 (3.1) | 2 (0.6) |
| Cardiac Failure Congestive @ | 5 (1.4) | 0 (0.0) |
| Nervous system disorders | ||
| Cerebrovascular accident @ | 7 (2.0) | 3 (0.9) |
| Gastrointestinal disorders | ||
| Diarrhea @ | 6 (1.7) | 2 (0.6) |
| Musculoskeletal and connective tissue disorders | ||
| Bone Pain | 4 (1.1) | 0 (0.0) |
