LENALIDOMIDE - lenalidomide capsule
Exelan Pharmaceuticals, Inc.
What is the most important information I should know about Lenalidomide Capsules?
Before you begin taking Lenalidomide Capsules, you must read and agree to all of the instructions in the Lenalidomide REMS program. Before prescribing Lenalidomide Capsules, your healthcare provider will explain the Lenalidomide REMS program to you and have you sign the Patient-Physician Agreement Form.
Lenalidomide Capsules may cause serious side effects including:
Lenalidomide Capsule is similar to the medicine thalidomide. We know thalidomide can cause severe life-threatening birth defects. Lenalidomide has not been tested in pregnant females. Lenalidomide has harmed unborn animals in animal testing.
Females must not get pregnant:
o For at least 4 weeks before starting Lenalidomide Capsules
o While taking Lenalidomide Capsules
o During any breaks (interruptions) in your treatment with Lenalidomide Capsules
o For at least 4 weeks after stopping Lenalidomide Capsules
Females who can become pregnant:
o Will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular.
o If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling.
o Must agree to use two acceptable forms of birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping Lenalidomide Capsules.
o Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy before, during, and after treatment with Lenalidomide Capsules.
o If you had unprotected sex or if you think your birth control has failed, stop taking Lenalidomide Capsules immediately and call your healthcare provider right away.
If you become pregnant while taking Lenalidomide Capsules, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call Cipla Ltd. at 1-866-604-3268. Healthcare providers and patients should report all cases of pregnancy to:
o FDA MedWatch at 1-800-FDA-1088, and
o Cipla Ltd. at 1-866-604-3268
There is a pregnancy exposure registry that monitors the outcomes of females who take Lenalidomide Capsules during pregnancy, or if their male partner takes Lenalidomide Capsules and they are exposed during pregnancy. You can enroll in this registry by calling Cipla Ltd. at the phone number listed above. Lenalidomide can pass into human semen:
o Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking Lenalidomide Capsules, during any breaks (interruptions) in your treatment with Lenalidomide Capsules, and for up to 4 weeks after stopping Lenalidomide Capsules.
o Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant.
o Do not donate sperm while taking Lenalidomide Capsules, during any breaks (interruptions) in your treatment, and for up to 4 weeks after stopping Lenalidomide Capsules. If a female becomes pregnant with your sperm, the baby may be exposed to lenalidomide and may be born with birth defects.
Men, if your female partner becomes pregnant, you should call your healthcare provider right away.
o If you have had a blood clot in the past
o If you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia)
o About all the medicines you take. Certain other medicines can also increase your risk for blood clots
Call your healthcare provider or get medical help right away if you get any of the following during treatment with Lenalidomide Capsules:
Lenalidomide Capsule is a prescription medicine, used to treat adults with:
Lenalidomide Capsules should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial.
It is not known if lenalidomide is safe and effective in children.
Do not take Lenalidomide Capsules if you:
Before you take Lenalidomide Capsules, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Lenalidomide Capsules and other medicines may affect each other, causing serious side effects. Talk with your healthcare provider before taking any new medicines.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.
How should I take Lenalidomide Capsules?
See "What is the most important information I should know about Lenalidomide Capsules?"
Females: Do not get pregnant and do not breastfeed while taking Lenalidomide Capsules.
Males: Do not donate sperm while taking Lenalidomide Capsules, during any breaks (interruptions) in your treatment, and for up to 4 weeks after stopping Lenalidomide Capsules.
Do not share Lenalidomide Capsules with other people. It may cause birth defects and other serious problems.
Lenalidomide can cause serious side effects, including:
| o yellowing of your skin or the white part of your eyes (jaundice)|| o pain on the upper right side of your stomach
| o dark or brown (tea-colored) urine|| o bleeding or bruising more easily than normal
| o feeling very tired
| o swelling of your lips, mouth, tongue, or throat|| o raised red areas on your skin (hives)
| o trouble breathing or swallowing|| o a very fast heartbeat
| o you feel dizzy or faint
Your healthcare provider may tell you to decrease your dose, temporarily stop or permanently stop taking Lenalidomide Capsules if you develop certain serious side effects during treatment with Lenalidomide Capsules.
| diarrhea|| swelling of your arms, hands, legs, feet and skin || upper respiratory tract infection or bronchitis
| rash|| sleep problems (insomnia) || inflammation of the stomach and intestine ("stomach flu")
| nausea|| headache || nose bleed
| constipation|| muscle cramps or spasms|| shaking or trembling (tremor)
| tiredness or weakness|| shortness of breath|| joint aches
| fever|| cough, sore throat, and other symptoms of a cold|| pain in your back or stomach-area (abdomen)
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
How should I store Lenalidomide Capsules?
General information about the safe and effective use of Lenalidomide Capsules
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take Lenalidomide Capsules for conditions for which it was not prescribed. Do not give Lenalidomide Capsules to other people, even if they have the same symptoms you have. It may harm them and may cause birth defects.
If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Lenalidomide Capsules that is written for health professionals.
What are the ingredients in Lenalidomide Capsules?
Active ingredient: lenalidomide
Inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and
The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink.
The 10 mg capsule shell contains gelatin, yellow iron oxide, indigotine FD&C Blue # 2, titanium dioxide, and black ink.
The 15 mg capsule shell contains gelatin, indigotine FD&C Blue # 2, titanium dioxide, and black ink.
The imprinting ink for 5 mg, 10 mg, 15 mg and 25 mg contains black iron oxide, potassium hydroxide, propylene glycol, purified water, and shellac.
For more information, call Cipla Ltd. at 1-866-604-3268 or go to www.lenalidomiderems.com.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Disclaimer: Other brands listed are the registered trademarks of their respective owners and are not trademarks of Exelan Pharmaceuticals, Inc.
At M/s Genvion Corporation
Winnipeg, Manitoba R2J 4K2 Canada
Manufactured for: Exelan Pharmaceuticals, Inc.
Boca Raton, FL 33432