Revlimid contains the active ingredient lenalidomide, which is a thalidomide analogue with immunomodulatory, antiangiogenic, and antineoplastic properties. It is available in capsule form for oral administration, with dosage strengths of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. Key inactive ingredients include lactose anhydrous, microcrystalline cellulose, and magnesium stearate. The drug is designed to modify immune function and inhibit the growth of new blood vessels and tumor cells.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the capsules whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is more than 12 hours late. If it is more than 12 hours late, skip the missed dose. Take the next dose at the normal time. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

It is important to get rid of the medication as soon as you no longer need it or it is expired. You can do this in two ways:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, follow the directions in the MedGuide.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Change in your skin, such as a new growth, a sore that doesn't heal, or a change in a mole
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• High thyroid levels (hyperthyroidism)—fast or irregular heartbeat, weight loss, excessive sweating or sensitivity to heat, tremors or shaking, anxiety, nervousness, irregular menstrual cycle or spotting
• Infection—fever, chills, cough, or sore throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low thyroid levels (hypothyroidism)—unusual weakness or fatigue, increased sensitivity to cold, constipation, hair loss, dry skin, weight gain, feelings of depression
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Back pain
• Cough
• Diarrhea
• Fatigue
• Headache
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Blood clots
• High blood pressure
• High cholesterol
• Kidney disease
• Lactose intolerant
• Liver disease
• Thyroid disease
• Tobacco use
• An unusual or allergic reaction to lenalidomide, thalidomide, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

This medication may interact with the following:

• Digoxin
• Estrogen hormones
• Medications that help the body make more red blood cells, such as epoetin alfa or darbepoetin alfa
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You may need blood work done while taking this medication.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancers if you take this medication.

Talk to your care team if you or your partner wish to become pregnant or think either of you might be pregnant. This medication can cause serious birth defects if taken during pregnancy or for 4 weeks after stopping treatment. Two negative pregnancy tests are required before starting this medication. A negative pregnancy test is also required every 2 to 4 weeks during treatment, even if you are not sexually active. Two reliable forms of contraception are recommended while you are taking this medication and for 4 weeks after stopping treatment. Talk to your care team about effective forms of contraception. If you become pregnant, miss a menstrual cycle, or stop using contraception, stop taking this medication. Call your care team. Severe birth defects may occur even if just 1 dose is taken.

Do not breastfeed while taking this medication. Talk to your care team about breastfeeding. Changes to your treatment plan may be needed.

If your partner can get pregnant, use a condom during sex while taking this medication and for 4 weeks after the last dose. Tell your care team right away if you think your partner might be pregnant. This medication can cause serious birth defects.

Do not donate sperm while taking this medication and for 4 weeks after the last dose.

Do not donate blood while you are talking this medication or for 4 weeks after stopping it. Donated blood may contain enough of this medication to cause birth defects in a fetus if transfused to someone who is pregnant.

What are the most serious risks of this medication?

This medication can decrease white blood cell levels in your body. White blood cells help protect your body from infection. Your care team will check your blood cell levels while you are taking this medication. Talk to your care team right away if you have symptoms of an infection, such as fever, chills, cough, sore throat, or general feeling of discomfort or being unwell.

This medicine increases the risk of blood clots.

Males who get this medicine must use a condom during sex with female partners who can get pregnant. If you get a woman pregnant during treatment, the baby could have severe birth defects or die before they are born. You may need to continue to avoid getting a female pregnant after stopping the medicine. The length of time depends on the medication. Talk to your healthcare provider about how long you should continue to wear condoms after stopping the medicine. Tell your healthcare provider right away if your partner becomes pregnant while you are taking this medicine.

This medicine can lower your blood platelet counts. Your healthcare provider will check your blood counts during your treatment.

This medication may cause serious birth defects if taken during pregnancy. Do not take this medication if you are pregnant.