Revlimid

Before taking lenalidomide, tell your doctor if you have:

• kidney disease; or

• a history of blood clots or stroke.

You may not be able to take lenalidomide, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Lenalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medication at the time of conception or during pregnancy. Even one dose of lenalidomide can cause major birth defects of the baby’s arms and legs, bones, ears, eyes, face, and heart. Never use lenalidomide if you are pregnant. Tell your doctor right away if your period is late while using the medication.

It is not known if lenalidomide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

For Women: If you have not had a hysterectomy or have not been in menopause for at least 24 months in a row, you will be required to use two forms of birth control beginning 4 weeks before you start taking lenalidomide and ending 4 weeks after you stop taking it. Even women with fertility problems are required to use birth control while taking this medication. You must also have a negative pregnancy test at 10 to 14 days before treatment and again at 24 hours before. While you are taking lenalidomide, you will have a pregnancy test every 4 weeks.

The birth control method you use must be proven highly effective, such as birth control pills, an intrauterine device (IUD), a tubal ligation, or a sexual partner’s vasectomy. The extra form of birth control you use must be a barrier method such as a latex condom, a diaphragm, or a cervical cap.

Stop using lenalidomide and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.

For Men: You must not cause a woman to become pregnant while you are taking lenalidomide because the medicine may affect your sperm and cause birth defects in the baby. You must agree in writing to always use latex condoms when having sex with a woman who is able to get pregnant, even if you have had a vasectomy. Contact your doctor if you have had unprotected sex, even once, or if you think your female sexual partner may be pregnant.

Lenalidomide is available only under a special program called RevAssist. Under this program, only registered doctors and pharmacists can prescribe and dispense lenalidomide. You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control measures as required by the program.

For patients between 12 and 18 years, a parent or legal guardian must read all written requirements for the RevAssist program and sign the agreements on behalf of the patient.

While you are using lenalidomide, you will be required to be listed on a patient registry and participate in occasional telephone surveys. You will be limited to a 28-day supply of lenalidomide each time your prescription is refilled. You may continue getting refills only if you participate fully in the RevAssist program and commit to all agreements.

Lenalidomide should be used exactly as your doctor has prescribed it for you. Do not use more of the medication than recommended. Do not take lenalidomide for longer than your doctor has prescribed.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Take each dose with a full glass of water.

Swallow the capsule whole, without breaking it open.

To be sure this medication is helping your condition, your blood will need to be tested every week for the first two months of treatment, and then every month after that. It is important that you not miss any scheduled visits to your doctor.

You must not donate blood or sperm while you are using lenalidomide.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Never give lenalidomide to another person, even if he or she has the same disorder for which you are being treated.

Store lenalidomide at room temperature away from moisture and heat.

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

Stop using lenalidomide and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• chest pain, sudden shortness of breath, coughing up blood;

• pain or swelling in your arm, thigh, or calf;

• easy bruising, unusual bleeding or weakness; or

• fever, chills, body aches, flu symptoms.

Other, less serious side effects may be more likely to occur. Talk with your doctor if you have any of these side effects:

• nausea, diarrhea, constipation;

• dry or itchy skin;

• runny or stuffy nose;

• muscle or joint pain;

• headache; or

• tiredness.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Lenalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medication at the time of conception or during pregnancy. Even one dose of lenalidomide can cause major birth defects of the baby’s arms and legs, bones, ears, eyes, face, and heart. Never use lenalidomide if you are pregnant.

For Women: You will be required to use two reliable forms of birth control beginning 4 weeks before you start taking lenalidomide and ending 4 weeks after you stop taking it. Any woman who has not had a hysterectomy or has not been in menopause for at least 24 months in a row must agree in writing to use birth control before, during, and after taking lenalidomide. Even women with fertility problems are required to use birth control while taking this medication. You must also have a negative pregnancy test at 10 to 14 days before treatment and again at 24 hours before. While you are taking lenalidomide, you will have a pregnancy test every 4 weeks.

Stop using lenalidomide and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.

For Men: You must not cause a woman to become pregnant while you are taking lenalidomide because the medicine may affect your sperm and cause birth defects in the baby. You must agree in writing to always use latex condoms when having sex with a woman who is able to get pregnant, even ifyou have had a vasectomy.

Lenalidomide is available only under a special program called RevAssist. You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control measures as required by the program.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Never give lenalidomide to another person, even if he or she has the same disorder for which you are being treated.

Do not donate blood or sperm while you are using lenalidomide.

Do not donate blood or sperm while you are using lenalidomide.

There may be other drugs that can affect lenalidomide. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of lenalidomide is not expected to produce life-threatening symptoms.