Lenalidomide

What it is used for

Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with: Multiple myeloma (MM), in combination with dexamethasone. MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT). Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.

Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product. Previously treated follicular lymphoma (FL), in combination with a rituximab product. Limitations of Use: Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

1.1 Multiple Myeloma Lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (MM). Lenalidomide capsules are indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT). 1.2 Myelodysplastic Syndromes Lenalidomide capsules are indicated for the treatment of adult 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.

1.3 Mantle Cell Lymphoma Lenalidomide capsules are indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. 1.4 Follicular Lymphoma Lenalidomide capsules in combination with a rituximab product, are indicated for the treatment of adult patients with previously treated follicular lymphoma (FL).

1.5 Marginal Zone Lymphoma Lenalidomide capsules in combination with a rituximab product, are indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL). 1.6 Limitations of Use Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with CLL outside of controlled clinical trials.

The most important thing to know

Before you begin taking lenalidomide capsules, you must read and agree to all of the instructions in the Lenalidomide REMS program. For more information, call 1‐888‐423‐5436 or go to www.lenalidomiderems.com. 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: Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take lenalidomide capsules. Lenalidomide is similar to the medicine thalidomide. We know thalidomide can cause severe life-threatening birth defects.

Lenalidomide capsules have not been tested in pregnant females. Lenalidomide capsules have harmed unborn animals in animal testing. Females must not get pregnant: For at least 4 weeks before starting lenalidomide capsules While taking lenalidomide capsules During any breaks (interruptions) in your treatment with lenalidomide capsules For at least 4 weeks after stopping lenalidomide capsules Females who can become pregnant: 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.

If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling. 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.

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. 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 the REMS Call Center at 1‐888‐423‐5436. Healthcare providers and patients should report all cases of pregnancy to: FDA MedWatch at 1-800-FDA-1088, and REMS Call Center at 1‐888‐423‐5436 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 the REMS Call Center at the phone number listed above. Lenalidomide can pass into human semen: 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.

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. 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. Low white blood cells (neutropenia) and low platelets (thrombocytopenia). Lenalidomide capsules cause low white blood cells and low platelets in most people.

You may need a blood transfusion or certain medicines if your blood counts drop too low. Your healthcare provider should check your blood counts

How to take it

Take lenalidomide capsules exactly as prescribed and follow all the instructions of the Lenalidomide REMS program Swallow lenalidomide capsules whole with water 1 time a day. Do not open, break, or chew your capsules. Lenalidomide capsules may be taken with or without food. Take lenalidomide capsules at about the same time each day.

Do not open or break lenalidomide capsules or handle them any more than needed. If powder from the lenalidomide capsule comes in contact with your skin, wash the skin right away with soap and water. If powder from the lenalidomide capsule comes in contact with the inside of your eyes, nose, or mouth, flush well with water.

If you miss a dose of lenalidomide capsules and it has been less than 12 hours since your regular time, take it as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time. If you take too much lenalidomide, call your healthcare provider right away.

Side effects, and when to stop

Lenalidomide capsules can cause serious side effects, including: Increased risk of death in people who have chronic lymphocytic leukemia (CLL). People with CLL who take lenalidomide capsules have an increased risk of death compared with people who take the medicine chlorambucil. Lenalidomide capsules may cause you to have serious heart problems that can lead to death, including atrial fibrillation, heart attack, or heart failure.

You should not take lenalidomide capsules if you have CLL unless you are participating in a controlled clinical trial. Risk of new cancers (malignancies). An increase in new (second) cancers has happened in patients who received lenalidomide capsules and melphalan, or a blood stem cell transplant, including certain blood cancers, such as acute myelogenous leukemia (AML), and myelodysplastic syndrome (MDS) and certain other types of cancers of the skin and other organs.

Talk with your healthcare provider about your risk of developing new cancers if you take lenalidomide capsules. Your healthcare provider will check you for new cancers during your treatment with lenalidomide capsules. Severe liver problems, including liver failure and death. Your healthcare provider should do blood tests to check your liver function during your treatment with lenalidomide capsules.

Tell your healthcare provider right away if you develop any of the following symptoms of liver problems: yellowing of your skin or the white part of your eyes (jaundice) dark or brown (tea-colored) urine pain on the upper right side of your stomach area (abdomen) bleeding or bruising more easily than normal feeling very tired Severe skin reactions and severe allergic reactions can happen with lenalidomide capsules and may cause death.

Call your healthcare provider right away if you develop any of the following signs or symptoms during treatment with lenalidomide capsules: a red, itchy, skin rash peeling of your skin or blisters severe itching fever Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with lenalidomide capsules: swelling of your lips, mouth, tongue, or throat trouble breathing or swallowing raised red areas on your skin (hives) a very fast heartbeat you feel dizzy or faint Tumor lysis syndrome (TLS).

TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure and sometimes death. Your healthcare provider may do blood tests to check you for TLS. Worsening of your tumor (tumor flare reaction) can happen with lenalidomide capsules and may cause death.

Tell your healthcare provider if you get any of these symptoms of tumor flare reaction during treatment with lenalidomide capsules: tender swollen lymph nodes, low grade fever, pain, or rash. 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.

Thyroid problems. Your healthcare provider may check your thyroid function before you start taking lenalidomide capsules and during treatment with lenalidomide capsules. Risk of Early Death in MCL. In people who have Mantle Cell Lymphoma (MCL), there may be a risk of dying sooner (early death) when taking lenalidomide capsules.

Talk with your healthcare provider about any concerns and possible risk factors. The most common side effects of lenalidomide capsules include: diarrhea rash nausea constipation tiredness or weakness fever itching swelling of your arms, hands, legs, feet and skin sleep problems (insomnia) headache muscle cramps or spasms shortness of breath cough, sore throat, and other symptoms of a cold upper respiratory tract infection or bronchitis inflammation of the stomach and intestine (“stomach flu”) nose bleed shaking or trembling (trem

Who should not take it

Do not take lenalidomide capsules if you: are pregnant, plan to become pregnant, or become pregnant during treatment with lenalidomide capsules. are allergic to lenalidomide or any of the ingredients in lenalidomide capsules. See the end of this Medication Guide for a complete list of ingredients in lenalidomide capsules.

What to say before you start

Before you take lenalidomide capsules, tell your healthcare provider about all of your medical conditions, including if you: have liver problems have kidney problems or receive kidney dialysis treatment have thyroid problems have had a serious skin rash with thalidomide treatment. You should not take lenalidomide capsules.

are lactose intolerant. Lenalidomide capsules contain lactose. are breastfeeding. Do not breastfeed during treatment with lenalidomide capsules. It is not known if lenalidomide passes into your breast milk and can harm your baby. 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.

What to avoid

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.

Do not donate blood while you take lenalidomide capsules, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping lenalidomide capsules. If someone who is pregnant gets your donated blood, her baby may be exposed to lenalidomide and may be born with birth defects.

Storing it

Store lenalidomide capsules at room temperature between 68°F to 77°F (20°C to 25°C). Return any unused lenalidomide capsules to Teva or your healthcare provider. Keep lenalidomide capsules and all medicines out of the reach of children.