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Savings are available through the Lenalidomide instant savings program†
Making Lenalidomide Capsules more affordable for patients†

Apotex is pleased to offer financial assistance with cost-sharing for Lenalidomide Capsules manufactured and labeled by Apotex to eligible commercially insured patients through the Lenalidomide instant savings† program:

Do you have commercial health insurance?

You may be eligible for the Lenalidomide instant savings† program

  • If eligible, commercially insured patients may pay as little as $0† out-of-pocket cost with the Lenalidomide instant savings card toward each fill, and the program will pay up to $150 per 30-day supply not covered by primary insurance, up to $1800 per calendar year.
  • Patients must deduct the savings received under this program from any reimbursement request submitted to their insurance plan, either directly by them or on their behalf.

Follow these simple steps for your Lenalidomide instant savings† program card:

Review the Lenalidomide instant savings† program Terms and Conditions here:

  • I understand this offer is not valid for patients who are uninsured or have no prescription drug coverage for Lenalidomide, or for patients whose prescriptions are paid for in whole or in part by either Medicaid, Medicare, TRICARE, the Federal Employee Health Benefits program, or any other Federal or State funded program.
  • I verify I have commercial health insurance and agree to the Terms and Conditions.
Enroll
†Click Enroll to agree to the Terms and Conditions and verify that you meet the eligibility requirements and get your printable Lenalidomide instant savings† program card.

If you have any questions regarding your eligibility or benefits, or if you wish to discontinue your participation, please call 1-833-944-5688.

Patient

  • Show the Lenalidomide instant savings† card with your Lenalidomide prescription at any participating pharmacy.
  • If eligible, commercially insured patients may pay as little as $0† out-of-pocket cost with the Lenalidomide instant savings card toward each fill, and the program will pay up to $150 per 30-day supply not covered by primary insurance, up to $1800 per calendar year.
  • By using this card, the patient acknowledges meeting the eligibility requirements and complying with our Terms and Conditions.
  • For questions about eligibility or about using the card, please call toll free at 1-833-495-8558.

Pharmacist

  • For commercially insured patients presenting the Lenalidomide instant savings program card for whom you have dispensed Lenalidomide Capsules. (Refer to this document for applicable NDCs). Process a coordination of benefits claim (COB/split bill) by using the patient's prescription insurance for the PRIMARY claim.
  • Submit a SECONDARY claim to CapitalRx under BIN: 610852 and PCN: 2001.
  • For questions about processing the card, please call toll free at 1-833-495-8558.

Limitations apply

  • Offer not valid for patients who are uninsured or have no prescription drug coverage for Lenalidomide or those with prescription drug coverage under Medicaid, Medicare, TRICARE, the Federal Employee Health Benefit Program or any other federal or state health care program or if the patients receive full reimbursement for prescriptions from private insurance plans or other health or pharmacy benefit programs (i.e. there is no cost-sharing obligation).

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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:

  • 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 has 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.
 
 

What are lenalidomide capsules?

Lenalidomide capsules are a prescription medicine, used to treat adults with:

  • multiple myeloma (MM) in combination with the medicine dexamethasone, or as maintenance treatment after autologous hematopoietic stem cell transplantation (a type of stem cell transplant that uses your own stem cells)
  • a condition called deletion 5q myelodysplastic syndrome (MDS), a chromosome problem where part of chromosome 5 is missing
  • mantle cell lymphoma (MCL) when the disease comes back or becomes worse after treatment with 2 prior medicines, one of which included bortezomib, and
  • follicular lymphoma (FL) or marginal zone lymphoma (MZL) in combination with a rituximab product, for patients who have previously been treated for their FL or MZL.

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 Capsules are safe and effective in children.

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:

  • 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 has 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
  • Lenalidomide REMS 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 Lenalidomide REMS 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 causes 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 often especially during the first several months of treatment with lenalidomide capsules, and then at least monthly. Tell your healthcare provider if you develop any bleeding or bruising, during treatment with lenalidomide capsules.
  • Blood clots. Blood clots in the arteries, veins, and lungs happen more often in people who take lenalidomide capsules. This risk is even higher for people with multiple myeloma who take the medicine dexamethasone with lenalidomide capsules. Heart attacks and strokes also happen more often in people who take lenalidomide capsules with dexamethasone. To reduce this increased risk, most people who take lenalidomide capsules will also take a blood thinner medicine. Before taking lenalidomide capsules, tell your healthcare provider:
    • If you have had a blood clot in the past
    • If you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia)
    • 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:
      • Signs or symptoms of a blood clot in the lung, arm, or leg may include: shortness of breath, chest pain, or arm or leg swelling
      • Signs or symptoms of a heart attack may include: chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen), feeling sweaty, shortness of breath, feeling sick or vomiting
      • Signs or symptoms of stroke may include: sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech, or balance

Who should not take lenalidomide capsules?

Do not take lenalidomide capsules if you:

  • are pregnant, plan to become pregnant, or become pregnant during treatment with lenalidomide capsules. See"What is the most important information I should know about lenalidomide capsules?"
  • are allergic to lenalidomide or any of the ingredients in lenalidomide capsules.

What should I tell my healthcare provider before taking lenalidomide capsules?

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.

How should I take lenalidomide capsules?

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 capsules, call your healthcare provider right away.

What should I avoid while taking 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.
  • 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.

What are the possible side effects of lenalidomide capsules?

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 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 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)
    • pain on the upper right side of your stomach area (abdomen)
    • dark or brown (tea-colored) urine
    • 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
  • 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 (tremor)
  • joint aches
  • pain in your back or stomach area (abdomen)

These are not all the possible side effects of lenalidomide capsules. Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact APOTEX at 1-800-706-5575 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please see full Prescribing Information and Medication Guide, including serious side effects.