Approval

Teva Announces Launch Of A First Generic Version Of Revlimid® Lenalidomide Capsules In The US

March 08,2022 10:45 AM
- By Admin

 Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the launch of a first generic version of Revlimid®1 (lenalidomide capsules), in 5mg, 10mg, 15mg, and 25mg strengths, in the United States.

Teva’s Lenalidomide capsules are a prescription medicine used in adults for the treatment of (1) multiple myeloma in combination with the medicine dexamethasone, (2) certain myelodysplastic syndromes, and (3) mantle cell lymphoma following specific prior treatment. Please see the below “What are lenalidomide capsules?” section for more information.

“The launch of our first generic version of Revlimid® in the U.S. provides patients with another important treatment option for these extremely challenging conditions, demonstrating Teva’s commitment to making complex generic drugs available to the patients who need them,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA. “This product adds to our broad generic portfolio of oncology treatments, which accounts for 73% of the essential medicines in this category, as defined by the World Health Organization.”

With nearly 550 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market, and holds the leading position in first-to-file opportunities, with approximately 100 pending first-to-files in the U.S. Currently, 1 in 12 generic prescriptions dispensed in the U.S. is filled with a Teva generic product.

Revlimid® had annual sales of $2.3 billion as of December 2021, according to IQVIA data.

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

  • multiple myeloma (MM)
    • in combination with the medicine dexamethasone
  • a condition called myelodysplastic syndromes (MDS). Lenalidomide capsules are for the type of MDS with a chromosome problem where part of chromosome 5 is missing. This type of MDS is known as deletion 5q MDS. People with this type of MDS may have low red blood cell counts that require treatment with blood transfusions.
  • mantle cell lymphoma (MCL) when the disease comes back or becomes worse after treatment with 2 prior medicines, one of which included bortezomib. MCL is a cancer of a type of white blood cell called lymphocytes that are in the lymph nodes.

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.

IMPORTANT SAFETY INFORMATION

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 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.