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.
- 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). Tell your healthcare provider if you get any of these symptoms of tumor flare reaction while taking 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:
- tiredness or weakness
- swelling of your arms, hands, legs, feet and skin
- sleep problems (insomnia)
- 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. You are encouraged to report side effects of prescription drugs to the FDA.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products.