Dr. Reddy’s Laboratories Canada announces the launch of Reddy-Lenalidomide, one of the first generic drugs of its kind for the Canadian market
HYDERABAD, India & MISSISSAUGA, Ontario – (COMMERCIAL THREAD) – Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, and its affiliates collectively referred to as “Dr. Reddy’s”) today announced that Reddy-Lenalidomide, a generic equivalent of Revlimid® (lenalidomide) capsules, is approved by Health Canada and has been launched on the Canadian market. Reddy-Lenalidomide is one of the first generic drugs of its kind to be launched in Canada.
“Our launch of Reddy-Lenalidomide represents our strong commitment to providing access to affordable medicines for the Canadian population of patients with multiple myeloma and myelodysplastic syndrome (MDS),” said Vinod Ramachandran, Ph.D., vice- President and CEO, Dr. Reddy’s Laboratories. Canada. “Along with this important launch, we are excited to introduce our Reddy2Assist platform, which provides one-stop and convenient access to help prescribers and pharmacists meet patient qualification requirements, as well as onboarding and patient registration via web portal, phone or fax.
Reddy-Lenalidomide hard capsules are available in strengths of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg, each in blister packs.
Indications and clinical use:
Reddy-Lenalidomide is indicated for the treatment of patients with transfusion-dependent anemia due to low or intermediate risk myelodysplastic syndromes 1 associated with 5q deletion cytogenetic abnormality with or without additional cytogenetic abnormalities. Approval for this indication is based on independence response rates to red blood cell transfusion. No overall survival benefit has been demonstrated (see CLINICAL TRIALS, Myelodysplastic Syndromes).
Reddy-Lenalidomide in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma who are not eligible for a stem cell transplant.
Limit of use:
Reddy-Lenalidomide is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials (see WARNINGS AND PRECAUTIONS, Increased Mortality in Patients with LLC).
Reddy-Lenalidomide is contraindicated in patients who are hypersensitive to this drug or to thalidomide, pomalidomide or any ingredient in the formulation or component of the container.
Reddy-Lenalidomide is contraindicated in pregnant women and women at risk of becoming pregnant. If lenalidomide is taken during pregnancy, it can cause serious birth defects or death to the fetus.
Male patients unable to follow or comply with required contraceptive measures.
Treatment with Reddy-Lenalidomide should not be initiated in patients with MDS whose platelet counts are less than 50 x 109/THE.
Most Serious Warnings and Precautions:
Reddy-Lenalidomide should be administered under the supervision of a qualified physician experienced in the use of anticancer chemotherapeutic agents and enrolled in the Reddy-Lenalidomide RMP controlled distribution program.
- Pregnancy: Potential for human birth defects, stillbirths and spontaneous abortions. Reddy-Lenalidomide is contraindicated in pregnant women and women at risk of becoming pregnant. Women of childbearing potential can be treated with Reddy-Lenalidomide provided that adequate contraception, with two effective methods of contraception at the same time, is used to prevent fetal exposure to the drug. The choice of two contraceptive methods that are effective simultaneously will require a risk / benefit discussion between the patient and a qualified physician experienced in the use of contraceptive methods.
- Hematologic: Reddy-Lenalidomide is associated with significant neutropenia and thrombocytopenia. Complete blood counts should be monitored. Patients should be advised to report febrile episodes promptly, as dose reduction may be necessary. In the event of thrombocytopenia, patients and physicians should be alert for signs and symptoms of bleeding, including petechiae and epistaxis.
- Venous and arterial thromboembolism: The combination of lenalidomide and dexamethasone is associated with an increased risk of venous thromboembolism (mainly deep vein thrombosis (DVT) and pulmonary embolism (PE) and arterial thromboembolism (mainly myocardial infarction (MI) and cerebrovascular events) in patients. patients with multiple myeloma Antithrombotic prophylaxis is recommended.
- Hepatic: Hepatotoxicity, including fatal cases, has occurred in patients treated with lenalidomide in combination with dexamethasone: acute hepatic failure, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis and mixed cytolytic / cholestatic hepatitis have been reported. . Periodically monitor liver enzymes. Stop Reddy-Lenalidomide if you have elevated liver enzymes.
- Anaphylaxis: Reddy-Lenalidomide should be stopped and should not be restarted.
Reddy-Lenalidomide is only available as part of a controlled distribution program called Reddy-Lenalidomide RMP.
Other relevant warnings and precautions:
Patients should not donate blood or semen while taking Reddy-Lenalidomide and for 4 weeks after stopping Reddy-Lenalidomide.
In the treatment of previously treated multiple myeloma, the dose of dexamethasone used in combination with Reddy-Lenalidomide should be taken into account.
Cardiovascular: Increased risk of heart problems. Patients with risk factors for developing atrial fibrillation (eg, existing heart disease, electrolyte abnormalities, hypertension, and infections) should be closely monitored.
Second primary malignant tumors (PMS) have been observed. Doctors should carefully assess patients before and during treatment using standard cancer screening to detect the occurrence of PMS.
Immune reactions: Angioedema, anaphylaxis and severe dermatological reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (NET) have been reported. Drug reactions with eosinophilia and systemic symptoms (DRESS) have also been reported. Patients with a history of severe rash associated with thalidomide treatment should not receive lenalidomide. Graft versus host disease and solid organ transplant rejection have also been reported, some fatal.
Infections: There have been reports of viral reactivation, including severe cases of shingles or hepatitis B virus (HBV) reactivation. Progressive multifocal leukoencephalopathies have been reported, including fatal cases.
Increased mortality in patients with chronic lymphocytic leukemia (CLL). Reddy-Lenalidomide is not indicated and is not recommended for use in LLC.
Renal function: Dose adjustment should be considered in patients with moderate or severe renal impairment and in patients on dialysis (patients with CrCl
Lenalidomide capsules contain lactose. Patients with rare hereditary problems of glucose intolerance, Lapp lactase deficiency or glucose and galactose malabsorption should not take this product.
Thyroid Disorders: Initial and ongoing monitoring of thyroid function is recommended.
Tumor lysis syndrome (TLS) has been observed in patients with CLL, multiple myeloma (MM), and non-Hodgkin lymphoma [unauthorized indication] treated with lenalidomide. Some cases of SLT have been fatal.
A tumor flare reaction has occurred with the experimental use of lenalidomide for CLL and mantle cell lymphoma (MCL) [unauthorized indication].
Laboratory tests are necessary and should be monitored at the start and throughout treatment.
For more information:
See the Product Monograph at: http://www.drreddys.com/canada/our-products/ for important information on contraindications, warnings, precautions, adverse reactions, interactions, dosage and conditions of clinical use. The Product Monograph is also available from our Medical Information Department.
Revlimid is a registered trademark owned or licensed by Celgene Corporation.
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (ESB: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, Custom Pharmacy Services, Generics, Biosimilars and Differentiated Formulations. Our main therapeutic areas are: gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets around the world. Our main markets are USA, India, Russia and CIS countries and Europe. For more information, log on to: www.drreddys.com
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