HYDERABAD, India & MISSISSAUGA, Ontario--(BUSINESS WIRE)-- Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced that Reddy-Lenalidomide, a generic equivalent to Revlimid® (lenalidomide) capsules, is approved by Health Canada and has been launched in the Canadian market. Reddy-Lenalidomide is one of the first generic medications of its kind to launch in Canada.

“Our launch of Reddy-Lenalidomide represents our firm commitment to providing access to affordable medicines for Canada’s Multiple Myeloma and Myelodysplastic Syndrome (MDS) patient population,” says Vinod Ramachandran, Ph.D., Vice President and General Manager, Dr. Reddy’s Laboratories Canada. “Along with this important launch, we are pleased to introduce our Reddy2Assist Platform, which provides convenient one-stop access to assist prescribers and pharmacists with qualification requirements for patients, as well as patient onboarding and registration via web portal, telephone or fax.”

Reddy-Lenalidomide capsules are available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg strengths, each in blister packs.

Indications & Clinical Use:

Reddy-Lenalidomide is indicated for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Approval for this indication is based on red blood cell transfusion independence response rates. Overall survival benefit has not been demonstrated (see CLINICAL TRIALS, Myelodysplastic Syndromes).

Reddy-Lenalidomide in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who are not eligible for stem cell transplant.

Limitation 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 CLL).

Contraindications:

• Reddy-Lenalidomide is contraindicated in patients who are hypersensitive to it or to thalidomide, pomalidomide or to 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 may cause severe birth defects or death to the fetus.
• Breast feeding women.
• Male patients unable to follow or comply with the required contraceptive measures.
• Reddy-Lenalidomide treatment should not be started in MDS patients whose platelet levels are less than 50 x 10⁹/L.

Most Serious Warnings and Precautions:

Reddy-Lenalidomide should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents and registered with 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. Females of Child-Bearing Potential may be treated with Reddy-Lenalidomide provided that adequate contraception, with two simultaneous effective methods of contraception, is used to prevent fetal exposure to the drug. The choice of the two simultaneously effective contraceptive methods will necessitate 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 promptly report febrile episodes as a dose reduction may be required. In cases of thrombocytopenia, patients and physicians should be observant for signs and symptoms of bleeding, including petechiae and epistaxes.