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Fact Sheet - Pr THALOMID« authorization for sale in Canada

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1. What is Thalomid?

Pr THALOMID«is the brand name of thalidomide sold by Celgene Corporation. Thalidomide was originally sold during the late 1950s and 1960s as a sleeping aid and to treat morning sickness in pregnant women. In 1960-61, it was found to cause birth defects, especially if taken during the first 25-50 days of pregnancy. Around 12,000 babies in 46 countries were born with birth defects, with only some 8,000 surviving past their first birthday. In 1962, thalidomide was withdrawn from the market by regulators around the world.

2. Given the decision to remove the drug from the market in 1962, why has it been made available to Canadians now?

In recent years, clinical trials have found thalidomide effective for treating a variety of conditions including leprosy, some autoimmune diseases and multiple myeloma (a disease of unregulated growth of plasma cells). In such trials, thalidomide demonstrated benefits in multiple myeloma patients and is being made available in Canada to treat those patients who are 65 years of age or older.

In 1998, thalidomide was approved by the US Food and Drug Administration (FDA) for the treatment of leprosy. In 2006, a new FDA approval was granted for thalidomide in combination with dexamethasone for the treatment of multiple myeloma. Thalidomide is also approved in other countries including Australia and the European Union.

3. What is it used for?

In Canada, Pr THALOMID« (in combination with a chemotherapy drug and a steroid) is currently indicated for the treatment of patients with previously untreated multiple myeloma who are 65 years of age or older. Multiple myeloma is an incurable disease but a clinical study showed prolongation of life of patients treated with Pr THALOMID«.

Under the practice of medicine a physician can prescribe this drug for a condition other than multiple myeloma. Consequently, he or she should be well apprised of the drug's risks and benefits in determining that it can be an effective therapy for a certain medical condition. Relevant, detailed information on the drug's risks and benefits is available in the Canadian Product Monograph.  It should be noted that regardless of the medical condition leading to the prescription of this drug, the terms of the RevAid« programme (described under point 5) must be followed to gain access.

4. How did Canadian patients gain access to the drug prior to the granting of marketing authorization?

Previously, Canadian physicians accessed thalidomide for patients via Health Canada's Special Access Programme. The Programme received approximately 6,300 requests in 2009, to date, the highest number for any drug. Approximately 95 % of requests were for multiple myeloma. The remaining requests were authorised for other cancers and conditions.

5. What special precautions are being taken to mitigate the risks of this drug (especially birth defects)?

The safety data for thalidomide has been carefully reviewed by Health Canada. Identified safety risks are available to healthcare professionals and patients through the Canadian Product Monograph. Practical guidance for healthcare professionals and patients regarding the early identification and management of these safety risks is also available.

Thalidomide is only available through a controlled distribution program called RevAid«. Only physicians and pharmacists registered with RevAid« will be able to prescribe and to dispense this product and all patients prescribed thalidomide must be registered in this program by their physician.

Prescriptions for thalidomide are only valid for a limited number of days. Female patients who may be able to become pregnant will be required to have regular and frequent medically supervised pregnancy tests during treatment to ensure that they are not pregnant prior to starting treatment and have not become pregnant while taking thalidomide.

Patients receive regular guidance and instructions from their healthcare professional regarding the safe use of thalidomide. If engaging in sexual activity while taking thalidomide, female patients will be required to utilize two forms of effective contraception while male patients must use a condom. In addition, patients must not donate semen or blood through the course of their treatment and for four weeks afterward.  

Collectively, these measures help to prevent potential exposure of any unborn baby to thalidomide and maximize the safety of patients.

6. Where can I find more information?

Further information for physicians and patients can be found in the Canadian Product Monograph.

Additional information on Pr THALOMID« and the pregnancy prevention programme can be obtained by calling 1-888-RevAid1 (1-888-738-2431), visiting www.RevAid.ca or by talking to your doctor or pharmacist.