Fact Sheet

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Contact: BMORS Enquiries

Approval with conditions of REVLIMID^® for 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

Fact Sheet

What is REVLIMID^®?

REVLIMID^® is a capsule containing 5 mg or 10 mg lenalidomide.

Health Canada has authorized REVLIMID^® with conditions, under the Notice of Compliance with Conditions Policy 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. This authorization reflects the promising nature of the clinical evidence which must be verified and/or extended with further studies. Products authorized under Health Canada's NOC/c Policy, have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment.

What is REVLIMID^® used for?

REVLIMID^® (lenalidomide) is used 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.

REVLIMID^® can only be given to patients who are registered and meet all conditions of the RevAid^SM program.

What is RevAid^SM?

RevAid^SM is a controlled distribution program for REVLIMID^®. Under this program, only prescribers and pharmacists registered with the program are able to prescribe and dispense REVLIMID^®. In addition, REVLIMID^® can only be dispensed to patients who are registered and meet all the conditions of the RevAid^SM program. Due to its structural similarities to thalidomide, a known human teratogen, lenalidomide is contraindicated in pregnant women and women at risk of becoming pregnant. The RevAid^SM controlled distribution program is a mechanism to minimize the risk of fetal exposure.

What is Myelodysplastic Syndrome (MDS)?

Patients with MDS have bone marrow that does not produce enough mature blood cells. This causes a lack of healthy blood cells that can function properly in the body. There are different types of MDS. REVLIMID^® is for the type of MDS with a chromosome problem where part of chromosome number 5 is missing. This type of MDS is known as deletion 5q MDS. Patients with this type of MDS may have low red blood cell counts that require treatment with blood transfusions.

How does REVLIMID^® work?

The details of how REVLIMID^® works in deletion 5q MDS are still being studied. When patients with deletion 5q MDS are treated with REVLIMID^®, abnormal cells in their bone marrow are often eliminated and replaced by normal-appearing cells. REVLIMID^® can also directly stimulate the production of red blood cells by the bone marrow. These effects can improve anemia, and reduce or eliminate the need for transfusions in patients with MDS.

What are the advantages of REVLIMID^®?

Some patients with MDS who are treated with REVLIMID^® are able to stop getting blood transfusions.

What do patients need to know about using REVLIMID^®?

REVLIMID^® is only available under a controlled distribution program called RevAid^SM. Information on this program is available at 1-888-RevAid1 (1-888-738-2431) or www.RevAid.ca.

1. REVLIMID^® is similar to the medicine thalidomide. We know thalidomide causes life-threatening birth defects. REVLIMID^® has not been tested in pregnant women. REVLIMID^® has harmed unborn animals in animal testing.

Female patients who are pregnant or who plan to become pregnant must not take REVLIMID^®.

Female patients must not get pregnant, and must use 2 simultaneous, effective methods of contraception:

• for 4 weeks before starting REVLIMID^®,
• while taking REVLIMID^®,
• during dose interruptions of REVLIMID^®and
• for 4 weeks after stopping REVLIMID^®.

It is not known if REVLIMID^® passes into semen. Male patients, including those who have had a vasectomy, must use a latex condom during any sexual contact with a pregnant female or a female that can become pregnant while taking REVLIMID^® and for 4 weeks after stopping REVLIMID^®.

Female patients of childbearing potential must provide two negative pregnancy tests prior to starting REVLIMID^® therapy, then once weekly for the first 4 weeks and once every 4 weeks for the duration of treatment, during treatment interruption, and 4 weeks after stopping Revlimid.

2. REVLIMID^® causes low white blood cells and low platelets in most patients. Blood counts should be checked weekly during the first 8 weeks of treatment with REVLIMID^®, and at least monthly thereafter.

3. There is an increased chance for blood clots in veins and in the lungs.

What are the side effects and how serious are they?

Serious side effects may occur with the use of REVLIMID^® and could include:

• birth defects (deformed babies) or death of an unborn baby.
• decrease in the production of blood cells resulting in very low levels of white blood cells (neutropenia) and of platelets (thrombocytopenia)
• blood clots in the veins (Deep Vein Thrombosis) and in the lung (Pulmonary Embolism)

Like all medicines, REVLIMID^® can have side effects. The following are the most commonly reported side effects (≥ 10%):

Very Common: decrease in white blood cells, decrease in platelets, diarrhea, itchy skin, rash, tiredness, nausea, infection of the nasal passages, constipation, joint pain, back pain, swelling of arms and/or legs, fever, cough, dizziness, difficulty breathing, headache, decrease in red blood cells, muscle cramp, infection of the pharynx, upper respiratory tract infection, nose bleed, lack or loss o f strength, dry skin, abdominal pain, pain in arm or leg, urinary tract infection, pneumonia, loss of appetite, decrease in blood potassium level, swelling, bronchitis, difficulty sleeping, sinus infection, vomiting, night sweats, muscle pain.

The following are commonly reported side effects (≥1% and ≤ 10%).

Common: falls, pain, increased sweating, bruise, upper abdominal pain, loose stools, arm and/or leg swelling, acquired decreased thyroid activity, high blood pressure, difficult or painful urination, dry mouth, toothache, allergy, (rhinitis), flu, decreased sensitivity to stimulation, ruptured blood vessels, skin redness, chest pain, rigors, foot pain, distortion of sense of taste, loss of sensation in limbs, decrease in blood magnesium level, weight loss, infection under the skin, depression, skin lesion, flatulence, sensation of pricking, tingling, or creeping on the skin, heart palpitations, acute leukemia.

Who should not be treated with REVLIMID^®?

• Patients with a history of allergic reactions to lenalidomide or thalidomide or to any other ingredients in REVLIMID^®. REVLIMID^® contains lactose.
• Patients with low platelet levels.
• Patients who are breastfeeding.
• Patients who are pregnant, or who plan to become pregnant. REVLIMID^® may cause birth defects.
• Patients who are not enrolled in or do not meet the requirements of the RevAidSM controlled distribution system.

How is REVLIMID^® taken?

The starting dose is 10 mg per day. Patients will have blood tests every week during the first 8 weeks of treatment, and at least monthly after that. The dose of REVLIMID^® will be adjusted or interrupted based on the results of these blood tests.

Patients should swallow REVLIMID^® capsules whole with water once a day. Patients should try to take REVLIMID^® at about the same time each day.

Females who could become pregnant, or who plan to become pregnant can handle REVLIMID^® capsules if they are using latex gloves.

What else should patients know about taking REVLIMID^®?

Store REVLIMID^® at 15-30°C. Keep out of the reach of children.

Where can I learn more about REVLIMID^®?

Additional information about REVLIMID^® can be obtained by calling 1-888-RevAid1 (1-888-738-2431), visiting www.RevAid.ca or by talking to your doctor or pharmacist.