Pomalidomide

Pomalidomide is a prescription medication used to treat people with multiple myeloma, a form of blood cancer that arises from cells of the bone marrow, whose cancer has progressed after being treated with other medicines. Pomalidomide belongs to a group of drugs called immunomodulators that affect the immune system causing it to destroy cancer cells and inhibit their growth.

This medication comes in capsule form and is taken once daily on an empty stomach. Swallow pomalidomide capsules whole with water.

Common side effects of pomalidomide include a decrease in infection-fighting white blood cells, tiredness, weakness, and constipation.

Because pomalidomide can cause birth defects, pomalidomide is only available through a restricted distribution called the "Pomalyst REMS" program.

Pomalidomide is a prescription medicine used to treat adult patients with multiple myeloma who:

• have received at least two prior medicines to treat multiple myeloma, including bortezomib and lenalidomide, and
• their disease has become worse during treatment or within 60 days of finishing the last treatment.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Pomalidomide may be found in some form under the following brand names:

• Pomalyst

Pomalidomide may cause serious side effects, including:

• see "Drug Precautions"
• low white blood cells (neutropenia), low platelets (thrombocytopenia) and low red blood cells (anemia)

The most common side effects of pomalidomide include:

• tiredness and weakness
• constipation
• shortness of breath
• diarrhea
• fever
• back pain
• nausea

This is not a complete list of pomalidomide side effects.  Ask your doctor or pharmacist for more information.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:

• ketoconazole
• rifampin

This is not a complete list of pomalidomide drug interactions. Ask your doctor or pharmacist for more information.

Do not take pomalidomide if you are pregnant, plan to become pregnant, or become pregnant during treatment with pomalidomide.

Males, including those who have had a vasectomy, must use a latex or synthetic condom during any sexual contact with a female, while taking pomalidomide, during any breaks (interruptions) in your treatment with pomalidomide, and for 4 weeks after stopping pomalidomide. Males should not donate sperm during treatment, and for 4 weeks after stopping pomalidomide. Notify your healthcare provider right away if your female partner becomes pregnant.

Pomalidomide may cause serious side effects including:

• Birth defects (deformed babies) or death of an unborn baby.
• Blood clots in your veins and lungs. Symptoms include:
  • shortness of breath
  • chest pain
  • arm or leg swelling

Medicines can interact with some foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of pomalidomide there are no specific foods that you must exclude from your diet when receiving pomalidomide.

Before receiving Pomalyst, tell your doctor about all of your medical conditions including if you:

• are allergic to thalidomide (Thalomid) or lenalidomide (Revlimid)
• smoke cigarettes
• are breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Women who are pregnant or who plan to become pregnant should not take pomalidomide.

• for at least 4 weeks before starting pomalidomide
• while taking pomalidomide
• during any breaks (interruptions) in your treatment with pomalidomide
• for at least 4 weeks after stopping pomalidomide  

Pomalidomide should not be used by women who are breastfeeding. It is not known if pomalidomide is excreted into human breast milk or if it will harm your nursing baby.

Take pomalidomide exactly as prescribed by your doctor. Follow the instructions of the Pomalyst REMS program.

• Pomalidomide capsules must be swallowed whole with water once daily. Do not break, chew, or open capsules.
• Take pomalidomide at the same time each day.
• Pomalidomide must be taken without food, at least 2 hours before or 2 hours after a meal.
• Handle pomalidomide capsules with care. Do not open capsules. If you touch a broken pomalidomide capsule, wash your hands, or the area of the body in contact with the capsule contents, with soap and water right away.
• If you miss a dose of pomalidomide, take it as soon as you remember. If it is less than 12 hours to your next dose, just skip the missed dose. Do not take 2 doses at the same time.

Women who can become pregnant:

• will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular. If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling.  

The recommended starting dosage is 4 mg taken by mouth, once daily, on days 1 through 21, in 28-day cycles.

Pomalidomide treatments may be temporarily interrupted if serious side effects occur, and restarted at a lower dose. Your healthcare provider will determine the best dose for you based on blood tests.

If you take too much pomalidomide, call your healthcare provider right away, or seek emergency medical attention.

Store pomalidomide at room temperature, between 59° and 86°F.

Return unused medication to the manufacturer or your healthcare provider.

Keep this and all medications out of the reach of children.

WARNING: EMBRYO-FETAL TOXICITY and VENOUS THROMBOEMBOLISM

Embryo-Fetal Toxicity

• Pomalyst is contraindicated in pregnancy. Pomalyst is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting Pomalyst treatment.
• Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping Pomalyst treatment.

Pomalyst is only available through a restricted distribution program called Pomalyst REMS.

Venous Thromboembolism

• Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE) occur in patients with multiple myeloma treated with Pomalyst. Prophylactic anti-thrombotic measures were employed in the clinical trial. Consider prophylactic measures after assessing an individual patient’s underlying risk factors.