Class: Biological Therapy

Generic Name:Pomalidomide
Trade Name: Pomalyst®

For which conditions is this drug approved?Pomalyst is indicated for patients with multiple myeloma who have received at least two prior therapies including Revlimid® (lenalidomide) and Velcade® (bortezomib) and have demonstrated disease progression on or within 60 days of completion of the last therapy.

What is the mechanism of action? Pomalyst is type of drug that can modify or regulate immune function to help fight cancer. It may interfere with myeloma cell growth by directly inhibiting tumor blood vessel formation, or angiogenesis. Pomalyst can also help kill cancer cells.

How is Pomalyst typically given (administered)?Pomalyst is taken orally at a dose of 4 mg per day on days 1–21 of repeated 28-day cycles until disease progression.

How are patients typically monitored?Patients should be monitored for complications affecting blood cells (hematologic toxicities) while taking Pomalyst—specifically for neutropenia (abnormally low count of neutrophils, a type of white blood cell that helps fight infection) and thrombocytopenia (low levels of blood platelets, cells that play an important role in blood clotting). Monitoring includes complete blood counts weekly for the first eight weeks, followed by monthly counts.

What are the common (occur in 30% or more of patients) side effects of treatment with Pomalyst?

• Fatigue
• Weakness
• Neutropenia
• Anemia
• Constipation
• Nausea
• Diarrhea
• Difficult, painful breathing or shortness of breath
• Upper-respiratory tract infections
• Back pain
• Fever

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Pomalyst?

• Vomiting
• Muscle spasm
• Pneumonia
• Musculoskeletal chest pain
• Musculoskeletal pain
• Joint pain
• Muscle weakness
• Bone pain
• Cough
• Nose bleed
• Decreased appetite
• High blood sugar
• Hyponatremia (lower than normal level of sodium in the blood)
• Hypercalcemia (higher than normal level of calcium in the blood)
• Hypokalemia (lower than normal level of potassium in bloodstream)
• Rash
• Dry skin
• Itching
• Dizziness
• Headache
• Tremor
• Peripheral neuropathy (pain, numbness, tingling, swelling, or muscle weakness in different parts of the body)
• Weight loss
• Increase in blood creatinine (a compound that is excreted from the body in urine; levels are measured to monitor kidney function)
• Confusion
• Anxiety
• Renal (kidney) failure 

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects? Take Pomalyst only as directed (once daily) at the same time each day. Take this medication without food (at least two hours before or two hours after a meal) and do not open, break, or chew capsules. Swallow capsules whole with water. If you miss a dose of Pomalyst, take the missed dose within 12 hours of the time you normally take it. If you can’t take the missed dose within 12 hours, skip that day’s dose and take Pomalyst at the usual time the next day. Do not take two doses to make up for a missed dose.

Are there any special precautions patients should be aware of before starting treatment?

It is not safe to take Pomalyst during pregnancy, as it may harm or kill a developing baby. Women of childbearing age must have a negative pregnancy test before beginning treatment with Pomalyst and should avoid becoming pregnant during treatment and for at least four weeks after completing treatment. Women of childbearing age and their partners should use two different forms of birth control (contraception) while taking Pomalyst, during interruptions in treatment, and for at least four weeks following treatment.

Because Pomalyst is so dangerous during pregnancy, this medication is only available through pharmacies certified by a restricted program called Pomalyst REMS. To get Pomalyst patients must sign a patient-prescriber agreement, which requires pregnancy testing and use of contraception for women and use of contraception for men.

Patients should not smoke during treatment with Pomalyst because smoking may make the drug less effective.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. 

For women: If you become pregnant while taking Pomalyst, stop treatment immediately and notify your doctor. Also stop taking Pomalyst and contact your doctor right away if you miss a period, experience unusual menstrual bleeding, stop taking birth control, or suspect for any reason that you may be pregnant. If your doctor is not available, call 1-888-668-2528 for information on emergency contraception. 

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.