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Care During Chemotherapy and Beyond

Pomalyst®

Generic name: Pomalidomide

Pomalyst® is the trade name for the generic chemotherapy drug pomalidomide. In some cases, health care professionals may use the generic drug name pomalidomide when referring to the trade name drug Pomalyst®.

Drug type: Pomalyst® is classified as an "immunomodulatory agent with antineoplastic activity," and an "anti-angiogenic agent." (For more detail, see "How this drug works" section below).

What Pomalyst Is Used For:

  • For treatment of multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of the last therapy.

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Pomalyst Is Given:

  • As a capsule by mouth. Capsules should be stored in a cool, dry place and protected from light.
  • Swallow capsules whole with water 1 time per day, at about the same time.
  • Do not break, chew or open the capsules. Do not open the Pomalyst® capsules or handle them any more than needed. If you touch a broken capsule or the medicine in the capsule, wash your hands right away with soap or water.
  • Pomalyst® can be taken with or without food.
  • If you miss a dose of Pomalyst®, and it has been less than 12 hours since your regular time, take it as soon as you remember. If it has been more than 12 hours, skip your next dose. Do not take 2 doses at the same time.
  • In order to receive this drug, there are strict guidelines that you must follow. You will be required to participate in a special program called the Risk Evaluation and Mitigation Strategy (REMS) Program. You will be asked to fill out a questionnaire before you receive the medication, and every month, while you are taking the drug. Only certain pharmacists and doctors may prescribe or dispense this medication. Patients must sign a Patient-Prescriber agreement and comply with the REMS requirements.
  • Do not share Pomalyst® with others.
  • You should not smoke cigarettes while taking Pomalyst®. Smoking cigarettes during treatment may affect how well Pomalyst® works.

The amount of Pomalyst® you will receive depends on many factors, including your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dosage and schedule.

Side Effects:

Important things to remember about the side effects of Pomalyst®:

  • Most people do not experience all of the side effects listed.
  • Side effects are often predictable in terms of their onset and duration.
  • Side effects are almost always reversible and will go away after treatment is complete.
  • There are many options to help minimize or prevent side effects

There is no relationship between the presence or severity of side effects and the effectiveness of the medication.

The following side effects are common (occurring in greater than 30%) for patients taking Pomalyst®:

These side effects are less common side effects (occurring in about 10-29%) of patients receiving Pomalyst® :

A serious but rare side effect of Pomalyst® is blood clots forming in the legs or lung. Call your provider right way if you experience shortness of breath, chest pain or arm or leg swelling.

Pomalyst® is not to be taken during pregnancy. This type of medication has can cause severe life-threatening birth defects.

Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

When to contact your doctor or health care provider:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

  • Fever of 100.4° F (38° C) or higher, chills (possible signs of infection).
  • Wheezing, difficulty breathing, closing up of the throat, swelling of facial features, hives (possible allergic reaction).
  • Shortness of breath, chest pain or arm or leg swelling (possible blood clot).

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

  • Extreme fatigue (unable to carry on self-care activities)
  • Constipation unrelieved by laxative use
  • New skin rashes
  • Numbness or tingling of your hands or feet
  • Swelling of the feet or ankles. Sudden weight gain
  • Signs of infection such as redness or swelling, pain on swallowing, coughing up mucous, or painful urination.
  • Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decrease amount of urine, or dizziness.
  • Failure in contraception.

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

  • Before starting pomalyst treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, or products containing aspirin unless your doctor specifically permits this.
  • Do not take other medications that may cause drowsiness without first consulting your health care provider. Also avoid alcohol.
  • For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking pomalyst. Severe, life-threatening birth defects may result. Two methods of contraception, such as latex condoms and spermicides, are required.
  • For women of childbearing potential. You must use contraception 4 weeks before you can begin pomalyst. The manufacturer requires you to take a pregnancy test every month before you start a new prescription of pomalyst. This is to ensure that you or your significant other is not pregnant. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy. Females must agree to use 2 different forms of effective birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping pomalyst.
  • Males, including those who have had a vasectomy, must use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking pomalyst, during any breaks (interruptions) in your treatment with pomalyst, and for 4 weeks after stopping pomalyst.
  • Do not donate sperm while taking pomalyst, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping.
  • Pregnancy category X (pomalyst may cause fetal harm when given to a pregnant woman. This drug must not be given to a pregnant woman or a woman who intends to become pregnant. If a woman becomes pregnant while taking pomalyst, the medication must be stopped immediately and the woman given appropriate counseling).
  • Do not breast feed while taking this medication.

Self-Care Tips:

  • Take this medication in the evening before bedtime. This may help to minimize daytime drowsiness.
  • You may experience drowsiness or dizziness; avoid driving or engaging in tasks that require alertness until your response to the drug is known.
  • Keep your bowels moving. Your health care provider may prescribe a stool softener to help prevent constipation that may be caused by this medicine.
  • Drink 2 to 3 quarts of fluid every 24 hours, unless you were told to restrict your fluid intake, and maintain good nutrition. This will decrease your chances of being constipated, and prevent dehydration.
  • You may be at risk of infection report fever or any other signs of infection immediately to your health care provider.
  • Wash your hands often.
  • Avoid sun exposure. Wear SPF 15 (or higher) sun block and protective clothing.
  • In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
  • Do not donate blood while you are taking this medication.
  • Don't share your pills with anyone!
  • Get plenty of rest.
  • Maintain good nutrition.
  • If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

You will be checked regularly by your health care professional while you are taking Pomalyst®, to monitor side effects and check your response to therapy. Periodic blood work to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor. For females of child-bearing potential a negative pregnancy test may be required monthly before the next month's prescription for Pomalyst® is given.

How Pomalyst Works:

Pomalyst®'s exact mechanism of action on cancer cells is not clear. It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production.

In normal tissue, new blood vessels are formed during tissue growth and repair (i.e. a healing wound), and during the development of baby during pregnancy. Blood vessels carry oxygen and nutrients to tissue that are necessary for growth and survival. In cancer, tumors need blood vessels in order to grow and spread. Through a complex process, endothelial cells (which line the blood vessels) are able to divide and grow and create new blood vessels. This process is called angiogenesis and it occurs in both healthy tissue and in cancerous tissue.

Additionally, Pomalyst® is known to have various effects on the immune system (immunomodulatory agent), which may contribute to its therapeutic effect. Pomalyst® may also alter the production and activity of cytokines (growth factors) involved in the growth and survival of certain cancer cells. There may be an effect on the genes that direct the cell's growth and activity particularly those associated with cytokines (growth factors), apoptosis (cell death), and metabolism. Pomalyst® enhances T cell- and natural killer cell-mediated immunity. Additionally, Pomalyst® has an effect on lenalidomide-resistant multiple myeloma.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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