Pomalidomide Capsule

COMMON BRAND(S): Pomalyst

GENERIC NAME(S): Pomalidomide

OTHER NAME(S): Pomalidomide Capsule

WARNINGS:

Pomalidomide can cause severe birth defects or death in unborn babies if taken during pregnancy. Therefore, it is important to prevent pregnancy while taking this medication. Women must use 2 reliable forms of birth control or avoid sexual intercourse for 4 weeks before starting treatment, during treatment and breaks, and for at least 4 weeks after stopping treatment. Women must also have 2 negative pregnancy tests before starting treatment, the first test 10 to 14 days before the first dose and the second test within 24 hours before the first dose. Women must also continue to have pregnancy tests regularly during treatment. (See also Notes section.) If you become pregnant or think you may be pregnant, stop taking pomalidomide and tell your doctor right away. Consult your doctor or pharmacist for more information.

Men who are taking pomalidomide must use latex or synthetic condoms during any sexual contact with female partners while on treatment, during breaks, and for at least 4 weeks after stopping treatment even if they have had a vasectomy. If your partner becomes pregnant or thinks she may be pregnant, tell your doctor right away.

For patients to receive this medication, all doctors, pharmacists, and patients must understand, agree to, and carefully follow the requirements of the Pomalyst REMS program, developed by the U.S. Food and Drug Administration. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Although unlikely, pomalidomide may cause very serious blood clots (such as heart attack, stroke, blood clots in the legs/lungs). Get medical help right away if you develop symptoms of blood clots, including chest/jaw/left arm pain, unusual sweating, weakness on one side of the body, vision changes, trouble speaking/breathing, or sudden pain/swelling/redness in the groin/calf. Your doctor should prescribe you medications such as "blood thinners" (examples include aspirin, warfarin) to prevent blood clots.

Who should not take Pomalidomide Capsule?

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Uses

Uses

Pomalidomide is used to treat a type of cancer in the bone marrow (multiple myeloma). It works by slowing or stopping the growth of cancer cells.

How to use Pomalidomide Capsule

This medication must be used only within the Pomalyst REMS guidelines in order to avoid any possible exposure of an unborn baby to the drug. Consult your doctor or pharmacist for more information. See also Warning section.

Read the Medication Guide provided by your pharmacist before you start taking pomalidomide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily for 21 days, then stopping the medication for 7 days. This is one cycle of treatment. Continue taking the medication this way as directed by your doctor.

Swallow the capsules whole with water. Do not open, break, crush or chew the capsules or handle them more than needed. If any of the powder from the capsule gets on your skin, wash the area with soap and water.

The dosage is based on your medical condition, response to treatment, laboratory test results, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Take this medication regularly to get the most benefit from it. Remember to take it at the same time each day that you are scheduled to take it.

Do not increase your dose or take this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

Side Effects

Side Effects

See also Warning section.

Dizziness, confusion, tiredness, weakness, constipation, diarrhea, back/bone pain, muscle pain/cramps, nausea, vomiting, and loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: numbness/tingling/swelling of the arms/legs/hands/feet, shortness of breath.

This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Get medical help right away if you have any of the following symptoms: unusual tiredness, pale skin, easy bruising/bleeding, signs of infection (such as fever, chills, swollen lymph nodes, persistent sore throat, cough).

Pomalidomide sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.

Pomalidomide has rarely caused very serious (possibly fatal) liver disease. Get medical help right away if you develop symptoms of liver disease, including: severe stomach/abdominal pain, dark urine, yellowing eyes/skin, persistent nausea/vomiting.

People who are treated with this medication may rarely get other cancers (such as leukemia). Consult your doctor for more details.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Precautions

Before taking pomalidomide, tell your doctor or pharmacist if you are allergic to it; or to thalidomide or lenalidomide; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, cigarette smoking, heart disease (such as heart attack), blood clots, stroke.

Pomalidomide can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy or confused. Alcohol or marijuana (cannabis) can make you more dizzy or confused. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Because pomalidomide can cause severe birth defects or death to an unborn baby, several precautions are noted below.

Do not donate blood during treatment and for at least 1 month after stopping treatment.

Men: Do not donate sperm during treatment and for at least 4 weeks after stopping treatment because pomalidomide passes into semen.

Women: Tell your doctor right away if your period is late or if you have abnormal vaginal (menstrual) bleeding. Use reliable forms of birth control even if you were unable to get pregnant in the past.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

This medication must not be used during pregnancy. It may harm an unborn baby. See also Warning section.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Tell your doctor or pharmacist if you are taking other products that cause dizziness or confusion including alcohol, marijuana (cannabis), antihistamines (such as diphenhydramine), drugs for sleep or anxiety (such as alprazolam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause dizziness. Ask your pharmacist about using those products safely.

Cigarette smoking decreases blood levels of this medication. Tell your doctor if you smoke or if you have recently stopped smoking.

Overdose

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as pregnancy tests, blood counts, liver function) must be performed before you start treatment and periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Test for pregnancy before treatment, and weekly during the first 4 weeks of treatment. If you have regular periods, then test every 4 weeks thereafter. If you have irregular periods, you should test every 2 weeks thereafter.

Missed Dose

If you miss a dose and it has been less than 12 hours since your usual dose time, take it as soon as you remember. If it has been more than 12 hours since your usual dose time, then skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised January 2019. Copyright(c) 2019 First Databank, Inc.

Images

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.