Generic Name: pomalidomide (POE-ma-LID-oh-mide)
Brand Name: Pomalyst
Do not take Pomalyst if you are pregnant. It may cause severe birth defects or death of the fetus if used during pregnancy. Pomalyst is similar to thalidomide, which causes life-threatening birth defects.
Women who are able to become pregnant and who take Pomalyst:
- must not become pregnant by either avoiding sexual contact with men or using at least 2 forms of effective birth control for at least 4 weeks before starting Pomalyst, while taking Pomalyst, during breaks in treatment, and for at least 4 weeks after stopping Pomalyst;
- must have a negative pregnancy test 10 to 14 days before starting Pomalyst and again within 24 hours before starting Pomalyst; and
- must have a pregnancy test after starting Pomalyst as told by the doctor.
Women who experience abnormal menstrual bleeding, miss their menstrual period, become pregnant, or suspect for any reason they may be pregnant while taking Pomalyst must stop taking it and contact their doctor immediately.
The risk of blood clots (eg, in the veins or lungs, heart attack, stroke) may be increased with Pomalyst. Your doctor may have you take a blood thinner to prevent blood clots. Follow what your doctor has told you to do. Call your doctor right away if you experience shortness of breath; chest pain; coughing up blood; or pain, redness, tenderness, or swelling in the arms or legs. Call your doctor right away if you have symptoms of a heart attack (eg, chest pain that may spread to the arms, neck, jaw, back, or stomach; unusual sweating; feeling sick, or vomiting. Call your doctor right away if you have symptoms of a stroke (eg, numbness or weakness on 1 side of the body; severe headache or confusion; or vision, speech, or balance problems).
Pomalyst can only be prescribed and dispensed through a special program. Make sure you understand all warnings and instructions for using Pomalyst. Ask your doctor or pharmacist if you have any questions about this program or the use of Pomalyst.
Pomalyst is used for:
Treating a certain type of cancer (multiple myeloma). It may also be used for other conditions as determined by your doctor.
Pomalyst is an immunomodulatory medicine. Exactly how it works is not known.
Do NOT use Pomalyst if:
- you are allergic to any ingredient in Pomalyst
- you are pregnant, planning to become pregnant, or become pregnant during treatment with Pomalyst
- you have severe kidney or liver problems
Contact your doctor or health care provider right away if any of these apply to you.
Before using Pomalyst:
Some medical conditions may interact with Pomalyst. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have had an allergic reaction to thalidomide or lenalidomide in the past
- if you have kidney problems, liver problems, blood problems (eg, low white blood cell levels, low platelet counts), high cholesterol or triglyceride levels, or high blood pressure
- if you have a history of blood clots
- if you smoke cigarettes
Some MEDICINES MAY INTERACT with Pomalyst. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Erythropoietic agents (eg, erythropoietin), estrogens (eg, estrogen, estradiol), progestins (eg, medroxyprogesterone), or medicines that contain estrogens or progestins (eg, birth control pills) because the risk of developing blood clots may be increased
- Ciprofloxacin, fluvoxamine, or ketoconazole because they may increase the risk of Pomalyst's side effects
- Carbamazepine because it may decrease Pomalyst's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Pomalyst may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Pomalyst:
Use Pomalyst as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Pomalyst comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Pomalyst refilled.
- Take Pomalyst by mouth on an empty stomach at least 2 hours before or 2 hours after a meal.
- Swallow Pomalyst whole with water. Do not break, crush, chew, or open before swallowing.
- Take Pomalyst at about the same time each day to get the most benefit from it.
- Do not open the capsules or handle them more than needed. If you touch a broken capsule or the medicine inside of the capsule, wash the area with soap and water. If a broken capsule or the medicine inside comes into contact with your eyes, flush thoroughly with water.
- If you miss a dose of Pomalyst, take it as soon as you remember. If it has been more than 12 hours since the missed dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Pomalyst.
Important safety information:
- Tell your doctor or dentist you take Pomalyst before you receive any medical or dental care, emergency care, or surgery.
- Pomalyst may cause dizziness or confusion. This effect may be worse if you take it with alcohol or certain medicines. Use Pomalyst with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Pomalyst may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Pomalyst may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Patients with multiple myeloma who use Pomalyst may be at increased risk of developing a second cancer. Discuss the benefits and risks of Pomalyst, as well as any questions or concerns, with your doctor.
- Severe and sometimes fatal liver problems have happened with Pomalyst. Call your doctor right away if you have symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, right-upper stomach pain, unusual tiredness, yellowing of the skin or eyes).
- Patients with cancer who take Pomalyst may be at greater risk of getting a severe and sometimes fatal health problem called tumor lysis syndrome (TLS). Call your doctor right away if you faint or have a fast or irregular heartbeat; muscle weakness or cramps; seizures; severe diarrhea, loss of appetite, nausea, or vomiting; sluggishness; or trouble passing urine.
- Do not donate sperm or blood while taking Pomalyst, during breaks in treatment, or within 4 weeks after stopping Pomalyst.
- Talk with your doctor about which methods of effective birth control may be appropriate for you.
- If you are using a hormonal contraceptive (eg, birth control pills) to prevent pregnancy, inform your doctor if you also take an HIV protease inhibitor (eg, ritonavir); griseofulvin, rifampin, rifabutin, penicillin, amoxicillin, ampicillin, or other antibiotic medicines; St. John's wort; modafinil; phenytoin; or carbamazepine. These medicines may decrease the effectiveness of hormonal contraceptives.
- If you are a man and have sex with a pregnant female or a female who can get pregnant, always use a latex or synthetic condom during sex. Do this even if you have had a vasectomy. Use a latex or synthetic condom while taking Pomalyst, during breaks in treatment, and for at least 4 weeks after stopping Pomalyst.
- If you are a man and have unprotected sex with a female who is or could get pregnant, or your female partner gets pregnant, call your doctor right away.
- Lab tests may be performed while you use Pomalyst. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Pomalyst with caution in the ELDERLY; they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: Do not use Pomalyst if you are pregnant. It may cause severe birth defects or death of the fetus. If you think you may be pregnant, miss your menstrual period, experience unusual menstrual bleeding, or stop using birth control, contact your doctor right away. If you become pregnant while using Pomalyst, consult an obstetrician/gynecologist experienced in reproductive toxicity. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Pomalyst.
Possible side effects of Pomalyst:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Anxiety; back pain; bone pain; constipation; diarrhea; dizziness; headache; joint pain; loss of appetite; muscle pain, spasms, or weakness; nausea; tiredness; vomiting; weakness; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); burning, numbness, or tingling; change in the amount of urine produced; chest pain; confusion; pain, tenderness, redness, or swelling of the arms or legs; red, swollen, blistered, or peeling skin; severe or persistent tiredness or weakness; shortness of breath; swelling of the hands, ankles, or feet; symptoms of bleeding (eg, vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; unusual vaginal bleeding; bruises without a reason or that get bigger; any bleeding that is severe or that you cannot stop); symptoms of electrolyte problems (eg, mood changes; confusion; muscle pain or weakness; irregular heartbeat; seizures; severe nausea, loss of appetite, or vomiting); symptoms of heart attack (eg, chest pain that may spread to the arms, neck, jaw, back, or stomach; unusual sweating; feeling sick or vomiting); symptoms of high blood sugar (eg, confusion; drowsiness; flushing; fruit-like breath odor; increased thirst, hunger, or urination; rapid breathing); symptoms of infection (eg, fever, chills, sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, painful or difficult urination, mouth sores, wound that will not heal); symptoms of stroke (eg, numbness or weakness on 1 side of the body; severe headache or confusion; vision, speech, or balance problems); tremor.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Pomalyst:
Store Pomalyst at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pomalyst out of the reach of children and away from pets.
- If you have any questions about Pomalyst, please talk with your doctor, pharmacist, or other health care provider.
- Pomalyst is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Pomalyst or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Pomalyst. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Pomalyst. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Pomalyst.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.