POMALYST contains the active ingredient pomalidomide, which is a thalidomide analog, in a racemic mixture of enantiomers. It comes in capsule form with strengths of 1 mg, 2 mg, 3 mg, and 4 mg, and is taken orally. Key inactive ingredients include mannitol, pregelatinized starch, and sodium stearyl fumarate. The capsule shells contain gelatin, titanium dioxide, and various colorants.

How should I use this medication?

Take this medication by mouth with a glass of water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Do not cut, crush, or chew this medication. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is more than 12 hours late. If it is more than 12 hours late, skip the missed dose. Take the next dose at the normal time.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Pain, tingling, or numbness in the hands or feet
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Constipation
• Diarrhea
• Fatigue
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• High blood pressure
• High cholesterol
• History of blood clots
• Irregular menstrual cycles
• Kidney disease
• Liver disease
• Tobacco use
• An unusual or allergic reaction to pomalidomide, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

• Ciprofloxacin
• Fluvoxamine
• Tobacco

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

You may need blood work while taking this medication.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

This medication is available only through a special program. Care teams, pharmacies, and patients must meet all the conditions of the program. Your care team will help you get signed up with the program if you need this medication. Through the program you will only receive up to a 28-day supply of the medication at one time. You will need a new prescription for each refill.

Do not give blood while taking the medication and for 1 month after the last dose.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancers if you take this medication.

If you smoke, tell your care team if you notice this medication is not working well for you. Talk to your care team if you decide to stop smoking.

Talk to your care team if you are pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy and for 4 weeks after the last dose. Two negative pregnancy tests are required before starting this medication. Two reliable forms of contraception are recommended while you are taking this medication and for 4 weeks after the last dose. Talk to your care team about effective forms of contraception. If you become pregnant, miss a menstrual cycle, or stop using contraception, stop taking this medication. Call your care team. Do not father a child while taking this medication and for 4 weeks after the last dose. Use a condom while having sex during this time period.

Do not donate sperm while taking this medication and for 4 weeks after the last dose.

Do not breastfeed while taking this medication.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What are the most serious risks of this medication?

This medicine increases the risk of blood clots.

Males who get this medicine must use a condom during sex with female partners who can get pregnant. If you get a woman pregnant during treatment, the baby could have severe birth defects or die before they are born. You may need to continue to avoid getting a female pregnant after stopping the medicine. The length of time depends on the medication. Talk to your healthcare provider about how long you should continue to wear condoms after stopping the medicine. Tell your healthcare provider right away if your partner becomes pregnant while you are taking this medicine.

This medication may cause serious birth defects if taken during pregnancy. Do not take this medication if you are pregnant.