Pronunciation:

poe-ma-LID-oh-mide

Brand Names:

• Pomalyst

Dosage Forms:

• Capsule

Warnings:

Pomalidomide is contraindicated in pregnancy. Pomalidomide is a thalidomide analogue, and thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. In females who can become pregnant, obtain 2 negative pregnancy test before treatment initiation. It is required that females of reproductive potential use 2 forms of contraception or abstain from heterosexual sex during and for 4 weeks after stopping treatment with pomalidomide. The only way to acquire pomalidomide is through a restricted distribution program called POMALYST REMS. DVT, pulmonary embolism, myocardial infarction, and stroke have been reported in patients with multiple myeloma treated with pomalidomide. Thromboprophylaxis is recommended, and the regimen choice should be based on assessment of the underlying risk factors of the patient .

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Pomalidomide is used in combination with dexamethasone to treat multiple myeloma (cancer of the blood) in patients who have received at least 2 other medicines that did not work well. This medicine is used in patients with multiple myeloma that has worsened during treatment or within 60 days of the last treatment. It interferes with the growth of multiple myeloma cells, which are eventually destroyed in the body. Pomalidomide is an antineoplastic (cancer medicine).

Pomalidomide is used to treat AIDS-related Kaposi sarcoma in patients who have received highly active antiretroviral therapy (HAART) that did not work well. This medicine is also used to treat Kaposi sarcoma in patients who do not have HIV infection (HIV-negative).

This medicine is available only under a restricted distribution program called the Pomalyst® REMS (Risk Evaluation and Mitigation Strategy) program.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of pomalidomide in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pomalidomide in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Viloxazine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Carbamazepine
• Ciprofloxacin
• Dihydroartemisinin
• Enasidenib
• Enoxacin
• Fluvoxamine
• Leniolisib
• Peginterferon Alfa-2b
• Pixantrone
• Taurursodiol
• Tocilizumab

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice
• Tobacco

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia (low red blood cells) or
• Blood clots or
• Bone marrow problems or
• Deep vein thrombosis (blood clot in the leg) or
• Neutropenia (low white blood cells) or
• Pulmonary embolism (blood clot in the lung) or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

• Kidney disease (eg, patients receiving dialysis) or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

It is very important that you understand the rules of the Pomalyst® REMS program. Read the patient Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. You might be asked to sign a form to show that you understand the information.

Swallow the capsule whole with water. Do not break, chew, or open it. If you accidentally open or handle the medicine in the capsule, wash your skin with soap and water right away.

You may take this medicine with or without food.

If you are on dialysis, take this medicine after receiving dialysis, on dialysis days.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For multiple myeloma:
    • Adults—At first, 4 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated. This medicine is usually taken on days 1 to 21 of a 28-day cycle. This schedule is repeated again every 28 days.
    • Children—Use and dose must be determined by your doctor.
  • For Kaposi sarcoma:
    • Adults—At first, 5 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated. This medicine is usually taken on days 1 to 21 of a 28-day cycle. This schedule is repeated again every 28 days.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of this medicine and it is less than 12 hours since your regular time, take it as soon as you can and take your next dose at the normal time. If you miss a dose and it is more than 12 hours since your regular time, skip the missed dose and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Return unused capsules to your doctor or pharmacist.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to see if it is working properly and to allow for a change in the dose. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Pregnancy tests are required before and during treatment with this medicine. Women who are sexually active must use 2 forms of effective birth control together to avoid pregnancy. You should begin using birth control 4 weeks before starting treatment with this medicine. Continue the birth control during treatment, even if the dose is stopped for a short time, and for at least 4 weeks after your last dose. Talk to your doctor about the most effective forms of birth control for you and your partner. Call your doctor right away if you think you are pregnant.

Men who are sexually active must protect their female partner from getting pregnant. Pomalidomide will appear in the semen so male patients must not donate sperm. If you are sexually active, you must use a latex or synthetic condom every time you have sex with a woman who could get pregnant even if you have had a vasectomy. Use a condom for sex during treatment with this medicine, even if the dose is stopped for a short time, and for at least 4 weeks after your last dose. Call your doctor right away if you think your sexual partner may be pregnant.

Do not donate blood while you are taking this medicine and for at least 4 weeks after your last dose.

Using this medicine may increase your risk for having blood clots (eg, deep vein thrombosis, pulmonary embolism, stroke, or heart attack). Your risk for these serious problems is even greater if you have high blood pressure or high cholesterol, or if you smoke cigarettes. Contact your doctor right away if you experience chest pain, confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscle, or an inability to speak.

Do not receive pembrolizumab together with pomalidomide or similar medicines and dexamethasone.

Pomalidomide can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious allergic reactions, including anaphylaxis or angioedema, which may be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, dizziness, fainting, fast heartbeat, trouble breathing or swallowing, or chest tightness while you are using this medicine.

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, cough, sore throat, trouble breathing or swallowing, swelling of your hands, face, mouth, or throat, swollen, painful, or tender lymph glands in the neck, armpit, or groin, or yellow skin or eyes while using this medicine.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

This medicine may cause nerve damage. Check with your doctor right away if you have tingling, burning, numbness, or pain in your hands or feet. These could be symptoms of a nerve condition called peripheral neuropathy.

Pomalidomide may increase your risk of having new cancers (eg, acute myelogenous leukemia). Talk with your doctor about this risk.

This medicine may make you dizzy or confused. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Talk with your doctor before using this medicine if you plan to have children. Some women who use this medicine have become infertile (unable to have children).

Avoid cigarette smoking while using this medicine. The blood level may be lower than normal if you smoke.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Black, tarry stools

bladder pain

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine or stools

bloody nose

body aches or pain

burning, numbness, tingling, or painful sensations

chest pain

chills

cloudy urine

confusion

constipation

cough

decreased or increased urination

difficult, burning, or painful urination

difficulty with breathing

discouragement

dizziness

dry mouth

ear congestion

fast or irregular heartbeat

feeling sad or empty

fever

frequent urge to urinate

headache

incoherent speech

increased thirst

irritability

lack of appetite

loss of appetite

loss of interest or pleasure

loss of voice

lower back or side pain

metallic taste

muscle pain or cramps

muscle weakness

nasal congestion

nausea

numbness or tingling in the hands, feet, or lips

pain

pale skin

pinpoint red spots on the skin

rapid weight gain

runny nose

shakiness in the legs, arms, hands, or feet

sneezing

sore throat

stomach pain

tightness in the chest

trembling or shaking of the hands or feet

trouble concentrating

trouble sleeping

troubled breathing with exertion

ulcers, sores, or white spots in the mouth

unsteadiness or awkwardness

unusual bleeding or bruising

unusual weight gain or loss

vomiting

weakness in the arms, hands, legs, or feet

Less common

Anxiety

dizziness or lightheadedness

fainting

pain, redness, or swelling in the arm or leg

troubled breathing

Incidence not known

Blistering, peeling, or loosening of the skin

diarrhea

difficulty in passing urine (dribbling)

itching

joint pain

red skin lesions, often with a purple center

red, irritated eyes

unusual tiredness or weakness

weakness or heaviness of the legs

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

blurred vision

decreased appetite

difficulty with moving

flushed, dry skin

fruit-like breath odor

increased hunger

increased sweating

lack or loss of strength

muscle spasms or stiffness

night sweats

rash

Incidence not known

Feeling of constant movement of self or surroundings

sensation of spinning

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.