Pomalidomide

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Dosage Forms & Strengths

capsule

• 1mg
• 2mg
• 3mg
• 4mg

Multiple Myeloma

Thalidomide analogue, in combination with dexamethasone, is indicated for multiple myeloma in patients who have received at least 2 prior therapies (including lenalidomide and a proteasome inhibitor) and have disease progression on or within 60 days of completion of the last therapy

4 mg PO qDay on days 1-21 of repeated 28-day cycles until disease progression; give in combination with low-dose dexamethasone

Low-dose dexamethasone

• Give PO only on Days 1, 8, 15, and 22 of each 28-day cycle
• ≤75 years: 40 mg/day
• >75 years: 20 mg/day

Dosage Modifications

Discontinue treatment if toxicities continue to occur after dose reductions to 1 mg

Neutropenia

• ANC <500/mcL or febrile neutropenia (ie, fever ≤38.5°C and ANC <1,000/mcL): Interrupt treatment and follow CBC weekly, may resume at 3 mg/day if ANC returns to ≥500/mcL
• For each subsequent drop <500/mcL: Interrupt treatment, may resume at 1 mg less than previous dose if ANC returns to ≥500/mcL

Thrombocytopenia

• Platelets <25,000/mcL: Interrupt treatment and follow CBC weekly, may resume at 3 mg/day if platelets returns to ≥50,000/mcL
• For each subsequent drop <25,000/mcL: Interrupt treatment, may resume at 1 mg less than previous dose if platelets returns to ≥50,000/mcL

Other

• Permanently discontinue for angioedema, skin exfoliation, bullae, or any other severe dermatologic reaction
• For other grade 3 or 4 toxicities, hold treatment and restart treatment at 1 mg less than the previous dose when toxicity has resolved to less than or equal to Grade 2 at the physician’s discretion

Renal & hepatic impairment

• Avoid use if serum creatinine >3 mg/dL
• Avoid use if serum bilirubin >2 mg/dL and AST/ALT >3x ULN

Dosing Considerations

Females of reproductive potential must have negative pregnancy testing and use contraception methods before initiating

To initiate a new cycle, the neutrophil count must be ≥500/mcL and the platelet count must be ≥50,000/mcL

Systemic Sclerosis (Orphan)

Orphan designation for treatment of systemic sclerosis

Orphan sponsor

• Celgene Corporation; 86 Morris Avenue; Summit, NJ 07901

<18 years: Safety and efficacy not established

Pomalidomide may cause serious side effects, including:

• see "Drug Precautions"
• low white blood cells (neutropenia), low platelets (thrombocytopenia) and low red blood cells (anemia)

The most common side effects of pomalidomide include:

• tiredness and weakness
• constipation
• shortness of breath
• diarrhea
• fever
• back pain
• nausea

This is not a complete list of pomalidomide side effects.  Ask your doctor or pharmacist for more information.

Do not take pomalidomide if you are pregnant, plan to become pregnant, or become pregnant during treatment with pomalidomide.

Males, including those who have had a vasectomy, must use a latex or synthetic condom during any sexual contact with a female, while taking pomalidomide, during any breaks (interruptions) in your treatment with pomalidomide, and for 4 weeks after stopping pomalidomide. Males should not donate sperm during treatment, and for 4 weeks after stopping pomalidomide. Notify your healthcare provider right away if your female partner becomes pregnant.

Pomalidomide may cause serious side effects including:

• Birth defects (deformed babies) or death of an unborn baby.
• Blood clots in your veins and lungs. Symptoms include:
  • shortness of breath
  • chest pain
  • arm or leg swelling

Store pomalidomide at room temperature, between 59° and 86°F.

Return unused medication to the manufacturer or your healthcare provider.

Keep this and all medications out of the reach of children.

WARNING: EMBRYO-FETAL TOXICITY and VENOUS THROMBOEMBOLISM

Embryo-Fetal Toxicity

• Pomalyst is contraindicated in pregnancy. Pomalyst is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting Pomalyst treatment.
• Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping Pomalyst treatment.

Pomalyst is only available through a restricted distribution program called Pomalyst REMS.

Venous Thromboembolism

• Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE) occur in patients with multiple myeloma treated with Pomalyst. Prophylactic anti-thrombotic measures were employed in the clinical trial. Consider prophylactic measures after assessing an individual patient’s underlying risk factors.

Never use pomalidomide if you are pregnant. Even one dose of pomalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medicine at the time of conception or during pregnancy.

Use birth control to prevent pregnancy, whether you are a man or a woman. For women: Use two forms of birth control beginning 4 weeks before you start taking pomalidomide and ending 4 weeks after you stop taking it. For men: Use a condom to prevent pregnancy during your treatment, and for up to 28 days after your treatment ends.

Pomalidomide may cause blood clots. Stop using pomalidomide and call your doctor at once if you have symptoms such as chest pain, wheezing, coughing up blood, or if you have pain, swelling, warmth, or redness in one or both legs.

Biologic response modifier; thalidomide analog with immunomodulatory, antineoplastic, and antiangiogenic activity.1 13 14 17

In the U.S.

• Pomalyst

Available Dosage Forms:

• Capsule

Take pomalidomide 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.

The medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Take pomalidomide with water and on an empty stomach, at least 2 hours before or 2 hours after a meal. Take pomalidomide at about the same time each day.

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

Dosing

The dose of pomalidomide 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 pomalidomide. 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. pomalidomide 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 pomalidomide, 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 pomalidomide 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.

• Tell all of your health care providers that you take pomalidomide. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• Do not donate blood while using pomalidomide and for 1 month after stopping.
• If you smoke, talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.
• Patients with cancer who take this medicine may be at a greater risk of getting a bad health problem called tumor lysis syndrome (TLS). Sometimes, this has been deadly. Call your doctor right away if you have a fast heartbeat or a heartbeat that does not feel normal; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, loose stools, or not able to eat; or feel sluggish.
• This medicine may add to the chance of getting some types of cancer. Talk with the doctor.
• If you are 65 or older, use pomalidomide with care. You could have more side effects.
• This medicine may cause you to not be able to get pregnant. Talk with the doctor.
• If you have sex without using 2 kinds of birth control that you can trust, if you think you may be pregnant, or if you miss your period, call your doctor right away.
• 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 during care, during any breaks in care, and for at least 4 weeks after care ends.
• If you are a man and have unprotected sex with a female who is or could get pregnant, or your female partner gets pregnant within 4 weeks of your last dose, call your doctor right away.
• If you are a man, do not donate sperm while using this medicine and for 1 month after stopping.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time pomalidomide is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take pomalidomide or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 pomalidomide. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Applies to pomalidomide: oral capsule

Cardiovascular

Common (1% to 10%): Thromboembolic events (venous: deep vein thrombosis, pulmonary embolism; and arterial: myocardial infarction, stroke), cardiac failure
Frequency not reported: Atrial fibrillation, angina pectoris, congestive cardiac failure, hypotension[Ref]

Hematologic

Very common (10% or more): Neutropenia (up to 53.3%), anemia (up to 45.7%), thrombocytopenia (up to 27%), leukopenia (up to 19.6%), lymphopenia (up to 15.2%)
Common (1% to 10%): Febrile neutropenia, neutropenic sepsis, sepsis, decreased neutrophil count, decreased white blood cell count, decreased platelet count, pancytopenia
Frequency not reported: Decreased lymphocyte count, septic shock, decreased hemoglobin[Ref]

Hepatic

Common (1% to 10%): Increased ALT
Uncommon (0.1% to 1%): Hepatitis, hyperbilirubinemia
Frequency not reported: Increased AST
Postmarketing reports: Hepatic failure[Ref]

Hypersensitivity

Postmarketing reports: Allergic reactions (e.g. angioedema, urticaria)[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 22.4%), peripheral neuropathy (up to 21.5%), neuropathy (up to 18%), headache (up to 15%), tremor (up to 13.4%), confusional state (up to 13.4%)
Common (1% to 10%): Depressed level of consciousness, vertigo
Frequency not reported: Syncope[Ref]

Oncologic

Frequency not reported: Second primary malignancies (e.g., acute myelogenous leukemia)
Postmarketing reports: Tumor lysis syndrome[Ref]

Respiratory

Very common (10% or more): Dyspnea (up to 44.6%), upper respiratory tract infection (up to 37.4%), pneumonia (33.9%), cough (up to 22.3%), epistaxis (up to 16.8%), productive cough (up to 12.5%), oropharyngeal pain (up to 10.7%)
Common (1% to 10%): Interstitial lung disease, bronchopneumonia, bronchitis, nasopharyngitis, epistaxis
Frequency not reported: Pneumonitis, chronic obstructive pulmonary disease, pneumocystis jiroveci pneumonia, respiratory syncytial viral, pneumonia streptococcal, lobar pneumonia, lung infection, respiratory failure, bronchospasm[Ref]

Dermatologic

Very common (10% or more): Rash (up to 20.6%), hyperhidrosis (up to 16.1%), pruritus (up to 15%), night sweats (up to 12.5%), dry skin (up to 10.7%)
Frequency not reported: Cellulitis[Ref]

Gastrointestinal

Very common (10% or more): Constipation (up to 36.6%), nausea (up to 36.4%), diarrhea (up to 35.7%), vomiting (up to 14.3%)
Very rare (less than 0.01%): Clostridium difficile colitis
Frequency not reported: Abdominal pain[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (up to 17%)
Common (1% to 10%): Urinary retention, pelvic pain
Frequency not reported: Urosepsis[Ref]

Metabolic

Very common (10% or more): Decreased appetite (up to 23.4%), hypercalcemia (up to 21.5%), hyperglycemia (up to 15.2%), decreased weight (up to 15%), hyponatremia (up to 12.5%), hypokalemia (up to 12.1%), hypocalcemia (up to 11.6%), increased weight (up to 10.7%)
Common (1% to 10%): Dehydration, hyperkalemia
Frequency not reported: Failure to thrive[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 34.6%), musculoskeletal chest pain (23.4%), muscle spasms (21.5%), bone pain (up to 18%), arthralgia (up to 16.8%), muscular weakness (up to 14%), musculoskeletal pain (up to 12.1%)
Common (1% to 10%): Extremity pain
Frequency not reported: Femur fracture, fall, compression fracture, spinal compression fracture[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 16.1%), anxiety (up to 13.1%)
Frequency not reported: Mental status change[Ref]

Renal

Very common (10% or more): Increased blood creatinine (up to 18.7%), renal failure (up to 15%)[Ref]

Other

Very common (10% or more): Fatigue and asthenia (up to 62.5%), infection (up to 55%), pyrexia (up to 32.1%), peripheral edema (up to 25.2%), chills (up to 12.5%)
Frequency not reported: Pain, general physical health deterioration, non-cardiac chest pain, multi-organ failure, viral infection[Ref]

Some side effects of pomalidomide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

US REMS: The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for this drug. It includes elements to assure safe use and an implementation system. For additional information: www.fda.gov/REMS.

US BOXED WARNING:
-EMBRYOFETAL TOXICITY: Pomalidomide is contradicted in pregnancy. This drug is an analog of thalidomide, a known human teratogen that causes severe birth defects or embryo-fetal death. Females of reproductive potential must have 2 negative pregnancy tests before starting treatment, and they must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping treatment. This drug is only available through a restricted distribution program.

-VENOUS AND ARTERIAL THROMBOEMBOLISM: Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in multiple myeloma patients treated with this drug. Thromboprophylaxis is recommended; the choice of regimen should be based on assessment of a patient's underlying risk factors.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.