Generic drug: pomalidomide
Brand name: Pomalyst
What is Pomalyst (pomalidomide), and how does it work?
Pomalyst is a prescription medicine used to treat adults with:
- Multiple myeloma. Pomalyst is taken along with the medicine dexamethasone, in people who:
- AIDS-related Kaposi sarcoma (KS). Pomalyst is taken when highly active antiretroviral therapy (HAART) has not worked well enough or stopped working (failed)
- KS who do not have HIV infection (HIV negative).
It is not known if Pomalyst is safe and effective in children.
Who should not take Pomalyst?
Do not take Pomalyst if you:
- are pregnant, plan to become pregnant, or become pregnant during treatment with Pomalyst.
- are allergic to pomalidomide or any of the ingredients in Pomalyst.
What are the side effects of Pomalyst?
EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM
- 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 and Arterial Thromboembolism
- Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with Pomalyst. Prophylactic antithrombotic measures were employed in clinical trials. Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient's underlying risk factors.
Pomalyst can cause serious side effects, including:
- Low white blood cells (neutropenia), low platelets (thrombocytopenia), and low red blood cells (anemia) are common with Pomalyst, but can also be serious. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your blood counts should be checked weekly for the first 8 weeks of treatment and monthly after that.
- Severe liver problems, including liver failure and death. Your healthcare provider should do blood tests to check your liver function during your treatment with Pomalyst. Tell your healthcare provider right away if you develop any of the following symptoms of liver problems:
- Severe allergic reactions and severe skin reactions can happen with Pomalyst and may cause death.
Call your healthcare provider if you develop any of the following signs or symptoms during treatment with Pomalyst:
Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with Pomalyst:
- Dizziness and confusion.
- Nerve damage. Stop taking Pomalyst and call your healthcare provider if you develop symptoms of nerve damage including: numbness, tingling, pain, burning sensation in your hands, legs, or feet.
- Risk of new cancers (malignancies). New cancers, including certain blood cancers (acute myelogenous leukemia or AML) have been seen in people who received Pomalyst. Talk with your healthcare provider about your risk of developing new cancers if you take Pomalyst.
- Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.
Your healthcare provider may tell you to stop taking Pomalyst if you develop certain serious side effects during treatment.
The most common side effects of Pomalyst in people with Multiple Myeloma include:
- tiredness and weakness
- shortness of breath
- upper respiratory tract infection
- back pain
The most common side effects of Pomalyst in people with KS include:
- abnormal kidney function tests
- decreased phosphate and calcium in the blood
- rash. See “Severe allergic reactions and severe skin reactions” above.
- increased blood sugar
- decreased albumin in the blood
These are not all the possible side effects of Pomalyst.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Pomalyst?
Pregnancy Testing Prior To Administration
- Females of reproductive potential must have negative pregnancy testing and use contraception methods before initiating Pomalyst.
Recommended Dosage For Multiple Myeloma
- The recommended dosage of Pomalyst is 4 mg once daily orally with or without food on Days 1 through 21 of each 28-day cycle until disease progression. Give Pomalyst in combination with dexamethasone.
Recommended Dosage For Kaposi Sarcoma
- The recommended dosage of Pomalyst is 5 mg once daily taken orally with or without food on Days 1 through 21 of each 28-day cycle until disease progression or unacceptable toxicity. Continue HAART as HIV treatment in patients with AIDS-related Kaposi sarcoma (KS).
Dosage Modifications For Hematologic Adverse Reactions
Multiple Myeloma: Dosage Modifications For Hematologic Adverse Reactions
- Initiate a new cycle of Pomalyst in patients with multiple myeloma (MM) when the neutrophil count is at least 500 per mcL and the platelet count is at least 50,000 per mcL.
- Dosage modification for Pomalyst for hematologic adverse reactions in patients with MM are summarized in Table 1.
Table 1: Dosage Modifications for Pomalyst for Hematologic in MM
|Adverse Reaction||Severity||Dosage Modification|
|* Permanently discontinue
Pomalyst if unable to tolerate 1 mg once daily.|
ANC= absolute neutrophil count
Kaposi Sarcoma: Dosage Modifications For Hematologic Adverse Reactions
- Initiate a new cycle of Pomalyst in patients with KS when the neutrophil count is at least 1000 per mcL and the platelet count is at least 75,000 per mcL.
- Dose modifications for Pomalyst for hematologic adverse reactions in patients with KS are summarized in Table 2.
Table 2: Dosage Modifications for Pomalyst for Hematologic Adverse Reactions in KS
|Adverse Reaction||Severity||Dosage Modification|
|Neutropenia||ANC 500 to less than 1,000 per mcL||Day 1 of cycle |
|ANC less than 500 per mcL|
|Febrile Neutropenia||ANC less than 1,000 per mcL and single temperature greater than or equal to 38.3°C or ANC less than 1,000 per mcL and sustained temperature greater than or equal to 38C for more than 1 hour|
|Thrombocytopenia||Platelet count 25,000 to less than 50,000 per mcL||Day 1 of cycle |
|Platelet count less than 25,000 per mcL||Permanently discontinue Pomalyst.|
|* Permanently discontinue
Pomalyst if unable to tolerate 1mg once daily.|
ANC= absolute neutrophil count
Dosage Modifications For Non-Hematologic Adverse Reactions
- Permanently discontinue Pomalyst for angioedema, anaphylaxis, Grade 4 rash, 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 physicianâ€™s discretion.
Dosage Modifications For Strong CYP1A2 Inhibitors
- Avoid concomitant use of Pomalyst with strong CYP1A2 inhibitors. If concomitant use of a strong CYP1A2 inhibitor is unavoidable, reduce Pomalyst dose to 2 mg.
Dosage Modification For Severe Renal Impairment On Hemodialysis
Take Pomalyst after completion of dialysis procedure on hemodialysis days.
- For patients with MM with severe renal impairment requiring dialysis, reduce the recommended dosage to 3 mg orally daily.
- For patients with KS with severe renal impairment requiring dialysis, reduce the recommended dosage to 4 mg orally daily.
Dosage Modification For Hepatic Impairment
- For patients with MM with mild or moderate hepatic impairment (Child-Pugh A or B), reduce the recommended dosage to 3 mg orally daily.
- For patients with MM with severe hepatic impairment (Child-Pugh C), reduce the recommended dosage to 2 mg.
- For patients with KS with mild, moderate, or severe hepatic impairment (Child-Pugh A, B, or C), reduce the recommended dosage to 3 mg orally daily.
- Swallow capsules whole with water. Do not break, chew, or open the capsules. Pomalyst may be taken with or without food.
What drugs interact with Pomalyst?
Drugs That Affect Pomalidomide Plasma Concentrations
- In healthy subjects, co-administration of fluvoxamine, a strong CYP1A2 inhibitor, increased Cmax and AUC of pomalidomide by 24% and 125% respectively.
- Increased pomalidomide exposure may increase the risk of exposure related toxicities.
- Avoid co-administration of strong CYP1A2 inhibitors (e.g. ciprofloxacin and fluvoxamine). If co-administration is unavoidable, reduce the Pomalyst dose.
Is Pomalyst safe to use while pregnant or breastfeeding?
- Based on the mechanism of action and findings from animal studies, Pomalyst can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy.
- There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to Pomalyst during pregnancy as well as female partners of male patients who are exposed to Pomalyst. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to Pomalyst to the FDA via the MedWatch program at 1-800-FDA-1088 and also to Celgene Corporation at 1-888-4235436.
- There is no information regarding the presence of pomalidomide in human milk, the effects of Pomalyst on the breastfed child, or the effects of Pomalyst on milk production.
- Because many drugs are excreted in human milk and because of the potential for adverse reactions in a breastfed child from Pomalyst, women should not breastfeed during treatment with Pomalyst.
Pomalyst is a prescription medicine used to treat adults with multiple myeloma, AIDS-related Kaposi sarcoma (KS), and non-AIDS-related Kaposi sarcoma (KS). Serious side effects include severe birth defects and miscarriage when taken in pregnancy, venous and arterial thromboembolism, low white blood cells (neutropenia), low platelets (thrombocytopenia), low red blood cells (anemia), severe liver problems, and Severe allergic reactions and severe skin reactions.
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Multiple myeloma is a form of cancer that develops in plasma cells, the white blood cells that make antibodies. Symptoms include bone pain, weakness, extreme thirst, nausea, frequent urination, and broken bones. Treatment of multiple myeloma depends upon the staging and symptoms of the disease.
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Though it's difficult to say why some people develop cancer while others don't, research shows that certain risk factors increase a person's odds of developing cancer. These risk factors include growing older, family history of cancer, diet, alcohol and tobacco use, and exposure to sunlight, ionizing radiation, certain chemicals, and some viruses and bacteria.
Multiple Myeloma: Deadly to Chronic
Multiple myeloma is cancer of the plasma cells. The plasma cells are a type of white blood cell present in the bone marrow. Plasma cells are part of the immune system and help fight against infections by producing antibodies that recognize and attack microorganisms. In multiple myeloma, cancer cells accumulate in the bone marrow and replace healthy blood cells.
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AIDS (Acquired Immunodeficiency Syndrome)
AIDS is the advanced stage of HIV infection. Symptoms and signs of AIDS include pneumonia due to Pneumocystis jiroveci, tuberculosis, toxoplasmosis, seizures, weakness, meningitis, yeast infection of the esophagus, and Kaposi's sarcoma. Anti-retroviral therapy (HAART) is used in the treatment of AIDS.
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Kaposi sarcoma (KS) is a form of cancer caused by herpesvirus infection. This virus is known as Kaposi sarcoma-associated herpesvirus (KSHV) or human herpesvirus 8 (HHV-8). Causes of Kaposi sarcoma include immune suppression, HIV infection and certain socioeconomic factors.
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