Pomalidomide

What is Pomalidomide?

• Pomalidomide (Pomalyst) is a thalidomide analogue used to treat Multiple myeloma, AIDS-related Kaposi sarcoma (KS),KS who do not have HIV infection (HIV negative).

What are the uses of this medicine?

Pomalidomide (Pomalyst) is used to treat adults with: Multiple myelomaː Pomalyst is taken along with the medicine dexamethasone, in people who:

• have received at least 2 prior medicines to treat multiple myeloma, including a type of medicine known as a proteasome inhibitor and lenalidomide, and
• their disease has become worse during treatment or within 60 days of finishing the last treatment

AIDS-related Kaposi sarcoma (KS)ː

• 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)

How does this medicine work?

• Pomalidomide (pom" a lid' oh mide) is a thalidomide derivative (3-amino-thalidomide) similar to lenalidomide that has potent immunomodulatory and antiangiogenic activity and is used as an antineoplastic agent.
• In vitro and in animal models, pomalidomide has greater antineoplastic activity and is less toxic than thalidomide and lenalidomide, but direct comparisons of these agents in humans have not been done.

Who Should Not Use this medicine ?

This medicine cannot be used:

• in females who are pregnant
• in patients who have demonstrated severe hypersensitivity (e.g., angioedema, anaphylaxis) to pomalidomide or any of the excipients

What drug interactions can this medicine cause?

• Avoid co-administration of strong CYP1A2 inhibitors (e.g. ciprofloxacin and fluvoxamine). If co-administration is unavoidable, reduce the Pomalyst dose.

Is this medicine FDA approved?

• FDA approved this drug in the year of 2013.

How should this medicine be used?

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

Recommended Dosage: 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 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 Multiple Myeloma

• 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.

Kaposi Sarcoma

• 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.

Administration

• Take Pomalyst exactly as prescribed and follow all the instructions of the Pomalyst REMS program.
• Swallow Pomalyst capsules whole with water 1 time a day. Do not break, chew, or open your capsules.
• Pomalyst may be taken with or without food.
• Take Pomalyst at about the same time each day.
• If you are on hemodialysis, take Pomalyst after hemodialysis, on hemodialysis days.
• Do not open the Pomalyst capsules or handle them any more than needed. If you touch a broken Pomalyst capsule or the medicine in the capsule, wash the area of your body right away with soap and water.
• If you miss a dose of Pomalyst and it has been less than 12 hours since your regular time, take it as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.
• If you take too much Pomalyst, call your healthcare provider right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 1 mg, 2 mg, 3 mg, and 4 mg

This medicine is available in fallowing brand namesː

• Pomalyst

What side effects can this medication cause?

The most common side effects of Pomalyst in people with Multiple Myeloma include:

• tiredness and weakness
• constipation
• nausea
• diarrhea
• shortness of breath
• upper respiratory tract infection
• back pain
• fever

The most common side effects of Pomalyst in people with KS include:

• tiredness
• diarrhea
• abnormal kidney function tests
• decreased phosphate and calcium in the blood
• rash
• nausea
• constipation
• increased blood sugar
• decreased albumin in the blood

Pomalyst can cause serious side effects, including:

• Possible birth defects (deformed babies) or death of an unborn baby
• Blood clots in your arteries, veins, and lungs, heart attack, and stroke can happen if you take Pomalyst
• Low white blood cells (neutropenia), low platelets (thrombocytopenia), and low red blood cells (anemia) are common with Pomalyst, but can also be serious
• Severe liver problems, including liver failure and death
• Severe allergic reactions and severe skin reactions
• Dizziness and confusion
• Nerve damage
• Risk of new cancers (malignancies)
• Tumor lysis syndrome (TLS)

What special precautions should I follow?

• Do not get pregnant and do not breastfeed while taking Pomalyst.
• Do not donate sperm.
• Do not share Pomalyst with other people. It may cause birth defects and other serious problems.
• Do not donate blood while you take Pomalyst, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping Pomalyst. If someone who is pregnant gets your donated blood, her baby may be exposed to Pomalyst and may be born with birth defects.
• Pomalyst can cause dizziness and confusion. Avoid taking other medicines that may cause dizziness and confusion during treatment with Pomalyst. Avoid situations that require you to be alert until you know how Pomalyst affects you.
• Increased Mortality was observed in patients with MM when pembrolizumab was added to dexamethasone and a thalidomide analogue.
• Neutropenia was the most frequently reported Grade 3/4 adverse event. Monitor patients for hematologic toxicities, especially neutropenia.
• Hepatotoxicity may occur. Hepatic failure including fatalities; monitor liver function tests monthly.
• Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. Discontinue Pomalyst for severe reactions.
• Tumor lysis syndrome (TLS) may occur in patients treated with Pomalyst. Monitor patients at risk of TLS (i.e., those with high tumor burden) and take appropriate precautions.
• Hypersensitivity, including angioedema, anaphylaxis, and anaphylactic reactions to Pomalyst have been reported. Permanently discontinue Pomalyst for angioedema or anaphylaxis.

What to do in case of emergency/overdose?

Management for overdosage:

• Hemodialysis can remove pomalidomide from circulation.

Can this medicine be used in pregnancy?

• Pomalyst can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy.

Can this medicine be used in children?

• The safety and effectiveness of Pomalyst have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient: pomalidomide Inactive ingredients: mannitol, pregelatinized starch, and sodium stearyl fumarate. The 1-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, white ink, and black ink. The 2-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, FD&C red 3, and white ink. The 3-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, and white ink. The 4-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 1, FD&C blue 2, and white ink.

Who manufactures and distributes this medicine?

• Manufactured for: Celgene Corporation, Summit, NJ

What should I know about storage and disposal of this medication?

• Store Pomalyst at room temperature between 68°F to 77°F (20°C to 25°C).
• Return any unused Pomalyst to Celgene or your healthcare provider.
• Keep Pomalyst and all medicines out of the reach of children.

• Dailymed label info on Pomalidomide
• FDA Pomalidomide

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