Pomaloz
Pomalidomide Capsules
Strength
✓1 mg✓2 mg✓4 mg
Pack Size
Capsule
Drug Class
Immunosuppressants, Other immunosuppressants
Specification
USP/BP/IH Specs offered for exports
Storage
Store at 25°C to 30°C.
Pomalidomide is a thalidomide analog.
Chemical name
(RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione
Empirical formula
C13H11N3O4
Molecular weight
273.24
Pomalidomide is a yellow solid powder.
It has
- limited to low solubility into organic solvents
- low solubility in all pH solutions (about 0.01 mg/mL)
Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers.
1. Multiple Myeloma
Pomalidomide in combination with dexamethasone is indicated for adult patients with multiple myeloma who have received at least two prior therapies including:
- lenalidomide
- a proteasome inhibitor
Patients should have demonstrated disease progression on or within 60 days of completion of the last therapy.
2. Kaposi Sarcoma
Pomalidomide is indicated for treatment of
- Adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy (HAART)
- Kaposi sarcoma in adult patients who are HIV-negative
This indication is approved under accelerated approval based on overall response rate.
Pomalidomide is used to treat multiple myeloma, a cancer resulting from a progressive blood disease.
It is generally used after at least two other medications have been tried without success.
Pomalidomide is also used to treat AIDS-related Kaposi sarcoma when other medications did not work or stopped working.
It can also be used to treat Kaposi Sarcoma in HIV-negative adults.
Pomalidomide is available only from a certified pharmacy under a special program requiring patient registration and compliance with birth control measures.
- Pomalidomide is contraindicated in pregnancy.
- It is a thalidomide analogue and may cause:
- severe birth defects
- embryo-fetal death
- Females of reproductive potential must:
- obtain 2 negative pregnancy tests before starting therapy
- use 2 forms of contraception
- or continuously abstain from heterosexual intercourse
- Contraception should continue during treatment and for 4 weeks after stopping treatment.
2.1 Pregnancy Testing Prior to Administration
- Females of reproductive potential must have negative pregnancy testing before initiating treatment.
- Appropriate contraception methods must be used.
2.2 Recommended Dosage for Multiple Myeloma
- Recommended dose:
- 4 mg once daily orally
- With or without food
- On Days 1 through 21 of each 28-day cycle
- Continue treatment until:
- disease progression
- unacceptable toxicity
- Pomalidomide should be given in combination with dexamethasone.
2.3 Recommended Dosage for Kaposi Sarcoma
- Recommended dose:
- 5 mg once daily orally
- With or without food
- On Days 1 through 21 of each 28-day cycle
- Continue until:
- disease progression
- unacceptable toxicity
- Continue HAART in patients with AIDS-related Kaposi sarcoma.
2.4 Dosage Modifications for Hematologic Adverse Reactions
- Initiate a new cycle in multiple myeloma patients when:
- neutrophil count is at least 500 per mcL
- platelet count is at least 50,000 per mcL