Pomalidomide is a potent immunomodulatory agent used for the treatment of specific hematologic malignancies and sarcomas.
I. Indications for Pomalidomide
1. Multiple Myeloma
Pomalidomide in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor, and who have demonstrated disease progression on or within 60 days of completion of the last therapy.
2. Kaposi Sarcoma
(1) Pomalidomide as a single agent is indicated for two types of Kaposi sarcoma patients: those with AIDS-related Kaposi sarcoma who have failed highly active antiretroviral therapy, and patients with HIV-negative Kaposi sarcoma.
(2) This indication is approved under accelerated approval based on overall response rate; confirmatory trials are required to verify clinical benefit.
II. Contraindications and Prohibited Foods for Pomalidomide
1. Absolute Contraindications
(1) Pregnancy: Absolutely contraindicated in pregnant women. Pomalidomide is a thalidomide analogue, and animal studies have confirmed its teratogenic potential, which may cause severe birth defects or embryo-fetal death.
(2) Hypersensitivity: Contraindicated in patients with a history of severe allergic reactions to pomalidomide or any of its excipients, including angioedema, anaphylactic shock, etc.
2. Prohibited Behaviors and Foods
(1) Blood and Sperm Donation: Patients must refrain from donating blood or sperm during treatment and for 4 weeks after discontinuation, as the drug is present in blood and semen and may cause harm to the fetus of a pregnant woman.
(2) Unprotected Sexual Intercourse: Females of childbearing potential must abstain from sexual intercourse or use two reliable methods of contraception; males must use a condom even if they have had a vasectomy.
(3) Smoking: Smoking may reduce pomalidomide blood concentrations by approximately 32%, potentially affecting efficacy; smoking cessation is recommended during treatment.
III. Use in Special Populations
1. Females of Childbearing Potential
(1) Two pregnancy tests must be performed before initiating treatment (first test 10-14 days in advance, second test within 24 hours prior to prescribing).
(2) Two effective contraceptive methods must be used simultaneously during treatment and for 4 weeks after discontinuation.
(3) Pregnancy testing weekly during the first month of treatment, then monthly for those with regular menses, and every two weeks for those with irregular menses.
2. Male Patients
The drug can be present in semen; therefore, during treatment and for 4 weeks after discontinuation, male patients must use a latex or synthetic condom during any sexual contact with females of childbearing potential and must not donate sperm.
3. Renal Impairment
(1) For patients with severe renal impairment requiring dialysis, the dose for multiple myeloma patients is reduced to 3 mg daily, and for Kaposi sarcoma patients reduced to 4 mg daily.
(2) On dialysis days, the drug should be taken after dialysis is completed.
4. Hepatic Impairment
(1) For multiple myeloma patients with mild to moderate hepatic impairment (Child-Pugh class A or B), the dose is reduced to 3 mg daily; for severe hepatic impairment (class C), reduced to 2 mg daily.
(2) For Kaposi sarcoma patients with any degree of hepatic impairment, the dose is reduced to 3 mg daily.
5. Breastfeeding Women
(1) It is recommended to discontinue breastfeeding during treatment.
(2) Animal studies show that pomalidomide is excreted in breast milk; the potential risk to human infants is unknown.
6. Elderly and Pediatric Patients
(1) No overall differences in efficacy were observed between elderly patients aged 65 years and older compared to younger patients, but the incidence of pneumonia is higher.
(2) The safety and efficacy of pomalidomide in pediatric patients have not been established.


