Pomalyst Dosage

Generic name: POMALIDOMIDE 1mg
Dosage form: capsule
Drug classes: Miscellaneous antineoplastics, Other immunosuppressants

Medically reviewed by Drugs.com. Last updated on Mar 24, 2023.

Pregnancy Testing Prior to Administration

Females of reproductive potential must have negative pregnancy testing and use contraception methods before initiating POMALYST [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1, 8.3)].

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 [see Clinical Studies (14.1)].

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) [see Clinical Studies (14.2)].

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
Neutropenia [see Warnings and Precautions (5.5)]	• ANC less than 500 per mcL or febrile neutropenia (fever greater than or equal to 38.5°C and ANC less than 1,000 per mcL)	• Withhold POMALYST until ANC is greater than or equal to 500 per mcL; follow CBC weekly. • Resume POMALYST dose at 1 mg less than the previous dose.*
Neutropenia [see Warnings and Precautions (5.5)]	• For each subsequent drop of ANC less than 500 per mcL	• Withhold POMALYST until ANC is greater than or equal to 500 mcL. • Resume POMALYST dose at 1 mg less than the previous dose.*
Thrombocytopenia [see Warnings and Precautions (5.5)]	• Platelets less than 25,000 per mcL	• Withhold POMALYST until platelets are greater than or equal to 50,000 per mcL; follow CBC weekly. • Resume POMALYST dose at 1 mg less than the previous dose*
Thrombocytopenia [see Warnings and Precautions (5.5)]	• For each subsequent drop of platelets less than 25,000 per mcL	• Withhold POMALYST until platelets are greater than or equal to 50,000 per mcL. • Resume POMALYST at 1 mg less than the previous dose*

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
* Permanently discontinue POMALYST if unable to tolerate 1mg once daily. ANC= absolute neutrophil count
Neutropenia [see Warnings and Precautions (5.5)]	ANC 500 to less than 1,000 per mcL	Day 1 of cycle • Withhold POMALYST until ANC is greater than or equal to 1,000 per mcL. • Resume POMALYST at the same dose. During cycle • Continue POMALYST at the current dose.
Neutropenia [see Warnings and Precautions (5.5)]	ANC less than 500 per mcL	• Withhold POMALYST until ANC is greater than or equal to 1,000 per mcL. • Resume POMALYST at the same dose.
Febrile Neutropenia [see Warnings and Precautions (5.5)]	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 38°C for more than 1 hour	• Withhold POMALYST until ANC is greater than or equal to 1,000 per mcL. • Resume POMALYST at dose 1 mg less than the previous dose.*
Thrombocytopenia [see Warnings and Precautions (5.5)]	Platelet count 25,000 to less than 50,000 per mcL	Day 1 of cycle • Withhold POMALYST until platelet count is greater than or equal to 50,000 per mcL. • Resume POMALYST at the same dose. During cycle: • Continue POMALYST at the current dose.
Thrombocytopenia [see Warnings and Precautions (5.5)]	Platelet count less than 25,000 per mcL	Permanently discontinue POMALYST.

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 [See Warnings and Precautions (5.7, 5.12)].

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.

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 [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

Dosage Modification for Severe Renal Impairment on Hemodialysis

Take POMALYST after completion of dialysis procedure on hemodialysis days [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

•: 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 [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

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 [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].