Pomalyst Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
YES
Pomalyst Indications
Indications
Pomalyst Dosage and Administration
Adult
Children
Renal Impairment
In patients with severe renal impairment requiring dialysis, the AUC of pomalidomide increased by 38% and the rate of SAE increased by 64% relative to patients with normal renal function; therefore, starting dose adjustment is recommended. For patients with severe renal impairment requiring dialysis, administer pomalidomide after the completion of hemodialysis on dialysis days because exposure of pomalidomide could be significantly decreased during dialysis.
Hepatic Impairment
Pomalidomide is metabolized primarily by the liver. Following single dose administration, the AUC of pomalidomide increased 51%, 58%, and 72% in subjects with mild (Child-Pugh class A), moderate (Child-Pugh class B), and severe (Child-Pugh class C) hepatic impairment, respectively compared to subjects with normal liver function. Dose adjustment is recommended in patients with hepatic impairment.
Pomalyst Contraindications
Contraindications
Pomalyst Boxed Warnings
Boxed Warning
Pomalyst Warnings/Precautions
Warnings/Precautions
REMS
Pomalyst Pharmacokinetics
Absorption
Following administration of single oral doses of pomalidomide, the maximum plasma concentration (Cmax) for pomalidomide occurs at 2 to 3 hours postdose in patients with MM or KS.
Distribution
Human plasma protein binding of pomalidomide ranges from 12% to 44% and is not concentration dependent.
Elimination
Pomalidomide is eliminated with a median plasma half-life of 9.5 hours in healthy subjects and 7.5 hours in patients with MM or KS.
Following a single oral administration of [14C]-pomalidomide to healthy subjects, ~73% and 15% of the radioactive dose was eliminated in urine and feces, respectively, with ~2% and 8% of the radiolabeled dose eliminated unchanged as pomalidomide in urine and feces.
Pomalyst Interactions
Interactions
Pomalyst Adverse Reactions
Adverse Reactions
Pomalyst Clinical Trials
Pomalyst Note
Notes
Available only through Pomalyst REMS program. More information about the Pomalyst REMS program is available at www.celgeneriskmanagement.com or call (888) 423-5436.
Pomalyst Patient Counseling
Cost Savings Program
The Pomalyst savings program is available here.
Pomalyst Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
YES
Pomalyst Indications
Indications
Pomalyst Dosage and Administration
Adult
Children
Renal Impairment
In patients with severe renal impairment requiring dialysis, the AUC of pomalidomide increased by 38% and the rate of SAE increased by 64% relative to patients with normal renal function; therefore, starting dose adjustment is recommended. For patients with severe renal impairment requiring dialysis, administer pomalidomide after the completion of hemodialysis on dialysis days because exposure of pomalidomide could be significantly decreased during dialysis.
Hepatic Impairment
Pomalidomide is metabolized primarily by the liver. Following single dose administration, the AUC of pomalidomide increased 51%, 58%, and 72% in subjects with mild (Child-Pugh class A), moderate (Child-Pugh class B), and severe (Child-Pugh class C) hepatic impairment, respectively compared to subjects with normal liver function. Dose adjustment is recommended in patients with hepatic impairment.
Pomalyst Contraindications
Contraindications
Pomalyst Boxed Warnings
Boxed Warning
Pomalyst Warnings/Precautions
Warnings/Precautions
REMS
Pomalyst Pharmacokinetics
Absorption
Following administration of single oral doses of pomalidomide, the maximum plasma concentration (Cmax) for pomalidomide occurs at 2 to 3 hours postdose in patients with MM or KS.
Distribution
Human plasma protein binding of pomalidomide ranges from 12% to 44% and is not concentration dependent.
Elimination
Pomalidomide is eliminated with a median plasma half-life of 9.5 hours in healthy subjects and 7.5 hours in patients with MM or KS.
Following a single oral administration of [14C]-pomalidomide to healthy subjects, ~73% and 15% of the radioactive dose was eliminated in urine and feces, respectively, with ~2% and 8% of the radiolabeled dose eliminated unchanged as pomalidomide in urine and feces.
Pomalyst Interactions
Interactions
Pomalyst Adverse Reactions
Adverse Reactions
Pomalyst Clinical Trials
Pomalyst Note
Notes
Available only through Pomalyst REMS program. More information about the Pomalyst REMS program is available at www.celgeneriskmanagement.com or call (888) 423-5436.
Pomalyst Patient Counseling
Cost Savings Program
The Pomalyst savings program is available here.
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