Adult Dosing

Multiple myeloma

• 4 mg PO qday on days 1-21 of repeated 28-day cycles until disease progression

Note:

• In the presence of strong inhibitors of CYP3A4, CYP1A2, reduce dose by 50%

Pediatric Dosing

• Safety and efficacy have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Multiple myeloma
• Indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy

• Hypersensitivity to any of the ingredients of the product
• Pregnancy

• Use is contraindicated in pregnancy. Pomalidomide is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe life-threatening birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting treatment
• Exclude pregnancy before start of treatment in females of reproductive potential. Prevent pregnancy during treatment by the use of two reliable methods of contraception
• Only available from a restricted distribution program
• Deep venous thrombosis (DVT) and pulmonary embolism (PE) have occured in multiple myeloma patients treated with pomalidomide. Consider prophylactic measures after assessing an individual patient’s underlying risk factors

Renal Dose Adjustment (Based on CrCl)

• Renal impairment: Dose adjustments not defined; avoid in patients with a serum creatinine greater than 3.0 mg/dL

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined; avoid in patients with a serum bilirubin greater than 2.0 mg/dL and AST/ALT greater than 3.0 x ULN

• Use is contraindicated in pregnancy. Pomalidomide is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe life-threatening birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting treatment [US black box warning]
• Exclude pregnancy before start of treatment in females of reproductive potential. Prevent pregnancy during treatment by the use of two reliable methods of contraception [US black box warning]
• Only available from a restricted distribution program [US black box warning]
• Deep venous thrombosis (DVT) and pulmonary embolism (PE) have occured in multiple myeloma patients treated with pomalidomide. Consider prophylactic measures after assessing an individual patient’s underlying risk factors [US black box warning]
• Therapy may lead to neutropenia, followed by anemia and thrombocytopenia. Closely monitor patients for hematologic toxicities, especially neutropenia
• Monitor complete blood counts weekly for the first 8 weeks and monthly thereafter
• Advise patients to avoid situations where dizziness or confusion may be a problem and not to take other medications that may cause dizziness or confusion without adequate medical advice

Pregnancy Category:X

Breastfeeding: It is not known if pomalidomide is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

• CNS: Fatigue, asthenia, pyrexia, chills, insomnia, dizziness, tremor, headache
• PSYCHIATRY: Confusional state, anxiety
• NEURO: Neuropathy
• MUSC: Pain, back pain, musculoskeletal chest pain, muscle spasms, arthralgia, musculoskeletal pain, pain in extremity, muscular weakness, bone pain
• HEMA: Neutropenia, anemia, thrombocytopenia, leukopenia, lymphopenia
• GI: Constipation, diarrhea, nausea, vomiting
• DERM: Hyperhidrosis, rash, night sweats, dry skin, pruritus
• RESP: Pneumonia, upper respiratory tract infection
• EENT: Dyspnea, cough, epistaxis
• GU: Urinary tract infection, renal failure
• METABOLISM: Decreased appetite, weight increased, hyperglycemia, hyponatremia, hypercalcemia, hypocalcemia, hypokalemia
• LAB TESTS: Blood creatinine increased

• Immunomodulatory agent; elicits immunomodulatory and antineoplastic activity; it inhibits proliferation and induced apoptosis of hematopoietic tumor cells. It also enhances T cell- and natural killer (NK) cell-mediated immunity and inhibits production of pro-inflammatory cytokines
• Metabolism: Metabolized in liver by CYP1A2 and CYP3A4
• Excretion: 73% urine (2% unchanged); 15% feces (8% unchanged)
• Half-life: Approximately 9.5 hours in healthy subjects; 7.5 hours in patients with multiple myeloma

US Trade Name(s)

• Pomalyst

US Availability

Pomalyst

• CAPS: 1, 2, 3, 4 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Hematology/Oncology

Antineoplastics

Immunomodulatory Agents