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Therapeutic Effects: 

· Decreased progression of multiple myeloma.

Distribution: Enters semen.

Metabolism/Excretion: Primarily metabolized in the liver by CYP1A2 and CYP3A4 with some metabolism by CYP2C19 and CYP2D6. Metabolites excreted in urine and feces. Minimal amounts excreted unchanged in urine.

Half-life:  Normal subjects — 9.5 hr; myeloma patients — 7.5 hr.

· Hypersensitivity, cross-sensitivity with thalidomide may occur

· Blood should not be donated

· Serum creatinine >3.0 mg/dL

· Serum bilirubin >2.0 mg/dL and AST/ALT >3.0 × ULN

· OB: May cause fetal harm/death

· Lactation: Should not be used by nursing mothers.

Use Cautiously in: 

· Patients with reproductive potential (pregnancy should be excluded/prevented, contraception should be practiced by both male and female patients)

· Pedi: Safety and effectiveness not established.

Resp: dyspnea.

CV: DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM, MI, STROKE, peripheral edema.

GI: HEPATOTOXICITY, appetite, constipation, diarrhea, nausea, vomiting.

GU: renal failure.

Derm: dry skin, hyperhidrosis, night sweats, pruritus, rash, skin exfoliation.

Endo: hyperglycemia.

F and E: hypercalcemia, hypocalcemia, hypokalemia, hyponatremia .

Hemat: anemia, neutropenia, THROMBOCYTOPENIA, leukopenia, lymphopenia.

MS: arthralgia, back pain, bone pain, muscle spasms, muscle weakness, musculoskeletal pain, pain in extremity .

Neuro: neuropathy, tremor.

Misc: HYPERSENSITIVITY REACTIONS INCLUDING ANGIOEDEMA, SKIN EXFOLIATION, AND BULLAE, infection, malignancy, fever, hypersensitivity reactions, chills.

· Blood levels and toxicity may be  drugs that inhibit CYP3A, CYP1A2 or P-gp inhibitors including ketoconazole; avoid concurrent use.

· Blood levels and effectiveness may be  by drugs that are strong inducers of CYP1A2, CYP3A or P-gp, including rifampin; avoid concurrent use.

· Cigarette smoking may  blood levels and effectiveness.

· PO: Administer with water on an empty stomach, at least 2 hrs before and 2 hrs after meals. Swallow capsule whole; do not open, break, or chew.

Pharmacologic Classification: immunomodulatory agents

· Assess for signs of deep venous thrombosis and pulmonary edema (dyspnea, chest pain, arm or leg swelling) periodically during therapy). Prophylactic anticoagulation is recommended.

· Monitor for hypersensitivity reactions (angioedema, skin exfoliation, bullae, severe dermatologic reactions) If symptoms occur discontinue therapy and do not resume.

Lab Test Considerations: 

· Monitor CBC with differential, platelet count, hemoglobin and hematocrit weekly for first 8 wks of therapy and at least monthly thereafter. May require dose reduction.

· May cause neutropenia. If absolute neutrophil count (ANC) <500/mcL or febrile neutropenia (fever 38.5° and ANC <1000/mcL), interrupt pomalidomide therapy and follow CBC weekly. If ANC returns to 500/mcL resume pomalidomide at 3 mg/day. For each subsequent drop <500/mcL, interrupt therapy and resume at 1 mg/day less than the previous dose when ANC returns to 500/mcL.

· May cause thrombocytopenia. If platelets fall to <25,000/mcL interrupt pomalidomide therapy and follow CBC weekly. When platelets return to >50,000/mcL, resume at 3 mg/day. For each subsequent drop <25,000/mcL, interrupt therapy and resume at 1 mg/day less than the previous dose when platelet count returns to 50,000/mcL. 

· Monitor liver function tests (AST, ALT, serum bilirubin) monthly during therapy. Interrupt therapy if liver enzymes  and evaluate. May restart therapy at a lower dose when levels return to normal.

· May cause anemia, leukopenia, lymphopenia.

· May cause hyperglycemia, hyponatremia, hypokalemia, hypocalcamia, and hypercalcemia.

· Caution patient not to share pomalidomide with anyone, even someone who has similar symptoms.

· Advise patient to notify health care professional if shortness of breath, chest pain, or arm or leg swelling occur.

· May cause dizziness and confusion. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.

· Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.

· Advise patient that they cannot donate blood and male patients cannot donate sperm while taking pomalidomide and for 1 month following therapy.

· Rep: Inform female patients that they must use one highly effective method (IUD, hormonal contraceptive, tubal ligation, partner's vasectomy) and one additional method (latex or synthetic condom, diaphragm, cervical cap) for at least 4 wks before, during therapy and interruptions of therapy, and for 4 wks following discontinuation of therapy.

· Rep: Male patients receiving pomalidomide must always use a latex or synthetic condom during any contact with females with child-bearing potential, even if they have undergone a successful vasectomy.