pomalidomide

poe-ma-lid-oh-mide

Trade Name(s): (Pomalyst)

BLACK BOX ALERT May cause life-threatening birth defects. Pregnancy contraindicated. Exclude pregnancy before initiating treatment. Females of reproductive potential must use two reliable forms of contraception or continuously abstain during treatment and for 4 wks after treatment. Deep vein thrombosis and pulmonary embolism may occur. Consider venous thromboembolism (VTE) prophylaxis during treatment.

• PHARMACOTHERAPEUTIC: Angiogenesis inhibitor. CLINICAL: Antineoplastic.

Multiple myeloma: Treatment of multiple myeloma (in combination with dexAMETHasone) in pts 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. Kaposi's sarcoma: Treatment of adults with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in pts with KS who are HIV negative.

■ALERT■ Do not donate blood products during therapy and for 1 month after therapy discontinuation; male pts must not donate sperm.

Contraindications: Hypersensitivity to pomalidomide. Pregnancy. Cautions: Anemia, HF, hepatic/renal impairment, smoking, breastfeeding, or prior history of CVA, MI, DVT, PE.

Inhibits tumor cell proliferation and induces apoptosis (cell death) of hematopoietic cells. Enhances T-cell–and natural killer (NK) cell–mediated immunity. Inhibits proinflammatory cytokines. Therapeutic Effect: Inhibits tumor cell growth and metastasis.

Widely distributed. Metabolized in liver. Protein binding: 12%–44%. Peak plasma concentration: 2–3 hrs. Excreted in urine (73%), feces (15%). Half-life: 8–10 hrs.

Pregnancy/Lactation: Pregnancy/breastfeeding contraindicated. May cause fetal harm. Unknown if distributed in breast milk. Do not breastfeed. Must verify negative pregnancy status before initiation. Must use two reliable forms of birth control (intrauterine device [IUD], tubal ligation) plus barrier methods. Avoid pregnancy for at least 4 wks after discontinuation. Males: Must use condoms during treatment and up to 1 mo after treatment, despite prior history of vasectomy. Do not donate sperm. Children: Safety and efficacy not established. Elderly: May have increased risk of serious adverse effects, renal failure, electrolyte imbalance.

DRUG: May decrease the therapeutic effect; increase adverse effects of vaccines (live). HERBAL: Echinacea may decrease therapeutic effect. FOOD: None significant. LAB VALUES: May decrease Hgb, Hct, neutrophils, platelets, leukocytes, lymphocytes, serum calcium, potassium, sodium. May increase serum calcium, creatinine, glucose.

Capsules: 1 mg, 2 mg, 3 mg, 4 mg.

PO

• May be given without regard to food.
• Administer whole with water. Do not break, open, or allow chewing.

Multiple Myeloma

Note: Absolute neutrophil count (ANC) should be 500 cells/mm³ or greater and platelet count 50,000 cells/mm³ or greater prior to starting new cycles of therapy.

PO: ADULTS/ELDERLY: 4 mg once daily on days 1–21 of 28-day cycle (in combination with dexAMETHasone. Continue until disease progression or unacceptable toxicity.

Kaposi Sarcoma

PO: ADULTS: 5 mg once daily on days 1–21 of a 28-day cycle. Continue until disease progression or unacceptable toxicity. Continue HAART as HIV treatment in pts with AIDS-related Kaposi sarcoma.

Dose Modification

Neutropenia

ANC less than 500 cells/mm³ or febrile neutropenia: Withhold treatment until ANC is greater than 500 cells/mm³, then reduce dose to 3 mg once daily. Any subsequent drop of ANC less than 500 cells/mm³ after prior reduction: Withhold treatment until ANC is greater than 500 cells/mm³, then reduce dose by 1 mg less than previous dose. Discontinue if 1-mg dose is intolerable.

Thrombocytopenia

Platelet count less than 25,000 cells/mm³: Withhold treatment until platelet count greater than 50,000 cells/mm³, then reduce dose to 3 mg once daily. Any subsequent platelet drop to less than 25,000 cells/mm³: Withhold treatment until platelet count greater than 50,000 cells/mm³, then reduce dose by 1 mg less than previous dose. Discontinue if 1-mg dose is intolerable.

Dosage in Renal Impairment

Avoid use in pts with serum creatinine more than 3 mg/dL or CrCl less than 45 mL/min.

Dosage in Hepatic Impairment

Avoid use in pts with serum bilirubin more than 2 mg/dL and ALT, AST more than 3 times upper limit of normal (ULN).

Frequent (55%–22%): Fatigue, constipation, nausea, diarrhea, dyspnea, back pain, peripheral edema, musculoskeletal chest pain, anorexia, rash. Occasional (20%–7%): Dizziness, pyrexia, muscle spasms, arthralgia, pruritus, vomiting, cough, weight loss, headache, bone pain, muscular weakness, anxiety, musculoskeletal pain, peripheral neuropathy, chills, dry skin, tremor, insomnia. Rare (6%–1%): Hyperhidrosis, extremity pain, back pain, night sweats, constipation.

Myelosuppression (neutropenia, leukopenia, thrombocytopenia) is an expected outcome of therapy; may increase risk of infection such as pneumonia, upper respiratory tract infection, UTI. Neurologic events such as acute confusion, dizziness reported. Peripheral neuropathy occurred in 18% of pts. Venous thromboembolism including DVT, PE occurred in 3% of pts. Epistaxis occurred in 15% of pts. Increased risk of secondary malignancies reported. Acute renal failure reported in 16% of pts. Additional adverse events may include interstitial lung disease (ILD), neutropenic sepsis, Pneumocystis jiroveci pneumonia, respiratory syncytial virus infection, urinary retention, vertigo.

• BASELINE ASSESSMENTObtain CBC, BMP; pregnancy test in females of reproductive potential. Receive full medication history. Obtain baseline neurologic exam. Question history of diabetes mellitus, electrolyte imbalance, hepatic/renal impairment, pulmonary disease, thromboembolism, smoking.INTERVENTION/EVALUATIONMonitor CBC, BMP. Obtain ECG for palpitations, chest pain, hypokalemia, hyperkalemia, hypocalcemia, bradycardia, ventricular arrhythmias. Immediately report dyspnea, chest pain, hypoxia, unilateral peripheral edema/pain (may indicate thromboembolic event). Perform routine neurologic assessments to screen for confusion, delirium. Monitor urine output, frequency.PATIENT/FAMILY TEACHING
• Treatment may depress your immune system response and reduce your ability to fight infection. Report symptoms of infection such as body aches, chills, cough, fatigue, fever. Avoid those with active infection.
• Report symptoms of bone marrow depression (e.g., bruising, fatigue, fever, shortness of breath, weight loss; bleeding easily, bloody urine or stool).
• Do not donate blood.
• Use effective contraception to avoid pregnancy. Do not breastfeed.
• Go from lying to standing slowly (prevents postural hypotension, dizziness). Avoid tasks that require alertness, motor skills until response to drug is established.
• Do not smoke.
• Do not eat 2 hrs before or 2 hrs after dose.
• Avoid alcohol.
• Report difficulty breathing, chest pain, extremity pain or swelling, dizziness, confusion.