Pomadex 1/Pomadex 2/Pomadex 3/Pomadex 4

Pomalidomide

In combination w/ dexamethasone for patients w/ multiple myeloma who have received at least 2 prior therapies including lenalinomide & PI & have demonstrated disease progression on or w/in 60 days of completion of the last therapy.

Multiple myeloma 4 mg once daily on days 1-21 of repeated 28-day cycles until disease progression in combination w/ dexamethasone. Severe renal impairment requiring dialysis 3 mg daily, taken after completion of dialysis procedure on hemodialysis days. Mild or moderate hepatic impairment (Child-Pugh classes A or B) 3 mg daily. Severe hepatic impairment (Child-Pugh class C) 2 mg daily.

May be taken with or without food: Do not break/chew/open cap.

Pregnancy.

Discontinue & do not resume therapy if angioedema, skin exfoliation, bullae, or any other severe dermatologic reaction occurs. Venous thromboembolic (DVT & pulmonary embolism) & arterial thromboembolic (MI & stroke) events. Addition of a PD-1 or PD-L1 blocking Ab is not recommended for patients w/ multiple myeloma. Hepatotoxicity. Neuropathy. Risk of 2nd primary malignancies. Tumor lysis syndrome may occur; high risk in patients w/ high tumor burden prior to treatment. Smoking tobacco may reduce the efficacy. Monitor patients for hematologic toxicities, especially neutropenia. Monitor CBC wkly for the 1st 8 wk & mthly thereafter; LFTs mthly. Avoid situations where dizziness or confusional state may be a problem. Females of reproductive potential must avoid pregnancy while on therapy & for at least 4 wk after completing therapy. Females must abstain continuously from sexual intercourse or to use 2 methods of birth control, beginning 4 wk prior to initiating treatment, during therapy/dose interruptions, & continuing for 4 wk following discontinuation of therapy. Males must always use a latex or synthetic condom during any sexual contact w/ females of reproductive potential while on therapy & for up to 4 wk after discontinuation even if they have undergone a successful vasectomy; must not donate sperm. Blood donation patients must not donate blood during treatment & for 1 mth following discontinuation as it might be given to a pregnant patient. Discontinue breastfeeding during treatment.

Neutropenia, anemia, thrombocytopenia, leukopenia, febrile neutropenia, lymphopenia; fatigue, asthenia, pyrexia, peripheral edema, chills; nausea, constipation, diarrhea, vomiting; back pain, musculoskeletal chest pain, muscle spasms, arthralgia, muscular weakness, bone pain, musculoskeletal pain, pain in extremity; URTI, pneumonia, UTI, sepsis; decreased appetite, hypercalcemia, hypokalemia, hyperglycemia, hyponatremia, dehydration, hypocalcemia; dyspnea, cough, epistaxis, productive cough, oropharyngeal pain; dizziness, peripheral neuropathy, headache, tremor; rash, pruritus, dry skin, hyperhidrosis, night sweats; increased blood creatinine, increased/decreased wt; anxiety, confusional state, insomnia; renal failure. COPD; depressed level of consciousness; decreased neutrophil, platelet, WBC & lymphocyte count, increased ALT/AST; renal failure; femur fracture; pelvic pain.

Increased C_max & AUC w/ fluvoxamine. Avoid co-administration w/ strong CYP1A2 inhibitors (eg, ciprofloxacin & fluvoxamine).

Cancer Immunotherapy / Immunosuppressants

L04AX06 - pomalidomide ; Belongs to the class of other immunosuppressants.

Rx