NEW
Kyprolis

Kyprolis

carfilzomib

Manufacturer:

Amgen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Carfilzomib
Indications/Uses
In combination w/ dexamethasone or lenalidomide + dexamethasone or daratumumab + dexamethasone for patients w/ relapsed or refractory multiple myeloma who have received 1-3 lines of therapy. Monotherapy in patients w/ relapsed or refractory multiple myeloma who have received at least 2 prior therapies including bortezomib & immunomodulatory agent & demonstrated disease progression on or w/in 60 days of completion of last therapy.
Dosage/Direction for Use
In combination w/ dexamethasone Administer as 30-min IV infusion once or twice wkly. Once wkly: Starting dose: 20 mg/m2 in Cycle 1 on Day 1. If tolerated, escalate dose to 70 mg/m2 on Day 8 of cycle 1. Take dexamethasone 30 min-4 hr before treatment on Days 1, 8 & 15 of each 28-day cycle. Twice wkly: Starting dose: 20 mg/m2 in cycle 1 on Days 1 & 2. If tolerated, escalate dose to 56 mg/m2 on Day 8 of cycle 1. Take dexamethasone 30 min-4 hr before treatment on Days 1, 2, 8, 9, 15, & 16 of each 28-day cycle. In combination w/ lenalidomide & dexamethasone Administer as 10-min IV infusion. Recommended starting dose: 20 mg/m2 in cycle 1 on Days 1 & 2. If tolerated, escalate dose to 27 mg/m2 on Day 8 of cycle 1. From cycle 13, administer on Days 1, 2, 15, 16 until cycle 18 & discontinue after cycle 18. Take lenalidomide & dexamethasone until disease progression or unacceptable toxicity occurs. In combination w/ daratumumab IV & dexamethasone Administer as 30-min IV infusion once or twice wkly. Once wkly: Starting dose: 20 mg/m2 in Cycle 1 on Day 1. If tolerated, escalate dose to 70 mg/m2 on Day 8 of cycle 1 & thereafter. Take dexamethasone 30 min-4 hr before treatment on Days 1, 8 & 15 of each 28-day cycle & 1-3 hr before daratumumab IV. Twice wkly: Starting dose: 20 mg/m2 in cycle 1 on Days 1 & 2. If tolerated, escalate dose to 56 mg/m2 on Day 8 of cycle 1 & thereafter. Take dexamethasone 30 min-4 hr before treatment on Days 1, 2, 8, 9, 15 & 16 of each 28-day cycle. Monotherapy Administer as 10-min IV infusion. Recommended starting dose: 20 mg/m2 in cycle 1 on Days 1 & 2. If tolerated, escalate dose to 27 mg/m2 on Day 8 of cycle 1 & thereafter. From cycle 13, administer on Days 1, 2, 15 & 16 of each 28-day cycle. Premedicate w/ dexamethasone 4 mg PO/IV 30 min-4 hr before each treatment dose in Cycle 1.
Contraindications
Hypersensitivity to carfilzomib or its derivatives.
Special Precautions
New onset or worsening of pre-existing cardiac failure (eg, CHF, pulmonary edema, decreased ejection fraction), cardiomyopathy, myocardial ischemia & infarction; NYHA class III & IV heart failure; tumor lysis syndrome; acute resp distress syndrome, resp failure & diffuse infiltrative pulmonary disease eg, pneumonitis, interstitial lung disease; pulmonary arterial HTN; dyspnea; HTN; venous thromboembolic events; infusion-related reactions; haemorrhage; thrombocytopenia; thrombotic microangiopathy eg, thrombotic thrombocytopenic purpura/hemolytic uremic syndrome; posterior reversible encephalopathy syndrome; progressive multifocal leukoencephalopathy. Asian patients. Concomitant use w/ OCs or hormonal contraception. Combination w/ melphalan & prednisone. Concurrent use w/ immunosuppressives. May affect ability to drive or operate machinery. Acute renal failure; end-stage renal disease. Hepatic toxicity & failure. Women of childbearing potential should use effective contraception during treatment & for at least 6 mth following final dose. Men should use effective contraception during treatment & for at least 3 mth following final dose. Not to be used during pregnancy & lactation. Ped patients. Elderly.
Adverse Reactions
Anemia, neutropenia, thrombocytopenia, lymphopenia, leukopenia; diarrhea, constipation, nausea, vomiting; fatigue, pyrexia, peripheral edema, asthenia, chills; upper resp tract infection, bronchitis, viral upper resp tract infection, pneumonia; hypokalemia, hypocalcemia, hyperglycemia, decreased appetite, hypercalcemia; muscle spasms, back pain, arthralgia, pain in extremity, musculoskeletal pain; peripheral neuropathies, headache, dizziness; insomnia; cough, dyspnea, epistaxis; rash; embolic & thrombotic events, HTN; increased blood creatinine; renal failure.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01XG02 - carfilzomib ; Belongs to the class of proteasome inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Kyprolis inj 30 mg
Packing/Price
1's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in