Kyprolis

Kyprolis

carfilzomib

Manufacturer:

Amgen

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Carfilzomib
Indications/Uses
In combination w/ lenalidomide & dexamethasone, w/ dexamethasone, or w/ daratumumab & dexamethasone for the treatment of adults w/ relapsed or refractory multiple myeloma who have received 1-3 lines of therapy.
Dosage/Direction for Use
In combination w/ lenalidomide & dexamethasone Administer Kyprolis as a 10-min IV infusion on days 1, 2, 8, 9, 15, 16 of each 28-day cycle in combination w/ lenalidomide & dexamethasone until cycle 12. Recommended starting dose: Kyprolis 20 mg/m2 on days 1 & 2 of cycle 1, escalate to 27 mg/m2 from day 8 of cycle 1 & thereafter if tolerated. From cycle 13, administer Kyprolis on days 1, 2, 15, & 16. Treatment w/ Kyprolis combined w/ lenalidomide & dexamethasone for longer than 18 cycles should be based on an individual benefit/risk assessment. In combination w/ dexamethasone Twice wkly 20/56 mg/m2 regimen: Administer Kyprolis as a 30-min IV infusion on days 1, 2, 8, 9, 15, 16 of each 28-day cycle in combination w/ dexamethasone. Recommended starting dose: Kyprolis 20 mg/m2 on days 1 & 2 of cycle 1, escalate to 56 mg/m2 from day 8 of cycle 1 & thereafter if tolerated. Administer dexamethasone 30 min-4 hr before Kyprolis. Once wkly 20/70 mg/m2 regimen: Administer Kyprolis as a 30-min IV infusion on days 1, 8, 15 of each 28-day cycle in combination w/ dexamethasone. Recommended starting dose: Kyprolis 20 mg/m2 on day 1 of cycle 1, escalate to 70 mg/m2 from day 8 of cycle 1 & thereafter if tolerated. Administer dexamethasone 30 min-4 hr before Kyprolis. In combination w/ IV daratumumab & dexamethasone Twice wkly 20/56 mg/m2 regimen: Administer Kyprolis as a 30-min IV infusion on days 1, 2, 8, 9, 15, 16 of each 28-day cycle in combination w/ IV daratumumab & dexamethasone. Recommended starting dose: Kyprolis 20 mg/m2 on days 1 & 2 of cycle 1, escalate to 56 mg/m2 from day 8 of cycle 1 & thereafter if tolerated. Administer dexamethasone 30 min-4 hr before Kyprolis & 1-3 hr before IV daratumumab. Once wkly 20/70 mg/m2 regimen: Administer Kyprolis as a 30-min IV infusion on days 1, 8, 15 of each 28-day cycle in combination w/ IV daratumumab & dexamethasone. Recommended starting dose: Kyprolis 20 mg/m2 on day 1 of cycle 1, escalate to 70 mg/m2 from day 8 of cycle 1 & thereafter if tolerated. Administer dexamethasone 30 min-4 hr before Kyprolis & 1-3 hr before IV daratumumab.
Special Precautions
Risk of new or worsening cardiac failure, cardiomyopathy, myocardial ischemia & MI; acute renal failure; tumor lysis syndrome; acute resp distress syndrome, acute resp failure & acute diffuse infiltrative pulmonary disease; pulmonary HTN; dyspnea; HTN; venous thromboembolic events; infusion-related reactions; hemorrhage; thrombocytopenia; hepatic failure; thrombotic microangiopathy; posterior reversible encephalopathy syndrome; HBV reactivation; progressive multifocal leukoencephalopathy. Ensure adequate hydration prior to each dose in cycle 1. Monitor patients for evidence of vol overload. Monitor serum K levels regularly during treatment. Monitor renal function w/ regular measurement of serum creatinine &/or estimated CrCl. Monitor BP regularly during treatment. Monitor platelet counts frequently during treatment. Monitor liver enzymes regularly. Test for HBV infection before treatment initiation. Consider antiviral prophylaxis for patients who are HBV carriers. Provide thromboprophylaxis for patients being treated w/ Kyprolis combination therapy. Consider non-hormonal contraception during treatment w/ Kyprolis combination therapy for patients using OCs or hormonal contraception associated w/ risk of thrombosis. May impair ability to drive or operate machinery. Reduce dose by 25% in patients w/ mild or moderate hepatic impairment. A recommended dose has not been established for patients w/ severe hepatic impairment. Administer after hemodialysis procedure for patients w/ ESRD on hemodialysis. Females of reproductive potential should use effective contraception during treatment & for at least 6 mth following the final dose. Males w/ female sexual partners of reproductive potential should use effective contraception during treatment & for at least 3 mth following the final dose. Can cause fetal harm when administered to pregnant woman. Do not breastfeed during & for 2 wk after treatment. Safety & effectiveness in ped patients have not been established. Not indicated in combination w/ melphalan & prednisone for transplant-ineligible patients w/ newly diagnosed multiple myeloma.
Adverse Reactions
Anemia, diarrhea, fatigue, HTN, pyrexia, URTI, thrombocytopenia, cough, dyspnea, insomnia.
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 powd for soln for infusion 30 mg
Packing/Price
1's
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Already a member? Sign in