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KYPROLIS
Leukemias, lymphomas, and other hematologic cancers
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Drug Name:

KYPROLIS Rx

Generic Name and Formulations:
Carfilzomib 60mg/vial; lyophilized pwd for IV inj after reconstitution; preservative-free.

Company:
Onyx Pharmaceuticals

Therapeutic Use:

Indications for KYPROLIS:

As monotherapy for treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy. In combination with lenalidomide and dexamethasone for treatment of patients with relapsed multiple myeloma who have received 1–3 prior therapies.

Adult:

See full labeling. Premedicate with dexamethasone for monotherapy prior to all Cycle 1 doses, during subsequent cycles, and if infusion reactions occur. Give by IV over 10 mins, on two consecutive days each week for 3 weeks (Days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (Days 17–28). In Cycle 1: 20mg/m2 per each dose on Days 1 and 2, if tolerated increase to 27mg/m2 on Day 8 and subsequent cycles. From Cycle 13, omit the Day 8 and 9 doses. In combination therapy: discontinue after Cycle 18; see full labeling for lenalidomide and dexamethasone dosing. Both therapies: continue until disease progression or unacceptable toxicity occurs. On dialysis: give dose after session. Toxicity dose modification: see full labeling.

Children:

Not established.

Warnings/Precautions:

Risk of cardiac complications (eg, CHF, MI, pulmonary edema); monitor and manage promptly if occurs. Pulmonary hypertension; if suspected, withold therapy until resolved; may consider restarting after reevaluate. Discontinue if pulmonary toxicity occurs. Monitor for dyspnea or tumor lysis syndrome, and manage promptly if occurs; interrupt therapy until resolved. Maintain adequate hydration. Monitor for volume overload. Monitor platelets frequently during therapy. Monitor for thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS); discontinue and evaluate if suspected. Discontinue and evaluate if posterior reversible encephalopathy syndrome (PRES) is suspected. Monitor BP, renal function regularly; reduce or withhold dose as needed. Hepatic impairment (monitor enzymes). Consider thromboprophylaxis for combination therapy. Consider antiviral prophylaxis for monotherapy. Elderly (≥75yrs). Pregnancy; avoid. Use effective contraception during and for ≥2 weeks after therapy completion. Nursing mothers.

Pharmacological Class:

Proteasome inhibitor.

Adverse Reactions:

Fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea, pyrexia, decreased platelets, headache, decreased hemoglobin, cough, edema peripheral; cardiac events, pulmonary HTN, acute kidney injury, infusion reactions, tumor lysis syndrome, hepatic toxicity/failure, TTP/HUS, PRES.

Metabolism:

Hepatic.

Elimination:

Not established.

Generic Availability:

NO

How Supplied:

Single-use vial—1

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