KYPROLIS Rx

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KYPROLIS

Leukemias, lymphomas, and other hematologic cancers
Only 4 drugs may be compared at once

Generic Name and Formulations:

Carfilzomib 10mg, 30mg, 60mg; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.

Company:

Amgen, Inc.

Select therapeutic use:

Indications for KYPROLIS:

In combination with dexamethasone or lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received 1–3 lines of therapy. As a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received ≥1 lines of therapy.

Adult:

See full labeling. Hydrate prior to and following administration as needed. Premedicate with dexamethasone prior to all Cycle 1 doses, during subsequent cycles, and if infusion reactions occur. Give by IV 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). Lenalidomide/dexamethasone combination: Infuse over 10mins. In Cycle 1: initially 20mg/m2 per 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. Discontinue carfilzomib after Cycle 18. See full labeling for lenalidomide and dexamethasone dosing. Dexamethasone combination: Infuse over 30mins. In Cycle 1: initially 20mg/m2 per dose on Days 1 and 2; if tolerated increase to 56mg/m2 on Day 8 and subsequent cycles. Monotherapy: initially 20mg/m2 per dose in Cycle 1 on Days 1 and 2; if tolerated increase to 27mg/m2 on Day 8 (by 10-min infusion regimen) or 56mg/m2 on Day 8 (by 30-min infusion regimen) and continue same dose for subsequent cycles. From Cycle 13, omit the Day 8 and 9 doses. All: continue until disease progression or unacceptable toxicity occurs. Mild or moderate hepatic impairment: reduce dose by 25%. ESRD on dialysis: give dose after session. Dose modifications for toxicity: see full labeling.

Children:

Not established.

Warnings/Precautions:

Monitor for signs/symptoms of cardiac failure or ischemia; evaluate promptly if toxicity is suspected. Increased risk of cardiac complications in patients with NYHA Class III and IV heart failure, recent MI, conduction abnormalities, angina, uncontrolled arrhythmias; do full medical assessment prior to starting. Pulmonary hypertension; if suspected, withhold therapy until resolved; may consider restarting after reevaluation. Discontinue if pulmonary toxicity occurs. Monitor for tumor lysis syndrome (TLS); interrupt therapy and manage promptly if occurs. Interrupt for Grade 3 or 4 dyspnea until resolved; consider restarting after reevaluation. Maintain adequate hydration. Monitor for volume overload. Evaluate signs/symptoms of blood loss; reduce or withhold dose as appropriate. 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. Control BP prior to initiation; withhold and evaluate if uncontrolled. Monitor BP, platelets, renal function, liver enzymes, electrolytes (eg, potassium) regularly; reduce or withhold dose as needed. Hepatic impairment. Give thromboprophylaxis for combination therapy. Consider antiviral prophylaxis to prevent herpes zoster reactivation. Elderly (≥75yrs). Embry-fetal toxicity. Use effective contraception during and for ≥30 days (females) or ≥90 days (males) after therapy completion. Pregnancy: avoid. Nursing mothers.

Pharmacological Class:

Proteasome inhibitor.

Interactions:

Increased risk of thrombosis with oral or hormonal contraceptives; consider alternatives during combination therapy. Increased fatal/serious toxicities in combination with melphalan + prednisone in newly diagnosed transplant-ineligible patients.

Adverse Reactions:

Anemia, neutropenia, diarrhea, dyspnea, fatigue, thrombocytopenia, pyrexia, insomnia, muscle spasm, cough, upper RTI, hypokalemia, nausea, headache, peripheral edema; cardiotoxicity, pulmonary HTN, acute renal failure (may be fatal), infusion reactions, hemorrhage, TLS, hepatic toxicity/failure, TTP/HUS, PRES.

Metabolism:

Hepatic.

Elimination:

Not established.

Generic Availability:

NO

How Supplied:

Single-use vial—1