Carfilzomib

DEA Class; Rx

Common Brand Names; Kyprolis

• Antineoplastics, Proteasome Inhibitors

Indicated for relapsed or refractory multiple myeloma in adults who have received 1-3 lines of therapy in combination with dexamethasone, lenalidomide plus dexamethasone, or daratumumab plus dexamethasone

Also indicated as a single agent for relapsed or refractory multiple myeloma in adults who received ≥1 lines

For the treatment of multiple myeloma.

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• Fatigue (55.5%)
• Anemia (46.8%)
• Nausea (44.9%)
• Thrombocytopenia (36.3%)
• Dyspnea (34.6%)
• Diarrhea (32.7%)
• Pyrexia (30.4%)
• Upper respiratory tract infection (28.3%)
• Headache (27.6%)
• Cough (26%)
• Increase in blood creatinine (24.1%)
• Lymphopenia (24%)
• Peripheral Edema (24%)
• Vomiting (22.2%)
• Constipation (20.9%)
• Neutropenia (20.7%)
• Back pain (20.2%)
• Insomnia (17.9%)
• Chills (16%)
• Arthralgia (15.8%)
• Muscle spasms (14.4%)
• Hypertension (14.3%)
• Asthenia (13.9%)
• Hypokalemia (13.7%)
• Hypomagnesemia (13.5%)
• Leukopenia (13.5%)
• Pain in extremity (13.3%)
• Pneumonia (12.7%)
• Increase in aspartate aminotransferase (12.5%)
• Dizziness (12.5%) Hypoesthesia (12.2%)
• Anorexia (12%) Pain (12%)
• Hyperglycemia (11.8%)
• Chest wall pain (11.4%)
• Hypercalcemia (11%)
• Hypophosphatemia (10.5%)
• Hyponatremia (10.3%)

Also see Dosage Modifications

Hydrate patients to reduce the risk of renal toxicity and of tumor lysis syndrome (TLS) and premedicate to avoid infusion reactions; maintain adequate fluid volume status throughout treatment and monitor blood chemistries closely (see Administration)

Tumor lysis syndrome, including fatal outcomes, reported; patients with multiple myeloma and a high tumor burden are at greater risk; ensure adequate hydration and consider uric acid-lowering drugs

Acute respiratory distress syndrome (ARDS) and acute respiratory failure reported; acute diffuse infiltrative pulmonary disease, such as pneumonitis and interstitial lung disease also reported

Monitor for pulmonary hypertension and other pulmonary complications (eg, ARDS) during and after treatment completion; dyspnea reported in 31% of patients

Dyspnea reported; evaluate dyspnea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes

Consider neuroradiological imaging (MRI) for onset of visual or neurological symptoms of posterior reversible encephalopathy syndrome (PRES); discontinue therapy if suspected

Monitor platelet counts; interrupt or reduce dosing as clinically indicated if thrombocytopenia occurs

Cases of hepatic failure, including fatal cases, reported; monitor liver enzymes regularly, regardless of baseline values, and modify dose based on toxicity

Fatal or serious cases of hemorrhage may occur, including gastrointestinal, pulmonary, and intracranial hemorrhage; promptly evaluate signs and symptoms of blood loss; bleeding can be spontaneous; intracranial hemorrhage has occurred without trauma; also reported in patients having either low or normal platelet counts and in patients who were not on antiplatelet therapy or anticoagulation; evaluate signs and symptoms or blood loss promptly; withhold or reduce dose as necessary

Increased fatal and serious toxicities reported in combination with melphalan and prednisone in newly diagnosed transplant-ineligible patients

Thrombocytopenia with platelet nadirs observed between Day 8 and Day 15 of each 28-day cycle, with recovery to baseline platelet count usually by the start of the next cycle; thrombocytopenia reported in ~32% of patients in clinical trials with carfilzomib

Can cause fetal harm based on findings from animal studies and the drug’s mechanism of action

There are no data on presence of drug in human milk, effects on breastfed child, or on milk production

Carfilzomib 

injection, lyophilized powder for reconstitution

• 10mg/vial
• 30mg/vial
• 60mg/vial