Kyfil Injection

Carfilzomib is a proteasome inhibitor that is indicated: for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with Lenalidomide and dexamethasone; or Dexamethasone; or Daratumumab and dexamethasone; or Daratumumab and hyaluronidase-fihj and dexamethasone; or Isatuximab and dexamethasone. as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. Relapsed or Refractory Multiple Myeloma Carfilzomib is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with: Lenalidomide and dexamethasone; or Dexamethasone; or Daratumumab and dexamethasone; or Isatuximab and dexamethasone. Carfilzomib is indicated as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.

---

Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Cardiac Toxicities: Monitor for signs and symptoms of cardiac failure or ischemia. Withhold Carfilzomib and evaluate promptly. Acute Renal Failure: Monitor serum creatinine regularly. Tumor Lysis Syndrome (TLS): Administer pre-treatment hydration. Monitor for TLS, including uric acid levels and treat promptly. Pulmonary Toxicity, including Acute Respiratory Distress Syndrome, Acute Respiratory Failure, and Acute Diffuse Infiltrative Pulmonary Disease: Withhold Carfilzomib and evaluate promptly. Pulmonary Hypertension: Withhold Carfilzomib and evaluate. Dyspnea: For severe or life-threatening dyspnea, withhold Carfilzomib and evaluate. Hypertension, including Hypertensive Crisis: Monitor blood pressure regularly. If hypertension cannot be controlled, interrupt treatment with Carfilzomib. Venous Thrombosis: Thromboprophylaxis is recommended. Infusion-related Reactions: Premedicate with dexamethasone. Hemorrhage: Fatal or serious cases of hemorrhage may occur, including gastrointestinal, pulmonary, and intracranial hemorrhage. Promptly evaluate signs and symptoms of blood loss. Thrombocytopenia: Monitor platelet counts; interrupt or reduce Carfilzomib dosing as clinically indicated. Hepatic Toxicity and Hepatic Failure: Monitor liver enzymes regularly. Withhold Carfilzomib if suspected. Thrombotic Microangiopathy: Monitor for signs and symptoms. Discontinue Carfilzomib if suspected. Posterior Reversible Encephalopathy Syndrome (PRES): Consider neuro-radiological imaging (MRI) for onset of visual or neurological symptoms; discontinue Carfilzomib if suspected. Progressive Multifocal Leukoencephalopathy: Consider PML if new or worsening neurologic manifestations. Discontinue Carfilzomib in patients who develop PML. Increased Fatal and Serious Toxicities in Combination with Melphalan and Prednisone in Newly Diagnosed Transplant-Ineligible Patients Embryo-Fetal Toxicity: Carfilzomib can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of potential risk to a fetus and to use effective contraception. Cardiac Toxicities New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pulmonary edema, decreased ejection fraction), cardiomyopathy, myocardial ischemia, and myocardial infarction including fatalities have occurred following administration of Carfilzomib. Some events occurred in patients with normal baseline ventricular function. In clinical studies with Carfilzomib, these events occurred throughout the course of Carfilzomib therapy. Death due to cardiac arrest has occurred within one day of Carfilzomib administration. Abridged from the full prescribing information.

---

Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are described elsewhere in the labeling: Cardiac Toxicities Acute Renal Failure Tumor Lysis Syndrome Pulmonary Toxicity Pulmonary Hypertension Dyspnea Hypertension Venous Thrombosis Infusion-Related Reactions Hemorrhage Thrombocytopenia Hepatic Toxicity and Hepatic Failure Thrombotic Microangiopathy Posterior Reversible Encephalopathy Syndrome Progressive Multifocal Leukoencephalopathy The most common adverse reactions occurring in at least 20% of patients treated with Carfilzomib in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, edema peripheral. The most common adverse reactions occurring in at least 20% of patients treated with Carfilzomib in the combination therapy trials: anemia, diarrhea, hypertension, fatigue, upper respiratory tract infection, thrombocytopenia, pyrexia, cough, dyspnea, and insomnia. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the Warnings and Precautions reflect exposure to Carfilzomib in 2,239 patients administered in combination with other drugs in ASPIRE, ENDEAVOR, A.R.R.O.W., CANDOR, IKEMA, EQUULEUS, and PLEIADES. The most common adverse reactions occurring in at least 20% of patients who received Carfilzomib in combination were anemia, diarrhea, hypertension, fatigue, upper respiratory tract infection, thrombocytopenia, pyrexia, cough, dyspnea, and insomnia. Carfilzomib in Combination with Lenalidomide and Dexamethasone The safety of Carfilzomib 20/27 mg/m 2 twice weekly in combination with lenalidomide and dexamethasone (KRd) was evaluated in ASPIRE. The median number of cycles initiated was 22 cycles for the KRd arm and 14 cycles for the Rd arm. Deaths due to adverse reactions within 30 days of the last dose of any therapy in the KRd arm occurred in 45/392 (12%) patients compared with 42/389 (11%) patients who died due to adverse reactions within 30 days of the last dose of any Rd therapy. The most frequent cause of deaths occurring in patients (%) in the two arms (KRd versus Rd) included infection 12 (3%) versus 11 (3%), cardiac 10 (3%) versus 9 (2%), and other adverse reactions 23 (6%) versus 22 (6%). Serious adverse reactions were reported in 65% of the patients in the KRd arm and 57% of the patients in the Rd arm. Abridged from the full prescribing information.

---

Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.