KYPROLIS（carfilzomib）注射液

【Function and indication】
KYPROLIS (Carfilzomib) injection is a new type of immunomodulatory drug, mainly used to treat multiple myeloma and myelodysplastic syndrome.
Rheumatoid arthritis, unlike age-related osteoarthritis, is an increasingly debilitating autoimmune disease, which means that the body attacks its own tissues. The disease is characterized by widespread inflammation of tissues, synovium, and joints.

【Model and specification】
Injection, 60mg/bottle.

【Usage and dosage】
Intravenous injection, two consecutive days a week, maintained for three weeks, followed by a 12-day rest period.
The recommended dose for cycle 1 is 20 mg/m2/day, and if tolerance increases, the dose for cycle 2 and subsequent cycles is 27 mg/m2/day.

【Clinical study】
The new drug trial of Kyprolis evaluated 266 patients with relapsed or refractory multiple myeloma who had received at least two prior treatments, including (Velcade) bortezomib and thalidomide. Kyprolis was previously used primarily for colorectal cancer and gastrointestinal stromal tumors.

The FDA believes that the benefit-risk assessment of Kyprolis (the proposed brand name of carfilzomib) is beneficial for patients with relapsed or refractory multiple myeloma who have previously received at least two therapies including protease inhibitors or immunomodulatory agents (IMiDs). Onyx is promoting the use of Kyprolis in multiple lines of treatment in multiple myeloma.

The new drug application for Kyprolis is based on the 003-A1 study and supported by more research data. The 003-A1 study is an open-label, single-arm Phase 2b trial. This trial evaluated 266 patients with relapsed or refractory multiple myeloma who had received at least two prior therapies, including (Velcade) bortezomib and thalidomide.

[Precautions]
Monitor: Cardiac complications including heart failure, adverse reactions of ischemic myocardium. Withhold KYPROLIS in time for treatment.
Pulmonary hypertension: Withhold dose if suspected.
Pulmonary complications: Monitor and manage dyspnea immediately; interrupt KYPROLIS until symptoms resolve or return to baseline.
Infusion reactions: Preempt dexamethasone. Remind patients to seek medical attention immediately if symptoms develop.
Tumor lysis syndrome (TLS): Prevent patients from hydrating. Monitor and treat TLS promptly.
Platelets: Monitor platelet count; reduce or interrupt medication as clinically indicated.
If hepatotoxicity and liver failure are suspected: monitor liver enzymes and withhold medication.
Embryo-fetal toxicity: KYPROLIS can cause fetal harm. Females of reproductive potential should avoid pregnancy while receiving treatment.

Adverse reactions and contraindications: The most commonly reported adverse reactions (incidence ≥ 30%) are fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea, and pyrexia.

Manufacturer: Onyx Pharmaceuticals, Inc.