KYPROLIS Carfilzomib Application Scope

A proteasome inhibitor indicated for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received 1–3 prior therapies.

It can be used as monotherapy or in combination with agents such as dexamethasone, lenalidomide, daratumumab, or isatuximab to reduce tumor burden, control disease progression, and improve patient survival and quality of life.

KYPROLIS is supplied as a lyophilized powder for intravenous injection (10 mg per vial, reconstituted to 2 mg/mL) and should be administered under the guidance of a healthcare professional.

KYPROLIS Carfilzomib Characteristics

Ingredients: Carfilzomib
Properties: A tetrapeptide epoxyketone and a selective proteasome inhibitor, a white to off-white sterile lyophilized powde
Packaging Specification: Each vial contains 10 mg of carfilzomib as a white to off-white lyophilized powder
Storage: Unopened vials should be stored refrigerated at 2°C to 8°C (36°F to 46°F) in the original package to protect from light
Expiry Date: Is indicated on the packaging
Executive Standard: Follows the relevant quality standards and specifications as approved by the regulatory authorities (e.g., US FDA, or other national drug regulatory agencies)
Approval Number: FDA NDA 202714; EMA EMEA/H/C/002370
Date of Revision: September 9, 2024
Manufacturer: Amgen Inc.

Guidelines for the Use of KYPROLIS Carfilzomib

Dosage and Administration:
- Recommended Dose:
  
  The dosing regimen varies based on the combination therapy used. Common regimens include:
  - Kyprolis + Dexamethasone (Kd)
  - Kyprolis + Lenalidomide + Dexamethasone (KRd)
  - Kyprolis + Daratumumab + Dexamethasone (DKd)
  - Kyprolis + Isatuximab + Dexamethasone (Isa-Kd)
    Specific dosing schedules and adjustments should be determined by the treating physician based on individual patient factors.
- Administration: Administered intravenously. The reconstituted solution should be inspected for particulate matter and discoloration prior to administration.
- Missed Dose: If a dose is missed, contact your healthcare provider for guidance on rescheduling. Do not administer extra doses to make up for a missed dose.
Adverse Reactions:
- Common Adverse Reactions: ≥20% Incidence: Anemia, diarrhea, hypertension, fatigue, upper respiratory tract infection, thrombocytopenia, pyrexia, cough, dyspnea, insomnia.
- Serious Adverse Reactions:
  - Cardiovascular: Heart failure, myocardial infarction, cardiac arrest, myocardial ischemia
  - Hematologic: Thrombocytopenia, anemia
  - Renal: Renal failure, elevated serum creatinine
  - Hepatic: Elevated liver enzymes, hepatic failure
  - Neurologic: Peripheral neuropathy
  - Infectious: Pneumonia, sepsis
Contraindications:
- Hypersensitivity to carfilzomib or any excipients in the formulation.
- The safety of KYPROLIS in patients with Class III or IV heart failure has not been established.
- Concomitant use with melphalan and prednisone for newly diagnosed transplant-ineligible patients is contraindicated due to increased fatal/serious toxicities.
Precautions:
- Cardiac Toxicity: Monitor for signs/symptoms of cardiac failure or ischemia. Manage promptly. Withhold KYPROLIS for Grade 3 or 4 cardiac events.
- Infusion Reactions: Premedicate with dexamethasone. Monitor patients during and after administration. Discontinue KYPROLIS for serious reactions.
- Tumor Lysis Syndrome (TLS): Ensure adequate hydration and monitor for TLS, especially in patients with high tumor burden. Discontinue KYPROLIS if TLS occurs.
- Hematologic Toxicity: Monitor platelet counts and neutrophil counts regularly. Dose interruptions or reductions may be necessary.
- Hepatic Toxicity: Monitor liver enzymes regularly.
- Pulmonary Toxicity: Monitor for pulmonary signs/symptoms.
- Thrombotic Microangiopathy: Cases have been reported; monitor for signs.
- Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential to use effective contraception during and after treatment.
- Lactation: Avoid breastfeeding during treatment.

KYPROLIS Interactions

Potential Interactions:
- CYP450 Substrates: Carfilzomib may affect the metabolism of drugs metabolized by CYP450 enzymes.
- Other Chemotherapeutic Agents: Concurrent use with other myelosuppressive agents may increase the risk of hematologic toxicities.
- Antihypertensive Medications: Monitor blood pressure regularly; carfilzomib may exacerbate hypertension.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.