What is Multiple Myeloma?

• Multiple myeloma is a cancer that forms in a type of white blood cell called a plasma cell. These cells help you fight infections by making antibodies that recognize and attack germs. In multiple myeloma, cancerous plasma cells accumulate in the bone marrow and crowd out healthy blood cells.

How Does Carfilzomib Work?

• Carfilzomib is a proteasome inhibitor. Proteasomes are enzymes that break down proteins that are no longer needed by the cell or are damaged. By inhibiting these proteasomes, carfilzomib causes an accumulation of defective proteins within the cancer cells, leading to cell death.

Indications and Usage

• Carfilzomib is approved for use in patients with relapsed or refractory multiple myeloma who have received one or more prior lines of therapy. It can be used as a monotherapy or in combination with other agents such as dexamethasone, lenalidomide, or daratumumab.

Administration

• Carfilzomib is administered intravenously. The dosing regimen varies depending on the treatment cycle and combination with other drugs. For instance, in Cycle 1, it is often started at 20 mg/m² and, if tolerated, increased to 56 or 70 mg/m² in subsequent cycles.

• Adequate hydration is important before and after administration to prevent renal complications. Patients should receive oral and intravenous fluids as part of the preparation.

Side Effects and Monitoring

• Serious side effects include kidney problems, tumor lysis syndrome, lung damage, pulmonary hypertension, high blood pressure, and blood clots. Patients should be closely monitored for these conditions.

• Infusion-related reactions are possible, with symptoms such as fever, chills, and difficulty breathing. These can occur immediately or up to 24 hours post-infusion.

• Cardiovascular risks, including heart failure and myocardial infarction, have been associated with carfilzomib. Regular monitoring of cardiac function and blood pressure is recommended.

Patient Education

• Patients should be informed about the potential side effects and advised to report any symptoms such as shortness of breath, chest pain, or swelling immediately[8].

• Discuss the importance of hydration and the need for regular monitoring during treatment.

• Advise patients on the potential reproductive risks and the need for effective contraception during treatment and for a specified period after the last dose.

Special Considerations

• Adjustments may be necessary for patients with renal impairment, and dosing should be carefully calculated to avoid overdosing.

• Carfilzomib should not be mixed with other medications in the infusion line, and the line should be flushed with normal saline before and after administration.

Reconstitution Steps:

1. Remove the Vial: Take the Kyprolis vial out of the refrigerator just prior to use.

2. Inject Diluent: Aseptically reconstitute the vial by slowly injecting 29 mL of Sterile Water for Injection, USP, directing the solution onto the inside wall of the vial to minimize foaming.

3. Dissolve: Gently swirl and/or invert the vial slowly for about 1 minute, or until complete dissolution occurs. Avoid shaking to prevent foam generation. If foaming occurs, let the solution rest for 2 to 5 minutes until it subsides.

4. Final Appearance: After reconstitution, the solution should be a clear, colorless solution. Do not use if there is any discoloration or particulate matter.

Dilution Steps:

1. Withdraw Dose: Withdraw the required dose from the reconstituted vial.

2. Dilute: Dilute the withdrawn dose into 50 mL of 5% Dextrose Injection, USP, in an intravenous bag.

Administration Steps:

1. Infusion: Administer the diluted solution intravenously over a period of 2 to 10 minutes. Do not administer as a bolus.

2. Flushing: Flush the intravenous administration line with normal saline or 5% Dextrose Injection, USP immediately before and after Kyprolis administration.

Additional Information:

• Storage: Unopened vials should be stored at 2°C to 8°C (36°F to 46°F) until the expiration date.

• Single-use: The vials do not contain preservatives and are intended for single use only.