C

Carfilez 30

Rx

30 mg • Injection

Carfilzomib • Beacon Pharmaceuticals PLC

Therapeutic class: Tetrapeptide epoxyketone proteasome inhibitor

Available as: 30 mg

Indications & Uses

Carfilzomib is a proteasome inhibitor. It is used in adults with relapsed or refractory multiple myeloma who have received one to three lines of therapy, and in this group it is given in combination with one of the following: Lenalidomide and dexamethasone, or Dexamethasone alone, or Daratumumab and dexamethasone, or Daratumumab and hyaluronidase-fihj and dexamethasone, or Isatuximab and dexamethasone. Carfilzomib can also be used as a single agent in patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.

Pharmacology

Carfilzomib is a tetrapeptide epoxyketone proteasome inhibitor. It binds irreversibly to the N-terminal threonine-containing active sites of the 20S proteasome, which is the proteolytic core particle inside the 26S proteasome. In laboratory (in vitro) studies, carfilzomib had antiproliferative and proapoptotic activities in solid and hematologic tumor cells. In animals, it inhibited proteasome activity in blood and tissue, and it delayed tumor growth in models of multiple myeloma, hematologic tumors and solid tumors.

Dosage Reference

Reference Information Only

Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.

Adults:

Hydration: Make sure the patient is well hydrated before Carfilzomib is given in Cycle 1, especially when there is a high risk of tumor lysis syndrome (TLS) or renal toxicity. Consider both oral fluids (30 mL per kg at least 48 hours before Cycle 1, Day 1) and intravenous fluids (250 mL to 500 mL of a suitable intravenous fluid before each dose in Cycle 1). If needed, give another 250 mL to 500 mL of intravenous fluids after the dose. In later cycles, continue oral and/or intravenous hydration as needed. Watch the patient for signs of volume overload and adjust the fluids to what each patient needs, particularly in those with cardiac failure or at risk of it.

Premedications and Concomitant Medications: Give the recommended dose of dexamethasone, whether it is for monotherapy or as part of the combination therapy. Give it orally or intravenously at least 30 minutes but no more than 4 hours before every dose of Carfilzomib in Cycle 1, to reduce how often infusion-related reactions occur and how severe they are. If these symptoms occur in later cycles, start the dexamethasone premedication again. Provide thromboprophylaxis for patients who receive Carfilzomib together with other therapies. Consider antiviral prophylaxis to lower the risk of herpes zoster reactivation.

Electrolyte Monitoring: Check serum potassium levels regularly during treatment.

Side Effects

In trials where Carfilzomib was given on its own, at least 20% of patients had these side effects: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough and peripheral edema. In trials where Carfilzomib was given as part of a combination, at least 20% of patients had these: anemia, diarrhea, hypertension, fatigue, upper respiratory tract infection, thrombocytopenia, pyrexia, cough, dyspnea and insomnia.

Cautions & Contraindications

Warnings & Precautions

Cardiac toxicities: watch for signs and symptoms of cardiac failure or ischemia. If they appear, withhold Kyprolis and evaluate the patient promptly. Acute renal failure: check serum creatinine regularly. Tumor lysis syndrome (TLS): give hydration before treatment starts. Monitor for TLS, including uric acid levels, and treat promptly if it occurs. Pulmonary toxicity, including Acute Respiratory Distress Syndrome, Acute Respiratory Failure, and Acute Diffuse Infiltrative Pulmonary Disease: withhold Kyprolis and evaluate promptly. Pulmonary hypertension: withhold Kyprolis and evaluate. Dyspnea: if it is severe or life-threatening, withhold Kyprolis and evaluate. Hypertension, including hypertensive crisis: check blood pressure regularly. If the hypertension can't be controlled, interrupt treatment with Kyprolis. 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. Evaluate any signs and symptoms of blood loss promptly. Thrombocytopenia: monitor platelet counts, and interrupt or reduce the Kyprolis dose as clinically indicated. Hepatic toxicity and hepatic failure: monitor liver enzymes regularly. Withhold Kyprolis if this is suspected. Thrombotic microangiopathy: monitor for signs and symptoms. Discontinue Kyprolis if it is suspected. Posterior Reversible Encephalopathy Syndrome (PRES): consider neuro-radiological imaging (MRI) when visual or neurological symptoms begin. Discontinue Kyprolis if PRES is suspected. Progressive Multifocal Leukoencephalopathy: consider PML if new or worsening neurologic manifestations appear. Discontinue Kyprolis in patients who develop PML. Fatal and serious toxicities have increased when Kyprolis is used in combination with melphalan and prednisone in newly diagnosed transplant-ineligible patients. Embryo-fetal toxicity: Kyprolis can cause fetal harm. Females of reproductive potential, and males with female partners of reproductive potential, should be told about the potential risk to a fetus and advised to use effective contraception.

Pregnancy & Breastfeeding

Carfilzomib can harm an unborn baby. This is based on findings from animal studies and on how the medicine works. There are no data on the use of carfilzomib in pregnant women, so the risk linked to the drug can't be properly assessed. In rabbits, carfilzomib caused embryo-fetal lethality at doses lower than the clinical dose. Pregnant women should be told about the potential risk to the fetus.

There are also no data on whether carfilzomib passes into human milk, what effect it has on a breastfed child, or whether it changes milk production. Because the breastfed child could have serious adverse reactions, women are advised not to breastfeed during treatment with carfilzomib and for 2 weeks after treatment.

⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.

Storage

Keep unopened Carfilzomib vials in a refrigerator at 2°C to 8°C. Leave them in the original package so the light doesn't reach them.

Drug Interactions

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Moderate Midazolam

Common questions about Carfilez 30 30 mg

What is Carfilez 30 30 mg Injection?

Carfilez 30 30 mg Injection is a medicine that contains Carfilzomib. It is made by Beacon Pharmaceuticals PLC. It belongs to the Tetrapeptide epoxyketone proteasome inhibitor group of medicines.

What is Carfilez 30 used for?

Carfilzomib is a proteasome inhibitor. It is used in adults with relapsed or refractory multiple myeloma who have received one to three lines of therapy, and in this group it is given in combination with one of the following: Lenalidomide and dexamethasone, or Dexamethasone alone, or Daratumumab and dexamethasone, or Daratumumab and hyaluronidase-fihj and dexamethasone, or Isatuximab and dexamethasone.

What are the side effects of Carfilez 30?

In trials where Carfilzomib was given on its own, at least 20% of patients had these side effects: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough and peripheral edema. In trials where Carfilzomib was given as part of a combination, at least 20% of patients had these: anemia, diarrhea, hypertension, fatigue, upper respiratory tract infection, thrombocytopenia, pyrexia, cough, dyspnea and insomnia.

Can I take Carfilez 30 during pregnancy or while breastfeeding?

Carfilzomib can harm an unborn baby. This is based on findings from animal studies and on how the medicine works. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.

How should I store Carfilez 30?