Brand Name
Kyprolis
Generic Name
Carfilzomib
View Brand Information FDA approval date: July 20, 2012
Classification: Proteasome Inhibitor
Form: Injection
What is Kyprolis (Carfilzomib)?
Kyprolis 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.
Approved To Treat
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Brand Information
KYPROLIS (carfilzomib)
1DOSAGE FORMS AND STRENGTHS
For injection: 10 mg, 30 mg and 60 mg as a white to off-white lyophilized cake or powder in single-dose vial for reconstitution.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
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
3.1Clinical 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
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of Kyprolis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: hemolytic uremic syndrome (HUS), hepatitis B virus reactivation, gastrointestinal perforation, pericarditis, and cytomegalovirus infection, including chorioretinitis, pneumonitis, enterocolitis, viremia, intestinal obstruction, and acute pancreatitis.
4OVERDOSAGE
Acute onset of chills, hypotension, renal insufficiency, thrombocytopenia, and lymphopenia has been reported following a dose of 200 mg of Kyprolis administered in error.
There is no known specific antidote for Kyprolis overdosage. In the event of overdose, monitor patients for adverse reactions and provide supportive care as appropriate.
5DESCRIPTION
Carfilzomib is a proteasome inhibitor. The chemical name for carfilzomib is (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)-4-methylpentanamide. Carfilzomib has the following structure:
Carfilzomib is a crystalline substance with a molecular weight of 719.9. The molecular formula is C
Kyprolis for injection, for intravenous use is a sterile, white to off-white lyophilized powder in a single-dose vial. Each 10 mg vial contains 10 mg of carfilzomib, 500 mg sulfobutylether beta-cyclodextrin, and 9.6 mg anhydrous citric acid and sodium hydroxide for pH adjustment (target pH 3.5). Each 30 mg vial contains 30 mg of carfilzomib, 1500 mg sulfobutylether beta-cyclodextrin, and 28.8 mg anhydrous citric acid and sodium hydroxide for pH adjustment (target pH 3.5). Each 60 mg vial contains 60 mg of carfilzomib, 3000 mg sulfobutylether beta-cyclodextrin, 57.7 mg citric acid, and sodium hydroxide for pH adjustment (target pH 3.5).
6PATIENT COUNSELING INFORMATION
Discuss the following with patients prior to treatment with Kyprolis:
7PRINCIPAL DISPLAY PANEL
1 Single-Dose Vial
Dilution: May be further diluted with 5% Dextrose Injection, USP.
For Intravenous Administration Only
8PRINCIPAL DISPLAY PANEL
1 Single-Dose Vial
NDC 76075-102-01
AMGEN
Kyprolis
(carfilzomib) for Injection
30 mg/vial
30 mg/vial
Single-dose vial. Discard unused portion.
Reconstitution: Reconstitute with 15 mL Sterile Water for Injection, USP.
Dilution: May be further diluted with 5% Dextrose Injection, USP.
For Intravenous Administration Only
Rx Only
9PRINCIPAL DISPLAY PANEL
1 Single-Dose Vial
NDC 76075-101-01
AMGEN
Kyprolis
(carfilzomib) for Injection
60 mg/vial
60 mg/vial
Single-dose vial. Discard unused portion.
Reconstitution: Reconstitute with 29 mL Sterile Water for Injection, USP.
Dilution: May be further diluted with 5% Dextrose Injection, USP.
For Intravenous Administration Only
Rx Only
