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KYPROLIS is a brand name for Carfilzomib, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 07/2023 4 DOSAGE AND ADMINISTRATION 07/2023 7 WARNINGS AND PRECAUTIONS 07/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ........................................................................................ 2 TABLE OF…
Verbatim from this product's HC label. Tap a section to expand.
07/2023 7 WARNINGS AND PRECAUTIONS 07/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................
4 1 INDICATIONS ................................................................................................................. 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS ..................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX........................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................ 1 Dosing Considerations ...........................................................................................
2 Recommended Dose and Dosage Adjustment....................................................... 3 Reconstitution ...................................................................................................... 4 Administration ......................................................................................................
5 Missed Dose ........................................................................................................ 15 5 OVERDOSAGE.............................................................................................................
15
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 9. Dosage Forms, Strengths, Composition and Packaging KYPROLIS single-use vial contains 10, 30, or 60 mg of carfilzomib.
After reconstitution, each mL contains 2 mg of carfilzomib. • Single-use 10 mL (10 mg vial), 30 mL (30 mg vial), or 50 mL (60 mg vial) vial Type 1 clear glass vial fluoropolymer laminated elastomeric stopper and aluminum seal with plastic flip off cap • Pack size of one vial (10, 30 or 60 mg carfilzomib per vial) 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
General KYPROLIS as a monotherapy did not show a benefit over an active comparator (corticosteroids and cyclophosphamide) in a Phase 3 trial in patients with relapsed and refractory multiple myeloma. 25]) between the two arms. KYPROLIS is not indicated as a monotherapy for the treatment of relapsed and refractory multiple myeloma.
Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intravenous infusion Powder for Solution / 10, 30, 60 mg carfilzomib per vial anhydrous citric acid, sodium hydroxide (for pH adjustment), sulfobutylether beta- cyclodextrin KYPROLIS (carfilzomib for injection) Page 16 of 89 The safety and efficacy of KYPROLIS when combined with lenalidomide and dexamethasone (KRd) have not been established in patients with renal impairment (creatinine clearance [CrCL] < 50 mL/min).
These patients were excluded from the ASPIRE study, which is the pivotal Phase 3 combination study comparing KRd to lenalidomide and dexamethasone (Rd) alone. Limited data are available in KRd-treated patients with renal impairment at baseline (< 5% of patients were enrolled into ASPIRE with a CrCL = 30-50 mL/min and no patients had CrCL < 30 mL/min).
07/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................
4 1 INDICATIONS ................................................................................................................. 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS ..................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX........................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................ 1 Dosing Considerations ...........................................................................................
2 Recommended Dose and Dosage Adjustment....................................................... 3 Reconstitution ...................................................................................................... 4 Administration ......................................................................................................
5 Missed Dose ........................................................................................................ 15 5 OVERDOSAGE.............................................................................................................
KYPROLIS is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .
KYPROLIS (carfilzomib for injection) Page 5 of 89
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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KYPROLIS administered with a short infusion time, without pre-medication with dexamethasone and adequate hydration, or without stepped up dosing, may not be well tolerated. In early studies, where a 1 to 2 minute intravenous (IV) bolus was used without pre-medication, adverse reactions were observed that appeared to be most severe within the first few doses.
These reactions were characterized by chills, dyspnea, arthralgia or myalgia, and rigors. A longer infusion time, pre-medication and adequate hydration, and stepped up dosing in subsequent studies appeared to mitigate this risk. Nonclinical studies in rats have demonstrated that the tolerability of KYPROLIS is significantly lower when administered as an IV bolus compared to a 30-minute infusion.
KYPROLIS dosed at 56 mg/m2 and 70 mg/m2 must be infused over 30 minutes, and KYPROLIS dosed at 27 mg/m2 must be infused over at least 10 minutes (see 4 DOSAGE AND ADMINISTRATION and 16 NON-CLINICAL TOXICOLOGY). Infusion Reactions Infusion reactions, including life-threatening reactions, have been reported in patients who received KYPROLIS.
4% of patients reported an event within a day of the first dose of KYPROLIS. Following the introduction of management strategies (see below and 4 DOSAGE AND ADMINISTRATION), most adverse events that were potentially associated with an infusion reaction in Phase 3 trials were low grade and non-serious.
In IKEMA, infusion-related reactions (IRRs), were reported in patients treated with isatuximab in combination with KYPROLIS and dexamethasone (IsaKd). Please refer to the isatuximab Product Monograph for further details. Signs and symptoms have included fever, chills, arthralgia, myalgia, facial flushing, facial edema, laryngeal edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina.
These reactions can occur immediately following or up to 24 hours after administration of KYPROLIS. Ensure patients are appropriately hydrated and are administered dexamethasone prior to KYPROLIS to reduce the incidence and severity of reactions (see 4 DOSAGE AND ADMINISTRATION).
Tumour Lysis Syndrome Cases of tumour lysis syndrome (TLS), including fatal outcomes, have been reported in patients who received KYPROLIS. 6% in patients receiving Kd. 9% in patients receiving Kd once weekly. 8% in patients receiving KRd.
0% in patients receiving KdD. KYPROLIS (carfilzomib for injection) Page 17 of 89 Patients with a high tumour burden should be considered to be at greater risk for TLS. Ensure that patients are well hydrated before administration of KYPROLIS in Cycle 1, and in subsequent cycles as needed.
Uric acid lowering drugs should be considered in patients at high risk for TLS (see 4 DOSAGE AND ADMINISTRATION). Monitor for evidence of TLS during treatment including regular measurement of serum electrolytes, and manage promptly.
Interrupt KYPROLIS until TLS is resolved (see 4 DOSAGE AND ADMINISTRATION). Infections Infections, including serious and fatal events have been reported in patients receiving KYPROLIS (see 8 ADVERSE REACTIONS). Patients should be monitored for signs and symptoms of infection, and treated promptly.
Carcinogenesis and Mutagenesis Second Primary Malignancies (SPMs) The incidence of second primary malignancies is increased in patients treated […]
15 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ....................... 15 7 WARNINGS AND PRECAUTIONS ............................................................................... 1 Special Populations .............................................................................................
24 8 ADVERSE REACTIONS ............................................................................................... 1 Adverse Reaction Overview ................................................................................. 2 Clinical Trial Adverse Reactions...........................................................................
3 Less Common Clinical Trial Adverse Reactions ................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other KYPROLIS (carfilzomib for injection) Page 3 of 89 Quantitative Data ..................................................................................................
5 Post-Market Adverse Reactions ........................................................................... 46 9 DRUG INTERACTIONS ................................................................................................ 1 Serious Drug Interactions ....................................................................................
2 Drug-Interactions Overview.................................................................................. 3 Drug-Behavioural Interactions .............................................................................. 4 Drug-Drug Interactions.........................................................................................
5 Drug-Food Interactions ........................................................................................ 6 Drug-Herb Interactions......................................................................................... 7 Drug-Laboratory Test Interactions........................................................................
8 Drug-Lifestyle Interactions ................................................................................... 47 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action ......................................................................................
2 Pharmacodynamics........................................................................................ 3 Pharmacokinetics ........................................................................................... 48 11 STORAGE,STABILITY AND DISPOSAL ......................................................................
51 12 SPECIAL HANDLING INSTRUCTIONS........................................................................ 51 PART II: SCIENTIFIC INFORMATION ..................................................................................... 52 13 PHARMACEUTICAL INFORMATION ...........................................................................
52 14 CLINICAL TRIALS ........................................................................................................ 1 Clinical Trials by Indication .............................................................................
52 15 MICROBIOLOGY .......................................................................................................... 74 16 NON-CLINICAL TOXICOLOGY ....................................................................................
74 PATIENT MEDICATION INFORMATION […]