KYPROLIS- carfilzomib injection, powder, lyophilized, for solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

CARFILZOMIB (UNII: 72X6E3J5AR) (CARFILZOMIB - UNII:72X6E3J5AR)

Inapatikana kutoka:

Onyx Pharmaceuticals, Inc.

INN (Jina la Kimataifa):

CARFILZOMIB

Tungo:

CARFILZOMIB 60 mg in 30 mL

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

- Kyprolis 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. - Lenalidomide and dexamethasone; or - Dexamethasone; or - Daratumumab and dexamethasone; or - Daratumumab and hyaluronidase-fihj and dexamethasone; or - Isatuximab and dexamethasone. - Kyprolis is indicated as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. None. Risk Summary Kyprolis can cause fetal harm based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1)] . There are no available data on Kyprolis use in pregnant women to evaluate for drug-associated risks. Kyprolis caused embryo-fetal lethality in rabbits at doses lower

Bidhaa muhtasari:

How Supplied Kyprolis (carfilzomib) is supplied as: Storage and Handling Unopened vials should be stored refrigerated 2°C to 8°C (36°F to 46°F). Retain in original package to protect from light.

Idhini hali ya:

New Drug Application

Tabia za bidhaa

KYPROLIS- CARFILZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
ONYX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KYPROLIS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KYPROLIS.
KYPROLIS (CARFILZOMIB) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2012
RECENT MAJOR CHANGES
Indications and Usage (1.1)
11/2021
Indications and Usage (1.1)
6/2022
Dosage and Administration (2.2)
6/2022
Dosage and Administration (2.2)
11/2021
INDICATIONS AND USAGE
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. (1, 14)
as a single agent for the treatment of patients with relapsed or
refractory multiple myeloma who have
received one or more lines of therapy. (1, 14)
DOSAGE AND ADMINISTRATION
Hydrate prior to and following Kyprolis as needed. (2.1)
Premedicate prior to all Cycle 1 doses and if infusion-related
reactions develop or reappear. (2.1)
The recommended dosing regimens are as follows. See Full Prescribing
Information for additional
dosage information. (2.2)
REGIMEN
DOSAGE
INFUSION TIME
Kyprolis and Dexamethasone (Kd) or
Kyprolis, Daratumumab and
Dexamethasone (DKd) or
Kyprolis, Daratumumab and
hyaluronidase-fihj and Dexamethasone
(DKd)
20/70 mg/m once weekly
30 minutes
Kyprolis and Dexamethasone (Kd) or
Kyprolis, Daratumumab and
Dexamethasone (DKd) or
Kyprolis, Daratumumab and
hyaluronidase-fihj and Dexamethasone
(DKd) or
Kyprolis, Isatuximab and Dexamethasone
(Isa-Kd) or
Kyprolis Monotherapy
20/56 mg/m twice weekly
30 minutes
Kyprolis, Lenalidomide and
Dexamethasone (KRd) or
Kyprolis Monotherapy
20/27 mg/m twice weekly
10 minutes
DOSAGE FORMS AND STRENGTHS
®
2
2
2
DOSAGE FORMS AND STR