Is Carfilzomib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 7 valid registrations of Carfilzomib, including Carfilzomib BOS (10 mg, Powder for solution for injection/infusion, SAR 529.40); Carfilzomib BOS (30 mg, Powder for solution for injection/infusion, SAR 1588.25); Carfilzomib BOS (60 mg, Powder for solution for injection/infusion, SAR 3176.50); Carfilzomib SPC (60 mg, Powder for injection, SAR 2408.85); Filozad (60 mg, powder for solution for injection, SAR 3441.20).

Is Carfilzomib approved by the US FDA?

Drugs@FDA lists 7 application product lines for Carfilzomib, including KYPROLIS (Prescription); CARFILZOMIB (Prescription); CARFILZOMIB (Prescription); KITPROZY (Prescription); CARFILZOMIB (Discontinued).

Is Carfilzomib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Carfilzomib: Kyprolis.

Are there safety signals or safety updates for Carfilzomib?

US FDA: 1 entry; MHRA: 2 entries (latest 2025-05-22).

Active substance

Carfilzomib

SFDA 8
US FDA 7
EMA 1
Health Canada 3
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Carfilzomib BOS	10 mg	Powder for solution for injection/infusion · Intravenous use	1 Vial	SAR 529.40	Generic · Prescription	Boston Oncology Arabia	Valid
Carfilzomib BOS	30 mg	Powder for solution for injection/infusion · Intravenous use	1 Vial	SAR 1588.25	Generic · Prescription	Boston Oncology Arabia	Valid
Carfilzomib BOS	60 mg	Powder for solution for injection/infusion · Intravenous use	1 Vial	SAR 3176.50	Generic · Prescription	Boston Oncology Arabia	Valid
Carfilzomib SPC	60 mg	Powder for injection · Intravenous use	1 Vial	SAR 2408.85	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Filozad	60 mg	powder for solution for injection · Intravenous use	1 Vial	SAR 3441.20	Generic · Prescription	Eugia Pharma Specialities Limited	Valid
KYPROLIS 60 mg Powder For Solution For Injection	60 mg	powder for solution for injection · Intravenous use	1 Vial	SAR 4235.30	NCE · Prescription	ONYX PHARMACEUTICALS INC.	Valid
OMFENTRY	60 mg	Powder for injection · Intravenous use	1 Vial	SAR 3176.50	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
KYPROLIS 60 mg Powder For Solution For Injection	60 mg	powder for solution for injection · Intravenous use	1 Vial	SAR 5294.15	NCE · Prescription	ONYX PHARMACEUTICALS INC.	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

AMYLOIDOSIS - LIGHT CHAIN

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
KYPROLIS	60MG/VIAL; 30MG/VIAL; 10MG/VIAL	powder · intravenous	ONYX PHARMS AMGEN	Prescription	20 Jul 2012
CARFILZOMIB	60MG/VIAL	powder · intravenous	DR REDDYS	Prescription	9 Sep 2019
CARFILZOMIB	60MG/VIAL	powder · intravenous	MSN	Prescription	20 Jul 2026
KITPROZY	60MG/ML, 2/ML; 120MG/2ML (60MG/ML), 2ML	vial · single-use	AMNEAL PHARMS NY	Prescription
CARFILZOMIB	60MG/VIAL	powder · intravenous	APOTEX	Discontinued	16 Mar 2020
CARFILZOMIB	30MG/VIAL	powder · intravenous	APOTEX	Discontinued	20 Mar 2020
CARFILZOMIB	10MG/VIAL; 60MG/VIAL	powder · intravenous	BRECKENRIDGE	Discontinued	11 Jun 2021

EMA European Union — centrally authorised medicines

Kyprolis Amgen Europe B.V. · Authorised · authorised 19 Nov 2015 · ATC L01XX45

Therapeutic indication (EMA)

Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
KYPROLIS	02451034	60 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	AMGEN CANADA INC
KYPROLIS	02459930	10 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	AMGEN CANADA INC
KYPROLIS	02459949	30 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	AMGEN CANADA INC

Safety signals and safety-related labeling changes

US FDA 22 May 2025 KYPROLIS — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 21 Nov 2019 Carfilzomib (Kyprolis▼): risk of reactivation of hepatitis B virus
Establish hepatitis B status before initiating carfilzomib and in patients with unknown hepatitis B virus serology who are already being treated with carfilzomib.
MHRA 19 Aug 2019 Carfilzomib (Kyprolis▼): reminder of risk of potentially fatal cardiac events
Anti-cancer therapy with carfilzomib has been associated with cases of cardiac arrest, cardiac failure, and myocardial infarction, including in patients without pre-existing cardiac disorders. Monitor patients for signs and symptoms of cardiac disorders before and during exposure to carfilzomib.

All safety entries for carfilzomib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.