carfilzomib
Kyprolis · ATC code L01XX45
Also known as: Karfilzomib
- Key facts
- Active substance
- carfilzomib
- ATC code
- L01XX45
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Kyprolis 10 mg powder for solution for infusion / Kyprolis 30 mg powder for solution for infusion / Kyprolis 60 mg powder for solution for infusion
- Marketing authorisation holder
- Amgen Europe B.V.
- Information as of
- 2026-10-28
Key facts
Carfilzomib is a proteasome inhibitor given by intravenous infusion in combination with other medicines to treat previously treated multiple myeloma in adults (Kyprolis).
What it is used for
- Adults with multiple myeloma who have received at least one prior therapy, in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone.
Dosing
- Dose based on body surface area (BSA); patients with BSA greater than 2.2 m² are dosed on 2.2 m². Given on two consecutive days each week for three weeks (days 1, 2, 8, 9, 15 and 16), then a rest period; each cycle is 28 days.
- With lenalidomide and dexamethasone: 10-minute infusion, starting dose 20 mg/m² (maximum 44 mg) on days 1 and 2 of cycle 1, increased from day 8 if tolerated to 27 mg/m² (maximum 60 mg); from cycle 13 the day 8 and 9 doses are omitted.
- With dexamethasone alone or with daratumumab and dexamethasone: 30-minute infusion, starting dose 20 mg/m² (maximum 44 mg) on days 1 and 2 of cycle 1, increased from day 8 if tolerated to 56 mg/m² (maximum 123 mg).
- Dexamethasone is given 30 minutes to 4 hours before Kyprolis; doses of the combination partners: see the full text.
- Adequate hydration before dosing in cycle 1. No starting dose adjustment in renal impairment or mild to moderate hepatic impairment; monitor liver tests monthly.
- Continue until disease progression or unacceptable toxicity.
Contraindications
- Hypersensitivity to the active substance or any excipient.
- Women who are breast-feeding.
- Contraindications of the combination partners: see their product information.
Important warnings
- Cardiac disorders: new or worsening cardiac failure, myocardial ischaemia and infarction, including fatal outcomes; higher risk in patients ≥ 75 years. Assess cardiovascular risk factors beforehand and monitor for volume overload.
- Pulmonary toxicity (ARDS, pneumonitis, interstitial lung disease), pulmonary hypertension and dyspnoea, some fatal.
- Hypertension including hypertensive crisis; control before and during treatment.
- Acute renal failure and tumour lysis syndrome; ensure adequate hydration.
- Infusion reactions, including life-threatening ones.
- With lenalidomide, its pregnancy prevention requirements apply.
Side effects
- Most common (> 20%): anaemia, fatigue, thrombocytopenia, nausea, diarrhoea, pyrexia, dyspnoea, respiratory tract infection, cough and neutropenia.
- Serious, including: cardiac failure, myocardial infarction, cardiac arrest, interstitial lung disease, acute kidney injury, tumour lysis syndrome, haemorrhages, hepatic failure, hepatitis B reactivation, PRES, thrombotic microangiopathy.
Interactions
- Carfilzomib pharmacokinetics are unlikely to be affected by cytochrome P450 inhibitors and inducers.
- Carfilzomib may decrease the efficacy of oral contraceptives; an alternative effective method should be used.
Pregnancy and breastfeeding
- Can cause foetal harm; use in pregnancy only if the benefit outweighs the risk. Women must use effective contraception during and for one month after treatment, men for 3 months.
- Contraindicated during breast-feeding.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- KyprolisAmgen Europe B.V. · EMEA/H/C/003790
Source: European Medicines Agency (EMA), product information
Turkey
- CafizoINPHARMUS İLAÇ SAN. TİC. A.Ş. · 1 register entry
- KarfilibSABA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- KarzomSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- KyprolisAMGEN İLAÇ TİC. LTD. ŞTİ. · 3 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 2 more European countries
- Iceland
- Kyprolis
- Norway
- Kyprolis
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Kyprolis – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/kyprolis-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.