Prescription medicine
Carfilzomib Brand names: Kyprolis
Carfilzomib (Kyprolis) is a prescription medicine with an FDA approval on record since 2012. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the carfilzomib FDA label on DailyMed (effective June 18, 2025, Onyx Pharmaceuticals, Inc.); the NDA 202714 record on Drugs@FDA; every carfilzomib label on DailyMed.
Highlights of the record
FDA label of June 18, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageKyprolis 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;
Forms and strengths
- 10 mg/5ml
- 30 mg/15ml
- 60 mg/30ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- July 20, 2012 Kyprolis, Onyx Pharms Amgen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first September 9, 2019; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 29, 2041 Kyprolis injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2016 0 Class I among all firms' recalls; latest June 12, 2019
- FAERS reports
- 28,118 through July 30, 2026
What is carfilzomib used for?
From the label: indications and usageKyprolis 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. […]
Conditions named in the indications of carfilzomib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Proteasome Inhibitor.
Source: FDA drug label (KYPROLIS), Onyx Pharmaceuticals, Inc., effective June 18, 2025 (SPL set ea66eb30-e665-4693-99a1-a9d3b4bbe2d6), via openFDA; the full label on DailyMed
Is there a generic for carfilzomib (Kyprolis)?
The FDA approved the first generic carfilzomib on September 9, 2019. 5 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 4 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 5 patents for Kyprolis injection: the compound patent runs to July 20, 2026 (pediatric exclusivity to January 20, 2027), and the last listed entry to October 29, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2019 first generic approved
- 2041 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has carfilzomib been recalled?
The FDA's Enforcement Report lists 2 recalls naming carfilzomib since 2016: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
| December 15, 2016 | Class II | Amgen, Inc. | Lack of Assurance of Sterility: Potential cracks in glass vials |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the carfilzomib label say about other medicines?
The carfilzomib label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name carfilzomib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bortezomib | warnings and precautions | … mg/m 2 by 30-minute infusion twice weekly for four of each six-week cycle), melphalan and prednisone (KMP) or bortezomib, melphalan and prednisone (VMP), a higher incidence of fatal adverse reactions (7% versus 4%) and serious adverse reactions (50% versus 42%) were observed in the KMP arm compared to patients in the … |
| Daratumumab | warnings and precautions | Provide thromboprophylaxis for patients being treated with Kyprolis in combination with lenalidomide and dexamethasone; with dexamethasone; or with intravenous daratumumab and dexamethasone. |
| Dexamethasone | warnings and precautions | Thromboprophylaxis is recommended. ( 5.8 ) Infusion-related Reactions: Premedicate with dexamethasone. |
| Lenalidomide | warnings and precautions | Provide thromboprophylaxis for patients being treated with Kyprolis in combination with lenalidomide and dexamethasone; with dexamethasone; or with intravenous daratumumab and dexamethasone. |
| Melphalan | warnings and precautions | Discontinue Kyprolis in patients who develop PML. ( 5.15 ) Increased Fatal and Serious Toxicities in Combination with Melphalan and Prednisone in Newly Diagnosed Transplant-Ineligible Patients ( 5.16 ) Embryo-Fetal Toxicity: |
| Prednisone | warnings and precautions | Discontinue Kyprolis in patients who develop PML. ( 5.15 ) Increased Fatal and Serious Toxicities in Combination with Melphalan and Prednisone in Newly Diagnosed Transplant-Ineligible Patients ( 5.16 ) Embryo-Fetal Toxicity: |
Source: FDA drug label (KYPROLIS), Onyx Pharmaceuticals, Inc., effective June 18, 2025 (SPL set ea66eb30-e665-4693-99a1-a9d3b4bbe2d6), via openFDA; the full label on DailyMed
What do FAERS reports show for carfilzomib?
The FDA Adverse Event Reporting System holds 28,118 reports that list carfilzomib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,377 are coded as a death and 9,417 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as carfilzomib?
36 other medicines are given the same way (intravenous) and in the same FDA class as carfilzomib or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | 16 labelers | n/a | A presentation being discontinued |
| Bendamustine | Leukemia, lymphoma and myeloma | 4 labelers | n/a | A presentation being discontinued |
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Idarubicin | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
| Clofarabine | Leukemia, lymphoma and myeloma | 9 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as carfilzomib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to carfilzomib
- 36 medicines for the same use
- Other proteasome inhibitors
- the pharmacologic class, with prices and generics
- Carfilzomib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other