Kyprolis (carfilzomib)
An approved treatment for Multiple Myeloma.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Carfilzomib wherever you encounter it, plus the key facts at a glance.
- Generic name
- Carfilzomib
- Brand name
- Kyprolis
- Drug class
- Proteasome inhibitor
- Manufacturer
- Amgen (Onyx Pharmaceuticals, an Amgen subsidiary)
- How it's taken
- Infusion into a vein over 10 or 30 minutes, once or twice weekly for 3 weeks of each 4-week cycle
Kyprolis (carfilzomib) is a proteasome inhibitor, given by vein, for adults with multiple myeloma that has come back or stopped responding after earlier treatment[1].
- The FDA granted Kyprolis accelerated approval on July 20, 2012 and converted it to regular approval on January 21, 2016, after the ENDEAVOR trial confirmed its benefit[3][4].
- In the ASPIRE trial of 792 people with relapsed myeloma, adding Kyprolis to lenalidomide and dexamethasone lengthened median progression-free survival from 17.6 to 26.3 months[1][13].
- Kyprolis has no boxed warning, and its label lists heart failure, kidney failure, high blood pressure and lung problems among its most serious risks, some of them fatal[1].
- Kyprolis is not approved for newly diagnosed myeloma, and the label warns that a Kyprolis, melphalan and prednisone combination caused more deaths from side effects in that setting[1].
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Where Carfilzomib fits
Kyprolis is approved only for relapsed or refractory multiple myeloma, meaning myeloma that has come back or stopped responding to treatment[1]. With lenalidomide and dexamethasone, with dexamethasone alone, with daratumumab (IV or Darzalex Faspro) and dexamethasone, or with isatuximab and dexamethasone, it is approved after 1 to 3 prior lines of therapy[1]. On its own, it is approved after 1 or more prior lines[1]. It has no approval for newly diagnosed myeloma, and the label specifically warns against the Kyprolis, melphalan and prednisone combination in people who cannot have a transplant[1].
How Carfilzomib works
Cells use a large protein complex called the proteasome to break down proteins they no longer need[1]. Carfilzomib binds permanently (irreversibly) to the active sites in the 20S core of the 26S proteasome, which shuts down that recycling work[1].
In laboratory studies, carfilzomib slowed the growth of blood cancer and solid tumor cells and pushed them toward programmed cell death (apoptosis)[1]. In animal models of multiple myeloma, it blocked proteasome activity in blood and tissue and delayed tumor growth[1].
Side effects and safety
- Cardiac toxicities. Heart failure, cardiomyopathy, reduced blood flow to the heart and heart attack, some fatal; heart failure events in 8% across combination trials.
- Acute renal failure. Kidney problems in about 9%, some fatal, more often with Kyprolis alone in advanced myeloma; creatinine is checked regularly.
- Tumor lysis syndrome. Rapid breakdown of myeloma cells can strain the kidneys; fluids are given before Cycle 1 doses and uric acid is watched.
- Pulmonary toxicity. Acute respiratory distress syndrome, respiratory failure and pneumonitis, each in about 2%, some fatal.
- Pulmonary hypertension. Raised blood pressure in the lungs in about 2%, severe in under 1%.
- Dyspnea. Shortness of breath in 25%, severe in 4%; doses are paused for grade 3 or 4 symptoms.
- Hypertension. High blood pressure, including hypertensive crisis and emergency, some fatal; blood pressure is controlled before starting and checked regularly.
- Venous thrombosis. Blood clots in the legs or lungs; the label calls for clot-preventing medicine with Kyprolis combinations.
- Infusion-related reactions. Fever, chills, flushing, swelling or chest tightness up to 24 hours after a dose; dexamethasone is given beforehand.
- Hemorrhage. Serious or fatal bleeding in the gut, lungs or brain, even with normal platelet counts.
- Thrombocytopenia. Platelets fall between Day 8 and Day 15 of each cycle in about 32%, usually recovering by the next cycle.
- Hepatic toxicity and hepatic failure. Liver failure in 2%, including fatal cases; liver enzymes are checked regularly.
- Thrombotic microangiopathy. TTP/HUS, a rare clotting and kidney disorder, some fatal; Kyprolis is stopped if it is suspected.
- Posterior reversible encephalopathy syndrome. Rare brain swelling with seizures, headache, confusion or vision loss; Kyprolis is stopped if suspected.
- Progressive multifocal leukoencephalopathy. Rare, possibly fatal brain infection; new or worsening neurologic symptoms are checked.
- Toxicity with melphalan and prednisone in newly diagnosed myeloma. In CLARION, fatal side effects occurred in 7% with Kyprolis, melphalan and prednisone versus 4% with the bortezomib version; this combination is not approved.
- Embryo-fetal toxicity. Can harm an unborn baby; birth control for 6 months after treatment for women and 3 months for men with partners who could become pregnant.
- Signs of heart failure or chest pain throughout treatment
- Blood pressure before starting and regularly during treatment
- Serum creatinine or kidney function regularly
- Potassium levels regularly
- Uric acid and other signs of tumor lysis syndrome, especially in Cycle 1
- Platelet counts frequently
- Liver enzymes regularly
- Fluid balance and signs of fluid overload during hydration
- Pregnancy test before starting in women who could become pregnant
Kyprolis does not carry a boxed warning, but its Warnings and Precautions section is long, and several of the listed problems have been fatal[1].
Heart problems are the risk the label describes first. New or worsening heart failure, heart muscle disease, reduced blood flow to the heart and heart attacks have occurred, sometimes in people whose hearts worked normally before treatment[1]. Across the randomized combination trials, heart failure events occurred in 8% of people and abnormal heart rhythms in 8%[1]. The label says people aged 75 or older have a higher risk of heart failure[1].
Other warnings on the label:
- Kidney problems, including acute kidney failure, in about 9% of people, some fatal[1]
- High blood pressure, including hypertensive crisis; in ENDEAVOR it occurred in 34% on Kyprolis with dexamethasone versus 11% on bortezomib with dexamethasone[1]
- Shortness of breath (dyspnea) in 25%, severe in 4%[1]
- Lung injury, such as acute respiratory distress syndrome and pneumonitis, each in about 2%, and pulmonary hypertension in about 2%[1]
- Blood clots in the veins, such as deep vein thrombosis and pulmonary embolism; in ASPIRE they occurred in 13% on the Kyprolis combination versus 6% without it[1]
- Infusion reactions with fever, chills, flushing, facial swelling or chest tightness, which can appear up to 24 hours after a dose[1]
- Low platelets in about 32%, and serious bleeding, including bleeding in the brain or gut[1]
- Liver failure in 2%, tumor lysis syndrome, thrombotic microangiopathy (a rare clotting disorder), posterior reversible encephalopathy syndrome (PRES) and progressive multifocal leukoencephalopathy (PML), a rare brain infection[1]
When Kyprolis is combined with other drugs, the most common side effects (20% or more) are anemia, diarrhea, high blood pressure, tiredness, upper respiratory tract infection, low platelets, fever, cough, shortness of breath and trouble sleeping[1]. On its own, the most common are anemia, tiredness, low platelets, nausea, fever, shortness of breath, diarrhea, headache, cough and swelling of the legs[1].
Kyprolis can harm an unborn baby. The label calls for a pregnancy test before starting, birth control for 6 months after the last dose for women and 3 months for men with partners who could become pregnant, and no breastfeeding for 2 weeks after treatment[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Carfilzomib
Kyprolis is a powder that a pharmacist mixes with sterile water, and a nurse gives it as an infusion into a vein over 10 or 30 minutes, depending on the regimen[1]. Doses are based on body surface area (BSA), a measure of body size, and BSA is capped at 2.2m2 for the calculation[1].
Schedules on the current label, all in 28-day cycles:
- Once weekly 20/70mg/m2 over 30 minutes on Days 1, 8 and 15, with dexamethasone alone or with daratumumab (IV or Darzalex Faspro) and dexamethasone[1]
- Twice weekly 20/56mg/m2 over 30 minutes on Days 1, 2, 8, 9, 15 and 16, alone, with dexamethasone, with daratumumab and dexamethasone, or with isatuximab and dexamethasone[1]
- Twice weekly 20/27mg/m2 over 10 minutes on Days 1, 2, 8, 9, 15 and 16, alone or with lenalidomide and dexamethasone[1]
Each schedule starts at 20mg/m2 and steps up to the full dose in Cycle 1 if the first doses are tolerated[1]. With lenalidomide and dexamethasone, Kyprolis moves to Days 1, 2, 15 and 16 from Cycle 13 and stops after Cycle 18, while the other 2 drugs can continue[1].
Before every Cycle 1 dose, people get dexamethasone 30 minutes to 4 hours ahead to lower the risk of infusion reactions, plus fluids by mouth and by vein[1]. The label calls for clot-preventing medicine with Kyprolis combinations and suggests antiviral medicine to lower the risk of shingles[1]. Doses are cut by 25% for mild or moderate liver impairment, and people on dialysis get Kyprolis after their dialysis session[1]. The label does not include a REMS program[1].
Availability and cost
Only available as the brand-name product.
Help paying for Kyprolis
With private insurance, the drugmaker's copay card can lower what you pay for Kyprolis. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE, but charity funds often can. Of the 5 charity funds for Multiple Myeloma, 1 was open on October 26, 2026. Without insurance, you can apply to the drugmaker's free medicine program, which sets its own eligibility rules. Pick your insurance below to see which offers fit you.
- Copay help
The Amgen SupportPlus Co-Pay Program may help eligible patients with private or commercial insurance pay as little as $0 out of pocket for each dose or cycle. It can apply to deductible, co-insurance and co-payment, and has no income requirement. Eligibility criteria and program maximums apply.
For: private insurance · source - Free medicine program
The Amgen Safety Net Foundation, a nonprofit patient assistance program sponsored by Amgen, may help patients with financial need who are uninsured or whose insurance plan excludes the Amgen medicine.
For: no insurance, underinsured · source - Insurance and case manager help
Amgen SupportPlus lists financial support options by insurance type for Kyprolis, including independent foundations for people who do not qualify for the co-pay program and Medicare Part B information. Call (866) 264-2778.
For: private insurance, Medicare, Medicaid, no insurance · source
Good to know: Amgen's page suggests a 3-step order: the co-pay program for commercial insurance, then independent foundations, then the Amgen Safety Net Foundation. Kyprolis is given in a clinic, so Medicare coverage usually falls under Part B. Amgen's own pages list slightly different phone hours, so they are left out here.
Charity funds for Multiple Myeloma
- From a charity · HealthWell FoundationMultiple Myeloma (Medicare Access) fundOpen
Pays for: Copays, premiums or other treatment costs. Medicare patients only.
Clinical trial results
ASPIRE (NCT01080391) randomized 792 people with relapsed myeloma after 1 to 3 prior lines to Kyprolis with lenalidomide and dexamethasone (KRd) or lenalidomide and dexamethasone alone[1][14][13].
ASPIRE results from the label:
ENDEAVOR (NCT01568866) randomized 929 people with relapsed myeloma after 1 to 3 prior lines to Kyprolis with dexamethasone or bortezomib (Velcade) with dexamethasone[1][15]. Median progression-free survival was 18.7 versus 9.4 months (hazard ratio 0.53), and median overall survival was 47.6 versus 40.0 months (hazard ratio 0.79)[1]. Overall response was 77% versus 63%[1].
Other trials on the label:
- A.R.R.O.W. (NCT02412878), 478 people: once-weekly Kyprolis 20/70mg/m2 with dexamethasone gave a median progression-free survival of 11.2 months versus 7.6 months with twice-weekly 20/27mg/m2[1]
- CANDOR (NCT03158688), 466 people: adding daratumumab to Kyprolis and dexamethasone lowered the risk of progression or death (hazard ratio 0.63), with median progression-free survival not reached versus 15.8 months[1]
- IKEMA (NCT03275285), 302 people: adding isatuximab to Kyprolis and dexamethasone gave a hazard ratio of 0.548 for progression or death at an interim analysis, with median progression-free survival not reached versus 20.27 months[1]
- PX-171-003 A1 (NCT00511238), 266 people with heavily pretreated myeloma: Kyprolis alone produced a response in 23%, lasting a median of 7.8 months; this single-arm study supported the 2012 accelerated approval[1][3]
Development history
Carfilzomib was developed by Onyx Pharmaceuticals, which is now a wholly owned subsidiary of Amgen[4][1].
Myeloma milestones from FDA records:
- July 20, 2012: accelerated approval for myeloma after at least 2 prior therapies, including bortezomib and an immunomodulatory drug, with progression on or within 60 days of the last one[3]
- July 24, 2015: approval with lenalidomide and dexamethasone after 1 to 3 prior lines, based on ASPIRE[2]
- January 21, 2016: approval with dexamethasone based on ENDEAVOR, and regular (full) approval for Kyprolis alone after 1 or more prior lines[4]
- September 28, 2018: once-weekly 20/70mg/m2 dosing with dexamethasone added[5]
- August 20, 2020: approval with IV daratumumab and dexamethasone, based on CANDOR[6]
- November 30, 2021: approval with Darzalex Faspro (daratumumab and hyaluronidase) and dexamethasone[7]
- June 30, 2022: approval with isatuximab (Sarclisa) and dexamethasone, based on IKEMA[8]
- May 22, 2025: pediatric information added from a study in children with relapsed acute lymphoblastic leukemia, where safety and effectiveness were not established; no new indication was approved[9][1]
No myeloma indication for Kyprolis has been withdrawn, and the label on DailyMed was last revised in June 2025[1]. Drugs@FDA lists approved generic carfilzomib 60mg vials from Dr. Reddy's (September 9, 2019) and MSN (July 20, 2026), and a tentative approval on March 19, 2026 for Kitprozy, an Amneal carfilzomib product[10][11][12]. As of November 4, 2026, DailyMed carries no generic carfilzomib label, so Trial Friend could not confirm that a generic is on sale in the US[1].
Explore Multiple Myeloma trials
Other Multiple Myeloma treatments
Kyprolis is 1 of 3 proteasome inhibitors on the US market, alongside Velcade (bortezomib), given by shot or vein, and Ninlaro (ixazomib), a capsule[1][16][17]. ENDEAVOR compared Kyprolis with dexamethasone directly against bortezomib with dexamethasone in relapsed myeloma, with median progression-free survival of 18.7 versus 9.4 months; that trial gave bortezomib twice weekly and did not test every bortezomib schedule or combination[1].
Kyprolis is mostly used as a partner drug, paired on its label with a steroid, the immunomodulatory drug lenalidomide, or the anti-CD38 antibodies daratumumab and isatuximab[1]. CAR-T cell therapies and bispecific antibodies are separate classes whose own labels set when they can be used.
Common questions about Carfilzomib
▸What is Carfilzomib (Kyprolis)?
Kyprolis (carfilzomib) is a proteasome inhibitor, given by vein, for adults with multiple myeloma that has come back or stopped responding after earlier treatment[1]. The FDA granted Kyprolis accelerated approval on July 20, 2012 and converted it to regular approval on January 21, 2016, after the ENDEAVOR trial confirmed its benefit[3][4]. In the ASPIRE trial of 792 people with relapsed myeloma, adding Kyprolis to lenalidomide and dexamethasone lengthened median progression-free survival from 17.6 to 26.3 months[1][13]. Kyprolis has no boxed warning, and its label lists heart failure, kidney failure, high blood pressure and lung problems among its most serious risks, some of them fatal[1]. Kyprolis is not approved for newly diagnosed myeloma, and the label warns that a Kyprolis, melphalan and prednisone combination caused more deaths from side effects in that setting[1].
▸How does Carfilzomib work?
Cells use a large protein complex called the proteasome to break down proteins they no longer need[1]. Carfilzomib binds permanently (irreversibly) to the active sites in the 20S core of the 26S proteasome, which shuts down that recycling work[1].
In laboratory studies, carfilzomib slowed the growth of blood cancer and solid tumor cells and pushed them toward programmed cell death (apoptosis)[1]. In animal models of multiple myeloma, it blocked proteasome activity in blood and tissue and delayed tumor growth[1].
Kyprolis is usually given with other myeloma medicines that work in different ways:
- Dexamethasone, a steroid[1]
- Lenalidomide, an immunomodulatory drug[1]
- Anti-CD38 antibodies, either daratumumab (Darzalex or Darzalex Faspro) or isatuximab (Sarclisa)[1]
▸What are the side effects of Carfilzomib?
Kyprolis does not carry a boxed warning, but its Warnings and Precautions section is long, and several of the listed problems have been fatal[1].
Heart problems are the risk the label describes first. New or worsening heart failure, heart muscle disease, reduced blood flow to the heart and heart attacks have occurred, sometimes in people whose hearts worked normally before treatment[1]. Across the randomized combination trials, heart failure events occurred in 8% of people and abnormal heart rhythms in 8%[1]. The label says people aged 75 or older have a higher risk of heart failure[1].
Other warnings on the label: Kidney problems, including acute kidney failure, in about 9% of people, some fatal[1] High blood pressure, including hypertensive crisis; in ENDEAVOR it occurred in 34% on Kyprolis with dexamethasone versus 11% on bortezomib with dexamethasone[1] Shortness of breath (dyspnea) in 25%, severe in 4%[1] Lung injury, such as acute respiratory distress syndrome and pneumonitis, each in about 2%, and pulmonary hypertension in about 2%[1] Blood clots in the veins, such as deep vein thrombosis and pulmonary embolism; in ASPIRE they occurred in 13% on the Kyprolis combination versus 6% without it[1] Infusion reactions with fever, chills, flushing, facial swelling or chest tightness, which can appear up to 24 hours after a dose[1] Low platelets in about 32%, and serious bleeding, including bleeding in the brain or gut[1] Liver failure in 2%, tumor lysis syndrome, thrombotic microangiopathy (a rare clotting disorder), posterior reversible encephalopathy syndrome (PRES) and progressive multifocal leukoencephalopathy (PML), a rare brain infection[1]
When Kyprolis is combined with other drugs, the most common side effects (20% or more) are anemia, diarrhea, high blood pressure, tiredness, upper respiratory tract infection, low platelets, fever, cough, shortness of breath and trouble sleeping[1]. On its own, the most common are anemia, tiredness, low platelets, nausea, fever, shortness of breath, diarrhea, headache, cough and swelling of the legs[1].
Kyprolis can harm an unborn baby. The label calls for a pregnancy test before starting, birth control for 6 months after the last dose for women and 3 months for men with partners who could become pregnant, and no breastfeeding for 2 weeks after treatment[1].
▸How is Carfilzomib taken?
Kyprolis is a powder that a pharmacist mixes with sterile water, and a nurse gives it as an infusion into a vein over 10 or 30 minutes, depending on the regimen[1]. Doses are based on body surface area (BSA), a measure of body size, and BSA is capped at 2.2m2 for the calculation[1].
Schedules on the current label, all in 28-day cycles:
- Once weekly 20/70mg/m2 over 30 minutes on Days 1, 8 and 15, with dexamethasone alone or with daratumumab (IV or Darzalex Faspro) and dexamethasone[1]
- Twice weekly 20/56mg/m2 over 30 minutes on Days 1, 2, 8, 9, 15 and 16, alone, with dexamethasone, with daratumumab and dexamethasone, or with isatuximab and dexamethasone[1]
- Twice weekly 20/27mg/m2 over 10 minutes on Days 1, 2, 8, 9, 15 and 16, alone or with lenalidomide and dexamethasone[1]
Each schedule starts at 20mg/m2 and steps up to the full dose in Cycle 1 if the first doses are tolerated[1]. With lenalidomide and dexamethasone, Kyprolis moves to Days 1, 2, 15 and 16 from Cycle 13 and stops after Cycle 18, while the other 2 drugs can continue[1].
Before every Cycle 1 dose, people get dexamethasone 30 minutes to 4 hours ahead to lower the risk of infusion reactions, plus fluids by mouth and by vein[1]. The label calls for clot-preventing medicine with Kyprolis combinations and suggests antiviral medicine to lower the risk of shingles[1]. Doses are cut by 25% for mild or moderate liver impairment, and people on dialysis get Kyprolis after their dialysis session[1]. The label does not include a REMS program[1].
▸Is Carfilzomib FDA approved?
Yes, Carfilzomib (Kyprolis) is FDA approved (2012) for the treatment of Multiple Myeloma.
▸Is Kyprolis chemotherapy?
The Kyprolis label calls carfilzomib a proteasome inhibitor, a targeted medicine that blocks the cell's protein-recycling machinery[1].
How it works: Carfilzomib binds permanently to the proteasome, which stops myeloma cells from growing and triggers cell death[1].
How it is given: Like many cancer medicines, it is given as an infusion into a vein at an infusion center[1].
Source: Kyprolis prescribing information (DailyMed)
▸How long does a Kyprolis infusion take?
Each Kyprolis infusion takes 10 or 30 minutes, depending on the dose schedule[1].
Shorter infusion: The 10-minute infusion is used for the 20/27mg/m2 schedule, given alone or with lenalidomide and dexamethasone[1].
Longer infusion: The 30-minute infusion is used for the 20/56mg/m2 twice-weekly and 20/70mg/m2 once-weekly schedules[1].
Extra time: In Cycle 1, dexamethasone is given 30 minutes to 4 hours before each dose, along with IV fluids before and sometimes after[1].
Source: Kyprolis prescribing information (DailyMed)
▸Does Kyprolis cause heart problems?
Yes, heart failure, heart attack and other heart problems are the first warning on the Kyprolis label, and some have been fatal[1].
How often: Heart failure events occurred in 8% of people across the randomized combination trials[1].
Who: The label says the risk of heart failure is higher in people aged 75 or older[1].
Blood pressure: High blood pressure, including hypertensive crisis, is a separate warning, and blood pressure is checked regularly[1].
Next step: Questions about personal heart risk belong with the oncology team, who can explain the checks they plan.
Source: Kyprolis prescribing information (DailyMed)
▸Is there a generic for Kyprolis?
Drugs@FDA lists approved generic carfilzomib, but Trial Friend could not confirm that any generic is on sale in the US as of November 4, 2026[10][11].
Approved: Generic carfilzomib 60mg vials from Dr. Reddy's (2019) and MSN (2026) appear as approved in Drugs@FDA[10][11].
On DailyMed: Kyprolis is the only carfilzomib label listed, which suggests no generic has launched[1].
Pending: Amneal's Kitprozy has tentative approval, which means it cannot be sold yet[12].
Source: Drugs@FDA; Kyprolis prescribing information (DailyMed)
▸How much does Kyprolis cost?
A price is not stated on the label, and Trial Friend does not publish a price it cannot confirm.
Commercial insurance: Amgen SupportPlus says eligible people may pay as little as $0 for each dose or cycle, with program maximums[19].
No insurance: The Amgen Safety Net Foundation may help people with financial need who are uninsured[18].
Phone: Amgen SupportPlus at (866) 264-2778[18].
Source: Amgen SupportPlus Kyprolis financial support page
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed (Onyx Pharmaceuticals, Inc., an Amgen subsidiary) · 2025-06. KYPROLIS (carfilzomib) for injection, for intravenous use, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ea66eb30-e665-4693-99a1-a9d3b4bbe2d6
- U.S. Food and Drug Administration · 2026-11. Drugs@FDA: KYPROLIS, NDA 202714, approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202714
- U.S. Food and Drug Administration · 2012-07-20. NDA 202714 accelerated approval letter: Kyprolis (carfilzomib) for Injection. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202714Orig1s000ltr.pdf
- U.S. Food and Drug Administration · 2016-01-21. NDA 202714/S-010 supplement approval: ENDEAVOR, regular approval of monotherapy and fulfillment of postmarketing requirements. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714Orig1s010ltr.pdf
- U.S. Food and Drug Administration · 2018-09-28. NDA 202714/S-021 supplement approval: once-weekly 20/70mg/m2 dosing with dexamethasone. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202714Orig1s021ltr.pdf
- U.S. Food and Drug Administration · 2020-08-20. NDA 202714/S-030 supplement approval: Kyprolis with daratumumab and dexamethasone. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202714Orig1s030ltr.pdf
- U.S. Food and Drug Administration · 2021-11-30. NDA 202714/S-033 supplement approval: Kyprolis with daratumumab and hyaluronidase-fihj and dexamethasone. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202714Orig1s033ltr.pdf
- U.S. Food and Drug Administration · 2022-06-30. NDA 202714/S-034 supplement approval: Kyprolis with isatuximab-irfc and dexamethasone. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202714Orig1s034ltr.pdf
- U.S. Food and Drug Administration · 2025-05-22. NDA 202714/S-036 supplement approval: pediatric use labeling update. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/202714Orig1s036ltr.pdf
- U.S. Food and Drug Administration · 2019-09-09. Drugs@FDA: carfilzomib for injection 60mg/vial, ANDA 209422. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209422
- U.S. Food and Drug Administration · 2026-07-20. Drugs@FDA: carfilzomib for injection, ANDA 209526. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209526
- U.S. Food and Drug Administration · 2026-03-19. Drugs@FDA: KITPROZY (carfilzomib), NDA 220712, tentative approval. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220712
- New England Journal of Medicine · 2015-01-08. Carfilzomib, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma. https://doi.org/10.1056/NEJMoa1411321
- ClinicalTrials.gov · 2026-11. Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma. https://clinicaltrials.gov/study/NCT01080391
- ClinicalTrials.gov · 2026-11. Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients. https://clinicaltrials.gov/study/NCT01568866
- U.S. National Library of Medicine, DailyMed (Takeda Pharmaceuticals America, Inc.) · 2025-08. VELCADE (bortezomib) for injection, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1521d321-e724-4ffc-adad-34bf4f44fac7
- U.S. National Library of Medicine, DailyMed (Takeda Pharmaceuticals America, Inc.) · 2026-08. NINLARO (ixazomib) capsules, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=038f2461-834b-4488-9ebd-863c83eef5a7
- Amgen · 2026-11. Financial Support, Kyprolis, Amgen SupportPlus. https://www.amgensupportplus.com/kyprolis/financial-support
- Amgen · 2026-11. Amgen SupportPlus Co-Pay Program, patient enrollment. https://www.amgensupportplus.com/patient/copay-program