Velcade (bortezomib)
Also marketed as Boruzu. An approved treatment for Multiple Myeloma.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Bortezomib wherever you encounter it, plus the key facts at a glance.
- Generic name
- Bortezomib
- Brand names
- Velcade, Boruzu
- Development code
- PS-341
- Drug class
- Proteasome inhibitor
- Manufacturer
- Takeda (Millennium Pharmaceuticals); generic bortezomib is made by several companies
- How it's taken
- Injection under the skin or into a vein by a healthcare provider, usually twice weekly or once weekly in cycles
Velcade (bortezomib) is a proteasome inhibitor injection, given under the skin or into a vein, for adults with multiple myeloma at any stage[1].
- The FDA first approved Velcade on May 13, 2003, under accelerated approval for myeloma after at least 2 prior therapies, and widened the approval to all adults with multiple myeloma on June 20, 2008[3][5].
- In the VISTA trial of 682 people with newly diagnosed myeloma, adding Velcade to melphalan and prednisone lengthened median time to progression from 15.0 to 20.7 months[1][13].
- Velcade has no boxed warning, and its main safety concern is nerve damage in the hands and feet (peripheral neuropathy), which is less common with the shot under the skin than with the vein injection[1].
- Generic bortezomib from many makers and a ready-to-use version called Boruzu are also FDA approved for myeloma[2][8].
We'll email you when Velcade's FDA label changes, when the FDA acts on it, and when new trials for Multiple Myeloma open. Unsubscribe anytime.
- Trial Alerts, when a new trial opens or a trial changes
- Disease Updates, FDA decisions and condition news, usually 1 or 2 emails a month
We never share your email. Unsubscribe anytime. Privacy policy · Check any health site
Where Bortezomib fits
The Velcade label covers adults with multiple myeloma at any stage, from newly diagnosed to relapsed, without a limit on prior lines of therapy[1]. The label gives dosing for Velcade with melphalan and prednisone in newly diagnosed myeloma, and for Velcade alone or with dexamethasone in relapsed myeloma, including retreatment[1]. Bortezomib is also a named partner drug in other medicines' labels, such as Darzalex Faspro combinations for newly diagnosed and relapsed myeloma and Xpovio with bortezomib and dexamethasone after at least 1 prior therapy[17][18]. Velcade is also approved for mantle cell lymphoma[1].
How Bortezomib works
Every cell uses a large protein complex called the proteasome to break down proteins it no longer needs[1]. Bortezomib attaches to the 26S proteasome and reversibly blocks one of its cutting functions, called the chymotrypsin-like activity[1].
When the proteasome is blocked, unwanted proteins build up and several signaling pathways inside the cell are thrown off balance, which can lead to cell death[1]. The label reports that bortezomib slowed tumor growth in laboratory models of cancer, including multiple myeloma[1].
Velcade is often given together with other myeloma medicines, such as dexamethasone (a steroid), melphalan and prednisone, or antibody drugs whose own labels include bortezomib combinations[1][17].
Side effects and safety
- Peripheral neuropathy. Mostly sensory nerve damage; grade 3 or higher in 6% with the shot under the skin versus 15% with the vein injection, managed by lowering or pausing the dose.
- Hypotension. Low blood pressure in 8%, with higher risk in people who are dehydrated, have fainted before or take blood pressure medicines.
- Cardiac toxicity. New or worsening heart failure and reduced heart pumping have occurred, including in people with no known risk factors.
- Pulmonary toxicity. Acute respiratory distress syndrome, pneumonitis and pulmonary hypertension have occurred, some fatal.
- Posterior reversible encephalopathy syndrome. Rare brain swelling disorder with seizures, headache, confusion or vision changes; Velcade is stopped if it occurs.
- Gastrointestinal toxicity. Nausea, diarrhea, constipation and vomiting may need anti-nausea or anti-diarrhea medicine and fluids.
- Thrombocytopenia and neutropenia. Platelets and neutrophils dip after each cycle and usually recover; platelet count is checked before every dose.
- Tumor lysis syndrome. Rapid breakdown of cancer cells can strain the kidneys, mainly in people with a high tumor burden.
- Hepatic toxicity. Acute liver failure, hepatitis and raised liver enzymes have been reported.
- Thrombotic microangiopathy. Rare, sometimes fatal clotting disorder (TTP/HUS) reported after approval; Velcade is stopped if suspected.
- Embryo-fetal toxicity. Can harm an unborn baby; birth control for 7 months after treatment for women and 4 months for men with partners who could become pregnant.
- Platelet count before each dose
- Complete blood counts often during treatment
- Symptoms of numbness, tingling, burning or pain in the hands and feet
- Blood pressure and signs of dehydration
- Heart and lung symptoms, especially in people with heart disease
- Liver enzymes during treatment
- Tumor lysis risk in people with a high tumor burden
Velcade does not carry a boxed warning[1]. The side effect that most often changes treatment is peripheral neuropathy, nerve damage that causes numbness, tingling, burning or pain in the hands and feet, and sometimes weakness[1].
In the trial that compared the 2 routes, grade 2 or higher neuropathy occurred in 24% of people who got the shot under the skin and 39% of those who got the vein injection[1]. Severe (grade 3 or higher) neuropathy occurred in 6% and 15%[1]. In the APEX trial, neuropathy improved or went away in 48% of people with grade 2 or higher neuropathy after a dose change or pause[1].
Other warnings on the label:
- Low blood pressure, including dizziness on standing, in 8% of people[1]
- New or worsening heart failure, including in people with no known heart risk factors[1]
- Lung problems such as acute respiratory distress syndrome and pneumonitis, some fatal, and rare pulmonary hypertension[1]
- Posterior reversible encephalopathy syndrome (PRES), a rare brain swelling disorder that can cause seizures, headache, confusion and vision loss[1]
- Nausea, diarrhea, constipation and vomiting that can lead to dehydration[1]
- Low platelets and low neutrophils that follow a cycle, falling after the last dose of each cycle and usually recovering before the next[1]
- Tumor lysis syndrome, liver injury and thrombotic microangiopathy, a rare and sometimes fatal clotting disorder[1]
Across clinical studies, the most common side effects (20% or more) were nausea, diarrhea, low platelets, low neutrophils, peripheral neuropathy, tiredness, nerve pain, anemia, low white cells, constipation, vomiting, low lymphocytes, rash, fever and loss of appetite[1]. In the APEX trial, nausea and diarrhea each affected 52% of people on Velcade[1]. Velcade can harm an unborn baby, and the label advises birth control for 7 months after treatment for women and 4 months for men with partners who could become pregnant[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 Bortezomib
Velcade is a powder that a healthcare professional mixes with salt water and gives either as a shot under the skin of the thigh or belly or as a 3 to 5 second injection into a vein[1]. The starting dose is 1.3mg/m2, a dose based on body surface area, and at least 72 hours must pass between doses[1].
Schedules on the current label:
- Newly diagnosed myeloma: with melphalan and prednisone for 9 cycles of 6 weeks each, twice weekly in cycles 1 to 4 and once weekly in cycles 5 to 9[1]
- Relapsed myeloma: twice weekly for 2 weeks (days 1, 4, 8 and 11), then a 10-day rest, in 21-day cycles[1]
- Beyond 8 cycles in relapsed myeloma, a once-weekly maintenance schedule is an option[1]
- Retreatment: people who responded before and relapsed at least 6 months after finishing Velcade can restart at their last tolerated dose, for up to 8 cycles[1]
The dose is lowered or paused for neuropathy, low blood counts and other serious side effects, and people with moderate or severe liver problems start at 0.7mg/m2[1]. The shot and the vein injection are mixed to different strengths (2.5mg/mL and 1mg/mL), so the label warns staff to calculate the volume carefully[1]. Velcade must never be given into the spinal fluid (intrathecally), because deaths have occurred that way[1]. Velcade has no REMS program[1].
Availability and cost
Generic versions may be available at a lower cost. Ask your pharmacist.
Help paying for Velcade
The maker of Velcade publishes no copay card, but its support program can check your insurance and explain any help that exists. 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. Pick your insurance below to see which offers fit you.
- Insurance and case manager help
Takeda Oncology Here2Assist helps patients with insurance coverage requirements, identifies available financial assistance and connects them with resources during treatment. Call 1-844-817-6468, Monday through Friday, 8 AM to 8 PM ET.
The official page does not say who qualifies. Ask the program. · source
Good to know: Takeda still lists Velcade among its US medicines, but the Here2Assist website's product menu no longer names Velcade, and no Velcade copay card is described on Takeda's current pages. Generic bortezomib and Boruzu are sold by other companies, so ask your cancer center or pharmacy which version your plan covers and whether foundation help is available.
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
VISTA (NCT00111319) randomized 682 people with newly diagnosed myeloma who were not candidates for high-dose therapy to Velcade with melphalan and prednisone or to melphalan and prednisone alone[1][13][16]. The median age was 71[1].
VISTA results from the label:
APEX (NCT00048230) randomized 669 people whose myeloma had relapsed after 1 to 3 prior therapies to Velcade alone or high-dose dexamethasone[1][14]. Median time to progression was 6.2 versus 3.5 months (hazard ratio 0.55), and 38% versus 18% responded[1]. Fewer people died on Velcade (15% versus 25%, hazard ratio 0.57) at a median follow-up of 8.3 months[1].
A third trial (NCT00722566) randomized 222 people with relapsed myeloma to Velcade under the skin or into a vein[1][15]. Response after 4 cycles was 43% versus 42%, meeting the goal of showing the shot was not meaningfully less effective, while severe neuropathy was less common with the shot (6% versus 15%)[1].
Development history
Bortezomib, first studied under the code PS-341, was developed by Millennium Pharmaceuticals, now part of Takeda[3][1].
Myeloma milestones from FDA records:
- May 13, 2003: accelerated approval for myeloma after at least 2 prior therapies with progression on the last one[3]
- March 25, 2005: approval for myeloma after at least 1 prior therapy, based on APEX, which fulfilled the accelerated approval commitments[4]
- June 20, 2008: approval for multiple myeloma without a prior-therapy limit, adding newly diagnosed myeloma based on VISTA[5][2]
- January 23, 2012: the shot under the skin approved as an alternative to the vein injection[6]
- August 8, 2014: dosing for retreatment in relapsed myeloma added to the label[7]
Velcade is also approved for mantle cell lymphoma, first in December 2006 after a prior therapy and in October 2014 for previously untreated disease[2]. Those uses are outside this page's myeloma focus.
Generic bortezomib arrived in 2022, and Drugs@FDA now lists 15 generic versions rated as therapeutically equivalent to Velcade[2]. Other bortezomib products were approved through a different pathway with their own vial strengths, including Hospira's 1mg and 2.5mg vials and Boruzu, a ready-to-use liquid that Drugs@FDA lists as approved on August 26, 2024[11][9][10]. The current Velcade label, updated in August 2025, has no boxed warning and no REMS[1].
Explore Multiple Myeloma trials
Other Multiple Myeloma treatments
Velcade, approved in 2003, was the first of 3 proteasome inhibitors on the US market; Kyprolis (carfilzomib), given into a vein, and Ninlaro (ixazomib), a capsule, belong to the same class[2][19][20]. Proteasome inhibitors are usually combined with drugs from other classes, such as steroids, immunomodulatory drugs like lenalidomide, and anti-CD38 antibodies like Darzalex Faspro[17].
The Kyprolis label describes the ENDEAVOR trial, which compared Kyprolis plus dexamethasone directly with Velcade plus dexamethasone in relapsed myeloma[19].
Common questions about Bortezomib
▸What is Bortezomib (Velcade)?
Velcade (bortezomib) is a proteasome inhibitor injection, given under the skin or into a vein, for adults with multiple myeloma at any stage[1]. The FDA first approved Velcade on May 13, 2003, under accelerated approval for myeloma after at least 2 prior therapies, and widened the approval to all adults with multiple myeloma on June 20, 2008[3][5]. In the VISTA trial of 682 people with newly diagnosed myeloma, adding Velcade to melphalan and prednisone lengthened median time to progression from 15.0 to 20.7 months[1][13]. Velcade has no boxed warning, and its main safety concern is nerve damage in the hands and feet (peripheral neuropathy), which is less common with the shot under the skin than with the vein injection[1]. Generic bortezomib from many makers and a ready-to-use version called Boruzu are also FDA approved for myeloma[2][8].
▸How does Bortezomib work?
Every cell uses a large protein complex called the proteasome to break down proteins it no longer needs[1]. Bortezomib attaches to the 26S proteasome and reversibly blocks one of its cutting functions, called the chymotrypsin-like activity[1].
When the proteasome is blocked, unwanted proteins build up and several signaling pathways inside the cell are thrown off balance, which can lead to cell death[1]. The label reports that bortezomib slowed tumor growth in laboratory models of cancer, including multiple myeloma[1].
Velcade is often given together with other myeloma medicines, such as dexamethasone (a steroid), melphalan and prednisone, or antibody drugs whose own labels include bortezomib combinations[1][17].
▸What are the side effects of Bortezomib?
Velcade does not carry a boxed warning[1]. The side effect that most often changes treatment is peripheral neuropathy, nerve damage that causes numbness, tingling, burning or pain in the hands and feet, and sometimes weakness[1].
In the trial that compared the 2 routes, grade 2 or higher neuropathy occurred in 24% of people who got the shot under the skin and 39% of those who got the vein injection[1]. Severe (grade 3 or higher) neuropathy occurred in 6% and 15%[1]. In the APEX trial, neuropathy improved or went away in 48% of people with grade 2 or higher neuropathy after a dose change or pause[1].
Other warnings on the label: Low blood pressure, including dizziness on standing, in 8% of people[1] New or worsening heart failure, including in people with no known heart risk factors[1] Lung problems such as acute respiratory distress syndrome and pneumonitis, some fatal, and rare pulmonary hypertension[1] Posterior reversible encephalopathy syndrome (PRES), a rare brain swelling disorder that can cause seizures, headache, confusion and vision loss[1] Nausea, diarrhea, constipation and vomiting that can lead to dehydration[1] Low platelets and low neutrophils that follow a cycle, falling after the last dose of each cycle and usually recovering before the next[1] Tumor lysis syndrome, liver injury and thrombotic microangiopathy, a rare and sometimes fatal clotting disorder[1]
Across clinical studies, the most common side effects (20% or more) were nausea, diarrhea, low platelets, low neutrophils, peripheral neuropathy, tiredness, nerve pain, anemia, low white cells, constipation, vomiting, low lymphocytes, rash, fever and loss of appetite[1]. In the APEX trial, nausea and diarrhea each affected 52% of people on Velcade[1]. Velcade can harm an unborn baby, and the label advises birth control for 7 months after treatment for women and 4 months for men with partners who could become pregnant[1].
▸How is Bortezomib taken?
Velcade is a powder that a healthcare professional mixes with salt water and gives either as a shot under the skin of the thigh or belly or as a 3 to 5 second injection into a vein[1]. The starting dose is 1.3mg/m2, a dose based on body surface area, and at least 72 hours must pass between doses[1].
Schedules on the current label:
- Newly diagnosed myeloma: with melphalan and prednisone for 9 cycles of 6 weeks each, twice weekly in cycles 1 to 4 and once weekly in cycles 5 to 9[1]
- Relapsed myeloma: twice weekly for 2 weeks (days 1, 4, 8 and 11), then a 10-day rest, in 21-day cycles[1]
- Beyond 8 cycles in relapsed myeloma, a once-weekly maintenance schedule is an option[1]
- Retreatment: people who responded before and relapsed at least 6 months after finishing Velcade can restart at their last tolerated dose, for up to 8 cycles[1]
The dose is lowered or paused for neuropathy, low blood counts and other serious side effects, and people with moderate or severe liver problems start at 0.7mg/m2[1]. The shot and the vein injection are mixed to different strengths (2.5mg/mL and 1mg/mL), so the label warns staff to calculate the volume carefully[1]. Velcade must never be given into the spinal fluid (intrathecally), because deaths have occurred that way[1]. Velcade has no REMS program[1].
▸Is Bortezomib FDA approved?
Yes, Bortezomib (Velcade) is FDA approved (2003) for the treatment of Multiple Myeloma.
▸Is Velcade chemotherapy?
The Velcade label classifies bortezomib as a proteasome inhibitor, a targeted medicine that blocks the cell's protein-recycling machinery[1].
How it differs: It does not work like melphalan, an older chemotherapy that Velcade is combined with for newly diagnosed myeloma[1].
Handling: The label still calls Velcade a hazardous drug, so clinics prepare and dispose of it with the same precautions used for chemotherapy[1].
Source: Velcade prescribing information (DailyMed)
▸Is there a generic for Velcade?
Yes, generic bortezomib is FDA approved and sold by many companies[2].
Equivalent versions: Drugs@FDA lists 15 generic bortezomib products rated as therapeutically equivalent (AP) to Velcade 3.5mg vials[2].
Other versions: Boruzu is a ready-to-use bortezomib liquid, and Hospira makes 1mg and 2.5mg vials, so the volume drawn up can differ from Velcade[8][11].
Same uses: The Boruzu and generic labels list the same myeloma and mantle cell lymphoma uses as Velcade[8][12].
Source: Drugs@FDA, NDA 021602 (Velcade); Boruzu prescribing information (DailyMed)
▸Does Velcade cause neuropathy?
Yes, peripheral neuropathy (numbness, tingling, burning or pain in the hands and feet) is the best-known side effect on the Velcade label[1].
Shot versus IV: Grade 2 or higher neuropathy occurred in 24% with the shot under the skin and 39% with the vein injection in a head-to-head trial[1].
Management: The label lowers the dose, switches to once weekly or stops Velcade depending on how severe the neuropathy is[1].
Recovery: In APEX, neuropathy improved or resolved in 48% of people with grade 2 or higher symptoms after a dose change[1].
Source: Velcade prescribing information (DailyMed)
▸How often do you get Velcade shots?
Most Velcade schedules give a dose twice a week for 2 weeks, followed by a rest period[1].
Relapsed myeloma: Doses on days 1, 4, 8 and 11 of a 21-day cycle, with a once-weekly option after 8 cycles[1].
Newly diagnosed: With melphalan and prednisone, twice weekly in cycles 1 to 4, then once weekly in cycles 5 to 9 of 6-week cycles[1].
Spacing: At least 72 hours must pass between doses[1].
Source: Velcade prescribing information (DailyMed)
▸How much does Velcade cost?
A price is not stated on the label, and Trial Friend does not publish a price it cannot confirm.
Generics: Generic bortezomib is FDA approved and widely available, which gives pharmacies and insurers more than 1 option[2].
Help: Takeda lists Here2Assist at 1-844-817-6468 for help with insurance coverage and finding financial assistance[21].
Source: Drugs@FDA, NDA 021602 (Velcade); Takeda Oncology US medicines 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 (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. Food and Drug Administration · 2026-11. Drugs@FDA: VELCADE, NDA 021602, approval history and therapeutic equivalents. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021602
- U.S. Food and Drug Administration · 2003-05-13. NDA 21-602 approval letter: Velcade (bortezomib) for Injection, accelerated approval. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21602ltr.pdf
- U.S. Food and Drug Administration · 2005-03-25. NDA 21-602/S-006 approval letter: multiple myeloma after at least 1 prior therapy. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21602s006ltr.pdf
- U.S. Food and Drug Administration · 2008-06-20. NDA 21-602/S-015 approval letter: treatment of patients with multiple myeloma. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021602se1-015ltr.pdf
- U.S. Food and Drug Administration · 2012-01-23. NDA 021602/S-027 supplement approval: subcutaneous route of administration. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021602s027ltr.pdf
- U.S. Food and Drug Administration · 2014-08-08. NDA 021602/S-038 supplement approval: retreatment for relapsed multiple myeloma. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021602Orig1s038ltr.pdf
- U.S. National Library of Medicine, DailyMed (Amneal Pharmaceuticals LLC) · 2025-07. BORUZU (bortezomib injection), full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b92628dd-fa09-4c3a-b6a3-66426025807c
- U.S. Food and Drug Administration · 2024-08-26. Drugs@FDA: bortezomib injection, NDA 212782. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212782
- Amneal Pharmaceuticals (Business Wire) · 2024-09-05. Amneal and Shilpa Announce U.S. FDA Approval of BORUZU, the First Ready-to-Use Version of Bortezomib for subcutaneous administration. https://www.businesswire.com/news/home/20240905166831/en
- U.S. Food and Drug Administration · 2022-05-02. Drugs@FDA: bortezomib for injection 1mg and 2.5mg vials, NDA 209191. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209191
- U.S. National Library of Medicine, DailyMed (Hospira, Inc.) · 2023-02. Bortezomib for Injection 1mg and 2.5mg, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fdf6169-699f-40eb-bda1-760253062b3c
- New England Journal of Medicine · 2008-08-28. Bortezomib plus Melphalan and Prednisone for Initial Treatment of Multiple Myeloma. https://doi.org/10.1056/NEJMoa0801479
- New England Journal of Medicine · 2005-06-16. Bortezomib or High-Dose Dexamethasone for Relapsed Multiple Myeloma. https://doi.org/10.1056/NEJMoa043445
- The Lancet Oncology · 2011-05. Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study. https://doi.org/10.1016/S1470-2045(11)70081-X
- ClinicalTrials.gov · 2026-11. VELCADE/Melphalan/Prednisone Versus Melphalan/Prednisone in Patients With Previously Untreated Multiple Myeloma (VISTA). https://clinicaltrials.gov/study/NCT00111319
- U.S. National Library of Medicine, DailyMed (Janssen Biotech, Inc.) · 2026-09. DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) injection, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bb241af-4299-4373-8762-2d6709515db0
- U.S. National Library of Medicine, DailyMed (Karyopharm Therapeutics Inc.) · 2026-05. XPOVIO (selinexor) tablets, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f6dd2682-75a6-4863-90a8-a3197f6f78a8
- U.S. National Library of Medicine, DailyMed (Onyx Pharmaceuticals, Inc., an Amgen subsidiary) · 2025-06. KYPROLIS (carfilzomib) for injection, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ea66eb30-e665-4693-99a1-a9d3b4bbe2d6
- 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
- Takeda Oncology · 2026-11. US Cancer Medicines, Takeda Oncology (Velcade listing and Here2Assist). https://www.takedaoncology.com/medicines/united-states/