Bortezomib: uses, dosing, side effects & brands
Bortezomib is a proteasome inhibitor sold in the U.S. under 2 brand and generic names, for multiple myeloma and mantle-cell lymphoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Proteasome Inhibitor
- Treats (across its forms)
- Multiple Myeloma and Mantle-Cell Lymphoma
- Available as
- Injectable · Powder
- Sold as
- 2 products — Bortezomib and Velcade
- Prescription?
- Prescription only
- Generic available?
- Yes
How Velcade is dosed
From the FDA label for Velcade (application NDA021602). Other bortezomib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For subcutaneous or intravenous use only. Each route of administration has a different reconstituted concentration. Exercise caution when calculating the volume to be administered. ( 2.1 , 2.10 ) The recommended starting dose of VELCADE is 1.3 mg/m 2 administered either as a 3 to 5 second bolus intravenous injection or subcutaneous injection. ( 2.2 , 2.4 , 2.6 ) Retreatment for Multiple Myeloma: May retreat starting at the last tolerated dose. ( 2.6 ) Hepatic Impairment: Use a lower starting dose for patients with moderate or severe hepatic impairment. ( 2.8 ) Dose must be individualized to prevent overdose. ( 2.10 ) 2.1 Important Dosing Guidelines VELCADE is for intravenous or subcutaneous use only. Do not administer VELCADE by any other route. Because each route of administration has a different reconstituted concentration, use caution when calculating the volume to be administered. The recommended starting dose of VELCADE is 1.3 mg/m 2 . VELCADE is administered intravenously at a concentration of 1 mg/mL, or subcutaneously at a concentration of 2.5 mg/mL [see Dosage and Administration (2.10) ] . VELCADE retreatment may be considered for patients with multiple myeloma who had previously responded to treatment with VELCADE and who have relapsed at least six months after completing prior VELCADE treatment. Treatment may be started at the last tolerated dose [see Dosage and…
Everything below is the FDA label for Velcade (injectable). Bortezomib is also sold as powder, and those are different medicines to take — follow the label for the one you were prescribed.
Velcade side effects
The following clinically significant adverse reactions are also discussed in other sections of the labeling: Peripheral Neuropathy [see Warnings and Precautions (5.1) ] Hypotension [see Warnings and Precautions (5.2) ] Cardiac Toxicity [see Warnings and Precautions (5.3) ] Pulmonary Toxicity [see Warnings and Precautions (5.4) ] Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.5) ] Gastrointestinal Toxicity [see Warnings and Precautions (5.6) ] Thrombocytopenia/Neutropenia [see Warnings and Precautions (5.7) ] Tumor Lysis Syndrome [see Warnings and Precautions (5.8) ] Hepatic Toxicity [see Warnings and Precautions (5.9) ] Thrombotic Microangiopathy [see Warnings and Precautions (5.10) ] Most commonly reported adverse reactions (incidence ≥20%) in clinical studies include nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia, anemia, leukopenia, constipation, vomiting, lymphopenia, rash, pyrexia, and anorexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-866-VELCADE or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not…
Who shouldn’t take Velcade
VELCADE is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol. Reactions have included anaphylactic reactions [see Adverse Reactions (6.1) ] . VELCADE is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of VELCADE. Patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. ( 4 ) Contraindicated for intrathecal administration. ( 4 )
Velcade drug interactions
Strong CYP3A4 Inhibitors: Closely monitor patients with concomitant use. ( 7.1 ) Strong CYP3A4 Inducers: Avoid concomitant use. ( 7.1 ) 7.1 Effects of Other Drugs on VELCADE Strong CYP3A4 Inducers Coadministration with a strong CYP3A4 inducer decreases the exposure of bortezomib [see Clinical Pharmacology (12.3) ] which may decrease VELCADE efficacy. Avoid coadministration with strong CYP3A4 inducers. Strong CYP3A4 Inhibitors Coadministration with a strong CYP3A4 inhibitor increases the exposure of bortezomib [see Clinical Pharmacology (12.3) ] which may increase the risk of VELCADE toxicities. Monitor patients for signs of bortezomib toxicity and consider a bortezomib dose reduction if bortezomib must be given in combination with strong CYP3A4 inhibitors. 7.2 Drugs Without Clinically Significant Interactions with VELCADE No clinically significant drug interactions have been observed when VELCADE was coadministered with dexamethasone, omeprazole, or melphalan in combination with prednisone [see Clinical Pharmacology (12.3) ] .
Every bortezomib product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Injectable | No data | — | View → | |
| 2 | Not yet rated | Prescription | Injectable | No data | — | View → |
Bortezomib recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long bortezomib keeps
No bortezomib label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does bortezomib expire? The in-use limits and storage rules from its labelsWhat people report to the FDA about bortezomib
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 33,589 reports naming bortezomib, and the FDA flagged 95% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- plasma cell myeloma5,209 reports
- neuropathy peripheral1,834 reports
- thrombocytopenia1,783 reports
- pneumonia1,616 reports
- diarrhoea1,427 reports
- neutropenia1,418 reports
- fatigue1,205 reports
- anaemia1,168 reports
Read these as a signal, not a rate. A report does not mean bortezomib caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is Velcade?
VELCADE ® for Injection, a proteasome inhibitor, contains bortezomib which is an antineoplastic agent. Bortezomib is a modified dipeptidyl boronic acid.
What kind of drug is bortezomib?
The FDA classifies bortezomib as a proteasome inhibitor. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take bortezomib with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run bortezomib against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is bortezomib sold under?
We track 2 bortezomib-containing products in the U.S.: Bortezomib and Velcade. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does bortezomib come in?
Across the brands we track, bortezomib is currently marketed as injectable and powder, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic bortezomib?
Yes. Our catalog lists 1 generic bortezomib product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has bortezomib been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions bortezomib. The most recent: Bortezomib for Injection 3.5mg/Vial (Jun 24, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Bortezomib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/bortezomib
- MLA
- “Bortezomib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/bortezomib.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for bortezomib on DailyMed (NIH) ↗.