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bortezomib

Velcade · ATC code L01XG01

Brand names: Velcade, Abormib, Bortezomib Ever Pharma, Bortezomib Ribosepharm, Bortezomib Stada, Bortezomib Viatris, Vorteza, Biemib, Boractib, Borcade, Bortirel, Veltezo

Key facts
Active substance
bortezomib
ATC code
L01XG01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
VELCADE 1 mg powder for solution for injection · VELCADE 3.5 mg powder for solution for injection
Marketing authorisation holder
Janssen-Cilag International NV
Information as of
2026-10-27

Key facts

Bortezomib is a proteasome inhibitor (antineoplastic agent). It is used alone or in combination to treat multiple myeloma and mantle cell lymphoma in adults.

What it is used for

  • Progressive multiple myeloma after at least 1 prior therapy in patients who have undergone or are unsuitable for stem cell transplantation (alone or with pegylated liposomal doxorubicin or dexamethasone)
  • Previously untreated multiple myeloma not eligible for high-dose chemotherapy: with melphalan and prednisone
  • Induction treatment of untreated multiple myeloma before high-dose chemotherapy with stem cell transplantation: with dexamethasone, with or without thalidomide
  • Previously untreated mantle cell lymphoma unsuitable for transplantation: with rituximab, cyclophosphamide, doxorubicin and prednisone

Dosing

  • Monotherapy in progressive myeloma: 1.3 mg/m2 body surface area twice weekly on days 1, 4, 8 and 11 of a 21-day cycle
  • At least 72 hours must elapse between consecutive doses
  • VELCADE 1 mg: intravenous only; VELCADE 3.5 mg: intravenous or subcutaneous; never intrathecal
  • Moderate or severe hepatic impairment: start at a reduced dose of 0.7 mg/m2 in the first cycle
  • Dose modifications for toxicity and combination regimens are in the full text

Contraindications

  • Hypersensitivity to bortezomib, boron or any excipient
  • Acute diffuse infiltrative pulmonary and pericardial disease
  • In combinations, the contraindications of the partner medicines also apply

Important warnings

  • Fatal cases after inadvertent intrathecal administration
  • Very commonly peripheral neuropathy, predominantly sensory; severe motor neuropathy has also been reported
  • Gastrointestinal toxicity (nausea, diarrhoea, vomiting, constipation); ileus uncommonly
  • Haematological toxicity, particularly thrombocytopenia
  • With thalidomide, particular attention to pregnancy testing and prevention

Side effects

  • Most common: nausea, diarrhoea, constipation, vomiting, fatigue, pyrexia, thrombocytopenia, anaemia, neutropenia
  • Also common: peripheral neuropathy, headache, paraesthesia, decreased appetite, dyspnoea, rash, herpes zoster, myalgia
  • Uncommon but serious: cardiac failure, tumour lysis syndrome, pulmonary hypertension, PRES, acute diffuse infiltrative pulmonary disorders

Interactions

  • Potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) increase bortezomib exposure; monitor closely
  • Strong CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, St. John's Wort) are not recommended as efficacy may be reduced

Pregnancy and breastfeeding

  • Women of childbearing potential use effective contraception during treatment and for 8 months after; men for 5 months after
  • No clinical data in pregnancy; teratogenic potential not fully investigated

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

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)

Source: European Medicines Agency (EMA), product information

Austria

  • AbormibG.L. Pharma Gmbh · 2 register entries
  • Bortezomib Ever PharmaEver Valinject Gmbh · 1 register entry
  • Bortezomib RibosepharmHikma Pharma Gmbh · 1 register entry
  • Bortezomib StadaStada Arzneimittel Gmbh · 1 register entry
  • Bortezomib ViatrisViatris Limited · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • BortezomibNovumgen Limited, Mas Pharmaconsult Gmbh, Ever Valinject Gmbh, Glenmark Arzneimittel Gmbh, Tillomed Pharma Gmbh, Onkovis Gmbh, Zentiva Pharma Gmbh, Amarox Pharma Gmbh, Koanaa Healthcare Spain S.L., Hexal Ag, Hikma Pharma Gmbh, Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel), Viatris Germany Gmbh, Eugia Pharma (Malta) Limited, Stadapharm Gmbh, Betapharm Arzneimittel Gmbh, Denk Pharma Gmbh & Co. Kg, Qilu Pharma Spain S.L. · 19 register entries
  • VortezaDemo Abee · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • BiemibBİEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • BoractibVEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • BorcadeKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
  • BortirelDEM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • VelcadeJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 1 register entry
  • VeltezoDEVA HOLDİNG A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 26 more European countries
Belgium
Bortezomib Eg, Bortezomib Eugia, Bortezomib Ever Pharma
Bulgaria
Bortezomib Ever Pharma, Бортезомиб Актавис, Бортезомиб Ромфарм, Вортемиел, Глофтринид
Croatia
Bortezomib Alpha-Medical, Bortezomib Ever Pharma, Bortezomib Pharmas, Bortezomib Pliva, Gloftrinid
Cyprus
Bortezomib Pharmazac, Bortezomib Stada, Bortezomib Teva, Bortezomib Venus Pharma
Czechia
Bortezomib Ever Pharma, Bortezomib Msn, Zegomib
Denmark
Bortezomib Actavis, Bortezomib Ever Pharma, Bortezomib Glenmark, Bortezomib Medac, Bortezomib Medical Valley, Bortezomib Stada, Bortezomib Viatris
Finland
Bortezomib Avansor, Bortezomib Ever Pharma, Bortezomib Glenmark, Bortezomib Medac, Bortezomib Medical Valley, Bortezomib Msn, Bortezomib Reddy, Bortezomib Stada, Bortezomib Viatris
France
Bortezomib
Greece
Bortezomib Pharmazac, Bortezomib Sandoz, Bortezomib Stada, Bortezomib Teva, Botevia, Velcozor, Vorteza
Hungary
Bortezomib Ever Pharma, Bortezomib Msn, Bortezomib Sandoz, Bortezomib Stada, Bortezomib Teva
Iceland
Bortezomib Accord, Bortezomib Actavis, Bortezomib Fresenius Kabi, Bortezomib Stada, Bortezomib Sun, Bortezomib W&h, Velcade, Vortemyel
Ireland
Bortezomib Aspire Pharma (Malta), Bortezomib Biotech Pharma Limited, Bortezomib Bortezomib, Bortezomib Clonmel, Bortezomib Medac, Bortezomib Msn Labs Europe, Bortezomib Reddy Holding, Bortezomib Rowex
Italy
Bortezomib Aurobindo, Bortezomib Dr. Reddy’s, Bortezomib Eg, Bortezomib Ever Pharma, Bortezomib Glenmark, Bortezomib Hikma, Bortezomib Medac, Bortezomib Mylan, Bortezomib Qilu, Bortezomib Sandoz Bv
Latvia
Bortezomib Tzf
Liechtenstein
Bortezomib Accord, Bortezomib Fresenius Kabi, Velcade
Luxembourg
Bortezomib Eg
Malta
Bortezomib Clonmel, Bortezomib Dr. Reddy’s
Netherlands
Bortezomib Amarox, Bortezomib Cf, Bortezomib Eugia, Bortezomib Ever Pharma, Bortezomib Glenmark, Bortezomib Medac, Bortezomib Msn, Bortezomib Reddy, Bortezomib Sandoz, Bortezomib Synthon, Bortezomib Zentiva, Vortemyel, Zegomib
Norway
Bortezomib Accord, Bortezomib Ever Pharma, Bortezomib Fresenius Kabi, Bortezomib Glenmark, Bortezomib Medac, Bortezomib Medical Valley, Bortezomib Reddy, Bortezomib Stada, Bortezomib Sun, Bortezomib Teva, Bortezomib Viatris, Velcade
Poland
Bortezomib Eugia, Bortezomib Ever Pharma, Bortezomib Glenmark, Bortezomib Medac, Bortezomib Msn, Bortezomib Reddy, Bortezomib Tzf
Portugal
Bortezomib Ever Pharma, Bortezomib Extrovis, Bortezomib Farmoz, Bortezomib Generis, Bortezomib Hikma, Bortezomib Mylan, Bortezomib Reddy, Bortezomib Sandoz, Bortezomib Stada, Bortezomib Tecnigen, Bortezomib Teva, Bortezomib Venus Pharma
Romania
Bortezomib
Slovakia
Bortezomib Ever Pharma, Bortezomib Glenmark, Bortezomib Stada, Zegomib
Slovenia
Bortezomib Actavis, Bortezomib Ever Pharma, Bortezomib Sandoz, Bortezomib Teva, Bortezomib Viatris, Gloftrinid
Spain
Bortezomib Aurovitas, Bortezomib Combix, Bortezomib Dr. Reddys, Bortezomib Ever Pharma, Bortezomib Farmoz, Bortezomib Glenmark, Bortezomib Kern Pharma, Bortezomib Koanaa, Bortezomib Qilu, Bortezomib Stada, Bortezomib Tarbis, Bortezomib Viatris, Bortezomib Vivanta
Sweden
Bortezomib Avansor, Bortezomib Ever Pharma, Bortezomib Glenmark, Bortezomib Medac, Bortezomib Medical Valley, Bortezomib Reddy, Bortezomib Stada

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Sources

  1. European Medicines Agency. Velcade – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/velcade-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · 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.