Proteasome Inhibitor — Myeloma Pregnancy: Should not be used during pregnancy unless the woman's clinical condition requires it; may cause foetal harm. Male and female patients of childbearing potential must use effective contraception during and for 3 months following treatment. Breastfeeding should be discontinued during treatment.

Bortezomib

Brand names: Velcade

Bortezomib is a proteasome inhibitor used to treat multiple myeloma and mantle cell lymphoma.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 1.3 mg/m2 body surface area

Route: Intravenous injection (SPC 1 mg product is IV only; 2.5 mg and 3.5 mg products are IV or subcutaneous)

Frequency: Twice weekly for two weeks on days 1, 4, 8 and 11, in a 21-day treatment cycle; at least 72 hours between consecutive doses

Max: 1.3 mg/m2 per dose (recommended dose; reduce for toxicity per dose-modification tables)

Specialist oncology use; must be reconstituted by a healthcare professional. FATAL if given intrathecally — for IV (and, for the higher-strength products, subcutaneous) use only; must NOT be administered intrathecally. Primary regimen shown is monotherapy for progressive multiple myeloma (patients who have received at least one prior therapy): 1.3 mg/m2 IV twice weekly on days 1, 4, 8, 11 in a 21-day cycle; recommend 2 cycles after confirmed complete response; responders not achieving CR should receive a total of 8 cycles. Dose reduction for toxicity: withhold at onset of any Grade 3 non-haematological or Grade 4 haematological toxicity (excluding neuropathy); on resolution re-initiate at 25% reduced dose (1.3 -> 1.0 mg/m2; 1.0 -> 0.7 mg/m2). Neuropathy modifications per Table 1 (e.g. Grade 1 with pain/Grade 2: reduce to 1.0 mg/m2 or change to 1.3 mg/m2 once weekly; Grade 2 with pain/Grade 3: withhold then re-initiate at 0.7 mg/m2 once weekly; Grade 4: discontinue). Combination regimens (same 1.3 mg/m2 bortezomib backbone): with pegylated liposomal doxorubicin (doxorubicin 30 mg/m2 IV on day 4); with dexamethasone (dexamethasone 20 mg orally on days 1,2,4,5,8,9,11,12); with melphalan + prednisone for previously untreated MM not eligible for stem cell transplant — 6-week cycles, bortezomib twice weekly (days 1,4,8,11,22,25,29,32) in cycles 1-4 and once weekly (days 1,8,22,29) in cycles 5-9, nine cycles total. Paediatric use: safety and effectiveness not established; US labelling describes investigational use at 1.3 mg/m2 (per-m2, not per-kg) within combination reinduction chemotherapy in relapsed lymphoid malignancies — verify against a children's formulary and current protocols.

Dose adjustments

Renal

Not specified in the eMC posology section captured. (US labelling: use a lower starting dose in moderate or severe hepatic impairment.)

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance, to boron or to any excipient
Acute diffuse infiltrative pulmonary and pericardial disease
Contraindicated for intrathecal administration (fatal events reported)
When given in combination, refer to the SPCs of the other medicinal products for additional contraindications

Side effects

Nausea, diarrhoea, constipation, vomiting
Fatigue, pyrexia
Thrombocytopenia, anaemia, neutropenia
Peripheral neuropathy (including sensory), paraesthesia, headache
Decreased appetite, dyspnoea, rash, herpes zoster, myalgia

Interactions

Strong CYP3A4 inhibitors (e.g. azole antifungals, HIV protease inhibitors) — increase bortezomib exposure; monitor for toxicity and consider dose reduction
Strong CYP3A4 inducers — decrease bortezomib exposure and may reduce efficacy; avoid concomitant use
Thalidomide (when used in combination) — adhere to the thalidomide pregnancy prevention programme
No clinically significant interaction observed with dexamethasone, omeprazole, or melphalan plus prednisone (per US labelling)

Clinical monograph

How it works

It reversibly inhibits the 26S proteasome, disrupting protein degradation and accumulating regulatory proteins that trigger cell-cycle arrest and apoptosis in malignant plasma cells.

Prescribing in practice

Peripheral neuropathy is a common dose-limiting toxicity, so assess neurological symptoms before each cycle and adjust dosing accordingly.
It is usually given by subcutaneous injection, which reduces neuropathy compared with intravenous use, in repeated cycles.
Herpes zoster reactivation and thrombocytopenia are recognised, so antiviral prophylaxis and blood count monitoring are advised.

Monitoring

Monitor full blood count and neurological symptoms before each dose, and watch for signs of herpes zoster reactivation.

Counselling the patient

Report numbness, tingling or burning in the hands or feet promptly.
Antiviral medicine is often given to prevent shingles during treatment.
Stay well hydrated and report dizziness, as blood pressure can drop.

Evidence & guidelines

Bortezomib improved outcomes in multiple myeloma in landmark trials and is recommended by NICE within several treatment regimens.

Reference: SPA Study (Moreau et al. Lancet Oncol 2011); NICE TA311; NICE TA573; BSH Myeloma Guidelines 2017; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways