TM Owner Janssen
Velcade 3.5mg Injection
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Indications & Clinical Uses
- Velcade 3.5 mg contains bortezomib, a proteasome inhibitor chemotherapy medicine supplied as a single-dose vial of lyophilized powder and given only by a healthcare provider, by intravenous injection or by subcutaneous injection.
- In the US it is indicated for adults with multiple myeloma and adults with mantle cell lymphoma.
- In the EU and UK, Velcade (Janssen-Cilag) is used alone or with pegylated liposomal doxorubicin or dexamethasone for adults with progressive multiple myeloma who have had at least one prior therapy, and in combinations for previously untreated multiple myeloma and previously untreated mantle cell lymphoma in adults not suitable for transplant.
- In the US the marketing authorisation holder is Takeda Pharmaceuticals America; outside the US it is Janssen.
- The subcutaneous and intravenous routes use different reconstituted concentrations from the same 3.5 mg vial.
Side Effects
- In the US label, the most common side effects are nausea (49%), diarrhoea (46%), fatigue (41%), peripheral neuropathy (38%), low platelets (32%), vomiting (28%), constipation (25%), fever (21%) and loss of appetite (20%).
- Serious reactions include peripheral neuropathy, low blood pressure, cardiac toxicity, lung toxicity, posterior reversible encephalopathy syndrome (PRES), gastrointestinal toxicity, low platelets and neutrophils, tumour lysis syndrome, liver toxicity and thrombotic microangiopathy.
- The current US label for Velcade carries no boxed warning, but it is contraindicated for intrathecal use because fatal events have occurred.
- Tell your care team about numbness or tingling, dizziness or fainting, shortness of breath, swelling, bleeding, or yellowing of the skin.
Precautions & Warnings
- Velcade is contraindicated in patients with hypersensitivity (excluding local reactions) to bortezomib, boron or mannitol, and for intrathecal administration, as fatal events have occurred.
- FORMULATION/ROUTE CHECK: the intravenous solution is 1 mg/mL (3.5 mL diluent per vial) and the subcutaneous solution is 2.5 mg/mL (1.4 mL diluent), so the volume must be calculated carefully for the chosen route.
- Subcutaneous administration had less grade 2 or higher neuropathy (24%) than intravenous (39%) in relapsed myeloma.
- Patients with moderate or severe liver impairment start at a reduced dose of 0.7 mg/m2.
- Velcade can cause fetal harm: females should use effective contraception during treatment and for 7 months after, and males with female partners for 4 months after (US label; EU/UK labels give longer periods).
- Storage: the UK leaflet says do not store above 30°C and keep the vial in the outer carton to protect from light; the US label states unopened vials are stable to the printed date in the original package protected from light.
Avoid Interactions
- Drugs that increase levels or toxicity: strong CYP3A4 inhibitors need close monitoring in patients receiving bortezomib.
- Drugs that reduce efficacy: strong CYP3A4 inducers should be avoided (the UK SmPC says use is not recommended because efficacy may be reduced).
- Tell your prescriber about all prescription and over-the-counter medicines, vitamins and herbal supplements.
- Do not mix Velcade with other medicines in the same syringe or vial; the vial is reconstituted only as directed.
- Intrathecal (spinal) injection is fatal, so Velcade must be given only into a vein or under the skin.
References
Frequently Asked Questions
Velcade (bortezomib) treats multiple myeloma and mantle cell lymphoma in adults. In the US it is approved for both cancers, while EU and UK labels also describe use with dexamethasone or pegylated liposomal doxorubicin in myeloma. It is prescribed and given by a cancer specialist.
Velcade (bortezomib) is given by a healthcare provider as an injection into a vein or under the skin, on a schedule your specialist sets. The same 3.5 mg vial is prepared at different concentrations for each route: 1 mg/mL for intravenous and 2.5 mg/mL for subcutaneous. It is never given into the spine.
Common Velcade side effects include nausea, diarrhoea, tiredness, nerve damage causing numbness or tingling, low platelets, vomiting, constipation and fever. Serious effects include low blood pressure, heart or lung problems and liver toxicity. Report numbness, dizziness, breathlessness or bleeding promptly. The US label has no boxed warning.
Avoid becoming pregnant with Velcade (bortezomib): women need effective contraception during treatment and for 7 months after, and men for 4 months (US label). Avoid strong CYP3A4 inducers, and have strong CYP3A4 inhibitors closely monitored. Velcade must never be given into the spinal fluid.
At a Velcade (bortezomib) appointment a healthcare professional prepares the vial and gives the injection into a vein or under the skin, and checks your blood counts and how you feel. Tell staff about tingling, numbness, dizziness, diarrhoea or breathlessness. Subcutaneous injection caused less nerve damage than intravenous in one relapsed myeloma comparison.
Velcade (bortezomib) is contraindicated for intrathecal administration, meaning injection into the spinal fluid, because fatal events have occurred. It must only be given into a vein or under the skin. This is the single most important safety rule for Velcade, alongside careful dose calculation for each route.
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