TM Owner Sanofi
Zaltrap 25mg/ml Injection
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Indications & Clinical Uses
- Zaltrap 25mg/ml (ziv-aflibercept) is a concentrate for solution for intravenous infusion supplied as 100 mg/4 mL and 200 mg/8 mL vials.
- Ziv-aflibercept is a recombinant fusion protein that blocks vascular endothelial growth factor (VEGF).
- Zaltrap is used together with FOLFIRI chemotherapy (irinotecan, 5-fluorouracil and folinic acid) in adults with metastatic colorectal cancer that is resistant to, or has progressed after, an oxaliplatin-containing regimen.
- The usual dose is 4 mg/kg as a 1-hour infusion every 2 weeks, given before the FOLFIRI components.
- It is given only in a hospital or clinic under specialist supervision, never as an injection or bolus.
- It is a different product from the aflibercept solutions injected into the eye and must not be interchanged with them.
- The US brand is marketed by Sanofi; the EU authorisation is held by Sanofi Winthrop Industrie (France).
Side Effects
- In the US label, the most common reactions (20% or more of patients) were low white cell counts, diarrhoea, low neutrophils, protein in the urine, raised liver enzymes, mouth sores (stomatitis), fatigue, low platelets, high blood pressure, weight loss, reduced appetite, nosebleeds, abdominal pain, hoarse voice (dysphonia), raised creatinine and headache.
- Serious effects include severe bleeding (any-grade bleeding 38% versus 19% with placebo), bowel perforation, abnormal connections between organs (fistula), poor wound healing, severe high blood pressure, arterial blood clots, kidney damage with protein loss, febrile neutropenia and infections, severe diarrhoea with dehydration, severe allergic reactions (0.3%), and reversible posterior leukoencephalopathy syndrome (headache, confusion, seizures, vision changes).
- The current US label has no boxed warning.
- Tell the treating team at once about bleeding, severe abdominal pain, severe headache or breathlessness.
Precautions & Warnings
- Blood pressure, urine protein and blood counts should be checked before and during treatment.
- Treatment is stopped for severe bleeding, bowel perforation, fistula, hypertensive crisis, arterial thromboembolic events, nephrotic syndrome, thrombotic microangiopathy or reversible posterior leukoencephalopathy syndrome.
- Withhold it for 4 weeks before and after planned surgery because of impaired wound healing.
- The US label lists no contraindications.
- Women who could become pregnant should use effective contraception during treatment and for 3 months after the last dose, and should not breastfeed during treatment and for 1 month after.
- It must be diluted and infused over 1 hour through a 0.2-micron polyethersulfone filter, never as a bolus and never mixed with other drugs in the same line.
- Unopened vials are stored at 2°C to 8°C in the original carton, protected from light.
Avoid Interactions
- Increase risk or effect: the US label reports no clinically important interaction with irinotecan or 5-fluorouracil, the FOLFIRI partners.
- Because of the bleeding and clotting warnings, tell the treating team if you take blood thinners or antiplatelet medicines.
- The EU label also highlights osteonecrosis of the jaw, particularly with bisphosphonates, and cardiac failure.
- Reduce efficacy: no medicines were identified that lower its effect.
- Pharmacy incompatibility: do not mix Zaltrap with other medicines in the same infusion line, and use only the specified filter and dilution.
- Tell your healthcare provider about all medicines and supplements you take.
References
Frequently Asked Questions
Zaltrap (ziv-aflibercept) treats metastatic colorectal cancer in adults when the cancer has resisted or progressed after an oxaliplatin-containing regimen. It is always given together with FOLFIRI chemotherapy (irinotecan, 5-fluorouracil and folinic acid). It is given by a healthcare professional in hospital.
Zaltrap is a 1-hour intravenous infusion of 4 mg/kg, given every 2 weeks before the FOLFIRI chemotherapy. A nurse or doctor prepares and gives it through a special 0.2-micron filter. It is never given as a rapid injection and is not mixed with other medicines in the same line.
Common Zaltrap side effects include low blood counts, diarrhoea, mouth sores, tiredness, high blood pressure, protein in the urine, nosebleeds, headache and weight loss. Tell your team at once about bleeding, severe stomach pain, severe headache, confusion, chest pain or swelling, as these can signal serious problems.
Avoid planned surgery for 4 weeks before and after Zaltrap, because wounds may heal poorly. Women should avoid pregnancy and use effective contraception during treatment and for 3 months after the last dose, and should not breastfeed for 1 month after. Tell the team if you take blood thinners.
During Zaltrap (ziv-aflibercept) treatment your team checks blood pressure, urine protein and blood counts before treatment. Treatment may be paused or stopped for severe bleeding, bowel perforation, fistula, uncontrolled high blood pressure, arterial blood clots, kidney damage or brain swelling (RPLS).
Zaltrap can harm an unborn baby, so women who could become pregnant should use effective contraception during treatment and for 3 months after the last dose. Do not breastfeed during treatment and for 1 month after the final dose. Tell your oncology team straight away if you become pregnant.
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