TM Owner Pierre Fabre
Navelbine IV 50mg/5ml Vial
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Indications & Clinical Uses
- Navelbine IV (vinorelbine) 50 mg/5 mL refers to the intravenous concentrate form of vinorelbine, a vinca-alkaloid chemotherapy medicine; note that no product is formally branded 'Navelbine IV' in FDA or EMA records - the 'IV' label here distinguishes this injectable vial from oral Navelbine capsules sold in some countries.
- This IV formulation is approved in combination with cisplatin as first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults, and as a single agent for first-line treatment of metastatic NSCLC.
- It is a hospital- and specialist-administered oncology medicine, never self-injected.
- In the United States, the branded Navelbine injection (Pierre Fabre) has been discontinued for commercial reasons, not for safety or effectiveness, and generic vinorelbine injection is used instead.
- This vial is the IV concentrate only; oral Navelbine capsules exist at entirely different strengths (20 mg, 30 mg, 80 mg) with different dosing, and the two forms must never be substituted for one another.
Side Effects
- Navelbine IV carries a boxed warning for severe myelosuppression: it can lower white blood cell, red blood cell and platelet counts to dangerous levels, leading to serious infection, septic shock, hospitalisation and death, and blood counts must be checked before every dose.
- Very common effects (affecting more than 1 in 10 people) include nausea, vomiting, constipation, fatigue, hair thinning, and pain, redness or a burning sensation at or spreading from the injection site if the drug leaks outside the vein (extravasation), which can cause severe tissue damage.
- Numbness or tingling in the hands or feet (peripheral neuropathy), shortness of breath, and liver enzyme changes are also reported.
- Seek urgent medical attention for fever, signs of infection, severe shortness of breath, chest pain, or pain, swelling or leakage at the injection site during the infusion.
- Because it is given intravenously by a healthcare professional in a monitored setting, patients themselves do not manage injection-site care.
Precautions & Warnings
- Navelbine IV must only be given intravenously by a trained healthcare professional, with correct needle or catheter placement confirmed before each dose, since leakage outside the vein can cause severe tissue damage; it must never be given by any other route.
- It must not be confused with, or substituted for, oral vinorelbine capsules, which use completely different strengths and dosing under the Navelbine name outside the United States - moving between the two forms without a full dose recalculation by the oncologist is a serious dosing-error risk.
- Blood counts are required before each dose, with treatment delayed or the dose reduced if neutrophil or platelet counts are too low.
- Dose adjustment is needed in significant liver impairment.
- Navelbine IV can cause fetal harm, so effective contraception is required during treatment; it is not recommended in pregnancy or breastfeeding.
- Use with caution after prior chest radiotherapy, and avoid live vaccines during treatment because of immune suppression.
Avoid Interactions
- Tell the treating team about every medicine, herbal product and supplement being taken, since several combinations affect how Navelbine IV is broken down or increase toxicity.
- Strong CYP3A4 inhibitors - such as ketoconazole, itraconazole, clarithromycin, ritonavir and grapefruit juice - can raise vinorelbine levels and increase the risk of severe side effects, so combinations are avoided or used with extra monitoring.
- Conversely, strong CYP3A4 inducers, including rifampicin, phenytoin and St John's Wort, may lower vinorelbine levels and reduce how well it works.
- Combining Navelbine IV with other bone-marrow-suppressing chemotherapy or radiotherapy increases the risk of severe low blood counts.
- Live or live-attenuated vaccines should be avoided during and shortly after treatment because of a weakened immune response and infection risk.
- Navelbine IV must never be mixed or diluted with other medicines in the same syringe or infusion line unless specifically directed, and it must never be given by any non-intravenous route.
References
Frequently Asked Questions
Navelbine IV (vinorelbine) is an intravenous chemotherapy used with cisplatin, or alone, as first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer. It is given only in a hospital or clinic by a specialist team. In the US the Navelbine brand is discontinued; generic vinorelbine injection is used instead.
Navelbine IV is given as a short intravenous infusion or injection, usually over 6 to 10 minutes, once weekly, directly into a correctly placed vein or catheter by a healthcare professional. You do not inject it yourself. Leakage outside the vein can cause serious tissue damage, so it is only ever given in a monitored clinical setting.
Navelbine IV carries a boxed warning for severe low blood cell counts, which can cause serious infection, septic shock and death, so blood tests are done before every dose. Common effects include nausea, fatigue, hair thinning, constipation and numbness or tingling in the hands or feet. Report fever or breathlessness urgently.
No. 'Navelbine IV' is this catalogue's name for the 50 mg/5 mL intravenous vinorelbine concentrate; no product is formally branded this way in FDA or EMA records. Oral Navelbine capsules, sold in some countries at 20 mg, 30 mg or 80 mg, have completely different dosing and must never be substituted for the IV form.
A nurse checks your blood counts, confirms your vein or catheter is correctly placed, then gives Navelbine IV as a brief injection or infusion, usually weekly. You are monitored for any burning, swelling or leakage at the injection site, since this can indicate the drug has escaped the vein.
No. Navelbine IV can harm an unborn baby, so effective contraception is required during treatment for patients who could become pregnant or father a child. It is not recommended during pregnancy or breastfeeding. Avoid live vaccines while on treatment, as it weakens the immune system.
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