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NAVELBINE is a brand name for Vinorelbine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Vinorelbine is indicated in adult patients for the treatment of: • advanced non-small-cell lung cancer as monotherapy or in combination with other chemotherapy • as adjuvant treatment of non-small-cell lung cancer in combination with platinum-based chemotherapy • advanced breast cancer as monotherapy or in combination…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology In adult patients As a single agent, the recommended regimen is:
First three administrations 60mg/m² of body surface area, administered once weekly Subsequent administrations Beyond the third administration, it is recommended to increase the dose of Navelbine to 80mg/m² once weekly except in those patients for whom the neutrophil count dropped once below 500/mm3 or more than once between 500 and 1000/mm3 during the first three administrations at 60mg/m².
Neutrophil count during the first 3 administrations of 60 mg/m2/week Neutrophils > 1000 Neutrophils ≥ 500 and < 1000 (1 episode) Neutrophils ≥ 500 and < 1000 (2 episodes) Neutrophils < 500 Recommended dose starting with the 4th administration 80 80 60 60 Dose modification For any administration planned to be given at 80mg/m², if the neutrophil count is below 500/mm3 or more than once between 500 and 1000 / mm3 the administration should be delayed until recovery and the dose reduced from 80 to 60mg/m2 per week during the 3 following administrations.
Neutrophil count beyond the 4th administration of 80 mg/m2/week Neutrophils > 1000 Neutrophils ≥ 500 and < 1000 (1 episode) Neutrophils ≥ 500 and < 1000 (2 episodes) Neutrophils < 500 Recommended dose starting with the next administration 80 60 It is possible to re-escalate the dose from 60 to 80 mg/m2 per week if the neutrophil count did not drop below 500/mm3 or more than once between 500 and 1000/mm3 during 3 administrations given at 60 mg/m2 according to the rules previously defined for the first 3 administrations.
For combination regimens, the dose and schedule will be adapted to the treatment protocol. Based on clinical studies, the oral dose of 80 mg/m2 was demonstrated to correspond to 30 mg/m2 of the iv form and 60 mg/m2 to 25 mg/m2. This has been the base for combination regimens alternating iv and oral forms improving patient convenience.
Capsules of different strengths (20, 30, 80 mg) are available in order to choose the adequate combination for the right dosage. The following table gives the dose required for appropriate ranges of body surface area (BSA). 95 70 70 80 80 90 100 100 110 110 120 90 100 100 110 120 130 140 140 150 160 Even for patients with BSA≥ 2 m2 the total dose should never exceed 120 mg per week at 60 mg /m2 and 160 mg per week at 80 mg/m2.
Administration Navelbine must be given strictly by the oral route. Navelbine must be swallowed whole with water, without chewing, sucking or dissolving the capsule. It is recommended to administer the capsule with some food. Administration in the elderly Clinical experience has not detected any significant differences among elderly patients with regard to the response rate, although greater sensitivity in some of these patients cannot be excluded.
The overall reported frequency of undesirable effects was determined from clinical studies in 316 patients (132 patients with non-small cell lung cancer and 184 patients with breast cancer) who received the recommended regimen of Navelbine (first three administrations at 60mg/m²/week followed by 80mg/m²/week).
Adverse reactions reported are listed below, by system organ and by frequency. Additional Adverse reactions pooled from Post Marketing experience and clinical trials have been added according to the MedDRA classification with the frequency Not known.
Very common ≥1/10 Common ≥1/100, <1/10 Uncommon ≥1/1,000, <1/100 Rare ≥1/10,000, <1/1,000 Very rare <1/10,000 Not known Cannot be estimated from the available data Undesirable effects reported with Navelbine soft capsule: Pre-marketing experience: The most commonly reported adverse drug reactions are bone marrow depression with neutropenia, anaemia and thrombocytopenia, gastrointestinal toxicity with nausea, vomiting, diarrhoea, stomatitis and constipation.
Fatigue and fever were also reported very commonly.
Post-marketing experience:
Navelbine soft capsule is used as single agent or in combination with other chemotherapeutic agents such as cisplatin or capecitabine. ’ This information is consistent with the pre-marketing experience. 4%, Common: Bacterial, viral or fungal infections resulting from bone marrow depression and/or immune system compromise (neutropenic infections) are usually reversible with an appropriate treatment.
5%.
Not known:
Neutropenic sepsis. 9%, is reversible and is the dose limiting toxicity. 7 %; G4: 6%. 8%. 8%. 8%. 1%.
Not known:
Special warnings Navelbine should be prescribed by a physician who is experienced in the use of chemotherapy with facilities for monitoring cytotoxic drugs. If the patient chews or sucks the capsule by error, the liquid is an irritant.
Proceed to mouth rinses with water or preferably a normal saline solution. In the event of the capsule being cut or damaged, the liquid content is an irritant, and so may cause damage if in contact with skin, mucosa or eyes. Damaged capsules should not be swallowed and should be returned to the pharmacy or to the doctor in order to be properly destroyed.
If any contact occurs, immediate thorough washing with water or preferably with normal saline solution should be undertaken. In the case of vomiting within a few hours after drug intake, do not re-administer. 5). Navelbine soft capsule is associated with a higher incidence of nausea/vomiting than the intravenous formulation.
2). Patients receiving concomitant morphine or opioid analgesics: laxatives and careful monitoring of bowel mobility are recommended. Prescription of laxatives may be appropriate in patients with prior history of constipation. Close haematological monitoring must be undertaken during treatment (determination of haemoglobin level and the leucocyte, neutrophil and platelet counts on the day of each new administration).
Dosing should be determined by haematological status: - If the neutrophil count is below 1500 /mm3 and/or the platelet count is below 100000/mm3, then the treatment should be delayed until recovery. 2). - For the administrations given at 80mg/m², if the neutrophil count is below 500/mm3 or more than once between 500 and 1000 /mm3, then the treatment should be delayed until recovery.
The administration should not only be delayed but also reduced to 60mg/m² per week. 2). During clinical trials where treatments were initiated at 80 mg/m2, a few patients developed excessive neutropenic complications including those with a poor performance status.
Known hypersensitivity to vinorelbine or other vinca-alkaloids or to any of the constituents. - Disease significantly affecting absorption - Previous significant surgical resection of stomach or small bowel. - Neutrophil count < 1500/mm3 or severe infection current or recent (within 2 weeks).
6). 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2. 1). 5 x ULN). 5 and 3 x ULN, independent of ALT and AST level), Navelbine needs to be administered at a dose of 50 mg/m²/week. 2). 2). 6).
Severe hyponatraemia. 8%. 1%, generally limited to loss of tendon reflexes and infrequently severe. 3%. 6%. 6%. 8%. 3%. 3%.
Cardiac disorders Uncommon:
Heart failure and cardiac dysrhythmia Not known: Myocardial infarction in patients with cardiac medical history or cardiac risk factors. 3%. 6%. 3%. 8%. 7%. 3%. 9% [exceptionally fatal], treatment may be resumed after recovery of normal bowel mobility.
Not known:
Gastro-intestinal bleeding. 3%. 4%, may occur. 7%.
Musculoskeletal and connective tissue disorders Common:
Arthralgia including jaw pain. 3%. 6%. 9%. 5%. 1%. 6%. 8%. 3%. 3%. For the intravenous formulation of Navelbine, the following additional Adverse Drug Reactions were reported: systemic allergic reactions, severe paresthesias, weakness of lower extremities, heart rhythm disorders, flushing, peripheral coldness, collapse, angina pectoris, bronchospasm, interstitial pneumopathy, pancreatitis, palmar-plantar erythrodysesthesia syndrome, acute respiratory distress syndrome.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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2. If patients present signs or symptoms suggestive of infection, a prompt investigation should be carried out. 11 mg sorbitol in each capsule. The additive effect of concomitantly administered product containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. 5 mg alcohol (ethanol) in each capsule. The amount in each capsule of this medicine is equivalent to less than 1 ml beer or 1 ml wine.
. The small amount of alcohol in this medicinal product will not have any noticeable effects. This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’. 8) - poor performance status.
Navelbine should not be given concomitantly with radiotherapy if the treatment field includes the liver. 3). 5), and its combination with phenytoin (like all cytotoxics) and with itraconazole (like all vinca alkaloids) is not recommended.
5 and 3 x ULN, independent of ALT and AST level). The safety and pharmacokinetics of vinorelbine were not changed in these patients at the tested doses. 2). 2).