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VINORELBINE MEDAC is a brand name for Vinorelbine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: As a single agent or in combination for: • The first line treatment of stage 3 or 4 non small cell lung cancer. • The treatment of advanced breast cancer stage 3 and 4 relapsing after or refractory to an anthracycline containing regimen.
Verbatim from this product's MHRA label. Tap a section to expand.
In adult patients As a single agent, the recommended regimen is:
First three administrations 60 mg/m² of body surface area, administered once weekly. Subsequent administrations Beyond the third administration, it is recommended to increase the dose of Vinorelbine medac to 80 mg/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 60 mg/m².
Dose modification For any administration planned to be given at 80 mg/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 60 mg/m² per week during the 3 following administrations.
If the neutrophil count is below 1500/mm³ and/or the platelet count below 100000/mm³, then the treatment should be delayed until recovery. 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. 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 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 This has been the base for combination regimens alternating iv and oral forms to improve patients’ 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). 95 120 160 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.
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 vinorelbine (first three administrations at 60 mg/m²/week followed by 80 mg/m²/week).
Adverse reactions reported are listed below, by system organ class 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.
The reactions were described using the NCI common toxicity criteria Very common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 Very rare <1/10,000 Not known Cannot be estimated from the available data Undesirable effects reported with Vinorelbine medac 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 Vinorelbine medac is used as single agent or in combination with other chemotherapeutic or targeted therapy agents such as cisplatin or capecitabine. The most commonly involved system organ classes during post-marketing experience are: ‘Blood and lymphatic system disorders’, ‘Gastrointestinal disorders’, and ‘General disorders and administration site conditions’.
This information is consistent with the pre-marketing experience. 9 %. Prescription of laxatives may be appropriate in patients with prior history of constipation and/or who received concomitant treatment with morphine or morphine-mimetics.
3 % For the intravenous formulation of vinorelbine, the following additional adverse drug reactions were reported: systemic allergic reactions, severe paraesthesias, weakness of lower extremities, heart rhythm disorders, flushing, peripheral coldness, collapse, angina pectoris, bronchospasm, interstitial pneumopathy, pancreatitis, palmar-plantar erythrodysaesthesia syndrome, acute respiratory distress syndrome.
Special warnings Vinorelbine medac 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. g. 5). Vinorelbine medac 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 100 000/mm³, then the treatment should be delayed until recovery. 2. - For the administrations given at 80 mg/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 60 mg/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.
5)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Administration Vinorelbine medac must be given strictly by the oral route. The Vinorelbine medac capsules must be swallowed whole with water without chewing, sucking or dissolving the capsule. It is recommended to administer the capsule with some food.
6). 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. 2).
Administration in children Safety and efficacy in children have not been established and administration is therefore not recommended. 5 x ULN). 5 to 3 x ULN, whatever the levels of ALAT and ASAT), Vinorelbine medac should be administered at a dose of 50 mg/m²/week.
2). 2).
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: […]
2. If patients present signs or symptoms suggestive of infection, a prompt investigation should be carried out. 35 mg sorbitol in each capsule. The additive effect of concomitantly administered products 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. This medicinal product contains 20 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 Vinorelbine medac 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) Total clearance of vinorelbine was neither modified between mild and moderate liver impairment nor was it altered in hepatically impaired patients when compared with clearance in patients with normal liver function.
2). 2).