f harmful effects for the child should be conducted. If pregnancy occurs during treatment genetic counseling should be offered.
Women of child-bearing potential
Women of child-bearing potential must use effective contraception during treatment and up to 3 months after treatment: see section 4.3
Lactation
It is unknown whether vinorelbine is excreted in human breast milk.
The excretion of vinorelbine in milk has not been studied in animal studies.
A risk to the suckling child cannot be excluded therefore breast feeding must be discontinued before starting treatment with Navelbine: see section 4.3.
Fertility
Men being treated with Navelbine are advised not to father a child during and minimally up to 3 months after treatment: see section 4.3.
Prior to treatment advice should be sought for conserving sperm due to the chance of irreversible infertility as a consequence of treatment with vinorelbine.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed but on the basis of the pharmacodynamic profile vinorelbine does not affect the ability to drive and use machines. However, caution is necessary in patients treated with vinorelbine considering some adverse effects of the drug: see section 4.8.
4.8 Undesirable effects
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 from Post Marketing experience has 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, <1/10
Uncommon
≥1/1,000, <1/100
Rare
≥1/10,000, <1/1,000
Very rare
<1/10,000
Not known
Post marketing reports
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 or targeted therapy agents such as cisplatin, capecitabine, carboplatin, epirubicin, trastuzumab, erlotinib, sorafenib.
The most commonly system organ classes involved during post-marketing experience are: 'Blood and lymphatic system disorders', 'Gastrointestinal disorders', 'Infections and infestations' and 'General disorders and administration site conditions'. This information is consistent with the pre-marketing experience.
Infections and infestations
Very common:
Bacterial, viral or fungal infections without neutropenia at different sites: G1-4: 12.7%; G3-4: 4.4%,
Common:
Bacterial, viral or fungal infections resulting from bone marrow depression and/or immune system comp |
