Navelbine

Monotherapy & combination chemotherapy of NSCLC & metastatic breast cancer.

Monotherapy 1st 3 administrations: 60 mg/m² once wkly. Subsequent administrations: Increase dose to 80 mg/m² once wkly except for patient whose neutrophil count has fallen once <500/mm³ or more than once between 500 & 1,000/mm³ during the 1st 3 administrations at 60 mg/m². Dose modification: For any planned administration at 80 mg/m², if the neutrophil count is <500/mm³ or has been between 500 & 1,000 mm³ more than once, delay administration until parameter has returned to normal & reduce dose from 80 to 60 mg/m² wkly for the subsequent 3 administrations. Increase dose from 60 to 80 mg/m² wkly if the neutrophil count is not <500/mm³ or between 500 & 1,000/mm³ more than once during the last 3 administrations at 60 mg/m². Combination chemotherapy Adjust dose & treatment regimen according to treatment protocol. For patient w/ BSA ≥2 m², total dose must never exceed 120 mg wkly (60 mg/m² dose) or 160 mg wkly (80 mg/m² dose). Patient w/ mild liver impairment (bilirubin <1.5 x ULN & AST &/or ALT 1.5-2.5 x ULN) 60 mg/m² wkly. Patient w/ moderate liver impairment (bilirubin 1.5-3 x ULN regardless of the ALT & AST) 50 mg/m² wkly.

Should be taken with food: Take at the end of a meal. Swallow whole w/ water, do not chew/suck.

Hypersensitivity to vinorelbine or other vinca alkaloids. Disease significantly affecting absorption. History of significant surgical resection of stomach or small bowel. Neutrophil count <1,500/mm³ or severe current/recent infection (w/in 2 wk). Platelet count <100,000/mm³. Patients requiring long-term O₂ therapy. Concomitant use w/ yellow fever vaccine. Lactation.

Do not repeat administration if vomiting occurs during hr after taking. Prophylactic antiemetic treatment is recommended. Caution in patients w/ history of ischaemic heart disease; poor performance status. Immediately wash thoroughly w/ water or preferably physiological saline soln in event of contact w/ liqd content. Administer treatment under strict haematological monitoring eg, check blood Hb, leukocyte, neutrophil & platelet count each day of administration. Perform further investigations w/o delay in signs or symptoms suggestive of infection. Caution in concomitant use w/ potent CYP3A4 inducers or inducers. Not recommended in concomitant use w/ phenytoin, fosphenytoin, itraconazole, ketoconazole or posaconazole. Not to be given concomitantly w/ RT if treatment fields include liver. Contains small amount of ethanol (>100 mg/dose). Not to be taken by patients w/ fructose intolerance. Not recommended in patients w/ severe hepatic disorder. Women of childbearing potential must use effective contraception during & for 3 mth after stopping treatment. Men should not conceive a child during & for at least 3 mth after treatment. Sperm storage should be considered prior to treatment. Not to be used during pregnancy unless expected individual benefit manifestly exceeds potential risks. Discontinue breast-feeding prior to beginning treatment. Not recommended in childn.

Bacterial, viral or fungal infections w/o neutropenia affecting different systems (resp, GI, urinary); bone marrow depression (particularly causing neutropenia), leucopenia, anaemia, thrombocytopenia; anorexia; neurosensory disorders; nausea, vomiting, diarrhoea, stomatitis, abdominal pain, constipation, gastric disorders; alopecia; fatigue/malaise, fever; wt loss. Bacterial, viral or fungal infections resulting from bone marrow depression or immunological disorder, infections associated w/ neutropenia; neutropenia associated w/ fever >38°C (including febrile neutropenia); insomnia; neuromotor disorders, headache, dizziness, altered taste; visual impairment; arterial HTN & hypotension; dyspnoea, cough; oesophagitis, dysphagia; hepatic disorders; skin reactions; arthralgia (particularly jaw pain), myalgia; dysuria, other genito-urinary symptom; pain (particularly pain at the tumour site), chills; wt gain.

Risk of fatal generalised vaccine disease w/ yellow fever vaccine; live attenuated vaccines. Increased hepatic metabolism by phenytoin or fosphenytoin. Increased risk of thrombosis & haemorrhage in tumour disease w/ vit K antagonists. Risk of increased toxicity w/ macrolides eg, clarithromycin, erythromycin, telithromycin. Increased neurotoxicity w/ cobicistat. Excessive immunosuppression w/ risk of lymphoproliferative syndrome w/ immunosuppressants eg, ciclosporin, everolimus, sirolimus, tacrolimus. Increased neurotoxicity w/ itraconazole, posaconazole, ketoconazole. Increased toxicity w/ PIs. Risk of increased pulmonary toxicity w/ mitomycin C. Caution in concomitant use w/ potent membrane transport modulators eg, P-gp. Worsened myelosuppressive adverse effects w/ other medicinal products known to have bone marrow toxicity. Greater incidence of granulocytopenias in combination w/ cisplatin than monotherapy w/ vinorelbine. Blood conc may be increased w/ potent CYP3A4 inhibitors & may be reduced w/ potent CYP3A4 inducers. Increased incidence of grade 3/4 neutropenia w/ lapatinib.

Cytotoxic Chemotherapy

L01CA04 - vinorelbine ; Belongs to the class of plant alkaloids and other natural products, vinca alkaloids and analogues. Used in the treatment of cancer.

Rx