Vargatef

Vargatef

nintedanib

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Nintedanib
Indications/Uses
In combination w/ docetaxel for locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after 1st-line chemotherapy.
Dosage/Direction for Use
200 mg bid administered approx 12 hr apart, on days 2-21 of a standard 21-day docetaxel treatment cycle. Do not take on the same day of docetaxel chemotherapy administration. Max daily dose: 400 mg. Dose adjustments: Diarrhoea ≥Grade 3 despite anti-diarrhoeal treatment, vomiting ≥Grade 2, nausea ≥Grade 3 despite anti-emetic treatment, other non-haematological or haematological adverse reaction of ≥Grade 3, elevation of AST &/or ALT values to >5x ULN 150 mg bid & if 2nd dose reduction is necessary: Reduce to 100 mg bid.
Administration
Should be taken with food: Swallow whole w/ water, do not chew/open/crush.
Contraindications
Hypersensitivity to nintedanib, peanut or soya. Pregnancy.
Special Precautions
Treat 1st signs of diarrhoea w/ adequate hydration & anti-diarrhoeal medicinal products eg, loperamide. Permanently discontinue if GI perforation develops. Discontinue in patients w/ life-threatening venous thromboembolic reactions. May require interruption, dose reduction or discontinuation of therapy if diarrhoea, nausea & vomiting persists & based on severity of liver enzyme elevations. Administer electrolytes & fluids in the event of dehydration & monitor plasma levels of electrolytes if relevant GI adverse events occur. Perform frequent monitoring of CBCs at the beginning of each treatment cycle & around nadir for patients receiving treatment w/ docetaxel & as clinically indicated after administration of the last combination cycle. Investigate transaminase, ALKP & bilirubin levels before initiation of combination treatment w/ docetaxel & monitor values as clinically indicated or periodically during treatment. Interrupt or permanently discontinue treatment in case of specific changes in liver values (AST/ALT >3x ULN in conjunction with bilirubin ≥ 2x ULN and ALKP <2x ULN). Close monitoring in patients w/ several risk factors (females, elderly, Asian race, <50 kg body wt). Increased risk of bleeding. Consider discontinuation in patients who experience grade 3/4 bleeding events. Not recommended in patients w/ recent pulmonary bleeding (>2.5 mL of red blood), centrally located tumours w/ radiographic evidence of local invasion of major blood vessels or of cavitary or necrotic tumours; active brain metastasis. Closely monitor for signs & symptoms of cerebral bleeding & thromboembolic events. Regularly monitor patients taking concomitant warfarin or phenprocoumon for changes in prothrombin time, INR or clinical bleeding episodes. Patients w/ higher CV risk including known CAD. Consider treatment interruption in patients who develop signs or symptoms of acute myocardial ischaemia & nephrotic syndrome. Patients w/ previous abdominal surgery or a recent history of a hollow organ perforation. Initiate therapy at least 4 wk after major (including abdominal) surgery. May impair wound healing. Not recommended in patients w/ moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Increased risk of adverse events in patients w/ mild hepatic impairment (Child Pugh A). May influence the ability to drive or use machines. Severe renal impairment (<30 mL/min CrCl). Women of childbearing potential should avoid becoming pregnant while receiving treatment & must use highly effective contraceptive methods prior to, during & at least 3 mth after the last dose. Pregnancy. Lactation (discontinue during treatment). Childn.
Adverse Reactions
Diarrhoea, vomiting, nausea, abdominal pain, perforation, pancreatitis; drug-induced liver injury, increased liver enzymes (eg, ALT, AST, alkaline phosphatase, γ-glutamyltransferase), hyperbilirubinemia; HTN, venous thromboembolism, bleeding; neutropenia, thrombocytopenia; sepsis, febrile neutropenia, abscesses; decreased appetite, dehydration, electrolyte imbalance, decreased wt; peripheral neuropathy, headache; mucositis including stomatitis, rash, pruritus, alopecia; proteinuria.
Drug Interactions
Increased exposure w/ potent P-gp inhibitors eg, ketoconazole or erythromycin. Decreased exposure w/ potent P-gp inducers eg, rifampicin, carbamazepine, phenytoin & St. John's wort.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EX09 - nintedanib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Vargatef softcap 100 mg
Packing/Price
6 × 10's
Form
Vargatef softcap 150 mg
Packing/Price
6 × 10's
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