Ofev

Ofev

nintedanib

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Nintedanib
Indications/Uses
Idiopathic pulmonary fibrosis in adults. Other chronic fibrosing ILD w/ progressive phenotype. Systemic sclerosis associated ILD (SSc-ILD).
Dosage/Direction for Use
Recommended dose: 150 mg bid approx 12 hr apart. Max daily dose: 300 mg. Dose adjustments: Resume treatment at 150 mg bid or reduce dose to 100 mg bid. Interruptions due to AST or ALT transaminase elevations >3x ULN Reintroduce at reduced dose of 100 mg bid, subsequently increased to 150 mg bid. Mild hepatic impairment (Child Pugh A) 100 mg bid approx 12 hr apart.
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
Discontinue in case of persisting severe diarrhoea; severe nausea & vomiting symptoms; if any liver test elevations are associated w/ clinical signs or symptoms of liver injury eg, jaundice; GI perforation develops. Diarrhoea & vomiting leading to dehydration w/ or w/o electrolyte disturbances. Increased risk of bleeding & thromboembolic events. Nephrotic syndrome. Patients w/ recent history of MI or stroke; higher CV risk including known CAD; previous abdominal surgery, recent history of hollow organ perforation, previous history of peptic ulceration, diverticular disease. Low body wt (<65 kg), Asian, female & Black patients. Monitor for hepatic transaminase & bilirubin levels upon initiation of treatment at regular intervals during 1st 3 mth of treatment & periodically thereafter. Concomitant use w/ corticosteroids or NSAIDs. May affect ability to drive & use machines. Not recommended in patients w/ moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Severe renal impairment (CrCl <30 mL/min). Women of childbearing potential should avoid becoming pregnant during treatment & use highly effective contraceptive methods at initiation, during & at least 3 mth after last dose. Women taking oral hormonal contraceptives experiencing vomiting & diarrhea should use alternative highly effective contraceptive measure. Not to be applied during pregnancy. Lactation. Childn & adolescents. Reduce dose to manage adverse effects in elderly ≥75 yr.
Adverse Reactions
Diarrhoea, vomiting, nausea, abdominal pain, pancreatitis; drug-induced liver injury; increased hepatic enzyme, ALT, AST, blood alkaline phosphatase & γ-glutamyltransferase, hyperbilirubinemia; HTN, bleeding; thrombocytopenia; decreased appetite & wt; rash, pruritus, alopecia; headache; proteinuria.
Drug Interactions
Increased exposure w/ ketoconazole or erythromycin. Decreased exposure w/ rifampicin, carbamazepine, phenytoin & St. John's wort.
MIMS Class
Other Drugs Acting on the Respiratory System
ATC Classification
L01EX09 - nintedanib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Ofev softcap 100 mg
Packing/Price
6 × 10's
Form
Ofev softcap 150 mg
Packing/Price
6 × 10's
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