Resources for patients and HCPs

OFEV is now covered for PF-ILD in all provinces (restrictions apply)^2–11*

OFEV^® Safety Information

Indications and clinical use:

OFEV is now covered for PF-ILD in all provinces (restrictions apply)^2–11*

OFEV (nintedanib) is indicated for:¹

• the treatment of Idiopathic Pulmonary Fibrosis (IPF)
• to slow the rate of decline in pulmonary function in patients with systemic sclerosis associated interstitial lung disease (SSc‑ILD)
• the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (also known as progressive fibrosing ILD)

Should not be used in patients under 18 years of age.

Contraindications:

• Patients with known hypersensitivity to nintedanib, peanut or soya, or any of the excipients
• Pregnancy

Most serious warnings and precautions:

Gastrointestinal perforations and ischemic colitis: Based on mechanism of action: increased risk of GI perforation. Cases of GI perforation have been reported in the post-marketing period; many serious and some fatal; definitive causal relationship to OFEV has not been established. Exercise caution in patients with previous abdominal surgery, recent hollow organ perforation, history of peptic ulceration or diverticular disease or receiving concomitant corticosteroids or NSAIDs. OFEV should only be initiated at least 4 weeks after abdominal surgery. Use OFEV in patients with a known risk of GI perforation only if the anticipated benefit outweighs the potential risk. Permanently discontinue OFEV in patients who develop GI perforation or ischemic colitis. Exceptionally, OFEV can be reintroduced after complete resolution of ischemic colitis and careful assessment of patient’s condition and other risk factors.

Hemorrhage: Based on mechanism of action: increased risk of bleeding. Monitor patients on full anticoagulation therapy closely for bleeding and adjust anticoagulation treatment as necessary. Serious and fatal bleeding events have been reported in clinical trials and in post-marketing surveillance systems. Use OFEV in patients with known risk of bleeding only if the anticipated benefit outweighs the potential risk.

Other relevant warnings and precautions:

• Treatment should be initiated and supervised by physicians experienced in the diagnosis and treatment of the indicated conditions
• Risk of diarrhea, nausea and vomiting; may lead to dehydration with/without electrolyte disturbances, may progress to renal function impairment
• Treatment interruption should be considered in patients who develop signs or symptoms of nephrotic syndrome
• Risk of weight loss; monitor weight
• Should be taken with food
• Use caution when treating patients with higher cardiovascular risk including known coronary artery disease
• Not recommended in patients with moderate or severe hepatic impairment
• Drug-induced liver injury
• Liver enzyme elevations
• Measure systemic blood pressure before treatment and periodically thereafter as clinically indicated
• Measure hepatic transaminase and bilirubin levels before treatment initiation; monthly during the first 3 months; periodically thereafter as clinically indicated. Conduct liver tests promptly in patients who report symptoms that may indicate liver injury. Dosage modifications or interruption may be necessary.
• Serious cases of artery dissection have been reported in patients using VEGFR TKIs, including nintedanib. This risk should be carefully considered in patients with risk factors.
• Use OFEV in patients with clinically significant pulmonary hypertension only if the anticipated benefit outweighs the potential risk
• Based on mechanism of action: potential for increased risk of thromboembolic events and impaired wound healing
• Women: use highly effective contraception at the initiation of, during OFEV treatment and for at least 3 months after the last dose of OFEV; women using hormonal contraceptives must add a barrier method
• Not recommended for use in nursing women or in children and adolescents
• Safety data for African American patients is limited

For more information:

Please consult the Product Monograph for important information relating to adverse reactions, drug interactions and dosing information which have not been discussed in this piece.

The Product Monograph is also available by calling 1-800-263-5103 x 84633.