OPSUMIT 10 MG — DIN 02415690

What is OPSUMIT?

OPSUMIT 10 MG contains MACITENTAN : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02415690, held by JANSSEN INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 09-Sep-2019. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is OPSUMIT used for?

OPSUMIT (macitentan) is indicated for: the long-term treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce morbidity in adult patients of WHO Functional Class II or III whose PAH is either idiopathic or heritable, or associated with connective tissue disease or congenital heart disease. the long-term treatment of pulmonary arterial hypertension (PAH, WHO Group I) in pediatric patients aged 2 to less than 18 years of WHO Function Class II-III whose PAH is either idiopathic or heritable, or associated with connective tissue disease or congenital heart disease. OPSUMIT is effective when used as monotherapy or in combination with phosphodiesterase-5 inhibitors.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

Adults (Film-coated tablet): The recommended dose of OPSUMIT in adult patients is one 10 mg film-coated tablet taken once daily. Tablets are to be swallowed whole, with or without food. Pediatrics (2 years to less than 18 years old) (Dispersible tablets for suspension): The recommended dose of OPSUMIT in pediatric patients aged 2 years to less than 18 years is based on-body weight (Table 1). OPSUMIT should be taken once daily, with or without food. Dispersible tablets must be dispersed in room temperature liquid (drinking water, orange juice, apple juice, skimmed milk) and taken as an oral suspension. For administration by a tablespoon: add dispersible tablet(s) to room temperature drinking water in a tablespoon, stir for 1 to 3 minutes. Administer right away or mix with apple sauce or yogurt. Add more liquid/food to ensure entire dose is taken. For administration by a glass: place dispersible tablet(s) in a small glass with 10-100 mL room temperature drinking water, stir for 1 to 2 minutes. Administer right away. Add minimum 5 mL more water to re-suspend any remaining medicine and administer. Hands must be thoroughly washed and dried before and after preparation. Missed Dose: If a dose is missed, take it as soon as remembered. Otherwise, skip the missed dose and take the next dose at the regular time. Do not take 2 doses on the same day.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

OPSUMIT (macitentan) is contraindicated in: patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. Women who are or may become pregnant. Nursing women.

Warnings and precautions

Hematologic: Treatment with OPSUMIT has been associated with a decrease in hemoglobin concentration. Decreases occurred early, were not progressive, and stabilized before 12 weeks. Cases of anemia requiring transfusion have been reported. Initiation of OPSUMIT is not recommended in patients with severe anemia. Hemoglobin concentrations should be measured prior to initiation, after one month, and periodically thereafter. Hepatic/Biliary/Pancreatic: Elevations of liver aminotransferases (AST, ALT) have been associated with PAH and endothelin receptor antagonists (ERAs). OPSUMIT is not to be initiated in patients with elevated aminotransferases (>3 x ULN) at baseline and is not recommended in patients with moderate to severe hepatic impairment. Liver enzyme tests should be obtained prior to initiation, monthly during the first year, and less frequently thereafter. If unexplained clinically relevant aminotransferase elevations occur, or if elevations are accompanied by an increase in bilirubin >2 x ULN, or by clinical symptoms of liver injury (e.g. jaundice), OPSUMIT treatment should be discontinued. Re-initiation may be considered after hepatic enzyme levels return to normal in patients without clinical symptoms of liver injury. Pulmonary Veno-Occlusive Disease: Cases of pulmonary edema have been reported with vasodilators in patients with pulmonary veno-occlusive disease. If signs of pulmonary edema occur when OPSUMIT is administered in patients with PAH, the possibility of pulmonary veno-occlusive disease should be considered. Renal: Patients with moderate or severe renal impairment may run a higher risk of experiencing hypotension and anemia. Monitoring of blood pressure and hemoglobin should be considered. OPSUMIT is not recommended in patients undergoing dialysis. Reproductive Health: Based on animal findings, OPSUMIT may impair fertility in males. Decreases in sperm cell count have been observed with ERAs. Counsel men about potential effects on fertility. OPSUMIT is teratogenic in rabbits and rats. Women of child-bearing potential must have pregnancy verified before initiation, use reliable contraception, and not become pregnant for 1 month after discontinuation. Monthly pregnancy tests are recommended.