Opsumit

Opsumit

macitentan

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Macitentan
Indications/Uses
Monotherapy or in combination for long-term treatment of pulmonary arterial HTN (PAH) in adult patients of WHO functional class II-III, including idiopathic & heritable PAH, PAH associated w/ connective tissue disorders & corrected simple congenital heart disease.
Dosage/Direction for Use
Administration
May be taken with or without food: Take at the same time each day. Swallow whole, do not break tab.
Contraindications
Hypersensitivity. Severe hepatic impairment. Baseline values of hepatic aminotransferase >3 x ULN. Women of childbearing potential who are not using effective contraception. Pregnancy & lactation.
Special Precautions
Liver function, discontinue use if unexplained clinically relevant aminotransferase elevations occur, or if elevations are accompanied by increased bilirubin >2x ULN or by clinical symptoms of liver injury (eg, jaundice), obtain liver enzyme tests prior to initiation of treatment. Not to be initiated in patients w/ elevated aminotransferases (>3x ULN). Hb conc, not recommended in patients w/ severe anemia, measure Hb conc prior to initiation, after 1 mth & periodically thereafter. Pulmonary veno-occlusive disease. Concomitant use w/ strong CYP3A4 inducers & inhibitors. Concomitant use w/ moderate dual or combined CYP3A4 & CYP2C9 inhibitors. Renal impairment, not recommended in severe renal impairment. Childn & adolescents <18 yr. Elderly >75 yr.
Adverse Reactions
Nasopharyngitis, anaemia, decreased Hb, headache, oedema, fluid retention, pharyngitis, flu, UTI, leukopenia, thrombocytopenia, aminotransferase elevations, hypotension, nasal congestion.
Drug Interactions
Reduced efficacy w/ strong CYP3A4 inducers eg, rifampicin. Strong CYP3A4 inhibitors eg, ketoconazole.
MIMS Class
Other Antihypertensives
ATC Classification
C02KX04 - macitentan ; Belongs to the class of other antihypertensives. Used in the treatment of pulmonary arterial hypertension.
Presentation/Packing
Form
Opsumit FC tab 10 mg
Packing/Price
30's
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