Opsumit

Opsumit

macitentan

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Macitentan
Indications/Uses
As monotherapy or in combination, for long-term treatment of pulmonary arterial HTN (PAH) in adult patients of WHO Functional Class (FC) II to III, including idiopathic & heritable PAH, PAH associated w/ connective tissue disorders, & PAH associated w/ corrected simple congenital heart disease.
Dosage/Direction for Use
Administration
May be taken with or without food: Take at about the same time every day. Swallow whole w/ water, do not break.
Contraindications
Hypersensitivity. Patients w/ severe hepatic impairment (w/ or w/o cirrhosis); baseline values of hepatic aminotransferases (AST &/or ALT >3 × ULN). Women of childbearing potential who are not using reliable contraception. Pregnancy & lactation.
Special Precautions
Patients w/ WHO class I functional status of PAH. Elevations of liver aminotransferases. Monitor for signs of hepatic injury; monitor ALT & AST mthly. Decrease in Hb conc. Not recommended in patients w/ severe anaemia. Measure Hb conc prior to initiation of treatment & repeatedly during treatment as clinically indicated. Patients w/ pulmonary veno-occlusive disease. Avoid concomitant use w/ strong CYP3A4 inducers (eg, rifampicin, St. John's wort, carbamazepine & phenytoin). Exercise caution when administered concomitantly w/ strong CYP3A4 inhibitors (eg, itraconazole, ketoconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir & saquinavir). Patients w/ renal impairment have higher risk of hypotension & anaemia. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Contains lecithin derived from soya. Minor influence on the ability to drive & use machines. Not recommended in patients w/ moderate hepatic impairment; patients undergoing dialysis. Should only be initiated in women of childbearing potential when absence of pregnancy has been verified. Women should not become pregnant for 1 mth after treatment discontinuation. Elderly >75 yr.
Adverse Reactions
Nasopharyngitis, bronchitis; anaemia; headache; oedema, fluid retention. Pharyngitis, flu, UTI; hypotension; nasal congestion.
Drug Interactions
Reduced efficacy w/ potent inducer of CYP3A4 eg, rifampicin. Caution when administered concomitantly w/ 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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