Uptravi

Uptravi

selexipag

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Selexipag
Indications/Uses
Long-term treatment of pulmonary arterial hypertension (PAH) in adult patients w/ WHO functional class II-III (including idiopathic & heritable PAH, PAH associated w/ connective tissue disorders, & PAH associated w/ corrected simple congenital heart disease), either as combination therapy in patients insufficiently controlled w/ an endothelin receptor antagonist &/or a phosphodiesterase type 5 inhibitor, or as monotherapy in patients who are not candidates for these therapies.
Dosage/Direction for Use
Initially 200 mcg bd, approx 12 hr apart. Should be up-titrated to the highest individually tolerated dose in increments of 200 mcg bd, usually at wkly intervals. Max: 1,600 mcg bd. Moderate hepatic impairment Initially 200 mcg once daily, increase at wkly intervals by increments of 200 mcg once daily.
Administration
May be taken with or without food: Swallow whole, do not split/crush/chew.
Contraindications
Hypersensitivity. Severe CHD or unstable angina. MI w/in the last 6 mth. Decompensated cardiac failure if not under close medical supervision. Severe arrhythmias. Cerebrovascular events (eg, transient ischaemic attack, stroke) w/in the last 3 mth. Congenital or acquired valvular defects w/ clinically relevant myocardial function disorders not related to pulmonary HTN. Concomitant use w/ strong CYP2C8 inhibitors (eg, gemfibrozil).
Special Precautions
May cause hypotension; hyperthyroidism. Perform thyroid function tests as clinically indicated. Patients w/ pulmonary veno-occlusive disease. Concomitant use w/ moderate CYP2C8 inhibitors. Minor influence on the ability to drive & use machines. Should not be administered in patients w/ severe liver impairment (Child-Pugh class C), severe renal impairment (eGFR <30 mL/min/1.73 m2), & in patients undergoing dialysis. Women of childbearing potential should practice effective contraception while on treatment. Not recommended during pregnancy & in women of childbearing potential not using contraception. Should not be used during breast-feeding. Elderly >75 yr.
Adverse Reactions
Headache; diarrhoea, nausea, vomiting; jaw pain, myalgia, pain in extremity, arthralgia; flushing; nasopharyngitis. Anaemia, Hb decreased; hyperthyroidism, TSH decreased; decreased appetite, wt decrease; hypotension; nasal congestion; abdominal pain; rash, urticaria, erythema; pain.
Drug Interactions
Increased exposure w/ gemfibrozil (strong CYP2C8 inhibitor). Potential pharmacokinetic interaction w/ moderate CYP2C8 inhibitor; CYP2C8 inducers (eg, rifampicin, carbamazepine, phenytoin); strong UGT1A3 & UGT2B7 inhibitors (eg, valproic acid, probenecid, fluconazole). Lower exposure of active metabolite w/ both endothelin receptor antagonist & a phosphodiesterase type 5 inhibitor.
ATC Classification
B01AC27 - selexipag ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Presentation/Packing
Form
Uptravi FC tab 1000 mcg
Packing/Price
60's
Form
Uptravi FC tab 1200 mcg
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60's
Form
Uptravi FC tab 1400 mcg
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60's
Form
Uptravi FC tab 1600 mcg
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60's
Form
Uptravi FC tab 200 mcg
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140's
Form
Uptravi FC tab 400 mcg
Packing/Price
60's
Form
Uptravi FC tab 600 mcg
Packing/Price
60's
Form
Uptravi FC tab 800 mcg
Packing/Price
60's
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