Uptravi Special Precautions

Additional Information on Special Populations: Studies with selexipag have been mainly performed in PAH patients classified as WHO functional Class II and III. Selexipag has only been studied in a limited number of patients with WHO functional Class IV (see PHARMACOLOGY: PHARMACODYNAMICS: CLINICAL TRIALS under Actions). Selexipag has only been studied in a limited number of patients with PAH due to drugs or toxins.
Hypotension: UPTRAVI has vasodilatory properties that may result in lowering of blood pressure. Before prescribing UPTRAVI, physicians should carefully consider whether patients with certain underlying conditions could be adversely affected by vasodilatory effects (e.g., patients on antihypertensive therapy, other PAH therapy or with resting hypotension, hypovolaemia, severe left ventricular outflow obstruction or autonomic dysfunction). Monitoring of blood pressure is recommended in such patients as clinically indicated.
Increase in heart rate: UPTRAVI may cause a moderate increase in heart rate after each dose.
Hyperthyroidism: Hyperthyroidism has been observed with UPTRAVI (2% patients on selexipag and 0% of placebo-treated patients) and other prostacyclin receptor agonists. Thyroid function tests are recommended as clinically indicated.
Pulmonary veno-occlusive disease: Should signs of pulmonary oedema occur, consider the possibility of associated pulmonary veno-occlusive disease. If confirmed, discontinue UPTRAVI.
Effects on laboratory tests: Refer to ADVERSE REACTIONS.
Effects on Ability to Drive and Use Machines: No studies on the effect of UPTRAVI on the ability to drive and use machines have been performed. UPTRAVI has a minor influence on the ability to drive and use machines. The clinical status of the patient and the adverse reaction profile of selexipag (such as headache or hypotension) should be kept in mind when considering the patient's ability to drive and use machines.
Use in hepatic impairment: No adjustment to the dosing regimen is needed in patients with mild hepatic impairment (Child-Pugh class A).
A once-daily regimen is recommended in patients with moderate hepatic impairment (Child-Pugh class B) due to the increased exposure to selexipag and its active metabolite in this population. There is no clinical experience with UPTRAVI in patients with severe hepatic impairment (Child-Pugh class C). Avoid use of UPTRAVI in patients with severe hepatic impairment (see CONTRAINDICATIONS).
Use in renal impairment: In patients with severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m²) caution should be exercised during dose titration. There is no clinical experience with UPTRAVI in patients undergoing dialysis or in patients with estimated glomerular filtration rates <15 mL/min/1.73 m².
Use in Children: The safety and efficacy of UPTRAVI in children (<18 years) has not been established.
Use in the Elderly: There is limited clinical experience with selexipag in patients over the age of 75 years, therefore UPTRAVI should be used with caution in this population.