SALEXI 800

Indications

• Pulmonary arterial hypertension (PAH)
• Persistent pulmonary hypertension of the newborn (off-label)

Dosage

Children: Refer to the latest clinical guidelines or BNF for specific dosing information.

Adults: Refer to the latest clinical guidelines or BNF for specific dosing information.

Mechanism of action

Saleixipag acts as a selective agonist of the prostacyclin receptor (IP receptor). Activation of the IP receptor results in increased intracellular cyclic AMP (cAMP) levels, leading to vasodilation and inhibition of platelet aggregation. This mechanism is crucial in managing pulmonary arterial hypertension, as it helps to reduce pulmonary vascular resistance and improve blood flow.

Pharmacodynamics

Saleixipag exhibits dose-dependent vasodilatory effects, primarily affecting the pulmonary and systemic arterial vascular beds. It improves hemodynamic parameters such as cardiac output and reduces pulmonary artery pressure. The drug also has antiplatelet effects, which may contribute to its efficacy in PAH by preventing thrombosis in the pulmonary circulation.

Pharmacokinetics

After oral administration, saleixipag is rapidly absorbed, with peak plasma concentrations typically occurring within 1-2 hours. It undergoes extensive hepatic metabolism, primarily via cytochrome P450 enzymes, resulting in various metabolites, some of which may contribute to its pharmacological effects. The elimination half-life is approximately 3-5 hours, and the drug is primarily excreted via the feces and urine. Dose adjustments may be necessary in patients with hepatic impairment.

Contra-indications

• Hypersensitivity to salexipag or any of its excipients
• Severe liver impairment
• Severe renal impairment

Adverse effects

• Headache
• Nausea
• Diarrhea
• Fatigue
• Dizziness
• Flushing
• Palpitations
• Hypotension
• Edema

Interactions

• Concomitant use with strong CYP3A4 inhibitors may increase salexipag plasma concentrations
• May interact with other antihypertensive agents leading to additive hypotensive effects

Precautions

• Use with caution in patients with moderate liver impairment
• Monitor blood pressure regularly
• Consider potential interactions with other medications
• Use in caution in patients with a history of syncope

Pregnancy

There is insufficient data on the use of salexipag in pregnant women. It should only be used if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether salexipag is excreted in human breast milk. Caution should be exercised when salexipag is administered to a nursing woman.

Storage

Store in a cool, dry place, protected from light. Keep out of reach of children.

Formulations

• Tablets for oral administration