Soluble Guanylate Cyclase Stimulator Pregnancy: Contraindicated (Pregnancy Prevention Programme mandatory)

Riociguat

Brand names: Adempas

Adult dose

Dose: Starting: 1 mg TDS. Increase by 0.5 mg TDS every 2 weeks to maximum 2.5 mg TDS if tolerated

Route: Oral

Frequency: Three times daily

Max: 2.5 mg TDS (7.5 mg/day)

For pulmonary arterial hypertension (PAH) and inoperable/recurrent CTEPH. Do NOT use with PDE5 inhibitors (absolute contraindication).

Paediatric dose

Route: N/A

Frequency: N/A

Max: Not licensed in children

No established paediatric dosing; clinical trials ongoing

Dose adjustments

Renal

Caution if eGFR <30; limited data

Hepatic

Avoid in severe hepatic impairment (Child-Pugh C)

Clinical pearls

CHEST-1 (CTEPH) and PATENT-1 (PAH) trials: improved 6-minute walk distance
NICE TA310: recommended for CTEPH after surgery or inoperable
Pregnancy Category X — mandatory contraception required (Pregnancy Prevention Programme)
Never combine with sildenafil or other PDE5i — life-threatening hypotension

Contraindications

PDE5 inhibitors (sildenafil, tadalafil, vardenafil) — absolute
Nitrates or nitric oxide donors
Pregnancy
Severe hypotension (SBP <95 mmHg)

Side effects

Hypotension
Headache
Dyspepsia
Nausea/vomiting
Haemoptysis
Anaemia
Peripheral oedema

Interactions

PDE5 inhibitors — profound hypotension (absolutely contraindicated)
Nitrates — profound hypotension (absolutely contraindicated)
Antacids — reduce absorption; take 1h before
Strong CYP inhibitors (azole antifungals) — increased exposure

Monitoring

Blood pressure (before each dose increase)
Haemoglobin
Respiratory function
Pregnancy test (monthly for women of childbearing potential)

Reference: BNFc; CHEST-1 (Ghofrani et al, NEJM 2013); PATENT-1 (Ghofrani et al, NEJM 2013); BNF; NICE TA310. Verify against your local formulary and the latest BNF before prescribing.

Curated clinical cross-links plus same-class fallbacks.

Pathways