Usual Adult Dose for Heart Failure

Initial dose: 2.5 mg orally once a day
Maintenance dose: The dose should be doubled about every 2 weeks to reach the target dose of 10 mg orally once a day, as tolerated by the patient.

Use: To reduce the risk of cardiovascular death and heart failure (HF) hospitalization after a hospitalization for HF or need for outpatient IV diuretics, in patients with symptomatic chronic HF and ejection fraction less than 45%

Renal Dose Adjustments

Estimated GFR at least 15 mL/min/1.73 m2 (not on dialysis): No adjustment recommended.
Estimated GFR less than 15 mL/min/1.73 m2: Data not available

Comments:

• This drug has not been studied in patients with estimated GFR less than 15 mL/min/1.73 m2 at treatment initiation.

Liver Dose Adjustments

Mild or moderate liver dysfunction (e.g., Child-Pugh A or B): No dose adjustment recommended.
Severe liver dysfunction (e.g., Child-Pugh C): Data not available

Comments:

• This drug has not been studied in patients with severe liver dysfunction.

Precautions

US BOXED WARNING:

• EMBRYOFETAL TOXICITY: Because this drug may cause fetal harm, it should not be administered to a pregnant patient. Pregnancy should be excluded in patients of childbearing potential before treatment initiation. To prevent pregnancy, patients of childbearing potential must use effective contraception during therapy and for 1 month after the last dose.

• Pregnancy
• Concomitant use with other soluble guanylate cyclase (sGC) stimulators

Dialysis

Data not available

Comments:

• This drug has not been studied in patients on dialysis.
• This drug is unlikely to be removed by hemodialysis due to high protein binding.

Other Comments

Administration advice:

• Before starting therapy, obtain a pregnancy test in patients of childbearing potential.
• Administer with food.
• Tablets may be crushed and mixed with water immediately before administration for patients unable to swallow whole tablets.

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).

• General: For pregnancy (before starting therapy)

• Read the US FDA-approved patient labeling (Medication Guide).
• If a dose is missed, take it as soon as you remember on the same day of the missed dose; do not take 2 doses on the same day.
• Inform health care provider of known/suspected pregnancy; if exposed to this drug during pregnancy, report the pregnancy to your health care provider.
• Patients of childbearing potential: Use effective contraception during therapy and for 1 month after the last dose.
• Do not breastfeed during therapy.