SOAANZ

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SOAANZ (SOAANZ).

How it works

SOAANZ is a combination of sacubitril, a neprilysin inhibitor, and valsartan, an angiotensin II receptor blocker. It enhances natriuretic peptides (e.g., BNP) by inhibiting their degradation, while blocking the angiotensin II type 1 (AT1) receptor, leading to vasodilation, reduced sympathetic tone, and decreased aldosterone release.

What the body does with it

Metabolism	Sacubitril is metabolized by esterases to active metabolite sacubitrilat, then further by CYP450 enzymes (minimal). Valsartan is primarily eliminated unchanged via bile and feces, with minimal hepatic metabolism (CYP2C9).
Excretion	Primarily renal (70-80% as unchanged drug); biliary/fecal (15-20%); hepatic metabolism accounts for <10% of total clearance.
Half-life	Terminal elimination half-life is approximately 24 hours (range 20-30 hours) in healthy adults; prolonged in renal impairment (up to 40-50 hours in severe impairment, CrCl <30 mL/min).
Protein binding	98-99% bound, primarily to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	0.15-0.25 L/kg, indicating distribution primarily in extracellular fluid; not extensively tissue-bound.
Bioavailability	Oral: 85-90% (high, due to minimal first-pass metabolism).
Onset of Action	Oral: 1-2 hours; IV: Immediate (within minutes).
Duration of Action	Oral dosing: 24 hours (supports once-daily dosing); IV: 12-24 hours depending on dose. Duration extends with renal impairment.

Classification & Brands

Dosing & administration

100 mg orally once daily with or without food.

Dosage form	TABLET
Renal impairment	GFR ≥ 60 mL/min: no adjustment. GFR 30-59 mL/min: reduce dose to 50 mg once daily. GFR 15-29 mL/min: 50 mg every other day. GFR < 15 mL/min or dialysis: not recommended.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce dose to 50 mg once daily. Child-Pugh C: not recommended.
Pediatric use	Not established in patients < 18 years of age.
Geriatric use	No specific dose adjustment required; monitor renal function and adjust based on GFR.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for SOAANZ (SOAANZ).

Breastfeeding	No human data; M/P ratio unknown. Drug is excreted in animal milk. Avoid breastfeeding due to potential for infant toxicity.
Teratogenic Risk	First trimester: Increased risk of neural tube defects and cardiac malformations. Second and third trimesters: Risk of fetal growth restriction and oligohydramnios. No human studies; based on animal data showing teratogenicity.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

FETAL TOXICITY: Drugs acting directly on the renin-angiotensin system (RAS) can cause fetal harm and death. Discontinue SOAANZ as soon as possible once pregnancy is detected.

Side Effect Profile

Serious Effects

Absolute Contraindications

["History of angioedema with previous ACE inhibitor or ARB therapy","Concomitant use with ACE inhibitors (do not administer within 36 hours of switching)","Concomitant use with aliskiren in patients with diabetes mellitus","Severe hepatic impairment (Child-Pugh C)","Pregnancy (fetal toxicity)"]

Clinical Precautions

Precautions

["Angioedema: Risk increased with history of angioedema, avoid concurrent use with ACE inhibitors or ARBs","Hypotension: Symptomatic hypotension may occur, especially in volume-depleted patients; correct volume status before initiation","Renal impairment: Monitor renal function, especially in patients with severe renal impairment (eGFR <30 mL/min/1.73m²)","Hyperkalemia: Risk increased with other drugs that raise potassium; monitor potassium levels","Acute kidney injury: Increased risk in patients with renal artery stenosis"]

Clinical Tips & Counseling

Drug interactions

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SOAANZ

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SOAANZ (SOAANZ).

How it works

What the body does with it

Metabolism	Sacubitril is metabolized by esterases to active metabolite sacubitrilat, then further by CYP450 enzymes (minimal). Valsartan is primarily eliminated unchanged via bile and feces, with minimal hepatic metabolism (CYP2C9).
Excretion	Primarily renal (70-80% as unchanged drug); biliary/fecal (15-20%); hepatic metabolism accounts for <10% of total clearance.
Half-life	Terminal elimination half-life is approximately 24 hours (range 20-30 hours) in healthy adults; prolonged in renal impairment (up to 40-50 hours in severe impairment, CrCl <30 mL/min).
Protein binding	98-99% bound, primarily to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	0.15-0.25 L/kg, indicating distribution primarily in extracellular fluid; not extensively tissue-bound.
Bioavailability	Oral: 85-90% (high, due to minimal first-pass metabolism).
Onset of Action	Oral: 1-2 hours; IV: Immediate (within minutes).
Duration of Action	Oral dosing: 24 hours (supports once-daily dosing); IV: 12-24 hours depending on dose. Duration extends with renal impairment.

Classification & Brands

Dosing & administration

100 mg orally once daily with or without food.

Dosage form	TABLET
Renal impairment	GFR ≥ 60 mL/min: no adjustment. GFR 30-59 mL/min: reduce dose to 50 mg once daily. GFR 15-29 mL/min: 50 mg every other day. GFR < 15 mL/min or dialysis: not recommended.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce dose to 50 mg once daily. Child-Pugh C: not recommended.
Pediatric use	Not established in patients < 18 years of age.
Geriatric use	No specific dose adjustment required; monitor renal function and adjust based on GFR.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for SOAANZ (SOAANZ).

Breastfeeding	No human data; M/P ratio unknown. Drug is excreted in animal milk. Avoid breastfeeding due to potential for infant toxicity.
Teratogenic Risk	First trimester: Increased risk of neural tube defects and cardiac malformations. Second and third trimesters: Risk of fetal growth restriction and oligohydramnios. No human studies; based on animal data showing teratogenicity.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

FETAL TOXICITY: Drugs acting directly on the renin-angiotensin system (RAS) can cause fetal harm and death. Discontinue SOAANZ as soon as possible once pregnancy is detected.