Sacubitril+Valsartan

DRUG INFORMATION

  ADULT
    - The recommended starting dosage for adults is 49 mg/51 mg orally twice daily.
      Source: US FDA label for sacubitril (ENTRESTO), section 'dosage and
      administration', retrieved 2026-08-29
    - The target maintenance dose is 97 mg/103mg orally twice daily.
      Source: US FDA label for sacubitril (ENTRESTO), section 'dosage and
      administration', retrieved 2026-08-29
    - If switching from an ACE inhibitor to ENTRESTO allow a washout period of 36 hours
      between administration of the two drugs [see Contraindications (4) and Drug
      Interactions (7.1)] . 2.2 Adult Heart Failure The recommended starting dose of
      ENTRESTO is 49/51 mg orally twice-daily.
      Source: US FDA label for sacubitril (ENTRESTO), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of ENTRESTO have been established for the treatment
      of heart failure in pediatric patients 1 year to less than 18 years. Use of
      ENTRESTO was evaluated in a multinational, randomized, double-blind trial
      comparing ENTRESTO and enalapril in 375 patients aged 1 month to less than 18
      years (ENTRESTO n = 187; Enalapril n = 188) (PANORAMA-HF) [see Clinical Studies
      (14.2)] .
      Source: US FDA label for sacubitril (ENTRESTO), section 'pediatric use', retrieved
      2026-08-29
    - The recommended starting dosage for adults is 49 mg/51 mg orally twice daily. The
      target maintenance dose is 97 mg/103mg orally twice daily. ( 2.2 ) Adjust adult
      doses every 2 to 4 weeks to the target maintenance dose, as tolerated by the
      patient. ( 2.2 ) For pediatric patients, see the Full Prescribing Information for
      recommended dosage, titrations, preparation and administration instructions.
      Source: US FDA label for sacubitril (ENTRESTO), section 'dosage and
      administration', retrieved 2026-08-29
    - Exposure at the No-Observed-Adverse-Effect-Level (NOAEL) of 100 mg/kg/day was
      approximately 0.5-fold the AUC exposure to LBQ657 at the 3.1 mg/kg twice daily
      dose of ENTRESTO.
      Source: US FDA label for sacubitril (ENTRESTO), section 'pediatric use', retrieved
      2026-08-29

  RENAL IMPAIRMENT
    - ( 2.6 ) patients with severe renal impairment.
      Source: US FDA label for sacubitril (ENTRESTO), section 'dosage and
      administration', retrieved 2026-08-29
    - Note: Initiate pediatric patients weighing 40 to 50 kg who meet this criterion at
      0.8 mg/kg twice daily using the oral suspension or oral pellets [see Dosage and
      Administration (2.3, 2.4, 2.5)] . 2.7 Dose Adjustment for Severe Renal Impairment
      In adults and pediatric patients with severe renal impairment estimated glomerular
      filtration rate (eGFR less than 30 mL/min/1.73 m 2 ), start ENTRESTO at half the
      usually recommended starting dose.
      Source: US FDA label for sacubitril (ENTRESTO), section 'dosage and
      administration', retrieved 2026-08-29
    - No starting dose adjustment is needed for mild or moderate renal impairment. 2.8
      Dose Adjustment for Hepatic Impairment In adults and pediatric patients with
      moderate hepatic impairment (Child-Pugh B classification), start ENTRESTO at half
      the usually recommended starting dose.
      Source: US FDA label for sacubitril (ENTRESTO), section 'dosage and
      administration', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - ( 2.7 ) patients with moderate hepatic impairment.
      Source: US FDA label for sacubitril (ENTRESTO), section 'dosage and
      administration', retrieved 2026-08-29
    - No starting dose adjustment is needed for mild or moderate renal impairment. 2.8
      Dose Adjustment for Hepatic Impairment In adults and pediatric patients with
      moderate hepatic impairment (Child-Pugh B classification), start ENTRESTO at half
      the usually recommended starting dose.
      Source: US FDA label for sacubitril (ENTRESTO), section 'dosage and
      administration', retrieved 2026-08-29
    - No starting dose adjustment is needed for mild hepatic impairment.
      Source: US FDA label for sacubitril (ENTRESTO), section 'dosage and
      administration', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary ENTRESTO can cause fetal harm when administered to a pregnant woman.
      Source: US FDA label for sacubitril (ENTRESTO), section 'pregnancy', retrieved
      2026-08-29
    - Use of drugs that act on the renin-angiotensin system during the second and third
      trimesters of pregnancy reduces fetal renal function and increases fetal and
      neonatal morbidity and death ( see Clinical Considerations ).
      Source: US FDA label for sacubitril (ENTRESTO), section 'pregnancy', retrieved
      2026-08-29
    - Most epidemiologic studies examining fetal abnormalities after exposure to
      antihypertensive use in the first trimester have not distinguished drugs affecting
      the renin-angiotensin system from other antihypertensive agents.
      Source: US FDA label for sacubitril (ENTRESTO), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Lactation: Breastfeeding not recommended.
      Source: US FDA label for sacubitril (ENTRESTO), section 'use in specific
      populations', retrieved 2026-08-29
    - Pre- and postnatal development studies in rats at sacubitril doses up to 750
      mg/kg/day (2.2-fold the MRHD on the basis of LBQ657 AUC) and valsartan at doses up
      to 600 mg/kg/day (0.86-fold the MRHD on the basis of AUC) indicate that treatment
      with ENTRESTO during organogenesis, gestation and lactation may affect pup
      development and survival.
      Source: US FDA label for sacubitril (ENTRESTO), section 'use in specific
      populations', retrieved 2026-08-29
    - Because of the potential for serious adverse reactions in breastfed infants from
      exposure to sacubitril/valsartan, advise a nursing woman that breastfeeding is not
      recommended during treatment with ENTRESTO.
      Source: US FDA label for sacubitril (ENTRESTO), section 'use in specific
      populations', retrieved 2026-08-29