FOVANE

Clinical safety rating: caution

Comprehensive clinical and safety monograph for FOVANE (FOVANE).

How it works

Selective serotonin reuptake inhibitor (SSRI); potentiates serotonergic activity by inhibiting reuptake of serotonin at the synaptic cleft.

What the body does with it

Metabolism	Extensively metabolized in the liver via CYP2D6, CYP2C9, CYP2C19, and CYP3A4; active metabolite norfluoxetine.
Excretion	Renal: 60% unchanged; fecal: 30% (as metabolites); biliary: 10%.
Half-life	Terminal half-life: 12-15 hours; clinical context: supports twice-daily dosing, steady-state achieved by day 3.
Protein binding	92% bound to albumin and α1-acid glycoprotein.
Volume of Distribution	Vd: 1.2-1.8 L/kg; clinical meaning: extensive tissue distribution, > total body water.
Bioavailability	Oral: 65% (with first-pass effect); IM: 85%; rectal: 50%.
Onset of Action	Oral: 30-60 minutes; IV: 5-10 minutes; IM: 15-30 minutes.
Duration of Action	Oral: 8-12 hours; IV: 6-8 hours; clinical notes: duration may extend in hepatic impairment.

Classification & Brands

Dosing & administration

Adults: 10 mg orally twice daily.

Dosage form	TABLET
Renal impairment	GFR 30-89 mL/min: No adjustment. GFR 15-29 mL/min: Reduce to 5 mg twice daily. GFR <15 mL/min: Not recommended.
Liver impairment	Child-Pugh A: No adjustment. Child-Pugh B: Reduce dose to 5 mg twice daily. Child-Pugh C: Contraindicated.
Pediatric use	Not approved for pediatric use.
Geriatric use	Initiate at 5 mg twice daily; increase based on tolerability.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for FOVANE (FOVANE).

Breastfeeding	FOVANE is excreted in human breast milk; M/P ratio not established. Likely to suppress lactation due to dopamine agonist action. Discontinue breastfeeding or avoid use; use only if essential.
Teratogenic Risk	FOVANE is a dopamine agonist. In first trimester, there is increased risk of congenital malformations (cardiac, neural tube) based on animal studies; human data limited. Second and third trimesters: risk of premature labor and placental abruption at high doses. FOVANE is contraindicated in pregnancy unless benefit outweighs risk.

Warnings & precautions

■ FDA Black Box Warning

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders.

Side Effect Profile

Serious Effects

Absolute Contraindications

Concurrent use with MAOIs or within 14 days of MAOI therapy; known hypersensitivity to fluoxetine.

Clinical Precautions

Precautions	Serotonin syndrome with co-administration of other serotonergic agents; risk of bleeding with NSAIDs or anticoagulants; hyponatremia; activation of mania/hypomania; seizures; angle-closure glaucoma.
Food/Dietary	Avoid grapefruit and grapefruit juice as they increase fovaptan exposure. No other significant food interactions identified.

Clinical Tips & Counseling

Drug interactions

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FOVANE

Clinical safety rating: caution

Comprehensive clinical and safety monograph for FOVANE (FOVANE).

How it works

Selective serotonin reuptake inhibitor (SSRI); potentiates serotonergic activity by inhibiting reuptake of serotonin at the synaptic cleft.

What the body does with it

Metabolism	Extensively metabolized in the liver via CYP2D6, CYP2C9, CYP2C19, and CYP3A4; active metabolite norfluoxetine.
Excretion	Renal: 60% unchanged; fecal: 30% (as metabolites); biliary: 10%.
Half-life	Terminal half-life: 12-15 hours; clinical context: supports twice-daily dosing, steady-state achieved by day 3.
Protein binding	92% bound to albumin and α1-acid glycoprotein.
Volume of Distribution	Vd: 1.2-1.8 L/kg; clinical meaning: extensive tissue distribution, > total body water.
Bioavailability	Oral: 65% (with first-pass effect); IM: 85%; rectal: 50%.
Onset of Action	Oral: 30-60 minutes; IV: 5-10 minutes; IM: 15-30 minutes.
Duration of Action	Oral: 8-12 hours; IV: 6-8 hours; clinical notes: duration may extend in hepatic impairment.

Classification & Brands

Dosing & administration

Adults: 10 mg orally twice daily.

Dosage form	TABLET
Renal impairment	GFR 30-89 mL/min: No adjustment. GFR 15-29 mL/min: Reduce to 5 mg twice daily. GFR <15 mL/min: Not recommended.
Liver impairment	Child-Pugh A: No adjustment. Child-Pugh B: Reduce dose to 5 mg twice daily. Child-Pugh C: Contraindicated.
Pediatric use	Not approved for pediatric use.
Geriatric use	Initiate at 5 mg twice daily; increase based on tolerability.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for FOVANE (FOVANE).

Breastfeeding	FOVANE is excreted in human breast milk; M/P ratio not established. Likely to suppress lactation due to dopamine agonist action. Discontinue breastfeeding or avoid use; use only if essential.
Teratogenic Risk	FOVANE is a dopamine agonist. In first trimester, there is increased risk of congenital malformations (cardiac, neural tube) based on animal studies; human data limited. Second and third trimesters: risk of premature labor and placental abruption at high doses. FOVANE is contraindicated in pregnancy unless benefit outweighs risk.

Warnings & precautions

■ FDA Black Box Warning

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders.

Side Effect Profile

Serious Effects

Absolute Contraindications

Concurrent use with MAOIs or within 14 days of MAOI therapy; known hypersensitivity to fluoxetine.

Clinical Precautions

Precautions	Serotonin syndrome with co-administration of other serotonergic agents; risk of bleeding with NSAIDs or anticoagulants; hyponatremia; activation of mania/hypomania; seizures; angle-closure glaucoma.
Food/Dietary	Avoid grapefruit and grapefruit juice as they increase fovaptan exposure. No other significant food interactions identified.

Clinical Tips & Counseling

Drug interactions

Loading safety data…