RIVIVE

Clinical safety rating: caution

Comprehensive clinical and safety monograph for RIVIVE (RIVIVE).

How it works

Selective serotonin reuptake inhibitor (SSRI). Increases extracellular levels of serotonin by inhibiting its reuptake into presynaptic neurons, enhancing serotonergic neurotransmission.

What the body does with it

Metabolism	Primarily metabolized by CYP2C19, CYP2D6, and CYP3A4 to an active metabolite, desmethylrivive. Also undergoes conjugation with glucuronic acid.
Excretion	RIVIVE is primarily eliminated via hepatic metabolism, with approximately 70% of the dose excreted in feces as metabolites and 30% in urine as unchanged drug and metabolites. Renal excretion of unchanged drug accounts for less than 5%.
Half-life	The terminal elimination half-life is approximately 24-30 hours in healthy adults, allowing for once-daily dosing. In patients with hepatic impairment, half-life may be prolonged, requiring dose adjustment.
Protein binding	RIVIVE is highly protein bound (>99%) primarily to albumin, with minor binding to alpha-1-acid glycoprotein. This extensive binding limits free drug concentration and distribution.
Volume of Distribution	The volume of distribution is approximately 0.2 L/kg, indicating limited extravascular distribution, consistent with high protein binding and low tissue penetration.
Bioavailability	Oral bioavailability is approximately 90%, indicating good absorption from the gastrointestinal tract with minimal first-pass metabolism. Food may slightly reduce the rate of absorption but does not significantly affect overall bioavailability.
Onset of Action	After oral administration, clinical effect (e.g., reduction in pain or inflammation) is typically observed within 1-2 hours. Peak plasma concentrations are achieved at 2-4 hours.
Duration of Action	Duration of action is approximately 12-24 hours, supporting once-daily dosing. Steady-state concentrations are reached within 5-7 days.

Classification & Brands

Dosing & administration

Intravenous infusion of 500 mg over 60 minutes every 12 hours for 14 days.

Dosage form	SPRAY, METERED
Renal impairment	If GFR 30-89 mL/min: no adjustment. If GFR <30 mL/min: use with caution; data insufficient for dosing recommendation.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B or C: not recommended due to lack of safety data.
Pediatric use	Not established for patients <18 years.
Geriatric use	No specific dose adjustment required for elderly; monitor renal function and hydration status.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for RIVIVE (RIVIVE).

Breastfeeding	RIVIVE is excreted in human milk; M/P ratio approximately 1.2. Potential for serious adverse reactions in nursing infants, including sedation and respiratory depression. Breastfeeding is not recommended during treatment and for 5 days after last dose.
Teratogenic Risk	RIVIVE is contraindicated in pregnancy due to demonstrated teratogenicity in animal studies and limited human data. First trimester exposure is associated with major congenital malformations including neural tube defects and cardiovascular anomalies. Second and third trimester exposure may cause fetal growth restriction and oligohydramnios. Effective contraception must be used during treatment.

Warnings & precautions

■ FDA Black Box Warning

Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults aged 18-24 during initial treatment. Monitor closely for clinical worsening, suicidality, or unusual changes in behavior.

Side Effect Profile

Serious Effects

Absolute Contraindications

Concurrent use with MAOIs or within 14 days of MAOI therapy, concurrent use with pimozide or thioridazine, hypersensitivity to rivive or any excipients.

Clinical Precautions

Precautions

Serotonin syndrome, risk of bleeding (especially with NSAIDs or anticoagulants), activation of mania/hypomania, hyponatremia, bone fracture risk, discontinuation syndrome upon abrupt withdrawal, angle-closure glaucoma risk, sexual dysfunction.

Clinical Tips & Counseling

Drug interactions

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RIVIVE

Clinical safety rating: caution

Comprehensive clinical and safety monograph for RIVIVE (RIVIVE).

How it works

Selective serotonin reuptake inhibitor (SSRI). Increases extracellular levels of serotonin by inhibiting its reuptake into presynaptic neurons, enhancing serotonergic neurotransmission.

What the body does with it

Metabolism	Primarily metabolized by CYP2C19, CYP2D6, and CYP3A4 to an active metabolite, desmethylrivive. Also undergoes conjugation with glucuronic acid.
Excretion	RIVIVE is primarily eliminated via hepatic metabolism, with approximately 70% of the dose excreted in feces as metabolites and 30% in urine as unchanged drug and metabolites. Renal excretion of unchanged drug accounts for less than 5%.
Half-life	The terminal elimination half-life is approximately 24-30 hours in healthy adults, allowing for once-daily dosing. In patients with hepatic impairment, half-life may be prolonged, requiring dose adjustment.
Protein binding	RIVIVE is highly protein bound (>99%) primarily to albumin, with minor binding to alpha-1-acid glycoprotein. This extensive binding limits free drug concentration and distribution.
Volume of Distribution	The volume of distribution is approximately 0.2 L/kg, indicating limited extravascular distribution, consistent with high protein binding and low tissue penetration.
Bioavailability	Oral bioavailability is approximately 90%, indicating good absorption from the gastrointestinal tract with minimal first-pass metabolism. Food may slightly reduce the rate of absorption but does not significantly affect overall bioavailability.
Onset of Action	After oral administration, clinical effect (e.g., reduction in pain or inflammation) is typically observed within 1-2 hours. Peak plasma concentrations are achieved at 2-4 hours.
Duration of Action	Duration of action is approximately 12-24 hours, supporting once-daily dosing. Steady-state concentrations are reached within 5-7 days.

Classification & Brands

Dosing & administration

Intravenous infusion of 500 mg over 60 minutes every 12 hours for 14 days.

Dosage form	SPRAY, METERED
Renal impairment	If GFR 30-89 mL/min: no adjustment. If GFR <30 mL/min: use with caution; data insufficient for dosing recommendation.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B or C: not recommended due to lack of safety data.
Pediatric use	Not established for patients <18 years.
Geriatric use	No specific dose adjustment required for elderly; monitor renal function and hydration status.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for RIVIVE (RIVIVE).

Breastfeeding	RIVIVE is excreted in human milk; M/P ratio approximately 1.2. Potential for serious adverse reactions in nursing infants, including sedation and respiratory depression. Breastfeeding is not recommended during treatment and for 5 days after last dose.
Teratogenic Risk	RIVIVE is contraindicated in pregnancy due to demonstrated teratogenicity in animal studies and limited human data. First trimester exposure is associated with major congenital malformations including neural tube defects and cardiovascular anomalies. Second and third trimester exposure may cause fetal growth restriction and oligohydramnios. Effective contraception must be used during treatment.

Warnings & precautions

■ FDA Black Box Warning

Side Effect Profile

Serious Effects

Absolute Contraindications

Concurrent use with MAOIs or within 14 days of MAOI therapy, concurrent use with pimozide or thioridazine, hypersensitivity to rivive or any excipients.