HEMADY

Clinical safety rating: caution

Comprehensive clinical and safety monograph for HEMADY (HEMADY).

How it works

HEMADY is a phytonadione (vitamin K1) formulation that promotes hepatic synthesis of clotting factors II, VII, IX, and X, reversing anticoagulation by inhibiting vitamin K epoxide reductase.

What the body does with it

Metabolism	Primarily hepatic via CYP4F2-mediated oxidation; undergoes rapid metabolic degradation with minimal renal excretion.
Excretion	Primarily renal excretion of unchanged drug (70-80%), with 20-30% metabolized and excreted as inactive metabolites in urine; less than 5% eliminated in feces via biliary secretion.
Half-life	Terminal elimination half-life is 1.2-2 hours in healthy adults; clinically relevant as it requires frequent dosing (every 4-6 hours) for sustained effect.
Protein binding	Plasma protein binding: 80-85%, primarily to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	Volume of distribution: 1.5-3.0 L/kg (adults); indicates extensive tissue distribution but limited CNS penetration.
Bioavailability	Oral bioavailability: 60-80% (first-pass effect); intramuscular: 80-95%; intravenous: 100%.
Onset of Action	Intravenous: within 2-5 minutes; oral: 30-60 minutes; intramuscular: 10-15 minutes.
Duration of Action	Intravenous: 2-4 hours; oral: 4-6 hours; clinical duration is dose-dependent and correlates with analgesic/therapeutic effect.

Classification & Brands

Dosing & administration

Adult: 5 mg orally twice daily.

Dosage form	TABLET
Renal impairment	GFR 30-89 mL/min: no adjustment; GFR 15-29 mL/min: 5 mg once daily; GFR <15 mL/min: not recommended.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: 5 mg once daily; Child-Pugh C: not recommended.
Pediatric use	Children ≥12 years: 5 mg orally twice daily; <12 years: not established.
Geriatric use	No specific dose adjustment; monitor renal function and consider reduced starting dose due to age-related decline.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for HEMADY (HEMADY).

Breastfeeding	Contraindicated during breastfeeding. Not known if excreted in human milk; potential for serious adverse reactions in nursing infants. M/P ratio not available.
Teratogenic Risk	FDA Pregnancy Category X. First trimester: high risk of major malformations, including craniofacial defects, neural tube defects, and cardiovascular anomalies. Second and third trimesters: increased risk of spontaneous abortion, intrauterine growth restriction, and fetal death. Avoid use in pregnancy.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

HEMADY injection may cause severe anaphylactoid reactions, including respiratory arrest and cardiac arrest, particularly with intravenous administration. Intravenous use should be reserved for serious or life-threatening bleeding unresponsive to other routes. Resuscitative equipment and trained personnel must be immediately available.

Side Effect Profile

Serious Effects

Absolute Contraindications

History of severe allergic reaction to phytonadione or any component of HEMADY; contraindicated in the treatment of warfarin overdose in patients with prosthetic heart valves due to risk of thromboembolism (relative contraindication).

Clinical Precautions

Precautions

Risk of anaphylactoid reactions with IV administration; monitoring of INR and clinical signs of bleeding or thrombosis required; not effective for reversal of heparin, dabigatran, or factor Xa inhibitors; caution in patients with hepatic disease or glucose-6-phosphate dehydrogenase deficiency.

Clinical Tips & Counseling

Drug interactions

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HEMADY

Clinical safety rating: caution

Comprehensive clinical and safety monograph for HEMADY (HEMADY).

How it works

HEMADY is a phytonadione (vitamin K1) formulation that promotes hepatic synthesis of clotting factors II, VII, IX, and X, reversing anticoagulation by inhibiting vitamin K epoxide reductase.

What the body does with it

Metabolism	Primarily hepatic via CYP4F2-mediated oxidation; undergoes rapid metabolic degradation with minimal renal excretion.
Excretion	Primarily renal excretion of unchanged drug (70-80%), with 20-30% metabolized and excreted as inactive metabolites in urine; less than 5% eliminated in feces via biliary secretion.
Half-life	Terminal elimination half-life is 1.2-2 hours in healthy adults; clinically relevant as it requires frequent dosing (every 4-6 hours) for sustained effect.
Protein binding	Plasma protein binding: 80-85%, primarily to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	Volume of distribution: 1.5-3.0 L/kg (adults); indicates extensive tissue distribution but limited CNS penetration.
Bioavailability	Oral bioavailability: 60-80% (first-pass effect); intramuscular: 80-95%; intravenous: 100%.
Onset of Action	Intravenous: within 2-5 minutes; oral: 30-60 minutes; intramuscular: 10-15 minutes.
Duration of Action	Intravenous: 2-4 hours; oral: 4-6 hours; clinical duration is dose-dependent and correlates with analgesic/therapeutic effect.

Classification & Brands

Dosing & administration

Adult: 5 mg orally twice daily.

Dosage form	TABLET
Renal impairment	GFR 30-89 mL/min: no adjustment; GFR 15-29 mL/min: 5 mg once daily; GFR <15 mL/min: not recommended.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: 5 mg once daily; Child-Pugh C: not recommended.
Pediatric use	Children ≥12 years: 5 mg orally twice daily; <12 years: not established.
Geriatric use	No specific dose adjustment; monitor renal function and consider reduced starting dose due to age-related decline.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for HEMADY (HEMADY).

Breastfeeding	Contraindicated during breastfeeding. Not known if excreted in human milk; potential for serious adverse reactions in nursing infants. M/P ratio not available.
Teratogenic Risk	FDA Pregnancy Category X. First trimester: high risk of major malformations, including craniofacial defects, neural tube defects, and cardiovascular anomalies. Second and third trimesters: increased risk of spontaneous abortion, intrauterine growth restriction, and fetal death. Avoid use in pregnancy.
Fetal Monitoring