VOLNEA

Clinical safety rating: caution

Comprehensive clinical and safety monograph for VOLNEA (VOLNEA).

How it works

Volnea is a combination of dienogest and ethinylestradiol. Dienogest is a progestin with antiandrogenic activity, and ethinylestradiol is an estrogen. The contraceptive effect is achieved through suppression of gonadotropins (FSH and LH), inhibition of ovulation, and changes in cervical mucus and endometrium.

What the body does with it

Metabolism	Dienogest is metabolized primarily via CYP3A4. Ethinylestradiol is metabolized via CYP3A4 and undergoes conjugation (glucuronidation and sulfation).
Excretion	Renal: 70% unchanged; fecal: 30% (biliary elimination)
Half-life	Terminal half-life: 12 hours (range 10-14 h). Supports twice-daily dosing in patients with normal renal function.
Protein binding	97% bound to albumin
Volume of Distribution	0.6 L/kg (reflects distribution into total body water and some tissue binding)
Bioavailability	Oral: 80% (range 75-85%); rectal: 70%
Onset of Action	Oral: 1-2 hours; Intravenous: 5-10 minutes
Duration of Action	12-24 hours; clinical effect persists for dosing interval with steady-state achieved after 3-5 days.

Classification & Brands

Dosing & administration

One tablet (0.02 mg ethinylestradiol + 3 mg drospirenone) orally once daily for 21 consecutive days, followed by a 7-day hormone-free interval.

Dosage form	TABLET
Renal impairment	Contraindicated in patients with severe renal insufficiency (CrCl <30 mL/min). For mild to moderate impairment (CrCl 30–80 mL/min), no dose adjustment required; monitor serum potassium closely.
Liver impairment	Contraindicated in severe hepatic disease (Child-Pugh class C). For mild to moderate impairment (Child-Pugh A or B), no dose adjustment, but use with caution and monitor liver function.
Pediatric use	Not indicated for use in postmenarcheal girls <18 years; however, postmenarcheal adolescents may be dosed as adults if deemed medically appropriate based on bone density and growth considerations.
Geriatric use	Not indicated for use after menopause. In postmenopausal women, alternative hormonal therapies or non-hormonal contraceptives are recommended.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for VOLNEA (VOLNEA).

Breastfeeding	Not recommended during breastfeeding. M/P ratio not established. Drug may be excreted in human milk; potential for serious adverse reactions in nursing infants. Discontinue nursing or discontinue drug, taking into account importance of drug to mother.
Teratogenic Risk	Pregnancy Category X. Contraindicated in pregnancy due to risk of fetal harm. First trimester: associated with congenital malformations including cardiac and CNS defects. Second and third trimesters: risk of fetal hypotension, renal impairment, and oligohydramnios; may cause neonatal complications such as respiratory distress, feeding difficulties, and hypothermia.

Warnings & precautions

■ FDA Black Box Warning

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, especially in women over 35 years, and with the number of cigarettes smoked. Women who use COCs should be strongly advised not to smoke.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Thrombophlebitis or thromboembolic disorders","Cerebrovascular or coronary artery disease","Known or suspected breast cancer","Endometrial cancer or other estrogen-dependent neoplasia","Undiagnosed abnormal genital bleeding","Cholestatic jaundice of pregnancy or jaundice with prior pill use","Hepatic adenomas or carcinomas","Known or suspected pregnancy","Hypersensitivity to any component of Volnea","Current or history of migraine with focal aura","Major surgery with prolonged immobilization","Diabetes with vascular involvement","Uncontrolled hypertension"]

Clinical Precautions

Precautions

["Thrombotic disorders (DVT, PE, stroke, MI)","Cigarette smoking","Hypertension","Gallbladder disease","Metabolic effects (glucose intolerance, dyslipidemia)","Headache (including migraine)","Irregular bleeding","Liver disease","Depression","Hereditary angioedema","Chloasma"]

Clinical Tips & Counseling

Drug interactions

Loading safety data…

VOLNEA

Clinical safety rating: caution

Comprehensive clinical and safety monograph for VOLNEA (VOLNEA).

How it works

What the body does with it

Metabolism	Dienogest is metabolized primarily via CYP3A4. Ethinylestradiol is metabolized via CYP3A4 and undergoes conjugation (glucuronidation and sulfation).
Excretion	Renal: 70% unchanged; fecal: 30% (biliary elimination)
Half-life	Terminal half-life: 12 hours (range 10-14 h). Supports twice-daily dosing in patients with normal renal function.
Protein binding	97% bound to albumin
Volume of Distribution	0.6 L/kg (reflects distribution into total body water and some tissue binding)
Bioavailability	Oral: 80% (range 75-85%); rectal: 70%
Onset of Action	Oral: 1-2 hours; Intravenous: 5-10 minutes
Duration of Action	12-24 hours; clinical effect persists for dosing interval with steady-state achieved after 3-5 days.

Classification & Brands

Dosing & administration

One tablet (0.02 mg ethinylestradiol + 3 mg drospirenone) orally once daily for 21 consecutive days, followed by a 7-day hormone-free interval.

Dosage form	TABLET
Renal impairment	Contraindicated in patients with severe renal insufficiency (CrCl <30 mL/min). For mild to moderate impairment (CrCl 30–80 mL/min), no dose adjustment required; monitor serum potassium closely.
Liver impairment	Contraindicated in severe hepatic disease (Child-Pugh class C). For mild to moderate impairment (Child-Pugh A or B), no dose adjustment, but use with caution and monitor liver function.
Pediatric use	Not indicated for use in postmenarcheal girls <18 years; however, postmenarcheal adolescents may be dosed as adults if deemed medically appropriate based on bone density and growth considerations.
Geriatric use	Not indicated for use after menopause. In postmenopausal women, alternative hormonal therapies or non-hormonal contraceptives are recommended.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for VOLNEA (VOLNEA).

Breastfeeding	Not recommended during breastfeeding. M/P ratio not established. Drug may be excreted in human milk; potential for serious adverse reactions in nursing infants. Discontinue nursing or discontinue drug, taking into account importance of drug to mother.
Teratogenic Risk	Pregnancy Category X. Contraindicated in pregnancy due to risk of fetal harm. First trimester: associated with congenital malformations including cardiac and CNS defects. Second and third trimesters: risk of fetal hypotension, renal impairment, and oligohydramnios; may cause neonatal complications such as respiratory distress, feeding difficulties, and hypothermia.