INZIRQO

Clinical safety rating: caution

Comprehensive clinical and safety monograph for INZIRQO (INZIRQO).

How it works

INZIRQO (avanafil) is a selective phosphodiesterase type 5 (PDE5) inhibitor. By inhibiting PDE5, it increases cyclic guanosine monophosphate (cGMP) levels in the corpus cavernosum, leading to smooth muscle relaxation and increased blood flow to the penis, facilitating erection. The effect is dependent on sexual stimulation.

What the body does with it

Metabolism	Primarily metabolized by CYP3A4 (major) and to a lesser extent by CYP2C9 and CYP2C19. The major metabolite is M4 (active), with other minor metabolites.
Excretion	Primarily renal excretion; approximately 79% of the dose recovered in urine (predominantly as intact drug) and 21% in feces.
Half-life	1.2 hours in healthy subjects (terminal elimination half-life).
Protein binding	Approximately 45–50%, primarily to albumin.
Volume of Distribution	0.34 L/kg; suggests distribution mainly in vascular space and extracellular fluid.
Bioavailability	Not applicable; administered only by intravenous infusion.
Onset of Action	Intravenous: Peak effect within 30 minutes post-infusion.
Duration of Action	6–8 hours based on pharmacodynamic response and sustained suppression of complement activity.

Classification & Brands

Dosing & administration

INZIRQO (olaparib) is administered orally at a dose of 300 mg twice daily, with or without food. Total daily dose: 600 mg.

Dosage form	FOR SUSPENSION
Renal impairment	For creatinine clearance (CrCl) 30-50 mL/min: reduce dose to 200 mg twice daily. For CrCl <30 mL/min: not recommended.
Liver impairment	Child-Pugh Class A: no adjustment. Child-Pugh Class B: reduce dose to 200 mg twice daily. Child-Pugh Class C: not recommended.
Pediatric use	Safety and efficacy not established in pediatric patients. No approved dosing guidelines.
Geriatric use	No specific dose adjustment required based on age alone. Monitor renal function and consider dose reduction if CrCl 30-50 mL/min as per renal adjustment.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for INZIRQO (INZIRQO).

Breastfeeding

It is unknown if INZIRQO is excreted in human breast milk. No M/P ratio available. Due to potential for serious adverse reactions in breastfed infant, advise women not to breastfeed during treatment and for at least 3 weeks after last dose.

Teratogenic Risk

INZIRQO (tirzepatide) is contraindicated in pregnancy due to risk of fetal harm. First trimester: potential teratogenic effects based on animal studies showing neural tube defects and skeletal abnormalities. Second and third trimesters: may cause fetal growth abnormalities and metabolic derangements. Human data limited; animal data indicate fetal exposure causes reduced fetal weight and increased skeletal variations.

Warnings & precautions

■ FDA Black Box Warning

No boxed warning.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Concomitant use with organic nitrates (any form) or riociguat.","Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) due to increased exposure."]

Clinical Precautions

Precautions

["Cardiovascular risk: Not recommended for patients with unstable angina, recent MI (within 6 months), uncontrolled hypertension, or NYHA Class II-IV heart failure.","Priapism: Advise patients to seek immediate medical attention if erection lasts >4 hours.","Vision loss: Non-arteritic anterior ischemic optic neuropathy (NAION) has been reported; discontinue if sudden vision loss occurs.","Hearing loss: Sudden decrease or loss of hearing has been reported; discontinue if occurs.","Concomitant use with alpha-blockers: Potential for hypotension; dose adjustments may be needed.","Alcohol: Avoid excessive alcohol intake (≥3 units) as it may increase risk of hypotension."]

Clinical Tips & Counseling

Drug interactions

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INZIRQO

Clinical safety rating: caution

Comprehensive clinical and safety monograph for INZIRQO (INZIRQO).

How it works

What the body does with it

Metabolism	Primarily metabolized by CYP3A4 (major) and to a lesser extent by CYP2C9 and CYP2C19. The major metabolite is M4 (active), with other minor metabolites.
Excretion	Primarily renal excretion; approximately 79% of the dose recovered in urine (predominantly as intact drug) and 21% in feces.
Half-life	1.2 hours in healthy subjects (terminal elimination half-life).
Protein binding	Approximately 45–50%, primarily to albumin.
Volume of Distribution	0.34 L/kg; suggests distribution mainly in vascular space and extracellular fluid.
Bioavailability	Not applicable; administered only by intravenous infusion.
Onset of Action	Intravenous: Peak effect within 30 minutes post-infusion.
Duration of Action	6–8 hours based on pharmacodynamic response and sustained suppression of complement activity.

Classification & Brands

Dosing & administration

INZIRQO (olaparib) is administered orally at a dose of 300 mg twice daily, with or without food. Total daily dose: 600 mg.

Dosage form	FOR SUSPENSION
Renal impairment	For creatinine clearance (CrCl) 30-50 mL/min: reduce dose to 200 mg twice daily. For CrCl <30 mL/min: not recommended.
Liver impairment	Child-Pugh Class A: no adjustment. Child-Pugh Class B: reduce dose to 200 mg twice daily. Child-Pugh Class C: not recommended.
Pediatric use	Safety and efficacy not established in pediatric patients. No approved dosing guidelines.
Geriatric use	No specific dose adjustment required based on age alone. Monitor renal function and consider dose reduction if CrCl 30-50 mL/min as per renal adjustment.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for INZIRQO (INZIRQO).

Breastfeeding

Teratogenic Risk

Warnings & precautions

■ FDA Black Box Warning

No boxed warning.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Concomitant use with organic nitrates (any form) or riociguat.","Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) due to increased exposure."]