Indinavir

CRIXIVAN

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Pronunciation: in-DI-na-veer (KRIK-si-van)

Indinavir ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Indinavir ballicule

What it isHIV protease inhibitor; HIV.

Why this oneEarly potent protease inhibitor central to the first effective combination therapy.

What limits itNephrolithiasis requires high fluid intake, and dosing is three times daily on an empty stomach. Largely obsolete.

Indinavir molecular structure (skeletal formula) — Molecular structure: Indinavir

Indinavir prescription history

Animated chart of estimated U.S. prescriptions per year, HIV antiretrovirals (1987–2026). Indinavir enters in 1996 (estimated).

FDA-approved for

HIV infection (1996)

Principal riskNephrolithiasis; three-times-daily fasting dosing

Classes and tags

Clinical profile

Therapeutic safety burden2 / 4

Overdose danger2 / 4

Weight-gain liability1 / 4

Sedation liability1 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryC

Defining liabilityNephrolithiasis and major CYP3A interactions

FDA label

Read the full label on DailyMed ↗

NO BOXED WARNINGS

FDA dosing	Population	Start	Target	Max
HIV-1 infection	Adults	800 mg q8h	800 mg q8h

Renal Undefined

Hepatic Mild-to-moderate insufficiency due to cirrhosis: reduce to 600 mg q8h; severe not studied

Must be taken at 8-hour intervals; interrupt 1–3 days for nephrolithiasis/urolithiasis

Instructions

Take without food, with water, 1 h before or 2 h after a meal (or with a light low-fat meal/other liquids)
Drink at least 1.5 L of fluids per 24 h to maintain hydration
Separate from didanosine by ≥1 h on an empty stomach

Available strengths

cap 400 mg

Contraindications

Coadministration with drugs whose CYP3A4-mediated metabolism indinavir inhibits, causing elevated levels with potentially serious or life-threatening reactions: alfuzosin; amiodarone; ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine); cisapride; lovastatin, simvastatin; pimozide; sildenafil for pulmonary arterial hypertension (Revatio); oral midazolam; triazolam; alprazolam

Cautions

Nephrolithiasis/urolithiasis — maintain hydration
Asymptomatic hyperbilirubinemia (indirect)
Hepatitis/hepatic failure
New-onset or worsening diabetes, hyperglycemia
Hemolytic anemia
Fat redistribution
Increased spontaneous bleeding in hemophilia

Adverse reactions

Nephrolithiasis/urolithiasis (flank pain, hematuria)
Asymptomatic hyperbilirubinemia
Nausea
Abdominal pain
Vomiting
Headache
Diarrhea

Pregnancy Optimal dosing not established; markedly reduced plasma levels during pregnancy

Lactation Undefined

Cost

Indinavir (CRIXIVAN)

Strength		#/mo	generic $/unit	CostPlus
400 mg	cap	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Indinavir is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

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Self-check

Why is high fluid intake needed with indinavir?
Nephrolithiasis risk.
How is indinavir dosed relative to meals?
Three times daily on an empty stomach.