Comprehensive Product Description: Crixivan (Indinavir Sulfate)

Crixivan (Indinavir) is an antiretroviral medicine used as part of combination therapy to treat HIV infection. It belongs to the class of protease inhibitors, which block HIV replication by inhibiting the HIV protease enzyme.

Crixivan Capsules
(Indinavir Sulfate)

Indinavir Sulfate

Other Common Names:
Indinavir

Indinavir sulfate capsules

HIV protease inhibitor

IDV (abbreviated name in antiretroviral therapy)

Generic Crixivan (available in some regions)
Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: HIV Protease Inhibitor

ATC Code: J05AE02

Prescription Schedule: S4 – Prescription Only (Australia and international markets)

Crixivan (Indinavir) inhibits the HIV-1 and HIV-2 protease enzyme, which is essential for the virus to produce mature, infectious particles. By blocking this enzyme, Crixivan interferes with viral replication and reduces the amount of HIV in the blood (viral load). It is always used in combination with other antiretroviral medications to delay disease progression and enhance efficacy.

Treatment of HIV-1 infection in adults and adolescents (≥12 years)

Part of Highly Active Antiretroviral Therapy (HAART)

May be used in post-exposure prophylaxis (PEP) in combination therapy

Reduces risk of HIV-related complications and progression to AIDS

Form: Oral capsules
Strengths Available: 200 mg and 400 mg

800 mg every 8 hours (three times daily)

Must be taken on an empty stomach or with a light, low-fat meal

Maintain adequate hydration (1.5 L daily) to reduce risk of kidney stones

Paediatric Use: Limited safety and efficacy data in children <12 years

Co-Administration: Often used in combination with nucleoside reverse transcriptase inhibitors (NRTIs) or non-nucleoside reverse transcriptase inhibitors (NNRTIs)

Route: Oral administration

Duration: Lifelong as per treatment response and physician direction

Monitoring: Regular viral load, CD4 counts, liver and kidney function tests

Contraindications:
Hypersensitivity to indinavir or formulation excipients

Concurrent use with medications highly dependent on CYP3A4 for clearance (e.g., midazolam, triazolam)

Severe hepatic impairment

Warnings and Precautions:
Nephrolithiasis (kidney stones) – ensure high fluid intake

Risk of hyperbilirubinemia and lipodystrophy

May cause immune reconstitution syndrome

Use with caution in hepatic insufficiency

Monitor blood glucose (rare risk of hyperglycaemia)
Common (>10%):
Nausea

Diarrhoea

Abdominal pain

Metallic taste

Headache

Less Common (1–10%):
Kidney stones

Back pain

Hyperbilirubinemia (elevated bilirubin levels)

Fat redistribution (lipodystrophy)

Serious (Rare):
Hemolytic anaemia

Hepatotoxicity

Immune reconstitution inflammatory syndrome

Allergic reactions (rash, fever, angioedema)

Indinavir is metabolised by CYP3A4. Drug interactions may occur with:

Contraindicated Combinations:

Rifampicin – drastically lowers indinavir levels

Midazolam, triazolam, cisapride – risk of life-threatening reactions

St. John’s Wort – reduces effectiveness

Caution With:

Ketoconazole, itraconazole – may increase indinavir levels

Warfarin – INR monitoring recommended

Statins (lovastatin, simvastatin) – risk of myopathy/rhabdomyolysis

Other antiretrovirals – dose adjustments may be required

Clinical Studies & Efficacy:
ACTG 320 Trial: Crixivan combined with zidovudine and lamivudine showed significant reductions in viral load and progression to AIDS/death compared to dual therapy.

Multiple Phase III trials confirm the reduction in HIV RNA to undetectable levels (<50 copies/mL) in a majority of compliant patients on HAART including indinavir.

Crixivan has shown superior early viral suppression compared to some older regimens in treatment-naïve patients.

Frequently Asked Questions (FAQs)
Q: Can Crixivan cure HIV?
A: No. Crixivan controls HIV replication but is not a cure. It is part of lifelong antiretroviral therapy.

Q: Should I take Crixivan with food?
A: It should be taken on an empty stomach or with a light, low-fat meal. High-fat meals reduce its absorption.

Q: How much water should I drink with Crixivan?
A: At least 1.5 litres of fluid per day to prevent kidney stones.

Q: Can I take Crixivan during pregnancy?
A: It should be used during pregnancy only if clearly needed. Consult your healthcare provider.

Q: What should I do if I miss a dose?
A: Take it as soon as possible, but if it's close to your next dose, skip the missed one. Never double-dose.

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