Apretude Injectable Suspension

Apretude (cabotegravir injectable suspension) is a long-acting antiretroviral used for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents. Each vial contains 200 mg/mL of cabotegravir in a 3 mL formulation, delivering a total of 600 mg per injection.

Benefits

• Reduces the risk of sexually acquired HIV-1 infection
• Long-acting formulation with injections every 2 months
• Improves adherence compared to daily oral PrEP
• Suitable for both adults and adolescents (≥35 kg)
• Reduces the burden of daily medication and enhances privacy

Dosage

• Optional oral lead-in: Cabotegravir 30 mg tablet daily for 28 days to assess tolerability
• Initiation phase: 600 mg (3 mL) intramuscular injection at month 1 and month 2
• Maintenance phase: 600 mg (3 mL) intramuscular injection every 2 months thereafter
• Injection should be administered into the gluteal muscle by a healthcare professional
• If injection is missed, consult a healthcare provider promptly for bridging options

Warnings and Precautions

• Only for individuals confirmed HIV-negative; HIV test required prior to each injection
• Do not use in patients with existing HIV infection—risk of drug-resistant virus
• May cause injection site reactions, including pain, redness, or induration
• Use caution in patients with liver disease or hepatitis B/C
• May interact with enzyme-inducing medications (e.g. rifampin, phenytoin)
• Long half-life—missed doses may reduce efficacy and require alternative PrEP strategies

Usage Instructions

• Administered by a healthcare professional via intramuscular injection
• Do not self-administer
• Maintain scheduled appointments—adherence to injection timeline is essential
• Oral tablets may be used to start or resume treatment if necessary
• Continue routine HIV testing as advised

Storage Information

• Store in original packaging in a refrigerator between 2°C and 8°C (36°F and 46°F)
• May be kept at room temperature (up to 25°C or 77°F) for up to 30 days before use
• Do not freeze
• Protect from light
• Keep out of reach of children

Common Side Effects

• Pain, swelling, or hardness at injection site
• Headache
• Fever, fatigue, or muscle aches
• Nausea or gastrointestinal upset
• Dizziness
• More serious side effects may include liver enzyme elevation or allergic reactions