Drug Guide
Cabotegravir Sodium
Classification
Therapeutic: Antiretroviral agent for HIV-1 infection
Pharmacological: Integrase strand transfer inhibitor (INSTI)
FDA Approved Indications
- Treatment of HIV-1 infection in adults and adolescents weighing at least 35 kg
Mechanism of Action
Cabotegravir inhibits HIV integrase enzyme, preventing viral DNA from integrating into the host DNA, thereby reducing viral replication.
Dosage and Administration
Adult: The recommended dose is 30 mg or 15 mg oral tablet once daily for lead-in period, followed by intramuscular injections of 600 mg or 400 mg every 8 weeks after the initial lead-in.
Pediatric: Safety and efficacy in pediatric patients have not been established.
Geriatric: No specific dosage adjustment recommended, but monitor closely due to potential comorbidities.
Renal Impairment: No dose adjustment necessary for mild or moderate impairment; data limited for severe impairment.
Hepatic Impairment: No specific adjustment recommended.
Pharmacokinetics
Absorption: Absorbed orally, steady-state achieved within 2 weeks with daily dosing.
Distribution: Widely distributed, high binding to plasma proteins.
Metabolism: Primarily hepatic via UGT1A1 and CYP3A4 pathways.
Excretion: Feces and urine, primarily as metabolites.
Half Life: Approximately 12-15 days, allowing for once every 8-week intramuscular dosing.
Contraindications
- Known hypersensitivity to cabotegravir or any component of the formulation.
Precautions
- Assess for medication allergies, hepatic impairment, and potential drug interactions. Consider baseline resistance testing before initiation. Use with caution in patients with a history of psychiatric disorders or substance abuse.
Adverse Reactions - Common
- Injection site reactions (pain, swelling, erythema) (Very common)
- Nausea (Common)
- Headache (Common)
Adverse Reactions - Serious
- Hypersensitivity reactions including rash, fever, and organ dysfunction (Rare)
- Elevated liver enzymes or hepatitis (Rare)
- Depressive symptoms, suicidality (Rare)
Drug-Drug Interactions
- Metformin (risk of increased metformin levels), concomitant medications impacting CYP3A4 or UGT1A1 enzymes.
Drug-Food Interactions
- None significant
Drug-Herb Interactions
- Potential interactions with herbal products affecting CYP3A4 or UGT1A1 pathways.
Nursing Implications
Assessment: Monitor for injection site reactions, adherence, and potential drug interactions. Baseline liver function tests and HIV viral load.
Diagnoses:
- Risk for non-adherence
- Risk of adverse drug reactions
Implementation: Administer IM injections as scheduled, counsel on injection site care, and assess for side effects.
Evaluation: Monitoring patient adherence, viral suppression, and adverse reactions.
Patient/Family Teaching
- Importance of adherence to dosing schedule.
- Report any allergic reactions or severe side effects.
- Seek medical advice before starting new medications.
- Keep appointments for injections.
- Use precautions to reduce injection site discomfort.
Special Considerations
Black Box Warnings:
- Potential for hypersensitivity reactions; implies need for vigilant monitoring.
Genetic Factors: Testing for resistance mutations may be considered.
Lab Test Interference: May affect or be affected by renal or hepatic function tests.
Overdose Management
Signs/Symptoms: Nausea, vomiting, dizziness, hypersensitivity symptoms.
Treatment: Supportive care. No specific antidote. Consider symptomatic treatment and monitoring.
Storage and Handling
Storage: Store at room temperature between 20°C to 25°C (68°F to 77°F).
Stability: Stable for at least 24 months when stored properly.