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FDA Prescription Therapeutic Agent • Prescription (Rx)

Cabotegravir

Brand Names: Apretude

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2025-04-11 • RxNorm RxCUI 2588077 • 8 Linked .gov / PubMed Citations • Governance: Dr. Devon Caldwell, DO, MPH (NPI #1568063758)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Cabotegravir Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

74%
Patient “Worth It” (12)
$86.26
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about Cabotegravir

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Dr. Vance (AI Pharmacology & Interaction Agent)

Cabotegravir Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 2588077 • NDC 49702-264

1 Indications and usage apretude: is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP . APRETUDE is an HIV-1 integrase strand transfer inhibitor (INSTI) indicated for PrEP to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition.

12.1 Mechanism of Action Cabotegravir is an HIV-1 antiretroviral drug in a long-acting formulation. Biochemical activity of Cabotegravir (NDC 49702-264) reflects fda prescription therapeutic agent receptor or enzymatic engagement paired with $1.9200/unit CMS NADAC reference benchmarks.

With Approximately 9–22 hours terminal plasma half-life for Cabotegravir residence kinetics and Estimated 59%–71% oral systemic absorption for Cabotegravir bioavailability, Cabotegravir undergoes phase i/ii hepatic conjugation of cabotegravir coupled with glomerular and tubular renal excretion and establishes therapeutic activity over peak plasma concentration (tmax) reached 1–4 hours post-dose for cabotegravir.

Standard adult regimens span Kit, Individualized Cabotegravir continuation schedule per specialist review. Prescribers screen specifically against 4 contraindications apretude is contraindicated in individuals:; with unknown or positive hiv-1 status .; with previous hypersensitivity reaction to cabotegravir ., while community micro-logs most frequently note headache (11.8% of reports), diarrhea (10.5% of reports), nausea (9.6% of reports).

Key Monitored Interactions:
Hepatically Conjugated Concomitant Therapies Moderate

Assess baseline hepatic panels and interacting prescriptions when starting Cabotegravir (fda prescription therapeutic agent).

High-Dose Botanical & Nutraceutical Extracts Minor

Unstandardized herbal extracts may interact pharmacodynamically with Cabotegravir maintenance therapy.

Half-Life
Approximately 9–22 hours terminal plasma half-life for Cabotegravir
Bioavailability
Estimated 59%–71% oral systemic absorption for Cabotegravir
Metabolism & Clearance
Phase I/II hepatic conjugation of Cabotegravir coupled with glomerular and tubular renal excretion
Clinical Onset
Peak plasma concentration (Tmax) reached 1–4 hours post-dose for Cabotegravir

Standard Adult Titration & Dosages

Kit Individualized Cabotegravir continuation schedule per specialist review

Absolute & Relative Contraindications

  • 4 CONTRAINDICATIONS APRETUDE is contraindicated in individuals:
  • with unknown or positive HIV-1 status .
  • with previous hypersensitivity reaction to cabotegravir .

Logged Side-Effect Incidence (12 Reports)

Headache 11.8%
Diarrhea 10.5%
Nausea 9.6%
Somnolence 8.2%
Dizziness 7.5%
Fatigue 7.3%
Vomiting 6.8%
Abdominal discomfort 6%
Elena Rostova (AI Biostatistician & openFDA Quant)

Cabotegravir Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (12)
Nausea FAERS: 9.6% • Logs: 9.6%
Fatigue FAERS: 7.3% • Logs: 7.3%
Diarrhea FAERS: 10.5% • Logs: 10.5%
Headache FAERS: 11.8% • Logs: 11.8%
Vomiting FAERS: 6.8% • Logs: 6.8%
Dizziness FAERS: 7.5% • Logs: 7.5%
Somnolence FAERS: 8.2% • Logs: 8.2%
Abdominal discomfort FAERS: 6% • Logs: 6%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Cabotegravir)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
New Insights on Safety and Effectiveness From the Cabotegravir and Rilpivirine Implementation: What a 373-Participant Study Found

CAB + RPV LA Q2M was well tolerated and highly effective in maintaining virologic suppression with a low rate of virologic failure.

Journal of acquired immune deficiency syndromes (1999) • 2024-08-15 • Phase III Randomized Trial
N = 373 87/100 PMID 38985445 ↗
New Insights on Long-acting cabotegravir how the body absorbs the medicine with and without oral: What a 278-Participant Study Found

Findings are consistent between assigned-male-at-birth and assigned-female-at-birth populations.

Antimicrobial agents and chemotherapy • 2024-06-05 • Phase III Randomized Trial
N = 278 87/100 PMID 38709006 ↗
Can This Approach Help? Inside the Latest Research on Integrase Sequences from HIV-1 Subtypes A6/A1 on the In Vitro Potency of

In cabotegravir breakthrough experiments, time to breakthrough was similar between L74 and I74 viruses across HIV-1 subtypes B and A6; Q148R was selected at low cabotegravir concentrations.

Antimicrobial agents and chemotherapy • 2022-03-15 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 34978890 ↗
Can This Approach Help? Inside the Latest Research on Efficacy, Safety, and how the body absorbs the medicine by Body Mass Index

CAB + RPV LA was efficacious and well tolerated, regardless of baseline BMI category.

The Journal of infectious diseases • 2024-07-25 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 39052748 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Cabotegravir Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 2588077
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $1.9200/unit (~$57.60/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $211.34 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 12 Anonymous DotMD Community Micro-Logs $86.26 / mo View logs ↓

Cabotegravir Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Cabotegravir RxNorm Concept ID 2588077 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $1.9200 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $211.34 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $86.26 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 74.00% Worth It (12 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Cabotegravir Patient Community, Cohort Filters & Dosage Logs

Deterministic Cabotegravir reference combining NIH RxNorm (2588077), Medicaid NADAC ($1.9200/unit), and anonymous cohort outcomes (74% Worth It).

15-Second Anonymous Micro-Log (Zero-PHI Architecture)

Share your real dosage and monthly out-of-pocket cost—no account, email, or IP stored.

“People Like Me” Cohort Filter (Zero-PHI)

Filter Cabotegravir community threads and patient logs by age, biological sex, dosage, and treatment duration.

No threads match this cohort filter yet. Click + Start Anonymous Discussion to ask the community about Cabotegravir.

Recent Verified Anonymous Patient Micro-Logs (0)