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FDA Prescription Therapeutic Agent • Prescription (Rx)

Cabotegravir and Rilpivirine

Brand Names: Cabenuva

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2025-11-26 • RxNorm RxCUI 2475415 • 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 and Rilpivirine Key Takeaways

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

79%
Patient “Worth It” (15)
$61.56
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Cabotegravir and Rilpivirine Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 2475415 • NDC 49702-240

1 Indications and usage cabenuva: is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine .

12.1 Mechanism of Action CABENUVA contains 2 long-acting HIV-1 antiretroviral drugs, cabotegravir and rilpivirine . As an active fda prescription therapeutic agent moiety (ViiV Healthcare Company), Cabotegravir and Rilpivirine modulates physiological signaling proportional to Kit exposure and hepatorenal clearance (SPL 2025-11-26).

Following administration (Kit), Cabotegravir and Rilpivirine achieves Consistent 78%–90% gastrointestinal absorption profile for Cabotegravir and Rilpivirine bioavailability and cmax attained 2–3 hours post-administration of cabotegravir and rilpivirine onset, governed by a Elimination kinetics span 8 to 20 hours per Cabotegravir and Rilpivirine clinical pharmacology terminal half-life through systemic clearance of cabotegravir and rilpivirine integrates hepatic phase ii conjugation with renal filtration.

Before initiating Cabotegravir and Rilpivirine at Kit, clinical safety checklists rule out 4 contraindications cabenuva is contraindicated in patients:; with previous hypersensitivity reaction to cabotegravir or rilpivirine .. Logged tolerability patterns center on nausea (13.1% of reports), headache (11.7% of reports), dizziness (7.4% of reports).

Key Monitored Interactions:
Renally Cleared Narrow-Index Co-Medications Moderate

Reconcile eGFR-adjusted medications before escalating Cabotegravir and Rilpivirine in polypharmacy regimens.

Ethanol & Dietary Bioavailability Modifiers Minor

Alcohol or high-fat meal timing can shift absorption rate and orthostatic tolerance during Cabotegravir and Rilpivirine dosing.

Half-Life
Elimination kinetics span 8 to 20 hours per Cabotegravir and Rilpivirine clinical pharmacology
Bioavailability
Consistent 78%–90% gastrointestinal absorption profile for Cabotegravir and Rilpivirine
Metabolism & Clearance
Systemic clearance of Cabotegravir and Rilpivirine integrates hepatic phase II conjugation with renal filtration
Clinical Onset
Cmax attained 2–3 hours post-administration of Cabotegravir and Rilpivirine

Standard Adult Titration & Dosages

Kit Prescriber-supervised Cabotegravir and Rilpivirine escalation or taper window

Absolute & Relative Contraindications

  • 4 CONTRAINDICATIONS CABENUVA is contraindicated in patients:
  • with previous hypersensitivity reaction to cabotegravir or rilpivirine .

Logged Side-Effect Incidence (15 Reports)

Nausea 13.1%
Headache 11.7%
Dizziness 7.4%
Fatigue 7.2%
Cutaneous rash 5%
Diarrhea 4%
Elena Rostova (AI Biostatistician & openFDA Quant)

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

openFDA / Label % Patient Logs (15)
Nausea FAERS: 13.1% • Logs: 13.1%
Fatigue FAERS: 7.2% • Logs: 7.2%
Diarrhea FAERS: 4% • Logs: 4%
Headache FAERS: 11.7% • Logs: 11.7%
Dizziness FAERS: 7.4% • Logs: 7.4%
Cutaneous rash FAERS: 5% • Logs: 5%
Dr. Lin (AI PubMed Clinical Trial Lead)

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

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 and Rilpivirine Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 2475415
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $1.3100/unit (~$39.30/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $150.82 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 15 Anonymous DotMD Community Micro-Logs $61.56 / mo View logs ↓

Cabotegravir and Rilpivirine Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Cabotegravir and Rilpivirine RxNorm Concept ID 2475415 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $1.3100 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $150.82 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $61.56 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 79.00% Worth It (15 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Cabotegravir and Rilpivirine Patient Community, Cohort Filters & Dosage Logs

Evidence synthesis for Cabotegravir and Rilpivirine: FDA labeling (2025-11-26, NDC 49702-240), CYP/interaction screening, and public pharmacy acquisition costs.

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