Cabotegravir / Rilpivirine
Cabotegravir and rilpivirine are two HIV-1 antiretroviral medicines combined in CABENUVA, a long-acting injectable regimen used to treat HIV-1 infection in adults and adolescents who are already virologically suppressed on their current therapy.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Cabotegravir / Rilpivirine: Patient Information Guide
A plain-language walkthrough of Cabotegravir / Rilpivirine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Cabotegravir / Rilpivirine is used for
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CABENUVA (cabotegravir + rilpivirine) is a complete two-drug injectable regimen for HIV-1 infection.
- CABENUVA is indicated for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older who weigh at least 35 kg, to replace their current antiretroviral regimen when they are virologically suppressed (HIV-1 is undetectable) with no history of treatment failure and no known resistance to cabotegravir or rilpivirine.
How Cabotegravir / Rilpivirine works
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CABENUVA combines two antiretroviral drugs that each block a different step in HIV's replication cycle. Cabotegravir is an integrase strand transfer inhibitor — it blocks the integrase enzyme that HIV needs to splice its DNA into the DNA of your cells. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) — it binds to and disables the reverse transcriptase enzyme, which the virus needs to convert its genetic material into a form it can copy. By attacking two steps at once, the combination keeps viral replication suppressed.
Both drugs are formulated as extended-release injectable suspensions, meaning they dissolve slowly from the injection site over weeks, maintaining effective blood levels between monthly or every-two-month doses.
How Cabotegravir / Rilpivirine is taken (dosage)
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CABENUVA is given only by a healthcare provider as two separate injections into the buttock muscle (one for cabotegravir, one for rilpivirine) at the same visit. Before starting, an optional oral lead-in of about one month with cabotegravir and rilpivirine tablets — taken once daily with a meal — may be used to check tolerability. Injections can then be scheduled monthly or every two months; your prescriber will help determine which schedule is right for you.
- Injections may be given up to 7 days early or late if you cannot make your scheduled visit — always contact your clinic as soon as possible if you miss an appointment.
- If you stop CABENUVA, a new HIV regimen must be started promptly — within 1 month (monthly schedule) or 2 months (every-2-month schedule) — because drug levels stay in your body long after the last injection.
Cabotegravir / Rilpivirine side effects in detail
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The most common side effects reported with CABENUVA include:
- Injection site reactions (pain, swelling, warmth, or redness)
- Fever
- Fatigue
- Headache
- Muscle or joint pain
- Nausea
- Sleep disturbances
- Dizziness and rash
Serious reactions to watch for include severe allergic reactions (rash with fever, blisters, or trouble breathing), post-injection reactions occurring within minutes of the shot (shortness of breath, chest pain, dizziness), liver inflammation, and significant depressive symptoms — seek medical attention immediately for any of these.
Cabotegravir / Rilpivirine warnings and precautions
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- Severe allergic reactions: Both cabotegravir and rilpivirine can cause life-threatening hypersensitivity reactions, including Stevens-Johnson syndrome (cabotegravir) and DRESS syndrome (rilpivirine). Stop CABENUVA immediately and seek emergency care if you develop a severe rash, mouth sores, blistering, swollen face, fever, or difficulty breathing.
- Post-injection reactions: Serious reactions — including shortness of breath, chest pain, dizziness, and changes in blood pressure — have been reported within minutes of a rilpivirine injection. You will be monitored after each injection.
- Long-acting drug tail: Cabotegravir and rilpivirine remain in your body for up to 12 months or longer after the last injection. If you stop CABENUVA, a full HIV regimen must be started quickly to prevent viral rebound and resistance.
- Liver toxicity: Liver problems have been reported; liver tests should be monitored during treatment.
- Depressive disorders: Depressive symptoms, including serious mood changes, have been reported. Contact your doctor promptly if you notice changes in mood or have thoughts of self-harm.
- Risk of resistance from missed doses: Missing injection visits can allow the virus to rebound and become resistant to cabotegravir, rilpivirine, or related drug classes. Staying on schedule is essential.
Cabotegravir / Rilpivirine interactions: what it interacts with
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CABENUVA interacts with several medicines that can change how well it works or increase the risk of side effects:
- Anti-seizure drugs (carbamazepine, oxcarbazepine, phenobarbital, phenytoin): Lower cabotegravir and rilpivirine levels — use is contraindicated.
- TB medicines (rifampin, rifapentine, rifabutin): Lower drug levels significantly — use is contraindicated.
- Systemic dexamethasone (more than a single dose): Lowers rilpivirine levels — contraindicated.
- St. John's Wort: This herbal supplement lowers rilpivirine levels and is contraindicated.
- Certain antibiotics (clarithromycin, erythromycin): Raise rilpivirine levels and can increase the risk of a dangerous heart rhythm problem; alternatives should be considered when possible.
- Methadone: CABENUVA may reduce methadone levels; clinical monitoring is recommended for patients on methadone maintenance therapy.
- Other HIV antiretroviral medicines: Not recommended to combine — CABENUVA is already a complete regimen.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
Before taking Cabotegravir / Rilpivirine
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- Previous allergic reaction: CABENUVA is contraindicated if you have ever had a serious allergic reaction to cabotegravir or rilpivirine.
- All current medicines and supplements: Tell your prescriber about everything you take, including herbal products like St. John's Wort, anti-seizure drugs, TB medicines, and steroids.
- Pregnancy: Data are limited; rilpivirine levels may be lower during pregnancy, which could affect HIV control. Both drugs can stay in the body for 12 months or longer after the last injection, so fetal exposure is possible even after stopping. Discuss risks and benefits with your prescriber. A pregnancy registry is available (Antiretroviral Pregnancy Registry, 1-800-258-4263).
- Breastfeeding: Rilpivirine is present in human breast milk; cabotegravir may also be present. Potential risks include HIV transmission to an HIV-negative infant and adverse effects similar to those seen in adults. Discuss with your doctor.
- Children under 12 or weighing less than 35 kg: Safety and effectiveness have not been established in this group.
- Older adults (65+): Limited data available; use with careful monitoring.
- Liver disease: Mild-to-moderate liver impairment does not significantly affect drug levels, but severe liver impairment has not been adequately studied.
- Kidney disease: Mild kidney impairment has no significant effect on drug levels; data are limited for moderate-to-severe kidney disease.
Cabotegravir / Rilpivirine overdose: if you take too much
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There is no specific antidote for an overdose of cabotegravir or rilpivirine. If an overdose occurs, medical staff will provide supportive care, monitor vital signs, and watch for heart rhythm changes (QT interval monitoring on an ECG). Because both drugs are highly bound to proteins in the blood, dialysis is unlikely to remove them effectively. The long-acting nature of CABENUVA means that after an injection overdose, the drugs remain in the body for an extended period, which must be factored into any treatment plan.
Pharmacodynamics: what Cabotegravir / Rilpivirine does in the body
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At recommended doses, neither cabotegravir nor rilpivirine prolongs the QT interval (a measure of heart rhythm) to a clinically meaningful degree. However, at much higher doses, rilpivirine has shown a dose-dependent effect on the QT interval — this is why CABENUVA should be used carefully alongside other medicines known to affect heart rhythm. Both drugs work to suppress HIV-1 replication, and maintaining adequate drug levels between injections is critical to keeping the virus undetectable.
Pharmacokinetics: how your body processes Cabotegravir / Rilpivirine
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After an intramuscular injection into the buttock, cabotegravir and rilpivirine are released slowly from the injection site — cabotegravir reaching peak blood levels in about 7 days, and rilpivirine in 3 to 4 days. Both drugs are highly bound to proteins in the blood (over 99%) and are broken down mainly in the liver — cabotegravir through UGT1A1 enzymes and rilpivirine through CYP3A enzymes. Their elimination half-lives (the time for blood levels to fall by half) are long: roughly 5.6 to 11.5 weeks for cabotegravir and 13 to 28 weeks for rilpivirine, meaning detectable drug levels can remain in the body for up to 12 months or longer after the last injection. This prolonged presence is why starting a new HIV regimen promptly after stopping CABENUVA is so important.
How to store Cabotegravir / Rilpivirine
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Store CABENUVA in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton until ready to use. Do not freeze. refrigerator.
📄 Written from Cabotegravir / Rilpivirine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Cabotegravir / Rilpivirine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Cabotegravir / Rilpivirine — the kind of thing our pharmacy team would talk through with you at the counter.
Why do I still need injections if my HIV is already undetectable?
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What happens if I miss an injection appointment?
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Will I feel anything right after the injection?
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If I decide to stop CABENUVA, can I just stop?
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Are there medicines or supplements I need to avoid while on CABENUVA?
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Is CABENUVA safe to use if I'm pregnant or thinking about becoming pregnant?
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Is Cabotegravir / Rilpivirine available over the counter?
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When was Cabotegravir / Rilpivirine first available?
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Who makes Cabotegravir / Rilpivirine?
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💬 Answers drafted from Cabotegravir / Rilpivirine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Cabotegravir / Rilpivirine on HelloPharmacist
📊 Cabotegravir / Rilpivirine on the U.S. market: products, makers and brands
How Cabotegravir / Rilpivirine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Kit (7) · Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Cabotegravir / Rilpivirine is used (Medicaid data)
A general measure of how commonly Cabotegravir / Rilpivirine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Cabotegravir / Rilpivirine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Cabotegravir / Rilpivirine prescribed? Of the 1,599 medications we measure, Cabotegravir / Rilpivirine ranks #610 by Medicaid prescriptions — more than 62% of them.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Cabotegravir / Rilpivirine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 4 listed Cabotegravir / Rilpivirine NDCs with Medicaid activity.
🔍 Compare Cabotegravir / Rilpivirine products
A representative set of FDA-listed product records for Cabotegravir / Rilpivirine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|
| 💊Kits | |||
| — | ViiV Healthcare Company × 7 listings | NDA | View NDC → |
| 💊Bulk drug substance | |||
| 300 mg/300 mg | Synergy Health AST, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 8 of 8 products — FDA National Drug Code Directory. See every product, package size and price: browse all 8 Cabotegravir / Rilpivirine NDCs →
📈 Cabotegravir / Rilpivirine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Cabotegravir / Rilpivirine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Cabotegravir / Rilpivirine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Cabotegravir / Rilpivirine FDA approval history
How Cabotegravir / Rilpivirine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Cabotegravir / Rilpivirine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Cabotegravir / Rilpivirine supply and shortage status
Whether Cabotegravir / Rilpivirine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Cabotegravir / Rilpivirine brand names
🏭 Who makes Cabotegravir / Rilpivirine: manufacturers and labelers
🔬 Sources for this Cabotegravir / Rilpivirine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. ViiV Healthcare Company is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.