Cabotegravir and Rilpivirine Injections
CABENUVA is a long-acting injectable HIV-1 treatment given once a month or every two months — replacing daily pills for adults and teens already controlling their virus.
🧬 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 and Rilpivirine Injections: Patient Information Guide
A plain-language walkthrough of Cabotegravir and Rilpivirine Injections — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
CABENUVA is used to treat HIV-1 infection as a complete, standalone regimen. It is not for people newly diagnosed or who have had treatment failures in the past.
- Adults and adolescents (age 12+, weight 35 kg or more) with HIV-1 infection
- People who are already virologically suppressed — meaning their HIV viral load is undetectable on a stable regimen
- People who have no known resistance to either cabotegravir or rilpivirine
- Used as a replacement for a current daily oral antiretroviral regimen
⚙️How it works▾
CABENUVA pairs two medicines that each block a different step HIV uses to copy itself. Cabotegravir blocks the integrase enzyme — without it, HIV can't weave its DNA into your cells' DNA. Rilpivirine blocks reverse transcriptase — without it, HIV can't convert its genetic blueprint into a form it can use to reproduce. Blocking two separate steps at once makes it very difficult for the virus to replicate.
Both drugs are formulated as extended-release injectable suspensions, meaning they release slowly from the injection site over weeks. This is what makes once-monthly or every-two-month dosing possible, and why drug levels persist in the body long after stopping.
💊How it's taken▾
CABENUVA is given as two separate gluteal (buttock) muscle injections by a healthcare provider — one injection of cabotegravir and one of rilpivirine at each visit. Before starting, your provider may prescribe oral versions of both medicines for about one month to make sure you tolerate them well.
- Monthly schedule: First injections on the last day of your current therapy or oral lead-in, then continued every month.
- Every-2-month schedule: First two injections one month apart, then continued every two months.
- You and your provider will decide together which schedule fits best. Missing or delaying injections raises the risk of the virus rebounding, so keeping appointments is essential.
🤒Side effects — in detail▾
The most commonly reported side effects in clinical trials include:
- Injection site reactions — pain, swelling, or redness at the shot site (the most frequent complaint)
- Fever
- Fatigue
- Headache
- Muscle or joint pain
- Nausea
- Sleep disturbances
- Dizziness and rash
More serious reactions — including severe skin reactions, liver problems, post-injection reactions (breathing difficulty, low blood pressure), and depressive disorders — require immediate medical attention. Don't wait to call your provider if something feels seriously wrong.
⚠️Warnings & precautions▾
- Long drug tail after stopping: Both medicines stay active in your bloodstream for up to 12 months or more after your last shot. If you discontinue CABENUVA for any reason, you must start a new effective HIV regimen promptly to avoid resistance developing during this period.
- Severe allergic reactions: Serious skin reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis) and a severe systemic reaction called DRESS have been reported. Seek emergency care immediately for blistering skin, mouth sores, high fever, or eye inflammation.
- Post-injection reactions: Serious reactions — including difficulty breathing, sweating, and changes in blood pressure — have occurred within minutes of the injection. You will be monitored after each dose.
- Liver toxicity: Liver enzyme levels should be checked regularly. Report jaundice (yellowing skin/eyes), dark urine, or unusual fatigue immediately.
- Depressive disorders: New or worsening depression, including thoughts of self-harm, has been reported. Contact your provider promptly for any mood changes.
🔀What it interacts with▾
Several medications can interfere with how CABENUVA works, and some combinations are outright contraindicated (must not be used together):
- Seizure medicines (carbamazepine, oxcarbazepine, phenobarbital, phenytoin) — lower drug levels, contraindicated
- Rifamycin antibiotics (rifampin, rifabutin, rifapentine) — dramatically lower drug levels, contraindicated
- Systemic dexamethasone (more than one dose) — lowers rilpivirine levels, contraindicated
- St. John's Wort (herbal supplement) — lowers drug levels, contraindicated
- Other HIV antiretrovirals — not recommended; CABENUVA is a complete regimen
- Drugs that can cause abnormal heart rhythms (Torsade de Pointes) — use with caution due to rilpivirine's effects on heart conduction at higher concentrations
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- You must already have an undetectable HIV viral load on a stable treatment before switching to CABENUVA
- Do not use if you have ever had a serious allergic reaction to cabotegravir or rilpivirine
- Do not use if you are taking any of the contraindicated medicines listed above — tell your provider about every medicine and supplement
- If you are pregnant or planning pregnancy, discuss the risks carefully — drug levels change during pregnancy and both medicines remain detectable in the body for up to 12 months or longer after stopping, meaning a fetus could be exposed
- If you have liver disease, liver function will need to be monitored closely
- If you have kidney disease, let your provider know — data are limited for moderate to severe kidney impairment
- CABENUVA is approved for adolescents 12 years and older who weigh at least 35 kg (about 77 lbs)
🚑If you take too much▾
There is no specific antidote for an overdose of cabotegravir or rilpivirine. Because both medicines are very strongly bound to proteins in the blood, dialysis is unlikely to remove them effectively. If an overdose is suspected, standard supportive care is provided, including monitoring of vital signs and heart rhythm (ECG).
Because of the long-acting nature of these injections, drug levels remain elevated for an extended period after each dose — this must be factored into any assessment of overdose or recovery.
📡Pharmacodynamics — effects in the body▾
At recommended doses, neither cabotegravir nor rilpivirine causes clinically meaningful changes to the heart's electrical conduction (specifically the QT interval, which relates to heart rhythm). However, rilpivirine at doses much higher than recommended has been shown to prolong the QT interval in a dose-dependent way — meaning the higher the dose, the greater the effect on heart rhythm. This is why CABENUVA should be used carefully with other medicines that affect heart conduction.
🔬Pharmacokinetics — how your body processes it▾
After injection into the buttock muscle, cabotegravir reaches peak blood levels in about 7 days, while rilpivirine peaks in 3 to 4 days. Both drugs release slowly from the injection site, giving them very long half-lives — roughly 5.6 to 11.5 weeks for cabotegravir and 13 to 28 weeks for rilpivirine — which is what allows monthly or every-two-month dosing.
Cabotegravir is mainly broken down by a liver enzyme called UGT1A1; rilpivirine is mainly broken down by CYP3A enzymes. Because both drugs are over 99% bound to proteins in the blood, they are unlikely to be removed by dialysis. Cabotegravir is eliminated primarily through metabolism, while rilpivirine is excreted mostly unchanged in the feces.
📦How to store it▾
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 and Rilpivirine Injections’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 →
Supplements & herbs that interact with Cabotegravir and Rilpivirine Injections
134 supplements and herbal products have documented interactions with Cabotegravir and Rilpivirine Injections in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 7
- Moderate · 98
- Minor · 29
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Cabotegravir and Rilpivirine Injections — the kind of thing our pharmacy team would talk through with you at the counter.
Why do I need injections every month instead of just taking a daily pill? ▾
What happens if I miss or delay an injection appointment? ▾
I've heard these drugs stay in my body a long time after stopping. Is that a problem? ▾
Are there any supplements or common medicines I need to avoid? ▾
What should I watch for right after getting the injections? ▾
Can I use CABENUVA if I'm pregnant or thinking about getting pregnant? ▾
Is Cabotegravir and Rilpivirine Injections available over the counter? ▾
💬 Answers drafted from Cabotegravir and Rilpivirine Injections’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 →
🧰 Keep exploring
📈 What people report — real-world data (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 and Rilpivirine Injections — 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 and Rilpivirine Injections 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.
🏛️ The road to your pharmacy
How Cabotegravir and Rilpivirine Injections went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
📦 Supply & shortage status
Whether Cabotegravir and Rilpivirine Injections 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.
🏷️ Sold under these brand names
RxNorm drug class
Cabotegravir and Rilpivirine Injections belongs to the Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
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.