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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.

Brand name Cabenuva
Rx
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 9, 2026
🧬 Where this information comes from

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 →

✓No current FDA shortage listed · checked Oct 9, 2026
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Cabenuva pairs two long-acting HIV medicines, cabotegravir (blocks integrase, the enzyme HIV uses to insert itself into your cells) and rilpivirine (blocks the enzyme it uses to copy itself), given as clinic injections monthly or every two months. It is a switch option for adults and teens already undetectable on daily treatment, not a starting regimen. Most people tolerate it well, and the usual complaint is soreness, swelling or redness where the shots go in, sometimes with fever or tiredness. Never miss or delay an appointment, and never stop without promptly starting another HIV regimen. The drugs fade slowly over many months, and during that tail the virus can rebound and become resistant.

Clinical pearls

  • Tell every prescriber and pharmacist about these shots, because the drugs can linger a year or longer after your last one.
  • Avoid St. John’s Wort, TB drugs like rifampin, and seizure medicines like carbamazepine or phenytoin, which drain drug levels dangerously low.
  • More than a single dose of the steroid dexamethasone is also off-limits, since it lowers rilpivirine levels.
  • Trouble breathing, sweating, agitation or feeling faint shortly after the shots is a known reaction, so tell clinic staff right away.
How we write & review this content — our editorial policy →
How you get itPrescription only
FDA label last updatedNov 26, 2025
FDA’s strongest warning (boxed)None on the label

Patient Information Guide A plain-language walkthrough of Cabotegravir and Rilpivirine Injections, written from its FDA label.

What Cabotegravir and Rilpivirine Injections Is Used For

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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 Cabotegravir and Rilpivirine Injections Works

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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.

Cabotegravir and Rilpivirine Injections Dosage

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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.

Dosing details from the FDA-approved label

From the Cabotegravir and Rilpivirine Injections prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • Refer to full prescribing information for detailed information on dosage and administration recommendations. ( 2 ) • Prior to initiating treatment with CABENUVA, oral lead-in dosing may be considered to assess the tolerability of cabotegravir and rilpivirine with the recommended dosage used for approximately 1 month. ( 2.3 ) • For gluteal intramuscular injection only. ( 2.4 , 2.5 , 2.9 ) • Recommended Monthly Dosing Schedule: Initiate injections of CABENUVA (600 mg of cabotegravir and 900 mg of rilpivirine) on the last day of current antiretroviral therapy or oral lead-in and continue with injections of CABENUVA (400 mg of cabotegravir and 600 mg of rilpivirine) every month thereafter. ( 2.4 ) • Recommended Every-2-Month Dosing Schedule: Initiate injections of CABENUVA (600 mg of cabotegravir and 900 mg of rilpivirine) on the last day of current antiretroviral therapy or oral lead-in for 2 consecutive months and continue with injections of CABENUVA every 2 months thereafter. ( 2.5 ) 2.1 Dosage and Administration Overview • CABENUVA contains cabotegravir extended-release injectable suspension in a single-dose vial and rilpivirine extended-release injectable suspension in a single-dose vial [see Dosage Forms and Strengths ( 3 )] . • CABENUVA must be administered by a healthcare provider by gluteal intramuscular injection [see Dosage and Administration ( 2.9 )] . • CABENUVA may be initiated with oral cabotegravir and oral rilpivirine prior to the intramuscular injections or the patient may proceed directly to injection of CABENUVA without an oral lead-in [see Dosage and Administration ( 2.3 )] . • CABENUVA can be injected monthly or every 2 months [see Dosage and Administration ( 2.4 , 2.5 )] . Healthcare providers should discuss these 2 dosing options with the patient prior to starting CABENUVA and decide which injection dosing frequency would be the most appropriate option for the patient [see Adverse Reactions ( 6.1 ), Microbiology ( 12.4 ), Clinical Studies ( 14.1 )] .

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Cabotegravir and Rilpivirine Injections Side Effects

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The most commonly reported side effects in clinical trials include:

Common side effects

  • Injection site reactions (pain, swelling, or redness where the shot was given)
  • Fever
  • Fatigue or tiredness
  • Headache
  • Musculoskeletal (muscle or joint) pain
  • Nausea
  • Sleep problems
  • Dizziness or rash

When to get medical help

  • Signs of a severe allergic reaction: skin blistering, peeling, fever, mouth sores, eye irritation, or swelling — stop treatment and get emergency help immediately
  • Post-injection reactions such as trouble breathing, agitation, sweating, or low blood pressure shortly after the shot — tell clinic staff right away
  • Liver problems: yellowing of the skin or eyes, dark urine, stomach pain, or unusual tiredness — contact your doctor
  • Depressive symptoms, low mood, or thoughts of self-harm — seek prompt mental health evaluation
  • Signs of treatment failure: if you suspect the virus is rebounding, contact your provider as soon as possible so an alternative regimen can be started quickly

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.

Cabotegravir and Rilpivirine Injections Warnings and Precautions

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  • 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.

Cabotegravir and Rilpivirine Injections Interactions

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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

Interactions listed in the FDA-approved label

From the Cabotegravir and Rilpivirine Injections prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

7 DRUG INTERACTIONS. Refer to the full prescribing information for important drug interactions with CABENUVA.

Read the label’s full interactions text

7 DRUG INTERACTIONS • Refer to the full prescribing information for important drug interactions with CABENUVA. ( 4 , 5.5 , 7 ) • Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended. ( 7.1 ) • Drugs that induce uridine diphosphate glucuronosyltransferase (UGT)1A1 or cytochrome P450 (CYP)3A4 may decrease the plasma concentrations of the components of CABENUVA. ( 4 , 7.3 , 7.4 ) • CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes. ( 7.3 , 7.4 ) 7.1 Concomitant Use with Other Antiretroviral Medicines Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended [see Indications and Usage ( 1 )] . 7.2 Use of Other Antiretroviral Drugs after Discontinuation of CABENUVA Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). These residual concentrations are not expected to affect the exposures of antiretroviral drugs that are initiated after discontinuation of CABENUVA [see Warnings and Precautions ( 5.6 ), Drug Interactions ( 7.4 ), Clinical Pharmacology ( 12.3 )] . 7.3 Potential for Other Drugs to Affect CABENUVA Refer to the prescribing information for VOCABRIA (cabotegravir) and EDURANT (rilpivirine) for additional drug interaction information related to oral cabotegravir and oral rilpivirine, respectively. Cabotegravir Cabotegravir is primarily metabolized by UGT1A1 with some contribution from UGT1A9. Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease cabotegravir plasma concentrations and may result in loss of virologic response; therefore, coadministration of CABENUVA with these drugs is contraindicated [see Contraindications ( 4 )] . Rilpivirine Rilpivirine is primarily metabolized by CYP3A.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿134 supplements and herbs with documented Cabotegravir and Rilpivirine Injections interactions, ranked by severity Check Cabotegravir and Rilpivirine Injections against a supplement or herb →

Before Taking Cabotegravir and Rilpivirine Injections

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  • 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)

Cabotegravir and Rilpivirine Injections Overdose

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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.

What Cabotegravir and Rilpivirine Injections Does in the Body

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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.

How Your Body Processes Cabotegravir and Rilpivirine Injections

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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 Cabotegravir and Rilpivirine Injections

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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 the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

134

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.

Severity mix
  • Major · 7
  • Moderate · 98
  • Minor · 29
AMERICAN HELLEBORE Major ARSENIC Major CESIUM Major EPHEDRA Major GRAPEFRUIT Major SIDA CORDIFOLIA Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate +126 more
Every supplement checked against Cabotegravir and Rilpivirine Injections — ranked by severity The full interaction hub: 7 major · 98 moderate · 29 minor · every one linked to its full report. Check Cabotegravir and Rilpivirine Injections against your exact supplements

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.

Cabotegravir and Rilpivirine Injections: Pharmacist Answers to Common Questions

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?

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That's actually the big advantage here — CABENUVA was designed specifically so you don't have to take a pill every single day. The two medicines are formulated to release slowly from the injection site over weeks, so one set of shots a month (or even every two months) keeps the virus suppressed. For many people, that's a big quality-of-life improvement. The trade-off is that you have to come into the clinic for each injection — you can't do this one at home.

What happens if I miss or delay an injection appointment?

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Missing an injection is a real concern with CABENUVA. If you go too long between doses, drug levels in your blood can drop low enough that the virus might start to rebound — and it could develop resistance to these medicines. That's why your prescriber will talk with you seriously about your ability to keep appointments before starting. If you know you'll miss one, call your provider as early as possible so they can figure out the safest plan.

I've heard these drugs stay in my body a long time after stopping. Is that a problem?

▾
Yes, and it's important to understand. Both cabotegravir and rilpivirine can linger in your system for up to 12 months or even longer after your last injection. At those low lingering levels, they can't fully suppress the virus on their own — which means if you stop CABENUVA without immediately starting a different effective HIV regimen, the virus could replicate in the presence of low drug levels and develop resistance. Your provider will make sure you have a transition plan in place if you ever need to stop.

Are there any supplements or common medicines I need to avoid?

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Yes — a few are actually contraindicated, meaning you cannot take them with CABENUVA at all. St. John's Wort (a common herbal supplement) is one of them, along with certain seizure medications and some antibiotics used for TB. These can dramatically lower the levels of CABENUVA in your blood, which could cause the treatment to stop working. Always tell every provider — including your dentist or any specialist — that you are on CABENUVA, and check before starting any new medicine or supplement.

What should I watch for right after getting the injections?

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Injection site reactions — soreness, swelling, or redness where the shot was given — are the most common complaint, and they're usually mild and temporary. You'll stay at the clinic briefly after your injection so staff can watch for a more serious post-injection reaction, which can include symptoms like shortness of breath, sweating, or a sudden drop in blood pressure. These are rare but serious, so it's good that you're monitored on-site. Fever, headache, and fatigue in the days after an injection are also fairly common.

Can I use CABENUVA if I'm pregnant or thinking about getting pregnant?

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This is something to discuss very carefully with your provider. There isn't enough human data yet to fully assess the risks of CABENUVA during pregnancy. One important thing to know: because the drugs stay in your body for up to 12 months or longer after stopping, a future pregnancy could still involve fetal exposure even after you've had your last injection. Drug levels of rilpivirine also tend to be lower during pregnancy than afterward, which could affect how well it works. Your provider will weigh all of this with you to find the safest approach.

Is Cabotegravir and Rilpivirine Injections available over the counter?

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No. Cabotegravir and Rilpivirine Injections is a prescription medicine: every Cabotegravir and Rilpivirine Injections product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More About Cabotegravir and Rilpivirine Injections on HelloPharmacist

📊Cabotegravir and Rilpivirine Injections supplement interactions134 checked — ranked by severity 🌿Drug & Supplement CheckerCabotegravir and Rilpivirine Injections vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Cabotegravir and Rilpivirine Injections NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed Data & References for Cabotegravir and Rilpivirine Injections Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Cabotegravir and Rilpivirine Injections on the U.S. Market: Products, Makers and Brands

How Cabotegravir and Rilpivirine Injections 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.

The FDA lists Cabotegravir and Rilpivirine Injections products. Brand names on the directory include Cabenuva; the rest are generics.

Cabotegravir and Rilpivirine Injections 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.

The FDA’s enforcement reports list no Cabotegravir and Rilpivirine Injections recalls since July 2021.

✅No Cabotegravir and Rilpivirine Injections recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 2026.

Cabotegravir and Rilpivirine Injections Brand Names

Cabotegravir and Rilpivirine Injections is sold under one brand name in the FDA directory — Cabenuva. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Cabenuva

Cabotegravir and Rilpivirine Injections Drug Class (RxNorm)

Cabotegravir and Rilpivirine Injections belongs to the Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor class.

Pharmacologic class Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Drug family (ATC) Non-nucleoside reverse transcriptase inhibitors
How it works Non-Nucleoside Reverse Transcriptase Inhibitors

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.

Sources for This Cabotegravir and Rilpivirine Injections 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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 26, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Cabotegravir and Rilpivirine Injections.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Cabotegravir and Rilpivirine Injections after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Linked representative label ⓘ
ViiV Healthcare Company
Linked label effective
Nov 26, 2025
Composite sections available
22
Linked SPL Set ID
1698baf3-f895-4c42-a1b1-e9ee3f20da36
Linked SPL Document ID
15253b2a-c96c-489c-be6d-b37fcb63ad5b
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. ViiV Healthcare Company is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →