Dolutegravir / Rilpivirine
Dolutegravir/rilpivirine is a two-drug antiretroviral combination used to treat HIV-1 infection in adults who are already virologically suppressed on a stable regimen.
🧬 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 →
📖 Dolutegravir / Rilpivirine: Patient Information Guide
A plain-language walkthrough of Dolutegravir / Rilpivirine — 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▾
Dolutegravir/rilpivirine is an antiretroviral combination approved for the treatment of HIV-1 infection in adults.
- Juluca (oral tablet) is indicated as a complete replacement regimen for adults with HIV-1 who are already virologically suppressed (HIV-1 RNA below 50 copies/mL) on a stable antiretroviral regimen for at least 6 months, with no history of treatment failure and no known substitutions associated with resistance to dolutegravir or rilpivirine.
- Juluca is a complete two-drug regimen — it should not be combined with additional HIV medications.
⚙️How it works▾
Juluca combines two antiretroviral drugs that each block a different step in HIV's replication process. Dolutegravir is an integrase strand transfer inhibitor (INSTI) — it blocks the integrase enzyme that HIV needs to embed its genetic code into the DNA of your cells. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) — it blocks the reverse transcriptase enzyme that HIV uses to convert its RNA into DNA in the first place. Blocking both steps at once makes it very difficult for the virus to reproduce.
Because these two drugs work at different points in HIV's life cycle, together they provide a complete suppressive regimen without the need for additional nucleoside backbone drugs.
💊How it's taken▾
Juluca is taken as one tablet by mouth once daily. It must always be taken with a meal — food significantly boosts absorption of both active ingredients, and taking it on an empty stomach can reduce drug levels enough to risk treatment failure. If you are also prescribed rifabutin, your prescriber will direct you to take an additional rilpivirine tablet with Juluca, also with a meal, for as long as you take rifabutin.
- Take it at the same time every day to keep drug levels steady.
- Do not skip meals when taking this medication.
- If you miss a dose, follow your prescriber's guidance — do not double up.
🤒Side effects — in detail▾
The most commonly reported side effects with Juluca include:
- Diarrhea
- Headache
- Nausea
- Depressive symptoms or low mood
- Psychiatric disorders (including anxiety and sleep disturbances)
More serious reactions — severe rash or skin peeling, signs of liver injury (yellow skin or eyes, dark urine, stomach pain), or worsening depression or thoughts of self-harm — require prompt medical attention. Do not wait to see if these improve on their own.
⚠️Warnings & precautions▾
- Severe allergic and skin reactions: Both dolutegravir and rilpivirine can cause serious hypersensitivity reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Stop Juluca immediately and seek care if you develop a severe rash, blistering, peeling, fever, swollen face, or trouble breathing. Delaying treatment after these symptoms begin can be life-threatening.
- Liver toxicity (hepatotoxicity): Liver problems have been reported with both components. People with underlying hepatitis B or C or elevated liver enzymes before starting treatment are at higher risk. Drug-induced acute liver failure has been reported with dolutegravir-containing products. Liver monitoring is recommended.
- Depressive disorders: Depression, low mood, negative thoughts, suicidal ideation, and suicide attempts have been reported. Tell your doctor right away if you experience severe or worsening depressive symptoms.
- Drug interactions causing treatment failure: Several common medications significantly lower rilpivirine blood levels, which can allow HIV to become resistant. Some drugs are strictly contraindicated; others require timing adjustments. Review all medications with your prescriber.
🔀What it interacts with▾
Juluca has clinically important interactions with many medications. Always tell your prescriber and pharmacist about everything you take.
- Proton pump inhibitors (PPIs) (e.g., omeprazole, esomeprazole, pantoprazole): contraindicated — raise stomach pH and drop rilpivirine levels, risking treatment failure.
- Certain seizure medications (carbamazepine, oxcarbazepine, phenobarbital, phenytoin): contraindicated — strongly lower levels of both dolutegravir and rilpivirine.
- Rifampin and rifapentine (tuberculosis antibiotics): contraindicated — dramatically reduce rilpivirine exposure.
- Rifabutin: can be used, but requires an extra rilpivirine dose — your prescriber will direct you.
- St. John's Wort: contraindicated — this herbal supplement lowers levels of both active ingredients.
- Dofetilide (heart rhythm medication): contraindicated — dolutegravir raises dofetilide to dangerous levels.
- Antacids: take Juluca at least 4 hours before or 6 hours after antacids.
- H2 blockers (e.g., famotidine): take Juluca at least 4 hours before or 12 hours after.
- Calcium/iron supplements and multivitamins: separate from Juluca by at least 4–6 hours, or take together with a meal.
- Metformin (diabetes drug): dolutegravir can raise metformin levels — review with your prescriber.
- Dalfampridine (MS drug): dolutegravir raises dalfampridine levels, increasing seizure risk.
- QT-prolonging drugs: consider alternatives to Juluca when combined with medications known to increase risk of a dangerous heart rhythm called Torsade de Pointes.
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▾
- Do not take Juluca if you have ever had a serious allergic reaction to dolutegravir or rilpivirine.
- Do not take Juluca with dofetilide, PPIs, rifampin, rifapentine, certain seizure medications, systemic dexamethasone (more than a single dose), or St. John's Wort.
- Tell your doctor if you have hepatitis B or C or any liver disease — you are at higher risk for liver complications and may need closer monitoring.
- Tell your doctor if you have a history of depression, mood disorders, or mental health conditions.
- If you are pregnant or planning to become pregnant: a pregnancy registry exists to monitor outcomes (call 1-800-258-4263). Discuss the risks and benefits with your provider — dolutegravir crosses the placenta and passes into breast milk.
- Breastfeeding is generally not recommended because of the risk of passing HIV to the infant and potential drug exposure through milk.
- Juluca has not been studied in children — safety and effectiveness in pediatric patients have not been established.
- Older adults should use Juluca with caution due to age-related decreases in liver, kidney, or heart function and the greater likelihood of other medications that may interact.
🚑If you take too much▾
There is no specific antidote for a Juluca overdose. If an overdose is suspected, standard supportive care should be provided, including monitoring of vital signs and heart rhythm (QT interval on an ECG). Because both dolutegravir and rilpivirine bind very strongly to proteins in the blood, dialysis (kidney filtering treatment) is unlikely to remove meaningful amounts of either drug.
📡Pharmacodynamics — effects in the body▾
At the doses used in Juluca, neither dolutegravir nor rilpivirine significantly prolongs the QT interval — the part of the heart's electrical cycle associated with dangerous rhythm problems. Higher doses of rilpivirine (3 to 12 times the Juluca dose) have been shown to prolong the QT interval, so Juluca should be used with caution alongside other drugs that carry a QT-prolonging risk.
Dolutegravir can cause a modest decrease in measured creatinine clearance (a marker used to estimate kidney function), but studies show it does not actually reduce true kidney filtration or blood flow. This change in lab values is expected and does not reflect real kidney damage.
🔬Pharmacokinetics — how your body processes it▾
Both dolutegravir and rilpivirine are absorbed more completely when taken with food — a moderate or high-fat meal meaningfully increases the amount of each drug that reaches the bloodstream, which is why Juluca must be taken with a meal. Both drugs bind very strongly (roughly 99%) to proteins in the blood. Dolutegravir is mainly broken down by the liver enzyme UGT1A1 and has a half-life of about 14 hours, while rilpivirine is mainly metabolized by CYP3A enzymes and has a much longer half-life of about 50 hours. Both are primarily eliminated through metabolism rather than unchanged in the urine.
📦How to store it▾
Store and dispense in the original package, protect from moisture, and keep the bottle tightly closed. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) .
📄 Written from Dolutegravir / 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 →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Dolutegravir / Rilpivirine — the kind of thing our pharmacy team would talk through with you at the counter.
Why do I have to eat before taking Juluca? Does it really matter? ▾
Can I take my heartburn or acid reflux medication while on Juluca? ▾
I've been feeling more down or anxious since starting Juluca. Is that related? ▾
What should I do if I notice a rash after starting Juluca? ▾
I take St. John's Wort for my mood. Is that okay with Juluca? ▾
Is Juluca safe to take during pregnancy? ▾
Is Dolutegravir / Rilpivirine available over the counter? ▾
When was Dolutegravir / Rilpivirine first available? ▾
Who makes Dolutegravir / Rilpivirine? ▾
💬 Answers drafted from Dolutegravir / 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 →
🧰 Keep exploring
💊 How Dolutegravir / Rilpivirine comes
Dolutegravir / Rilpivirine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Juluca is used as a complete treatment regimen for HIV-1 infection in adults who are already virologically suppressed on a stable antiretroviral regimen for at least 6 months, with no history of treatment failure and no known resistance to either component.
- Juluca: take one tablet by mouth once daily with a meal — food is required for proper absorption.
- Juluca: if you are also taking rifabutin, take an additional rilpivirine 25-mg tablet with Juluca once daily with a meal, for as long as you are on rifabutin.
- Juluca: do not take with proton pump inhibitors (PPIs) — this combination is contraindicated.
- Juluca: take at least 4 hours before or 6 hours after antacids or products containing polyvalent cations such as calcium or iron supplements.
📊 Dolutegravir / Rilpivirine across the U.S. market
How Dolutegravir / 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Dolutegravir / Rilpivirine is used
A general measure of how commonly Dolutegravir / 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 Dolutegravir / 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 Dolutegravir / Rilpivirine prescribed? Of the 1,597 medications we measure, Dolutegravir / Rilpivirine ranks #762 by Medicaid prescriptions — more than 52% of them.
Utilization by Dolutegravir / Rilpivirine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
dolutegravir 50 MG / rilpivirine 25 MG Oral Tablet
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1989500
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Dolutegravir / 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 1 of 2 listed Dolutegravir / Rilpivirine NDCs with Medicaid activity.
🔍 Compare Dolutegravir / Rilpivirine products
A representative set of FDA-listed product records for Dolutegravir / 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 | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| DOLUTEGRAVIR SODIUM 50 mg/1; RILPIVIRINE HYDROCHLORIDE 25 mg | — | Glaxo Operations UK Ltd | DRUG FOR FURTHER PROCESSING | View NDC → |
| DOLUTEGRAVIR SODIUM 50 mg/1; RILPIVIRINE HYDROCHLORIDE 25 mg | Oral | ViiV Healthcare Company × 2 listings | NDA | View NDC → |
| 50; 25 mg/1; mg | Oral | ViiV Healthcare Company × 2 listings | NDA | View NDC → |
Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Dolutegravir / Rilpivirine NDCs →
📈 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 Dolutegravir / 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 Dolutegravir / 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.
🏛️ The road to your pharmacy
How Dolutegravir / Rilpivirine 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.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 1989499 1 dose form · 1 strength
-
Dose form (SCDF) Oral Tablet RxCUI 1989498In current FDA listingsClinical drug / strength (SCD) dolutegravir 50 MG / rilpivirine 25 MGRxCUI 1989500
Look up RxCUI 1989499 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Dolutegravir / 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.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Dolutegravir / Rilpivirine 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.