Dolutegravir
Dolutegravir is an HIV-1 integrase strand transfer inhibitor (INSTI) used with other HIV medicines to treat HIV-1 infection in adults and children, and with rilpivirine as a complete regimen for some adults.
🧬 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 4 clinical label sets 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 (Tivicay) is an HIV medicine that blocks integrase, the enzyme the virus uses to insert itself into your cells’ DNA, and since arriving around 2013 it has become a preferred cornerstone of HIV treatment, always taken with other HIV medicines. Most people tolerate it well, and the side effects they notice are usually trouble sleeping, headache or tiredness. Stop it and get help right away if a rash comes with fever, blisters, mouth sores, facial swelling or feeling very unwell, because that can be a serious allergic reaction that sometimes harms the liver.
Clinical pearls
- Take it 2 hours before or 6 hours after magnesium or aluminum antacids, laxatives or sucralfate.
- Calcium, iron and multivitamins need the same spacing, unless you take dolutegravir with a meal, when they can go together.
- Dolutegravir raises metformin levels, so whoever prescribes your metformin should know you take both.
- If you could become pregnant, use reliable contraception, since it may raise brain and spine birth defect risk around conception.
Patient information guide A plain-language walkthrough of Dolutegravir, written from its FDA label.
What Dolutegravir is used for
▾
Dolutegravir treats HIV-1 infection as part of combination therapy.
- Tivicay and Tivicay PD (oral): used with other HIV medicines in adults who are new to treatment or have taken HIV medicines before.
- Tivicay and Tivicay PD (oral): used in children who have not taken an INSTI before, within the age and weight limits on the label.
- Tivicay (oral): used with rilpivirine as a complete regimen in adults whose HIV is already controlled on a stable regimen for at least 6 months, with no history of treatment failure or known resistance to either medicine.
How Dolutegravir works
▾
Dolutegravir is an HIV-1 antiretroviral medicine in the integrase strand transfer inhibitor (INSTI) class. It is used together with other HIV medicines to treat HIV-1 infection.
Dolutegravir dosage
▾
Dolutegravir is taken by mouth and can be taken with or without food. How often depends on your treatment and on other medicines you take. Some interacting medicines mean it is taken twice daily.
- Tivicay and Tivicay PD are different forms and are not interchangeable.
- Always follow your prescriber's directions and the label.
Dosing details from the FDA-approved label
From the Dolutegravir 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.
TIVICAY o Available as 10 mg, 25 mg, and 50 mg tablets. o Recommended for adults and pediatric patients weighing at least 14 kg.
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • May be taken without regard to food. ( 2.2 ) UGT = uridine diphosphate glucuronosyltransferase; CYP = cytochrome P450. a Rilpivirine dose is 25 mg once daily for those switching to dolutegravir plus rilpivirine. b Alternative combinations that do not include metabolic inducers should be considered where possible. Adult Population Recommended Dose Treatment-naïve or treatment-experienced INSTI-naïve or virologically suppressed (HIV-1 RNA <50 copies per mL) adults switching to dolutegravir plus rilpivirine a ( 2.1 ) 50 mg once daily Treatment-naïve or treatment-experienced INSTI-naïve when coadministered with certain UGT1A or CYP3A inducers ( 2.1 , 7.2 , 7.3 ) 50 mg twice daily INSTI-experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance b ( 2.1 , 12.4 ) 50 mg twice daily Pediatric Patients: Treatment-naïve or treatment-experienced INSTI-naïve patients weighing at least 2 kg. See Tables 2 , 3 , and 4 for complete pediatric dosing recommendations. ( 2.3 ). • TIVICAY and TIVICAY PD are not bioequivalent and are not substitutable on a milligram-per-milligram basis. • Pediatric Patients ≥4 weeks of age: if certain UGT1A or CYP3A inducers are coadministered, then adjust the weight-based dose of TIVICAY or TIVICAY PD to twice daily. ( 2.3 , 7.2 , 7.3 ) TIVICAY PD Tablets for Oral Suspension ( Table 2 and Table 3 ): Term Neonates ≥2 kg (from birth to <4 weeks of age): • Birth to 14 Days: 1 tablet every other day • 15 Days to <4 Weeks: 1 tablet once daily Pediatric Population (≥4 Weeks of Age) Body Weight Recommended Dose TIVICAY PD Tablets for Oral Suspension 3 kg to less than 6 kg 1 tablet once daily 6 kg to less than 10 kg 3 tablets once daily 10 kg to less than 14 kg 4 tablets once daily 14 kg to less than 20 kg 5 tablets once daily 20 kg and greater 6 tablets once daily TIVICAY Tablets ( Table 4 ): Alternative dosing recommendations for TIVICAY tablets for patients weighing at least 14 kg: • 14 kg to less than 20 kg: 4 x 10 mg tablets once daily. • 20 kg and greater: 1 x 50 mg tablet once daily. 2.1 Overview of Different Dosage Forms and Important Dosage Considerations TIVICAY is available in two dosage forms: • TIVICAY o Available as 10 mg, 25 mg, and 50 mg tablets. o Recommended for adults and pediatric patients weighing at least 14 kg.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Dolutegravir side effects
▾
The most common side effects of moderate to severe intensity in adult trials were:
Common side effects
- Trouble sleeping (insomnia)
- Fatigue
- Headache
When to get medical help
- Stop the medicine and get medical help right away if you develop a severe rash, or a rash with fever, feeling very unwell, muscle or joint aches, blisters or peeling skin, mouth sores, red eyes, swelling of the face, or trouble breathing. These can be signs of a serious allergic reaction.
- Call your doctor if you have signs of liver problems. Liver injury has been reported, including in people with no known liver disease.
- Tell your doctor if you notice new symptoms of infection or inflammation soon after starting HIV treatment. This can happen as your immune system recovers (immune reconstitution syndrome).
- Tell your doctor right away if you become pregnant or are trying to become pregnant.
Get help right away for signs of a serious allergic reaction or liver problems, such as severe rash, fever, blistering skin, facial swelling, trouble breathing, or yellowing of the skin or eyes.
Dolutegravir warnings and precautions
▾
- Allergic reactions: stop the medicine immediately and get help if a rash with other symptoms appears. A delay can be life-threatening.
- Liver problems: hepatitis, elevated liver tests and liver failure have been reported. Risk may be higher with hepatitis B or C. Monitoring is recommended.
- Pregnancy: a possible increased risk of neural tube defects around conception and in early pregnancy. Discuss options with your doctor.
- Immune reconstitution syndrome: inflammation from past infections can flare as your immune system recovers.
- Drug interactions: some medicines can make dolutegravir work less well and risk resistance.
Dolutegravir interactions
▾
Several medicines and supplements can change dolutegravir levels or be affected by it.
- Dofetilide: contraindicated because levels can rise to a dangerous degree.
- Antacids, laxatives, sucralfate, buffered medicines: separate from dolutegravir (2 hours before or 6 hours after) because they lower absorption.
- Calcium or iron supplements: separate unless taken together with food.
- Efavirenz, rifampin, carbamazepine and certain HIV medicines: lower dolutegravir, and a twice-daily dose may be needed.
- Nevirapine, oxcarbazepine, phenytoin, phenobarbital, St. John's wort: avoid or ask your prescriber, since they lower dolutegravir.
- Metformin and dalfampridine: dolutegravir can raise their levels. Dalfampridine levels raise seizure risk.
Interactions listed in the FDA-approved label
From the Dolutegravir prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Etravirine (without atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir): Decreases dolutegravir concentrations. Use of TIVICAY or TIVICAY PD with etravirine without coadministration of atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir is not recommended.
- Efavirenz: Decreases dolutegravir concentrations. Adjust dose of TIVICAY to twice daily for treatment-naïve and treatment-experienced, INSTI-naïve adult patients. In pediatric patients (at least 4 weeks of age), increase the weight-based dose of TIVICAY or TIVICAY PD to twice daily (Tables 3 and 4). Use alternative combinations that do not include metabolic inducers where possible for INSTI-experienced pati
- Nevirapine: Decreases dolutegravir concentrations. Avoid coadministration with nevirapine because there are insufficient data to make dosing recommendations.
- Fosamprenavir/ritonavir, tipranavir/ritonavir: Decreases dolutegravir concentrations. Adjust dose of TIVICAY to twice daily for treatment-naïve and treatment-experienced, INSTI-naïve adult patients. In pediatric patients (at least 4 weeks of age), increase the weight-based dose to twice daily (Tables 3 and 4). Use alternative combinations that do not include metabolic inducers where possible for INSTI-experienced patients with certain INSTI-a
- Dofetilide: Increases dofetilide concentrations. Coadministration is contraindicated with TIVICAY or TIVICAY PD.
- Carbamazepine: Decreases dolutegravir concentrations. Adjust dose of TIVICAY to twice daily in treatment-naïve or treatment-experienced, INSTI-naïve adult patients. In pediatric patients (at least 4 weeks of age), increase the weight-based dose to twice daily (Tables 3 and 4). Use alternative treatment that does not include carbamazepine where possible for INSTI-experienced patients with certain INSTI-associate
- Oxcarbazepine, phenytoin, phenobarbital, St. John's wort (Hypericum perforatum): Decreases dolutegravir concentrations. Avoid coadministration with TIVICAY or TIVICAY PD because there are insufficient data to make dosing recommendations.
- Medications containing polyvalent cations (e.g., Mg or Al): cation-containing antacids or laxatives, sucralfate, buffered medications: Decreases dolutegravir concentrations. Administer TIVICAY or TIVICAY PD 2 hours before or 6 hours after taking medications containing polyvalent cations.
- Oral calcium or iron supplements, including multivitamins containing calcium or iron: Decreases dolutegravir concentrations. When taken with food, TIVICAY and supplements or multivitamins containing calcium or iron can be taken at the same time. Under fasting conditions, TIVICAY or TIVICAY PD should be taken 2 hours before or 6 hours after taking supplements containing calcium or iron.
- Dalfampridine: Increases dalfampridine concentrations; elevated levels of dalfampridine increase the risk of seizures. The potential benefits of taking dalfampridine concurrently with TIVICAY or TIVICAY PD should be considered against the risk of seizures in these patients.
Read the label’s full interactions text
7 DRUG INTERACTIONS • Refer to the full prescribing information for important drug interactions with TIVICAY or TIVICAY PD. ( 4 , 7 ) • Drugs that are metabolic inducers may decrease the plasma concentrations of dolutegravir. ( 7.2 , 7.3 ) • TIVICAY or TIVICAY PD should be taken 2 hours before or 6 hours after taking cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. When taken with food, TIVICAY and supplements containing calcium or iron can be taken at the same time. ( 7.3 ) 7.1 Effect of Dolutegravir on the Pharmacokinetics of Other Agents In vitro, dolutegravir inhibited the renal organic cation transporters, OCT2 (IC 50 = 1.93 microM) and multidrug and toxin extrusion transporter (MATE) 1 (IC 50 = 6.34 microM). In vivo, dolutegravir inhibits tubular secretion of creatinine by inhibiting OCT2 and potentially MATE1. Dolutegravir may increase plasma concentrations of drugs eliminated via OCT2 or MATE1 (dofetilide, dalfampridine, and metformin, Table 8 ) [see Contraindications ( 4 ), Drug Interactions ( 7.3 )] . In vitro, dolutegravir inhibited the basolateral renal transporters, organic anion transporter (OAT) 1 (IC 50 = 2.12 microM) and OAT3 (IC 50 = 1.97 microM). However, in vivo, dolutegravir did not alter the plasma concentrations of tenofovir or para-amino hippurate, substrates of OAT1 and OAT3. In vitro, dolutegravir did not inhibit (IC 50 greater than 50 microM) the following: cytochrome P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A, uridine diphosphate glucuronosyltransferase (UGT)1A1, UGT2B7, P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), bile salt export pump (BSEP), organic anion transporter polypeptide (OATP)1B1, OATP1B3, OCT1, multidrug resistance protein (MRP)2, or MRP4. In vitro, dolutegravir did not induce CYP1A2, CYP2B6, or CYP3A4.
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.
Before taking Dolutegravir
▾
- Do not use with a past allergic reaction to dolutegravir or with dofetilide.
- Tell your doctor about liver disease or hepatitis B or C.
- Pregnancy testing is recommended before starting if you could become pregnant. Use effective contraception consistently.
- Tell your doctor if you are pregnant or trying to conceive.
- Breastfeeding is not recommended with HIV-1.
- Not established in children under 4 weeks or under 3 kg, or in those with resistance to other INSTIs.
- Use with caution in older adults.
Dolutegravir overdose
▾
There is no known specific treatment for an overdose. The person should be monitored and given standard supportive care. Dialysis is unlikely to remove much dolutegravir because it is highly bound to proteins in the blood.
What Dolutegravir does in the body
▾
In a study of healthy volunteers, dolutegravir did not prolong the QTc interval, a measure of heart rhythm timing. It slightly lowered measured creatinine clearance, but did not significantly change the true glomerular filtration rate (kidney filtering) compared with placebo.
How your body processes Dolutegravir
▾
After a dose by mouth, blood levels peak in about 1 to 3 hours. Food increases how much is absorbed, but it can be taken with or without food. Its half-life is about 14 hours. It is mostly broken down by the UGT1A1 enzyme, with some help from CYP3A, and most of it leaves in the stool, with the rest in the urine. Tivicay and Tivicay PD are absorbed differently and are not interchangeable.
How to store Dolutegravir
▾
Store and dispense the 10-mg tablets in the original package, protect from moisture, and keep the bottle tightly closed. Store TIVICAY tablets at 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F) . Store TIVICAY PD tablets for oral suspension below 30°C (86°F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Dolutegravir
65 supplements and herbal products have documented interactions with Dolutegravir in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 46
- Minor · 16
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.
Dolutegravir: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Dolutegravir — the kind of thing our pharmacy team would talk through with you at the counter.
What is dolutegravir for?
▾
Do I need to take it with food?
▾
What side effects should I expect?
▾
When should I get help right away?
▾
Can I take my antacid or vitamins with it?
▾
What if I am pregnant or planning to be?
▾
Is Dolutegravir available over the counter?
▾
When was Dolutegravir first available?
▾
Who makes Dolutegravir?
▾
Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Dolutegravir on HelloPharmacist
Dolutegravir forms and strengths (how it comes)
Dolutegravir 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
- Tivicay and Tivicay PD are used with other HIV medicines to treat HIV-1 infection in adults and in children who have not used an INSTI before.
- Tivicay is also used with rilpivirine as a complete regimen in certain adults whose HIV is already controlled.
- Tivicay and Tivicay PD can be taken with or without food.
- Tivicay tablets and Tivicay PD tablets for oral suspension are not interchangeable milligram for milligram.
- If a child switches between Tivicay and Tivicay PD, the dose must be adjusted for the new form.
Dolutegravir on the U.S. market: products, makers and brands
How Dolutegravir 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.
2 companies list 5 Dolutegravir product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2013. Brand names on the directory include Tivicay, Tivicay PD; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (14) — 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 Dolutegravir is used (Medicaid data)
A general measure of how commonly Dolutegravir 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 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 prescribed? Of the 1,601 medications we measure, Dolutegravir ranks #517 by Medicaid prescriptions — more than 68% of them.
Utilization by Dolutegravir 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 Oral Tablet Most dispensed
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1433873
dolutegravir 5 MG Tablet for Oral Suspension
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2374562
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, 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 7 listed Dolutegravir NDCs with Medicaid activity.
Compare Dolutegravir products
A representative set of FDA-listed product records for Dolutegravir — 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 | ||||
| 50 mg | Oral | St. Mary's Medical Park Pharmacy | NDA | View NDC → |
| 5 mg | Oral | ViiV Healthcare Company | NDA | View NDC → |
| 10 mg | Oral | ViiV Healthcare Company | NDA | View NDC → |
| 25 mg | Oral | ViiV Healthcare Company | NDA | View NDC → |
| 50 mg | Oral | ViiV Healthcare Company | NDA | View NDC → |
Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Dolutegravir NDCs →
Dolutegravir 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 Dolutegravir — 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 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.
Dolutegravir FDA approval history
How Dolutegravir went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Dolutegravir 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 2 Dolutegravir recalls since July 2021. None of them is still listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tablets, one 30-mL dosing cup and one 10-mL oral dosing syringe, Rx Only, Mfd for: V… Lots: Lot #: AG4M, Labeled Expiry date on carton May 2026, correct Exp. Date 04/2025 FDA record D-0544-2024 →
- Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13. Lots: Lot: 2A9E, Exp 1/2027 FDA record D-0896-2022 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1433868 2 dose forms · 4 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 1433872In current FDA listings -
Dose form (SCDF) Tablet for Oral Suspension RxCUI 2374561In current FDA listingsClinical drug / strength (SCD) 5 MGRxCUI 2374562
Look up RxCUI 1433868 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.
Dolutegravir supply and shortage status
Whether Dolutegravir 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.
💵 What Dolutegravir costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 50 mg | $77.64 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Dolutegravir brand names
Dolutegravir is sold under 2 brand names in the FDA directory — Tivicay, Tivicay PD. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Dolutegravir: manufacturers and labelers
2 companies list Dolutegravir products with the FDA. By number of product records, the largest are ViiV Healthcare Company, St. Mary's Medical Park Pharmacy. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Dolutegravir drug class (RxNorm)
Dolutegravir belongs to the Human Immunodeficiency Virus Integrase Strand Transfer 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.
Sources for this Dolutegravir 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 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 →