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Tivicay dolutegravir sodium 50 mg Tablet, Film Coated, 30-count — NDC 53808-1130-1 (Billing 53808-1130-01)

by DOH CENTRAL PHARMACY · 30 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of 30 tablets of Tivicay dolutegravir sodium 50 mg Tablet, Film Coated from DOH CENTRAL PHARMACY, no longer marketed, no longer in the FDA NDC Directory. It is this product's only package size.

NDC 53808-1130-01
🏷️ FDA NDC (as labeled) 53808-1130-1 billing pads the package segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 14, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 53808-1130-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
53808 labeler · 1130 product · 1 package
Barcode (UPC-A, from the NDC)
3 5380811301 5
FDA record last changed
Jul 14, 2026
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53808-1130-1
Product NDC 53808-1130
11-digit billing NDC 53808113001
Application # NDA204790
SPL Set ID 807b0cd2-093c-4353-a4a5-2e1f264616ba
Mechanism of action HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2023)
Route ORAL
Dosage form TABLET, FILM COATED
Substance DOLUTEGRAVIR SODIUM
Why two NDCs? The FDA registers this code as 53808-1130-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 53808-1130-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It treats HIV-1 infection and is always used with other HIV medicines. Tivicay can also be paired with rilpivirine as a complete regimen for certain adults whose HIV is already con...
  • No. You can take it with or without food. Just follow the schedule your prescriber gave you and keep it consistent.
  • The most common ones are trouble sleeping, tiredness and headache. Call your doctor about anything that bothers you or does not go away.
  • If you get a severe rash, a rash with fever, blisters or peeling skin, facial swelling, or trouble breathing, stop the medicine and get medical help. These can be signs of a seriou...
📖 Read our full Dolutegravir guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
53808-1130-01 You're viewing this Main listing 30 TABLET, FILM COATED in 1 BLISTER PACK 2017-07-10 — Inactivated by FDA

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tivicay 50 mgthis 53808-1130-01 DOH 30 tablets — — Discontinued —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2013
First FDA approval
Aug 2013
📍
2026
Currently FDA-listed
13 years listed
🛡️
2030
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jun 2030. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Aug 12, 2013 RLD RS ⏳ ~3.7 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

When could a generic Tivicay arrive?

Our estimate: sometime in 2028 sometime that year

How sure: Probable. More likely than not, but it can still move.

Why then: The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.

That is before the June 2030 date above, which is common: a court ruling or a deal with the brand’s maker often lets a generic in before the last patent runs out.

See the full forecast for generic Tivicay →
Patents & exclusivity — FDA Orange Book
US 8129385 — drug substance
US 8129385 — drug substance
US 9242986 — drug substance
US 9242986 — drug substance
US 8129385 — drug substance
US 9242986 — drug substance
US 8129385*PED — drug product
US 9242986*PED — drug product
US 9242986*PED — drug product
US 8129385*PED — drug product
US 9242986*PED — drug product
US 8129385*PED — drug product
2013 2015 2017 2019 2021 2023 2025 2027 2029
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (12)
PatentTypeUse codeExpires
US 8129385 ↗ Drug substance — Oct 5, 2027
US 8129385 ↗ Drug substance — Oct 5, 2027
US 9242986 ↗ Drug substance — Dec 8, 2029
US 9242986 ↗ Drug substance — Dec 8, 2029
US 8129385 ↗ Drug substance — Oct 5, 2027
US 9242986 ↗ Drug substance — Dec 8, 2029
US 8129385*PED ↗ Drug product — Apr 5, 2028
US 9242986*PED ↗ Drug product — Jun 8, 2030
US 9242986*PED ↗ Drug product — Jun 8, 2030
US 8129385*PED ↗ Drug product — Apr 5, 2028
US 9242986*PED ↗ Drug product — Jun 8, 2030
US 8129385*PED ↗ Drug product — Apr 5, 2028
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jun 2030 — an estimate, not a guaranteed launch date. We expect the first generic Tivicay sometime in 2028. See the forecast.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Dolutegravir inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerDOH CENTRAL PHARMACY
Application holderVIIV HEALTHCARE CO
FDA applicationNDA204790 (NDA)
Labeler code53808
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 207 words ▾

1 INDICATIONS AND USAGE TIVICAY is indicated in combination with: • other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients weighing at least 30 kg [see Microbiology ( 12.4 )] . • rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.

TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with: • other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients weighing at least 30 kg. ( 1 ) • rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.

( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION • Pregnancy Testing: Perform pregnancy testing before initiation of TIVICAY in adolescents and adults of childbearing potential. ( 2.1 , 5.3 ) • May be taken without regard to food. ( 2.2 , 2.3 ) 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 ( 2.2 ) 50 mg once daily Treatment-naïve or treatment-experienced INSTI-naïve when coadministered with certain UGT1A or CYP3A inducers ( 2.2 , 7.3 ) 50 mg twice daily INSTI-experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance b ( 12.4 ) 50 mg twice daily Pediatric Patients: (Treatment-naïve or treatment-experienced INSTI-naïve patients weighing at least 30 kg).

( 2.3 ) • If at least 40 kg: The recommended dose is TIVICAY 50 mg once daily. • Patients 30 kg to less than 40 kg: The recommended dose is TIVICAY 35 mg once daily. • If certain UGT1A or CYP3A inducers are coadministered, then adjust the weight-based dose of TIVICAY to twice daily. ( 2.3 , 7.3 )

2.1Pregnancy Testing before Initiation of TIVICAY Perform pregnancy testing before initiation of TIVICAY in adolescents and adults of childbearing potential [see Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.1 , 8.3 )].

2.2Adults TIVICAY tablets may be taken with or without food. Table 1. Dosing Recommendations for TIVICAY in Adult Patients 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 [see Drug Interactions ( 7 )] .

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 50 mg once daily Treatment-naïve or treatment-experienced INSTI-naïve when coadministered with certain UGT1A or CYP3A inducers [see Drug Interactions ( 7.3 )] 50 mg twice daily INSTI-experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance b [see Microbiology ( 12.4 )] 50 mg twice daily

2.3Pediatric Patients TIVICAY tablets may be taken with or without food. Treatment-Naïve or Treatment-Experienced INSTI-Naïve The recommended dose of TIVICAY in pediatric patients weighing at least 30 kg is provided in Table 2 . Table 2.

Dosing Recommendations for TIVICAY in Pediatric Patients Weighing at Least 30 kg a If certain UGT1A or CYP3A inducers are coadministered, then increase the weight-based dose of TIVICAY to twice daily [see Drug Interactions ( 7.3 ) for relevant inducers] . Body Weight (kg) Daily Dose a (Number of Tablets per Dose when Different Strength(s) are Required) 30 to less than 40 35 mg once daily (One 25-mg tablet and one 10-mg tablet) 40 or greater 50 mg once daily Safety and efficacy of TIVICAY have not been established in pediatric patients who are INSTI-experienced with documented or clinically suspected resistance to other INSTIs (raltegravir, elvitegravir).

💊 Dosage Forms and Strengths 114 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 10 mg: Each tablet contains 10 mg of dolutegravir (as dolutegravir sodium). Tablets are white, round, film-coated, biconvex tablets debossed with “SV 572” on one side and “10” on the other side. 25 mg: Each tablet contains 25 mg of dolutegravir (as dolutegravir sodium).

Tablets are pale yellow, round, film-coated, biconvex tablets debossed with “SV 572” on one side and “25” on the other side. 50 mg: Each tablet contains 50 mg of dolutegravir (as dolutegravir sodium). Tablets are yellow, round, film-coated, biconvex tablets debossed with “SV 572” on one side and “50” on the other side.

Tablets: 10 mg, 25 mg, and 50 mg ( 3 )

⛔ Contraindications 64 words ▾

4 CONTRAINDICATIONS TIVICAY is contraindicated in patients: • with previous hypersensitivity reaction to dolutegravir [see Warnings and Precautions ( 5.1 )]. • receiving dofetilide due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events [see Drug Interactions ( 7 )] . • Previous hypersensitivity reaction to dolutegravir. ( 4 ) • Coadministration with dofetilide. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

• Hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported. Discontinue TIVICAY and other suspect agents immediately if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. ( 5.1 ) • Hepatotoxicity has been reported in patients receiving dolutegravir-containing regimens.

Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations. Monitoring for hepatotoxicity is recommended. ( 5.2 ) • Embryo-fetal toxicity may occur when used at the time of conception and in early pregnancy.

Avoid use of TIVICAY at the time of conception through the first trimester of pregnancy due to the risk of neural tube defects. Advise adolescents and adults of childbearing potential to use effective contraception. ( 2.1 , 5.3 , 8.1 , 8.3 ) • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy.

( 5.5 )

5.1Hypersensitivity Reactions Hypersensitivity reactions have been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. The events were reported in less than 1% of subjects receiving TIVICAY in Phase 3 clinical trials. Discontinue TIVICAY and other suspect agents immediately if signs or symptoms of hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters or peeling of the skin, oral blisters or lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema, difficulty breathing).

Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated. Delay in stopping treatment with TIVICAY or other suspect agents after the onset of hypersensitivity may result in a life-threatening reaction. TIVICAY is contraindicated in patients who have experienced a previous hypersensitivity reaction to dolutegravir.

5.2Hepatotoxicity Hepatic adverse events have been reported in patients receiving a dolutegravir-containing regimen. Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of TIVICAY [see Adverse Reactions ( 6.1 )]. In some cases, the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation particularly in the setting where anti-hepatitis therapy was withdrawn.

Cases of hepatic toxicity, including elevated serum liver biochemistries, hepatitis, and acute liver failure have been reported in patients receiving a dolutegravir-containing regimen without pre-existing hepatic disease or other identifiable risk factors. Drug-induced liver injury leading to liver transplant has been reported with TRIUMEQ (abacavir, dolutegravir, and lamivudine). Monitoring for hepatotoxicity is recommended.

5.3Embryo-Fetal Toxicity Preliminary data from an observational study showed that TIVICAY was associated with increased risk of neural tube defects when administered at the time of conception and in early pregnancy. As there is limited understanding of reported types of neural tube defects associated with dolutegravir use and because the date of conception may not be determined with precision, avoid use of TIVICAY at the time of conception through the first trimester of pregnancy [see Use in Specific Populations ( 8.1 )].

If there are plans to become pregnant or if pregnancy is confirmed within the first trimester while on TIVICAY, if possible, switch to an alternative regimen. Perform pregnancy testing before initiation of TIVICAY in adolescents and adults of childbearing potential to exclude use of TIVICAY during the first trimester of pregnancy [see Dosage and Administration ( 2.1 )]. Advise adolescents and adults of childbearing potent… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse drug reactions are discussed in other sections of the labeling: • Hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] . • Hepatotoxicity [see Warnings and Precautions ( 5.3 )]. • Immune Reconstitution Syndrome [see Warnings and Precautions ( 5.5 )] . The most common adverse reactions of moderate to severe intensity and incidence at least 2% (in those receiving TIVICAY in any one adult trial) are insomnia, fatigue, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-877-844-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials Experience in Adult Subjects Treatment-Naïve Subjects: The safety assessment of TIVICAY in HIV‑1‑infected treatment-naïve subjects is based on the analyses of data from 2 international, multicenter, double-blind trials, SPRING-2 (ING113086) and SINGLE (ING114467) and data from the international, multicenter, open-label FLAMINGO (ING114915) trial.

In SPRING-2, 822 subjects were randomized and received at least 1 dose of either TIVICAY 50 mg once daily or raltegravir 400 mg twice daily, both in combination with fixed-dose dual nucleoside reverse transcriptase inhibitor (NRTI) treatment (either abacavir sulfate and lamivudine [EPZICOM] or emtricitabine/tenofovir [TRUVADA]). There were 808 subjects included in the efficacy and safety analyses. Through 96 weeks, the rate of adverse events leading to discontinuation was 2% in both treatment arms.

In SINGLE, 833 subjects were randomized and received at least 1 dose of either TIVICAY 50 mg with fixed-dose abacavir sulfate and lamivudine (EPZICOM) once daily or fixed-dose efavirenz/emtricitabine/tenofovir (ATRIPLA) once daily (study treatment was blinded through Week 96 and open-label from Week 96 through Week 144). Through 144 weeks, the rates of adverse events leading to discontinuation were 4% in subjects receiving TIVICAY 50 mg once daily + EPZICOM and 14% in subjects receiving ATRIPLA once daily. Treatment-emergent adverse reactions (ARs) of moderate to severe intensity observed in at least 2% of subjects in either treatment arm in SPRING-2 and SINGLE trials are provided in Table 3 .

Side-by-side tabulation is to simplify presentation; direct comparisons across trials should not be made due to differing trial designs. Table 3. Treatment-Emergent Adverse Reactions of at Least Moderate Intensity (Grades 2 to 4) and at Least 2% Frequency in Treatment-Naïve Subjects in SPRING-2 (Week 96 Analysis) and SINGLE Trials (Week 144 Analysis) a Includes pooled terms: rash, rash generalized, rash macular, rash maculo-papular, rash pruritic, and drug eruption.

System Organ Class/ Preferred Term SPRING-2 SINGLE TIVICAY 50 mg Once Daily + 2 NRTIs (n = 403) Raltegravir 400 mg Twice Daily + 2 NRTIs (n = 405) TIVICAY 50 mg + EPZICOM Once Daily (n = 414) ATRIPLA Once Daily (n = 419) Psychiatric Insomnia <1% <1% 3% 3% Depression <1% <1% 1% 2% Abnormal dreams <1% <1% <1% 2% Nervous System Dizziness <1% <1% <1% 5% Headache <1% <1% 2% 2% Gastrointestinal Nausea 1% 1% <1% 3% Diarrhea <1% <1% <1% 2% Skin and Subcutaneous Tissue Rash a 0 <1% <1% 6% General Disorders Fatigue <1% <1% 2% 2% Ear and Labyrinth Vertigo 0 <1% 0 2% In addition, Grade 1 insomnia was reported by 1% and less than 1% of subjects receiving TIVICAY and raltegravir, respectively, in SPRING-2; whereas in SINGLE the rates were 7% and 4% for TIVICAY and ATRIPLA, respectively.

These events were not treatment limiting. In a multicenter, open-label trial (FLAMINGO), 243 subjects received TIVICAY 50 mg once daily versus 242 subjects who received darunavir 800 mg/ritonavir 100 mg once daily, both in combination with… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

• Refer to the full prescribing information for important drug interactions with TIVICAY. ( 4 , 7 ) • Drugs that are metabolic inducers may decrease the plasma concentrations of dolutegravir. ( 7.2 , 7.3 ) • TIVICAY 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.

Alternatively, TIVICAY and supplements containing calcium or iron can be taken together with food. ( 7.3 )

7.1Effect 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 and metformin, Table 6 ) [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 (UDP)-glucuronosyl transferase 1A1 (UGT1A1), 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. Based on these data and the results of drug interaction trials, dolutegravir is not expected to affect the pharmacokinetics of drugs that are substrates of these enzymes or transporters.

7.2Effect of Other Agents on the Pharmacokinetics of Dolutegravir Dolutegravir is metabolized by UGT1A1 with some contribution from CYP3A. Dolutegravir is also a substrate of UGT1A3, UGT1A9, BCRP, and P-gp in vitro. Drugs that induce those enzymes and transporters may decrease dolutegravir plasma concentration and reduce the therapeutic effect of dolutegravir.

Coadministration of dolutegravir and other drugs that inhibit these enzymes may increase dolutegravir plasma concentration. Etravirine significantly reduced plasma concentrations of dolutegravir, but the effect of etravirine was mitigated by coadministration of lopinavir/ritonavir or darunavir/ritonavir, and is expected to be mitigated by atazanavir/ritonavir ( Table 6 ) [see Drug Interactions ( 7.3 ), Clinical Pharmacology ( 12.3 )] . In vitro, dolutegravir was not a substrate of OATP1B1 or OATP1B3.

7.3Established and Other Potentially Significant Drug Interactions Table 6 provides clinical recommendations as a result of drug interactions with TIVICAY. These recommendations are based on either drug interaction trials or predicted interactions due to the expected magnitude of interaction and potential for serious adverse events or loss of efficacy. [See Dosage and Administration ( 2 ), Clinical Pharmacology ( 12.3 ).] Table 6. Established and Other Potentially Significant Drug Interactions: Alterations in Dose or Regimen May Be Recommended Based on Drug Interaction Trials or Predicted Interactions [see Dosage and Administration ( 2 )] a See Clinical Pharmacology ( 12.3 ) Table 9 or Table 10 for magnitude of interaction. b The lower dolutegravir exposures observed in INSTI-experienced patients (with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance [see Microbiology ( 12.4 )] ) upon coadministration with certain inducers may result in loss of therapeutic effect and development of resistance to TIVICAY or other coadministered antiretroviral agents… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: Avoid use of TIVICAY at the time of conception through the first trimester due to the risk of neural tube defects. ( 2.1 , 5.3 , 8.1 ) • Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission. ( 8.2 ) • Females and males of reproductive potential: Pregnancy testing and contraception are recommended in adolescents and adults of childbearing potential. ( 8.3 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to TIVICAY during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Preliminary data from an observational study has identified a possible increased risk of neural tube defects when TIVICAY is administered at the time of conception compared with non-dolutegravir-containing antiretroviral regimens.

As defects related to closure of the neural tube occur from conception through the first 6 weeks of gestation, embryos exposed to dolutegravir from the time of conception through the first 6 weeks of gestation are at potential risk. In addition, 2 of the 4 birth defects (encephalocele and iniencephaly), which have been observed with dolutegravir use, although often termed neural tube defects, may occur post-neural tube closure, the time period of which may be later than 6 weeks of gestation, but within the first trimester.

Due to the limited understanding of the types of reported neural tube defects associated with dolutegravir use and because the date of conception may not be determined with precision, avoid use of TIVICAY at the time of conception through the first trimester of pregnancy. No neural tube defects have been reported in infants born to mothers who have started TIVICAY after the first trimester of pregnancy (see Data) . If there are plans to become pregnant or if pregnancy is confirmed while on TIVICAY during the first trimester, if possible, switch to an alternative regimen.

Advise pregnant adolescents and adults of the potential risk to the embryo exposed to TIVICAY from the time of conception through the first trimester of pregnancy. There are insufficient human data on the use of TIVICAY during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage. The background risk for major birth defects for the indicated population is unknown.

In the U.S. general population, the estimated background rate for major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. In animal reproduction studies, no evidence of adverse developmental outcomes was observed with dolutegravir at systemic exposures (AUC) less than (rabbits) and approximately 27 times (rats) the exposure in humans at the maximum recommended human dose (MRHD) of TIVICAY (see Data) . Data Human Data: As of May 2018, in an ongoing birth outcome surveillance study in Botswana, there have been 4 cases of neural tube defects reported out of 426 births (0.94%) to mothers who were exposed to dolutegravir-containing regimens at the time of conception.

In comparison, the neural tube defect prevalence rates were 0.12% (14/11,300) in the non-dolutegravir arm and 0.09% (61/66,057) in the HIV-uninfected arm. Four cases reported with dolutegravir included one case each of encephalocele, anencephaly, myelomeningocele, and iniencephaly. No infant born to a woman who started dolutegravir during pregnancy had a neural tube defect (n = 2,812).

Data analyzed to date from other sources including the APR, clinical trials, and postmarketing data are insufficient to address the risk of neural tube defects with dolutegravir. Animal Data: Dolutegravir was administered orally at up to 1,000 mg per kg daily to pregnant rats and rabbits on gestation Days 6 to 17 and 6 to 18, respectively, and to rats on gestation Day 6 to lactation/post-pa… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to TIVICAY during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Preliminary data from an observational study has identified a possible increased risk of neural tube defects when TIVICAY is administered at the time of conception compared with non-dolutegravir-containing antiretroviral regimens.

As defects related to closure of the neural tube occur from conception through the first 6 weeks of gestation, embryos exposed to dolutegravir from the time of conception through the first 6 weeks of gestation are at potential risk. In addition, 2 of the 4 birth defects (encephalocele and iniencephaly), which have been observed with dolutegravir use, although often termed neural tube defects, may occur post-neural tube closure, the time period of which may be later than 6 weeks of gestation, but within the first trimester.

Due to the limited understanding of the types of reported neural tube defects associated with dolutegravir use and because the date of conception may not be determined with precision, avoid use of TIVICAY at the time of conception through the first trimester of pregnancy. No neural tube defects have been reported in infants born to mothers who have started TIVICAY after the first trimester of pregnancy (see Data) . If there are plans to become pregnant or if pregnancy is confirmed while on TIVICAY during the first trimester, if possible, switch to an alternative regimen.

Advise pregnant adolescents and adults of the potential risk to the embryo exposed to TIVICAY from the time of conception through the first trimester of pregnancy. There are insufficient human data on the use of TIVICAY during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage. The background risk for major birth defects for the indicated population is unknown.

In the U.S. general population, the estimated background rate for major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. In animal reproduction studies, no evidence of adverse developmental outcomes was observed with dolutegravir at systemic exposures (AUC) less than (rabbits) and approximately 27 times (rats) the exposure in humans at the maximum recommended human dose (MRHD) of TIVICAY (see Data) . Data Human Data: As of May 2018, in an ongoing birth outcome surveillance study in Botswana, there have been 4 cases of neural tube defects reported out of 426 births (0.94%) to mothers who were exposed to dolutegravir-containing regimens at the time of conception.

In comparison, the neural tube defect prevalence rates were 0.12% (14/11,300) in the non-dolutegravir arm and 0.09% (61/66,057) in the HIV-uninfected arm. Four cases reported with dolutegravir included one case each of encephalocele, anencephaly, myelomeningocele, and iniencephaly. No infant born to a woman who started dolutegravir during pregnancy had a neural tube defect (n = 2,812).

Data analyzed to date from other sources including the APR, clinical trials, and postmarketing data are insufficient to address the risk of neural tube defects with dolutegravir. Animal Data: Dolutegravir was administered orally at up to 1,000 mg per kg daily to pregnant rats and rabbits on gestation Days 6 to 17 and 6 to 18, respectively, and to rats on gestation Day 6 to lactation/post-partum Day 20. No adverse effects on embryo-fetal (rats and rabbits) or pre/post-natal (rats) development were observed at up to the highest dose tested.

During organogenesis, systemic exposures (AUC) to dolutegravir in rabbits were less than the exposure in humans at the MRHD and in rats were approximately 27 times the exposure in humans at the MRHD. In the rat pre/post-natal development study, decreased body weight of the developing… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 46 words ▾

10 OVERDOSAGE There is no known specific treatment for overdose with TIVICAY. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required. As dolutegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Dolutegravir is an HIV-1 antiretroviral agent [see Microbiology ( 12.4 )].

12.2Pharmacodynamics Effects on Electrocardiogram In a randomized, placebo-controlled, cross-over trial, 42 healthy subjects received single-dose oral administrations of placebo, dolutegravir 250-mg suspension (exposures approximately 3–fold of the 50-mg once-daily dose at steady state), and moxifloxacin 400 mg (active control) in random sequence. After baseline and placebo adjustment, the maximum mean QTc change based on Fridericia correction method (QTcF) for dolutegravir was 2.4 msec (1-sided 95% upper CI: 4.9 msec).

TIVICAY did not prolong the QTc interval over 24 hours postdose. Effects on Renal Function The effect of dolutegravir on renal function was evaluated in an open-label, randomized, 3‑arm, parallel, placebo-controlled trial in healthy subjects (n = 37) who received dolutegravir 50 mg once daily (n = 12), dolutegravir 50 mg twice daily (n = 13), or placebo once daily (n = 12) for 14 days. A decrease in creatinine clearance, as determined by 24-hour urine collection, was observed with both doses of dolutegravir after 14 days of treatment in subjects who received 50 mg once daily (9% decrease) and 50 mg twice daily (13% decrease).

Neither dose of dolutegravir had a significant effect on the actual glomerular filtration rate (determined by the clearance of probe drug, iohexol) or effective renal plasma flow (determined by the clearance of probe drug, para-amino hippurate) compared with the placebo.

12.3Pharmacokinetics The pharmacokinetic properties of dolutegravir have been evaluated in healthy adult subjects and HIV‑1–infected adult subjects. Exposure to dolutegravir was generally similar between healthy subjects and HIV‑1–infected subjects. The non-linear exposure of dolutegravir following 50 mg twice daily compared with 50 mg once daily in HIV‑1–infected subjects ( Table 7 ) was attributed to the use of metabolic inducers in the background antiretroviral regimens of subjects receiving dolutegravir 50 mg twice daily in clinical trials.

Table 7. Dolutegravir Steady-State Pharmacokinetic Parameter Estimates in HIV‑1–Infected Adults a Based on population pharmacokinetic analyses using data from SPRING-1 and SPRING-2. b Based on population pharmacokinetic analyses using data from VIKING (ING112961) and VIKING-3. Parameter 50 mg Once Daily Geometric Mean a (%CV) 50 mg Twice Daily Geometric Mean b (%CV) AUC (0-24) (mcg.h/mL) 53.6 (27) 75.1 (35) C max (mcg/mL) 3.67 (20) 4.15 (29) C min (mcg/mL) 1.11 (46) 2.12 (47) Absorption Following oral administration of dolutegravir, peak plasma concentrations were observed 2 to 3 hours postdose.

With once-daily dosing, pharmacokinetic steady state is achieved within approximately 5 days with average accumulation ratios for AUC, C max , and C 24 h ranging from 1.2 to 1.5. Dolutegravir plasma concentrations increased in a less than dose-proportional manner above 50 mg. Dolutegravir is a P‑gp substrate in vitro.

The absolute bioavailability of dolutegravir has not been established. Effect of Food: TIVICAY may be taken with or without food. Food increased the extent of absorption and slowed the rate of absorption of dolutegravir.

Low-, moderate-, and high-fat meals increased dolutegravir AUC (0-∞) by 33%, 41%, and 66%; increased C max by 46%, 52%, and 67%; and prolonged T max to 3, 4, and 5 hours from 2 hours under fasted conditions, respectively. Distribution Dolutegravir is highly bound (greater than or equal to 98.9%) to human plasma proteins based on in vivo data and binding is independent of plasma concentration of dolutegravir. The apparent volume of distribution (Vd/F) following 50-mg once-daily administration is estimated at

17.4L based on a population pharmacokinetic analysis. Cerebrospinal Fluid (CSF): In 12 treatment-naïve subjects on dolutegravir 50 mg daily plus abacavir/lamivudine, the median dolutegravir concentration in CSF was 13.2 ng per mL (r… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 15 words ▾

12.1Mechanism of Action Dolutegravir is an HIV-1 antiretroviral agent [see Microbiology ( 12.4 )].

📦 How Supplied / Storage and Handling 129 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING TIVICAY tablets, 10 mg, are white, round, film-coated, biconvex tablets debossed with “SV 572” on one side and “10” on the other side. TIVICAY tablets, 25 mg, are pale yellow, round, film-coated, biconvex tablets debossed with “SV 572” on one side and “25” on the other side. TIVICAY tablets, 50 mg, are yellow, round, film-coated, biconvex tablets debossed with “SV 572” on one side and “50” on the other side.

They are supplied by DOH CENTRAL PHARMACY as follows: NDC Strength Quantity/Form Color Source Prod. Code 53808-1130-1 50 MG 30 Tablets in a Blister Pack YELLOW 49702-228 Store at 25 ° C (77 ° F); excursions permitted 15 ° to 30 ° C (59 ° to 86 ° F) [See USP Controlled Room Temperature].

📋 Description 145 words ▾

11 DESCRIPTION TIVICAY contains dolutegravir, as dolutegravir sodium, an HIV INSTI. The chemical name of dolutegravir sodium is sodium (4 R ,12a S )-9-{[(2,4-difluorophenyl)methyl]carbamoyl}-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2 H -pyrido[1',2':4,5]pyrazino[2,1- b ][1,3]oxazin-7-olate. The empirical formula is C 20 H 18 F 2 N 3 NaO 5 and the molecular weight is 441.36 g per mol.

It has the following structural formula: Dolutegravir sodium is a white to light yellow powder and is slightly soluble in water. Each film-coated tablet of TIVICAY for oral administration contains 10.5, 26.3, or 52.6 mg of dolutegravir sodium, which is equivalent to 10, 25, or 50 mg dolutegravir free acid, respectively, and the following inactive ingredients: D-mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, and sodium stearyl fumarate. The tablet film‑coating contains the inactive ingredients iron oxide yellow (25-mg and 50-mg tablets only), macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide. dolutegravir chemical structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Drug Interactions TIVICAY may interact with other drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription or nonprescription medication or herbal products, including St. John’s wort [see Contraindications ( 4 ), Drug Interactions ( 7 )] .

Hypersensitivity Reactions Advise patients to immediately contact their healthcare provider if they develop rash. Instruct patients to immediately stop taking TIVICAY and other suspect agents, and seek medical attention if they develop a rash associated with any of the following symptoms, as it may be a sign of a more serious reaction such as severe hypersensitivity: fever; generally ill feeling; extreme tiredness; muscle or joint aches; blisters or peeling of the skin; oral blisters or lesions; eye inflammation; facial swelling; swelling of the eyes, lips, tongue, or mouth; breathing difficulty; and/or signs and symptoms of liver problems (e.g., yellowing of the skin or whites of the eyes, dark or tea-colored urine, pale-colored stools or bowel movements, nausea, vomiting, loss of appetite, or pain, aching, or sensitivity on the right side below the ribs) [see Warnings and Precautions ( 5.1 )] .

Hepatotoxicity Inform patients that hepatotoxicity has been reported with dolutegravir [see Warnings and Precautions ( 5.2 )] . Advise patients that laboratory monitoring for hepatoxicity during therapy with TIVICAY is recommended, especially for patients with liver disease, such as hepatitis B or C. Embryo-Fetal Toxicity Advise adolescents and adults of childbearing potential to avoid use of TIVICAY at the time of conception through the first trimester of pregnancy.

Advise adolescents and adults of childbearing potential to contact their healthcare provider if they plan to become pregnant, become pregnant, or if pregnancy is suspected during treatment with TIVICAY [see Warnings and Precaution ( 5.3 )] . Advise adolescents and adults of childbearing potential taking TIVICAY to consistently use effective contraception [see Use in Specific Populations ( 8.1 , 8.3 )] . Immune Reconstitution Syndrome Advise patients to inform their healthcare provider immediately of any signs or symptoms of infection as inflammation from previous infection may occur soon after combination antiretroviral therapy, including when TIVICAY is started [see Warnings and Precautions ( 5.5 )] .

Pregnancy Registry Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes in those exposed to TIVICAY during pregnancy [see Use in Specific Populations ( 8.1 )] . Lactation Instruct mothers with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Specific Populations ( 8.2 )] . Missed Dosage Instruct patients that if they miss a dose of TIVICAY, to take it as soon as they remember.

Advise patients not to double their next dose or take more than the prescribed dose [see Dosage and Administration ( 2 )] . Storage Instruct patients to store the TIVICAY 10-mg tablets in the original package, keep the bottle tightly closed, and protect from moisture. Do not remove desiccant [see How Supplied/Storage and Handling ( 16 )] .

TIVICAY, EPZICOM, JULUCA, and TRIUMEQ are trademarks owned by or licensed to the ViiV Healthcare group of companies. The other brands listed are trademarks owned by or licensed to their respective owners and are not owned by or licensed to the ViiV Healthcare group of companies. The makers of these brands are not affiliated with and do not endorse the ViiV Healthcare group of companies or its products.

Manufactured for: ViiV Healthcare Research Triangle Park, NC 27709 by: GlaxoSmithKline Research Triangle Park, NC 27709 ©2018 ViiV Healthcare group of companies or its licensor. This Product was Repackaged By: DOH CENTRAL PHARMACY 104 HAMILTON PARK DR # 2 TALLAHASSEE, FL 32… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetic properties of dolutegravir have been evaluated in healthy adult subjects and HIV‑1–infected adult subjects. Exposure to dolutegravir was generally similar between healthy subjects and HIV‑1–infected subjects. The non-linear exposure of dolutegravir following 50 mg twice daily compared with 50 mg once daily in HIV‑1–infected subjects ( Table 7 ) was attributed to the use of metabolic inducers in the background antiretroviral regimens of subjects receiving dolutegravir 50 mg twice daily in clinical trials.

Table 7. Dolutegravir Steady-State Pharmacokinetic Parameter Estimates in HIV‑1–Infected Adults a Based on population pharmacokinetic analyses using data from SPRING-1 and SPRING-2. b Based on population pharmacokinetic analyses using data from VIKING (ING112961) and VIKING-3. Parameter 50 mg Once Daily Geometric Mean a (%CV) 50 mg Twice Daily Geometric Mean b (%CV) AUC (0-24) (mcg.h/mL) 53.6 (27) 75.1 (35) C max (mcg/mL) 3.67 (20) 4.15 (29) C min (mcg/mL) 1.11 (46) 2.12 (47) Absorption Following oral administration of dolutegravir, peak plasma concentrations were observed 2 to 3 hours postdose.

With once-daily dosing, pharmacokinetic steady state is achieved within approximately 5 days with average accumulation ratios for AUC, C max , and C 24 h ranging from 1.2 to 1.5. Dolutegravir plasma concentrations increased in a less than dose-proportional manner above 50 mg. Dolutegravir is a P‑gp substrate in vitro.

The absolute bioavailability of dolutegravir has not been established. Effect of Food: TIVICAY may be taken with or without food. Food increased the extent of absorption and slowed the rate of absorption of dolutegravir.

Low-, moderate-, and high-fat meals increased dolutegravir AUC (0-∞) by 33%, 41%, and 66%; increased C max by 46%, 52%, and 67%; and prolonged T max to 3, 4, and 5 hours from 2 hours under fasted conditions, respectively. Distribution Dolutegravir is highly bound (greater than or equal to 98.9%) to human plasma proteins based on in vivo data and binding is independent of plasma concentration of dolutegravir. The apparent volume of distribution (Vd/F) following 50-mg once-daily administration is estimated at

17.4L based on a population pharmacokinetic analysis. Cerebrospinal Fluid (CSF): In 12 treatment-naïve subjects on dolutegravir 50 mg daily plus abacavir/lamivudine, the median dolutegravir concentration in CSF was 13.2 ng per mL (range: 3.74 ng per mL to 18.3 ng per mL) 2 to 6 hours postdose after 16 weeks of treatment. The clinical relevance of this finding has not been established.

Elimination Dolutegravir has a terminal half-life of approximately 14 hours and an apparent clearance (CL/F) of

1.0L per hour based on population pharmacokinetic analyses. Metabolism: Dolutegravir is primarily metabolized via UGT1A1 with some contribution from CYP3A. Polymorphisms in Drug ‑ Metabolizing Enzymes: In a meta-analysis of healthy subject trials, subjects with UGT1A1 (n = 7) genotypes conferring poor dolutegravir metabolism had a 32% lower clearance of dolutegravir and 46% higher AUC compared with subjects with genotypes associated with normal metabolism via UGT1A1 (n = 41).

Excretion: After a single oral dose of [ 14 C] dolutegravir, 53% of the total oral dose was excreted unchanged in feces. Thirty-one percent of the total oral dose was excreted in urine, represented by an ether glucuronide of dolutegravir (18.9% of total dose), a metabolite formed by oxidation at the benzylic carbon (3.0% of total dose), and its hydrolytic N-dealkylation product (3.6% of total dose). Renal elimination of unchanged drug was low (less than 1% of the dose).

Specific Populations Pediatric Patients: The pharmacokinetics of dolutegravir in HIV‑1–infected children (n = 17) weighing at least 30 kg (dosed by weight bands, receiving either 35 mg or 50 mg) were similar to those observed in HIV‑1–infected adults who received dolutegravir 50 mg once daily ( Table 8 ) [see Clinical Studies ( 14.… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 216 words ▾

12.2Pharmacodynamics Effects on Electrocardiogram In a randomized, placebo-controlled, cross-over trial, 42 healthy subjects received single-dose oral administrations of placebo, dolutegravir 250-mg suspension (exposures approximately 3–fold of the 50-mg once-daily dose at steady state), and moxifloxacin 400 mg (active control) in random sequence. After baseline and placebo adjustment, the maximum mean QTc change based on Fridericia correction method (QTcF) for dolutegravir was 2.4 msec (1-sided 95% upper CI: 4.9 msec).

TIVICAY did not prolong the QTc interval over 24 hours postdose. Effects on Renal Function The effect of dolutegravir on renal function was evaluated in an open-label, randomized, 3‑arm, parallel, placebo-controlled trial in healthy subjects (n = 37) who received dolutegravir 50 mg once daily (n = 12), dolutegravir 50 mg twice daily (n = 13), or placebo once daily (n = 12) for 14 days. A decrease in creatinine clearance, as determined by 24-hour urine collection, was observed with both doses of dolutegravir after 14 days of treatment in subjects who received 50 mg once daily (9% decrease) and 50 mg twice daily (13% decrease).

Neither dose of dolutegravir had a significant effect on the actual glomerular filtration rate (determined by the clearance of probe drug, iohexol) or effective renal plasma flow (determined by the clearance of probe drug, para-amino hippurate) compared with the placebo.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Description of Clinical Studies The efficacy and safety of TIVICAY were evaluated in the studies summarized in Table 13 . Table 13. Trials Conducted with TIVICAY in HIV‑1‑Infected Subjects BR = Background regimen; CAR = Current antiretroviral regimen; OBT = Optimized background therapy Population Trial Trial Arms Timepoint (Week) Adults: Treatment-naïve SPRING-2 (ING113086) (NCT01227824) TIVICAY + 2 NRTIs (n = 403) Raltegravir +3 NRTIs (n = 405) 96 SINGLE (ING114467) (NCT01263015) TIVICAY + EPZICOM (n = 414) ATRIPLA (n = 419) 144 FLAMINGO (ING114915) (NCT01449929) TIVICAY + NRTI BR (n = 243) Darunavir/ritonavir + NRTI BR (n = 242) 96 Treatment-experienced, INSTI-naïve SAILING (ING111762) (NCT01231516) TIVICAY + BR (n = 354) Raltegravir + BR (n = 361) 48 INSTI-experienced VIKING-3 (ING112574) (NCT01328041) TIVICAY + OBT (n = 183) 48 Virologically suppressed SWORD-1 (NCT02429791) SWORD-2 (NCT02422797) Pooled presentation TIVICAY + Rilpivirine (n = 513) CAR (n = 511) 48 Pediatrics: 6 years and older without INSTI resistance IMPAACT P1093 (NCT01302847) TIVICAY + BR (n = 46) 48

14.2Adult Subjects Treatment-Naïve Subjects In SPRING-2, 822 subjects were randomized and received at least 1 dose of either TIVICAY 50 mg once daily or raltegravir 400 mg twice daily, both in combination with fixed-dose dual NRTI treatment (either abacavir sulfate and lamivudine [EPZICOM] or emtricitabine/tenofovir [TRUVADA]). There were 808 subjects included in the efficacy and safety analyses. At baseline, the median age of subjects was 36 years, 13% female, 15% non-white, 11% had hepatitis B and/or C virus co-infection, 2% were CDC Class C (AIDS), 28% had HIV-1 RNA greater than 100,000 copies per mL, 48% had CD4+ cell count less than 350 cells per mm 3 , and 39% received EPZICOM; these characteristics were similar between treatment groups.

In SINGLE, 833 subjects were randomized and received at least 1 dose of either TIVICAY 50 mg once daily with fixed-dose abacavir sulfate and lamivudine (EPZICOM) or fixed-dose efavirenz/emtricitabine/tenofovir (ATRIPLA). At baseline, the median age of subjects was 35 years, 16% female, 32% non-white, 7% had hepatitis C co-infection (hepatitis B virus co-infection was excluded), 4% were CDC Class C (AIDS), 32% had HIV-1 RNA greater than 100,000 copies per mL, and 53% had CD4+ cell count less than 350 cells per mm 3 ; these characteristics were similar between treatment groups.

Outcomes for SPRING-2 (Week 96 analysis) and SINGLE (Week 144 open-label phase analysis which followed the Week 96 double-blind phase) are provided in Table 14 . Side-by-side tabulation is to simplify presentation; direct comparisons across trials should not be made due to differing trial designs. Table 14.

Virologic Outcomes of Randomized Treatment in SPRING-2 at Week 96 and SINGLE at Week 144 (Snapshot Algorithm) a Adjusted for pre-specified stratification factors. b Includes subjects who discontinued due to an adverse event or death at any time point if this resulted in no virologic data on treatment during the analysis window. c Other includes reasons such as withdrew consent, loss to follow-up, moved, and protocol deviation. d The primary endpoint was assessed at Week 48 and the virologic success rate was 88% in the group receiving TIVICAY and 86% in the raltegravir group, with a treatment difference of 2.6% and 95% CI of (-1.9%, 7.2%). e The primary endpoint was assessed at Week 48 and the virologic success rate was 88% in the group receiving TIVICAY and 81% in the ATRIPLA group, with a treatment difference of 7.4% and 95% CI of (2.5%, 12.3%).

SPRING-2 Week 96 SINGLE Week 144 TIVICAY 50 mg Once Daily + 2 NRTIs (n = 403) Raltegravir 400 mg Twice Daily + 2 NRTIs (n = 405) TIVICAY 50 mg + EPZICOM Once Daily (n = 414) ATRIPLA Once Daily (n = 419) HIV-1 RNA <50 copies/mL 82% 78% 71% 63% Treatment difference a 4.9% (95% CI: -0.6%, 10.3%) d 8.3% (95% CI: 2.0%, 14.6%) e Virologic nonresponse 5% 10% 10% 7% Data in window not… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 206 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Two-year carcinogenicity studies in mice and rats were conducted with dolutegravir. Mice were administered doses of up to 500 mg per kg, and rats were administered doses of up to 50 mg per kg. In mice, no significant increases in the incidence of drug-related neoplasms were observed at the highest doses tested, resulting in dolutegravir AUC exposures approximately 14 times higher than those in humans at the recommended dose of 50 mg twice daily.

In rats, no increases in the incidence of drug-related neoplasms were observed at the highest dose tested, resulting in dolutegravir AUC exposures 10 times and 15 times higher in males and females, respectively, than those in humans at the recommended dose of 50 mg twice daily. Mutagenesis Dolutegravir was not genotoxic in the bacterial reverse mutation assay, mouse lymphoma assay, or in the in vivo rodent micronucleus assay. Impairment of Fertility In a study conducted in rats, there were no effects on mating or fertility with dolutegravir up to 1,000 mg per kg per day.

This dose is associated with an exposure that is approximately 24 times higher than the exposure in humans at the recommended dose of 50 mg twice daily.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 203 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Two-year carcinogenicity studies in mice and rats were conducted with dolutegravir. Mice were administered doses of up to 500 mg per kg, and rats were administered doses of up to 50 mg per kg. In mice, no significant increases in the incidence of drug-related neoplasms were observed at the highest doses tested, resulting in dolutegravir AUC exposures approximately 14 times higher than those in humans at the recommended dose of 50 mg twice daily.

In rats, no increases in the incidence of drug-related neoplasms were observed at the highest dose tested, resulting in dolutegravir AUC exposures 10 times and 15 times higher in males and females, respectively, than those in humans at the recommended dose of 50 mg twice daily. Mutagenesis Dolutegravir was not genotoxic in the bacterial reverse mutation assay, mouse lymphoma assay, or in the in vivo rodent micronucleus assay. Impairment of Fertility In a study conducted in rats, there were no effects on mating or fertility with dolutegravir up to 1,000 mg per kg per day.

This dose is associated with an exposure that is approximately 24 times higher than the exposure in humans at the recommended dose of 50 mg twice daily.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION TIVICAY (TIV-eh-kay) (dolutegravir tablets) What is TIVICAY? TIVICAY is a prescription medicine that is used to treat Human Immunodeficiency Virus-1 (HIV-1) infection together with: • other antiretroviral medicines in adults and children who weigh at least 66 pounds (30 kg). • rilpivirine in adults to replace their current anti-HIV-1 medicines when their healthcare provider determines that they meet certain requirements. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

It is not known if TIVICAY is safe and effective in children who weigh less than 66 pounds (30 kg) or in children who have received certain types of medicine for HIV-1 infection. Do not take TIVICAY if you: • have ever had an allergic reaction to a medicine that contains dolutegravir. • take dofetilide. Before you take TIVICAY, tell your healthcare provider about all of your medical conditions, including if you: • have ever had an allergic reaction to dolutegravir. • have or have had liver problems, including hepatitis B or C infection. • are pregnant or plan to become pregnant.

TIVICAY may harm your unborn baby. o You should not take TIVICAY at the time of becoming pregnant or during the first 12 weeks of pregnancy. Your healthcare provider may change your medicine during this time in your pregnancy. o If you can become pregnant, your healthcare provider will perform a pregnancy test before you start treatment with TIVICAY. o If you can become pregnant, you should consistently use effective birth control (contraception) during treatment with TIVICAY. o Tell your healthcare provider right away if you are planning to become pregnant, you become pregnant, or think you may be pregnant during treatment with TIVICAY.

Pregnancy Registry. There is a pregnancy registry for individuals who take antiretroviral medicines, including TIVICAY, during pregnancy. The purpose of this registry is to collect information about the health of you and your baby.

Talk with your healthcare provider about how you can take part in this registry. • are breastfeeding or plan to breastfeed. Do not breastfeed if you take TIVICAY. o You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. o It is not known if TIVICAY can pass to your baby in your breast milk. Talk with your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with TIVICAY. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. • You can ask your healthcare provider or pharmacist for a list of medicines that interact with TIVICAY. • Do not start taking a new medicine without telling your healthcare provider.

Your healthcare provider can tell you if it is safe to take TIVICAY with other medicines. How should I take TIVICAY? • Take TIVICAY exactly as your healthcare provider tells you to take it. • Take TIVICAY with or without food. • Do not change your dose or stop taking TIVICAY without talking with your healthcare provider. • If you take antacids, laxatives, or other medicines that contain aluminum, magnesium, or buffered medicines, TIVICAY should be taken at least 2 hours before or 6 hours after you take these medicines. • If you need to take iron or calcium supplements by mouth during treatment with TIVICAY: o If you take TIVICAY with food, you may take these supplements at the same time that you take TIVICAY. o If you do not take TIVICAY with food, take TIVICAY at least 2 hours before or 6 hours after you take these supplements. • Do not miss a dose of TIVICAY. • If you miss a dose of TIVICAY, take it as soon as you remember.

Do not take 2 doses at the same time or take more than your prescribed dose. • Stay under the care of a healthcare provider during treatment with TIVICAY. • Do not run out of TIVICAY… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 70 words ▾

Indications and Usage ( 1 ) 11/2017 Dosage and Administration, Pregnancy Testing before Initiation of TIVICAY ( 2.1 ) 09/2018 Dosage and Administration, Adults ( 2.2 ) Warnings and Precautions, Hepatotoxicity ( 5.2 ) 11/2017 11/2017 Warnings and Precautions, Fat Redistribution (previous 5.3) Removed 11/2017 Warnings and Precautions, Embryo-Fetal Toxicity ( 5.3 ) 09/2018 Warnings and Precautions, Risk of Adverse Reactions or Loss of Virologic Response ( 5.4 ) 11/2017

📄 Package Label / Principal Display Panel 11 words ▾

PACKAGE LABEL Label Image for 53808-1130 50mg Label Image for 50mg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Tivicay — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Tivicay. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$146.53M
Claims incl. refills
57.4K
Beneficiaries
21.8K
Spend / beneficiary
$6,716.27
Spend / claim
$2,554.95
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Who lists this product with the FDA?
DOH CENTRAL PHARMACY is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 53799-0277-11 · Similasan 53809-0201-01 · Domel →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.