Dobataf 3 — Dolutegravir / Emtricitabine / TAF Tablets, 30 Tablets

Dobataf-3 is supplied as film-coated tablets for oral administration.

Qualitative and Quantitative Composition per Tablet:

• • Dolutegravir (as dolutegravir sodium): 50 mg.
• • Emtricitabine: 200 mg.
• • Tenofovir Alafenamide (as fumarate): 25 mg.
• • Excipients: Microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, colloidal silicon dioxide; film-coating.

Packaging Configuration: Tablets are supplied in white HDPE bottles containing 30 tablets with child-resistant closures. Each bottle and outer carton display official Aurobindo branding, "For Oral Use Only" and "30 Tablets" label text.

Pharmacodynamics:
Dobataf-3 combines three antiretroviral agents targeting different stages of the HIV life cycle:

• • Dolutegravir: Inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral DNA integration.
• • Emtricitabine & Tenofovir Alafenamide: Substrate analogs that inhibit HIV-1 reverse transcriptase competitively, causing DNA chain termination.

Pharmacokinetics:

• • Absorption: Rapidly absorbed after oral administration. Food increases exposure to dolutegravir and TAF.
• • Distribution: Dolutegravir is highly bound to plasma proteins (>99%). TAF accumulates intracellularly in PBMCs.
• • Metabolism: Dolutegravir is metabolized by UGT1A1 and CYP3A4. TAF is hydrolyzed intracellularly by cathepsin A.
• • Elimination: Dolutegravir is cleared via hepatic metabolism; emtricitabine and TAF metabolites are excreted renally.

Dobataf-3 is indicated for the treatment of HIV-1 infection in adults and pediatric patients (aged 12 years and older weighing at least 40 kg):

• • Antiretroviral-naïve patients without prior treatment history.
• • Virologically suppressed patients (HIV-1 RNA < 50 copies/mL) on a stable ART regimen with no history of treatment failure or known resistance to individual components.

Treatment with Dobataf-3 should be prescribed by a physician experienced in managing HIV infection.

Method of Administration:
Take 1 tablet orally once daily. Taking the tablet with food is recommended to optimize drug absorption. Swallow the tablet whole with water. Do not chew or crush the tablet.

Missed Dose: If a dose is missed by less than 18 hours, take it as soon as remembered and resume the normal daily schedule. If missed by more than 18 hours, skip the missed dose.

Administration of Dobataf-3 is contraindicated in:

• • Hypersensitivity: Known hypersensitivity to dolutegravir, emtricitabine, tenofovir alafenamide, or any excipients.
• • Co-administration with Dofetilide: Risk of significant dofetilide plasma elevation and life-threatening arrhythmias.
• • Co-administration with Strong CYP3A/UGT1A1 Inducers (carbamazepine, phenytoin, rifampin, St. John's Wort): Significantly reduces plasma levels of active components.
• • Age/Weight: Pediatric patients under 12 years or weighing under 40 kg.

Concomitant medications must be carefully reviewed when prescribing Dobataf-3:

• • Cation-containing Antacids & Supplements (Mg, Al, Fe, Ca): Bind dolutegravir and decrease absorption. Administer Dobataf-3 at least 2 hours before or 6 hours after cation supplements.
• • Metformin: Dolutegravir increases metformin plasma levels; blood glucose monitoring and dose adjustment may be required.
• • Hepatitis B Co-infection: Discontinuation in HBV co-infected patients may trigger severe acute exacerbations of hepatitis.

Pregnancy:
Use during pregnancy should be considered only if the potential benefit outweighs potential fetal risk. Neural tube defect risks associated with dolutegravir during the first trimester should be discussed.

Lactation:
Women living with HIV should not breastfeed to prevent postnatal HIV transmission. Drug components are excreted in human milk.

Dobataf-3 is generally well tolerated. Common adverse reactions include:

• • Nervous System: Headache, insomnia, abnormal dreams, dizziness.
• • Gastrointestinal: Nausea, diarrhea, flatulence, abdominal pain.
• • Dermatologic: Rash, pruritus.
• • Laboratory Abnormalities: Elevations in CPK, ALT, AST, and benign, reversible increases in serum creatinine due to OCT2 inhibition.
• • Immune Reconstitution Inflammatory Syndrome (IRIS): May occur during initiation in severely immunocompromised patients.

Symptoms:
Experience with acute overdose is limited. Exacerbation of known adverse events may occur.

Treatment:
No specific antidote exists. Supportive care and monitoring are recommended. Hemodialysis removes emtricitabine but is ineffective for dolutegravir or TAF.

Storage Requirements for Dobataf-3:

• 🌡️ Temperature: Store below 30°C.
• ☀️ Moisture Protection: Store in the original container with the cap tightly closed to protect from moisture. Do not remove desiccant.
• 👶 Safety: Keep out of reach of children.
• ⏳ Shelf Life: Stated on the bottle and box. Rx Only.

To verify the authenticity of original Dobataf-3 manufactured by Aurobindo Pharma, check the following details:

• ✅ Aurobindo Corporate Logo: Official blue Aurobindo logo (stylized 'A' in circle) printed on the carton and bottle label.
• ✅ Product Title: Branding "Dobataf-3™" in cyan and orange lettering, with Hindi script underneath.
• ✅ Color Accent: Clean white box layout with teal and orange curved borders.
• ✅ Carton Marking: Includes "For Oral Use Only", "30 Tablets", and "For India Only" designations.
• ✅ Batch Identification: Stamped Lot/Batch Number, MFG Date, and Expiration Date on bottle and box flaps.