

Spegra Tablet (Dolutegravir 50mg + Emtricitabine 200mg + Tenofovir Alafenamide 25mg)
Manufactured By
Emcure
Pack Of
90
Salt Composition
Dolutegravir 50mg + Emtricitabine 200mg + Tenofovir Alafenamide 25mg
Storage
Ambient / below 30°C
Overview
Spegra Tablet is a fixed-dose HIV treatment containing dolutegravir 50mg, emtricitabine 200mg and tenofovir alafenamide (TAF) 25mg. Dolutegravir is an integrase strand-transfer inhibitor (INSTI), while emtricitabine 200mg and TAF are NRTIs. Integrase-based regimens are preferred in many current treatment guidelines because they provide rapid viral suppression and a high resistance barrier. TAF delivers lower circulating tenofovir 25mg exposure than TDF, generally reducing kidney and bone toxicity, although weight and lipid changes can be clinically relevant.
Quick Product Facts
| Field | Publication wording |
|---|---|
| Brand | Spegra |
| Molecule / Combination | Dolutegravir 50 mg + Emtricitabine 200 mg + Tenofovir alafenamide 25 mg |
| Strength / Composition | 50mg/ 200mg/ 25mg |
| Dosage form | Tablet |
| Manufacturer / Marketer | Emcure Pharmaceuticals Ltd |
| Pack / Presentation | Pack / Presentation |
| Storage | Ambient / below 30°C; verify exact pack. |
| Prescription | Required |
Uses and Indications
This combination is used as a complete once-daily regimen for HIV-1 infection in appropriately selected adults/adolescents where locally approved. Before initiation or switching, clinicians review prior resistance, hepatitis B status, kidney function, pregnancy considerations, and drug interactions. FTC and TAF suppress HBV; stopping them in HBV coinfection can cause severe hepatitis flare. Spegra is not a PrEP product unless specifically approved for that purpose in the jurisdiction.
How Spegra Tablet Works
Dolutegravir 50 mg + Emtricitabine 200 mg + Tenofovir alafenamide 25 mg blocks HIV integrase and prevents viral DNA from integrating into host-cell DNA. FTC and tenofovir 25mg diphosphate inhibit reverse transcriptase and terminate viral DNA elongation.
Clinical Evidence for Spegra Tablet
ADVANCE: Dolutegravir, emtricitabine, and tenofovir alafenamide with FTC/TAF or FTC/TDF achieved strong virologic efficacy compared with efavirenz-based ART; weight gain differed between regimens.
Integrase-regimen evidence: Multiple phase III studies established dolutegravir as a potent, high-barrier anchor drug for initial ART.
Side Effects of Spegra Tablet
Like most antiretroviral medications, the Spegra tablet can cause side effects as your body adjusts to the treatment.
Common side effects
- Headache
- Insomnia
- Nausea
- Diarrhea
- Weight gain
- Fatigue
Serious side effects
- Severe hypersensitivity
- Hepatotoxicity
- HBV flare after discontinuation
- Drug interactions causing loss of virologic control
Critical Safety Warning
HBV AND CATION-INTERACTION WARNING: Stopping FTC/TAF in HBV coinfection can trigger severe hepatitis. Dolutegravir 50 mg + Emtricitabine 200 mg + Tenofovir alafenamide 25 mg binds polyvalent cations, so antacids/mineral supplements can reduce absorption if timing is incorrect.
Spegra Tablet Dosage and How To Take It
Important: Dose and regimen must be prescribed by the treating specialist. Tablet/vial strength is not necessarily the patient dose. Do not start, stop, split, combine, or substitute treatment based on website information.
| Clinical situation | Dose |
|---|---|
| Fixed dose | One tablet once daily when the combination is appropriate. |
| Food | Can generally be taken with or without food. |
| Cautions | Separate from magnesium/aluminum antacids; calcium/iron timing depends on whether taken with food. |
| Renal/hepatic impairmentCautions | Fixed-dose use depends on the current label thresholds. |
Spegra Tablet Missed Dose
Take a missed dose when remembered unless it is close to the next dose; do not double. Repeated missed doses can cause viral rebound and resistance.
Safety Advice for Spegra Tablet
| Category | Status | Guidance |
|---|---|---|
| Pregnancy | Specialist guided | Dolutegravir 50mg-based ART is widely recommended in pregnancy in current HIV guidance, but care is individualised. |
| Kidney | Monitor | TAF is kidney-sparing versus TDF but renal function is still assessed. |
| HBV | Do not stop abruptly | Monitor for hepatic flare. |
| Weight/lipids | Monitor | Weight gain and lipid changes can occur. |
| Driving | Usually minimal | Avoid if dizziness occurs. |
Monitoring During Spegra Tablet Treatment
Regular monitoring during Spegra treatment is essential for assessing safety, viral suppression, and overall health outcomes.
- HIV viral load
- Renal function
- Liver function/HBV status
- Weight and metabolic parameters
- Adherence and resistance history
Spegra Tablet Fact Box
| Parameter | Verified / publication wording |
|---|---|
| Brand | Spegra |
| Generic / Combination | Dolutegravir 50 mg + Emtricitabine 200 mg + Tenofovir alafenamide 25 mg |
| Strength | 50mg/ 200mg/ 25mg |
| Form | Tablet |
| Manufacturer / Marketer | Emcure Pharmaceuticals Ltd |
| Pack | 30 tablets |
| Storage | Ambient / below 30°C |
| Major safety theme | HBV AND CATION-INTERACTION WARNING |
| Prescription | Yes |
Spegra Tablet Drug Interactions
| Drug / Class | Risk | What To Do |
|---|---|---|
| Antacids/iron/calcium | Can reduce dolutegravir tablet absorption | Use label-directed separation/timing. |
| Rifampicin and enzyme inducers | Can lower dolutegravir 50mg exposure | Dose strategy may require extra dolutegravir or alternative regimen. |
| Metformin | Dolutegravir, Emtricitabine & Tenofovir alafenamide can increase metformin exposure | Monitor and adjust metformin when needed. |
| Other tenofovir/FTC products | Duplicate therapy | Do not combine. |
FAQs About Spegra Tablet
Is Spegra a complete HIV regimen?
Yes, when the fixed-dose combination is appropriate for the patient.
Why is dolutegravir 50mg preferred in many guidelines?
It is potent, generally well tolerated, and has a high resistance barrier.
Can I take antacids at the same time?
Some antacids/mineral supplements must be separated because they bind dolutegravir 50mg.
Does TAF affect kidneys less than TDF?
TAF generally produces lower plasma tenofovir exposure and less renal/bone toxicity, though monitoring is still required.
Why is hepatitis B status important?
FTC/TAF also suppress HBV, and stopping can trigger a flare.
Can spegra cause weight gain?
Weight gain has been observed with integrase- and TAF-containing regimens.
Can I stop spegra treatment after viral load becomes undetectable?
No. ART must continue to maintain viral suppression.
Where can I get spegra tablet in India?
Current stock and prescription fulfillment can be confirmed by visiting our website. Availability may vary by location, so it is advised to first check the stock before placing an order.
References
- Current dolutegravir 50mg, emtricitabine 200mg and tenofovir alafenamide 25mg component prescribing information. https://hetero.com/images/pdf/DETaf_Tab_Leaf%20let_%20English.pdf.
- Current WHO/DHHS/IAS-USA HIV treatment guidelines. https://www.iasusa.org/2024/12/01/the-2024-ias-usa-hiv-treatment-and-prevention-guidelines-are-now-published/
- National library of medicine. dolutegravir, emtricitabine and tenofovir alafenamide treatment. https://pubmed.ncbi.nlm.nih.gov/33010240/
- National library of medicine. Clinical review report. https://www.ncbi.nlm.nih.gov/books/NBK538758/
Marketer Details
Emcure
Disclaimer
Globanspharma main goal is to ensure that its consumers get correct, authentic, and reliable information that has been examined by medical professionals. This website's content has only been created for informational purposes. However, this is not meant to replace the medical advice and treatment given by a qualified physician. The information presented herein may not cover everything about particular lab tests, medicines, and health conditions, all possible side effects, and warnings. Please discuss all your queries related to any medication and illness with your doctor. We intend to support and maintain the doctor-patient relationship, not to substitute it or take its place.


