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Active substance

Dolutegravir

Favourites

Integrase inhibitor antiretroviral. No registration in force in Georgia. Forms: coated tablet.

Dose and use

Doses

We have no dose with a cited source for this substance yet.

Before use

Safety information

No sourced safety entry is currently shown. This does not mean the substance is risk-free.

Latin name
Dolutegravir
Georgian name
დოლუტეგრავირი
Authorisation status
Human medicine, cascade use
No veterinary authorisation was found in any register checked. Veterinary use is off-label, under the prescribing cascade.
Registered in Georgia
0 of 3 forms
Products
Tivicay
Controlled in Georgia
No
Checked against the narcotics law, Annex 1, lists I-IV, and Order No. 22/n.
Verified on: 16 Oct 2026
All forms and registration3

Registration in Georgia and abroad: the register, number, validity and source are behind (i).

Tivicay 10 mg, Coated tablet

film-coated tablet, human medicine
vetman assessment
vetman’s 10-point assessment brings together a product’s regulatory credibility, clinical efficacy, safety and practicality. Cost-effectiveness is assessed only when reliable data are available. It is informational and does not replace a veterinarian’s clinical judgment for an individual patient.
Cat
2.6/10
Poor / unconvincing
vetman assessment

Tivicay

10 mg, film-coated tablet, human medicine
Assessed clinical scopeCat · Experimental oral use of this exact human Tivicay tablet as the dolutegravir component of combination antiretroviral therapy for feline immunodeficiency virus infection (FIV) · By mouth
Care settingExperimental specialist-managed use only, within a documented combination protocol with infectious-disease consultation, informed consent, baseline testing and predefined virological, haematological and biochemical monitoring.
vetman score 2.6/10 Poor / unconvincing
Evidence confidence: Low Georgia: Suspended · № რ-038589 · Verified on 16 Oct 2026 Off-label use

Poor/unconvincing, low-confidence experimental candidate (2.6/10). Exact human-product quality and integrase-inhibitor plausibility are clear, but the missing feline oral regimen, route/formulation mismatch and failure of the only direct combination study to significantly suppress viraemia do not support routine clinical use. The score is a negative evidence judgment, not a dosing recommendation.

Regulatory and scientific credibility3.0/10

The exact ViiV human product, strengths and current official labels are transparent and authorised in major human-medicine jurisdictions. The assessed feline oral FIV use has no veterinary authorisation, feline oral dossier or formulation-specific target-animal evidence; the species, route and regimen mismatch limits regulatory and scientific applicability.

Clinical efficacy2.0/10

The only direct feline study treated six experimentally infected cats with subcutaneous dolutegravir plus tenofovir and emtricitabine. Selected haematological and immunophenotypic findings improved, but blood and saliva viraemia did not fall significantly; the study cannot isolate dolutegravir, oral delivery or this tablet, and no natural-infection clinical outcome study establishes benefit.

Safety and tolerability2.5/10

Extensive human labelling and the small 18-week feline combination experiment provide limited safety context, not an oral feline safety profile. Oral exposure, chronic toxicity, resistance selection, reproductive safety, organ-disease effects and interaction magnitude in cats remain unvalidated, so a favourable safety judgment is not supported.

Clinical practicality3.0/10

The 10 mg tablet is the lowest whole-tablet strength and therefore the least impractical of the three, but no validated feline oral dose, PK bridge, tablet division/crushing instruction or treatment schedule exists. It cannot yet support an actionable prescription.

Full-course cost-effectiveness-

Current Georgian full-course price and a validated feline regimen are unavailable, so cost-effectiveness is not scored.

Important safety and use flags

  • No oral feline dose or treatment schedule is established for Tivicay. Do not convert the experimental 2.5 mg/kg/day subcutaneous figure into an oral-tablet prescription or use this assessment as a dosing recommendation.
  • The only direct feline study used daily subcutaneous dolutegravir together with tenofovir disoproxil fumarate and emtricitabine in six experimentally infected cats. It did not study oral tablets, monotherapy or naturally infected clinical patients.
  • The experimental combination produced selected haematological and immunophenotypic changes but no significant reduction in blood or saliva viraemia. Do not present it as proven antiviral control, clinical improvement or cure of FIV.
  • Any observed combination effect cannot be attributed to dolutegravir alone. Evidence for human HIV treatment, another antiretroviral, another species, another route or another virus must not be transferred to this exact feline use.
  • This exact 10 mg film-coated tablet has no validated score line, subdivision or crushing instruction for feline dosing. Do not estimate a cat dose from fragments or unmeasured crushed powder.
  • Polyvalent cations and antacids can reduce dolutegravir absorption. If experimental oral use is ever undertaken under a formal protocol, reconcile aluminium, magnesium, calcium, iron and sucralfate products and follow exact label separation rules.
  • Review all concomitant medicines for transporter and enzyme interactions, including metformin and strong inducers. Human product information also contraindicates dofetilide; species-specific interaction magnitude in cats is not established.
  • Feline safety, long-term toxicity, resistance selection, pregnancy, lactation and breeding safety for this oral product are not established. Monitor CBC, chemistry, hepatic variables, clinical status and protocol-defined viral endpoints; stop and reassess adverse findings.
Assessment sources
  1. Tivicay market audit2026
  2. Tivicay EU product information2026
  3. Tivicay US label2026
  4. Feline experimental cART study2023
  5. Australian feline retrovirus guideline2022
  6. AAFP retrovirus 20202020
  7. ABCD FIV guideline2024
Assessed: 24 Oct 2026The overall score uses 25/25/25/15/10 weights. An unassessed price is excluded and the remaining weights are proportionally renormalised.
Composition / strength
Dolutegravir10 mg
Formulation Type
Coated tablet
Administration route
By mouth
Manufacturer
ViiV Healthcare · United Kingdom
Registration
Georgia Suspended
Suspended or cancelled
Human (Ministry of Health, RAMA)
In the register: ტივიკაი 10 მგ, აპკიანი აბი
№ რ-038589
Verified on: 16 Oct 2026
 EU Yes, human
Verified on: 16 Oct 2026
 UK Yes, human
№ PLGB357280044, PLGB357280045, PLGB357280046, PLGB357280059
Verified on: 16 Oct 2026
 US Yes, human
№ NDA204790, NDA213983
Verified on: 16 Oct 2026
Controlled in Georgia
No
Checked against the narcotics law, Annex 1, lists I-IV, and Order No. 22/n.
Verified on: 16 Oct 2026

Tivicay 25 mg, Coated tablet

film-coated tablet, human medicine
vetman assessment
vetman’s 10-point assessment brings together a product’s regulatory credibility, clinical efficacy, safety and practicality. Cost-effectiveness is assessed only when reliable data are available. It is informational and does not replace a veterinarian’s clinical judgment for an individual patient.
Cat
2.4/10
Poor / unconvincing
vetman assessment

Tivicay

25 mg, film-coated tablet, human medicine
Assessed clinical scopeCat · Experimental oral use of this exact human Tivicay tablet as the dolutegravir component of combination antiretroviral therapy for feline immunodeficiency virus infection (FIV) · By mouth
Care settingExperimental specialist-managed use only, within a documented combination protocol with infectious-disease consultation, informed consent, baseline testing and predefined virological, haematological and biochemical monitoring.
vetman score 2.4/10 Poor / unconvincing
Evidence confidence: Low Georgia: Suspended · № რ-038590 · Verified on 16 Oct 2026 Off-label use

Poor/unconvincing, low-confidence experimental candidate (2.4/10). Exact human-product quality and integrase-inhibitor plausibility are clear, but the missing feline oral regimen, route/formulation mismatch and failure of the only direct combination study to significantly suppress viraemia do not support routine clinical use. The score is a negative evidence judgment, not a dosing recommendation.

Regulatory and scientific credibility3.0/10

The exact ViiV human product, strengths and current official labels are transparent and authorised in major human-medicine jurisdictions. The assessed feline oral FIV use has no veterinary authorisation, feline oral dossier or formulation-specific target-animal evidence; the species, route and regimen mismatch limits regulatory and scientific applicability.

Clinical efficacy2.0/10

The only direct feline study treated six experimentally infected cats with subcutaneous dolutegravir plus tenofovir and emtricitabine. Selected haematological and immunophenotypic findings improved, but blood and saliva viraemia did not fall significantly; the study cannot isolate dolutegravir, oral delivery or this tablet, and no natural-infection clinical outcome study establishes benefit.

Safety and tolerability2.5/10

Extensive human labelling and the small 18-week feline combination experiment provide limited safety context, not an oral feline safety profile. Oral exposure, chronic toxicity, resistance selection, reproductive safety, organ-disease effects and interaction magnitude in cats remain unvalidated, so a favourable safety judgment is not supported.

Clinical practicality2.0/10

The whole-only 25 mg tablet adds a substantial dose-unit precision problem for a cat, on top of the absent feline oral dose, PK bridge and treatment schedule. Unvalidated splitting or crushed-powder estimation would not make the regimen reliable.

Full-course cost-effectiveness-

Current Georgian full-course price and a validated feline regimen are unavailable, so cost-effectiveness is not scored.

Important safety and use flags

  • No oral feline dose or treatment schedule is established for Tivicay. Do not convert the experimental 2.5 mg/kg/day subcutaneous figure into an oral-tablet prescription or use this assessment as a dosing recommendation.
  • The only direct feline study used daily subcutaneous dolutegravir together with tenofovir disoproxil fumarate and emtricitabine in six experimentally infected cats. It did not study oral tablets, monotherapy or naturally infected clinical patients.
  • The experimental combination produced selected haematological and immunophenotypic changes but no significant reduction in blood or saliva viraemia. Do not present it as proven antiviral control, clinical improvement or cure of FIV.
  • Any observed combination effect cannot be attributed to dolutegravir alone. Evidence for human HIV treatment, another antiretroviral, another species, another route or another virus must not be transferred to this exact feline use.
  • This exact 25 mg film-coated tablet has no validated score line, subdivision or crushing instruction for feline dosing. Do not estimate a cat dose from fragments or unmeasured crushed powder.
  • Polyvalent cations and antacids can reduce dolutegravir absorption. If experimental oral use is ever undertaken under a formal protocol, reconcile aluminium, magnesium, calcium, iron and sucralfate products and follow exact label separation rules.
  • Review all concomitant medicines for transporter and enzyme interactions, including metformin and strong inducers. Human product information also contraindicates dofetilide; species-specific interaction magnitude in cats is not established.
  • Feline safety, long-term toxicity, resistance selection, pregnancy, lactation and breeding safety for this oral product are not established. Monitor CBC, chemistry, hepatic variables, clinical status and protocol-defined viral endpoints; stop and reassess adverse findings.
Assessment sources
  1. Tivicay market audit2026
  2. Tivicay EU product information2026
  3. Tivicay US label2026
  4. Feline experimental cART study2023
  5. Australian feline retrovirus guideline2022
  6. AAFP retrovirus 20202020
  7. ABCD FIV guideline2024
Assessed: 24 Oct 2026The overall score uses 25/25/25/15/10 weights. An unassessed price is excluded and the remaining weights are proportionally renormalised.
Composition / strength
Dolutegravir25 mg
Formulation Type
Coated tablet
Administration route
By mouth
Manufacturer
ViiV Healthcare · United Kingdom
Registration
Georgia Suspended
Suspended or cancelled
Human (Ministry of Health, RAMA)
In the register: ტივიკაი 25 მგ, აპკიანი აბი
№ რ-038590
Verified on: 16 Oct 2026
 EU Yes, human
Verified on: 16 Oct 2026
 UK Yes, human
№ PLGB357280044, PLGB357280045, PLGB357280046, PLGB357280059
Verified on: 16 Oct 2026
 US Yes, human
№ NDA204790, NDA213983
Verified on: 16 Oct 2026
Controlled in Georgia
No
Checked against the narcotics law, Annex 1, lists I-IV, and Order No. 22/n.
Verified on: 16 Oct 2026

Tivicay 50 mg, Coated tablet

film-coated tablet, human medicine
vetman assessment
vetman’s 10-point assessment brings together a product’s regulatory credibility, clinical efficacy, safety and practicality. Cost-effectiveness is assessed only when reliable data are available. It is informational and does not replace a veterinarian’s clinical judgment for an individual patient.
Cat
2.3/10
Poor / unconvincing
vetman assessment

Tivicay

50 mg, film-coated tablet, human medicine
Assessed clinical scopeCat · Experimental oral use of this exact human Tivicay tablet as the dolutegravir component of combination antiretroviral therapy for feline immunodeficiency virus infection (FIV) · By mouth
Care settingExperimental specialist-managed use only, within a documented combination protocol with infectious-disease consultation, informed consent, baseline testing and predefined virological, haematological and biochemical monitoring.
vetman score 2.3/10 Poor / unconvincing
Evidence confidence: Low Georgia: Expired · № რ-029990 · Verified on 15 Oct 2026 Off-label use

Poor/unconvincing, low-confidence experimental candidate (2.3/10). Exact human-product quality and integrase-inhibitor plausibility are clear, but the missing feline oral regimen, route/formulation mismatch and failure of the only direct combination study to significantly suppress viraemia do not support routine clinical use. The score is a negative evidence judgment, not a dosing recommendation.

Regulatory and scientific credibility3.0/10

The exact ViiV human product, strengths and current official labels are transparent and authorised in major human-medicine jurisdictions. The assessed feline oral FIV use has no veterinary authorisation, feline oral dossier or formulation-specific target-animal evidence; the species, route and regimen mismatch limits regulatory and scientific applicability.

Clinical efficacy2.0/10

The only direct feline study treated six experimentally infected cats with subcutaneous dolutegravir plus tenofovir and emtricitabine. Selected haematological and immunophenotypic findings improved, but blood and saliva viraemia did not fall significantly; the study cannot isolate dolutegravir, oral delivery or this tablet, and no natural-infection clinical outcome study establishes benefit.

Safety and tolerability2.5/10

Extensive human labelling and the small 18-week feline combination experiment provide limited safety context, not an oral feline safety profile. Oral exposure, chronic toxicity, resistance selection, reproductive safety, organ-disease effects and interaction magnitude in cats remain unvalidated, so a favourable safety judgment is not supported.

Clinical practicality1.0/10

The whole-only 50 mg tablet has the greatest dose-unit mismatch for a cat, while no feline oral dose, PK bridge or treatment schedule exists. It is the least practical presentation and must not be converted from the experimental SC figure.

Full-course cost-effectiveness-

Current Georgian full-course price and a validated feline regimen are unavailable, so cost-effectiveness is not scored.

Important safety and use flags

  • No oral feline dose or treatment schedule is established for Tivicay. Do not convert the experimental 2.5 mg/kg/day subcutaneous figure into an oral-tablet prescription or use this assessment as a dosing recommendation.
  • The only direct feline study used daily subcutaneous dolutegravir together with tenofovir disoproxil fumarate and emtricitabine in six experimentally infected cats. It did not study oral tablets, monotherapy or naturally infected clinical patients.
  • The experimental combination produced selected haematological and immunophenotypic changes but no significant reduction in blood or saliva viraemia. Do not present it as proven antiviral control, clinical improvement or cure of FIV.
  • Any observed combination effect cannot be attributed to dolutegravir alone. Evidence for human HIV treatment, another antiretroviral, another species, another route or another virus must not be transferred to this exact feline use.
  • This exact 50 mg film-coated tablet has no validated score line, subdivision or crushing instruction for feline dosing. Do not estimate a cat dose from fragments or unmeasured crushed powder.
  • Polyvalent cations and antacids can reduce dolutegravir absorption. If experimental oral use is ever undertaken under a formal protocol, reconcile aluminium, magnesium, calcium, iron and sucralfate products and follow exact label separation rules.
  • Review all concomitant medicines for transporter and enzyme interactions, including metformin and strong inducers. Human product information also contraindicates dofetilide; species-specific interaction magnitude in cats is not established.
  • Feline safety, long-term toxicity, resistance selection, pregnancy, lactation and breeding safety for this oral product are not established. Monitor CBC, chemistry, hepatic variables, clinical status and protocol-defined viral endpoints; stop and reassess adverse findings.
Assessment sources
  1. Tivicay market audit2026
  2. Tivicay EU product information2026
  3. Tivicay US label2026
  4. Feline experimental cART study2023
  5. Australian feline retrovirus guideline2022
  6. AAFP retrovirus 20202020
  7. ABCD FIV guideline2024
Assessed: 24 Oct 2026The overall score uses 25/25/25/15/10 weights. An unassessed price is excluded and the remaining weights are proportionally renormalised.
Composition / strength
Dolutegravir50 mg
Formulation Type
Coated tablet
Administration route
By mouth
Manufacturer
ViiV Healthcare · United Kingdom
Registration
Georgia Expired
Expired on 01 May 2025, not renewed yet
Human (Ministry of Health, RAMA)
In the register: ტივიქეი 50მგ
№ რ-029990
Verified on: 15 Oct 2026
 EU Yes, human
Verified on: 16 Oct 2026
 UK Yes, human
№ PLGB357280044, PLGB357280045, PLGB357280046, PLGB357280059
Verified on: 16 Oct 2026
 US Yes, human
№ NDA204790, NDA213983
Verified on: 16 Oct 2026
Controlled in Georgia
No
Checked against the narcotics law, Annex 1, lists I-IV, and Order No. 22/n.
Verified on: 16 Oct 2026

Professional reference for veterinary professionals. Not advertising and not a substitute for the product label/SPC.

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This reference is still growing. Missing a product? Let us know. · Report an error or request an addition · Updated: 16 Oct 2026

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