Dolutegravir is an active pharmaceutical ingredient in the Integrase Inhibitors group (J05AJ). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
CAOfficial regulatory label· revised May 6, 2026[1]
Sandoz Dolutegravir, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adults and in INSTI-naïve children at least 6 years of age and weighing ≥ 40kg.
1 Pediatrics Pediatrics (aged less than 6 years or weighing less than 40 kg or INSTI-experienced): Safety and efficacy of dolutegravir have not been established in children aged less than 6 years or who are INSTI-experienced with documented or clinical suspected resistance to other INSTIs.
Sandoz Dolutegravir is not recommended in patients weighing less than 40 kg because no dose adjustment can be made. 2 Geriatrics Geriatrics (> 65 years of age): Clinical studies of dolutegravir did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from adult patients < 65 years of age.
GBUnited Kingdom· MHRA
6 products
Uses
GBOfficial regulatory label· revised May 29, 2026[2]
Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg.
How to take
GB
EUEuropean Union· EMA
3 products
Uses
EUOfficial regulatory label· revised February 16, 2026[3]
1).
How to take
EUOfficial regulatory label· revised February 16, 2026
Drug interactions
Known interactions involving Dolutegravir. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]Health Canada (DPD) · 02501457 · revised May 6, 2026
[2]MHRA (UK) · PLGB357280044 · revised May 29, 2026
[3]European Medicines Agency · EMEA/H/C/004909 · revised February 16, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
How to take
CAOfficial regulatory label· revised May 6, 2026[1]
1 Dosing Considerations As with all antiretroviral drugs, dolutegravir therapy should be initiated by a healthcare practitioner experienced in the management of HIV infection. Perform pregnancy testing before initiation of Sandoz Dolutegravir in individuals of childbearing potential.
Sandoz Dolutegravir (dolutegravir sodium) Product Monograph Page 5 of 60 The following should be considered prior to initiating treatment with dolutegravir: • Poor virologic response was observed in subjects treated with Sandoz Dolutegravir 50mg twice daily with an integrase strand transfer inhibitor (INSTI) -resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions, including, but not limited to T66A, L74I/M, E138A/K/T, G140A/C/S, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R.
Dolutegravir tablets may be taken with or without food. Sandoz Dolutegravir is available as tablets. For dosing recommendations using tablets see the recommenced dose for adults and Table 2 for pediatric patients. 2 Recommended Dose and Dosage Adjustment Adult Patients Table 1 Recommended Dosing Regimen in Adults Patient Population Tablet Dose Regimen Treatment-naïvea 50 mg QD* Treatment-experienced, INSTI- naïvea 50 mg QD Treatment-experienced, INSTI- resistantb 50 mg BID** * QD – once daily ** BID – twice daily a The dose of dolutegravir is 50 mg twice daily when co-administered with potent UGT1A/CYP3A inducers, including efavirenz, tipranavir/ritonavir, fosamprenavir/ritonavir or rifampin (see 9 DRUG INTERACTIONS).
b Alternative combinations that do not include metabolic inducers should be used where possible for INSTI-resistant patients. The safety and efficacy of doses above 50 mg twice daily have not been evaluated (see 9 DRUG INTERACTIONS).
Geriatrics There are limited data available on the use of dolutegravir in patients aged 65 years and older. In general, caution should be exercised in the administration of Sandoz Dolutegravir in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Pediatric Treatment-naive or Treatment-experienced INSTI-naive Sandoz Dolutegravir (dolutegravir sodium) Product Monograph Page 6 of 60 The recommended dose of Sandoz Dolutegravir in pediatric patients aged at least 6 years and weighing at least 40 kg is provided in Table 2.
Safety and efficacy of dolutegravir have not been established in pediatric patients aged less than 6 years, or who are INSTI-experienced with suspected or confirmed INSTI-resistant HIV-1. Sandoz Dolutegravir is not recommended in patients weighing less than 40 kg because no dose adjustment can be made.
Table 2 Recommended Dosing Regimen in pediatric patients Body Weight (kg) Once Daily Dosing Regimena ≥ 40 50 mg (one 50 mg tablet) a If certain UGT1A or CYP3A inducers including efavirenz, tipranavir/ritonavir, fosamprenavir/ritonavir or rifampin are coadministered, then increase the weight-based dose of dolutegravir to twice daily (see 9 DRUG INTERACTIONS).
To reduce the risk of choking, do not swallow more than one tablet at a time. Hepatic Insufficiency No dosage adjustment is required in patients with mild or moderate hepatic impairment (Child- Pugh Score A or B). The effect of severe hepatic impairment (Child-Pugh Score C) on the pharmacokinetics of dolutegravir has not been studied.
3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency). Renal Insufficiency Dolutegravir plasma concentrations were decreased in subjects with severe renal impairment compared with those in matched healthy controls.
No dosage adjustment is required in INSTI- naïve patients with mild, moderate or severe (CrCl<30 mL /min, not on dialysis) renal impairment. Caution is advised for INSTI-resistant patients with severe renal impairment as the decreased dolutegravir exposure may result in loss of therapeutic effect and development of resistance to dolutegravir.
3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). 5 Missed Dose If a dose is missed, patients should take the missed dose as soon as possible unless it is within 4 hours of their next scheduled dose. If a dose is skipped, the patient should not double the next dose.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised May 6, 2026[1]
1 Adverse Reaction Overview The overall safety profile of dolutegravir is based on over 1500 HIV-infected patients treated with a dolutegravir-based regimen in Phase 2 and 3 clinical studies. The overall safety profile was similar across the treatment-naïve, treatment-experienced (and integrase-naïve) and integrase-resistant patient populations.
The most common adverse reactions of moderate to severe intensity and incidence ≥ 2% (in those receiving dolutegravir in any one study) are insomnia, headache, fatigue, nausea, and diarrhea. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from Sandoz Dolutegravir (dolutegravir sodium) Product Monograph Page 12 of 60 clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Treatment-Naïve Patients The safety assessment of dolutegravir in HIV-1-infected treatment-naïve patients is based on the analyses of 48-week data from two randomized, ongoing, international, multicentre, double-blind studies, SPRING-2 (ING113086) and SINGLE (ING114467).
In SPRING-2, 822 adult patients were randomized and received at least one dose of either dolutegravir 50 mg once daily (QD) or ISENTRESS 400 mg twice daily (BID), both in combination with fixed-dose dual nucleoside reverse transcriptase inhibitor (NRTI) treatment (either abacavir sulfate and lamivudine [KIVEXA] or emtricitabine/tenofovir [TRUVADA]).
The rate of adverse events leading to discontinuation was 2% in both treatment arms. In SINGLE, 833 adult patients were randomized to receive at least one dose of either dolutegravir 50 mg with fixed-dose abacavir and lamivudine (KIVEXA) once daily or fixed-dose efavirenz/emtricitabine/tenofovir (ATRIPLA) once daily.
The rate of adverse events leading to discontinuation were 2% in patients receiving dolutegravir 50 mg once daily + KIVEXA and 10% in patients receiving ATRIPLA once daily. Treatment-emergent adverse reactions (adverse events assessed as causally related by the investigators) of moderate to severe intensity with a ≥ 2% frequency in either treatment arm in SPRING-2 and SINGLE studies are provided in Table 4.
The adverse drug reactions and laboratory abnormalities observed at 96 weeks in SPRING-2 and at 144 weeks in SINGLE were generally consistent with those seen at 48 weeks.
Table 4:
Treatment-Emergent Adverse Reactions of at Least Moderate Intensity (Grades 2-4) and ≥ 2% Frequency in Treatment-Naïve Patients in SPRING-2 and SINGLE Trials (Through 48 weeks) SPRING-2 SINGLE Body System/ Preferred Term Dolutegravir 50 mg QD + 2 NRTIs (N = 411) ISENTRESS 400 mg BID + 2 NRTIs (N = 411) Dolutegravir 50 mg + KIVEXA QD (N = 414) ATRIPLA QD (N = 419) Psychiatric Insomnia Abnormal dreams 1 (<1%) 1 (<1%) 1 (<1%) 1 (<1%) 13 (3%) 2 (<1%) 9 (2%) 8 (2%) Nervous System Dizziness 1 (<1%) 1 (<1%) 2 (<1%) 19 (5%) Sandoz Dolutegravir (dolutegravir sodium) Product Monograph Page 13 of 60 SPRING-2 SINGLE Body System/ Preferred Term Dolutegravir 50 mg QD + 2 NRTIs (N = 411) ISENTRESS 400 mg BID + 2 NRTIs (N = 411) Dolutegravir 50 mg + KIVEXA QD (N = 414) ATRIPLA QD (N = 419) Headache 3 (<1%) 4 (<1%) 7 (2%) 9 (2%) Gastrointestinal Nausea Diarrhea 6 (1%) 2 (<1%) 5 (1%) 2 (<1%) 3 (<1%) 4 (<1%) 12 (3%) 7 (2%) Skin and Subcutaneous Tissue Rash 0 2 (<1%) 1 (<1%) 14 (3%) Ear and Labyrinth Vertigo 0 1 (<1%) 0 7 (2%) Antiretroviral-Experienced and Integrase Inhibitor-Naïve Patients In an international, multicentre, double-blind study (ING111762, SAILING), 719 HIV-1-infected, antiretroviral treatment-experienced adults were randomized to receive either dolutegravir 50 mg once daily or ISENTRESS 400 mg twice daily with investigator-selected background regimen (BR) consisting of up to 2 agents, including at least one fully active agent.
At 48 weeks, the rates of adverse events leading to discontinuation were 2% (7/357) in patients receiving dolutegravir 50 mg once daily + BR and 4% (13/362) in patients receiving ISENTRESS 400 mg twice daily + BR. Through 48 wks, the only treatment-emergent adverse reaction of moderate to severe intensity with a ≥ 2% frequency in either treatment group was diarrhea, 2% (6/357) in subjects receiving dolutegravir 50 mg once daily + BR and 1% (5/362) in subjects receiving ISENTRESS 400 mg twice daily + BR.
Integrase Inhibitor-Resistant Patients In a multicentre, open-label, single-arm study (ING112574, VIKING-3), 183 HIV-1-infected, antiretroviral treatment-experienced adults with virologic failure with current or historical evidence of raltegravir and/or elvitegravir resistance received dolutegravir 50 mg twice daily with the current failing background regimen for 7 days and with Optimized Background Therapy (OBT) from Day 8.
The rate of discontinuation due to adverse events was 4% of patients at the Week 48 analysis. Treatment-emergent adverse reactions (adverse events assessed as causally related by the investigator) of moderate to severe intensity with a ≥ 2% frequency are listed in Table 5.
Table 5:
Treatment-Emergent Adverse Reactions of at Least Moderate Intensity (Grades 2 to 4) and ≥ 2% Frequency in Integrase Inhibitor-Resistant Patients in the VIKING-3 Study (Week 24 and Week 48 Analyses) Sandoz Dolutegravir (dolutegravir sodium) Product Monograph Page 14 of 60 Week 24 Week 48 Body System/ Preferred Term Dolutegravir 50 mg BID + OBT (N = 183) Dolutegravir 50 mg BID + OBT (N = 183) Gastrointestinal Diarrhea Nausea 4 (2%) 3 (2%) 4 (2%) 3 (2%) Nervous System Headache 3 (2%) 2 (1%) Co-infection with Hepatitis B or C In Phase III studies, patients with hepatitis B and/or C co-infection were permitted to enrol provided that baseline liver chemistry tests did not exceed 5 times the upper limit of normal (ULN).
Overall, the […]
CAOfficial regulatory label· Warnings and precautions· revised May 6, 2026[1]
General Patients receiving Sandoz Dolutegravir or any other antiretroviral therapy may still develop Sandoz Dolutegravir (dolutegravir sodium) Product Monograph Page 8 of 60 opportunistic infections and other complications of HIV infection.
Therefore patients should remain under close clinical observation by physicians experienced in the treatment of these associated HIV diseases. While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded Precautions to prevent transmission should be taken in accordance with national guidelines.
Driving and Operating Machinery Exercise caution when driving or operating a vehicle or potentially dangerous machinery. Hepatic/Biliary/Pancreatic Hepatoxicity Cases of hepatic toxicity including elevated serum liver biochemistries, hepatitis, and acute liver failure have been reported in patients receiving a dolutegravir-containing regimen who had no pre-existing hepatic disease or other identifiable risk factors.
Drug-induced liver injury leading to liver transplant has been reported with TRIUMEQ (dolutegravir/abacavir/lamivudine). Monitoring for hepatotoxicity is recommended. Liver chemistry changes in patients with hepatitis B or C co-infection Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of dolutegravir.
Liver chemistry elevations consistent with immune reconstitution inflammatory syndrome were observed in some hepatitis B and/or C co- infected patients at the start of dolutegravir therapy. Monitoring of liver chemistries is recommended in patients with hepatitis B and/or C co-infection.
2 Clinical Trial Adverse Reactions, Co-infection with Hepatitis B or C). Hypersensitivity Reactions Hypersensitivity reactions have been reported with integrase inhibitors, including dolutegravir, and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including liver injury.
Discontinue Sandoz Dolutegravir 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, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema).
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised May 6, 2026[1]
• Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Sandoz Dolutegravir is contraindicated in combination with drugs with narrow therapeutic windows, that are substrates of organic cation transporter 2 (OCT2), including but not limited to dofetilide, or fampridine (also known as dalfampridine) (see 9 DRUG INTERACTIONS).
This is not medical advice. Consult a qualified healthcare professional.
Tivicay should be prescribed by physicians experienced in the management of HIV infection. Posology Adults Patients infected with HIV-1 without documented or clinically suspected resistance to the integrase class The recommended dose of dolutegravir is 50 mg orally once daily.
g. efavirenz, nevirapine, tipranavir/ritonavir, or rifampicin). 5. Patients infected with HIV-1 with resistance to the integrase class (documented or clinically suspected) The recommended dose of dolutegravir is 50 mg twice daily. 2). 1).
Adolescents aged 12 and above, to less than 18 years, and weighing at least 20 kg In patients infected with HIV-1 without resistance to the integrase class, the recommended dose of dolutegravir is 50 mg once daily. 2). In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for dolutegravir in adolescents.
2). 2). Table 2 Alternative paediatric dose recommendations for film-coated tablets Body weight (kg) Dose 14 to less than 20 20 mg twice daily 20 or greater 25 mg twice daily In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for dolutegravir in children.
Dispersible Tablets Tivicay is available as film-coated tablets for patients aged 6 years and above and weighing at least 14 kg. Tivicay is also available as dispersible tablets for patients aged 4 weeks and above and weighing at least 3 kg, or for patients in whom film- coated tablets are not appropriate.
Patients can change between film-coated tablets and dispersible tablets. 2). For example, the recommended adult dose for film-coated tablets is 50 mg versus 30 mg for dispersible tablets. Patients changing between film-coated and dispersible tablets should follow the dosing recommendations that are specific for the formulation.
Missed doses If the patient misses a dose of Tivicay, the patient should take Tivicay as soon as possible, providing the next dose is not due within 4 hours. If the next dose is due within 4 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Elderly There are limited data available on the use of dolutegravir in patients aged 65 years and over. 2). Renal impairment No dosage adjustment is required in patients with mild, moderate or severe (CrCl <30 mL/min, not on dialysis) renal impairment.
2). Hepatic impairment No dosage adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh grade A or B). 2). Paediatric population Dolutegravir is also available in dispersible tablets for children aged 4 weeks and above and weighing at least 3 kg.
However, the safety and efficacy of dolutegravir in children aged less than 4 weeks or weighing less than 3 kg have not yet been established. In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for dolutegravir in children and adolescents.
2, but no recommendation on a posology can be made. Method of administration Oral use. 2). 2). To reduce the risk of choking, patients should not swallow more than one tablet at a time, and where possible, children weighing 14 to less than 20 kg should preferentially take the dispersible tablet formulation.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 29, 2026[2]
4). The most commonly seen treatment emergent adverse reactions were nausea (13%), diarrhoea (18%) and headache (13%). Tabulated list of adverse reactions The adverse reactions considered at least possibly related to dolutegravir are listed by body system, organ class and absolute frequency.
Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000). 4) 2 Common Insomnia Common Abnormal dreams Common Depression Common Anxiety Uncommon Panic attack Psychiatric disorders Uncommon Suicidal ideation*, suicide attempt* *particularly in patients with a pre-existing history of depression or psychiatric illness.
Rare Completed suicide* *particularly in patients with a pre-existing history of depression or psychiatric illness. Very common HeadacheNervous system disorders Common Dizziness Very common Nausea Very common Diarrhoea Common Vomiting Common Flatulence Common Upper abdominal pain Common Abdominal pain Gastrointestinal disorders Common Abdominal discomfort Common Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) elevations Uncommon Hepatitis Hepatobiliary disorders Rare Acute hepatic failure, increased bilirubin3 Common RashSkin and subcutaneous tissue disorders Common Pruritus Uncommon ArthralgiaMusculoskeletal and connective tissue disorders Uncommon Myalgia General disorders and administration site conditions Common Fatigue Investigations Common Creatine phosphokinase (CPK) elevations, weight increased 1reversible sideroblastic anaemia has been reported with dolutegravir-containing regimens.
The contribution of dolutegravir in these cases is unclear. 2see below under Description of selected adverse reactions. 3in combination with increased transaminases Description of selected adverse reactions Changes in laboratory biochemistries Increases in serum creatinine occurred within the first week of treatment with dolutegravir and remained stable through 48 weeks.
96 μmol/L was observed after 48 weeks of treatment. Creatinine increases were comparable by various background regimens. These changes are not considered to be clinically relevant since they do not reflect a change in glomerular filtration rate.
Co-infection with Hepatitis B or C In Phase III studies patients with hepatitis B and/or C co-infection were permitted to enrol provided that baseline liver chemistry tests did not exceed 5 times the upper limit of normal (ULN). Overall, the safety profile in patients co-infected with hepatitis B and/or C was similar to that observed in patients without hepatitis B or C co- infection, although the rates of AST and ALT abnormalities were higher in the subgroup with hepatitis B and/or C co-infection for all treatment groups.
4). Immune reactivation syndrome In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
4). 4). Paediatric population Based on available data from the ongoing P1093 (ING112578) and ODYSSEY (201296) studies in 172 infants, children and adolescents (aged 4 weeks and above, to less than 18 years, and weighing at least 3 kg) who received the recommended doses of film-coated tablets or dispersible tablets once daily, there were no additional types of adverse reactions beyond those observed in the adult population.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised May 29, 2026[2]
1). 2). Hypersensitivity reactions Hypersensitivity reactions have been reported with dolutegravir, and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including severe liver reactions. Dolutegravir and other suspect medicinal products should be discontinued immediately if signs or symptoms of hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by raised liver enzymes, fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, eosinophilia, angioedema).
Clinical status including liver aminotransferases and bilirubin should be monitored. Delay in stopping treatment with dolutegravir or other suspect active substances after the onset of hypersensitivity may result in a life-threatening allergic reaction.
Immune Reactivation Syndrome In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART. Relevant examples are Cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary. Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reconstitution, however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Liver biochemistry elevations consistent with immune reconstitution syndrome were observed in some hepatitis B and/or C co-infected patients at the start of dolutegravir therapy. Monitoring of liver biochemistries is recommended in patients with hepatitis B and/or C co-infection.
8). Opportunistic infections Patients should be advised that dolutegravir or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 29, 2026[2]
1. 5).
This is not medical advice. Consult a qualified healthcare professional.
Dovato should be prescribed by physicians experienced in the management of HIV infection. Posology Adults and adolescents (above 12 years of age weighing at least 40 kg). The recommended dose of Dovato in adults and adolescents is one 50 mg/300 mg tablet once daily.
g. rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. 5). In these cases the physician should refer to the individual product information for dolutegravir. Missed doses If the patient misses a dose of Dovato, the patient should take Dovato as soon as possible, providing the next dose is not due within 4 hours.
If the next dose is due within 4 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. Elderly There are limited data available on the use of Dovato in patients aged 65 years and over. 2). 2).
No dose adjustment is required in patients with mild or moderate renal impairment. 4). Hepatic impairment No dosage adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh grade A or B). 2). Paediatric population The safety and efficacy of Dovato in children aged less than 12 years and in adolescents weighing less than 40 kg have not been established.
No data are available. Method of administration Oral use. 2).
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised February 16, 2026[3]
Summary of the safety profile The most frequently reported adverse reactions are headache (3%), diarrhoea (2%), nausea (2%) and insomnia (2%). 4). Tabulated list of adverse reactions The adverse reactions from clinical study and post-marketing experience are listed in Table 2 by body system, organ class and absolute frequency.
Frequencies are defined as very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data). 4) Metabolism and nutrition disorders: Very rare: lactic acidosis Psychiatric disorders: Common: depression, anxiety, insomnia, abnormal dreams Uncommon: suicidal ideation*, suicide attempt*, panic attack *particularly in patients with a pre-existing history of depression or psychiatric illness.
Rare: completed suicide* *particularly in patients with a pre-existing history of depression or psychiatric illness.
Nervous system disorders:
Very common: headache Common: dizziness, somnolence Very rare: peripheral neuropathy, paraesthesia Gastrointestinal disorders: Very common: nausea, diarrhoea Common: vomiting, flatulence, abdominal pain/ discomfort Rare: pancreatitis Hepatobiliary disorders: Common: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) elevations Uncommon: hepatitis Rare: acute hepatic failure2, increased bilirubin3 Skin and subcutaneous tissue disorders: Common: rash, pruritus, alopecia Rare: angioedema Musculoskeletal and connective tissue disorders: Common: arthralgia, muscle disorders (including myalgia) Rare: rhabdomyolysis General disorders and administration site conditions: Common: fatigue Investigations: Common: creatine phosphokinase (CPK) elevations, weight increased Rare: amylase elevations 1 Reversible sideroblastic anaemia has been reported with dolutegravir-containing regimens.
The contribution of dolutegravir in these cases is unclear. 16 2 This adverse reaction was identified through post-marketing surveillance for dolutegravir in combination with other ARVs. The frequency category of rare was estimated based on post-marketing reports.
3 In combination with increased transaminases. Description of selected adverse reactions Changes in laboratory biochemistries Dolutegravir has been associated with an increase in serum creatinine occuring in the first week of treatment when administered with other antiretroviral medicinal products.
Increases in serum creatinine occurred within the first four weeks of treatment with dolutegravir plus lamivudine and remained stable through 48 weeks. 7 μmol/L) was observed after 48 weeks of treatment. These changes are linked to the inhibiting effect of dolutegravir on renal tubular transporters of creatinine.
The changes are not considered to be clinically relevant and do not reflect a change in glomerular filtration rate. Co-infection with Hepatitis B or C In the Phase III studies for the dolutegravir single agent, patients with hepatitis B and/or C co-infection were permitted to enrol provided that baseline liver chemistry tests did not exceed 5 times the upper limit of normal (ULN).
Overall, the safety profile in patients co-infected with hepatitis B and/or C was similar to that observed in patients without hepatitis B or C co-infection, although the rates of AST and ALT abnormalities were higher in the subgroup with hepatitis B and/or C co-infection for all treatment groups.
4). 4). Osteonecrosis Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART. 4). Immune response syndrome In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
4). Paediatric population There are no clinical study data on the effects of Dovato in the paediatric population. Individual components have been investigated in adolescents (12 to 17 years). Based on limited available data with the dolutegravir single entity or lamivudine single entity used in combination with other antiretroviral agents to treat adolescents (12 to 17 years), there were no additional types of adverse reactions beyond those observed in the adult population.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked […]
EUOfficial regulatory label· Warnings and precautions· revised February 16, 2026[3]
Hypersensitivity reactions Hypersensitivity reactions have been reported with dolutegravir, and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including severe liver reactions. Dovato and other suspect medicinal products should be discontinued immediately if signs or symptoms of hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by raised liver enzymes, fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, eosinophilia, angioedema).
Clinical status including liver aminotransferases and bilirubin should be monitored. Delay in stopping treatment with Dovato or other suspect active substances after the onset of hypersensitivity may result in a life-threatening allergic reaction.
Weight and metabolic parameters An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy. Such changes may in part be linked to disease control and lifestyle. For lipids and weight, there is in some cases evidence for a treatment effect.
For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines. Lipid disorders should be managed as clinically appropriate. Liver disease Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse reactions.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products. 4 Dovato includes lamivudine, which is active against hepatitis B. Dolutegravir lacks such activity.
Lamivudine monotherapy is generally not considered an adequate treatment for hepatitis B, since the risk for hepatitis B resistance development is high. If Dovato is used in patients co-infected with hepatitis B an additional antiviral is therefore generally needed.
Reference should be made to treatment guidelines. If Dovato is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of both liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised February 16, 2026[3]
1. 5).
This is not medical advice. Consult a qualified healthcare professional.
Clinical status including liver aminotransferases should be monitored and appropriate therapy initiated. Delay Sandoz Dolutegravir (dolutegravir sodium) Product Monograph Page 9 of 60 in stopping treatment with Sandoz Dolutegravir or other suspect agents after the onset of hypersensitivity may result in a life-threatening reaction.
Immune Immune Reconstitution Inflammatory Syndrome (IRIS) Immune reconstitution inflammatory syndrome has been reported in HIV-infected patients treated with combination antiretroviral therapy, including dolutegravir. During the initial phase of treatment, patients responding to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections [such as Mycobacterium avium- complex (MAC), cytomegalovirus (CMV), Pneumocystis jirovecii pneumonia (PCP), and tuberculosis (TB)], which may necessitate further evaluation and treatment.
Autoimmune disorders (such as Graves’ disease, polymyositis, autoimmune hepatitis and Guillain-Barre syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment and sometimes can be an atypical presentation.
1 Pregnant Women Dolutegravir has not been studied in pregnant women. Sandoz Dolutegravir should not be used in pregnant women unless the potential benefits outweigh the potential risks to the fetus (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
Women of childbearing potential (WOCBP) should be informed about the potential risk of neural tube defects with Sandoz Dolutegravir and counselled about the use of effective contraception. It is recommended that pregnancy testing is conducted prior to initiation of Sandoz Dolutegravir.
If there are plans to become pregnant, or if pregnancy is confirmed within the first trimester while on Sandoz Dolutegravir, the risks and benefits of continuing Sandoz Dolutegravir versus switching to another antiretroviral regimen should be discussed with the patient.
Factors to consider should include feasibility of switching, tolerability, ability to maintain viral suppression, actual gestational age, risk of transmission to the infant and the available data around the potential risk of neural tube defects and other pregnancy outcomes for dolutegravir and alternative antiretroviral drugs.
In a birth outcome surveillance study in Botswana, a numerically higher rate of neural tube defects was identified with exposure to dolutegravir compared to non-dolutegravir-containing antiretroviral regimens at the time of conception, however, the difference was not statistically significant.
30). In the same study, an increased risk of neural tube defects was not identified in women who started dolutegravir during pregnancy. 04%) to mothers who started dolutegravir during pregnancy had a neural tube […]
Therefore, patients should remain under close clinical observation by physicians experienced in the treatment of these associated HIV diseases. Drug interactions Factors that decrease dolutegravir exposure should be avoided in the presence of integrase class resistance.
g. magnesium/ aluminium-containing antacid, iron and calcium supplements, multivitamins and inducing agents, etravirine (without boosted protease inhibitors), tipranavir/ritonavir, rifampicin, St. 5). When taken with food, Tivicay and supplements or multivitamins containing calcium, iron or magnesium can be taken at the same time.
5). Dolutegravir increased metformin concentrations. 5). Metformin is eliminated renally and, therefore, it is of importance to monitor renal function when co-treated with dolutegravir. This combination may increase the risk for lactic acidosis in patients with moderate renal impairment (stage 3a creatinine clearance [CrCl] 45– 59 mL/min) and a cautious approach is recommended.
Reduction of the metformin dose should be highly considered. Osteonecrosis Although the aetiology is considered to be multifactorial (including corticosteroid use, biphosphonates, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported in patients with advanced HIV- disease and/or long-term exposure to CART.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement. Weight and metabolic parameters An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Such changes may in part be linked to disease control and lifestyle. For lipids and weight, there is in some cases evidence for a treatment effect. For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Lipid disorders should be managed as clinically appropriate. 1). This regimen is only suitable for the treatment of HIV-1 infection where there is no known or suspected resistance to the integrase inhibitor class, or to lamivudine. Excipients Tivicay contains less than 1 mmol sodium (23 mg) per tablet, that is to say is essentially ‘sodium free’.
Patients with pre-existing liver dysfunction, including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered. Immune reactivation syndrome In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART. Relevant examples are Cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP).
Any inflammatory symptoms should be evaluated and treatment instituted when necessary. Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Liver chemistry elevations consistent with immune reconstitution syndrome were observed in some hepatitis B and/or C co-infected patients at the start of dolutegravir therapy. Monitoring of liver chemistries is recommended in patients with hepatitis B and/or C co-infection.
8). Mitochondrial dysfunction following exposure in utero Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine. There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues, these have predominantly concerned treatment with regimens containing zidovudine.
The main adverse reactions reported are haematological disorders (anaemia, neutropenia), and metabolic disorders (hyperlactatemia, hyperlipasemia). These reactions have often been transitory. Some late-onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour).
Whether such neurological disorders are transient or permanent is currently unknown. These findings should be considered for any child exposed in utero to nucleoside and nucleotide analogues, who presents with severe clinical findings of unknown aetiology, particularly neurologic findings.
These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV. Osteonecrosis Although the aetiology is considered to be multifactorial (including corticosteroid use, biphosphonates, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported in patients with advanced HIV-disease and/or long-term exposure to CART.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement. 5 Opportunistic infections Patients should be advised that dolutegravir, lamivudine or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection.
Therefore, patients should remain under close clinical observation by physicians experienced in the treatment of these associated HIV diseases. Administration in subjects with moderate renal […]