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Tivicay is a brand name for Dolutegravir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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. 3
Verbatim from this product's EMA label. Tap a section to expand.
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.
4 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.
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), and not known (cannot be estimated from the available data). 4)2 Psychiatric disorders Common Insomnia Common Abnormal dreams Common Depression Common Anxiety Uncommon Panic attack 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. Nervous system disorders Very common Headache Common Dizziness Gastrointestinal disorders Very common Nausea Very common Diarrhoea Common Vomiting Common Flatulence Common Upper abdominal pain Common Abdominal pain Common Abdominal discomfort Hepatobiliary disorders Common Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) elevations Uncommon Hepatitis Rare Acute hepatic failure, increased bilirubin3 Skin and subcutaneous tissue disorders Common Rash Common Pruritus Musculoskeletal and connective tissue disorders Uncommon Arthralgia 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.
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.
1. 5). 5
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
96 mol/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 14 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
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.
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’.