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Dovato is a brand name for Dolutegravir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Dovato is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine (see section 5.1).
Verbatim from this product's EMA label. Tap a section to expand.
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).
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.
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.
1. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 […]
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.
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 […]