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Dutrebis is a brand name for Lamivudine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: DUTREBIS is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg without present or past evidence of viral resistance to antiviral agents of the…
Verbatim from this product's EMA label. Tap a section to expand.
Therapy should be initiated by a physician experienced in the management of HIV infection. 1). Adults, adolescents, and children (6 through 11 years of age weighing at least 30 kg) The recommended dosage is one tablet (150 mg lamivudine/300 mg raltegravir) twice daily.
Raltegravir is also available in a chewable tablet formulation for children weighing at least 11 kg and in granules for oral suspension formulation for infants and toddlers from 4 weeks of age and weighing at least 3 kg to less than 20 kg.
Refer to the chewable tablet and granules for oral suspension SmPCs for additional dosing information. Lamivudine is also available as an oral solution for children over three months of age and who weigh less than 14 kg or for patients who are unable to swallow tablets.
The maximum dose is one tablet twice daily. Advice on missed doses If DUTREBIS is missed within 6 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of DUTREBIS as soon as possible. 2). Therefore DUTREBIS should be used with caution in this population.
Because lamivudine is substantially excreted by the kidney and older people are more likely to have decreased renal function, renal function should be monitored. A reduction in renal function may necessitate switching DUTREBIS to a regimen of the individual components (lamivudine and raltegravir).
Please refer to the SmPC for the individual components of DUTREBIS for dosing instructions. Renal impairment DUTREBIS should not be given in patients with a creatinine clearance of <50 ml/min. Renal function should be monitored in patients more likely to have decreased renal function.
If creatinine clearance decreases to <50 ml/min, DUTREBIS should be switched to a regimen of the individual components (lamivudine and raltegravir). Please refer to the SmPC for the individual components of DUTREBIS for dosing instructions.
2). Hepatic impairment No dosage adjustment for DUTREBIS is required for patients with mild to moderate hepatic impairment. The safety and efficacy of lamivudine and raltegravir have not been established in patients with severe underlying liver disorders.
2). Paediatric population DUTREBIS should not be used in children below 6 years of age. Dosing in children less than 6 years of age and those weighting less than 30 kg requires weight based dose adjustments for the individual components of DUTREBIS.
Summary of the safety profile Clinical studies in patients have not been specifically performed with DUTREBIS. The safety profile of DUTREBIS is based on the safety data from the individual components of DUTREBIS (lamivudine and raltegravir).
The most common adverse reactions reported during treatment with lamivudine are headache, nausea, malaise, fatigue, nasal signs and symptoms, diarrhoea and cough. The most frequently reported adverse reactions during treatment with raltegravir were headache and nausea.
4). Cancers were reported in treatment-experienced and treatment-naïve patients who initiated raltegravir in conjunction with other antiretroviral agents. The types and rates of specific cancers were those expected in a highly immunodeficient population.
Medicinal product no longer authorised 14 Grade 2-4 creatine kinase laboratory abnormalities were observed in subjects treated with raltegravir. Myopathy and rhabdomyolysis have been reported. 4). CART has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
4). Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART. 4). In HIV-infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
4). Tabulated list of adverse reactions The following adverse reactions have been reported during therapy for HIV disease with lamivudine and/or raltegravir (alone or in combination with other ART). The adverse reactions seen in clinical studies and in post-marketing experience are listed below by body system, organ class and absolute frequency.
DUTREBIS is not recommended for use as monotherapy. Depression Depression, including suicidal ideation and behaviours, has been reported with raltegravir, particularly in patients with a pre-existing history of depression or psychiatric illness.
Caution should be used when administering DUTREBIS in patients with a pre-existing history of depression or psychiatric illness. Renal impairment DUTREBIS should not be given in patients with a creatinine clearance of <50 ml/min. Renal function should be monitored in patients more likely to have decreased renal function.
2). Medicinal product no longer authorised 4 Opportunistic infections Patients receiving lamivudine or any other ART may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with associated HIV diseases.
Transmission of HIV Patients should be advised that current antiretroviral therapy does not cure HIV and has not been proven to prevent the risk of transmission of HIV to others through blood contact. 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. 2). Raltegravir has a relatively low genetic barrier to resistance. 1). Pancreatitis Cases of pancreatitis have occurred rarely with lamivudine.
However, it is not clear whether these cases were due to the ART or to the underlying HIV disease. Treatment with DUTREBIS should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis occur.
Lactic acidosis Lactic acidosis, usually associated with hepatomegaly and hepatic steatosis, has been reported with the use of nucleoside reverse transcriptase inhibitors (NRTIs), such as lamivudine. Early symptoms (symptomatic hyperlactatemia) include benign digestive symptoms (nausea, vomiting and abdominal pain), non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/or deep breathing) or neurological symptoms (including motor weakness).
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Please refer to the SmPC for the individual components of DUTREBIS for dosing instructions. 2. Method of administration Oral use. DUTREBIS tablets can be administered with or without food. The tablets should be swallowed whole, without crushing or chewing.
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). System Organ Class Frequency Lamivudine and/or Raltegravir (alone or in combination with other ART)* Infections and infestations uncommon genital herpes, folliculitis, gastroenteritis, herpes simplex, herpes virus infection, herpes zoster, influenza, lymph node abscess, molluscum contagiosum, nasopharyngitis, upper respiratory tract infection Neoplasms benign, malignant and unspecified (including cysts and polyps) uncommon skin papilloma Blood and lymphatic system disorders uncommon iron deficiency anaemia, lymph node pain, lymphadenopathy, neutropenia and anaemia (both occasionally severe), thrombocytopenia very rare pure red cell aplasia Immune system disorders uncommon immune reconstitution syndrome, drug hypersensitivity, hypersensitivity Metabolism and nutrition disorders common decreased appetite uncommon cachexia, diabetes mellitus, dyslipidaemia, hypercholesterolaemia, hyperglycaemia, hyperlipidaemia, hyperphagia, increased appetite, polydipsia, body fat disorderMedicinal product no longer authorised 15 System Organ Class Frequency Lamivudine and/or Raltegravir (alone or in combination with other ART)* Psychiatric disorders common abnormal dreams, insomnia, nightmare, abnormal behaviour, depression uncommon mental disorder, suicide attempt, anxiety, confusional state, depressed mood, major depression, middle insomnia, mood altered, panic attack, sleep disorder, suicidal ideation, suicidal behaviour (particularly in patients with a pre-existing history of psychiatric illness) Nervous system disorders common dizziness, headache, psychomotor hyperactivity uncommon amnesia, carpal tunnel syndrome, cognitive disorder, disturbance in attention, dizziness postural, dysgeusia, hypersomnia, hypoaesthesia, lethargy, memory impairment, migraine, neuropathy peripheral, paraesthesia, somnolence, tension headache, tremor, poor quality sleep Eye disorders uncommon visual impairment Ear and labyrinth disorders common vertigo uncommon tinnitus Cardiac disorders uncommon palpitations, sinus bradycardia, ventricular extrasystoles Vascular disorders uncommon hot flush, hypertension Respiratory, thoracic and mediastinal disorders common cough, nasal congestion uncommon dysphonia, epistaxis Gastrointestinal disorders common abdominal distention, diarrhoea, flatulence, nausea, vomiting, dyspepsia, abdominal pain or cramps uncommon gastritis, abdominal discomfort, abdominal pain upper, abdominal tenderness, anorectal discomfort, constipation, dry mouth, epigastric discomfort, erosive duodenitis, eructation, gastrooesophageal reflux disease, gingivitis, glossitis, odynophagia, pancreatitis, peptic ulcer, rectal haemorrahage Hepato-biliary disorders uncommon hepatitis, hepatic steatosis, hepatitis alcoholic, hepatic failure Skin and subcutaneous common rash, alopeciaMedicinal product no longer authorised 16 System Organ Class Frequency Lamivudine and/or Raltegravir (alone or […]
Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure, or renal failure. Lactic acidosis generally occurred after a few or several months of treatment. Treatment with NRTIs should be discontinued in the setting of symptomatic hyperlactatemia and metabolic/lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Caution should be exercised when administering NRTIs to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
Patients co-infected with hepatitis C and treated with alpha interferon and ribavirin may constitute a special risk. Patients at increased risk should be followed closely. Hepatic impairment No dosage adjustment for DUTREBIS is required for patients with mild to moderate hepatic impairment.
The safety and efficacy of lamivudine and raltegravir have not been established in patients with severe underlying liver disorders. 2). Patients with pre-existing liver dysfunction including chronic hepatitis have an increased frequency of liver function abnormalities during CART and should be monitored according to standard practice.
IfMedicinal product no longer authorised 5 there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment should be considered. Patients with HIV and hepatitis B or C virus co-infection Patients with chronic hepatitis B or C treated with ART are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Physicians should refer to current HIV treatment guidelines for the optimal management of HIV infection in patients co-infected with HBV. In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
If DUTREBIS is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis.
Osteonecrosis Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly 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. Lipodystrophy CART has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
The long-term consequences of these events are currently unknown. Knowledge about the mechanism is incomplete. A connection between visceral lipomatosis and protease inhibitors (PIs) and lipoatrophy and NRTIs has been hypothesised. A higher risk of lipodystrophy has been associated with individual factors […]