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Lamivudine Teva Pharma B.V. is a brand name for Lamivudine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Lamivudine Teva Pharma B.V. is indicated as part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children.
Verbatim from this product's EMA label. Tap a section to expand.
The therapy should be initiated by a physician experienced in the management of HIV infection. 4). 2) Posology Adults, adolescents and children (weighing at least 25 kg) The recommended dose of lamivudine is 300 mg daily. 4). The 300 mg tablet is only suitable for the once a day regimen.
V. tablets.
Children weighing ≥20 kg to <25 kg:
The recommended dose is 225 mg daily. This may be administered as either 75 mg (one-half of a 150 mg tablet) taken in the morning and 150 mg (one whole 150 mg tablet) taken in the evening, or 225 mg (one and a half 150 mg tablets) taken once daily.
Children weighing 14 kg to <20 kg:
The recommended dose is 150 mg daily. This may be administered as 75 mg (one-half of a 150 mg tablet) taken twice daily, or 150 mg (one whole 150 mg tablet) taken once daily. V. 150 mg scored tablet formulation is used and the corresponding recommended dosage instructions are followed.
2). Patients changing from the twice daily dosing regimen to the once daily dosing regimen should take the recommended once daily dose (as described above) approximately 12 hours after the last twice daily dose, and then continue to take the recommended once daily dose (as described above) approximately every 24 hours.
When changing back to a twice daily regimen, patients should take the recommended twice daily dose approximately 24 hours after the last once daily dose.
Special populations Older people:
No specific data are available; however, special care is advised in this age group due to age-associated changes such as the decrease in renal function and alteration of haematological parameters.
Renal impairment:
Lamivudine concentrations are increased in patients with moderate - severe renal impairment due to decreased clearance. The dose should therefore be adjusted, using an oral solution presentation of lamivudine for patients whose creatinine clearance falls below 30 ml/min (see tables).
Dosing recommendations – Adults, adolescents and children (weighing at least 25 kg): Creatinine clearance (ml/min) First dose Maintenance dose ≥50 300 mg or 150 mg 300 mg once daily or 150 mg twice daily 30-<50 150 mg 150 mg once daily <30 As doses below 150 mg are needed the use of an oral solution is recommended 15 to <30 150 mg 100 mg once daily 5 to <15 150 mg 50 mg once daily <5 50 mg 25 mg once daily There are no data available on the use of lamivudine in children with renal impairment.
The following adverse reactions have been reported during therapy for HIV disease with lamivudine: The adverse reactions considered at least possibly related to the treatment are listed below 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). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Blood and lymphatic systems disorders Uncommon:
Neutropenia and anaemia (both occasionally severe), thrombocytopenia.
Very rare:
Pure red cell aplasia.
Metabolism and nutrition disorders Very rare:
Lactic acidosis. 8 Nervous system disorders Common: Headache, insomnia.
Very rare:
Peripheral neuropathy (or paraesthesia).
Respiratory, thoracic and mediastinal disorders Common:
Cough, nasal symptoms.
Gastrointestinal disorders Common:
Nausea, vomiting, abdominal pain or cramps, diarrhoea.
Rare:
Pancreatitis, elevations in serum amylase.
Hepatobiliary disorders Uncommon:
Transient elevations in liver enzymes (AST, ALT).
Rare:
V. is not recommended for use as monotherapy. 2).
Triple nucleoside therapy:
There have been reports of a high rate of virological failure and of emergence of resistance at an early stage when lamivudine was combined with tenofovir disoproxil fumarate and abacavir as well as with tenofovir disoproxil fumarate and didanosine as a once daily regimen.
V. or any other antiretroviral therapy 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.
Pancreatitis:
Cases of pancreatitis have occurred rarely. However, it is not clear whether these cases were due to the antiretroviral treatment or to the underlying HIV disease. V. should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis occur.
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 5 concerned treatment with regimens containing zidovudine.
The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia). These events have often been transitory. 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 etiology, particularly neurologic findings.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Based on the assumption that creatinine clearance and lamivudine clearance are correlated similarly in children as in adults it is recommended that the dosage in children with renal impairment be reduced according to their creatinine clearance by the same proportion as in adults.
A 10 mg/mL oral solution may be the most appropriate formulation to achieve the recommended dose in children with renal impairment aged at least 3 months and weighing less than 25kg. 9 mg/kg once daily Hepatic impairment: Data obtained in patients with moderate to severe hepatic impairment shows that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction.
Based on these data, no dose adjustment is necessary in patients with moderate or severe hepatic impairment unless accompanied by renal impairment. V. may be administered with or without food. To ensure the administration of the entire dose, the tablet(s) should ideally be swallowed without crushing.
2).
Hepatitis.
Skin and subcutaneous tissue disorders Common:
Rash, alopecia.
Rare:
Angioedema.
Musculoskeletal and connective tissue disorders Common:
Arthralgia, muscle disorders.
Rare:
Rhabdomyolysis.
General disorders and administration site conditions Common:
Fatigue, malaise, fever. 4) 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). Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term combined antiretroviral exposure (CART). 4). 1). No additional safety issues have been identified in paediatric subjects receiving either once or twice daily dosing compared to adults.
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.
These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
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 life style. For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines. Lipid disorders should be managed as clinically appropriate.
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 mycobacterium 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 disease:
If lamivudine is being used concomitantly for the treatment of HIV and HBV, additional information relating to the use of lamivudine in the treatment of hepatitis B infection is available in the lamivudine 100 mg SmPC. 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 events.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products. V. 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 (see lamivudine 100 mg SmPC).
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.
8). 1 ARROW study), lower rates of virologic suppression and more frequent viral resistance were reported in children receiving an oral solution of lamivudine as compared to those receiving the tablet formulation. Whenever possible in children, lamivudine as tablet formulation should preferably be used.
Osteonecrosis:
Although the etiology 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 combination antiretroviral therapy (CART).
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in […]