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TENOFOVIR DISOPROXIL SANDOZ is a brand name for Tenofovir Disoproxil. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: HIV-1 infection Tenofovir disoproxil Sandoz 245 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults. In adults, the demonstration of the benefit of tenofovir disoproxil in HIV-1 infection is based on results of one study in…
Verbatim from this product's MHRA label. Tap a section to expand.
Therapy should be initiated by a physician experienced in the management of HIV infection and/or treatment of chronic hepatitis B. Posology HIV-1 and Chronic hepatitis B Adults and adolescents aged 12 to < 18 years and weighing ≥ 35 kg: The recommended dose of Tenofovir disoproxil Sandoz 245 mg film-coated tablets for the treatment of HIV or for the treatment of chronic hepatitis B is 245 mg (one tablet) once daily taken orally with food.
The decision to treat paediatric patients (adolescents) should be based on careful consideration of individual patient needs and with reference to current paediatric treatment guidelines including the value of baseline histological information.
4). Serum ALT should be persistently elevated for at least 6 months prior to treatment of paediatric patients with compensated liver disease due to HBeAg positive chronic hepatitis B; and for at least 12 months in patients with HBeAg negative disease.
Duration of therapy in adult and adolescent patients with chronic hepatitis B The optimal duration of treatment is unknown. 4). Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse.
• In HBeAg negative patients without cirrhosis, treatment should be administered at least until HBs seroconversion or there is evidence of loss of efficacy. e. for at least 3 years) provided serum ALT and HBV DNA levels are followed regularly after treatment discontinuation to detect any late virological relapse.
With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient. In adult patients with decompensated liver disease or cirrhosis, treatment cessation is not recommended.
1). Please refer to the accompanying Summary of Product Characteristics of suitable formulations. The safety and efficacy of tenofovir disoproxil in HIV-1 infected children or children with chronic hepatitis B under 2 years of age have not been established.
No data are available. Missed dose If a patient misses a dose of Tenofovir within 12 hours of the time it is usually taken, the patient should take Tenofovir with food as soon as possible and resume their normal dosing schedule. If a patient misses a dose of Tenofovir by more than 12 hours and it is almost time for their next dose, the patient should not take the missed dose and simply resume the usual dosing schedule.
Summary of the safety profile HIV-1 and hepatitis B:
In patients receiving tenofovir disoproxil, rare events of renal impairment, renal failure and uncommon events of proximal renal tubulopathy (including Fanconi syndrome) sometimes leading to bone abnormalities (infrequently contributing to fractures) have been reported.
4).
HIV-1:
Approximately one third of patients can be expected to experience adverse reactions following treatment with tenofovir disoproxil in combination with other antiretroviral agents. These reactions are usually mild to moderate gastrointestinal events.
Approximately 1% of tenofovir disoproxil -treated adult patients discontinued treatment due to the gastrointestinal events.
Hepatitis B:
Approximately one quarter of patients can be expected to experience adverse reactions following treatment with tenofovir disoproxil, most of which are mild. 4%). 4). Tabulated summary of adverse reactions Assessment of adverse reactions for tenofovir disoproxil is based on safety data from clinical studies and post-marketing experience.
All adverse reactions are presented in Table 2.
HIV-1 clinical studies:
Assessment of adverse reactions from HIV-1 clinical study data is based on experience in two studies in 653 treatment-experienced patients receiving treatment with tenofovir disoproxil (n = 443) or placebo (n = 210) in combination with other antiretroviral medicinal products for 24 weeks and also in a double-blind comparative controlled study in which 600 treatment-naïve patients received treatment with tenofovir disoproxil 245 mg (n = 299) or stavudine (n = 301) in combination with lamivudine and efavirenz for 144 weeks.
General HIV antibody testing should be offered to all HBV infected patients before initiating tenofovir disoproxil therapy (see below Co-infection with HIV-1 and hepatitis B). Hepatitis B Patients must be advised that tenofovir disoproxil has not been proven to prevent the risk of transmission of HBV to others through sexual contact or contamination with blood.
Appropriate precautions must continue to be used. Co-administration of other medicinal products • Tenofovir should not be administered concomitantly with other medicinal products containing tenofovir disoproxil or tenofovir alafenamide..
• Tenofovir should not be administered concomitantly with adefovir dipivoxil. 5). • Triple therapy with nucleosides/nucleotides There have been reports of a high rate of virological failure and of emergence of resistance at an early stage in HIV patients when tenofovir disoproxil was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once- daily regimen.
Renal and bone effects in adult population Renal effects Tenofovir is principally eliminated via the kidney. 8). Renal monitoring It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy with tenofovir disoproxil and renal function (creatinine clearance and serum phosphate) is also monitored after two to four weeks of treatment, after three months of treatment and every three to six months thereafter in patients without renal risk factors.
In patients at risk for renal impairment, a more frequent monitoring of renal function is required. 8, proximal tubulopathy). 32 mmol/l). Interrupting treatment with tenofovir disoproxil should also be considered in case of progressive decline of renal function when no other cause has been identified.
g. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2). If concomitant use of tenofovir disoproxil and nephrotoxic agents is unavoidable, renal function should be monitored weekly.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If the patient vomits within 1 hour of taking Tenofovir, another tablet should be taken. If the patient vomits more than 1 hour after taking Tenofovir they do not need to take another dose. 4). Renal impairment Tenofovir is eliminated by renal excretion and the exposure to tenofovir increases in patients with renal dysfunction.
Adults There are limited data on the safety and efficacy of tenofovir disoproxil in adult patients with moderate and severe renal impairment (creatinine clearance < 50 ml/min) and long-term safety data has not been evaluated for mild renal impairment (creatinine clearance 50-80 ml/min).
Therefore, in adult patients with renal impairment tenofovir disoproxil should only be used if the potential benefits of treatment are considered to outweigh the potential risks. Administration of other formulations of tenofovir disoproxil to provide a reduced daily dose of tenofovir disoproxil is recommended for adult patients with creatinine clearance < 50 ml/min, including haemodialysis patients.
Please refer to the Summary of Product Characteristics of suitable formulations. Mild renal impairment (creatinine clearance 50-80 ml/min) Limited data from clinical studies support once daily dosing of 245 mg tenofovir disoproxil in patients with mild renal impairment.
Moderate renal impairment (creatinine clearance 30-49 ml/min) For patients unable to take other available formulations such as granule formulation of tenofovir disoproxil, prolonged dose intervals using the 245 mg film-coated tablets may be used.
Administration of 245 mg tenofovir disoproxil every 48 hours can be used based on modelling of single-dose pharmacokinetic data in HIV negative and non-HBV infected subjects with varying degrees of renal impairment, including end- stage renal disease requiring haemodialysis, but has not been confirmed in clinical studies.
2). Severe renal impairment (creatinine clearance < 30 ml/min) and haemodialysis patients For patients unable to take other available formulations such as granule formulation of tenofovir disoproxil and with no alternative treatment available, prolonged dose intervals using the 245 mg […]
Hepatitis B clinical studies:
Assessment of adverse reactions from HBV clinical study data is primarily based on experience in two double-blind comparative controlled studies in which 641 adult patients with chronic hepatitis B and compensated liver disease received treatment with tenofovir disoproxil 245 mg daily (n = 426) or adefovir dipivoxil 10 mg daily (n = 215) for 48 weeks.
The adverse reactions observed with continued treatment for 384 weeks were consistent with the safety profile of tenofovir disoproxil. 73 m2 per year (using MDRD equation).
Patients with decompensated liver disease:
The safety profile of tenofovir disoproxil in patients with decompensated liver disease was assessed in a double-blind active controlled study (GS-US-174-0108) in which adult patients received treatment with tenofovir disoproxil (n = 45) or emtricitabine plus tenofovir disoproxil (n = 45) or entecavir (n = 22) for 48 weeks.
5 mg/dl or confirmed serum phosphate of < 2 mg/dl through week 48; there were no statistically significant differences between the combined tenofovir- containing arms and the entecavir arm. After 168 weeks, 16% (7/45) of the tenofovir disoproxil group, 4% (2/45) of the emtricitabine plus tenofovir disoproxil group, and 14% (3/22) of the entecavir group experienced tolerability failure.
5 mg/dl or confirmed serum phosphate of < 2 mg/dl. At week 168, in this population of patients with decompensated liver disease, the rate of death was of 13% (6/45) in the tenofovir disoproxil group, 11% (5/45) in the emtricitabine plus tenofovir disoproxil group and 14% (3/22) in the entecavir group.
The rate of hepatocellular carcinoma was 18% (8/45) in the tenofovir disoproxil group, 7% (3/45) in the emtricitabine plus tenofovir disoproxil group and 9% (2/22) in the entecavir group. 4).
Patients with lamivudine-resistant chronic hepatitis B:
No new adverse reactions to tenofovir disoproxil were identified from a randomised, double-blind study (GS-US- 174-0121) in which 280 lamivudine-resistant patients received treatment with tenofovir disoproxil (n = 141) or emtricitabine/tenofovir disoproxil (n = 139) for 240 weeks.
The adverse reactions with suspected (at least possible) relationship to treatment are listed below by body system organ class and frequency. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000).
Table 2:
Tabulated summary of adverse reactions associated with tenofovir disoproxil based on clinical study and post-marketing experience Frequency Tenofovir disoproxil Metabolism and nutrition disorders: Very common: hypophosphataemia1 Uncommon: hypokalaemia1 Rare: lactic acidosis Nervous system disorders: Very common: dizziness Common: headache Gastrointestinal disorders: Very common: diarrhoea, vomiting, nausea Common: abdominal pain, abdominal distension, flatulence Uncommon: pancreatitis Hepatobiliary disorders: […]
Cases of acute renal failure after initiation of high dose or multiple non-steroidal anti- inflammatory drugs (NSAIDs) have been reported in patients treated with tenofovir disoproxil and with risk factors for renal dysfunction. If tenofovir disoproxil is co- administered with an NSAID, renal function should be monitored adequately.
A higher risk of renal impairment has been reported in patients receiving tenofovir disoproxil in combination with a ritonavir or cobicistat boosted protease inhibitor. 5). In patients with renal risk factors, the co-administration of tenofovir disoproxil with a boosted protease inhibitor should be carefully evaluated.
g. cidofovir, a known nephrotoxic medicinal product). These renal transport proteins may be responsible for tubular secretion and in part, renal elimination of tenofovir and cidofovir. Consequently, the pharmacokinetics of these medicinal products, which are secreted by the same renal pathway including transport proteins hOAT 1 and 3 or MRP 4, might be modified if they are co-administered.
5). Renal impairment Renal safety with tenofovir disoproxil has only been studied to a very limited degree in adult patients with impaired renal function (creatinine clearance < 80 ml/min). Adult patients with creatinine clearance < 50 ml/min, including haemodialysis patients: There are limited data on the safety and efficacy of tenofovir disoproxil in patients with impaired renal function.
Therefore, tenofovir disoproxil should only be used if the potential benefits of treatment are considered to outweigh the potential risks. In patients with severe renal impairment (creatinine clearance < 30 ml/min) and in patients who require haemodialysis use of tenofovir disoproxil is not recommended.
2). 8). 1). These BMD decreases generally improved after treatment […]