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Telzir is a brand name for Fosamprenavir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Telzir in combination with low dose ritonavir is indicated for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults, adolescents and children of 6 years and above in combination with other antiretroviral medicinal products. In moderately antiretroviral experienced adults, Telzir in combination…
Verbatim from this product's EMA label. Tap a section to expand.
Telzir must only be given with low dose ritonavir as a pharmacokinetic enhancer of amprenavir and in combination with other antiretroviral medicinal products. The Summary of Product Characteristics of ritonavir must therefore be consulted prior to initiation of therapy with Telzir.
Therapy should be initiated by a physician experienced in the management of HIV infection. Fosamprenavir is a pro-drug of amprenavir and must not be administered concomitantly with other medicinal products containing amprenavir. The importance of complying with the full recommended dosing regimen should be stressed to all patients.
4). Medicinal product no longer authorised 3 Telzir tablet is administered orally. Telzir tablet can be taken with or without food. Telzir is also available as an oral suspension for use in patients unable to swallow tablets, and in paediatric patients less than 39 kg (please refer to the Summary of Product Characteristics for Telzir oral suspension).
Adults The recommended dose is 700 mg fosamprenavir twice daily with 100 mg ritonavir twice daily. Paediatric patients from 6 years of age The adult dose of Telzir tablet 700 mg twice daily with ritonavir 100 mg twice daily may be used in children weighing at least 39 kg and able to swallow tablets.
For children weighing less than 39 kg, Telzir oral suspension is the recommended option for the most accurate dosing in children based on body weight (please refer to the Summary of Product Characteristics for Telzir oral suspension).
2). 2). Therefore, no recommendations can be made in this patient population. 2). Hepatic impairment For adults with mild hepatic impairment (Child-Pugh score: 5-6) the recommended dose is 700 mg fosamprenavir twice daily with 100 mg ritonavir once daily.
For adults with moderate hepatic impairment (Child-Pugh score: 7-9) the recommended dose is 450 mg fosamprenavir twice daily with 100 mg ritonavir once daily. 2). As it is not possible to achieve this fosamprenavir dose using the tablet formulation, these patients should be treated with fosamprenavir oral suspension.
For adults with severe hepatic impairment (Child-Pugh score: 10-15): fosamprenavir should be used with caution and at a reduced dose of 300 mg fosamprenavir twice daily with 100 mg ritonavir once daily. As it is not possible to achieve this fosamprenavir dose using the tablet formulation, these patients should be treated with fosamprenavir oral suspension.
Summary of safety profile The adverse reaction profile was similar across all the respective adult studies: antiretroviral naïve patients (APV30002, ESS100732), protease inhibitor experienced (twice daily dosing, APV30003) patients.
This is based on safety data from a total of 864 patients exposed to fosamprenavir/ritonavir in these three studies. The most frequently (> 5% of adult subjects treated) reported adverse reactions with fosamprenavir/ritonavir combination were gastrointestinal reactions (nausea, diarrhoea, abdominal pain and vomiting) and headache.
Most adverse reactions associated with fosamprenavir/ritonavir combination therapies were mild to moderate in severity, early in onset and rarely treatment limiting. More serious adverse reactions such as serious skin rashes and hepatic transaminase elevations have also been reported (cf paragraph Description of selected adverse reactions).
Tabulated summary of adverse reactions Adverse reactions are listed by MedDRA 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) or Very rare (< 1/10,000), or Not known. Frequency categories for the reactions below have been based on clinical trials and postmarketing data.
Most of the adverse reactions below were reported from three large clinical studies in adults, where the adverse events were of at least moderate intensity (Grade 2 or more) occurring in at least 1% of patients and reported by investigators as being attributable to the medicinal products used in the studies.
Medicinal product no longer authorised 20 Body System Adverse reaction Frequency Nervous system disorders Headache, dizziness, oral paraesthesia Common Gastrointestinal disorders Diarrhoea Very common Loose stools, nausea, vomiting, abdominal pain Common Skin and subcutaneous tissue disorders Stevens Johnson syndrome Angioedema Rash (see text below “rash/cutaneous reactions”) Rare Uncommon Common General disorders and administration site conditions Fatigue Common Investigations Blood cholesterol increased Blood triglycerides increased Alanine aminotransferase increased Aspartate aminotransferase increased Lipase increased Very common Common Common Common Common Description of selected adverse reactions Rash / cutaneous reactions: erythematous or maculopapular cutaneous eruptions, with or without pruritus, may occur during therapy.
Patients should be advised that treatment with Telzir, or any other current antiretroviral therapy, does not cure HIV and that they may still develop opportunistic infections and other complications of HIV infection. Fosamprenavir contains a sulphonamide moiety.
The potential for cross-sensitivity between medicinal products in the sulphonamide class and fosamprenavir is unknown. In the pivotal studies of Telzir, in patients receiving fosamprenavir with ritonavir there was no evidence of an increased risk of rashes in patients with a history of sulphonamide allergy versus those who did not have a sulphonamide allergy.
Yet, Telzir should be used with caution in patients with a known sulphonamide allergy. Co-administration of Telzir 700 mg twice daily with ritonavir in doses greater than 100 mg twice daily has not been clinically evaluated. The use of higher ritonavir doses might alter the safety profile of the combination and therefore is not recommended.
2). Medicinal product no longer authorised 5 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 Summary of Product Characteristics for these medicinal products.
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. 5). g. 5). 5). 3). A reduction in the rifabutin dosage by at least 75 % is recommended when administered with Telzir with ritonavir.
5). 5). No data are available on the co-administration of fosamprenavir and ritonavir with oestrogens and/or progestogens when used as hormonal replacement therapies. The efficacy and safety of these therapies with fosamprenavir and ritonavir has not been established.
1. g. 5). 5). 5). 5). g. 5). 5). 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2), therefore close monitoring of safety and virologic response is warranted. No dose recommendation can be made for children and adolescents with hepatic impairment as no studies have been conducted in these age groups. Medicinal product no longer authorised 4
The rash generally will resolve spontaneously without the necessity of discontinuing treatment with the fosamprenavir with ritonavir. Severe or life-threatening cases of rash, including Stevens-Johnson syndrome are rare. 4). Clinical chemistry abnormalities: clinical chemistry abnormalities (Grade 3 or 4) potentially related to treatment with fosamprenavir with ritonavir and reported in greater than or equal to 1 % of adult patients, included: increased ALT (common), AST (common), serum lipase (common) and triglycerides (common).
4). Medicinal product no longer authorised 21 Rhabdomyolysis: an increase in CPK, myalgia, myositis, and rarely, rhabdomyolysis, have been reported with protease inhibitors, more specifically in association with nucleoside analogues.
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). 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). 1 for information on dosing regimens applied for each age group).
79 % of subjects received greater than 48 weeks of exposure. Overall the safety profile in these 158 children and adolescents was similar to that observed in the adult population. Vomiting occurred more frequently amongst paediatric patients.
Drug-related adverse reactions were more common in APV20003 (57%) where subjects received once daily fosamprenavir / ritonavir when compared to APV29005 (33%) where subjects received twice daily fosamprenavir / ritonavir. No new safety concerns were identified from analyses of 48 week data from studies APV29005 or APV20002, in which 54 subjects 4 weeks to <2 years of age received twice daily fosamprenavir / ritonavir with background nucleoside reverse transcriptase inhibitor therapy and 5 subjects received only single doses of fosamprenavir with or without ritonavir.
4). 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 […]
Anticonvulsants (carbamazepine, phenobarbital) should be used with caution. 5). 5). g. 5). 5). 5). Co-administration of fosamprenavir/ritonavir with other antineoplastics metabolised by CYP3A (for example dasatinib, nilotinib, ibrutinib, vinblastine and everolimus) may increase concentrations of these medicinal products, potentially increasing the risk of adverse events usually associated with these agents.
5). 5). Rash / cutaneous reactions Most patients with mild or moderate rash can continue Telzir. g. cetirizine dihydrochloride) may reduce pruritus and hasten the resolution of rash. Severe and life-threatening skin reactions, including Stevens-Johnson syndrome, were reported in less than 1% of patients included in the clinical development programme.
8). Haemophiliac patients There have been reports of increased bleeding including spontaneous skin haematomas and haemarthroses in haemophiliac patients type A and B treated with protease […]