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Medicine information : TELZIR 50 mg/ml oral suspension (HIV)
| Drug class description : | Antiviral/Protease Inhibitor |
| Generic Name : | Fosamprenavir |
| Drug description : | Oral suspension. The suspension is white to off-white in colour. |
| Presentation : | Each ml of oral suspension contains 50 mg fosamprenavir as fosamprenavir calcium (equivalent to approximately 43 mg amprenavir). |
| Indications : | Telzir in combination with low dose ritonavir is indicated for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults in combination with other antiretroviral medicinal products. In moderately antiretroviral experienced patients, Telzir in combination with low dose ritonavir has not been shown to be as effective as lopinavir / ritonavir. In heavily pretreated patients the use of Telzir in combination with low dose ritonavir has not been sufficiently studied. In protease inhibitor (PI) experienced patients, the choice of Telzir should be based on individual viral resistance testing and treatment history. |
| Adult Dosage : | 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. Telzir (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. For antiretroviral naïve and experienced patients the recommended dose is 700 mg fosamprenavir twice daily with 100 mg ritonavir twice daily, in combination with other antiretroviral medicinal products. Caution is advised if the recommended doses of fosamprenavir with ritonavir detailed above are exceeded (See Special Precautions). Renal impairment No initial dose adjustment is considered necessary in patients with renal impairment. Hepatic impairment There are limited data regarding the use of Telzir with ritonavir when co-administered to patients with hepatic impairment and therefore specific dosage recommendations cannot be made. Consequently, Telzir in combination with ritonavir should be used with caution in patients with mild or moderate hepatic impairment and is contraindicated in those with severe hepatic impairment (See Contraindications and Special Precautions). Telzir is administered orally. Telzir is also available as 700 mg film-coated tablets. The oral suspension should be taken without food and on an empty stomach. Shake the bottle vigorously for 20 seconds before first dose is removed and 5 seconds before each subsequent dose. |
| Child Dosage : | Children (less than 12 years of age) and adolescents (12 to 17 years of age) The safety and efficacy of Telzir with ritonavir has not yet been established in these patient populations. Therefore, this combination must not be used in this age group until further data becomes available. |
| Elderly Dosage : | The pharmacokinetics of fosamprenavir have not been studied in this patient population |
| Contra Indications : | Hypersensitivity to fosamprenavir, amprenavir or to any of the excipients of Telzir, or to ritonavir. Patients with severe hepatic impairment (See Special Precautions). Telzir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4), e.g. amiodarone, astemizole, bepridil, cisapride, dihydroergotamine, ergotamine, pimozide, quinidine, terfenadine (See Interactions). Telzir with ritonavir must not be co-administered with medicinal products with narrow therapeutic windows that are highly dependent on CYP2D6 metabolism e.g. flecainide and propafenone (See Interactions). Rifampicin must not be administered concurrently with Telzir (See Interactions). Herbal preparations containing St John’s wort (Hypericum perforatum) must not be used while taking Telzir due to the risk of decreased plasma concentrations and reduced clinical effects of amprenavir (See Interactions). |
| Special Precautions : | Patients should be advised that treatment with the 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. Current antiretroviral therapies, including Telzir, have not been proven to prevent the risk of transmission of HIV to others through sexual contact or blood contamination. Appropriate precautions should continue to be taken. 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. The Telzir oral suspension contains propyl and methyl parahydroxybenzoate. These products may cause an allergic reaction in some individuals. This reaction may be delayed. 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. Liver disease The safety and efficacy of Telzir have not been established in patients with significant underlying liver disease. Telzir should be used with caution in patients with mild or moderate hepatic impairment and is contraindicated in patients with severe hepatic impairment. 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 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. Medicinal products interactions The use of Telzir concomitantly with midazolam or triazolam is not recommended (See Interactions). The use of Telzir concomitantly with halofantrine or lidocaine (systemic) is not recommended. The use of Telzir concomitantly with PDE5 inhibitors (e.g. sildenafil and vardenafil) is not recommended (See Interactions). Concomitant use of Telzir with simvastatin or lovastatin is not recommended due to an increased risk of myopathy, including rhabdomyolysis (See Interactions). A reduction in the rifabutin dosage by at least 75 % is recommended when administered with Telzir with ritonavir. Further dose reduction may be necessary (See Interactions). Because of the interactions with amprenavir, the efficacy of hormonal contraceptives may be impaired. Therefore, alternative reliable barrier methods of contraception are recommended for women of childbearing potential (See Interactions). Anticonvulsants (carbamazepine, phenobarbital, phenytoin) should be used with caution. Telzir may be less effective due to decreased amprenavir plasma concentrations in patients taking these medicinal products concomitantly (See Interactions). Therapeutic concentration monitoring is recommended for immunosuppressant medicinal products (cyclosporine, tacrolimus, rapamycin) when co-administered with Telzir (See Interactions). Therapeutic concentration monitoring is recommended for tricyclic antidepressants (e.g. desipramine and nortriptyline) when co-administered with Telzir (See Interactions. When methadone is co-administered with Telzir, patients should be closely monitored for opiate abstinence syndrome (See Interactions). When warfarin or other oral anticoagulants are co-administered with Telzir a reinforced monitoring of INR (International normalised ratio) is recommended (See Interactions). Concomitant use of Telzir with ritonavir and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing’s syndrome and adrenal suppression (See Interactions). Rash / cutaneous reactions Most patients with mild or moderate rash can continue Telzir. Appropriate antihistamines (e.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. Telzir should be permanently discontinued in case of severe rash, or in case of rash of moderate intensity with systemic or mucosal symptoms (See Adverse Reactions). 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 inhibitors (PIs). In some patients administration of factor VIII was necessary. In more than half of the reported cases, treatment with protease inhibitors was continued, or reintroduced if treatment had been discontinued. A causal relationship has been evoked, although the mechanism of action has not been elucidated. Haemophiliac patients should therefore be informed of the possibility of increased bleeding. Hyperglycaemia New onset of diabetes mellitus, hyperglycaemia or exacerbations of existing diabetes mellitus have been reported in patients receiving antiretroviral therapy, including protease inhibitors. In some of these, the hyperglycaemia was severe and in some cases also associated with ketoacidosis. Many of the patients had confounding medical conditions, some of which required therapy with medicinal products that have been associated with the development of diabetes mellitus or hyperglycaemia. Lipodystrophy Combination antiretroviral therapy 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 and lipoatrophy and nucleoside reverse transcriptase inhibitors has been hypothesised. A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances. Clinical examination should include evaluation for physical signs of fat redistribution. Consideration should be given to the measurement of fasting serum lipids and blood glucose. Lipid disorders should be managed as clinically appropriate (See Adverse Reactions). 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 carinii pneumonia. Any inflammatory symptoms should be evaluated and treatment instituted when necessary. |
| Interactions : | When fosamprenavir and ritonavir are co-administered, the ritonavir metabolic drug interaction profile may predominate because ritonavir is a more potent CYP3A4 inhibitor. The full prescribing information for ritonavir must therefore be consulted prior to initiation of therapy with Telzir with ritonavir. Ritonavir also inhibits CYP2D6 but to a lesser extent than CYP3A4. Ritonavir induces CYP3A4, CYP1A2, CYP2C9 and glucuronosyl transferase. Additionally, both amprenavir, the active metabolite of fosamprenavir, and ritonavir are primarily metabolised in the liver by CYP3A4. Therefore, any medicinal products that either share this metabolic pathway or modify CYP3A4 activity may modify the pharmacokinetics of amprenavir and ritonavir. Similarily, administration of fosamprenavir with ritonavir may modify the pharmacokinetics of other active substances that share this metabolic pathway. Associations contraindicated (See Contraindications) CYP3A4 substrates with narrow therapeutic index Telzir must not be administered concurrently with medicinal products with narrow therapeutic windows containing active substances that are substrates of cytochrome P450 3A4 (CYP3A4). Co-administration may result in competitive inhibition of the metabolism of these active substances thus increasing their plasma levels and leading to serious and / or life-threatening adverse reactions such as cardiac arrhythmia (e.g. amiodarone, astemizole, bepridil, cisapride, pimozide, quinidine, terfenadine) or peripheral vasospasm or ischaemia (e.g. ergotamine, dihydroergotamine). CYP2D6 substrates with narrow therapeutic index Telzir with ritonavir must not be co-administered with medicinal products containing active substances that are highly dependent on CYP2D6 metabolism and for which elevated plasma concentrations are associated with serious and / or life-threatening adverse reactions. These active substances include flecainide and propafenone. Rifampicin Rifampicin reduces the amprenavir plasma AUC by approximately 82 %. Based on information for other protease inhibitors, it is expected that co-administration of Telzir with ritonavir with rifampicin will also result in large decreases in plasma concentrations of amprenavir. Accordingly, Telzir with ritonavir must not be co-administered with rifampicin. St John’s wort (Hypericum perforatum) Serum levels of amprenavir and ritonavir can be reduced by concomitant use of the herbal preparation St John’s wort (Hypericum perforatum). This is due to induction of drug metabolising enzymes by St John’s wort. Herbal preparations containing St John’s wort should therefore not be combined with Telzir with ritonavir. If a patient is already taking St John’s wort, check amprenavir, ritonavir and if possible viral levels and stop St John’s wort. Amprenavir and ritonavir levels may increase on stopping St John’s wort. The inducing effect may persist for at least 2 weeks after cessation of treatment with St John’s wort. Other combinations Antiretroviral medicinal products Non-nucleoside reverse transcriptase inhibitors Efavirenz: there was no clinically relevant interaction when fosamprenavir 700 mg twice daily and ritonavir 100 mg twice daily was used concurrently with efavirenz (600 mg once daily). Nevirapine: based on the effect of nevirapine on other HIV protease inhibitors, nevirapine may decrease the serum concentration of amprenavir. Appropriate doses of the combination with respect to safety and efficacy have not been established. This combination should be used with caution. Nucleoside / Nucleotide reverse transcriptase inhibitors Interaction studies with abacavir, lamivudine and zidovudine have been performed with amprenavir without ritonavir. Based on data derived from these studies and because ritonavir is not expected to have a significant impact on the pharmacokinetics of NRTIs, the co-administration of fosamprenavir and ritonavir with these medicinal products is not expected to significantly alter the exposure of the co-administered active substances. Didanosine chewable tablet: no pharmacokinetic study has been performed with fosamprenavir in combination with didanosine. Clinically significant interaction resulting from an increase in the stomach pH due to the didanosine antacid component is unlikely and no dose separation or adjustment is considered necessary when fosamprenavir and didanosine are administered concomitantly (see chapter, Antacids). No significant interaction is expected with didanosine gastro-resistent capsule Tenofovir: no recommendations can be drawn at this stage on the co-administration of fosamprenavir with ritonavir with tenofovir. Protease Inhibitors Lopinavir / ritonavir: no dose recommendation can be given for the co-administration of Telzir with ritonavir and lopinavir / ritonavir, but close monitoring is advised because the safety and efficacy of this combination is unknown. The Cmax, AUC and Cmin of lopinavir were increased by 30 %, 37 % and 52 % respectively when lopinavir 400 mg with ritonavir 100 mg was given with fosamprenavir 700 mg with ritonavir 100 mg twice daily for two weeks. The Cmax, AUC and Cmin of amprenavir were decreased by 58 %, 63 % and 65 % respectively. When lopinavir 533 mg with ritonavir 133 mg was administered in combination with fosamprenavir 1400 mg twice daily for two weeks, the Cmax, AUC, and Cmin of lopinavir were unchanged compared to values observed for lopinavir 400 mg with ritonavir 100 mg twice daily. However, the AUC and Cmin of amprenavir were decreased by 26 % and 42 %, respectively; whereas, Cmax was not significantly altered compared to values obtained for fosamprenavir 700 mg with ritonavir 100 mg twice daily. No interaction studies have been undertaken between fosamprenavir with ritonavir and the following protease inhibitors: indinavir, saquinavir, nelfinavir and atazanavir. Antibiotics / Antifungals Clarithromycin: a reduction in the clarithromycin dose should be considered when co-administered with Telzir with ritonavir in patients with renal impairment as moderate increases in clarithromycin concentrations are expected when coadministered with Telzir with ritonavir. Erythromycin: no pharmacokinetic study has been performed with fosamprenavir with ritonavir in combination with erythromycin, however, plasma levels of erythromycin may be increased when co-administered. Ketoconazole / Itraconazole: co-administration of amprenavir with ketoconazole increased ketoconazole AUC by 44%. When ritonavir is co-administered, a larger increase in ketoconazole concentration may occur. Itraconazole concentrations are expected to increase in the same manner as ketoconazole. In the absence of specific studies of fosamprenavir with ritonavir in combination with ketoconazole or itraconazole, no recommendations can be drawn in terms of dose adjustment. Rifabutin: co-administration of amprenavir with rifabutin results in a 200 % increase in rifabutin plasma concentrations (AUC) which could potentially lead to an increase of rifabutin related adverse reactions, notably uveitis. When ritonavir is co-administered a larger increase in rifabutin concentrations may occur. A reduction in the rifabutin dosage by at least 75 % is recommended when administered with Telzir with ritonavir. Further dose reduction may be necessary. Other medicinal products Medicinal products that may reduce plasma amprenavir concentrations when co-administered with Telzir Antacids, Histamine H2 receptor antagonist and Proton-Pump inhibitors: no dose adjustment for any of the respective medicinal products is considered necessary when antacids, proton-pump inhibitors or histamine H2 receptor antagonists are administered concomitantly with fosamprenavir. The AUC and Cmax of amprenavir were decreased by 18 % and 35 % respectively, whilst the Cmin (C12h) was comparable, when a single 1400 mg dose of fosamprenavir was co-administered with a single 30 ml dose of antacid suspension (equivalent to 3.6 grams aluminium hydroxide and 1.8 grams magnesium hydroxide). Serum levels of amprenavir can be reduced by concomitant use of histamine H2 receptor antagonists (for example ranitidine and cimetidine). Concurrent administration of ranitidine (300 mg single dose) with fosamprenavir (1400 mg single dose) decreased plasma amprenavir AUC by 30 % and Cmax by 51 %. There was, however, no change observed in the amprenavir Cmin (C12h). Anticonvulsant active substances: concomitant administration of anticonvulsant active substances known as enzymatic inductors (phenytoin, phenobarbital, carbamazepine) with fosamprenavir may lead to a decrease in the plasma concentrations of amprenavir. These combinations should be used with caution. Medicinal products whose plasma levels may be increased when co-administered with Telzir Other medicinal products with a narrow therapeutic window: some substances (e.g. lidocaine (by systemic route) and halofantrine) given with Telzir may cause serious adverse reactions. Concomitant use is not recommended. Benzodiazepines: concomitant use of Telzir with midazolam or triazolam could result in prolonged sedation or respiratory depression and thus is not recommended. Erectile dysfunction medicinal products: concomitant use is not recommended. Based on data for ritonavir and other protease inhibitors, plasma concentrations of PDE5 inhibitors (e.g. sildenafil and vardenafil) are expected to substantially increase when co-administered with Telzir with ritonavir and may result in an increase in PDE5 inhibitor associated adverse reactions, including hypotension, visual changes and priapism. Fluticasone propionate (interaction with ritonavir): in a clinical study where ritonavir 100 mg capsules bid were co-administered with 50 µg intranasal fluticasone propionate (4 times daily) for 7 days in healthy subjects, the fluticasone propionate plasma levels increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86 % (90 % confidence interval 82-89 %). Greater effects may be expected when fluticasone propionate is inhaled. Systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway e.g. budesonide. Consequently, concomitant administration of Telzir with ritonavir and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (See Special Precautions). A dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g. beclomethasone). Moreover, in case of withdrawal of glucocorticoids progressive dose reduction may have to be performed over a longer period. The effects of high fluticasone systemic exposure on ritonavir plasma levels is yet unknown. HMG-CoA reductase inhibitors: if treatment with a HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended because their metabolism is not dependent on CYP3A4 and interactions are not expected with protease inhibitors. HMG-CoA reductase inhibitors which are highly dependent on CYP3A4 for metabolism, such as lovastatin and simvastatin, are expected to have markedly increased plasma concentrations when co-administered with Telzir with ritonavir. Since increased concentrations of HMG-CoA reductase inhibitors may cause myopathy, including rhabdomyolysis, the combination of lovastatin or simvastatin with Telzir with ritonavir is not recommended. No adjustment of the fosamprenavir or ritonavir dose is required when co-administered with atovarstatin. The Cmax , AUC and Cmin of atorvastatin were increased by 184 %, 153 % and 73 % respectively when atorvastatin (10 mg once daily for 4 days) was given with fosamprenavir 700 mg twice daily with ritonavir 100 mg twice daily for two weeks. The Cmax, AUC and Cmin of amprenavir were unchanged. When used with Telzir with ritonavir, doses of atorvastatin no greater than 20 mg/day should be administered, with careful monitoring for atorvastatin toxicity. Immunosuppressants: frequent therapeutic concentration monitoring of immunosuppresant levels is recommended until levels have stabilised as plasma concentrations of cyclosporin, rapamycin and tacrolimus may be increased when co-administered with fosamprenavir with ritonavir. Tricyclic antidepressants: careful monitoring of the therapeutic and adverse reactions of tricyclic antidepressants is recommended when they (for example desipramine and nortriptyline) are concomitantly administered with Telzir. Medicinal products whose plasma levels may be decreased when co-administered with Telzir Methadone: no data are available on the co-administration of fosamprenavir with ritonavir and methadone. Amprenavir and ritonavir both decrease plasma concentrations of methadone. When methadone is co-administered with Telzir with ritonavir, patients should be closely monitored for opiate abstinence syndrome, with concomitant monitoring of methadone plasma levels. Oral anticoagulants: a reinforced monitoring of the International Normalised Ratio is recommended in case of administration of Telzir with ritonavir with warfarin or other oral anticoagulants, due to a possible decrease or increase of their antithrombotic effect. Oral contraceptives: alternative reliable barrier methods of contraception are recommended for women of childbearing potential. Oestrogens and progestogens may interact with fosamprenavir and ritonavir, thus concomitant use may impair the efficacy of hormonal contraceptives. Pregnancy and lactation Pregnancy There is no clinical experience with fosamprenavir in pregnant women. In animal studies at systemic plasma exposures (AUC) to amprenavir lower than therapeutic exposure in patients treated with Telzir, some developmental toxicity was observed. In view of the low exposure in reproductive toxicity studies, the potential developmental toxicity of Telzir has not been fully determined. Telzir should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Lactation Amprenavir-related material was found in rat milk, but it is not known whether amprenavir is excreted in human milk. Rat pups exposed pre and post-natally to amprenavir and fosamprenavir showed developmental toxicity. It is therefore recommended that mothers treated with Telzir do not breast-feed their infants. As a general rule, it is recommended that HIV-infected women must not breast-feed under any circumstances to avoid transmission of HIV. |
| Adverse Reactions : | It should be noted that the Telzir oral suspension has not been evaluated clinically and that the adverse reaction profile detailed in this section is based on the experience with the Telzir film coated tablets. The safety of fosamprenavir has been studied in 755 patients in Phase II and III controlled clinical trials. The safety of the co-administration of fosamprenavir with low dose ritonavir was established in two pivotal Phase III trials: APV30002 (n = 322) in antiretroviral naïve patients, fosamprenavir (1400 mg) given once daily in combination with ritonavir (200 mg) as part of a triple regimen including abacavir and lamivudine. APV30003 in protease inhibitor experienced patients, fosamprenavir given in combination with low dose ritonavir either once daily (1400 mg / 200 mg) (n = 106) or twice daily (700 mg / 100 mg) (n = 106) in combination with two active reverse transcriptase inhibitors (RTIs). The adverse reaction profile was similar across all the respective studies: antiretroviral naïve (APV30002) and protease inhibitor experienced (twice daily dosing, APV30003) patient populations. The adverse reactions are listed by body system, organ class and absolute frequency. Frequencies are defined as: Very common (= 1/10), Common (= 1/100, < 1/10), Uncommon (= 1/1,000, < 1/100), Rare (= 1/10,000, < 1/1,000) or Very rare (< 1/10,000), including isolated reports. The frequency of the reactions were calculated using adverse reactions that were of at least moderate intensity (Grade 2 or more) and reported by investigators as being attributable to the medicinal products used in the studies. The most frequent clinical adverse reactions (occurring in at least 1 % of patients) reported in the two large clinical studies in adults with at least a possible casual relationship to Telzir are summarised below. Body System Adverse reaction Frequency Nervous system disorders Headache, dizziness Common Gastrointestinal disorders Diarrhoea Loose stools, nausea, vomiting, abdominal pain Very common Common Skin and subcutaneous tissue disorders Rash Common General disorders and administration site conditions Fatigue Common Rash / cutaneous reactions: erythematous or maculopapular cutaneous eruptions, with or without pruritus, may occur during therapy. The rash generally will resolve spontaneously without the necessity of discontinuing treatment with the fosamprenavir with ritonavir. Severe or life-threatening rash, including Stevens-Johnson syndrome is rare, reported in less than 1 % of patients included in the clinical development programme. Fosamprenavir with ritonavir therapy should be definitively stopped in case of severe rash or in case of rash of mild or moderate intensity associated with systemic or mucosal signs (See Special Precautions). 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 patients, included: increased ALT (common), AST (common), serum lipase (common) and triglycerides (very common). Grade 3 or 4 elevations in total cholesterol values were observed in less than 1 % of patients (< 1 % APV30002 ; 0 % APV 30003). Lipodystrophy: combination antiretroviral therapy 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) (See Special Precautions). Metabolic abnormalities: combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (See Special Precautions). Hyperglycaemia: new onset of diabetes mellitus, hyperglycaemia or exacerbations of existing diabetes mellitus have been reported in patients receiving antiretroviral protease inhibitors (See Special Precautions). Rhabdomyolysis: an increase in CPK, myalgia, myositis, and rarely, rhabdomyolysis, have been reported with protease inhibitors, more specifically in association with nucleoside analogues. Haemophiliac patients: there have been reports of increased spontaneous bleeding in haemophiliac patients receiving antiretroviral protease inhibitors (See Special Precautions). 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 (See Special Precautions). |
| Manufacturer : | GlaxoSmithKline(GSK) |
| Drug Availability : | (POM) |
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