EMTRIVA

Therapy should be initiated by a physician experienced in the management of HIV infection. Posology Emtriva 10 mg/mL oral solution may be taken with or without food. 5).

Adults:

The recommended dose of Emtriva 10 mg/mL oral solution is 240 mg (24 mL) once daily. If a patient misses a dose of Emtriva within 12 hours of the time it is usually taken, the patient should take Emtriva with or without food as soon as possible and resume their normal dosing schedule.

If a patient misses a dose of Emtriva 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. If the patient vomits within 1 hour of taking Emtriva, another dose should be taken.

If the patient vomits more than 1 hour after taking Emtriva they do not need to take another dose. Emtriva 200 mg hard capsules are available for adults, adolescents and children who weigh at least 33 kg and can swallow hard capsules.

Please refer to the Summary of Product Characteristics for Emtriva 200 mg hard capsules. 2).

Special populations Elderly:

There are no safety and efficacy data available in patients over the age of 65 years. However, no adjustment in the recommended daily dose for adults should be required unless there is evidence of renal insufficiency. 2). 4). Table 1 below provides daily doses of Emtriva 10 mg/mL oral solution according to the degree of renal insufficiency.

The safety and efficacy of these doses have not been clinically evaluated. 4). Patients with renal insufficiency can also be managed by administration of Emtriva 200 mg hard capsules at modified dose intervals. Please refer to the Summary of Product Characteristics for Emtriva 200 mg hard capsules.

Table 1:

Daily doses of Emtriva 10 mg/mL oral solution adjusted according to creatinine clearance Creatinine clearance (mL/min) ≥ 30 15-29 < 15 (functionally anephric, requiring intermittent haemodialysis)* Recommended dose of Emtriva 10 mg/mL oral solution every 24 hours 240 mg (24 mL) 80 mg (8 mL) 60 mg (6 mL) * Assumes a 3-hour haemodialysis session three times a week commencing at least 12 h after administration of the last dose of emtricitabine.

0%). 8%) occurred more frequently in clinical trials involving HIV infected paediatric patients. 4). Tabulated summary of adverse reactions Assessment of adverse reactions from clinical study data is based on experience in three studies in adults (n = 1,479) and three paediatric studies (n = 169).

In the adult studies, 1,039 treatment-naïve and 440 treatment- experienced patients received emtricitabine (n = 814) or comparator medicinal product (n = 665) for 48 weeks in combination with other antiretroviral medicinal products.

The adverse reactions with suspected (at least possible) relationship to treatment in adults from clinical trial and post-marketing experience are listed in Table 2 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) or uncommon (≥ 1/1,000 to < 1/100). 8, Description of selected adverse reactions for more details. 8, Paediatric population). 3 This adverse reaction, which was identified through post-marketing surveillance, was not observed in randomised controlled clinical trials in adults or paediatric HIV clinical trials of emtricitabine.

The frequency category of uncommon was estimated from a statistical calculation based on the total number of patients exposed to emtricitabine in these clinical studies (n = 1,563). Description of selected adverse reactions Skin discolouration (increased pigmentation): Skin discolouration, manifested by hyperpigmentation mainly on the palms and/or soles, was generally mild, asymptomatic and of little clinical significance.

The mechanism is unknown. 4).

Immune Reactivation Syndrome:

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).

General Emtricitabine is not recommended as monotherapy for the treatment of HIV infection. It must be used in combination with other antiretrovirals. Please also refer to the Summaries of Product Characteristics of the other antiretroviral medicinal products used in the combination regimen.

Co-administration of other medicinal products Emtriva should not be taken with any other medicinal products containing emtricitabine or medicinal products containing lamivudine. Opportunistic infections Patients receiving emtricitabine 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 HIV associated diseases.

Renal function Emtricitabine is principally eliminated by the kidney via glomerular filtration and active tubular secretion. Emtricitabine exposure may be markedly increased in patients with severe renal insufficiency (creatinine clearance < 30 mL/min) receiving daily doses of 200 mg emtricitabine as hard capsules or 240 mg as the oral solution.

Consequently, either a dose interval adjustment (using Emtriva 200 mg hard capsules) or a reduction in the daily dose of emtricitabine (using Emtriva 10 mg/mL oral solution) is required in all patients with creatinine clearance < 30 mL/min.

2 are based on single dose pharmacokinetic data and modelling and have not been clinically evaluated. 2). 5). 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.

1.