Posology : מינונים

4.2    Posology and method of administration

Therapy should be initiated by a physician experienced in the management of HIV infection.
Posology

One tablet to be taken once daily with food (see section 5.2).

If the patient misses a dose of Odefsey within 12 hours of the time it is usually taken, the patient should take Odefsey with food as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Odefsey by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.

If the patient vomits within 4 hours of taking Odefsey another tablet should be taken with food. If a patient vomits more than 4 hours after taking Odefsey they do not need to take another dose of Odefsey until the next regularly scheduled dose.

Odefsey_film_coated_tablets_PI_May2023
    Elderly
No dose adjustment of Odefsey is required in elderly patients (see section 5.2).

Renal impairment
No dose adjustment of Odefsey is required in adults or in adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 30 mL/min. Odefsey should be discontinued in patients with estimated CrCl that declines below 30 mL/min during treatment (see section 5.2).

No dose adjustment of Odefsey is required in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis; however, Odefsey should, generally, be avoided but may be used with caution in these patients if the potential benefits are considered to outweigh the potential risks (see sections 4.4 and 5.2). On days of haemodialysis, Odefsey should be administered after completion of haemodialysis treatment.

Odefsey should be avoided in patients with estimated CrCl ≥ 15 mL/min and < 30 mL/min, or< 15 mL/min who are not on chronic haemodialysis, as the safety of Odefsey has not been established in these populations.

No data are available to make dose recommendations in children less than 18 years with end stage renal disease.
Hepatic impairment
No dose adjustment of Odefsey is required in patients with mild (Child Pugh Class A) or moderate (Child Pugh Class B) hepatic impairment. Odefsey should be used with caution in patients with moderate hepatic impairment. Odefsey has not been studied in patients with severe hepatic impairment (Child Pugh Class C); therefore, Odefsey is not recommended for use in patients with severe hepatic impairment (see sections 4.4 and 5.2).

Paediatric population
The safety and efficacy of Odefsey in children younger than 12 years of age, or weighing < 35 kg, have not yet been established. No data are available.


Method of administration
Oral use.

Odefsey should be taken orally, once daily with food (see section 5.2). It is recommended that the film-coated tablet is not chewed, crushed or split due to the bitter taste.