Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Odefsey is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus-1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine and with a viral load ≤100,000 HIV-1 RNA copies/mL (see sections 4.2, 4.4 and 5.1).
Therapy should be initiated by a physician experienced in the management of HIV infection.
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.
No dose adjustment of Odefsey is required in elderly patients (see section 5.2).
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.
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).
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.
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.
If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary including observation of the clinical status of the patient and monitoring of vital signs and ECG (QT interval).
There is no specific antidote for overdose with Odefsey. Up to 30% of the emtricitabine dose can be removed by haemodialysis. Tenofovir is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%. It is not known whether emtricitabine or tenofovir can be removed by peritoneal dialysis. Since rilpivirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance. Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
3 years.
Store in the original package in order to protect from moisture. Keep the bottle tightly closed.
High density polyethylene (HDPE) bottle with a polypropylene continuous-thread, child-resistant cap, lined with an induction activated aluminium foil liner containing 30 film-coated tablets. Each bottle contains silica gel desiccant and polyester coil.
The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
