KOMYCITAF Film-coated tablet Ref.[51212] Active ingredients: Dolutegravir Emtricitabine Tenofovir alafenamide

Testing prior to initiation of KOMYCITAF Tablets

Prior to initiation of KOMYCITAF tablets, patients should be tested for hepatitis B virus infection [see section 4.4].

Estimated creatinine clearance, urine glucose, and urine protein should be assessed before initiating KOMYCITAF tablets therapy and should be monitored during therapy in all patients [see section 4.4].

Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed in all individuals.

Adults and paediatric patients weighing at least 40 kg

The recommended dosage of KOMYCITAF is one tablet taken orally once daily with or without food in adults and paediatric patients weighing at least 40 kg and creatinine clearance greater than or equal to 30 mL per minute.

Paediatric use

KOMYCITAF tablets should only be administered to paediatric patients with a body weight of at least 40 kg because they are a fixed-dose combination that cannot be adjusted. The safety and efficacy have been established for the individual components in this weight group.

Elderly

Dolutegravir

Clinical trials of dolutegravir did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. Caution should be exercised in the administration of dolutegravir in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other medicine therapy.

Emtricitabine and tenofovir alafenamide

In clinical trials, 80 of the 97 subjects enrolled aged 65 years and over received FTC + TAF and EVG + COBI. No differences in safety or efficacy have been observed between elderly subjects and adults between 18 and less than 65 years of age.

Hepatic impairment

No dosage adjustment of KOMYCITAF tablets is recommended in patients with mild (Child-Pugh Class A) hepatic impairment. The effect of moderate or severe hepatic impairment (Child-Pugh Class B or C) on the pharmacokinetics of dolutegravir, emtricitabine and tenofovir alafenamide has not been studied. Therefore, KOMYCITAF tablets are not recommended for use in patients with moderate or severe hepatic impairment (see section 4.3).

Renal impairment

KOMYCITAF tablets are not recommended for patients with severe renal impairment (estimated creatinine clearance below 30 mL per min) because KOMYCITAF tablets are a fixed-dose combination and the dosage of the individual components cannot be adjusted. No dosage adjustment of KOMYCITAF tablets is recommended in patients with mild or moderate renal impairment (estimated creatinine clearance greater than or equal to 30 mL per minute).

There is no known specific treatment for overdose with KOMYCITAF tablets. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required.

Dolutegravir: As dolutegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.

Emtricitabine (FTC): Limited clinical experience is available at doses higher than the recommended dose of FTC.

Haemodialysis treatment removes approximately 30% of the FTC dose over a 3-hour dialysis period starting within 1,5 hours of FTC dosing (blood flow rate of 400 mL per minute and a dialysate flow rate of 600 mL per minute). It is not known whether FTC can be removed by peritoneal dialysis.

Tenofovir alafenamide (TAF): Limited clinical experience is available at doses higher than the recommended dose of TAF. Tenofovir is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%.

2 years.

Store at or below 30°C in original container.

Blue, opaque, HDPE bottle with blue opaque PP screw closure with aluminium induction sealing liner and desiccant canister/sachet.

Pack sizes of 30’s, 90’s & 180’s (Not all packs may be marketed).

No special requirements.