Kocitaf

Kocitaf Dosage/Direction for Use

Manufacturer:

Mylan

Distributor:

Atlanta Medicare
Full Prescribing Info
Dosage/Direction for Use
Therapy should be initiated by a physician experienced in the management of HIV infection.
Posology: Adults and adolescents aged 12 years and older, weighing at least 40 kg infected with HIV-1 without documented or clinically suspected resistance to the integrase class.
Fixed dose combination of Dolutegravir, Emtricitabine and Tenofovir alafenamide 50 mg/200 mg/25 mg should be administered orally once daily.
Dolutegravir, Emtricitabine and Tenofovir alafenamide 50 mg/200 mg/25 mg is not recommended in patients infected with HIV-1 with documented or clinically suspected resistance to the integrase class. In these cases, the physician should refer to the individual product information for these medicinal products.
Separate preparations of Dolutegravir, Emtricitabine and Tenofovir alafenamide are available in cases where discontinuation or dose adjustment of one of the active substances is indicated.
Missed doses: If the patient misses a dose of Dolutegravir, Emtricitabine and Tenofovir alafenamide within 18 hours of the time it is usually taken, the patient should take Dolutegravir, Emtricitabine and Tenofovir alafenamide as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Dolutegravir, Emtricitabine and Tenofovir alafenamide by more than 18 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
If the patient vomits within 1 hour of taking Dolutegravir, Emtricitabine and Tenofovir alafenamide another tablet should be taken.
Elderly: There are limited data available on the use of Dolutegravir, Emtricitabine and Tenofovir alafenamide in patients aged 65 years and over. There is no evidence that elderly patients require a different dose than younger adult patients (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment of Dolutegravir, Emtricitabine and Tenofovir alafenamide is required in adults or adolescents (aged at least 12 years and of at least 40 kg body weight) with estimated creatinine clearance (CrCl) ≥ 30 mL/min.
Dolutegravir, Emtricitabine and Tenofovir alafenamide should not be initiated in patients with estimated CrCl < 30 mL/min as there are no data available regarding the use of Dolutegravir, Emtricitabine and Tenofovir alafenamide in this population, although difference in pharmacokinetics is not expected in this population (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Dolutegravir, Emtricitabine and Tenofovir alafenamide should be discontinued in patients with estimated CrCl that declines below 30 mL/min during treatment (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment of Dolutegravir, Emtricitabine and Tenofovir alafenamide is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. Dolutegravir, Emtricitabine and Tenofovir alafenamide has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore, Dolutegravir, Emtricitabine and Tenofovir alafenamide is not recommended for use in patients with severe hepatic impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of Dolutegravir, Emtricitabine and Tenofovir alafenamide in children younger than 12 years of age, or weighing < 40 kg, has not yet been established. No data are available. In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for dolutegravir in children and adolescents. (See Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Method of administration: Oral Use.
Dolutegravir, Emtricitabine and Tenofovir alafenamide can be taken with or without food (see Pharmacology: Pharmacokinetics under Actions). In the presence of integrase class resistance, Dolutegravir, Emtricitabine and Tenofovir alafenamide should preferably be taken with food to enhance exposure (particularly in patients with Q148 mutations) (see Pharmacology: Pharmacokinetics under Actions).
The film-coated tablet should not be chewed, crushed, or split.
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