BIKTARVY FILM-COATED TABLETS 50MG200MG25MG

Страна: Сингапур

Език: английски

Източник: HSA (Health Sciences Authority)

Активна съставка:

Bictegravir Sodium 52.45mg eqv Bictegravir; Emtricitabine; Tenofovir Alafenamide Fumarate 28.04mg eqv Tenofovir Alafenamide

Предлага се от:

GILEAD SCIENCES SINGAPORE PTE. LTD.

АТС код:

J05AR20

Лекарствена форма:

TABLET, FILM COATED

Композиция:

Bictegravir Sodium 52.45mg eqv Bictegravir 50mg; Emtricitabine 200mg; Tenofovir Alafenamide Fumarate 28.04mg eqv Tenofovir Alafenamide 25mg

Начин на приложение:

ORAL

Вид предписание :

Prescription Only

Произведено от:

Rottendorf Pharma GmbH

Статус Оторизация:

ACTIVE

Дата Оторизация:

2019-01-02

Данни за продукта

GILEAD SCIENCES
1
BIKTARVY
® (BICTEGRAVIR, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE) TABLETS
℞
ONLY
FULL PRESCRIBING INFORMATION
WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN
PATIENTS WHO ARE
COINFECTED WITH HIV-1 AND HBV AND HAVE DISCONTINUED PRODUCTS
CONTAINING
EMTRICITABINE (FTC) AND/OR TENOFOVIR DISOPROXIL FUMARATE (TDF), AND
MAY OCCUR
WITH DISCONTINUATION OF BIKTARVY.
CLOSELY MONITOR HEPATIC FUNCTION WITH BOTH CLINICAL AND LABORATORY
FOLLOW-UP FOR AT
LEAST SEVERAL MONTHS IN PATIENTS WHO ARE COINFECTED WITH HIV-1 AND HBV
AND
DISCONTINUE BIKTARVY. IF APPROPRIATE, ANTI-HEPATITIS B THERAPY MAY BE
WARRANTED
_[SEE WARNINGS AND PRECAUTIONS (5.1)]_.
1
INDICATIONS AND USAGE
BIKTARVY is indicated as a complete regimen for the treatment of human
immunodeficiency
virus type 1 (HIV-1) infection in adults and pediatric patients
weighing at least 25 kg who have
no antiretroviral treatment history or to replace the current
antiretroviral regimen in those who
are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on
a stable antiretroviral
regimen with no history of treatment failure and no known
substitutions associated with
resistance to the individual components of BIKTARVY.
2
DOSAGE AND ADMINISTRATION
2.1
TESTING WHEN INITIATING AND DURING TREATMENT WITH BIKTARVY
Prior to or when initiating BIKTARVY, test patients for hepatitis B
virus infection _[see Warnings _
_and Precautions (5.1)]_.
Prior to or when initiating BIKTARVY, and during treatment with
BIKTARVY, assess serum
creatinine, estimated creatinine clearance, urine glucose and urine
protein in all patients as
clinically appropriate. In patients with chronic kidney disease, also
assess serum phosphorus
_[see Warnings and Precautions (5.4)]. _
2.2
RECOMMENDED DOSAGE
BIKTARVY is a three-drug fixed dose combination product containing 50
mg of bictegravir
(BIC), 200 mg of emtricitabine (FTC), and 25 mg of tenofovir
alafenamide (TAF). The
recommended dosage of BIKTARVY is one tab