AIKENING (Albuvirtide for Injection 160 mgvial)

Nchi: Malesia

Lugha: Kiingereza

Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Viambatanisho vya kazi:

Albuvirtide

Inapatikana kutoka:

PAHANG PHARMACY SDN. BHD.

INN (Jina la Kimataifa):

Albuvirtide

Vitengo katika mfuko:

1 Vials; 8 Vials

Viwandani na:

Frontier Biotechnologies Inc.

Tabia za bidhaa

FULL PRESCRIBING INFORMATION
See full prescribing information for AIKENING and use it under the
instruction of medical
professionals.
AIKENING (ALBUVIRTIDE FOR INJECTION) FOR INTRAVENOUS USE
[PRODUCT NAME]
Generic name: Albuvirtide for Injection
Trade name: AIKENING
[INGREDIENTS]
Active pharmaceutical ingredient (API): albuvirtide
Chemical name:
Acetyl-Trp-Glu-Glu-Trp-Asp-Arg-Glu-Ile-Asn-Asn-Tyr-Thr-(N-{2-[2-(N-(3-maleimidepropionyl)
amino) ethoxy] ethoxy} acetyl) Lys-Leu-Ile-His-Glu-Leu-Ile-Glu-Glu-
Ser-Gln-Asn-Gln-Gln-Glu-Lys-Asn-Glu-Gln-Glu-Leu-Leucinamide
Chemical structure:
O
N
H
N
O
O
O
O
O
NH
Ac-Trp-Glu-Glu-Trp-Asp-Arg-Glu-Ile-Asn-Asn-Tyr-Thr-Lys-Leu-Ile-
His-Glu-Leu-Ile-Glu-Glu-Ser-Gln-Asn-Gln-Gln-Glu-Lys-Asn-Glu-Gln-
G l u - L e u - L e u - N H
2
Molecular formula: C
204
H
306
N
54
O
72
Molecular weight: 4666.93
This product contains no pharmaceutical excipients.
[DESCRIPTION]
Off-white or yellowish porous cake or powder.
[INDICATIONS]
Albuvirtide is a human immunodeficiency virus type 1 (HIV-1) fusion
inhibitor indicated in
combination with other antiretroviral agent(s) for treatment of HIV-1
infection in
treatment-experienced patients with HIV-1 replication despite ongoing
antiretroviral therapy.
[STRENGTH]
160 mg/vial.
[DOSAGE AND ADMINISTRATION]
1. DOSAGE REGIMEN
For adults 18 years old and above, AIKENING is administered by
intravenous infusion
at a dose of 320 mg once a day on Day 1, 2, 3, and 8, and thereafter
once a week.
Children
The safety and efficacy of AIKENING have not been established in
children under 18
years old.
Geriatric
No adequate human data are available in geriatric patients aged over
60 years; it is
unknown whether their response to AIKENING is different from young
people.
2. PREPARATION OF AIKENING
STEP 1
Number of
AIKENING
vial
2
STEP 2
Volume of 5%
sodium
bicarbonate
solution for
injection
1.2 mL to each
vial
STEP 3
Volume of 0.9%
sodium chloride
solution for
infusion
6 mL to each vial
STEP 4
Volume of 0.9%
sodium chloride
solution for
infusion
in the infusion bag
~76 mL
IV in