Fuzeon

Country: New Zealand

Bahasa: Inggeris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Enfuvirtide 108mg (includes overage 20%)

Boleh didapati daripada:

Roche Products (NZ) Ltd

INN (Nama Antarabangsa):

Enfuvirtide 108 mg (includes overage 20%)

Dos:

90 mg/mL

Borang farmaseutikal:

Injection with diluent

Komposisi:

Active: Enfuvirtide 108mg (includes overage 20%) Excipient: Hydrochloric acid Mannitol Sodium carbonate Sodium hydroxide Water for injection

Unit dalam pakej:

Combination pack, 60xfuzeon, 60xdiluent + 60x1mL and 60x3 mL syringes, 60 dose units

Kelas:

Prescription

Jenis preskripsi:

Prescription

Dikeluarkan oleh:

Corden Pharma Colorado Inc

Tanda-tanda terapeutik:

FUZEON (enfuvirtide) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in antiretroviral experienced patients with treatment failure due to intolerance to previous antiretroviral agents or with evidence of HIV-1 replication despite ongoing therapy. Evidence to support this indication is based on surrogate endpoints (change in viral load and CD4 count) in controlled studies following 48 weeks of treatment (see Clinical Trials).

Ringkasan produk:

Package - Contents - Shelf Life: Combination pack, 60xfuzeon, 60xdiluent + 60x1mL and 60x3 mL syringes - 60 dose units - 48 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Diluent, type I - 2 mL - 48 months from date of manufacture stored at or below 30°C - Vial, glass, Fuzeon powder, type I - 3 mL - 48 months from date of manufacture stored at or below 30°C

Tarikh kebenaran:

2003-09-15

Risalah maklumat

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Fuzeon
®
 CMI 110811   

1 of 11 
DS 110610 

CONSUMER MEDICINE INFORMATION 
FUZEON
®

ENFUVIRTIDE  
POWDER FOR INJECTION 108 MG 

WHAT IS IN THIS LEAFLET 
This leaflet answers some common questions about FUZEON. It does
not contain all the available 
information. 
It does not take the place of talking to your
doctor or pharmacist. 
All medicines have risks and benefits. Your doctor has weighed the
risks of you using FUZEON 
against the benefits they expect it will have for you. 
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST. 
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it
again. 
WHAT FUZEON IS USED FOR  
FUZEON is used for the treatment of HIV (Human Immunodeficiency
Virus), the virus which causes 
AIDS. 

FUZEON belongs to a group of medicines called anti-HIV medicines. 

FUZEON is the first in a new class of medicines called HIV fusion
inhibitors. 

It works by blocking the entry of HIV into cells that the
virus attacks (called CD4 or T cells) in your 
blood. 

FUZEON is used in combination with other anti-HIV medicines to treat
people with HIV. 

FUZEON has been shown to reduce the amount of HIV in the
blood (“viral load”) and increase the 
number of CD4 cells. Reducing the amount of HIV in the blood reduces
the risk of death or infections 
which are due to your low immunity (called opportunistic
infections). 

You should always report any changes in your condition to your doctor
to ensure that any 
opportunistic infections are treated promptly. 

Your doctor, however, may have prescribed FUZEON for
another purpose. ASK YOUR DOCTOR IF YOU 
HAVE ANY QUESTIONS ABOUT WHY FUZEON HAS
BEEN PRESCRIBED FOR YOU. 

FUZEON does not cure HIV infection or AIDS. 

FUZEON does not reduce the risk of passing HIV to other people
through unprotected sexual contact, 
sharing needles, or contaminated blood. 
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Fuzeon
®
 CMI 1108

Ciri produk

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_ _
Fuzeon
®
 DS 110610 

1 of 18 
T2009-101

DATA SHEET

FUZEON
®

_Enfuvirtide _

CAS Registry Number: 159519-65-0 

O
N
H
N
H
O
NH
2
N
H
N
H
O
NH
O
N
H
N
H
O
O
O
H
N
H
O
N
H
O
O
OH
N
H
O
NH
2
N
H
O
NH
N
H
O
N
H
O
OH
N
H
O
N
H
O
N
H
O
N
H
O
O
N
H
2
N
H
O
NH
O
O
O
H
N
H
O
O
OH
NH
O
N
H
2
N
H
O
O
N
H
2
NH
O
O
N
H
2
N
H
O
O
H
N
H
O
O
H
N
H
O
O
H
N
H
O
N
H
O
N
H
O
NH
N
N
H
O
O
H
N
H
O
N
H
O
N
H
O
O
OH
N
H
O
O
OH
N
H
O
O
H
N
H
O
O
NH
2
N
H
O
O
N
H
2
N
H
O
NH
2
O
O
H
O
O
NH
2
O

The empirical formula of enfuvirtide is C
204
H
301
N
51
O
64
, and the molecular weight is 4,492.  It has the 
following primary amino acid sequence: 
Ac-Tyr-Thr-Ser-Leu-Ile-His-Ser-Leu-Ile-Glu-Glu-Ser-Gln-Asn-Gln-Gln-Glu-Lys-Asn-Glu-Gln-Glu-Leu-
Leu-Glu-Leu-Asp-Lys-Trp-Ala-Ser-Leu-Trp-Asn-Trp-Phe-NH
2

DESCRIPTION 
FUZEON (enfuvirtide) is derived from a naturally occurring motif,
amino acid residues (643-678) within 
the gp41 transmembrane glycoprotein of human immunodeficiency virus
type 1 strain LAI (HIV-1
LAI
).  
Enfuvirtide is a linear 36-amino acid synthetic peptide, composed of
naturally occurring L-amino acid 
residues. 

FUZEON is a white to off-white lyophilised powder. Each vial
contains 108 mg enfuvirtide.  
Reconstituted FUZEON solution contains 90mg/mL of enfuvirtide. 

FUZEON also contains sodium carbonate (anhydrous), mannitol, sodium
hydroxide and hydrochloric 
acid. 
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_ _
Fuzeon
®
 DS 110610 

2 of 18 
T2009-101

_ _
_ _
PHARMACOLOGY 
_MECHANISM OF ACTION _
Enfuvirtide is a member of the therapeutic class called fusion
inhibitors. It is an inhibitor of the 
structural rearrangement of HIV-1 gp41 that functions
by specifically binding to this virus protein 
extracellularly and thereby blocking the virus from entering the
cell. The antiviral activity of enfuvirtide 
results from its association with a heptad-repeat motif, HR1,
within native gp41 on the viral surface. 
_ _
_MICROBIOLOGY _
ANTIVIRAL A