FUZEON
(enfuvirtide) is used with other anti-HIV medicines to treat HIV-1 infection in
patients who are treatment-experienced and have detectable viral loads even though
they are taking anti-HIV medicines. This indication is based on results from 2
studies that lasted 48 weeks each. Patients in the studies were treatment-experienced
adults, and many of them had advanced HIV disease. There are no studies of FUZEON
in patients who haven’t taken anti-HIV medicines.
What
are the possible side effects of FUZEON?
Injection
site reactions
FUZEON causes injection site reactions. Almost all
people get injection site reactions with FUZEON. Reactions are usually mild to
moderate but occasionally may be severe. Reactions on the skin where FUZEON is
injected include:
itching
swelling
redness
pain or tenderness
hardened skin
bumps
These
reactions usually happen within the first week of FUZEON treatment and can happen
again as you keep using FUZEON. A reaction at one skin injection site usually
lasts for less than 7 days.
Injection
site reactions may be worse when injections are given again in the same place
on the body, or when the injection is given deeper than it should be (for example,
into the muscle).
If
you are worried about the reaction you are having, call your healthcare provider
to help you decide if you need medical care. If the injection site reaction you
are having is severe, call your healthcare provider right away. If you have an
injection site reaction, you can discuss with your healthcare provider ways to
help the symptoms.
An
injection site can get infected. It is important to follow the FUZEON Injection
Instructions to lower your chances of getting an injection site infection. Call
your healthcare provider right away if there are signs of infection at the injection
site such as oozing, increasing heat, swelling, redness or pain.
Injection
using Biojector® 2000
Shooting nerve pain and tingling lasting
up to 6 months from injecting close to large nerves or near joints, and bruising
and/or collections of blood under the skin have been reported with use of the
Biojector 2000 needle-free device to inject FUZEON. If you are taking any blood
thinners, or have hemophilia or any other bleeding disorder, you may be at higher
risk of bruising or bleeding after using the Biojector.
Pneumonia
Patients
with HIV get bacterial pneumonia more often than patients without HIV. Patients
taking FUZEON with other HIV medicines may get bacterial pneumonia more often
than patients not receiving FUZEON. It is unclear if this is related to the use
of FUZEON. You should contact your healthcare provider right away if you have
a cough, fever or trouble breathing. Patients are more likely to get bacterial
pneumonia if they have a low number of CD4 cells, have a high viral load, use
intravenous (injected into the vein) drugs, smoke or have had lung disease in
the past. It is unclear if pneumonia is related to FUZEON.
Allergic
reactions
FUZEON
can cause serious allergic reactions. Symptoms of a serious allergic reaction
with FUZEON can include:
trouble
breathing
fever with vomiting and a skin rash
blood in your urine
swelling
of your feet
Call
your healthcare provider right away if you get any of these symptoms.
Other
side effects
The following side effects were seen more often in
patients using FUZEON with their other anti-HIV medicines than in patients not
using FUZEON with their other anti-HIV medicines:
pain
and numbness in feet or legs
loss of sleep
depression
decreased appetite
sinus problems
enlarged lymph nodes
weight decrease
weakness or
loss of strength
muscle pain
constipation
pancreas problems
These
are not all the side effects of FUZEON. FUZEON is still being studied in children.
The safety of FUZEON in children under 6 years of age is not known. The side effects
of FUZEON for HIV-positive children aged 6 through 16 years were similar to those
seen in adult patients.
If
you have questions about side effects, ask your healthcare provider. Report any
new or worsening symptoms to your healthcare provider. Your healthcare provider
will tell you what to do and may be able to help you with these side effects.
FUZEON
is not a cure for HIV infection or AIDS. FUZEON does not prevent the transmission
of HIV. People taking FUZEON may still get opportunistic infections or other conditions
that can happen with HIV infection. For these reasons it is very important that
you remain under the care of your healthcare provider while taking FUZEON.
View
the Patient Product Information.
