20 JUNE 25, 2004
www.houstonvoice.com HOUSTON VOICE
Genenc Name: enfuvirtide (en-FEW-ver-tide) lor Injection
This leaflet contains important information Iw patients and their caregivers about
FUZEON. Please read tins leaflet and FUZEON Injection Instructions carefully before
you start using FUZEON. Always read the section 'Changes since the last version of
this leafier at the end of this leaflet each time you get-your FUZEON prescription
refilled. There may be important new information aboul the use ol FUZEON.
This information does net take the place ol talking with your healthcare provider
about your medical conditions or treatment.
What is FUZEON?
FUZEON is a medicine called an HIV (human immunodeficiency virus] fusion inhibitor.
FUZEON is always used with other anti HIV medicines to treat adults and children
aged 6 years and older with HIV infection. FUZEON is not used by itself to treat
FUZEON blocks HIVs ability to infect healthy CD4 cells. When used with other
ami HIV medicines. FUZEON can reduce the amount ol HIV in Die blood and increase
the number of CD4 cells. This may keep your immune system healthy, so it can help
FUZEON -tees Mt care WV intoetton or AIDS. The long term effects of FUZEON are
not known at this time. People laking FUZEON may still get opportunistic
infections w other conditions that can happen with HIV infection. For these
reasons, it is very trwportart that yon remain under the care of ytw Iwrttkiri
prmnwtr while taking FUZEON.
Does FUZEON lower the chince of passing HIV to other people?
FUZEON tees not lower your chance of passing HIV to other peopk through
unprotected set, sharing needtes or being exposed to your Hood. For your own
health and the health of others, it is important to continue to practice sater sex. Use
a latex or potyurethane condom or other barrier method to lower the chance of
sexual contact with semen, vaginal secretions or Mood. Never use or share dirty
needles. Ask your healthcare provider if you have any questions about safei sex ot
how to prevent passing Hiv to other people.
Who should not use FUZEON?
Do not use FUZEON if you are allergic to any of the ingredients in FUZEON.
See (he end ol this leaflet lor a list of ingredients in FUZEON.
leN your healthcare pro-riser:
if rou are pregnant or plan to become pregnant We do not know if FUZEON can
harm your unborn child. You and your healthcare provider will need to decide if
FUZEON is n-ght for you. If you use FUZEON while you are pregnant, talk with your
healthcare provider about how you can be in the Antiretroviral Pregnancy Registry.
If yon art hrta-ft fcpfcig. You should not breast-teed if you ate HIV positive
because of the chance of passing HIV to your baby. Also. i( is not known if
FUZEON can pass into your breast milk and if it can harm your baby.
ah-wt al the merkemes ye* use. including prescription and nonprescription
medicines, vitamins and herbal supplements FUZEON has not been tested
with all medicines.
Before you use FUZEON. make sure you understand all of the information in tins
leaflet and the FUZEON Jnyecfion instructions that come with your medicine. You or
your caregiver should be trained by a healthcare provider before injecting it. if vou do
not understand all the information, talk wilh youi healthcare provider about your
Questions or concerns.
* Use FUZEON with other arm Hiv medicines Do not use FUZEON as your only
* FUZEON must be injected. FUZEON does not work if it Is Swallowed.
■ Do not mix other medicines in ihe same syringe with HJZEON.
■ FUZEON is given under the skin by injection (a "shot") in the upper aim. ii-pper leg
or abdomen two times a day. See the FUZEON /n/ecDon Instructions that come with
your medicine for step by-step instructions about how to inject FUZEON.
■ Oo not inject FUZEON in the same area as you did the time before. Do not inject
FUZEON into the following areas around the navel [belly button), scar tissue, a
bruise or a mole, or where there is an injection site reaction.
* Do not inject FUZEON if you see particles boating in the FUZEON vial after you
■ You can use FUZEON whethei you have eaten ot not Food does not affect FUZEON.
However, you must keep taking youi other medicines the way you did before.
■ Do nol change your dose or stop taking FUZEON without first talking with your
- See your healttirjare provider regularly wttile using FUZEON.
- When your FUZEON supply runs low, be sure to have il refilled. This is very
important because the amount of virus in your Mood may increase if the medicine
is stopped for even a short lime. If you miss or skip doses of FUZEON, HIV may
develop resistance to FUZEON and become harder to treat.
If you mss a dose of FUZEON. take the missed dose as soon as you can and then
take your next dose as scheduled. If you have missed a dose of FUZEON and it is
dose to the time when you are supposed to take your next dose, wait and take the
next dose as regUarty scheduled. Do not take two doses of FUZEON at the same time.
■ If you take too much FUZEON, call your healthcare provider right away. We do not
know what can happen if you take too much FUZEON. You will be watched very
carefully if you take too much FUZEON.
It is important that you pot your use* syringrn into i-^Kial sharps c
after injecting FUZEON. Your healthcare provider will give you more instructions
about the safe disposal of your used synnges. Du —t wrt then In a trash rare
If you do not have a sharps container, call your healthcare provider or pharmacist
to get one before using FUZEON.
Can FUZEON be used with other medicines?
HJZEON does not affect othei anb-HIV medicines or the medicine nlampin (also
known as rifampicm and manufactured under the brand names Rifadin* and
Rimactane*). You can take FUZEON at the same limes or at different times than
your other anti-HIV medicines
What should I avoid while using FUZEON?
■ Avoid doing anything that can spiead HIV infection, since FUZEON does not stop
you from passing the HIV infection to others.
■ Do not share needles or other injection equipment.
Do not share personal "Hems that can have blood or body fluids on them, like
toothbrushes or razor blades.
- Do not have any kind of sex without protection. Always practice safer sex by using
a latex or potyurethane condom or other barrier method to reduce the chance of
sexual contact with semen, vaginal secietions or blood.
- Do not drive or operate heavy machinery il FUZEON makes you feel ditfy.
What are the possible sifle effects df FUZEON?
Injection site reactions
FUZEON causes injection site tttcOtms. Almost all people get injection site
reactions with FUZEON. Reactions are usually mid to moderate but occasionally may
be severe. Reactions on the skin where FUZEON is injected include:
These reactions generally happen within the first week ol FUZEON treatment and
usually happen again as you keep using FUZEON. A reaction at one skin injection
site usually lasts for less than 7 days.
Injection site leactkms 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 (lot
example, into the muscle).
If you are worried about Vie reaction you are having, call your healthcare provider
to help rou decide if you need medical care. If the inaction site reaction yw
art havwig Is severe, call your healthcare provider right away. II you have an
injection site reaction, you can discuss with your healthcare provider ways to help
Ao injection site cao get inlected. To lower your chances of getting an
injection site infection, it is important to follow the fUZEON yn/eefmn Instructions that
come with your medicine. Call your healthcare provider right away If there art
signs of Mecttrrn at the injection site such as ooifng, increasing heat, swelling.
Patients with HIV get bacterial pneumonia more often than patients without HIV.
In clinical trials, patienis taking FUZEON with other HIV medicines got bacterial
pneumonia mote often than patients not receiving FUZEON It is uncleai if this was
related to the use ol FUZEON. You shrruU contact your hrrttttrcare provider right
amy if you have a cough, fever or trouble t-reathrrtg. Patients are more likely to
get bacterial pneumonia il they had a tow number of CD4 cells, increased amount of
HIV in the blood, intravenous (injected into [he vein) drug use, smoking or had
expenenced lung disease in the past. It is unclear if pneumonia is related to FUZEON.
FUZEON can cause serious allergic reaction. Symptoms of a scnous allergic
reaction with FUZEON can include;
- trouble breathing
* fever with vomiting and a skin rash
■ Wood in youi unne
swelling ol your leet
Call your healthcare [no-rider right away it you get any of these symptoms
Other side effects
The tallowing side effects were seen more often in patients using FUZEON with
their other anti-HfV medicines than in patients not using FUZEON with their other
pain and numbness in feet or legs
loss ol sleep
These are not all the side effects of FUZEON. The list of side effects with FUZEON is
not complete at this time because FUZEON is still being studied.
If you have questions aboul side effects, ask your healthcare provider Deport any
new or anttiiutu-g symptoms to your healthcare pravMer. Youi healthcare provider
will tell you what to do and may be able to help you with these side eflects.
FUZEON vials not mixed with stenle water cao be stored at room temperature (HC
to 86' F). FUZEON should be refrigerated if it cannot be stored at room temperature.
The Sterile Water for Injection (diluent) may be stored al room temperature
After FUZEON has been mixed with the sterile water, the vial can be stored in a
refrigerator toe up to 24 hours.
Do not use FUZEON or sterile water after the expiration date on the vials. Do not keep
FUZEON that is out of date or that you no longer need.
Medicines are sometimes prescribed for conditions not mentioned in patient
information leaflets. Do not use FUZEON lor a condition for which it was not
prescribed. Do not give FUZEON to other people, eveo if they have the same
symptoms you have. It may harm them. Keep FUZEON and all medicines out of the
reach rjf children.
This leaflet summanzes the most important information about FUZEON. tf you would
like more information, lalk with your healthcare provider or see the section, 'rVhere
can I #1 more information about FUZEON?" in this leaflet. You can ask your
healthcare prowler « pharmacist for information about FUZEON that is written for
Active Ingredients: enfuvirtide
Inactive Ingredients: Mannilol, sodium carbonate, sodium hydroxide and
-UZEON conies packaged as a convenience kit containing the following
60 vials of FUZEON (2 cartons of 30 each)
60 vials of Stenle Water tor Injection (2 cartons of 30 each)
syringes for mixing (3 ml/cc)
synnges fw injecting (1 ml/cc)
Call your healthcare provider or pharmacist If you need more lupoHes.
Where EM I fiel BOH ttKMttn '-bom FUZEON1
The best source for more information about FUZEON is youi healthcare
provider. More information about FUZEON is located at www.FUZEON.com and
1-877-4 FUZEON (1*877 438*9366).
This is the fiist version of this leaflet; it was wmtten in March 2003. Please check this
section when you' medicine is refilled lor any important new information
Roche and FUZEON are trademarks ol Hoffmann-La Roche Inc.
Rifadin is a trademark of Merrell Pharmaceuticals Inc.
Rimactane is a trademart of Ciba.
FUZEON has been jointly developed by lumens. Inc. and Hoffmann La Roche Inc.
FUZEON is manufactured by Hoffmann La Roche Inc.
weakness or toss ol strength
Roche Laboratories Inc.
340 Kingsland Street
Nutley. New Jersey 07110-1199
4727 University Drive
Durham. North Carolina 27707
Issued: March 2003
Copyright © 20O4 by Roche Laboratones Inc. aod Tnmens. Inc. All rights resetted.