What is enfuvirtide?
Enfuvirtide is an antiviral medication in a group of HIV medicines called fusion
inhibitors. Enfuvirtide prevents human immunodeficiency virus (HIV) from entering and taking
over the cells in your body.
Enfuvirtide is used to treat HIV, which causes acquired immunodeficiency syndrome
(AIDS). Enfuvirtide is not a cure for HIV or AIDS.
Enfuvirtide is usually given after other medications have been tried without successful
treatment of HIV.
Enfuvirtide may also be used for other purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking enfuvirtide?
Do not use this medication if you are allergic to enfuvirtide.
Before using enfuvirtide, tell your doctor if you are allergic to any drugs, or if you have a
bleeding or blood clotting disorder, such as hemophilia. You may need a dose adjustment or
special tests to safely use enfuvirtide.
FDA pregnancy category B. This medication is not expected to be harmful to an
unborn baby, but HIV can be passed to the baby if the mother is not properly treated during
pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
Take all of your HIV medicines as directed to control your infection while you are pregnant.
You should not breast-feed while you are using enfuvirtide. Women with HIV or
AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the
virus to the baby in your breast milk.
Enfuvirtide may increase your risk of developing pneumonia, especially if you have a
high viral load, a history of lung disease, or if you smoke. Call your doctor at once if you have
symptoms of pneumonia, such as cough, fever, rapid breathing, or shortness of breath.
How should I take enfuvirtide?
Use this medication exactly as it was prescribed for you. Do not use enfuvirtide in larger
amounts, or use it for longer than recommended by your doctor. Follow the directions on your
prescription label.
Enfuvirtide is given as an injection under the skin of your arm, upper thigh, or stomach.
Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown
how to inject your medicine at home. Do not self-inject this medicine if you do not fully
understand how to give the injection and properly dispose of used needles and syringes.
Carefully follow all instructions about giving yourself an enfuvirtide injection. Most
people using this medication have a skin reaction where the medicine is injected. Your
caregivers can tell you what type of skin reactions are serious and when to call your doctor.
Enfuvirtide is usually injected twice a day. Each vial of enfuvirtide is for a single use
only.
Enfuvirtide is a powder that must be mixed with a liquid (sterile water) provided with the
medicine. After mixing the powder and the liquid, gently tap the vial for 10 seconds and then
slowly roll it between your hands. Let the vial stand until the powder completely dissolves (up to
45 minutes). If the mixture is foamy or gel-like, allow more time for it to dissolve.
Do not shake the mixture. Shaking will make the medicine foam and it will take
much longer to dissolve. Do not use the medication if it has changed colors or has any particles
in it. Call your doctor for a new prescription.
You may mix both of your day's doses at the same time, but once the medicine is
mixed you must keep it in a refrigerator and use it within 24 hours.
When you are ready to use the medicine, take the vial out of the refrigerator and allow it
to reach room temperature. Inspect the mixture again for particles or change in color. Do not
draw your enfuvirtide dose into a syringe until you are ready to give yourself an injection. Then
throw away the vial, even if there is medicine left in it.
Use each disposable needle only one time. Throw away used needles in a puncture-proof
container (ask your pharmacist where you can get one and how to dispose of it). Keep this
container out of the reach of children and pets.
Do not use enfuvirtide as your only HIV medication. HIV/AIDS is usually treated
with a combination of different drugs. Your disease may become resistant to enfuvirtide if you do
not use it in combination with other HIV medicines your doctor has prescribed.
To best treat your condition, use all of your medications as directed by your doctor. Do
not change your doses or medication schedule without advice from your doctor. Every person
with HIV or AIDS should remain under the care of a doctor.
To be sure this medication is helping your condition, your blood will need to be tested on
a regular basis. Do not miss any scheduled appointments.
It is important to use enfuvirtide regularly to get the most benefit. Get your prescription
refilled before you run out of medicine completely.
Store unmixed enfuvirtide powder at room temperature away from moisture and heat.
What happens if I miss a dose of enfuvirtide?
Use the missed dose as soon as you remember. If it is almost time for your next dose,
skip the missed dose and use the medicine at your next regularly scheduled time.
Do not
use extra medicine to make up the missed dose.
Where can I get more information about enfuvirtide?
Your pharmacist has information about enfuvirtide written for health professionals that you may read.
What are the possible side effects of enfuvirtide?
Get emergency medical help if you have any of these
signs of an allergic
reaction:
skin rash or hives; fever, chills; nausea, vomiting; difficulty breathing; feeling
light-headed or fainting; swelling of your face, lips, tongue, or throat.
Stop using enfuvirtide and call your doctor at once if you have any of these serious
side effects:
-
cough with fever, chest congestion, and shortness of breath;
-
signs of a new infection, such as fever or chills, cough, or
flu symptoms.
-
nerve pain lasting for several weeks or months; or
-
severe or prolonged (more than 7 days) injection site
reaction.
Less serious side effects may include:
-
pain, itching, irritation, redness, swelling, or raised bumps under
your skin where the medicine was injected;
-
pain or numbness in your feet or legs;
-
weakness or loss of strength;
-
muscle pain;
-
sleep problems (insomnia);
-
depression;
-
loss of appetite; or
-
constipation.
This is not a complete list of side effects and others may occur. Tell
your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about enfuvirtide?
Before using enfuvirtide, tell your doctor if you are allergic to any drugs, if you take a
blood thinner such as Coumadin, or if you have a bleeding or blood clotting disorder, such as
hemophilia. You may not be able to use enfuvirtide, or you may need dosage adjustments or
special tests during treatment.
Enfuvirtide may increase your risk of developing pneumonia, especially if you have a
high viral load, a history of lung disease, or if you smoke. Call your doctor at once if you have
symptoms of pneumonia, such as cough, fever, rapid breathing, or shortness of breath.
Do not use enfuvirtide as your only HIV medication. HIV/AIDS is usually treated
with a combination of different drugs. Your disease may become resistant to enfuvirtide if you do
not use it in combination with other HIV medicines your doctor has prescribed.
To best treat your condition, use all of your medications as directed by your doctor. Do
not change your doses or medication schedule without advice from your doctor. Every person
with HIV or AIDS should remain under the care of a doctor.
To be sure this medication is helping your condition, your blood will need to be tested on
a regular basis. Do not miss any scheduled visits to your doctor.
Stop using enfuvirtide and call your doctor at once if you have serious side effects
such as a signs of a new infection, such as fever or chills, cough, or flu symptoms; or severe pain,
irritation, or skin changes where you injected the medicine.
What should I avoid while taking enfuvirtide?
Avoid injecting this medication near your elbow, knee, groin, navel, or buttocks. Do
not inject into moles, scars, tattoos, burns, bruises, or skin that is not otherwise healthy.
Using enfuvirtide will not prevent you from passing HIV to other people through
unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing
HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine
needles is never safe, even for a healthy person.
Enfuvirtide can cause side effects that may impair your thinking or reactions. Be
careful if you drive or do anything that requires you to be awake and alert.
What other drugs will affect enfuvirtide?
Before using enfuvirtide, tell your doctor if you are using a blood thinner such as warfarin
(Coumadin). You may need a dosage dose adjustment or special tests during treatment.
There may be other drugs that can interact with enfuvirtide. Tell your doctor about all the
prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal
products, and drugs prescribed by other doctors. Do not start using a new medication without
telling your doctor.
What happens if I have an overdose of enfuvirtide?
