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Fuzeon - enfuvirtide

General Information Enfuvirtide (Fuzeon) is almost always used as one component of a multidrug combination to suppress the human immunodeficiency (HIV) viral load.
Specifics Enfuvirtide is one of the newest and most effective antiviral medications used to treat HIV.

Enfuvirtide is different from all other FDA-approved HIV medications (as of August 2005) in that it is administered by a (self-administered) injection, and it works against HIV in a different manner from other drugs.

Enfuvirtide works by inhibiting the binding of HIV to uninfected T-cells (also known as CD4-lymphocytes.)  Enfuvirtide is classified as a fusion inhibitor (FI).

Dosing
including preparation and administration
Generally enfuvirtide is taken as the contents of one vial (90 mg) injected under the skin (subcutaneously) twice a day.

The nurses at your clinic will be happy to demonstrate the preparation and administration to you.  Also there is a video that comes with the medicine set that is extremely important for you to watch and understand.

It is probably a very good idea for you to wash your hands before preparing and injecting enfuvirtide.  Also you should wear gloves after you wash your hands if possible.

"Reconstitution" of enfuvirtide is necessary for preparation of each injection prior to your giving it to yourself:

1.  1cc of sterile water from one vial is injected slowly into the vial of enfuvirtide that comes as a powder.
2.  The vial is then gently rolled until all the powder is wet and is starting to dissolve.  Never shake the vial as this will damage the drug.
3.  That vial is then set aside for up to 20 minutes until all the powder is dissolved and no longer visible.  This is very important.
4.  You may prepare two vials at one time and store one of them for later use that same day.

After this preparation phase above, the enfuvirtide is administered as follows:

1.  Find a suitable site for subcutaneous injection on the front or sides of your thighs or on your abdomen.  It is important to avoid areas where you have recently injected and especially areas that are tender or inflamed.  If a friend knows how to give subcutaneous injections, you can also use the back of your upper arms as a "target."
2.  Wipe off the planned injection site very well with an alcohol wipe to remove any germs from the skin and let it dry.  If you are visibly dirty, you should bathe or shower before you inject.
3.  Wipe off the rubber top of the enfuvirtide vial with another alcohol wipe.
4.  Remove the cap from the needle and syringe.  Pierce the rubber top of the enfuvirtide vial with the needle of the syringe to be used for the injection
5.  Slowly aspirate or suck the contents of the vial into the syringe as you hold the vial upside down.  Enfuvirtide may be thick after the powder is dissolved so it may take a few seconds to get all of it into the syringe.  You may have to move the needle a bit to get every last bit of the enfuvirtide.
6.  Avoiding areas of the skin where there have been recent injections or reactions, pinch the skin of the site you wish to use for your injection and insert the needle into the pinched area and slowly inject the enfuvirtide.

After the enfuvirtide is injected, it is extremely important to gently massage the area.  Consider using a clean terry cloth wash cloth rolled into a ball to knead the area of injection for several minutes after each injection.  This massage will decrease your chances for having injection area problems.

Dispose of your needles and syringes in a container that will not be accessible by anyone else.

Adherence
(this refers to your willingness, ability, and actual performance in taking your medications)
The "all or none" rule applies to all antiviral medications such as enfuvirtide: you should commit yourself to taking every dose, every day OR take none at all.  Missing doses leads to a worsening of HIV infections (resistance to medications) and makes finding a good antiviral medication harder to do.

As with any antiviral drug or antibiotic, try not to ever miss a dose.  If you miss a dose and notice that you have done so within a few hours of its scheduled time, you may take the dose as usual and take the next dose at its regular time. 

You should never change the dose of enfuvirtide without speaking to your healthcare provider first.

If you miss more than one dose, look at the reasons why you missed them and come up with a plan to avoid it in the future.  For example, if you fell asleep too early, take the medicine earlier in the evening, with your later meal, set an alarm, or have someone appointed to wake you up for your medicine. 

It is strongly recommended that you consider using weekly pill boxes and arrange all of your doses a week in advance.  Buy a small pill box so that you can carry a dose or two of your medicines with you in case you are away from home.  Obviously in the case of enfuvirtide, a lot of planning has to be done as it may be difficult to carry extra enfuvirtide, syringes, and other supplies with you.

Possible Side Effects
The package insert for most drugs including enfuvirtide is often overwhelming and scary with perhaps an overemphasis on side effects.  We have summarized the important and more common problems here.

Many people take enfuvirtide without many side effects. 

The most common side effect of enfuvirtide is inflammation at the sites of injection.  Inflammation refers to pain, redness, lumpiness, and tenderness.  As mentioned above, these reactions can be minimized by kneading the injections sites afterwards.  Avoid injecting in areas that are inflamed.

Sometimes the sites can become infected with staph or strept, and this can spread over the skin ("cellulitis") or cause abscesses.  These problems may be prevented by washing your hands, wearing gloves, and preparing the injection sites with the alcohol wipes.

Rarely some persons may be allergic to enfuvirtide and they can develop skin rashes and fever.

Usually you will have blood tests done in the first month to look for the beneficial effects of enfuvirtide and any side effects. 

Many minor side effects will either stay constant or get better with time.  It is mainly the side effects that are severe or get worse that may cause significant health risks for you.

Interactions
This refers to the way that enfuvirtide affects other medications
There are not many known effects of enfuvirtide on other drugs.  However, make sure your healthcare providers knows all the medications you are taking including any herbal and over the counter medications.
Report to you healthcare provider or go to an Emergency Room if you have severe side effects, increasing side effects, shortness of breath, uncontrollable diarrhea, back pain, groin pain, fever, weakness, jaundice (eyes and skin turn yellow,) muscle pain, nausea and vomiting so that you cannot hold down your food and liquids.
You can download this handout in PDF format by clicking HERE.

8.10.2005