Enfuvirtide Injection 

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 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 discuss  with my healthcare provider  before using 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 use 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? 

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. 

What happens if I overdose? 

Seek emergency medical attention if you think you have used too much  of this medicine. Symptoms of an  enfuvirtide overdose are unknown. 

What should I avoid while using 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. 

Enfuvirtide side effects

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. 

• 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.