Uses

This drug is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life.

Enfuvirtide is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, continue to take all HIV medications exactly as prescribed by your doctor. Use an effective barrier method (latex or polyurethane condoms/dental dams) during sexual activity as directed by your doctor. Do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

Other Uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This product may also be used to lessen the risk of HIV infection after contact with the virus (for example, due to a needle stick). Ask your doctor for more details.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using enfuvirtide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin (subcutaneously) usually twice daily into the upper arm, thigh, or abdomen. Do not inject into the buttock or near the elbow, knee or groin. Rotate injection sites with each shot. Do not inject in or near bumps from past injections. Also, do not inject into moles, scars, bruises, tattoos, burn areas, or your belly button.

For children, the dosage is based on their weight.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

It is very important to continue using this medication (and other anti-HIV medications) exactly as prescribed by your doctor. Do not skip any doses.

For the best effect, use this medication at evenly spaced times. To help you remember, use this medication at the same times every day.

If you have a very serious allergic reaction to enfuvirtide, do not use it again (see Side Effects section).

Side Effects

Pain, redness, itching, bruising, hardened skin, or bumps at the injection site may occur. These types of reactions are common and may last up to 7 days. Runny nose may also occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including:

• unexplained weight loss
• severe tiredness
• muscle aches/weakness that doesn't go away
• headaches that are severe or don't go away
• joint pain
• numbness/tingling of the hands/feet/arms/legs
• vision changes
• signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores)
• signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter)
• signs of a certain nerve problem known as Guillain-Barre syndrome (such as unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes)
• signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)

Tell your doctor right away if you have any serious side effects, including:

• anxiety
• numbness/tingling/shooting nerve pain near injection site
• signs of injection site infection (such as pain and redness that don't go away, oozing, warmth)
• abdominal pain
• loss of appetite

An allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of an allergic reaction include:

• rash
• itching/swelling (especially of the face/tongue/throat)
• dizziness
• trouble breathing
• fever
• chills
• nausea/vomiting

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using enfuvirtide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• bleeding problems (such as hemophilia, coagulopathy)
• smoking
• IV drug abuse
• lung disease

During pregnancy, this medication should be used only when clearly needed. Treatment can lower the risk of passing HIV infection to your baby, and enfuvirtide may be part of that treatment. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• "blood thinners" (such as warfarin, heparin, enoxaparin)
• orlistat

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as liver function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Before mixing, store the dry powder and mixing solution at room temperature. Once mixed, store the medication in the refrigerator and use within 24 hours. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.