Precautions
Before turning the vial upside down, slowly inject the air into the FUZEON. Gently turn the vial upside down and slowly pull the plunger to get 1 mL of FUZEON solution and remove the needle and syringe from the vial. Pinch and hold a fold of skin around the injection site and pierce the skin.
How do I use the Fuzeon?
The recommended dosage of FUZEON is 90 mg (1mL) twice daily injected subcutaneously into the upper arm, anteriorthigh or abdomen [seeAssessment Prior to Administration andAdministration]. Recommended Dosage For Pediatric Patients
What is the recommended dosage of Fuzeon?
Stop using FUZEON and call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of these signs and symptoms of an allergic reaction: Pneumonia. Pneumonia which can be serious and cause hospitalization and death has happened in people who use FUZEON.
What should I do if I am allergic to Fuzeon?
Use enfuvirtide exactly as your doctor tells you to. The usual dose for an adult is 90 mg twice a day. This is given as a 1 ml injection just under the skin (subcutaneous injection) on your upper arm, the outside of the upper part of your thigh, or your stomach area (abdomen).
How do you administer enfuvirtide?
Where do you inject FUZEON?
Pick Where to Inject: Upper thighs, abdomen, upper arms are the optimal places.
Is FUZEON subcutaneous?
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.
Is FUZEON an injection?
FUZEON (enfuvirtide) for Injection is a white to off-white, sterile, lyophilized powder and it is packaged in a single-dose clear glass vial containing 108 mg of enfuvirtide for the delivery of approximately 90 mg/1 mL when reconstituted with 1 mL of Sterile Water for Injection.
How do you give yourself enfuvirtide?
You can inject enfuvirtide anywhere on the front of your thighs, your stomach, or upper arms. Do not inject enfuvirtide in or near your navel (belly button) or in any area directly under a belt or waistband; near the elbow, knee, groin, the lower or inner buttocks; or directly over a blood vessel.
What is FUZEON used for?
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 ages 6 years and older with HIV infection. FUZEON blocks HIV's ability to infect healthy CD4 cells.
Which antiretroviral medication is suitable for administration through the subcutaneous route?
T-20 is a novel antiretroviral agent that inhibits the fusion of human immunodeficiency virus (HIV) with target cell membranes. It is delivered by self-administered, twice-daily, subcutaneous injections.
How much does Fuzeon cost?
The cost for Fuzeon subcutaneous powder for injection 90 mg is around $3,785 for a supply of 60 powder for injection, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.
Is Fuzeon a fusion inhibitor?
Abstract. T20 (generic name: Enfuvirtide, brand name: Fuzeon) is the only FDA-approved HIV fusion inhibitor that is being used for treatment of HIV/AIDS patients who have failed to respond to current antiretroviral drugs.
What are the side effects of fusion inhibitors?
WHAT ARE SIDE EFFECTS OF HIV FUSION INHIBITORS?Pain and discomfort.Redness.Itching.Diarrhea.Nausea.Fatigue.Insomnia.Depression.More items...
Who should not take enfuvirtide?
Enfuvirtide is not approved for use by anyone younger than 6 years old.
How effective is enfuvirtide?
A recently presented analysis of resistance to enfuvirtide in TORO 1 and TORO 2 found that 94 percent of patients with protocol-defined virologic failure and demonstrated suboptimal viral suppression had virus with amino-acid substitutions at codons 36 through 45 of the viral glycoprotein 41 (known to be associated ...
What is the cost of enfuvirtide?
FORMSbrand namepreparationcost*FuzeonEnfuvirtide (ENF, T20)$71.71Jul 29, 2019
What kind of drug is Fuzeon (enfuvirtide)?
Fuzeon (enfuvirtide) works in a unique way and is the only HIV ARV that is classified as a fusion inhibitor. Since it works differently against the...
Can you have Fuzeon (enfuvirtide) injected by a healthcare provider?
Fuzeon (enfuvirtide) must be given two times every day, so unless you reside in an assisted living facility it's likely that the medication will ne...
How do you administer Fuzeon (enfuvirtide)?
Fuzeon (enfuvirtide) should be injected into the fatty part of the upper arm, thigh, or belly area. One hand can gently pinch and fold the skin, wh...
Should I store Fuzeon (enfuvirtide) in the fridge?
The unmixed powder vials of Fuzeon (enfuvirtide) can be stored at room temperature. Once the medication has been mixed with water, it can be stored...
Can I give Fuzeon (enfuvirtide) with the Biojector 2000?
The Biojector 2000 was a device studied as a potential option for administering Fuzeon (enfuvirtide) without a needle. It is not currently availabl...
What is Fuzeon (enfuvirtide)?
Fuzeon (enfuvirtide) is an entry inhibitor and prevents the HIV virus from entering and fusing with your immune cells.
Pros and cons of Fuzeon (enfuvirtide)
Good option for people with HIV who are resistant to other HIV ARV classes like NNRTIs, NRTIs, and PIs
Pharmacist tips for Fuzeon (enfuvirtide)
Plan for each dose to take you about 30 minutes from start to finish. Start by injecting 1 mL of sterile water into the vial containing the Fuzeon (enfuvirtide) powder. Gently mix the vial by rolling the vial between your hands, DON'T shake it.
What are the side effects of Fuzeon (enfuvirtide)?
With any medication, there are risks and benefits. Even if the medication is working, you may experience some unwanted side effects.
What are the risks and warnings for Fuzeon (enfuvirtide)?
Fuzeon (enfuvirtide) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options
Interactions between Fuzeon (enfuvirtide) and other medications
Fuzeon (enfuvirtide) may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking.
How much does Fuzeon (enfuvirtide) cost?
There is currently no generic for Fuzeon (enfuvirtide), so it can be expensive, even with insurance. GoodRx coupons, copay cards and patient assistance programs may help lower the cost.
DESCRIPTION
FUZEON (enfuvirtide) is an inhibitor of the fusion of HIV-1 with CD4 cells. Enfuvirtide is a linear 36-amino acid synthetic peptide with the N-terminus acetylated and the C-terminus is a carboxamide. It is composed of naturally occurring L-amino acid residues.
INDICATIONS
FUZEON® in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
DOSAGE AND ADMINISTRATION
FUZEON is available in a single-dose lyophilized powder for injection containing 108 mg enfuvirtide per vial.
HOW SUPPLIED
Lyophilized powder for injection: 108 mg enfuvirtide per single-dose vial
SIDE EFFECTS
The following adverse reactions are discussed in greater detail in other sections:
PRECAUTIONS
The majority of subjects (98%) receiving FUZEON in randomized, controlled, open-label, multicenter clinical trials had at least one local injection site reaction; ISRs occurred throughout treatment with FUZEON. Manifestations may include pain and discomfort, induration, erythema, nodules and cysts, pruritus, and ecchymosis [see ADVERSE REACTIONS ].
OVERDOSE
There are no reports of human experience of acute overdose with FUZEON. The highest dose administered to 12 subjects in a clinical trial was 180 mg as a single-dose subcutaneously. There is no specific antidote for overdose with FUZEON. Treatment of overdose should consist of general supportive measures.
Before using enfuvirtide
Some medicines are not suitable for people with certain conditions, and sometimes a medicine can only be used if extra care is taken. For these reasons, before you start using enfuvirtide it is important that your doctor knows:
How to use enfuvirtide
Before you start the treatment, read the manufacturer's printed information leaflet from inside the pack. It will give you more information about enfuvirtide and how to administer it, and it will also provide you with a full list of the side-effects which you could experience from having it.
Getting the most from your treatment
Keep your regular appointments with your doctor so that your progress can be monitored. You will need to have regular blood tests.
Can enfuvirtide cause problems?
Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with enfuvirtide. You will find a full list in the manufacturer's information leaflet supplied with your medicine.
Important information about all medicines
Never use more than the prescribed dose. If you suspect that you might have taken an overdose of this medicine, or someone else has taken some by accident, go to the accident and emergency department of your local hospital at once. Take the container with you, even if it is empty.
Before taking Fuzeon, tell your doctor
If you are allergic to Fuzeon; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
How is Fuzeon best taken?
Use Fuzeon as ordered by your doctor. Read all information given to you. Follow all instructions closely.
What are the side effects of Fuzeon that I need to call my doctor about immediately?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
What are some other side effects of Fuzeon?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
If overdose is suspected
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Consumer information use and disclaimer
If your symptoms or health problems do not get better or if they become worse, call your doctor.
