- HIV AIDS Myths and Facts Slideshow Pictures
- Take the HIV/AIDS Quiz
- AIDS Retrospective Slideshow Pictures
- What is enfuvirtide (Fuzeon), and what is it used for?
- What are the side effects of enfuvirtide (Fuzeon)?
- What is the dosage for enfuvirtide (Fuzeon)?
- What drugs interact with enfuvirtide (Fuzeon)?
- Is enfuvirtide (Fuzeon) safe to take while pregnant or breastfeeding?
- What else should I know about enfuvirtide (Fuzeon)?
What is enfuvirtide (Fuzeon), and what is it used for?
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. This indication is based on results from two controlled studies of 48 weeks duration. Subjects enrolled were treatment-experienced adults; many had advanced disease. There are no studies of Fuzeon in antiretroviral naive subjects.
What are the side effects of enfuvirtide (Fuzeon)?
Injection site reactions Fuzeon causes injection site reactions. Almost all people get injection site reactions with Fuzeon. Reactions are usually mild to moderate but occasionally may be severe.
Reactions on the skin where Fuzeon is injected include:
These reactions generally happen within the first week of Fuzeon treatment and usually happen again as you keep using Fuzeon. A reaction at one skin injection site usually lasts for less than 7 days. Injection site reactions may be worse when injections are given again in the same place on the body or when the injection is given deeper than it should be (for example, into the muscle).
If you are worried about the reaction you are having, call your healthcare provider to help you decide if you need medical care. If the injection site reaction you are having is severe, call your healthcare provider right away. If you have an injection site reaction, you can discuss with your healthcare provider ways to help the symptoms.
An injection site can get infected. It is important to follow the Fuzeon Injection Instructions that come with your medicine to lower your chances of getting an injection site infection. Call your healthcare provider right away if there are signs of infection at the injection site such as oozing, increasing heat, swelling, redness or pain.
Injection using Biojector 2000
Shooting nerve pain and tingling lasting up to 6 months from injecting close to large nerves or near joints, and bruising and/or collections of blood under the skin have been reported with use of the Biojector 2000 needlefree device to inject Fuzeon.
Pneumonia Patients with HIV get bacterial pneumonia more often than patients without HIV. Patients taking Fuzeon with other HIV medicines may get bacterial pneumonia more often than patients not receiving Fuzeon. It is unclear if this is related to the use of Fuzeon.
Patients are more likely to get bacterial pneumonia if they had 4 a low number of CD4 cells, increased amount of HIV in the blood, intravenous (injected into the vein) drug use, smoking or had experienced lung disease in the past. It is unclear if pneumonia is related to Fuzeon.
Call your healthcare provider right away if you get any of these symptoms. Other side effects The following side effects were seen more often in patients using Fuzeon with their other anti-HIV medicines than in patients not using Fuzeon with their other anti-HIV medicines:
- pain and numbness in feet or legs
- loss of sleep
- decreased appetite
- sinus problems
- enlarged lymph nodes
- weight decrease
- weakness or loss of strength
- muscle pain
- pancreas problems
These are not all the side effects of Fuzeon. For more information, ask your healthcare provider or pharmacist. If you have questions about side effects, ask your healthcare provider. Report any new or continuing symptoms to your healthcare provider. Your healthcare provider will tell you what to do and may be able to help you with these side effects.
What is the dosage for enfuvirtide (Fuzeon)?
The recommended dose of Fuzeon is 90 mg (1 mL) twice daily injected subcutaneously into the upper arm, anterior thigh or abdomen. Each injection should be given at a site different from the preceding injection site, and only where there is no current injection site reaction from an earlier dose. Fuzeon should not be injected near any anatomical areas where large nerves course close to the skin, such as near the elbow, knee, groin or the inferior or medial section of the buttocks, skin abnormalities, including directly over a blood vessel, into moles, scar tissue, bruises, or near the navel, surgical scars, tattoos or burn sites. Additional detailed information regarding the administration of Fuzeon is described in the Fuzeon Injection Instructions.
Insufficient data are available to establish a dose recommendation of Fuzeon in pediatric patients below the age of 6 years. In pediatric patients 6 years through 16 years of age, the recommended dosage of Fuzeon is 2 mg/kg twice daily up to a maximum dose of 90 mg twice daily injected subcutaneously into the upper arm, anterior thigh or abdomen. Each injection should be given at a site different from the preceding injection site and only where there is no current injection site reaction from an earlier dose. Fuzeon should not be injected into moles, scar tissue, bruises or the navel. Table 1 contains dosing guidelines for Fuzeon based on body weight. Weight should be monitored periodically and the Fuzeon dose adjusted accordingly.
What drugs interact with enfuvirtide (Fuzeon)?
Potential for Fuzeon to Affect Other Drugs
Based on the results from an in vitro human microsomal study, enfuvirtide is not an inhibitor of CYP450 enzymes. In an in vivo human metabolism study (N=12), Fuzeon at the recommended dose of 90 mg twice daily did not alter the metabolism of CYP3A4, CYP2D6, CYP1A2, CYP2C19 or CYP2E1 substrates.
Potential for Other Drugs to Affect Enfuvirtide
Based on the available data, co-administration of Fuzeon and other drugs which are inducers or inhibitors of CYP450 is not expected to alter the pharmacokinetics of enfuvirtide. No dose adjustments are needed when Fuzeon is co-administered with other antiretroviral and non-antiretroviral drugs.
Is enfuvirtide (Fuzeon) safe to take while pregnant or breastfeeding?
Pregnancy Category B Reproduction studies have been performed in rats and rabbits at doses up to 27 times and 3.2 times the adult human dose on a m2 basis and have revealed no evidence of impaired fertility or harm to the fetus due to enfuvirtide. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Antiretroviral Pregnancy Registry To monitor maternal-fetal outcomes of pregnant women exposed to Fuzeon and other antiretroviral drugs, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263.
The Centers for Disease Control and Prevention recommends that HIV-infected mothers not breast-feed their infants to avoid the risk of postnatal transmission of HIV. It is not known whether enfuvirtide is excreted in human milk. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breast-feed if they are receiving Fuzeon. Studies where radio-labeled 3 H-enfuvirtide was administered to lactating rats indicated that radioactivity was present in the milk. It is not known whether the radioactivity in the milk was from radio-labeled enfuvirtide or from radio-labeled metabolites of enfuvirtide (i.e., amino acids and peptide fragments).
What else should I know about enfuvirtide (Fuzeon)?
How does enfuvirtide work?
Enfuvirtide interferes with the entry of HIV-1 into cells by inhibiting fusion of viral and cellular membranes. Enfuvirtide binds to the first heptad-repeat (HR1) in the gp41 subunit of the viral envelope glycoprotein and prevents the conformational changes required for the fusion of viral and cellular membranes.
Latest HIV News
- PrEP HIV Prevention Pills to Be Free for Insured
- People With HIV Have Near-Normal Life Expectancy
- People With HIV Have Much Higher Risk for Suicide
- Living With HIV Raises Sudden Cardiac Death Risk
- Disappointment and Hope From HIV Prevention Trials
- Want More News? Sign Up for MedicineNet Newsletters!
Daily Health News
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.
Multimedia: Slideshows, Images & Quizzes
HIV AIDS: Myths and Facts
What is HIV versus AIDS? What are the symptoms of HIV? Is there an HIV cure? Discover myths and facts about living with HIV/AIDS....
A Timeline of the HIV/AIDS Pandemic
Get a historical overview of the HIV/AIDS pandemic from human contraction to the present through this slideshow of pictures.
What Are HIV & AIDS? Symptoms, Treatment, and Prevention
HIV, or human immunodeficiency virus, causes acquired immunodeficiency syndrome, or AIDS. Learn about HIV positive, being HIV...
HIV & AIDS Quiz: HIV Testing & Symptoms
Now, more than ever, you should know about HIV/AIDS, especially its causes, symptoms treatments, and complications. Take the...
Picture of HIV/AIDS
Acronym for the Human Immunodeficiency Virus, the cause of AIDS (acquired immunodeficiency syndrome). See a picture of HIV/AIDS...
Picture of HIV Lipodystrophy
HIV lipodystrophy describes a constellation of changes in subcutaneous and visceral fat distribution in patients on...
Picture of HIV Lipodystrophy Treatment
HIV lipodystrophy describes a constellation of changes in subcutaneous and visceral fat distribution in patients on...
Picture of HIV-associated Dementia (HAD)
A 40-year-old woman diagnosed with HIV presented with confusion and decline in memory. See a picture of HIV-associated Dementia...
Related Disease Conditions
HIV and AIDS
Second Source article from WebMD
Human Immunodeficiency Virus (HIV)
HIV (human immunodeficiency virus) infection left untreated causes AIDS (acquired immunodeficiency syndrome). Still incurable, AIDS describes immune system collapse that opens the way for opportunistic infections and cancers to kill the patient. Early symptoms and signs of HIV infection include flu-like symptoms and fungal infections, but some people may not show any symptoms for years. Highly active antiretroviral therapy (ART) is the standard treatment for HIV infection. These combination drug regimens have made HIV much less deadly, but a cure or vaccine for the pandemic remains out of reach. HIV is usually transmitted through sexual contact or sharing IV drug needles, but can also infect someone through contact with infected blood. Sexual abstinence, safe sex practices, quitting IV drugs (or at least using clean needles), and proper safety equipment by clinicians and first responders can drastically reduce transmission rates for HIV/AIDS.
HIV vs. AIDS
Human immunodeficiency virus causes HIV infection. Acquired immunodeficiency syndrome (AIDS) is a condition that results after HIV has extensively damaged a person's immune system. Risk factors for HIV and AIDS include use of contaminated needles or syringes, unprotected sex, STDs, receiving a blood transfusion prior to 1985 in the United States, having many sex partners, and transmission from a mother to her child.
Treatment & Diagnosis
- HIV-AIDS FAQs
- HIV Treatment, Medications, and Prevention
- HIV Urine Test Approved
- HIV: Two Patients Face The Diagnosis
- HIV Treatment - To Interrupt or Not
- Unprotected Sex Between HIV-Infected Partners: What's the Harm?
- HIV Transmission and Progression to AIDS Continues
- Physical and Biochemical Changes in HIV Disease
- Babies On The Breast Of HIV Moms
- Retrovirus & Opportunistic Infections Part II
- Retroviruses and Opportunistic Infections Conf. 2/2006
- Can HIV Cause Kaposi's Sarcoma?
- Do You Need Antiretroviral Therapy for HIV with No Symptoms?
- Does HIV Cause Colorectal Cancer?
- Does Anti-Retroviral Therapy for HIV Cause Diabetes?
- What Liver Problems Does HIV Cause?
- Does Circumcision Prevent HIV and AIDS?
- HIV Infection Facts, History, Causes, and Risk Factors
- HIV Tests, Symptoms, Signs, and Stages of Infection
- Baby "Cured" of HIV Infection
Medications & Supplements
Health Solutions From Our Sponsors
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
FDA Prescribing Information