Enfuvirtide

Name: Enfuvirtide

Administration

SC Administration

Inject SC into the upper arm, anterior thigh, or abdomen

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Enfuvirtide Interactions

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. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. 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.

Tell your doctor about all other medicines you use, especially a blood thinner such as warfarin (Coumadin, Jantoven).

This list is not complete and other drugs may interact with enfuvirtide. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Enfuvirtide Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of enfuvirtide there are no specific foods that you must exclude from your diet when receiving this medication.

 

Inform MD

Tell your healthcare provider:

  • if you are pregnant or breastfeeding
  • about all your medical conditions
  • about all the medicines you use, including prescription and non-prescription medicines, vitamins, and herbal supplements

Where can i get more information?

Your pharmacist can provide more information about enfuvirtide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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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. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. 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 Dosage and Administration

Administration

Sub-Q Administration

Administer sub-Q into upper arm, anterior thigh, or abdomen (avoid the navel).1 201

Rotate injection sites with each injection (i.e., inject at a site different from preceding injection sites).1

Do not inject into areas where skin shows signs of a previous injection site reaction and do not inject near anatomical areas where large nerve tracts lie close to the skin (e.g., near elbow, knee, groin, inferior or medial section of the buttocks).1 Do not inject directly over blood vessels, near the navel, or into skin abnormalities, moles, scars (including surgical scars), bruises, tattoos, or burn sites.1

Allow refrigerated reconstituted solution to come to room temperature before injection.1

May be self-administered if clinician determines that the patient and/or their caregiver is competent to safely administer the drug.1

Reconstitution

Add 1.1 mL of sterile water for injection diluent provided by the manufacturer to vial containing 108 mg; tap vial gently with a fingertip for 10 seconds and then gently roll between the hands (avoid foaming) to ensure that drug is in contact with diluent.1 Let vial stand until all of the powder goes into solution; reconstitution can take up to 45 minutes.1

Reconstituted solution contains 90 mg/mL.1

Dosage

Must be given in conjunction with other antiretrovirals.1

Pediatric Patients

Treatment of HIV Infection Sub-Q

Children 6–16 years of age: 2 mg/kg (maximum 90 mg) twice daily.1 201

Adolescents >16 years of age: 90 mg twice daily.1 201

Adults

Treatment of HIV Infection Sub-Q

90 mg twice daily.1 200

Postexposure Prophylaxis following Occupational Exposure to HIV† Sub-Q

90 mg twice daily.199 Use in conjunction with other antiretrovirals (see Postexposure Prophylaxis following Occupational Exposure to HIV under Uses).199

Initiate PEP as soon as possible following occupational exposure to HIV (preferably within hours); continue for 4 weeks, if tolerated.199

Prescribing Limits

Pediatric Patients

Treatment of HIV Infection Sub-Q

Children 6–16 years of age: Maximum 90 mg twice daily.1

Special Populations

Hepatic Impairment

Dosage adjustments not needed.1 200

Renal Impairment

Treatment of HIV Infection

Dosage adjustments not needed.1 200

What are some side effects that I need to call my doctor about right away?

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:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Signs of skin infection like oozing, heat, swelling, redness, or pain.
  • Very bad irritation where the shot was given.
  • Fever or chills.
  • Very upset stomach or throwing up.
  • Very bad dizziness or passing out.
  • Swelling in the arms or legs.
  • Swollen gland.
  • Low mood (depression).
  • This medicine may help the immune system work. If you have an infection that you did not know you had, it may show up when you take enfuvirtide. Tell your doctor right away if you notice any signs of infection like fever, sore throat, weakness, cough, or shortness of breath after you start this medicine.
  • Very bad and sometimes deadly kidney problems have happened with enfuvirtide. Call your doctor right away if you are unable to pass urine or if you have blood in the urine or a change in the amount of urine passed.
  • A nervous system problem called Guillain-Barre syndrome has happened with this medicine. Sometimes, this has been deadly. Call your doctor right away if you have weakness or a burning, numbness, or tingling feeling that is not normal.
  • Some people taking enfuvirtide may get pneumonia more often than people not taking this medicine. It is not clear if this effect is caused by enfuvirtide. Call your doctor right away if you have a cough, fever, shortness of breath, or trouble breathing.

Drug Interactions

Orlistat: May decrease the serum concentration of Antiretroviral Agents. Monitor therapy

Protease Inhibitors: May increase the serum concentration of Enfuvirtide. Enfuvirtide may increase the serum concentration of Protease Inhibitors. Monitor therapy

Monitoring Parameters

Viral load; CD4 count; hypersensitivity and injection site reactions; pediatric weight (periodically; adjust dose accordingly); signs and symptoms of pneumonia

Precautions

An increased incidence of pneumonia has been reported in clinical trials. Patients should be closely monitored for signs and symptoms of pneumonia, especially if they have any predisposing risk factors (low initial CD4 cell count, high initial viral load, intravenous drug use, smoking, and a previous history of lung disease). Patients should be advised to immediately seek medical assistance if they develop possible signs of pneumonia (e.g., cough with fever, rapid breathing, shortness of breath).

Hypersensitivity reaction have occurred and may recur on rechallenge. Immediate medical evaluation is recommended for patients who develop signs of a systemic hypersensitivity reaction (e.g., rash, fever, nausea, vomiting, chills, rigors, hypotension, elevated liver transaminases, primary immune complex reaction, respiratory distress, glomerulonephritis, Guillain-Barre syndrome).

Immune reconstitution syndrome has occurred during combination antiretroviral therapy. Patients responding to therapy may develop an inflammatory response to indolent or residual opportunistic infections and require evaluation and treatment.

Enfuvirtide must be taken as part of a combination antiretroviral regimen. Monotherapy may lead to rapid development of viral resistance.

Safety and efficacy have not been established in pediatric patients under the age of 6 years.

Enfuvirtide Identification

Substance Name

Enfuvirtide

CAS Registry Number

159519-65-0

Drug Class

Antiinfective Agents

Anti-HIV Agents

Antiviral Agents

Anti-Retroviral Agents

HIV Fusion Inhibitors

Administrative Information

LactMed Record Number

906

Last Revision Date

20170110

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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