Enfuvirtide Side Effects

Brand Names: Fuzeon

Please note - some side effects for Enfuvirtide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Enfuvirtide - for the Consumer

Enfuvirtide

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Enfuvirtide:

Constipation; diarrhea; dizziness; injection site reactions (pain, redness, itching, bleeding, bruising, hardened skin, or bumps); loss of appetite; muscle pain; nausea; tiredness; trouble sleeping; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; blood in the urine; depression; fever with vomiting and skin rash; flu-like symptoms; severe of persistent stomach pain; signs of infection at the injection site (eg, oozing, swelling, increasing heat); signs of pneumonia (eg, cough with fever, rapid breathing, shortness of breath); stomach pain; swelling of the feet.

Side Effects by Body System

General

In general, the most common side effects in patients receiving enfuvirtide and a background regimen have included injection site reactions, diarrhea, nausea, and fatigue.

Local

Local reactions have been reported in 98% of patients and have included pain/discomfort at the injection site (96%), induration (90%), erythema (91%), nodules and cysts (80%), pruritus (65%), ecchymosis (52%), injection site infection (including abscess and cellulitis, 1.7%), minor local bleeding, injection site reactions, injection site mass, injection site inflammation, and injection site edema. The administration of enfuvirtide using the Biojector (R) 2000 needle-free device has been associated with hematomas, bruising, tenderness, and swelling.

Gastrointestinal

Gastrointestinal side effects associated with enfuvirtide and a background regimen have included diarrhea (31.7%), nausea (22.8%), abdominal pain (3.9%), dry mouth (2.1%), pancreatitis (3.0%), abdominal distension, vomiting, flatulence, and oral candidiasis. Constipation, increased amylase, and increased lipase have also been reported; however, causality has not been determined.

Hypersensitivity

Hypersensitivity side effects have included hypersensitivity reactions in less than 1% of patients and in some cases have recurred upon rechallenge. Signs and symptoms of reactions have included rash, fever, nausea, vomiting, chills, rigors, hypotension, elevated liver transaminases, primary immune complex reaction, respiratory distress, glomerulonephritis, and Guillain-Barre syndrome. Worsening of abacavir hypersensitivity reaction has been reported; however, causality has not been established. General allergic reaction (not defined as hypersensitivity reaction) has also been reported.

Metabolic

Metabolic side effects associated with enfuvirtide in combination with a background regimen have included decreased weight (6.6%), decreased appetite (3.2%), anorexia (2.3%), and hyperlipemia. Increased triglycerides and hyperglycemia have also been reported; however, causality has not been established.

Nervous system

Nervous system side effects associated with enfuvirtide and a background regimen have included peripheral neuropathy, taste disturbance, sixth nerve palsy and fatal Guillain-Barre syndrome have also been reported; however, causality has not been established. Dizziness, headache, and epidural abscess have also been reported. The administration of enfuvirtide using the Biojector (R) 2000 needle-free device has been associated with neuralgia and/or paresthesia (nerve pain) lasting up to 6 months when injected at sites where large nerves run close to the skin.

Other

Other side effects reported in patients receiving enfuvirtide and a background regimen have included fatigue (20.2%), herpes simplex (3.5%), influenza-like illness (2.4%), malaise, fever, and chills. Asthenia and sepsis have also been reported; however, causality has not been determined.

Psychiatric

Psychiatric side effects associated with enfuvirtide and a background regimen have included insomnia, depression, anxiety, and suicide attempt; however, causality has not been established. Abnormal thinking and agitation have also been reported.

Respiratory

Respiratory side effects associated with enfuvirtide and a background regimen have included cough (3.9%), sinusitis (6.0%), bronchitis, nasopharyngitis, and upper respiratory tract infection. Pneumonia (2.7%), including fatalities, pneumopathy, and respiratory distress have also been reported; however, causality has not been determined. Patients should be carefully monitored for symptoms of pneumonia.

Dermatologic

Dermatologic side effects associated with enfuvirtide and a background regimen have included folliculitis (2.4%), dermatitis, pruritus, dry skin, skin papilloma, skin discoloration, and rash (not defined as hypersensitivity reaction).

Musculoskeletal

Musculoskeletal side effects associated with enfuvirtide and a background regimen have included myalgia (2.7%), limb pain (2.9%), and increased creatine phosphokinase (Grade 3, 6.9%; Grade 4, 2.6%). Vertebral osteomyelitis has also been reported.

Ocular

Ocular side effects associated with enfuvirtide and a background regimen have included conjunctivitis (2.0%).

Hematologic

Hematologic side effects associated with enfuvirtide and a background regimen have included eosinophilia (1 to 2 times ULN, 9.1%; greater than 2 times ULN, 1.8%), leukopenia, and anemia. Thrombocytopenia, neutropenia, and lymphadenopathy have also been reported; however, causality has not been established.

Renal

Renal side effects have included glomerulonephritis, tubular necrosis, renal insufficiency, and renal failure (including fatalities); however, causality has not been established.

Hepatic

Hepatic side effects associated with enfuvirtide and a background regimen have included increased ALT (Grade 3, 4.1%; Grade 4, 1.2%). Increased AST, increased GGT, toxic hepatitis, and hepatic steatosis have also been reported; however, causality has not been determined.

Cardiovascular

Cardiovascular side effects associated with enfuvirtide and a background regimen have included unstable angina pectoris; however, causality has not been established.

Genitourinary

Genitourinary side effects have included hematuria.

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