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Pharmacologic class: Human immunodeficiency-1 (HIV-1) fusion inhibitor
Therapeutic class: Antiretroviral
Pregnancy risk category B
Interferes with entry of HIV-1 into cells by inhibiting fusion of viral and cellular membranes
Powder for injection: 90 mg/1-ml vial
Indications and dosages
➣ HIV-1 infection in adults in combination with other antiretrovirals
Adults: 90 mg subcutaneously b.i.d. in upper arm, anterior thigh, or abdomen
Children ages 6 to 16: 2 mg/kg subcutaneously b.i.d. in upper arm, anterior thigh, or abdomen. Maximum dosage is 90 mg b.i.d.
• Hypersensitivity to drug or its components
Use cautiously in:
• increased risk of pneumonia
• injection site reaction
• concurrent use of anticoagulants
• hemophilia or other coagulant disorders
• elderly patients
• children younger than age 6 (safety and efficacy not established).
• Rotate injection sites.
• Be aware that preferred injection sites are upper arm, anterior thigh, and abdomen.
• Reconstitute with 1.1 ml of sterile water for injection, and gently tap vial for 10 seconds. Then gently roll vial between hands or allow vial to stand until product dissolves completely (could take up to 45 minutes).
• Know that drug is usually given with other antiretrovirals.
• Use reconstituted solution immediately.
CNS: fatigue, asthenia, insomnia, depression, anxiety, peripheral neuropathy
EENT: conjunctivitis, sinusitis
GI: nausea, diarrhea, upper abdominal pain, dry mouth, anorexia, pancreatitis
Musculoskeletal: limb pain, myalgia
Respiratory: cough, pneumonia
Other: taste disturbance, decreased appetite, weight loss, herpes simplex infection, injection site reactions (erythema, induration, nodules, cysts, mild to moderate pain, infection), flulike illness, hypersensitivity reactions
Drug-diagnostic tests. Alanine aminotransferase, amylase, aspartate aminotransferase, creatine kinase, eosinophils, gamma-glutamyltransferase, lipase, triglycerides: increased levels
Hemoglobin: decreased level
• Inspect injection sites frequently for adverse reactions.
• Monitor CBC with white cell differential, lipid panel, liver function test results, and gastric enzymes levels.
• Watch for hypersensitivity reactions.
• Monitor nutritional and hydration status in light of GI adverse effects and underlying disease.
• Teach patient (or caregiver) how to reconstitute and self-administer drug, as appropriate.
☞ Instruct patient not to change dosage or stop taking drug unless prescriber approves.
☞ Tell patient to immediately report signs or symptoms of hypersensitivity reaction (such as rash, fever, nausea and vomiting, and chills).
• Teach patient how to recognize signs and symptoms of injection site reaction. Tell him to contact prescriber if these occur, especially if they last more than 7 days.
• Advise female patient to notify prescriber if she is pregnant or plans to become pregnant.
• Tell HIV-infected patient not to breastfeed.
• If patient misses a dose, instruct him to take it as soon as he remembers. However, if it's almost time for next dose, tell him to skip the missed dose and take next dose on schedule.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the tests mentioned above.