Agenerase Side Effects
Generic Name: amprenavir
Note: This page contains information about the side effects of amprenavir. Some of the dosage forms included on this document may not apply to the brand name Agenerase.
For the Consumer
Applies to amprenavir: oral liquid-filled capsules, oral solution
Side effects include:
Nausea, vomiting, diarrhea, abdominal pain/discomfort, taste disorder, rash, paresthesia (oral/perioral).
For Healthcare Professionals
Applies to amprenavir: oral capsule, oral solution
Gastrointestinal side effects and skin rashes were the most frequent side effects in clinical trials of amprenavir (the active ingredient contained in Agenerase) in combination with other antiretrovirals. Gastrointestinal effects (nausea, vomiting, diarrhea, and abdominal pain) most often resulted in discontinuation of amprenavir during the first 12 weeks of treatment. Skin rashes had a median onset and duration of 11 and 10 days, respectively, and led to discontinuation of amprenavir in 3% of patients.[Ref]
Gastrointestinal side effects have included nausea (74%), vomiting (34%), and diarrhea or loose stools (39%) in clinical trials when amprenavir (the active ingredient contained in Agenerase) was administered with lamivudine and zidovudine in therapy-naive patients. This compares to an incidence of 50%, 17%, and 34%, respectively, when therapy-naive patients were only administered lamivudine and zidovudine. Abdominal symptoms (unspecified, 14%) and anorexia have been reported in patients receiving amprenavir in combination with ritonavir plus other antiretrovirals.[Ref]
Rashes were usually maculopapular, mild to moderate in intensity, and some with pruritus. The onset of rash development was approximately 10 days and ranged from 7 to 73 days. Amprenavir (the active ingredient contained in Agenerase) was often continued with mild to moderate rash and if discontinued, rash did not recur when the drug was restarted. Amprenavir should be discontinued for severe or life-threatening rashes and for moderate rashes accompanied by systemic symptoms.[Ref]
Dermatologic side effects have been reported frequently. Skin rash occurred in 28% of HIV-1 infected patients treated with amprenavir in all multidose studies. Severe or life-threatening rash, including Stevens-Johnson syndrome, occurred in 1% of patients.[Ref]
Metabolic side effects have included hyperglycemia (37%), hypertriglyceridemia (36%), and hypercholesterolemia (4%) in clinical trials when amprenavir (the active ingredient contained in Agenerase) was administered with lamivudine and zidovudine in therapy-naive nonfasting patients. This compares to an incidence of 29%, 22% and 3%, respectively, when therapy-naive nonfasting patients were only administered lamivudine and zidovudine. Grade 3/4 hypertriglyceridemia (8% to 13%) and hyperglycemia (2% to 3%) have been reported in patients receiving amprenavir in combination with ritonavir. New onset and exacerbation of preexisting diabetes mellitus, elevated serum creatine kinase, and ketoacidosis have also been reported.[Ref]
Hepatic side effects have included elevations in AST (greater than 5 times ULN), ALT (greater than 5 times ULN), and amylase (greater than 2 times ULN) in 3% to 5% of patients receiving amprenavir (the active ingredient contained in Agenerase) in combination with ritonavir.[Ref]
Nervous system side effects have included oral/perioral paresthesia (26%) and other paresthesias (10%), including peripheral paresthesias, in clinical trials when amprenavir (the active ingredient contained in Agenerase) was administered with lamivudine and zidovudine in therapy-naive patients. This compares to an incidence of 6% and 4%, respectively, when therapy-naive patients were only administered lamivudine and zidovudine. Headache (12% to 16%) has been reported in patients receiving amprenavir in combination with ritonavir plus other antiretrovirals.[Ref]
Psychiatric side effects have included depression and mood disorder in 15% of therapy-naive patients who were administered amprenavir (the active ingredient contained in Agenerase) with lamivudine and zidovudine in clinical trials. This compares to an incidence of 4% when therapy-naive patients were only administered lamivudine and zidovudine.[Ref]
Hematologic side effects have included neutropenia and hemolytic anemia. Hematologic side effects associated with protease inhibitors have included spontaneous bleeding in patients with hemophilia A and B. In many of the reported cases, treatment with protease inhibitors was continued or restarted and some patients required additional factor VIII. A causal relationship between protease inhibitor therapy and these episodes has not been established.[Ref]
Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement, peripheral wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving protease inhibitors. The mechanism and long-term consequences of these events are currently unknown and a causal relationship has not been established. In one case, reduction of neck fat disposition (buffalo hump) was reported when amprenavir (the active ingredient contained in Agenerase) replaced indinavir in a regimen.[Ref]
Other side effects have included taste disorders in 10% of therapy-naive patients who were administered amprenavir with lamivudine and zidovudine in clinical trials. This compares to an incidence of 5% when therapy-naive patients were only administered lamivudine and zidovudine. Fatigue (7% to 14%) and chills have been reported in patients receiving amprenavir in combination with ritonavir plus other antiretrovirals.[Ref]
Hypersensitivity side effects have included urticaria.[Ref]
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Not all side effects for Agenerase may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
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