Amprenavir Side Effects

Some side effects of amprenavir may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to amprenavir: oral capsule, oral solution

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking amprenavir and call your doctor at once if you have any of these serious side effects:

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

• pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• increased urination or extreme thirst;

• easy bruising or bleeding;

• signs of a new infection, such as fever or chills, cough, or flu symptoms; or

• seizures, muscle pain and weakness, fast heart rate, numbness or cold feeling in your arms or legs (while using amprenavir oral liquid).

Keep taking the medication and talk with your doctor if you have any of these less serious side effects:

• nausea, vomiting, diarrhea, stomach pain;

• numbness or tingling, especially around your mouth;

• headache, mood changes; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to amprenavir: oral capsule, oral solution

General

Gastrointestinal side effects and skin rashes were the most frequent side effects in clinical trials of amprenavir 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.

Gastrointestinal

Gastrointestinal side effects have included nausea (74%), vomiting (34%), and diarrhea or loose stools (39%) in clinical trials when amprenavir 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.

Dermatologic

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 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.

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.

Metabolic

Metabolic side effects have included hyperglycemia (37%), hypertriglyceridemia (36%), and hypercholesterolemia (4%) in clinical trials when amprenavir 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.

Hepatic

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 in combination with ritonavir.

Nervous system

Nervous system side effects have included oral/perioral paresthesia (26%) and other paresthesias (10%), including peripheral paresthesias, in clinical trials when amprenavir 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.

Psychiatric

Psychiatric side effects have included depression and mood disorder in 15% of therapy-naive patients who were administered amprenavir with lamivudine and zidovudine in clinical trials. This compares to an incidence of 4% when therapy-naive patients were only administered lamivudine and zidovudine.

Hematologic

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.

Other

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 replaced indinavir in a regimen.

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.

Hypersensitivity

Hypersensitivity side effects have included urticaria.

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