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Agenerase Oral Solution

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Agenerase Oral Solution

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Agenerase Oral Solution

Agenerase Oral Solution Side Effects Center

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Agenerase Oral Solution in Detail - Patient Information: Side Effects

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.

Read the entire detailed patient monograph for Agenerase Oral Solution (Amprenavir Oral Solution) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Agenerase Oral Solution FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

In clinical studies, adverse events leading to amprenavir discontinuation occurred primarily during the first 12 weeks of therapy, and were mostly due to gastrointestinal events (nausea, vomiting, diarrhea, and abdominal pain/discomfort), which were mild to moderate in severity.

Skin rash occurred in 22% of patients treated with amprenavir in studies PROAB3001 and PROAB3006. Rashes were usually maculopapular and of mild or moderate intensity, some with pruritus. Rashes had a median onset of 11 days after amprenavir initiation and a median duration of 10 days. Skin rashes led to amprenavir discontinuation in approximately 3% of patients. In some patients with mild or moderate rash, amprenavir dosing was often continued without interruption; if interrupted, reintroduction of amprenavir generally did not result in rash recurrence.

Severe or life-threatening rash (Grade 3 or 4), including cases of Stevens -Johnson syndrome, occurred in approximately 1% of recipients of AGENERASE (see WARNINGS). Amprenavir therapy should be discontinued for severe or life-threatening rashes and for moderate rashes accompanied by systemic symptoms.

Table 9. Selected Clinical Adverse Events of All Grades Reported in > 5% of Adult Patients

Adverse Event PROAB 3001 Therapy-Naive Patients PROAB 3006 NRTI-Experienced Patients
AGENERASE*/
Lamivudine/Zidovudine
(n = 113)
Lamivudine/
Zidovudine
(n = 109)
AGENERASE*/
NRTI
(n = 245)
Indinavir/
NRTI
(n = 241)
Digestive
  Nausea 74% 50% 43% 35%
  Vomiting 34% 17% 24% 20%
  Diarrhea or loose stools  39% 35% 60% 41%
  Taste disorders 10% 6% 2% 8%
Skin
  Rash 27% 6% 20% 15%
Nervous
  Paresthesia, oral/perioral 26% 6% 31% 2%
  Paresthesia, peripheral 10% 4% 14% 10%
Psychiatric
  Depressive or mood disorders 16% 4% 9% 13%

Among amprenavir-treated patients in Phase 3 studies, 2 patients developed de novo diabetes mellitus, 1 patient developed a dorsocervical fat enlargement (buffalo hump), and 9 patients developed fat redistribution.

In studies PROAB3001 and PROAB3006, no increased frequency of Grade 3 or 4 AST, ALT, amylase, or bilirubin elevations was seen compared to controls.

Pediatric Patients: An adverse event profile similar to that seen in adults was seen in pediatric patients.

Concomitant Therapy With Ritonavir: Tables 10 and 11 present adverse clinical events and laboratory abnormalities observed in subjects who received AGENERASE plus ritonavir. Since the trials were small, open- label, of varying duration, and often included different patient populations, direct comparisons to the frequency of events with AGENERASE Capsules alone (see Table 9) cannot be made.

Table 10. Selected Clinical Adverse Events of All Grades Reported in Adult Patients in Open-Label Clinical Trials of AGENERASE Capsules in Combination With Ritonavir Capsules

Adverse Event AGENERASE 1,200 mg
plus Ritonavir 200 mg q.d.*
(n = 101)
AGENERASE 600 mg
plus Ritonavir 100 mg b.i.d.†
(n = 239)
Nausea 31% 23%
Diarrhea/loose stools 30% 28%
Headache 16% 12%
Abdominal symptoms 14% 14%
Vomiting 11% 9%
Rash 10% 9%
Paresthesias 9% 11%
Fatigue 7% 14%
Depressive & mood disorders 4% 9%
*Data from 2 open- label studies in treatment- naive patients also receiving abacavir/lamivudine.
Data from 3 open- label studies in treatment- naive and treatment-experienced patients receiving combination antiretroviral therapy.

Table 11. Grade 3/4 Laboratory Abnormalities Reported in ≥ 2% of Adult Patients in Open-Label Clinical Trials of AGENERASE Capsules in Combination With Ritonavir

Laboratory Abnormality
(non- fasting specimens)
AGENERASE 1,200 mg
plus Ritonavir 200 mg q.d.*
(n = 101)
AGENERASE 600 mg
plus Ritonavir 100 mg b.i.d.†
(n = 239)
Hypertriglyceridemia ( > 750 mg/dL) 8% 13%
Hyperglycemia ( > 251 mg/dL) 2% 3%
AST ( > 5 x ULN) 3% 5%
ALT ( > 5 x ULN) 4% 4%
Amylase ( > 2 x ULN) 4% 3%
*Data from 2 open- label studies in treatment- naive patients also receiving abacavir/lamivudine.
Data from 3 open- label studies in treatment- naive and treatment-experienced patients receiving combination antiretroviral therapy.

Read the entire FDA prescribing information for Agenerase Oral Solution (Amprenavir Oral Solution) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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