Agenerase

Name: Agenerase

Uses of Agenerase

Agenerase is a prescription medication used with other medications to treat human immunodeficiency virus (HIV) infection. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Agenerase Drug Class

Agenerase is part of the drug class:

  • Protease inhibitors

Inform MD

Before taking Agenerase, tell your healthcare provider about all of your medical conditions including if you:

  • are allergic to Agenerase or any of its ingredients
  • are allergic to sulfa medicines
  • are pregnant or breastfeeding
  • have liver problems
  • have kidney problems
  • have diabetes
  • have hemophilia

Before taking fosamprenavir, tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. 

Other Requirements

  • Agenerase solution may be stored at room temperature and should not be refrigerated.
  • Keep this and all medicines out of the reach of children.
  • Do not keep medicine that is out of date or that you no longer need. Be sure that if you throw any medicine away, it is out of the reach of children.

Warnings

ALERT

Find out about medicines that should not be taken with Agenerase.

Serious and/or life-threatening drug interactions could occur between amprenavir and amiodarone, lidocaine (systemic), tricyclic antidepressants, and quinidine. Concentration monitoring of these agents is recommended if these agents are used concomitantly with Agenerase (see CONTRAINDICATIONS).

Rifampin should not be used in combination with amprenavir because it reduces plasma concentrations and AUC of amprenavir by about 90%.

A drug interaction study in healthy subjects has shown that ritonavir significantly increases plasma fluticasone propionate exposures, resulting in significantly decreased serum cortisol concentrations. Concomitant use of Agenerase with ritonavir and fluticasone propionate is expected to produce the same effects. Systemic corticosteroid effects including Cushing’s syndrome and adrenalsuppression have been reported during postmarketing use in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate. Therefore, coadministration of fluticasone propionate and Agenerase/ritonavir is not recommended unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects (see PRECAUTIONS: Drug Interactions).

Concomitant use of Agenerase and St. John's wort (hypericum perforatum) or products containing St. John’s wort is not recommended. Coadministration of protease inhibitors, including Agenerase, with St. John's wort is expected to substantially decrease protease inhibitor concentrations and may result in suboptimal levels of amprenavir and lead to loss of virologic response and possible resistance to Agenerase or to the class of protease inhibitors.

Concomitant use of Agenerase with lovastatin or simvastatin is not recommended. Caution should be exercised if HIV protease inhibitors, including Agenerase, are used concurrently with other HMG-CoA reductase inhibitors that are also metabolized by the CYP3A4 pathway (e.g., atorvastatin). The risk of myopathy, including rhabdomyolysis, may be increased when HIV protease inhibitors, including amprenavir, are used in combination with these drugs.

Particular caution should be used when prescribing sildenafil in patients receiving amprenavir. Coadministration of Agenerase with sildenafil is expected to substantially increase sildenafil concentrations and may result in an increase in sildenafil-associated adverse events, including hypotension, visual changes, and priapism (see PRECAUTIONS: Drug Interactions and Information for Patients, and the complete prescribing information for sildenafil).

Because of the potential toxicity from the large amount of the excipient, propylene glycol, contained in Agenerase Oral Solution, that formulation is contraindicated in certain patient populations and should be used with caution in others. Consult the complete prescribing information for Agenerase Oral Solution for full information.

Severe and life-threatening skin reactions, including Stevens-Johnson syndrome, have occurred in patients treated with Agenerase (see ADVERSE REACTIONS). Acute hemolytic anemia has been reported in a patient treated with Agenerase.

New onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and hyperglycemia have been reported during post-marketing surveillance in HIV-infected patients receiving protease inhibitor therapy. Some patients required either initiation or dose adjustments of insulin or oral hypoglycemic agents for treatment of these events. In some cases, diabetic ketoacidosis has occurred. In those patients who discontinued protease inhibitor therapy, hyperglycemia persisted in some cases. Because these events have been reported voluntarily during clinical practice, estimates of frequency cannot be made and causal relationships between protease inhibitor therapy and these events have not been established.

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