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FOSAMPRENAVIR CALCIUM


DIR Classification


Classification:Moderate-DIR concern
Severity Score:3

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • CONTRAINDICATIONS
  • LEXIVA is contraindicated:
  • • in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome) to any of the components of this product or to amprenavir.
  • • when coadministered with drugs that are highly dependent on cytochrome P450 3A4 (CYP3A4) for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events ( TABLE 2).

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Rhabdomyolysis
10
42902
Other ADRs
662
14116617

Odds Ratio = 4.971

Drug Property Information



ATC Code(s):
  • J05AE07 - fosamprenavir calcium
    • J05AE - Protease inhibitors
    • J05A - DIRECT ACTING ANTIVIRALS
    • J05 - ANTIVIRALS FOR SYSTEMIC USE
    • J - ANTIINFECTIVES FOR SYSTEMIC USE
Active Ingredient:fosamprenavir calcium
Active Ingredient UNII:ID1GU2627N
Drugbank ID:DB01319
PubChem Compound:131536
CAS Number:226700-79-4
Dosage Form(s):suspension; tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
  • 1400.0 mg/day J05AE07
Chemical Structure:
SMILE Code:
CC(C)CN(C[C@H]([C@H](CC1=CC=CC=C1)NC(=O)O[C@H]2CCOC2)OP(=O)(O)O)S(=O)(=O)C3=CC=C(C=C3)N

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

N/A

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