Rx Item-Vyondys 53 (golodirsen) 100mg/2ml SDV Injection by Sarepta Therapeutics

For: Duchenne Muscular Dystrophy

Vyondys 53 (golodirsen) is a phosphordiamidate morpholino oligimer for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping. HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
VYONDYS 53™ safely and effectively. See full prescribing information
for VYONDYS 53.
VYONDYS 53 (golodirsen) injection, for intravenous use
Initial U.S. Approval: 2019
__________________INDICATIONS AND USAGE___________________
VYONDYS 53 is an antisense oligonucleotide indicated for the treatment of
Duchenne muscular dystrophy (DMD) in patients who have a confirmed
mutation of the DMD gene that is amenable to exon 53 skipping. This
indication is approved under accelerated approval based on an increase in
dystrophin production in skeletal muscle observed in patients treated with
VYONDYS 53. Continued approval for this indication may be contingent
upon verification of a clinical benefit in confirmatory trials. (1)
________________DOSAGE AND ADMINISTRATION______________
• Measure glomerular filtration rate prior to initiation (2.1)
• 30 milligrams per kilogram once weekly (2.2)
• Administer as an intravenous infusion over 35 to 60 minutes (2.2, 2.4)
• Dilution required prior to administration (2.3)
_______________DOSAGE FORMS AND STRENGTHS______________
Injection: 100 mg/2 mL (50 mg/mL) in a single-dose vial (3)
___________________CONTRAINDICATIONS_____________________
None (4)
-----------------------WARNINGS AND PRECAUTIONS------------------------
• Hypersensitivity Reactions: Hypersensitivity reactions, including rash,
pyrexia, pruritus, urticaria, dermatitis, and skin exfoliation have
occurred in patients who were treated with VYONDYS 53. If a
hypersensitivity reaction occurs, institute appropriate medical treatment
and consider slowing the infusion or interrupting the VYONDYS 53
therapy. (2.3, 5.1)
• Renal Toxicity: Based on animal data, may cause renal toxicity. Renal
function should be monitored; creatinine may not be a reliable measure
of renal function in DMD patients. (5.2, 13.2)
____________________ADVERSE REACTIONS_____________________
The most common adverse reactions (incidence ≥20% and higher than
placebo) were headache, pyrexia, fall, abdominal pain, nasopharyngitis,
cough, vomiting, and nausea. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Sarepta
Therapeutics, Inc. at 1-888-SAREPTA (1-888-727-3782) or FDA at 1-800-
FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION
Revised: 12/2019

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