Vyondys 53 (Page 4 of 4)
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
VYONDYS 53 injection is supplied in single dose vials. The solution is a clear to slightly opalescent, colorless liquid, and may contain trace amounts of small, white to off-white amorphous particles.
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16.2 Storage and Handling
Store VYONDYS 53 at 2°C to 8°C (36°F to 46°F). Do not freeze. Store in original carton until ready for use to protect from light.
17 PATIENT COUNSELING INFORMATION
Hypersensitivity Reactions
Advise patients and/or caregivers that hypersensitivity reactions, including rash, pyrexia, pruritus, urticaria, dermatitis, and skin exfoliation have occurred in patients who were treated with VYONDYS 53. Instruct them to seek immediate medical care should they experience signs and symptoms of hypersensitivity [see Warnings and Precautions (5.1)].
Kidney Toxicity
Inform patients nephrotoxicity has occurred with drugs similar to VYONDYS 53. Advise patients of the importance of monitoring for kidney toxicity by their healthcare providers during treatment with VYONDYS 53 [see Warnings and Precautions (5.2)].
Manufactured for:
Sarepta Therapeutics, Inc.
Cambridge, MA 02142 USA
SAREPTA, SAREPTA THERAPEUTICS, and VYONDYS are trademarks of Sarepta Therapeutics, Inc. registered in the U.S. Patent and Trademark Office and may be registered in various other jurisdictions. VYONDYS 53, and the Vyondys 53 logo are trademarks of Sarepta Therapeutics, Inc.
Principal Display Panel — Carton Label
NDC: 60923-465-02
Rx Only
VYONDYS 53
(golodirsen) Injection
100 mg/2 mL
(50 mg/mL)
For Intravenous Infusion
After Dilution
Use a 0.2 micron in-line
filter during infusion
Single Dose
1 vial
SAREPTA
THERAPEUTICS
Principal Display Panel — Vial Label
NDC: 60923-465-02
VYONDYS 53
(golodirsen) Injection
100 mg/2 mL (50 mg/mL)
Single Dose. Rx Only
Mfg for: Sarepta Therapeutics,
Inc., Cambridge, MA 02142
VYONDYS 53
golodirsen injection | ||||||||||||||||||
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Labeler — Sarepta Therapeutics, Inc. (121653406) |
Revised: 03/2022 Sarepta Therapeutics, Inc.
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