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.

  • Single-dose vials containing 100 mg/2mL (50 mg/mL)
NDC 60923-465-02

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.

Vyondys 53 Logo

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 -- Carton Label
(click image for full-size original)

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

Principal Display Panel -- Vial Label
(click image for full-size original)
VYONDYS 53
golodirsen injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60923-465
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
golodirsen (golodirsen) golodirsen 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride
potassium chloride
potassium phosphate, monobasic
sodium phosphate, dibasic, anhydrous
sodium hydroxide
hydrochloric acid
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60923-465-02 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 2 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (60923-465-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA211970 12/12/2019
Labeler — Sarepta Therapeutics, Inc. (121653406)

Revised: 03/2022 Sarepta Therapeutics, Inc.

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