Vasovist (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

VASOVIST Injection is a sterile, clear, colorless to pale yellow solution containing 244 mg/mL (0.25 mmol/mL) of gadofosveset trisodium in rubber-stoppered vials with an aluminum seal. VASOVIST Injection is supplied as follows:

NDC 50419-310-01 — 10 mL fills in 10 mL single use vials packages of 10 vials
NDC 50419-310-02 — 15 mL fills in 20 mL single use vials in packages of 10 vials

Store VASOVIST Injection at 25°C (77°F: excursions permitted to 15 to 30°C [59 to 86°F]). Protect from light and freezing.

17 PATIENT COUNSELING INFORMATION

Instruct patients receiving VASOVIST Injection to inform their physician or healthcare provider if they:

  • are pregnant or breast feeding
  • have a history of allergic reaction to contrast media, a history of bronchial asthma or allergic respiratory disorder
  • have a history of kidney and/or liver disease
  • have recently received a gadolinium-based contrast agent
  • have a history of heart rhythm disturbances, or cardiac disease
  • are taking any prescription or over-the counter medications

Gadolinium-based contrast agents, including VASOVIST, increase the risk for NSF in patients with severe renal insufficiency or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative setting of liver transplantation. Patients with less severe renal insufficiency who receive repetitive administrations of a gadolinium-based contrast agent may have an increased risk for the development of NSF, especially if the time interval between the administrations precludes clearance of the previously administered contrast agent from the body. If VASOVIST is administered in these situations, instruct patients to contact their physician or healthcare provider if they develop signs or symptoms of NSF, such as burning, itching, swelling, scaling, hardening and tightening of the skin, red or dark patches on the skin, stiffness in joints with trouble moving, bending or straightening of the arms, hands, legs, or feet, pain deep in the hip bones or ribs, or muscle weakness [see Warnings and Precautions (5.1) ].

Inform patients that they may experience:

  • reactions at the injection site, such as: redness, mild and transient burning or pain or feeling of warmth or coldness
  • side effects of itching or nausea

Distributed by Bayer Healthcare, Inc., Wayne, NJ

Co-Developed by EPIX Pharmaceuticals, Inc., Lexington, MA

US Patents: 7,060,250; 7,229,606; and 5,919,967

VASOVIST
gadofosveset trisodium injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50419-310
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
gadofosveset trisodium (gadofosveset) gadofosveset 244 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
fosveset 0.27 mg in 1 mL
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50419-310-01 10 VIAL, GLASS (10 VIAL) in 1 CARTON contains a VIAL, GLASS
1 10 mL (10 MILLILITER) in 1 VIAL, GLASS This package is contained within the CARTON (50419-310-01)
2 NDC:50419-310-02 10 VIAL, GLASS (10 VIAL) in 1 CARTON contains a VIAL, GLASS
2 15 mL (15 MILLILITER) in 1 VIAL, GLASS This package is contained within the CARTON (50419-310-02)
Labeler — Bayer Healthcare, Inc.

Revised: 01/2009 Bayer Healthcare, Inc.

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.