Ferrlecit (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Ferrlecit is a clear, dark brown liquid supplied in colorless glass vials. Each sterile, single-dose vial contains 62.5 mg of elemental iron in 5 mL for intravenous use. Discard unused portion.

Carton containing 10 vials: NDC 0024-2794-10

Storage

Store at 20°C–25°C (68°F–77°F); excursions permitted to 15°C–30°C (59°F–86°F). See USP Controlled Room Temperature. Do not freeze.

Keep out of the reach of children.

17 PATIENT COUNSELING INFORMATION

Prior to Ferrlecit administration:

  • Question patients regarding any prior history of reactions to parenteral iron products.
  • Advise patients of the risks associated with Ferrlecit.
  • Advise patients to report adverse reactions associated with the use of Ferrlecit, including hypersensitivity, allergic reactions, chest pain which can be a symptom of a potentially serious allergic reaction called Kounis syndrome, dizziness, lightheadedness, swelling, and breathing problems [see Warnings and Precautions (5.1, 5.2) and Adverse Reactions (6.1, 6.2)].

Advise patients that Ferrlecit may reduce the absorption of concomitantly administered oral iron preparations [see Drug Interactions (7)].

Pregnancy

Advise pregnant women about the risk of hypersensitivity reactions which may have serious consequences for the fetus. Advise patients who may become pregnant to inform their healthcare provider of a known or suspected pregnancy (contains benzyl alcohol) [see Use in Specific Populations (8.1)].

Lactation

Advise patients that treatment with Ferrlecit is not recommended for use while breastfeeding [see Use in Specific Populations (8.2)].

sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY

PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license

©2021 sanofi-aventis U.S. LLC
Ferrlecit is a registered trademark of A. Nattermann & Cie. GmbH

PRINCIPAL DISPLAY PANEL — 5 mL Vial Carton

NDC 0024-2794-10
Rx only

Ferrlecit®

sodium ferric gluconate
complex in sucrose injection

62.5 mg elemental iron/
5 mL Sterile Single-dose Vial

For Intravenous Use Only

Ten 5 mL single-dose vials

PREMIERProRx®

PRINCIPAL DISPLAY PANEL -- 5 mL Vial Carton
(click image for full-size original)
FERRLECIT
sodium ferric gluconate complex injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0024-2794
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FERRIC GLUCONATE COMPLEX (FERRIC CATION) FERRIC CATION 12.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL 9 mg in 1 mL
SUCROSE 195 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0024-2794-10 10 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (0024-2794-01)
1 NDC:0024-2794-01 5 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (0024-2794-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020955 07/07/2014
Labeler — sanofi-aventis U.S. LLC (824676584)
Establishment
Name Address ID/FEI Operations
Sanofi S.r.l. 338454274 ANALYSIS (0024-2794), MANUFACTURE (0024-2794), PACK (0024-2794), LABEL (0024-2794)

Revised: 07/2021 sanofi-aventis U.S. LLC

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