ZALTRAP (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

ZALTRAP (ziv-aflibercept) injection is a clear, colorless to pale-yellow solution supplied in single-dose vials with a concentration of 25 mg/mL.

NDC 0024-5840-01: carton containing one single-dose vial of 100 mg/4 mL (25 mg/mL)

NDC 0024-5841-01: carton containing one single-dose vial of 200 mg/8 mL (25 mg/mL)

Store ZALTRAP vials in a refrigerator at 2°C to 8°C (36°F to 46°F). Keep the vials in the original outer carton to protect from light. Discard unused portion.

17 PATIENT COUNSELING INFORMATION

Hemorrhage

  • Inform patients that ZALTRAP can cause severe bleeding and advise patients to contact their health care provider for bleeding or symptoms of bleeding, including lightheadedness [see Warnings and Precautions (5.1)].

Gastrointestinal Perforation and Fistula Formation

  • Advise patients to immediately contact their health care provider for signs and symptoms of gastrointestinal perforation or fistula [see Warnings and Precautions (5.2, 5.4)].

Impaired Wound Healing

  • Advise patients that ZALTRAP may impair wound healing. Instruct patients to discuss any planned surgical procedure (including tooth extractions) with all their healthcare providers. [see Warnings and Precautions (5.3)].

Hypertension

  • Inform patients that ZALTRAP can cause or exacerbate existing hypertension. Advise patients to undergo routine blood pressure monitoring and to contact their health care provider if blood pressure is elevated or if symptoms from hypertension occur including severe headache, lightheadedness, or neurologic symptoms [see Warnings and Precautions (5.5)].

Arterial Thromboembolic Events

Proteinuria

Neutropenia and Neutropenic Complications

Diarrhea and Dehydration

Posterior Reversible Leukoencephalopathy Syndrome

  • Advise patients to immediately contact their health care provider for new onset or worsening neurological function [see Warnings and Precautions (5.10)].

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential:

Lactation

Manufactured by:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY
U.S. License No. 1752

ZALTRAP is a registered trademark of Regeneron Pharmaceuticals, Inc.

©2020 sanofi-aventis U.S. LLC

PRINCIPAL DISPLAY PANEL — 100 mg/4 mL Vial Carton

NDC 0024-5840-01

ZALTRAP®
(ziv-aflibercept)
Injection for
Intravenous Infusion

100 mg/4 mL
(25 mg/mL)

For intravenous infusion only.
Not to be administered by
other routes.
Hyperosmotic, must be diluted.

Single-dose vial.Discard unused portion

Rx ONLY

SANOFI

PRINCIPAL DISPLAY PANEL -- 100 mg/4 mL Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 200 mg/8 mL Vial Carton

NDC 0024-5841-01

ZALTRAP®
(ziv-aflibercept)
Injection for
Intravenous Infusion

200 mg/8 mL
(25 mg/mL)

For intravenous infusion only.
Not to be administered by
other routes.
Hyperosmotic, must be diluted.

Single-dose vial.Discard unused portion

Rx ONLY

SANOFI

PRINCIPAL DISPLAY PANEL -- 200 mg/8 mL Vial Carton
(click image for full-size original)
ZALTRAP ziv-aflibercept solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0024-5840
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AFLIBERCEPT (AFLIBERCEPT) AFLIBERCEPT 100 mg in 4 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE
SODIUM CHLORIDE
TRISODIUM CITRATE DIHYDRATE
CITRIC ACID MONOHYDRATE
POLYSORBATE 20
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0024-5840-01 1 VIAL in 1 CARTON contains a VIAL
1 4 mL in 1 VIAL This package is contained within the CARTON (0024-5840-01)
2 NDC:0024-5840-03 3 VIAL in 1 CARTON contains a VIAL
2 4 mL in 1 VIAL This package is contained within the CARTON (0024-5840-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125418 08/03/2012
ZALTRAP ziv-aflibercept solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0024-5841
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AFLIBERCEPT (AFLIBERCEPT) AFLIBERCEPT 200 mg in 8 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE
SODIUM CHLORIDE
TRISODIUM CITRATE DIHYDRATE
CITRIC ACID MONOHYDRATE
POLYSORBATE 20
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0024-5841-01 1 VIAL in 1 CARTON contains a VIAL
1 8 mL in 1 VIAL This package is contained within the CARTON (0024-5841-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125418 08/03/2012
Labeler — sanofi-aventis U.S. LLC (824676584)
Establishment
Name Address ID/FEI Operations
Regeneron Pharmaceuticals, Inc. 945589711 ANALYSIS (0024-5840), ANALYSIS (0024-5841), API MANUFACTURE (0024-5840), API MANUFACTURE (0024-5841)
Establishment
Name Address ID/FEI Operations
Sanofi-Aventis Deutschland GmbH 313218430 ANALYSIS (0024-5840), ANALYSIS (0024-5841), LABEL (0024-5840), LABEL (0024-5841), MANUFACTURE (0024-5840), MANUFACTURE (0024-5841), PACK (0024-5840), PACK (0024-5841)

Revised: 03/2020 sanofi-aventis U.S. LLC

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