Avastin: Package Insert and Label Information (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Avastin (bevacizumab) injection is a clear to slightly opalescent, colorless to pale brown, sterile solution for intravenous infusion supplied as single-dose vials in the following strengths:

  • 100 mg/4 mL: carton of one vial (NDC 50242-060-01) ; carton of 10 vials (NDC 50242-060-10).
  • 400 mg/16 mL: carton of one vial (NDC 50242-061-01) ; carton of 10 vials (NDC 50242-061-10).

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton until time of use to protect from light. Do not freeze or shake the vial or carton.

17 PATIENT COUNSELING INFORMATION

Gastrointestinal Perforations and Fistulae: Avastin may increase the risk of developing gastrointestinal perforations and fistulae. Advise patients to immediately contact their health care provider for high fever, rigors, persistent or severe abdominal pain, severe constipation, or vomiting [ see Warnings and Precautions (5.1)].

Surgery and Wound Healing Complications: Avastin can increase the risk of wound healing complications. Advise patients that Avastin should not be used for at least 28 days before or after surgery and until surgical wounds are fully healed [see Warnings and Precautions (5.2)].

Hemorrhage: Avastin can increase the risk of hemorrhage. Advise patients to immediately contact their health care provider for signs and symptoms of serious or unusual bleeding including coughing or spitting blood [see Warnings and Precautions (5.3)].

Arterial and Venous Thromboembolic Events: Avastin increases the risk of arterial and venous thromboembolic events. Advise patients to immediately contact their health care provider for signs and symptoms of arterial or venous thromboembolism [see Warnings and Precautions (5.4, 5.5)].

Hypertension: Avastin can increase blood pressure. Advise patients that they will undergo routine blood pressure monitoring and to contact their healthcare provider if they experience changes in blood pressure [see Warnings and Precautions (5.6)].

Posterior Reversible Leukoencephalopathy Syndrome: Posterior reversible encephalopathy syndrome (PRES) has been associated with Avastin treatment. Advise patients to immediately contact their health care provider for new onset or worsening neurological function [see Warnings and Precautions (5.7)].

Renal Injury and Proteinuria: Avastin increases the risk of proteinuria and renal injury, including nephrotic syndrome. Advise patients that treatment with Avastin requires regular monitoring of renal function and to contact their health care provider for proteinuria or signs and symptoms of nephrotic syndrome [ see Warnings and Precautions (5.8)].

Infusion-Related Reactions: Avastin can cause infusion-related reactions. Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions [see Warnings and Precautions (5.9)].

Congestive Heart Failure: Avastin can increase the risk of developing congestive heart failure. Advise patients to contact their healthcare provider immediately for signs and symptoms of CHF [see Warnings and Precautions (5.12)].

Embryo-Fetal Toxicity: Advise female patients that Avastin may cause fetal harm and to inform their healthcare provider with a known or suspected pregnancy [see Warnings and Precautions (5.10), Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment with Avastin and for 6 months after the last dose [see Use in Specific Populations (8.3)].

Ovarian Failure: Avastin may lead to ovarian failure. Advise patients of potential options for preservation of ova prior to starting treatment [see Warnings and Precautions (5.11)].

Lactation: Advise women not to breastfeed during treatment with Avastin and for 6 months after the last dose [see Use in Specific Populations (8.2)].

Avastin® (bevacizumab)
Manufactured by:
Genentech, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990

Avastin® is a registered trademark of Genentech, Inc.
© 2019 Genentech, Inc.

Representative sample of labeling (see the HOW SUPPLIED section for complete listing):

PRINCIPAL DISPLAY PANEL — 4 mL Vial Carton

NDC 50242-060-01

100 mg/4 mL
(25 mg/mL)

AVASTIN®
(bevacizumab)
Injection

For Intravenous Use.

Single-Dose Vial.
Discard Unused Portion.
No preservative.

1 vialRx only

Genentech

10213744

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

PRINCIPAL DISPLAY PANEL — 16 mL Vial Carton

NDC 50242-061-01

400 mg/16 mL
(25 mg/mL)

AVASTIN®
(bevacizumab)
Injection

For Intravenous Use.

Single-Dose Vial.
Discard Unused Portion.
No preservative.

1 vialRx only

10213746

PRINCIPAL DISPLAY PANEL -- 16 mL Vial Carton
(click image for full-size original)
AVASTIN bevacizumab injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-060
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
bevacizumab (bevacizumab) bevacizumab 100 mg in 4 mL
Inactive Ingredients
Ingredient Name Strength
Trehalose Dihydrate 240 mg in 4 mL
Sodium Phosphate, Monobasic, Monohydrate 23.2 mg in 4 mL
Sodium Phosphate, Dibasic, Anhydrous 4.8 mg in 4 mL
Polysorbate 20 1.6 mg in 4 mL
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50242-060-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 4 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (50242-060-01)
2 NDC:50242-060-10 10 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
2 4 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (50242-060-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125085 02/26/2004
AVASTIN bevacizumab injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-061
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
bevacizumab (bevacizumab) bevacizumab 400 mg in 16 mL
Inactive Ingredients
Ingredient Name Strength
Trehalose Dihydrate 960 mg in 16 mL
Sodium Phosphate, Monobasic, Monohydrate 92.8 mg in 16 mL
Sodium Phosphate, Dibasic, Anhydrous 19.2 mg in 16 mL
Polysorbate 20 6.4 mg in 16 mL
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50242-061-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 16 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (50242-061-01)
2 NDC:50242-061-10 10 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
2 16 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (50242-061-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125085 02/26/2004
Labeler — Genentech, Inc. (080129000)
Establishment
Name Address ID/FEI Operations
Genentech, Inc. (SSF) 080129000 API MANUFACTURE (50242-060), API MANUFACTURE (50242-061), MANUFACTURE (50242-060), MANUFACTURE (50242-061), ANALYSIS (50242-060), ANALYSIS (50242-061), LABEL (50242-060), LABEL (50242-061), PACK (50242-060), PACK (50242-061)
Establishment
Name Address ID/FEI Operations
Genentech, Inc. (Vacaville) 004074162 ANALYSIS (50242-060), ANALYSIS (50242-061)
Establishment
Name Address ID/FEI Operations
Genentech, Inc. (Hillsboro) 833220176 MANUFACTURE (50242-060), MANUFACTURE (50242-061), ANALYSIS (50242-060), ANALYSIS (50242-061), PACK (50242-060), PACK (50242-061)
Establishment
Name Address ID/FEI Operations
Genentech, Inc. (Oceanside) 146373191 API MANUFACTURE (50242-060), API MANUFACTURE (50242-061), ANALYSIS (50242-060), ANALYSIS (50242-061)
Establishment
Name Address ID/FEI Operations
Roche Singapore Technical Operations Pte. Ltd. 937189173 API MANUFACTURE (50242-060), API MANUFACTURE (50242-061), ANALYSIS (50242-060), ANALYSIS (50242-061)
Establishment
Name Address ID/FEI Operations
F. Hoffmann-La Roche Ltd 482242971 ANALYSIS (50242-060), ANALYSIS (50242-061), API MANUFACTURE (50242-060), API MANUFACTURE (50242-061)
Establishment
Name Address ID/FEI Operations
F. Hoffmann-La Roche Ltd 485244961 MANUFACTURE (50242-060), MANUFACTURE (50242-061), ANALYSIS (50242-060), ANALYSIS (50242-061)

Revised: 06/2019 Genentech, Inc.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2019. All Rights Reserved.