OGIVRI: Package Insert and Label Information (Page 10 of 10)

PRINCIPAL DISPLAY PANEL – 420 mg/vial

NDC 67457-845-20 Rx only

Ogivri^®
(trastuzumab-dkst)
For Injection
420 mg/vial

For intravenous infusion after reconstitution

No preservative

KEEP REFRIGERATED

Multiple-Dose
Vial

Contents: Each carton contains one 420 mg vial of Ogivri.

The content of each Ogivri^® vial is 420 mg trastuzumab-dkst, D-sorbitol (322.6 mg), L-Histidine (6.0 mg), L-Histidine hydrochloride monohydrate (9.4 mg) and Polyethylene glycol 3350/Macrogol 3350 (94.1 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer.

No U.S. standard of potency.

Store in refrigerator at 2° to 8°C (36° to 46°F) until time of reconstitution.

Reconstitution, Dosage, and Administration: Do not use if vacuum is not present. See prescribing information for dosage, preparation, and administration. Reconstitute with 20 mL Bacteriostatic Water for Injection (BWFI), USP (0.9% to 1.1% benzyl alcohol) to yield a multiple-dose solution containing 21 mg/mL trastuzumab-dkst that delivers 20 mL (420 mg trastuzumab-dkst). Do Not Shake. Store reconstituted solution in refrigerator at 2° to 8°C (36° to 46°F). Do not Freeze. Discard unused reconstituted solution after 28 days.

Do Not Freeze. Do Not Shake Reconstituted

Solution. KEEP REFRIGERATED

Manufactured by: Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

U.S. License No. 2210

Distributed by: Mylan Institutional LLCMorgantown, WV 26505 U.S.A.

Product of India

KR/DRUGS/KTK/28D/07/2006

B:845:1C:R1

Ogivri^® and the Ogivri Logo are registered trademarks of Mylan Institutional Inc.

Copyright © 2020 Mylan Inc. All rights reserved.

Mylan.com

PRINCIPAL DISPLAY PANEL – 150 mg/vial

NDC 67457-991-15 Rx only

Ogivri^®
(trastuzumab-dkst)
For Injection
150 mg/vial

For intravenous infusion after reconstitution

No preservative

KEEP REFRIGERATED

Single-Dose Vial
Discard Unused
Portion

The content of each Ogivri^® vial is 150 mg trastuzumab-dkst, D-sorbitol (115.2 mg), L-Histidine (2.16 mg), L-Histidine hydrochloride monohydrate (3.36 mg) and Polyethylene glycol 3350/Macrogol 3350 (33.6 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer.

No U.S. standard of potency.

Usual dosage: See package insert for dosage, preparation, and administration information.

Storage: Refrigerate at 2° to 8°C (36° to 46°F) until time of reconstitution.

Reconstitute immediately before use.

Do Not Freeze. Do Not Shake After Reconstitution.

Manufactured by: Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

U.S. License No. 2210

Distributed by: Mylan Institutional LLC
Morgantown, WV 26505 U.S.A.Product of India

KR/DRUGS/KTK/28D/07/2006 B:991:1C:R5

Ogivri^® and the Ogivri Logo are registered trademarks of Mylan Institutional Inc.

Copyright © 2020 Mylan Inc. All rights reserved.

Mylan.com

OGIVRI trastuzumab kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-847

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67457-847-44 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, MULTI-DOSE 20 mL Part 2 1 VIAL 20 mL

Part 1 of 2 OGIVRI trastuzumab injection, powder, lyophilized, for solution

Product Information Item Code (Source) NDC:67457-845 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRASTUZUMAB (TRASTUZUMAB) TRASTUZUMAB 420 mg in 20 mL

Inactive Ingredients Ingredient Name Strength HISTIDINE MONOHYDROCHLORIDE 9.4 mg in 20 mL HISTIDINE 6.0 mg in 20 mL POLYETHYLENE GLYCOL 3350 94.1 mg in 20 mL SORBITOL 322.6 mg in 20 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67457-845-50 20 mL in 1 VIAL, MULTI-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761074 11/29/2019

Part 2 of 2 BACTERIOSTATIC WATER bacteriostatic water solution

Product Information Item Code (Source) NDC:67457-846 Route of Administration INTRAVENOUS DEA Schedule

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL 11 mg in 20 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67457-846-20 20 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761074 11/29/2019

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761074 11/29/2019

OGIVRI trastuzumab injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-845 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRASTUZUMAB (TRASTUZUMAB) TRASTUZUMAB 420 mg in 20 mL

Inactive Ingredients Ingredient Name Strength HISTIDINE MONOHYDROCHLORIDE 9.4 mg in 20 mL HISTIDINE 6.0 mg in 20 mL POLYETHYLENE GLYCOL 3350 94.1 mg in 20 mL SORBITOL 322.6 mg in 20 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67457-845-20 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE 1 20 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (67457-845-20)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761074 11/29/2019

OGIVRI trastuzumab injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-991 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRASTUZUMAB (TRASTUZUMAB) TRASTUZUMAB 150 mg in 7.4 mL

Inactive Ingredients Ingredient Name Strength HISTIDINE MONOHYDROCHLORIDE HISTIDINE POLYETHYLENE GLYCOL 3350 SORBITOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67457-991-15 1 VIAL in 1 CARTON contains a VIAL 1 15 mL in 1 VIAL This package is contained within the CARTON (67457-991-15)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761074 11/29/2019

Labeler — Mylan Institutional LLC (790384502)

Revised: 02/2021 Mylan Institutional LLC