OGIVRI (Page 15 of 15)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Ogivri (trastuzumab-dkst) for injection 420 mg/vial is supplied in a multiple-dose vial as an off-white to pale yellow lyophilized sterile powder, under vacuum. Each carton contains one multiple-dose vial of Ogivri and one vial (20 mL) of Bacteriostatic Water for Injection (BWFI), USP, containing 1.1% benzyl alcohol as a preservative.

NDC 67457-847-44

Ogivri (trastuzumab-dkst) for injection 420 mg/vial is supplied in a multiple-dose vial as an off-white to pale yellow lyophilized sterile powder, under vacuum. Each carton contains one multiple-dose vial of Ogivri. No diluent is provided.

NDC 67457-845-20

Ogivri (trastuzumab-dkst) for injection 150 mg/vial is supplied in a single-dose vial as an off-white to pale yellow lyophilized sterile powder, under vacuum. Each carton contains one single-dose vial of Ogivri.

NDC 67457-991-15

16.2 Storage

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

17 PATIENT COUNSELING INFORMATION

Cardiomyopathy

Advise patients to contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness [see Boxed Warning: Cardiomyopathy].

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential that Ogivri exposure during pregnancy or within 7 months prior to conception can result in fetal harm. Advise female patients to contact their healthcare provider with a known or suspected pregnancy [see Use in Specific Populations (8.1)].
Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of Ogivri [see Use in Specific Populations (8.3)].

Ogivri® and the Ogivri Logo are registered trademarks of Mylan Institutional Inc., a Viatris Company.

© 2021 Viatris Inc.

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

US License No. 2210

KR/DRUGS/KTK/28D/07/2006
KR/DRUGS/KTK/28/0456/2019

B:TRAS4224B:R6

PRINCIPAL DISPLAY PANEL — 420 mg/vial

NDC 67457-847-44

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 and one vial containing 20 mL of Bacteriostatic Water for Injection, USP (1.1% benzyl alcohol).

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.

Bacteriostatic Water for Injection, USP is a sterile water containing 1.1% benzyl alcohol as an antimicrobial preservative packaged in a multi-use vial. The diluent is pH 4.5 to 7.

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

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

Copyright © 2020 Mylan Inc. All rights reserved.

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 KR/DRUGS/KTK/28/0456/2019

B:847:2KC:R14

Mylan.com

Ogivri for Injection 420 mg/vial Carton Label
(click image for full-size original)

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

Ogivri for Injection 420 mg/vial Carton Label
(click image for full-size original)

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 for Injection 150 mg/vial Carton Label
(click image for full-size original)
OGIVRI trastuzumab-dkst 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 04/30/2027
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 04/30/2027
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761074 11/29/2019 04/30/2027
OGIVRI trastuzumab-dkst 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 02/28/2027
Labeler — Mylan Institutional LLC (790384502)

Revised: 02/2021 Mylan Institutional LLC

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