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
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
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OGIVRI trastuzumab-dkst injection, powder, lyophilized, for solution | |||||||||||||||||
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Labeler — Mylan Institutional LLC (790384502) |
Revised: 02/2021 Mylan Institutional LLC
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