For Breast Cancer, Gastric Cancer
Ogivri (trastuzumab-dkst) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer and the treatment of HER2-overexpressing stomach cancer.
Ogivri (trastuzumab-dkst), a Biosimilar to Herceptin. 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.
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 Storage
Store Ogivri vials in the refrigerator at 2° to 8°C (36° to 46°F) until time of reconstitution. These highlights do not include all the information needed to use OGIVRI safely and effectively. See full prescribing information for OGIVRI.
OGIVRI (trastuzumab-dkst) for injection, for intravenous use
Initial U.S. Approval: 2017
OGIVRI (trastuzumab-dkst) is biosimilar* to HERCEPTIN (trastuzumab).
WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY
See full prescribing information for complete boxed warning.
Cardiomyopathy: trastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue Ogivri for cardiomyopathy. (2.3, 5.1)
Infusion Reactions, Pulmonary Toxicity: Discontinue Ogivri for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. (5.2, 5.4)
Embryo-Fetal Toxicity: Exposure to trastuzumab products during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception. (5.3, 8.1, 8.3)
RECENT MAJOR CHANGES
Dosage and Administration (2.4) 11/2019
Dosage Forms and Strengths (3) 04/2019
INDICATIONS AND USAGE
Ogivri is a HER2/neu receptor antagonist indicated for:
The treatment of HER2-overexpressing breast cancer. (1.1, 1.2)
The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3)
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product (1, 2.1).
DOSAGE AND ADMINISTRATION
For intravenous (IV) infusion only. Do not administer as an IV push or bolus. (2.2)
Do not substitute Ogivri (trastuzumab-dkst) for or with ado-trastuzumab emtansine. (2.2)
Perform HER2 testing using FDA-approved tests by laboratories with demonstrated proficiency. (1, 2.1)
Adjuvant Treatment of HER2-Overexpressing Breast Cancer (2.2)
Administer at either:
Initial dose of 4 mg/kg over 90 minute IV infusion, then 2 mg/kg over 30 minute IV infusion weekly for 12 weeks (with paclitaxel or docetaxel) or 18 weeks (with docetaxel and carboplatin). One week after the last weekly dose of Ogivri, administer 6 mg/kg as an IV infusion over 30 to 90 minutes every three weeks to complete a total of 52 weeks of therapy, or
Initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30 to 90 minutes IV infusion every three weeks for 52 weeks.
Metastatic HER2-Overexpressing Breast Cancer (2.2)
Initial dose of 4 mg/kg as a 90 minute IV infusion followed by subsequent weekly doses of 2 mg/kg as 30 minute IV infusions.
Metastatic HER2-Overexpressing Gastric Cancer (2.2)
Initial dose of 8 mg/kg over 90 minutes IV infusion, followed by 6 mg/kg over 30 to 90 minutes IV infusion every 3 weeks.
DOSAGE FORMS AND STRENGTHS
For Injection: 150 mg lyophilized powder in a single-dose vial for reconstitution
For Injection: 420 mg lyophilized powder in a multiple-dose vial for reconstitution
WARNINGS AND PRECAUTIONS
Exacerbation of Chemotherapy-Induced Neutropenia. (5.5, 6.1)
Adjuvant Breast Cancer
Most common adverse reactions (? 5%) are headache, diarrhea, nausea, and chills. (6.1)
Metastatic Breast Cancer
Most common adverse reactions (? 10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash. (6.1)
Metastatic Gastric Cancer
Most common adverse reactions (? 10%) are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Females and Males of Reproductive Potential: Verify the pregnancy status of females prior to initiation of Ogivri (8.3).
*Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of Ogivri has been demonstrated for the condition(s) of use (e.g. indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.
See 17 for PATIENT COUNSELING INFORMATION.