OGIVRI
trastuzumab-dkst · KIT · Biocon Biologics Inc.
OGIVRI is a kit containing trastuzumab-dkst. Manufactured by Biocon Biologics Inc..
Key Facts
- Brand Name
- OGIVRI
- Generic Name
- trastuzumab-dkst
- NDC Code (Product)
83257-004- Manufacturer
- Biocon Biologics Inc.
- Dosage Form
- KIT
- Marketing Status
- Application #
- BLA761074
- Drug Class
- HER2/neu Receptor Antagonist [EPC]
- Marketing Start
- 10/01/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Ogivri is a HER2/neu receptor antagonist indicated in adults 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 , 2.2 ). 1.1 Adjuvant Breast Cancer Ogivri is indicated in adults for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1) ] ) breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel as part of a treatment regimen with docetaxel and carboplatin as a single agent following multi-modality anthracycline based therapy. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.2) ]. 1.2 Metastatic Breast Cancer Ogivri is indicated in adults: In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer As a single agent for treatment of HER2-overex…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For intravenous (IV) infusion only. Do not administer as an IV push or bolus. Ogivri has different dosage and administration instructions than subcutaneous trastuzumab products. ( 2.3 ) Do not substitute Ogivri (trastuzumab-dkst) for or with ado-trastuzumab emtansine or fam-trastuzumab deruxtecan. ( 2.3 ) Perform HER2 testing using FDA-approved tests by laboratories with demonstrated proficiency. ( 1 , 2.2 ) Adjuvant Treatment of HER2-Overexpressing Breast Cancer ( 2.2 ) Administer at either: Initial dose of 4 mg/kg over 90 minutes IV infusion, then 2 mg/kg over 30 minutes 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 ( 2.3 ) Initial dose of 4 mg/kg as a 90 minutes IV infusion followed by subsequent weekly doses of 2 mg/kg as 30 minutes IV infusions. …
Contraindications
4 CONTRAINDICATIONS None. • None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Anthracyclines Patients who receive anthracycline after stopping trastuzumab products may be at increased risk of cardiac dysfunction because of trastuzumab products estimated long washout period [see Clinical Pharmacology (12.3) ] . If possible, avoid anthracycline-based therapy for up to 7 months after stopping trastuzumab products. If anthracyclines are used, closely monitor the patient’s cardiac function.
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Cardiomyopathy [see Warnings and Precautions (5.1) ] Infusion Reactions [see Warnings and Precautions (5.2) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.3) ] Pulmonary Toxicity [see Warnings and Precautions (5.4) ] Exacerbation of Chemotherapy-induced Neutropenia [see Warnings and Precautions (5.5) ] 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 Biocon Biologics at 1-833-986-1468 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying condition…
Frequently Asked Questions
What is OGIVRI used for?
OGIVRI contains trastuzumab-dkst. It is a kit taken as directed. Consult your doctor for specific uses.
Is OGIVRI a controlled substance?
OGIVRI is not classified as a controlled substance by the DEA.
What is the generic name for OGIVRI?
The generic name for OGIVRI is trastuzumab-dkst. There are no other listed brand versions of trastuzumab-dkst.
What is the NDC code for OGIVRI ?
The NDC (National Drug Code) for OGIVRI is 83257-004, listed by Biocon Biologics Inc..
Other OGIVRI Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)