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OGIVRI (TRASTUZUMAB-DKST)
OGIVRI (generic name: TRASTUZUMAB-DKST) is a HER2/neu Receptor Antagonist [EPC] drug developed by MYLAN GMBH. It is currently FDA-approved for HER2-positive carcinoma of breast, HER2-positive colon cancer, HER2-positive rectal cancer.
OGIVRI is a biosimilar of trastuzumab, an antibody that inhibits the receptor tyrosine-protein kinase erbB-2, a receptor protein-tyrosine kinase. It is used to treat breast cancer, specifically HER2-positive breast carcinoma, in various stages including Stage IA, IB, IIA, and is also used in combination with aromatase inhibition therapy, cyclophosphamide, and doxorubicin hydrochloride.
At a glance
| Generic name | TRASTUZUMAB-DKST |
|---|---|
| Sponsor | MYLAN GMBH |
| Drug class | HER2/neu Receptor Antagonist [EPC] |
| Target | Receptor tyrosine-protein kinase erbB-2 |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- HER2-positive carcinoma of breast
- HER2-positive colon cancer
- HER2-positive rectal cancer
- HER2-positive salivary gland tumors
- Human epidermal growth factor 2 positive gastric cancer
- Secondary malignant neoplasm of female breast
- Secondary malignant neoplasm of stomach
Boxed warnings
- WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY Cardiomyopathy Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. Evaluate left ventricular function in all patients prior to and during treatment with Ogivri. Discontinue Ogivri treatment in patients receiving adjuvant therapy and withhold Ogivri in patients with metastatic disease for clinically significant decrease in left ventricular function [see Dosage and Administration (2.5) and Warnings and Precautions (5.1) ] . Infusion Reactions; Pulmonary Toxicity Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration of trastuzumab products. Interrupt Ogivri infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue Ogivri for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome [see Warnings and Precautions (5.2 , 5.4 )] . Embryo-Fetal Toxicity Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1 , 8.3 )] . 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. ( 2.5 , 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 )
Common side effects
- Fever
- Nausea
- Vomiting
- Infusion reactions
- Diarrhea
- Infections
- Increased cough
- Headache
- Fatigue
- Dyspnea
- Rash
- Neutropenia
Serious adverse events
- Cardiomyopathy
- Cardiac failure
- Asymptomatic cardiac dysfunction
- Pulmonary toxicity
- Interstitial pneumonitis
- Pulmonary hypertension
- Febrile neutropenia
- Sudden death
- Hypersensitivity
- Ventricular disorder
Key clinical trials
- A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Canc (Phase 3)
- Phase II Study of Doxil and Carboplatin, Plus Herceptin in HER2+ Patients, in Metastatic Breast Cancer (Phase 2)
- A Phase I/II Trial of Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer (Phase 1)
- Phase Ib/II Trial of Copanlisib in Combination With Trastuzumab and Pertuzumab After Induction Treatment of HER2 Positive (HER2+) Metastatic Breast Cancer (MBC) With PIK3CA Mutation or PTEN Mutation (Phase 1)
- ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer (EARLY/Phase 1)
- National Phase IIIb Prospective Two-Cohort Non-Randomized, Multi-centre, Open Label Study to Assess the Safety of Subcutaneous Trastuzumab and Molecular Biomarkers in Patients With Early and Locally A (Phase 3)
- A Phase II Study of Lapatinib for Brain Metastases in Subjects With ErbB2-Positive Breast Cancer Following Trastuzumab-based Systemic Therapy and Cranial Radiotherapy (Phase 2)
- Omission of Surgery and Sentinel Lymph Node Dissection in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant (Phase 2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- OGIVRI CI brief — competitive landscape report
- OGIVRI updates RSS · CI watch RSS
- MYLAN GMBH portfolio CI
Frequently asked questions about OGIVRI
What is OGIVRI?
OGIVRI (TRASTUZUMAB-DKST) is a HER2/neu Receptor Antagonist [EPC] drug developed by MYLAN GMBH, indicated for HER2-positive carcinoma of breast, HER2-positive colon cancer, HER2-positive rectal cancer.
What is OGIVRI used for?
OGIVRI is indicated for HER2-positive carcinoma of breast, HER2-positive colon cancer, HER2-positive rectal cancer, HER2-positive salivary gland tumors, Human epidermal growth factor 2 positive gastric cancer.
Who makes OGIVRI?
OGIVRI is developed and marketed by MYLAN GMBH (see full MYLAN GMBH pipeline at /company/mylan-gmbh).
What is the generic name of OGIVRI?
TRASTUZUMAB-DKST is the generic (nonproprietary) name of OGIVRI.
What drug class is OGIVRI in?
OGIVRI belongs to the HER2/neu Receptor Antagonist [EPC] class. See all HER2/neu Receptor Antagonist [EPC] drugs at /class/her2-neu-receptor-antagonist-epc.
What development phase is OGIVRI in?
OGIVRI is FDA-approved (marketed).
What are the side effects of OGIVRI?
Common side effects of OGIVRI include Fever, Nausea, Vomiting, Infusion reactions, Diarrhea, Infections. Serious adverse events: Cardiomyopathy, Cardiac failure, Asymptomatic cardiac dysfunction, Pulmonary toxicity.
What does OGIVRI target?
OGIVRI targets Receptor tyrosine-protein kinase erbB-2 and is a HER2/neu Receptor Antagonist [EPC].
Related
- Drug class: All HER2/neu Receptor Antagonist [EPC] drugs
- Target: All drugs targeting Receptor tyrosine-protein kinase erbB-2
- Manufacturer: MYLAN GMBH — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for HER2-positive carcinoma of breast
- Indication: Drugs for HER2-positive colon cancer
- Indication: Drugs for HER2-positive rectal cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing