Generic Name
Trastuzumab
Brand Names
Ontruzant, Ogivri, Trazimera, Kanjinti, Herceptin, Herceptin Hylecta, Herzuma
FDA approval date: February 10, 2017
Classification: HER2/neu Receptor Antagonist
Form: Injection, Kit
What is Ontruzant (Trastuzumab)?
TRAZIMERA is a HER2/neu receptor antagonist indicated in adults for: The treatment of HER2-overexpressing breast cancer.
Approved To Treat
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Brand Information
Ontruzant (trastuzumab)
1DOSAGE FORMS AND STRENGTHS
- For injection: 150 mg of Ontruzant as a white to pale yellow, preservative-free lyophilized powder in a single-dose vial.
- For injection: 420 mg of Ontruzant as a white to pale yellow, preservative-free lyophilized powder in a multiple-dose vial.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the label:
- Cardiomyopathy
- Infusion Reactions
- Embryo-Fetal Toxicity
- Pulmonary Toxicity
- Exacerbation of Chemotherapy-induced Neutropenia
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most common adverse reactions in patients receiving trastuzumab products in the adjuvant and metastatic breast cancer setting are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia. Adverse reactions requiring interruption or discontinuation of trastuzumab product treatment include CHF, significant decline in left ventricular cardiac function, severe infusion reactions, and pulmonary toxicity
In the metastatic gastric cancer setting, the most common adverse reactions (≥ 10%) that were increased (≥ 5% difference) in the trastuzumab arm as compared to the chemotherapy alone arm were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia. The most common adverse reactions which resulted in discontinuation of treatment on the trastuzumab-containing arm in the absence of disease progression were infection, diarrhea, and febrile neutropenia.
3.2Post-Marketing Experience
The following adverse reactions have been identified during post-approval use of trastuzumab products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Infusion reaction
- Oligohydramnios or oligohydramnios sequence, including pulmonary hypoplasia, skeletal abnormalities, and neonatal death
- Glomerulopathy
- Immune thrombocytopenia
- Tumor lysis syndrome (TLS): Cases of possible TLS have been reported in patients treated with trastuzumab products. Patients with significant tumor burden (e.g. bulky metastases) may be at a higher risk. Patients could present with hyperuricemia, hyperphosphatemia, and acute renal failure which may represent possible TLS. Providers should consider additional monitoring and/or treatment as clinically indicated.
4DESCRIPTION
Trastuzumab-dttb is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-dttb is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture.
Ontruzant (trastuzumab-dttb) for injection is a sterile, white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration.
Each multiple-dose vial of Ontruzant delivers 420 mg trastuzumab-dttb, 381.4 mg α,α-trehalose dihydrate, 9.4 mg L-histidine HCl monohydrate, 6.1 mg L-histidine, and 1.7 mg polysorbate 20. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-dttb at a pH of approximately 6. If Ontruzant is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose.
Each single-dose vial of Ontruzant delivers 150 mg trastuzumab-dttb, 136.2 mg α,α-trehalose dihydrate, 3.4 mg L-histidine HCl monohydrate, 2.2 mg L-histidine, and 0.6 mg polysorbate 20. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-dttb that delivers 7.15 mL (150 mg trastuzumab-dttb), at a pH of approximately 6.
5PRINCIPAL DISPLAY PANEL - 150 mg Vial Carton
NDC 78206-147-01
150
Ontruzant
150 mg/vial
For Intravenous Infusion Only.
Must reconstitute and dilute
One single-dose vial.
Discard unused portion.
Rx only
ORGANON | SAMSUNG BIOEPIS
6PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 78206-148-01
420
Ontruzant
420 mg/vial
For Intravenous Infusion Only.
Must reconstitute and dilute before
Multiple-dose vial.
DO NOT FREEZE RECONSTITUTED SOLUTION.
Rx only
ORGANON | SAMSUNG BIOEPIS
