Breast Cancer, Gastric Cancer
Ontruzant (trastuzumab-dttb) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Ontruzant (trastuzumab-dttb) for injection 150 mg/vial is supplied in a single-dose vial as a white to pale yellow lyophilized sterile powder, under vacuum. Each carton contains one single-dose vial of Ontruzant. NDC 0006-5033-02. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not in clude al l the infor mation needed to use ONTRUZANT safely and effectively. See full prescribing infor mation for ONTRUZANT. ONTRUZANT (trastuzumab-dttb) for injection, for intravenous use Initial U.S. Appro val: 2019 ONTRUZANT (trastuzumab-dttb) 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 Ontruzant for cardiomyopathy. (2.3, 5.1) Infusion Reactions, Pulmonary Toxicity: Discontinue Ontruzant 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) ---------------------------INDICATIONS AND USAGE----------------------------Ontruzant is a HER2/ neu recept or antagonist indi cated 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 patient s for therapy based on an FDA-approved compani on diagnostic for a trastuzumab product (1, 2.1). ------------------------DOSAGE AND ADMINISTRATION--------------------- �For intravenous (IV) infusion only. Do not administer as an IV push or bol us. (2.2) Do not sub st itut e Ontruzant (trastuzumab-dttb) for or with ado-trastuzumabemtansine. (2.2)Pe rform HER2 testing using FDA-approved tests by labor ator ies withdemonstrated proficienc y. (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 Ontruzant, 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-Overexpre ssing Breast Cancer (2.2) ?Initial dose of 4 mg/kg as a 90 minu te IV infusion followed by subsequent weekly doses of 2 mg/kg as 30 minute I V infusions. Metastatic HER2-Overexpre ssing Gastric Cancer (2.2) ?Initial dose of 8 mg/kg over 90 min ut es IV infusion, followed by 6 mg/kg over 30 to 90 minut es IV infusion every 3 weeks. ---------------------DOSAGE FORMS AND STRENGTHS---------------------�?For Inj ection: 150 mg lyophili zed powder in a singl e-dose vial for reconstitution ------------------------------CONTRAINDICATIONS------------------------- ----�?None. (4) -----------------------WARNINGS AND PRECAUTIONS-----------------------�?Exacerbation of Chemother apy-Induced Neut ropenia. (5.5, 6.1) ---------------------- --------ADVERSE REACTIONS------------------------------Adjuvant Brea st Cancer ?Most co mmon adverse re actions (?5%) are heada che, diarrhea, nausea, and chills. (6.1) Metastatic Breast Cancer ?Most co mmon adverse re actions (?10%) are fever, chills, heada ch e, infection, congestive heart failure, insomni a, cough, and rash. (6.1) Metastatic Gastric Cancer ?Most co mmon adverse re actions (?10%) are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respi rator y tract infection s, fever, thrombocytopenia, mucosal inflammation, na sopha ryngitis, an d dysgeusia. (6.1) To repor t SUSPECTED ADVERSE REACTIONS, contac t Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ----------------------USE IN SPECIFIC POPULATIONS---------------------- Females and Males of Reproduc tive Pote nt ial: Verify the pregna ncy status of females prior to initiation of Ontruzant (8.3). See 17 for PATIENT COUNSELING INFORMATION. * 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 Ontruzant 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. Revised: 01/2019
