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Ontruzant Generic Name & Formulations
Legal Class
Rx
General Description
Trastuzumab-dttb 150mg, 420mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution.
Pharmacological Class
Human epidermal growth factor receptor (HER2) inhibitor.
How Supplied
Single-dose vial (150mg)—1 (preservative-free); multiple-dose vial (420mg)—1 (w. BWFI diluent; contains benzyl alcohol)
Manufacturer
Generic Availability
NO
Ontruzant Indications
Indications
HER2-overexpressing metastatic breast cancer as a single agent in patients who have received one or more chemotherapy regimens; or in combination with paclitaxel for first-line treatment. Adjuvant treatment in HER2-overexpressing, node-positive or node-negative breast cancer (as a single agent following multi-modality anthracycline based therapy; in combination with doxorubicin, cyclophosphamide and either paclitaxel or docetaxel; or in combination with docetaxel and carboplatin).
Ontruzant Dosage and Administration
Adult
Do not substitute for or with ado-trastuzumab emtansine. Give as IV infusion. Metastatic treatment (alone or with paclitaxel): initially 4mg/kg over 90mins, followed by 2mg/kg over 30mins once weekly until disease progression. Adjuvant treatment (give total of 52 weeks of trastuzumab) in combination therapy: initially 4mg/kg over 90mins, followed by 2mg/kg over 30mins once weekly for the 1st 12 weeks (concurrently w. paclitaxel or docetaxel) or 18 weeks (concurrently w. docetaxel/carboplatin). One week after the last trastuzumab weekly dose, give trastuzumab 6mg/kg over 30–90mins every 3 weeks. As a single agent following multi-modality anthracycline based therapy: initially 8mg/kg over 90mins, then 6mg/kg over 30–90mins every 3 weeks. Infusion reactions or cardiomyopathy: see full labeling.
Children
Not established.
Ontruzant Contraindications
Not Applicable
Ontruzant Boxed Warnings
Boxed Warning
Cardiomyopathy. Infusion reactions. Pulmonary toxicity. Embryo-fetal toxicity.
Ontruzant Warnings/Precautions
Warnings/Precautions
Increased risk of cardiomyopathy. Conduct cardiac assessment (eg, history, physical exam, LVEF) at baseline, every 3 months during and after therapy or every 6 months for ≥2yrs after therapy (if adjuvant); repeat LVEF at 4 week intervals if dose is withheld due to significant left ventricular cardiac dysfunction. Interrupt therapy if dyspnea or significant hypotension occurs; consider discontinuing permanently if severe infusion reactions, CHF, pulmonary toxicity, or significant left ventricular cardiac dysfunction develops. Symptomatic intrinsic lung disease. Extensive tumor involvement of the lungs. Test for HER2 protein overexpression and HER2 gene amplification using FDA-approved tests for specific tumor type (breast or gastric-gastroesophageal adenocarcinoma). Embryo-fetal toxicity (eg, oligohydramnios). Advise females of reproductive potential to use effective contraception during and for 7 months after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers.
Ontruzant Pharmacokinetics
See Literature
Ontruzant Interactions
Interactions
Increased cardiomyopathy with anthracycline-containing chemotherapy; if possible, avoid for up to 7 months after discontinuing trastuzumab products. Increased toxicity with other myelosuppressives.
Ontruzant Adverse Reactions
Adverse Reactions
Headache, fever, arthralgia, nasopharyngitis, nausea, vomiting, diarrhea, chills, infections, increased cough, CHF, fatigue, dyspnea, rash, febrile neutropenia, anemia, myalgia; infusion reactions, exacerbation of chemotherapy-induced neutropenia, interstitial pneumonitis.
Ontruzant Clinical Trials
See Literature
Ontruzant Note
Not Applicable
Ontruzant Patient Counseling
See Literature
Ontruzant Generic Name & Formulations
Legal Class
Rx
General Description
Trastuzumab-dttb 150mg, 420mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution.
Pharmacological Class
Human epidermal growth factor receptor (HER2) inhibitor.
How Supplied
Single-dose vial (150mg)—1 (preservative-free); multiple-dose vial (420mg)—1 (w. BWFI diluent; contains benzyl alcohol)
Manufacturer
Generic Availability
NO
Ontruzant Indications
Indications
HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, in combination with cisplatin and capecitabine or 5-fluorouracil, in patients who have not received prior treatment.
Ontruzant Dosage and Administration
Adult
Do not substitute for or with ado-trastuzumab emtasine. Give as IV infusion. Initially 8mg/kg over 90mins, followed by 6mg/kg over 30–90mins every 3 weeks until disease progression. Infusion reactions or cardiomyopathy: see full labeling.
Children
Not established.
Ontruzant Contraindications
Not Applicable
Ontruzant Boxed Warnings
Boxed Warning
Cardiomyopathy. Infusion reactions. Pulmonary toxicity. Embryo-fetal toxicity.
Ontruzant Warnings/Precautions
Warnings/Precautions
Increased risk of cardiomyopathy. Conduct cardiac assessment (eg, history, physical exam, LVEF) at baseline, every 3 months during and after therapy or every 6 months for ≥2yrs after therapy (if adjuvant); repeat LVEF at 4 week intervals if dose is withheld due to significant left ventricular cardiac dysfunction. Interrupt therapy if dyspnea or significant hypotension occurs; consider discontinuing permanently if severe infusion reactions, CHF, pulmonary toxicity, or significant left ventricular cardiac dysfunction develops. Symptomatic intrinsic lung disease. Extensive tumor involvement of the lungs. Test for HER2 protein overexpression and HER2 gene amplification using FDA-approved tests for specific tumor type (breast or gastric-gastroesophageal adenocarcinoma). Embryo-fetal toxicity (eg, oligohydramnios). Advise females of reproductive potential to use effective contraception during and for 7 months after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers.
Ontruzant Pharmacokinetics
See Literature
Ontruzant Interactions
Interactions
Increased cardiomyopathy with anthracycline-containing chemotherapy; if possible, avoid for up to 7 months after discontinuing trastuzumab products. Increased toxicity with other myelosuppressives.
Ontruzant Adverse Reactions
Adverse Reactions
Neutropenia, diarrhea, fatigue, anemia, thrombocytopenia, stomatitis, weight loss, fever, mucosal inflammation, upper RTIs, nasopharyngitis, dysgeusia; infusion reactions, exacerbation of chemotherapy-induced neutropenia, interstitial pneumonitis.
Ontruzant Clinical Trials
See Literature
Ontruzant Note
Not Applicable
Ontruzant Patient Counseling
See Literature
