T-Mab
(Trastuzumab)
Dosage form:
Lyophilizate for solution for infusion 100 mg
Lyophilizate for concentrate preparation for solution for infusion 440 mg
Pharmacotherapeutic group:
anti-tumor agent, a monoclonal antibody
ATC code: L01XC03
Pharmacological properties:
Trastuzumab – humanized monoclonal antibody(lgG1), that selectively interacts with extracellular domain of EGF receptor of the human growth type 2(HER2)
BCD-022blocks the proliferation of cancer cells with the HER2 overexpressing
Indications:
Breast Cancer
HER2 positive metastatic breast cancer:
– as a monotherapy after one or more chemotherapy regimens;
– in combination with taxans (e.g.paclitaxel),in case of previous chemotherapy absence (first line therapy);
– in combination with inhibitors aromatase with positive hormone receptors (estrogen and /or progesterone) in postmenopausal women.
Early HER2 positive breast cancer:
– adjuvant therapy after surgery, after chemotherapy termination (neoadjuvant or adjuvant), after radiotherapy;
– in combination with adjuvant chemotherapy and after it, in combination with taxans (e.g.paclitaxel)
– in combination with neoadjuvant chemotherapy and the subsequent adjuvant trastuzumab monotherapy, for locally advanced (including inflammatory form) disease or when the tumor is larger than 2 cm in diameter.
Advanced Gastric Cancer:
Advanced gastric or gastroesophageal junction adenocarcinoma with HER2 overexpressing
– in combination with capecitabine or 5-fluorouracil and platinum-based drugs, for the treatment of patients who have not received prior treatment for metastatic disease
Dosage and Administration:
HER2 testing before treatment obligatory.
Do not administer as an intravenous push or bolus!
DONOTUSE DEXTROSE(5%)SOLTION!
Peculiarity of dosing regimens for various indications – see full text of T-Mab prescription information.
Contraindications:
Hypersensitivity to trastuzumb or to any other component of the drug, including benzyl alcohol contained as a preservative in bacteriostatic water for injection.
Children under 18 years old (efficacy and safety in children has not been established).
Severe dyspnoea at rest, caused by lungs metastases or requiring therapy with oxygen .
Patients in the early stages of breast cancer with myocardial infarction in history, treatment required stenocardia, CHF (ll-lV functional class NYHA), LVEF<55%, cardiomyopathy, arrhythmias, clinically significant valvular heart disease, uncontrolled hypertension, hemodynamically significant pericardial effusion (efficacy and safety in these patient groups have not been studied); simultaneously use of the drug with anthracycline in the adjuvant treatment of patients with early- stage Breast cancer.
Side effects:
The most serious or/and common adverse reactions are cardiac dysfunction, infusion reactions, hematological toxicity (in particular neutropenia), infections, pulmonary toxicity.
Pregnancy:
Women of reproductive age should use reliable methods of contraception during trastuzumab treatment and for at least 7 months after the end of treatment. In the case of pregnancy it is necessary to warn the women about possible harmful effects on the fetus. If a pregnant women continues trastuzumab therapy, she should be under the doctors control.
Nursing Mothers:
Breast – feeding is not recommended during treatment and for at least 7 months after trastuzumab therapy.
Prescription Status:
Available on prescription
Expiration date:
4 years.