Used as monotherapy after prior chemotherapy that included trastuzumab, and drugs from the group of taxanes (sequentially or in combination), or after disease progression trenbolone enanthate cycle during or within 6 months after completion of adjuvant therapy, including trastuzumab, and drugs group taxanes (sequentially or in combination) in patients with unresectable locally advanced or metastatic positive breast cancer.
Hypersensitivity to trastuzumab emtanzinu to other trenbolone enanthate cycle components of the preparation.
Infuzionnnye reactions associated with the use of trastuzumab, which led to the cancellation of therapy.
Pregnancy and lactation.
Age 18 years (effectiveness and safety of use in children has not been established).
Diffuse interstitial lung disease, pneumonitis.
Increase in trenbolone enanthate cycle amintoransferaz> 3hverhney limit of normal (ULN) or total bilirubin concentration> 2hVGN. Nodal regenerative hyperplasia of the liver. . Symptomatic congestive heart failure,
renal failure, severe and terminal degree (creatinine clearance <30 mL / min), liver failure (efficacy and safety have not been established).
The value of ejection fraction of the left ventricle trenbolone enanthate cycle before treatment; Chronic heart failure in history; dyspnea at rest due to the progression of malignant disease or concomitant diseases; serious cardiac arrhythmia requiring drug therapy; myocardial infarction or unstable angina, which evolved during the 6 months prior to treatment; platelet count prior to treatment; peripheral neuropathy >Grade 3 prior to treatment (efficacy and safety have not been established).
in trenbolone enanthate cycle transaminases> or the concentration of total before treatment before treatment, before or after adjuvant treatment with paclitaxel,
prior or simultaneous use of antihypertensive drugs,
prior anthracycline therapy;
aged> patients 50 years
in patients with a body mass index> 25 kg / m 2 .
Use during pregnancy and during breastfeeding
Women have reproductive potential and male patients, as well as women of childbearing age who are sexual partners of patients receiving the drug Quds ® , must use effective contraception during treatment with Quds ® and for 6 months after the last dose. In case of pregnancy the patient should consult a doctor immediately.
It is necessary to warn women about the possibility of harmful effects on the fetus. If a pregnant woman chooses to continue therapy with Quds ® , it should be under close medical supervision.
It is not known whether trastuzumab emtanzin into breast milk. Breast-feeding is not recommended during treatment and for at least 6 months after the end of therapy with Quds ® .
Dosing and Administration
Before using the drug you need to check the label on the bottle and make sure that used for the preparation and administration of the drug is a Quds drug ® (trastuzumab emtanzin), rather than the drug Gertseptink (trastuzumab).
Use of the drug Quds ® should only be done under the supervision of a physician with experience treatment of cancer.
It is necessary to carry out testing for the expression of HER2 tumor before treatment with Quds ® . Essential criteria a score of 3+ on the results of immunohistochemistry (IHC) and / or the degree of amplification of > 2.0 as a result of hybridization in situ conservation (the ISH). The methods used should be validated test.
The patient’s medical records should indicate the trade name of the drug (Quds ® ). Replacement product Quds ® to another drug of biological origin should be agreed with your doctor. Dosage The recommended dose Quds drug ® is 3.6 mg / kg body weight of 1 every 3 weeks (21-day cycle) in the form of an intravenous drip infusion. Treatment with Quds ® should continue until evidence of disease progression trenbolone enanthate cycle or unacceptable toxicity. The first dose is recommended to be administered as a 90-minute intravenous drip infusion. it is necessary to watch the patient during the first infusion, and at least 90 minutes after its completion for the onset of fever , chills or other infusion reactions. Also, a careful examination of the injection site for a possible formation of subcutaneous infiltration. If prior infusion was well tolerated, the next infusion can be carried out for 30 minutes while continuing to monitor the patient for at least 30 minutes after the infusion. It is necessary to reduce the infusion rate or time to stop administering the drug Quds ® with the appearance of the patient’s symptoms of infusion reactions. In the event of a life-threatening infusion reactions therapy with Quds ® should be completely discontinued.medications for the treatment of potential infusion reactions, allergic / anaphylactic type, as well as equipment for emergency treatment should be trenbolone enanthate cycle available for immediate use. Skip to the planned introductionwhen skipping a planned introduction of the drug Quds ® is necessary before a drug can be put in the recommended dose, and the infusion rate may be the same, in which the prior infusion was well tolerated by the patient. Do not wait for the next scheduled cycle. Timetable for the introduction of the drug should be adjusted to maintain a 3-week interval between doses. Correction dose Possible measures to address the symptoms of adverse reactions are dose reduction, temporary treatment interruption or total cessation of drug therapy Quds ® . The relevant recommendations are listed below in Tables 1-5. If the dose of the drug Quds ® was reduced, the increase can not be subsequent administrations.