ТЕЦЕНТРИК

ТЕЦЕНТРИК Uses, Dosage, Side Effects, Food Interaction and all others data.

Binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells suppresses cytotoxic T-cell activity through the inhibition of T-cell proliferation and cytokine production. PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells, and can contribute to the inhibition of the antitumor immune response in the microenvironment. ТЕЦЕНТРИК is an Fc-engineered humanized immunoglobulin G1 (IgG1) monoclonal antibody that directly binds to PD-L1 and blocks interactions with the PD-1 and B7.1 receptors, releasing PD-L1 / PD-1 pathway-mediated inhibition of the immune response, including reactivating the antitumor immune response. ТЕЦЕНТРИК leaves the PD-L2/PD-1 interaction intact. In syngeneic mouse tumor models, blocking PD-L1 activity resulted in decreased tumor growth

ТЕЦЕНТРИК is a humanized monoclonal antibody used to prevent the interaction of PD-L1 and PD-1, removing inhibition of immune responses seen in some cancers. This drug has a long duration of action as it is usually given every 3-4 weeks. ТЕЦЕНТРИК should not be used in patients with immune mediated penumonitis, hepatitis, colitis, and some endocrinopathies.

ТЕЦЕНТРИК
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	ТЕЦЕНТРИК
Availability	Prescription only
Generic	Atezolizumab
Atezolizumab Other Names	Atezolizumab
Related Drugs	Opdivo, methotrexate, Keytruda, pembrolizumab, doxorubicin, cisplatin, Tagrisso, Avastin, bevacizumab, nivolumab
Type
Weight	145000.0 Da
Protein binding	Monoclonal antibodies are not expected to bind to proteins in plasma they are not designed to target.
Groups	Approved, Investigational
Therapeutic Class	Anti neoplastic preparations, Vaccines, Anti-sera & Immunoglobulin
Manufacturer
Available Country	Russia
Last Updated:	September 19, 2023 at 7:00 am

Uses

ТЕЦЕНТРИК is used for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC):

After prior chemotherapy, or
Who are considered cisplatin ineligibleand whose tumours have a PD-L1 expression ≥ 5%, or
Who are not eligible for any platinum-containing chemotherapy regardless of level of tumor PD-L1 expression.

ТЕЦЕНТРИК is used for the treatment of patients with locally advanced or metastatic non-small cell lung cancer NSCLC after prior chemotherapy.
Pediatric use: The safety and efficacy of ТЕЦЕНТРИК in children and adolescents below 18 years of age have not been established.

Geriatric use: Based on a population pharmacokinetic analysis, no dose adjustment of ТЕЦЕНТРИК is required in patients ≥ 65 years of age

Renal impairment: Based on a population pharmacokinetic analysis, no dose adjustment is required in patients with renal impairment

Hepatic impairment: Based on a population pharmacokinetic analysis, no dose adjustment is required for patients with mild hepatic impairment. There are no data in patients with moderate or severe hepatic impairment

ТЕЦЕНТРИК is also used to associated treatment for these conditions: Metastatic Non-Small Cell Lung Cancer, Small Cell Lung Cancer (SCLC), Triple Negative Breast Cancer (TNBC), Urothelial carcinoma ureter metastatic, Locally advanced Urothelial Carcinoma

How ТЕЦЕНТРИК works

ТЕЦЕНТРИК is a humanized IgG antibody that binds PD-L1, preventing its interaction with PD-1 and B7-1. Preventing the interaction of PD-L1 and PD-1 removes inhibition of immune responses such as the anti-tumor immune response but not antibody dependent cellular cytotoxicity.

Dosage

ТЕЦЕНТРИК dosage

General: ТЕЦЕНТРИК must be administered as an intravenousinfusion under the supervision of a qualified healthcare professional. Do not administer as an IV push or bolus. Substitution by any other biological medicinal product requires the consent of the prescribing physician. The initial dose of ТЕЦЕНТРИК must be administered over 60 minutes. If the first infusion is tolerated all subsequent infusions may be administered over 30 minutes. The recommended dose of ТЕЦЕНТРИК is either:

1200 mg administered by IV infusion every 3 weeks or
1680 mg administered by IV infusion every 4 weeks.

1L cisplatin-ineligible mUC: Patients should be selected for treatment based on the tumor expression of PD-L1 confirmed by a validated test

Toxicity

Most common adverse reactions (≥ 20% of patients) included: fatigue, decreased appetite, nausea, urinary tract infection, pyrexia, and constipation.

Overdose data for atezolizumab is scarce but the most common adverse reactions are fatigue, nausea, cough, dyspnea, decreased appetite, alopecia, constipation, diarrhea, peripheral neuropathies, anemia, headache, neutropenia, and vomiting.

Precaution

Immune-related pneumonitis: Cases of pneumonitis, including fatal cases, have been observed in clinical trials with ТЕЦЕНТРИК. Patients should be monitored for signs and symptoms of pneumonitis.

Immune-related hepatitis: Cases of hepatitis, some leading to fatal outcomes, have been observed in clinical trials with ТЕЦЕНТРИК. Patients should be monitored for signs and symptoms of hepatitis. Monitor aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin prior to and periodically during treatment with ТЕЦЕНТРИК. Consider appropriate management of patients with abnormal liver function tests (LFTs) at baseline.

Immune-related colitis: Cases of diarrhea or colitis have been observed in clinical trials with ТЕЦЕНТРИК. Patients should be monitored for signs and symptoms of colitis.

Immune-related endocrinopathies: Hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, and type 1 diabetes mellitus, including diabetic ketoacidosis, have been observed in clinical trials with ТЕЦЕНТРИК. Patients should be monitored for clinical signs and symptoms of endocrinopathies. Monitor thyroid function prior to and periodically during treatment with ТЕЦЕНТРИК. Consider appropriate management of patients with abnormal thyroid function tests at baseline. Patients with abnormal thyroid function tests who are asymptomatic may receive ТЕЦЕНТРИК.

Food Interaction

No interactions found.

ТЕЦЕНТРИК Drug Interaction

Unknown: paclitaxel protein-bound, charcoal, aspirin, ubiquinone, docusate, prochlorperazine, ubiquinone, apixaban, sodium iodide, metoprolol, magnesium hydroxide, morphine, esomeprazole, insulin aspart/insulin aspart protamine, acetaminophen, bioflavonoids, paclitaxel, metoprolol, cholecalciferol, levocetirizine

ТЕЦЕНТРИК Disease Interaction

Major: endocrinopathies, hepatitis, infections, meningitis, neuropathy, pancreatitisModerate: colitis, liver disease, pneumonitis, renal impairment

Volume of Distribution

The volume of distribution of atezolizumab is 6.91L.

Elimination Route

Pharmacokinetic analysis was performed in patients with metastatic urothelial carcinoma. In these patients, the AUC was 2.19-2.73day*µg/mL/mg, the C_max was 0.27-0.35µg/mL/mg, and the C_min was 0.004-0.008µg/mL/mg.

Half Life

The half life of atezolizumab is 27 days.

Clearance

The clearance of atezolizumab is 0.200L/day.

Elimination Route

ТЕЦЕНТРИК is not renally excreted.

Pregnancy & Breastfeeding use

There are no clinical studies of ТЕЦЕНТРИК in pregnant women. ТЕЦЕНТРИК is not recommended during pregnancy unless the potential benefit for the mother outweighs the potential risk to the fetus

It is not known whether ТЕЦЕНТРИК is excreted in human breast milk. No studies have been conducted to assess the impact of ТЕЦЕНТРИК on milk production or its presence in breast milk.Asthe potential for harm to the nursing infant is unknown,a decision must be madeto either discontinue breast-feeding ordiscontinue ТЕЦЕНТРИКtherapy.