Σημαντικές Πληροφορίες Ασφαλείας

Indications

Urothelial carcinoma

TECENTRIQ® is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma after prior chemotherapy or who are considered cisplatin ineligible.

Non-small cell lung cancer

TECENTRIQ® is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy.

Common Adverse Reactions

The safety of TECENTRIQ® is based on pooled data in 2,160 patients with metastatic urothelial carcinoma and NSCLC, with supporting data from the cumulative exposure in 6,000 patients across all clinical trials in multiple tumour types. The most common adverse reactions were fatigue (35.4%), decreased appetite (25.5%), nausea (22.9%), dyspnoea (21.8%), diarrhoea (18.6%), pyrexia (18.3%), rash (18.6%), vomiting (15.0%), arthralgia (14.2%), asthenia (13.8%) and pruritus (11.3%).

Immune-related adverse events

Immune-Related Pneumonitis

Pneumonitis occurred in 3.1% (68/2,160) of patients who received TECENTRIQ® for metastatic urothelial carcinoma and NSCLC. Of the 68 patients, one experienced a fatal event. Patients should be monitored for signs and symptoms of pneumonitis.

Immune-Related Hepatitis

Hepatitis occurred in 0.3% (7/2,160) of patients who received TECENTRIQ® for metastatic urothelial carcinoma and NSCLC. Patients should be monitored for signs and symptoms of hepatitis.

Immune-Related Colitis

Colitis occurred in 1.1% (23/2,160) of patients who received TECENTRIQ® for metastatic urothelial carcinoma and NSCLC. Patients should be monitored for signs and symptoms of colitis.

Immune-Related Endocrinopathies

Hypothyroidism occurred in 4.7% (101/2,160) of patients, hyperthyroidism occurred in 1.7% (36/2,160) of patients, adrenal insufficiency occurred in 0.3% (7/2,160) of patients, hypophysitis occurred in < 0.1% (1/2,160) of patients and diabetes mellitus occurred in 0.3% (6/2,160) of patients who received TECENTRIQ ® for metastatic urothelial carcinoma and NSCLC.

Immune-Related Meningoencephalitis

Meningitis occurred in 0.1% (3/2,160) of patients who received TECENTRIQ® for metastatic urothelial carcinoma and NSCLC. Patients should be monitored for clinical signs and symptoms of meningitis or encephalitis.

Immune-Related Neuropathies

Guillain-Barré syndrome and demyelinating polyneuropathy occurred in 0.2% (5/2,160) of patients who received TECENTRIQ® for metastatic urothelial carcinoma and NSCLC. Myasthenic syndrome Myasthenia gravis occurred in <0.1% (4/6,000) of patients across all TECENTRIQ® clinical trials. Patients should be monitored for symptoms of motor and sensory neuropathy.

Immune-Related Pancreatitis

Pancreatitis, including amylase increased and lipase increased, occurred in 0.5% (10/2,160) of patients who received TECENTRIQ® for metastatic urothelial carcinoma and NSCLC. Patients should be closely monitored for signs and symptoms that are suggestive of acute pancreatitis.

Immune-Related Reactions

Infusion related reactions (IRRs) have been observed in clinical trials with TECENTRIQ® .

Special warnings and precautions for use

Most immune-related adverse reactions occurring during treatment with TECENTRIQ® were reversible and managed with interruptions of TECENTRIQ® and initiation of corticosteroids and/or supportive care. Immune-related adverse reactions affecting more than one body system were observed.

For suspected immune-related adverse reactions, thorough evaluation to confirm aetiology or exclude other causes should be performed. Based on the severity of the adverse reaction, TECENTRIQ® should be withheld and corticosteroids administered. Upon improvement to Grade ≤ 1, corticosteroid should be tapered over ≥ 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with systemic corticosteroid use, administration of other systemic immunosuppressants may be considered.

TECENTRIQ® must be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for any Grade 4 immune-related adverse reactions, except for endocrinopathies that are controlled with replacement hormones.

For more information, please refer to TECENTRIQ® Summary of Product Characteristics at www.medicines.org.uk/emc [To be completed at the local level for each country]

PR/ATEZ/1704/0013a (replace with local ZINC number)