Risk of Severe Cutaneous Adverse Reactions (SCARs) with atezolizumab
Risk of Severe Cutaneous Adverse Reactions (SCARs) with atezolizumab
Risk of Severe Cutaneous Adverse Reactions (SCARs) with atezolizumab
25 MArch 2021: European Medicines Agency (EMA) has published Direct healthcare professional communication (DHPC) contains important information for healthcare professionals prescribing, dispensing or administering the medicine(s).
DHPC also includes a communication plan with details of intended recipients and the dissemination date.
The DHPC is regarding “Risk of Severe Cutaneous Adverse Reactions (SCARs) with atezolizumab”.
Key facts of DHPC
| Medicine name | Tecentriq |
| Active substance | atezolizumab |
| Therapeutic area (MeSH) | Carcinoma, Transitional Cell
Carcinoma, Non-Small-Cell Lung Urologic Neoplasms Breast Neoplasms Small Cell Lung Carcinoma |
| DHPC type | Adverse event |
| Date Dissemination | 25 March 2021 |
Tecentriq is a medicine that contains the active substance atezolizumab.
Tecentriq as monotherapy is indicated for the treatment of
- adult patients with locally advanced or metastatic urothelial carcinoma (UC):
- after prior platinum-containing chemotherapy, or
- who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5%
Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR mutant or ALK-positive NSCLC should also have received targeted therapies before receiving Tecentriq.
Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.
Summary of DHPC: Risk of Severe Cutaneous Adverse Reactions (SCARs) with atezolizumab
Healthcare professionals are reminded of the following in order to minimize the Risk of Severe Cutaneous Adverse Reactions (SCARs) with atezolizumab. Health care professionals should report any adverse events suspected to be associated with the use of TECENTRIQ (atezolizumab) to respective health authorities.
- Severe cutaneous adverse reactions (SCARs), including cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in patients treated with Tecentriq (atezolizumab).
- Patients should be monitored for suspected severe skin reactions and other causes should be excluded. In case a SCAR is suspected, Tecentriq should be withheld and patients should be referred to a specialist in SCARs for diagnosis and treatment.
- In case SJS or TEN is confirmed, and for any grade 4 rash/SCAR, treatment with Tecentriq should be permanently discontinued.
- Caution is recommended when considering the use of Tecentriq in patients with previous history of a severe or life-threatening SCAR with other immune-stimulatory cancer medicines.
DHPC Communication Plan: Risk of Severe Cutaneous Adverse Reactions (SCARs) with atezolizumab
| Medicinal product(s)/active substance(s) | TECENTRIQ (atezolizumab) |
| Safety concern and purpose of the communication | To inform healthcare professionals that severe cutaneous adverse reactions (SCARs) are now considered to be an identified risk of Tecentriq (atezolizumab). |
| DHPC recipients | Prescribing physicians for example oncologists, nurses/pharmacists as per country specific distribution channels, wholesalers, hospitals, and oncology clinics, according to local regulations. |
| Member States where the DHPC will be distributed | All EEA member states where Tecentriq is approved. |
Source from EMA site
To know more information,
Risk of Severe Cutaneous Adverse Reactions (SCARs) with atezolizumab click here.
Top Related Articles:
- Safety signal (Risk of acute adrenal insufficiency) Hydrocortisone
- Drug Safety Alerts UK MHRA November-2020
- FDA alerts potential risks associated with the compounding of Remdesivir drug products.
- Potential-risk-of-encephalopathy-using-ceftriaxone-containing-products-health-canada
- Monitor the liver function of patients treated with Lojuxta (lomitapide) and to avoid use in pregnancy.
- Risk of serious liver failure with Ulipristal
Disclaimer: This is only for information purposes.
