Tremelimumab AstraZeneca

Treatment with Tremelimumab AstraZeneca must be initiated and supervised by a physician experienced in the treatment of cancer. Posology The recommended dose of Tremelimumab AstraZeneca is presented in Table 1.

Table 1:

Recommended dose of Tremelimumab AstraZeneca Indication Recommended Tremelimumab AstraZeneca dose Duration of therapy Metastatic NSCLC During platinum chemotherapy: 75 mga in combination with durvalumab 1 500 mgb and Up to a maximum of 5 doses.

Patients may receive less than five doses of Tremelimumab AstraZeneca in combination Medicinal product no longer authorised 3 Indication Recommended Tremelimumab AstraZeneca dose Duration of therapy platinum-based chemotherapyc every 3 weeks (21 days) for 4 cycles (12 weeks).

Post-platinum chemotherapy:

Durvalumab 1 500 mgc every 4 weeks and histology-based pemetrexed maintenance c,d therapy every 4 weeks. A fifth dose of Tremelimumab AstraZeneca 75 mge,f should be given at week 16 alongside durvalumab dose 6. with durvalumab 1 500 mg and platinum-based chemotherapy if there is disease progression or unacceptable toxicity.

a For Tremelimumab AstraZeneca, metastatic NSCLC patients with a body weight of 34 kg or less must receive weight-based dosing, equivalent to 1 mg/kg of Tremelimumab AstraZeneca until the weight improves to greater than 34 kg. For durvalumab, patients with a body weight of 30 kg or less must receive weight-based dosing, equivalent to durvalumab 20 mg/kg until the weight improves to greater than 30 kg.

b When Tremelimumab AstraZeneca is administered in combination with durvalumab and platinum-based chemotherapy, refer to the summary of product characteristics (SmPC) for durvalumab for dosing information. c When Tremelimumab AstraZeneca is administered in combination with durvalumab and platinum-based chemotherapy, refer to the SmPC for nab-paclitaxel, gemcitabine, pemetrexed and carboplatin or cisplatin for dosing information.

d Consider maintenance administration of pemetrexed for patients with non-squamous tumours who received treatment with pemetrexed and carboplatin/cisplatin during the platinum-based chemotherapy stage. e In the case of dose delay(s), a fifth dose of Tremelimumab AstraZeneca can be given after Week 16, alongside durvalumab.

03. ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal; BLV: baseline value. b Upon improvement to ≤ Grade 1, corticosteroid taper should be initiated and continued over at least 1 month. Consider increasing dose of corticosteroids and/or using additional systemic immunosuppressants if there is worsening or no improvement.

c After withholding, Tremelimumab AstraZeneca and/or durvalumab can be resumed within 12 weeks if the adverse reactions improved to ≤ Grade 1 and the corticosteroid dose has been reduced to ≤ 10 mg prednisone or equivalent per day.

Tremelimumab AstraZeneca and durvalumab should be permanently discontinued for recurrent Grade 3 adverse reactions, as applicable. d For patients with alternative cause follow the recommendations for AST or ALT increases without concurrent bilirubin elevations.

e If no improvement within 2 to 3 days despite corticosteroids, promptly start additional immunosuppressive therapy. Upon resolution (< Grade 1), corticosteroid taper should be initiated and continued over at least 1 month. f Permanently discontinue Tremelimumab AstraZeneca and durvalumab if the adverse reaction does not resolve to ≤ Grade 1 within 30 days or if there are signs of respiratory insufficiency.

g Includes immune thrombocytopenia and pancreatitis. h With the exception of Grade 4 laboratory abnormalities, about which the decision to discontinue should be based on accompanying clinical signs/symptoms and clinical judgment. For suspected immune-mediated adverse reactions, adequate evaluation should be performed to confirm aetiology or exclude alternate aetiologies.

Special populations Paediatric population The safety and efficacy of Tremelimumab AstraZeneca in children and adolescents aged below 18 years of age have not been established. No data are available. 2). Data on patients aged 75 years of age or older are limited.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 8). Patients should be monitored for signs and symptoms of pneumonitis.

2. 8). Patients should be monitored for abnormal liver tests prior to and periodically during treatment with tremelimumab in combination with durvalumab and chemotherapy, and as indicated based on clinical evaluation. 2. 8). Intestinal perforation and large intestine perforation were reported in patients receiving tremelimumab in combination with durvalumab.

2. 8). Patients should be monitored for abnormal thyroid function tests prior to and periodically during treatment and as indicated based on clinical evaluation. 2. 8). Patients should be monitored for clinical signs and symptoms of adrenal insufficiency.

2. 8). Patients should be monitored for clinical signs and symptoms of type 1 diabetes mellitus. 2. 8). Patients should be monitored for clinical signs and symptoms of hypophysitis or hypopituitarism. 2. 8). 2. 8). Events of Stevens-Johnson Syndrome or toxic epidermal necrolysis have been reported in patients treated with PD-1 inhibitors.

2. 8). 2. 8). 2. Other immune-mediated adverse reactions Given the mechanism of action of tremelimumab in combination with durvalumab, other potential immune-mediated adverse reactions may occur. The following immune-related adverse reactions have been observed in patients treated with tremelimumab in combination with durvalumab: myasthenia gravis, myositis, polymyositis, meningitis, encephalitis, Guillain-Barré syndrome, immune thrombocytopenia and cystitis noninfective.

2. Infusion-related reactions Patients should be monitored for signs and symptoms of infusion-related reactions. Severe infusion- related reactions have been reported in patients receiving […]

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