Imjudo Dosage/Direction for Use

Treatment must be initiated and supervised by a physician experienced in the treatment of cancer.
Posology: The recommended dose of Tremelimumab (IMJUDO) is presented in Table 3. Tremelimumab (IMJUDO) is administered as an intravenous infusion over 1 hour. (See Table 3.)

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Dose escalation or reduction is not recommended during treatment with Tremelimumab (IMJUDO) in combination with durvalumab. Treatment withholding or discontinuation may be required based on individual safety and tolerability.
Guidelines for management of immune-mediated adverse reactions are described in Table 4 (see Precautions). Refer also to the SmPC for durvalumab. (See Table 4.)

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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 (IMJUDO) in children and adolescents below 18 years of age have not been established. No data are available.
Elderly: No dose adjustment is required for elderly patients (≥65 years of age) (see Pharmacology: Pharmacokinetics under Actions). Data on patients aged 75 years or older with metastatic NSCLC are limited (see Precautions).
Renal impairment: No dose adjustment of Tremelimumab (IMJUDO) is recommended in patients with mild or moderate renal impairment. Data from patients with severe renal impairment are too limited to draw conclusions on this population (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment of Tremelimumab (IMJUDO) is recommended for patients with mild or moderate hepatic impairment. Tremelimumab (IMJUDO) has not been studied in patients with severe hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Method of administration: Tremelimumab (IMJUDO) is for intravenous use, it is administered as an intravenous infusion after dilution, over 1 hour (see Special precautions for disposal and other handling under Cautions for Usage).
For instructions on dilution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.
Tremelimumab (IMJUDO) in combination with durvalumab: When Tremelimumab (IMJUDO) is given in combination with durvalumab, administer Tremelimumab (IMJUDO) as a separate intravenous infusion prior to durvalumab on the same day. Refer to the SmPC for durvalumab administration information.
Tremelimumab (IMJUDO) in combination with durvalumab and platinum-based chemotherapy: When Tremelimumab (IMJUDO) is given in combination with durvalumab and platinum-based chemotherapy, Tremelimumab (IMJUDO) is given first, followed by durvalumab and then platinum-based chemotherapy on the day of dosing.
When Tremelimumab (IMJUDO) is given as a fifth dose in combination with durvalumab and pemetrexed maintenance therapy at week 16, Tremelimumab (IMJUDO) is given first, followed by durvalumab and then pemetrexed maintenance therapy on the day of dosing.
Tremelimumab (IMJUDO), durvalumab, and platinum-based chemotherapy are administered as separate intravenous infusions. Tremelimumab (IMJUDO) and durvalumab are each given over 1 hour. For platinum-based chemotherapy, refer to the SmPC for administration information. For pemetrexed maintenance therapy, refer to the SmPC for administration information. Separate infusion bags and filters for each infusion should be used.
During cycle 1, Tremelimumab (IMJUDO) is to be followed by durvalumab starting approximately 1 hour (maximum 2 hours) after the end of the Tremelimumab (IMJUDO) infusion. Platinum-based chemotherapy infusion should start approximately 1 hour (maximum 2 hours) after the end of the durvalumab infusion. If there are no clinically significant concerns during cycle 1, then at the physician's discretion, subsequent cycles of durvalumab can be given immediately after Tremelimumab (IMJUDO) and the time period between the end of the durvalumab infusion and the start of chemotherapy can be reduced to 30 minutes.