Imfinzi

/ Astra Zeneca

The recommended dosages for Durvalumab as a single agent and in combination with other therapeutic agents are provided in the prescribing information.

* Urothelial Carcinoma
* Non-Small Cell Lung Cancer
* Small Cell Lung Cancer
* Biliary Tract Cancers
* Hepatocellular Carcinoma
See prescribing information for full details.

Hypersensitivity to the active substance or to any of the excipients

Immune-Mediated Adverse Reactions
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment with a PD-1/PDL1 blocking antibody. While immune-mediated adverse reactions usually manifest during treatment with PD-1/PDL1 blocking antibodies, immune-mediated adverse reactions can also manifest after discontinuation of PD-1/PD-L1 blocking antibodies. The incidence and severity of immune-mediated adverse reactions were similar when this medical product was administered as a single agent or in combination with chemotherapy or in combination with tremelimumab and platinum-based chemotherapy, unless otherwise noted.
Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of PD-1/PD-L1 blocking antibodies. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection.
Withhold or permanently discontinue this medial product depending on severity. In general, if this medical product requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.
Immune-Mediated Pneumonitis
Immune-mediated pneumonitis may occur, with a higher incidence observed in patients who have previously undergone thoracic radiation.
Immune-Mediated Colitis
Durvalumab can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.
Immune-Mediated Hepatitis
Immune-Mediated Endocrinopathies
Adrenal Insufficiency
Durvalumab can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold or permanently discontinue this medical product based on the severity.
Hypophysitis
Durvalumab can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated. Withhold or permanently discontinue this medical product depending on severity.
Thyroid Disorders
Durvalumab can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or discontinue this medical product based on the severity.
Type 1 Diabetes Mellitus which can present with diabetic ketoacidosis
Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold or permanently discontinue this medical product based on the severity.
Immune-Mediated Nephritis with Renal Dysfunction
Immune-Mediated Dermatologic Reactions
Durvalumab can cause immune-mediated rash or dermatitis. Exfoliative dermatitis including Stevens Johnson Syndrome (SJS) drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN) has occurred with PD-1/L-1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Withhold or permanently discontinue this medical product depending on severity.
Immune-Mediated Pancreatitis
Durvalumab in combination with tremelimumab can cause immune-mediated pancreatitis.
Infusion-Related Reactions
This medical product can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue this medical product based on the severity. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses.
Complications of Allogeneic HSCT after Durvalumab
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT.
Embryo-Fetal Toxicity
Based on its mechanism of action and data from animal studies, Durvalumab can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with Durvalumab and for at least 3 months after the last dose of Durvalumab.
See prescribing information for full details.

Due to the diverse conditions under which clinical trials are conducted, the rates of adverse reactions observed in the trials of one drug cannot be directly compared to those in the trials of another drug, and may not accurately represent the rates seen in real practice.
See prescribing information for full details.

There are no available data.
Please refer to the license holder for further details.

Pregnancy: There are no available data on the use of Durvalumab in pregnant women.
Lactation: There are no data on the presence of Durvalumab in human milk, its effects on the breastfed child, or the effects on milk production. Maternal IgG is known to be present in human milk. Because of the potential for adverse reactions in a breastfed child, advise women not to breastfeed during treatment with Durvalumab and for 3 months after the last dose.
Reproductive Potential:
* Verify pregnancy status of females of reproductive potential prior to initiating treatment.
* Females of reproductive potential are advised to use effective contraception during treatment with Durvalumab and for 3 months following the last dose.
See prescribing information for full details.

There is no information on overdose with this medical product.