Imfinzi (durvalumab)

Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with

• locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy; or
• who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

It is also used to treat non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).

Common side effects of Imfinzi include:

• fatigue,
• musculoskeletal pain,
• constipation,
• decreased appetite,
• nausea,
• swelling of extremities,
• urinary tract infection,
• abdominal pain,
• diarrhea/colitis,
• fever,
• shortness of breath,
• cough, and
• rash.

The most common side effects of Imfinzi in people with urothelial carcinoma include:

• feeling tired
• nausea
• muscle or bone pain
• swelling of your arms and legs
• constipation
• urinary tract infection
• decreased appetite

The most common side effects of Imfinzi in people with NSCLC include:

• cough
• upper respiratory tract infections
• feeling tired
• shortness of breath
• inflammation in the lungs (pneumonitis)
• rash

The most common side effects of Imfinzi when used with other anticancer medicines in people with ES-SCLC include:

• nausea
• hair loss
• feeling tired or weak

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Imfinzi. Ask your healthcare provider or pharmacist for more information.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Recommended Dosage

The recommended dosages for Imfinzi as a single agent and Imfinzi in combination with chemotherapy are presented in Table 1.

Imfinzi is administered as an intravenous infusion over 60 minutes.

Table 1. Recommended Dosages of Imfinzi

Dosage Modifications For Adverse Reactions

No dose reductions are recommended. Withhold or discontinue Imfinzi to manage adverse reactions as described in Table 2.

Table 2. Recommended Dosage Modifications for Adverse Reactions

No Information Provided

• Based on its mechanism of action and data from animal studies, Imfinzi can cause fetal harm when administered to a pregnant woman. There are no data on the use of Imfinzi in pregnant women.
• There is no information regarding the presence of durvalumab in human milk, the effects on the breastfed infant, or the effects on milk production.
• Human IgG1 is excreted in human milk. Durvalumab was present in the milk of lactating cynomolgus monkeys and was associated with premature neonatal death.
• Because of the potential for adverse reactions in breastfed infants, advise women not to breastfeed during treatment with Imfinzi and for at least 3 months after the last dose.