What is Imfinzi, and how does it work?
What are the side effects of Imfinzi?
What is the dosage for Imfinzi?
What drugs interact with Imfinzi?
Is Imfinzi safe to use while pregnant or breastfeeding?

What is Imfinzi, and how does it work?

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).

What are the side effects of Imfinzi?

Common side effects of Imfinzi include:

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.

What is the dosage for Imfinzi?

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

Indication	Recommended Imfinzi dosage	Duration of Therapy
Urothelial Carcinoma	10 mg/kg every 2 weeks	Until disease progression or unacceptable toxicity
Unresectable stage III NSCLC	10 mg/kg every 2 weeks	Until disease progression, unacceptable toxicity, or a maximum of 12 months
ES-SCLC	1500 mg¹ in combination with chemotherapy² every 3 weeks (21 days) for 4 cycles, followed by 1500 mg every 4 weeks as a single agent	Until disease progression or unacceptable toxicity
¹ Patients with a body weight of 30 kg or less must receive weight-based dosing, equivalent to Imfinzi 20 mg/kg in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 20 mg/kg every 4 weeks as a single agent until weight increases to greater than 30 kg. ² Administer Imfinzi prior to chemotherapy on the same day. When Imfinzi is administered in combination with chemotherapy, refer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosing information.

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

Adverse Reaction	Severity¹	Dosage Modification
Pneumonitis	Grade 2	Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).
Pneumonitis	Grade 3 or 4	Permanently discontinue
Hepatitis	For ALT or AST greater than 3 but less than or equal to 8 times the ULN or Total bilirubin greater than 1.5 but less than or equal to 5 times the ULN	Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).
Hepatitis	ALT or AST greater than 8 times the ULN or total bilirubin greater than 5 times the ULN or Concurrent ALT or AST greater than 3 times the ULN and total bilirubin greater than 2 times the ULN with no other cause	Permanently discontinue
Colitis or diarrhea	Grade 2	Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).
Colitis or diarrhea	Grade 3 or 4	Permanently discontinue
Hyperthyroidism or thyroiditis	Grade 2-4	Withhold dose until clinically stable
Adrenal insufficiency or Hypophysitis/Hypopituitarism	Grade 2-4	Withhold dose until clinically stable
Type 1 Diabetes Mellitus	Grade 2-4	Withhold dose until clinically stable
Nephritis	For Creatinine greater than 1.5 to 3 times the ULN	Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).
Nephritis	For Creatinine greater than 3 times the ULN	Permanently discontinue
Rash or dermatitis	Grade 2 for longer than 1 week or Grade 3	Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).
Rash or dermatitis	Grade 4	Permanently discontinue
Infection	Grade 3 or 4	Withhold dose until clinically stable
Infusion-related reactions	Grade 1 or 2	Interrupt or slow the rate of infusion
Infusion-related reactions	Grade 3 or 4	Permanently discontinue
Other immune-mediated adverse reactions	Grade 3	Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).
Other immune-mediated adverse reactions	Grade 4	Permanently discontinue
Persistent Grade 2 or 3 adverse reaction (excluding endocrinopathies)	Grade 2 or 3 adverse reaction that does not recover to Grade 0 or 1 within 12 weeks after last Imfinzi dose	Permanently discontinue
Inability to taper corticosteroid	Inability to reduce to less than or equal to prednisone 10 mg per day (or equivalent) within 12 weeks after the last Imfinzi dose	Permanently discontinue
Recurrent Grade 3 or 4 adverse reaction	Recurrent Grade 3 or 4 (severe or life-threatening) adverse reaction	Permanently discontinue
¹ National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal.

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What drugs interact with Imfinzi?

No Information Provided

Is Imfinzi safe to use while pregnant or breastfeeding?

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.

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Summary

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 (bladder cancer) 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).