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:

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

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

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

IndicationRecommended Imfinzi dosageDuration of Therapy
Urothelial Carcinoma10 mg/kg every 2 weeksUntil disease progression or unacceptable toxicity
Unresectable stage III NSCLC10 mg/kg every 2 weeksUntil disease progression, unacceptable toxicity, or a maximum of 12 months
ES-SCLC1500 mg1 in combination with chemotherapy2 every 3 weeks (21 days) for 4 cycles, followed by 1500 mg every 4 weeks as a single agentUntil 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 ReactionSeverity1Dosage Modification
PneumonitisGrade 2Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).
Grade 3 or 4Permanently 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).
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 diarrheaGrade 2Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).
Grade 3 or 4Permanently discontinue
Hyperthyroidism or thyroiditisGrade 2-4Withhold dose until clinically stable
Adrenal insufficiency or Hypophysitis/Hypopituitarism Grade 2-4Withhold dose until clinically stable
Type 1 Diabetes Mellitus Grade 2-4Withhold dose until clinically stable
NephritisFor Creatinine greater than 1.5 to 3 times the ULNWithhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).
For Creatinine greater than 3 times the ULNPermanently discontinue
Rash or dermatitis Grade 2 for longer than 1 week or Grade 3Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).
Grade 4Permanently discontinue
Infection Grade 3 or 4Withhold dose until clinically stable
Infusion-related reactions Grade 1 or 2Interrupt or slow the rate of infusion
Grade 3 or 4Permanently discontinue
Other immune-mediated adverse reactionsGrade 3Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).
Grade 4Permanently 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 dosePermanently discontinue
Inability to taper corticosteroidInability to reduce to less than or equal to prednisone 10 mg per day (or equivalent) within 12 weeks after the last Imfinzi dosePermanently discontinue
Recurrent Grade 3 or 4 adverse reactionRecurrent Grade 3 or 4 (severe or life-threatening) adverse reactionPermanently 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.

QUESTION

Lung cancer is a disease in which lung cells grow abnormally in an uncontrolled way. See Answer

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.

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).

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Medically Reviewed on 12/3/2020
References
All sections courtesy of the U.S. Food and Drug Administration