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:
- 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.
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). |
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). |
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). |
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). |
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). |
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 |
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). |
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. |

SLIDESHOW
Lung Cancer: Early Signs, Symptoms, Stages See SlideshowIs 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).
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