Who is IMFINZI for?
IMFINZI® (durvalumab) is FDA approved for 3 types of cancer.1
- For US healthcare professionals
- For patients & caregivers »
- Important Safety Information
- Prescribing Information
- Medical Resources
Who is IMFINZI for?
IMFINZI® (durvalumab) is FDA approved for 3 types of cancer.1
For adult patients with non-small cell lung cancer (NSCLC) when1:
The cancer has not spread outside the chest
AND
The cancer cannot be removed by surgery
AND
The cancer has not progressed after concurrent platinum-based chemotherapy and radiation therapy
For adult patients with extensive-stage small cell lung cancer (ES-SCLC) when1:
The patient has not been previously treated
AND
The cancer has spread within the lungs (or to other parts of the body)
For adult patients with urothelial carcinoma (UC) when1:
The patient has been previously treated with chemotherapy containing platinum which did not work or is no longer working
AND
The cancer has spread or cannot be removed by surgery
Understanding these indications may help you answer patients’ questions about their cancer and why IMFINZI is part of their treatment plan.
IMFINZI blocks the interaction of PD-L1 with PD-1 and CD801
PD-L1=programmed death-ligand 1; PD-1=programmed cell death protein 1; CD80=cluster of differentiation 80.
Recommended dosage1
IMFINZI is administered as an IV infusion with no premedication required1
For UC or Unresectable Stage III NSCLC: Weight-based dose (10 mg/kg)
IMFINZI
until disease progression or
unacceptable toxicity (NSCLC:
Maximum of 26 doses [12 months])
IMFINZI may be administered until disease progression, unacceptable toxicity, or up to 26 doses (12 months)*†
For ES-SCLC: Fixed 1500-mg dose‡
IMFINZI
1500-mg fixed dose
PLATINUM-BASED
CHEMOTHERAPY
ETOPOSIDE
IMFINZI
1500-mg fixed dose
until disease progression or
unacceptable toxicity
IV=intravenous; Q2W=once every 2 weeks; Q3W=once every 3 weeks; Q4W=once every 4 weeks; EP=etoposide and either carboplatin or cisplatin; AUC=area under the curve.
*Based on Q2W dosing for 52 weeks.2
†Refer to Prescribing Information for information on dosage modifications.
‡For ES-SCLC, patients with a body weight of ≤30 kg 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 body weight increases to >30 kg.1
Dosage forms and strengths1
Available in 120 mg/2.4 mL (50 mg/mL) and 500 mg/10 mL (50 mg/mL) single-dose vials. Clear to opalescent, colorless to slightly yellow solution
Preparation1
Visually inspect drug product for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the vial if the solution is cloudy, discolored, or visible particles are observed
Do not shake the vial
Withdraw the required volume from the vial(s) of IMFINZI and transfer into an IV bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Mix diluted solution by gentle inversion. Do not shake the solution. The final concentration of the diluted solution should be between 1 mg/mL and 15 mg/mL
Discard partially used or empty vials of IMFINZI
Storage of infusion solution1
IMFINZI does not contain a preservative. Administer infusion solution immediately once prepared. If infusion solution is not administered immediately and needs to be stored, the total time from vial puncture to the start of the administration should not exceed:
24 hours in a refrigerator at 2°C to 8°C (36°F to 46°F)
8 hours at room temperature up to 25°C (77°F)
Do not freeze
Do not shake
Administration1
Administer infusion solution intravenously over 60 minutes through an IV line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter
Do not coadminister other drugs through the same infusion line
For indication specific dosing information, please select one of the following
Help your patients prepare for treatment by telling them:
Why IMFINZI is part of their treatment plan
How immunotherapy works
When, where, and how often they will receive IMFINZI infusions
Helpful downloads when preparing for treatment
For you:
For your patients:
Immune-mediated adverse reactions (imARs) can be different than what is expected with chemotherapy. It's important to understand the safety profile of IMFINZI and encourage your patients to track any signs and symptoms they may experience.
Educate your patients
Make sure your patients:
Monitor their health
Create an action plan
Intervene when necessary
Download the imAR Navigator App now
CBC=complete blood count; OTC=over-the-counter.
If your patient is experiencing imARs greater than Grade 1, you may need to withhold or discontinue treatment with IMFINZI. Refer to the table below for guidance.
Dosage reduction of IMFINZI is not recommended1
WITHHOLD IMFINZI*Specific immune-mediated adverse reactions
Pneumonitis†: Grade 2
Colitis†: Grade 2 or 3
Hepatitis with no tumor involvement of the liver†:
ALT or AST >3 and up to 8 × ULN
or
Total bilirubin >1.5 and up to 3 × ULN
Hepatitis with tumor involvement of the liver†‡:
ALT or AST at baseline >1 and up to 3 × ULN and increases to >5 and up to 10 × ULN
or
ALT or AST at baseline >3 and up to 5 × ULN and increases to >8 and up to 10 × ULN
Endocrinopathies:Grade 3 or 4, withhold until stable
Nephritis with renal dysfunction†: Grade 2 or 3 increased blood creatinine
Exfoliative dermatologic conditions†: Suspected SJS, TEN, or DRESS
Myocarditis: N/A
Neurological toxicities†: Grade 2
General guidance
Other adverse reactions
Infusion-related reactions: Grade 1 or 2, interrupt or slow rate of infusion
After complete or partial resolution (Grade 0 or 1) and corticosteroid taper
PERMANENTLY DISCONTINUE IMFINZI*Specific immune-mediated adverse reactions
Pneumonitis: Grade 3 or 4
Colitis: Grade 4
Hepatitis with no tumor involvement of the liver:
ALT or AST >8 × ULN
or
Total bilirubin >3 × ULN
Hepatitis with tumor involvement of the liver‡:
ALT or AST >10 × ULN
or
Total bilirubin >3 × ULN
Endocrinopathies: Grade 3 or 4, permanently discontinue
depending on severity
Nephritis with renal dysfunction: Grade 4 increased blood creatinine
Exfoliative dermatologic conditions: Confirmed SJS, TEN, or DRESS
Myocarditis: Grade 2, 3, or 4
Neurological toxicities: Grade 3 or 4
General guidance
Other adverse reactions
Infusion-related reactions: Grade 3 or 4
Prescribing Information has additional information for dosage modification and management specific to adverse reactions.
ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal; SJS=Stevens Johnson Syndrome; TEN=toxic epidermal necrolysis; DRESS=Drug Rash with Eosinophilia and Systemic Symptoms; N/A=not applicable.
*Based on National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
†Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
‡If AST and ALT are less than or equal to ULN at baseline in patients with liver involvement, withhold or permanently discontinue IMFINZI based on recommendations for hepatitis with no liver involvement.
Remind your patients1-3
Report any signs, symptoms, or changes from baseline
imARs may be different from side effects associated with chemotherapy
imARs may develop after the first dose, or long after a course of immunotherapy has ended
Helpful downloads for monitoring patients & managing imARs
For you:
For your patients:
Supporting and empowering patients to take ownership of their treatment with IMFINZI® (durvalumab)
Lighthouse empowers patients to take an active role in their treatment journey by facilitating relationships with Nurse Advocates who:
To learn more about how patients will experience the Lighthouse program, call 1-855-LHOUSE1 (1-855-546-8731).
Helping patients access the care they need
The AstraZeneca Access 360TM program provides personal support to connect patients to affordability programs and streamline access and reimbursement for IMFINZI. Access 360TM provides:
To learn more about the AstraZeneca Access 360TM program, please call 1-844-ASK-A360 (1-844-275-2360) Monday-Friday, 8 AM-8 PM ET, or visit www.MyAccess360.com.
Choose the most convenient method of enrollment
CALL Access 360 at 1-844-ASK-A360 (1-844-275-2360) Monday to Friday, 8 AM-8 PM EST
VISIT the provider portal at
Select a state to find an ONE near you:
IMFINZI Nurse Center Library
For you:
For your patients:
The imAR Navigator App
Download the app that puts IMFINZI imAR management information at your fingertips.
Available on iPhone, iPad, and Android devices.
There are no contraindications for IMFINZI® (durvalumab).
Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated 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 or after discontinuation. 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. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI depending on severity. See Dosing and Administration for specific details. In general, if IMFINZI 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.
IMFINZI can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2% (28/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions. In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 16.6% (79/475) in patients receiving IMFINZI and 13.2% (31/234) in patients receiving placebo. Of the 79 patients who received IMFINZI, 1.1% were fatal and 2.5% were Grade 3-4 adverse reactions. The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC when in combination with chemotherapy.
IMFINZI 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 colitis occurred in 1.6% (31/1889) of patients receiving IMFINZI, including Grade 4 (0.1%) and Grade 3 (0.3%) adverse reactions.
IMFINZI can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 1% (19/1889) of patients receiving IMFINZI, including fatal (<0.1%) and Grade 3 (0.6%) adverse reactions.
IMFINZI can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (5/1889) of patients receiving IMFINZI, including Grade 3 (0.1%) adverse reactions.
IMFINZI 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), have 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. Immune-mediated rash or dermatitis occurred in 1.6% (30/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.
The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI or were reported with the use of other PD-1/PD-L1 blocking antibodies.
IMFINZI 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 IMFINZI based on the severity. See Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions.
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.
Based on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMFINZI and for at least 3 months after the last dose of IMFINZI.
There is no information regarding the presence of IMFINZI in human milk; however, because of the potential for adverse reactions in breastfed infants from IMFINZI, advise women not to breastfeed during treatment and for at least 3 months after the last dose.
The safety and effectiveness of IMFINZI have not been established in pediatric patients.
Please see complete Prescribing Information, including Medication Guide.
You may report side effects related to AstraZeneca products by clicking here.
There are no contraindications for IMFINZI® (durvalumab).