IMFINZI Nurse Center

Education and resources for oncology nurses designed to help you support IMFINZI patients

Monitoring patients & managing their imARs

Nurse Discussion Series

Listen to leading oncology nurses discuss how they help manage different imARs in patients being treated with IMFINZI

...the importance of early symptom recognition... where there could be early intervention.

—Blanca Ledezma, MSN, NP-C, OCN*

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 about IMFINZI Educate your patients

Make sure your patients:

  • Understand imAR symptoms and what to look for
  • Immediately report anything of concern to you and/or their oncologist
  • Go directly to their oncologist’s office for evaluation/treatment

Monitor your patient’s health while taking IMFINZI Monitor their health

  • Regularly perform blood tests (CBC, renal, hepatic, pancreatic, thyroid)
  • Schedule patients for regular visits for blood tests and monitoring of symptoms
  • Encourage patients to use their symptom tracker

Create an action plan Create an action plan

  • Follow a clear management algorithm for all grades of toxicities
  • Understand when a specialist should be contacted to help manage imARs

Intervene when necessary Intervene when necessary

  • Take immediate action, even for Grade 1 toxicities
    • Hold dosing until symptoms resolve
    • Start with OTC medications; initiate steroids early if needed
  • Refer to the imAR Management Handbook for more information

imARs=immune-mediated adverse reactions; CBC=complete blood count; OTC=over-the-counter.

The imAR Navigator App

IMFINZI imAR Navigator App

Download the app that puts IMFINZI imAR management information at your fingertips.

Available on iPhone, iPad, and Android devices.

Apple app store logoGoogle Play logo

Nurse Discussion Series

Listen to Blanca Ledezma, MSN, NP-C, OCN discuss a patient with pneumonitis

... she didn’t feel sick. And so I told her, hey, come in...let’s just image you sooner…

... she didn’t feel sick. And so I told her, hey, come in...let’s just image you sooner…

—Blanca Ledezma, MSN, NP-C, OCN*

Dosage modifications

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

IMFINZI dosage modifications IMFINZI dosage modifications

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 and 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 or 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.

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COUNSELING TIPS

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

Resources for oncology nurses and your patients

For patient counseling materials, see the IMFINZI Nurse Center Library below.

Nurse Discussion Series

Listen to leading oncology nurses discuss some of the resources they use when communicating with other nurses and with their patients

I think that IMFINZI has a lot of great educational resources for the nurses, too, who are administering IMFINZI.

—Kimberly Rohan, APN-BC, AOCN*

IMFINZI Nurse Center Library

For nurses and for patients and caregivers

For nurses and for patients and caregivers

For nurses and for patients and caregivers

For nurses and for patients and caregivers

Provides additional information on administration and storage of IMFINZI, and treatment modifications for both Stage III unresectable NSCLC and ES-SCLC

Track and monitor the grade, duration, and symptoms associated with imARs that patients may experience

To help you identify and manage imARs that patients may experience

An educational reference tool for you to review dosing, administration, modification, and AR management in both indications

Ensure patients have this card to alert a doctor who is not part of their regular care team that they are receiving an immunotherapy

Help your patients and their caregivers understand unresectable Stage III NSCLC, how IMFINZI works, and what they can expect during treatment

Help your patients and their caregivers understand ES-SCLC, how IMFINZI works, and what they can expect during treatment

To help caregivers understand the medical and emotional support they can provide for their loved one diagnosed with ES-SCLC, as well as how they can care for themselves

Assist patients in staying organized with a printable journal designed to support them during their treatment journey

DownloadPlease choose a resource to download.

The imAR Navigator App

IMFINZI imAR Navigator App

Download the app that puts IMFINZI imAR management information at your fingertips.

Available on iPhone, iPad, and Android devices.

Apple app store logoGoogle Play logo

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:

  • Assistance with understanding patient insurance coverage and pharmacy options
  • Prior authorization support
  • Claims and appeal process support
 

Choose the most convenient method to learn more and enroll

CALL Access 360TM at 1-844-ASK-A360 (1-844-275-2360) Monday to Friday, 8 AM-8 PM ET

LEARN MORE at

www.MyAccess360.com

VISIT the portal to enroll at

ProviderPortal.MyAccess360.com

 

Nurse Educators can:

  • Deliver disease-state education to you and other healthcare staff at your facility
  • Provide education on the early recognition and management of adverse reactions associated with AstraZeneca therapies
  • Deliver educational tools and resources designed for you, your patients, and their caregivers
 

Select a state to find a Nurse Educator near you:

 

The imAR Navigator App

IMFINZI imAR Navigator App

Download the app that puts IMFINZI imAR management information at your fingertips.

Available on iPhone, iPad, and Android devices.

Apple app store logoGoogle Play logo

Preparing for treatment with IMFINZI

Nurse Discussion Series

Listen to leading oncology nurses discuss how they help patients prepare for treatment with IMFINZI

I try to be open... You know your patients who are super-scared or somebody who comes in who’s very knowledgeable… you have to feel the patient out...

—Sara Beeler, AOCNP*

Preparing for treatment with IMFINZI

For indication-specific dosing information, please select one of the following:

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COUNSELING TIPS

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

NSCLC=non-small cell lung cancer; ES-SCLC=extensive-stage small cell lung cancer.

*The views and opinions expressed in this video series are those of the individual panel members and do not represent the views or opinions of AstraZeneca. These videos contain anecdotal information gathered from a discussion with 3 nurses based on their opinions/experiences. Recommendations are general and may vary with patients.

Important Safety Information

There are no contraindications for IMFINZI® (durvalumab).

Immune-Mediated Adverse Reactions

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.

Indications

IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Immune-Mediated Pneumonitis

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 2.4% (34/1414), 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 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 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.

Immune-Mediated Colitis

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 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions.

Immune-Mediated Hepatitis

IMFINZI can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions.

Immune-Mediated Endocrinopathies

  • Adrenal Insufficiency: IMFINZI can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
  • Hypophysitis: IMFINZI can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated. Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI.
  • Thyroid Disorders: IMFINZI can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated.
  • Thyroiditis: Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
  • Hyperthyroidism: Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI.
  • Hypothyroidism: Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
  • Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Grade 3 immune-mediated type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI.

Immune-Mediated Nephritis with Renal Dysfunction

IMFINZI can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.

Immune-Mediated Dermatology 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 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.

Other Immune-Mediated 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.

  • Cardiac/vascular: Myocarditis, pericarditis, vasculitis.
  • Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy.
  • Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.
  • Gastrointestinal: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis.
  • Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic.
  • Endocrine: Hypoparathyroidism
  • Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection.

Infusion-Related Reactions

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.

Complications of Allogeneic HSCT after IMFINZI

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.

Embryo-Fetal Toxicity

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.

Lactation

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.

Adverse Reactions

  • In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (≥20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonitis/radiation pneumonitis (3.4%) and pneumonia (7%)
  • In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms
  • In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (≥20%) were nausea (34%), fatigue/asthenia (32%), and alopecia (31%). The most common Grade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%)
  • In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%), and COPD (1.1%). Fatal adverse reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy

The safety and effectiveness of IMFINZI have not been established in pediatric patients.

Indications

IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Please see complete Prescribing Information, including Medication Guide.

You may report side effects related to AstraZeneca products by clicking here.

Important Safety Information +

There are no contraindications for IMFINZI® (durvalumab).

Important Safety Information

There are no contraindications for IMFINZI® (durvalumab).

Immune-Mediated Adverse Reactions

Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible

Indication+

IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.