Ordering & Resources

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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:

  • Provide 24/7 personalized attention to your patients and their caregivers
  • Encourage your patients to keep you updated on their treatment experience so you can make better decisions for their care
  • Partner with your patients to help them better understand what they can expect during and after treatment with IMFINZI
  • Enable you and your practice to remain informed about your patients' treatment experience

The Pillars of Lighthouse

  • Building Relationships: When your patient enrolls in Lighthouse, he or she is matched with their own Nurse Advocate. At its core, Lighthouse is all about creating a supportive relationship between a patient and their Advocate, so it’s important for the two of them to be in contact on a regular basis. Patients can contact their Advocates for emotional support, help with setting goals and reminders, or to simply talk about how they are feeling.

  • Treatment Support: Advocates partner with your patients to get a firm understanding of their personal health and concerns. They support your patients by tracking any changes that may occur during treatment and after treatment ends, so that patients can focus more on the things they enjoy. If a patient mentions something that sounds like an imAE, the Advocate will take note, follow up, and if necessary, direct the patient to either you or the emergency room so that appropriate action can be taken. Detailed summary reports of your patients’ experiences are kept by the Advocate and can be provided to you at your patients’ request.

  • Empowering Patients: Patients don’t always know how or when to bring up concerns. The goal of Lighthouse is to ensure that they are coming to you and telling you what you need to know at the first sign of an issue. Advocates work alongside your patients during treatment and after treatment ends, encouraging them to speak up about their experience. The Advocates support patients with regular check-ins as often as the patient would like and additional resources, ultimately encouraging them to take an active role in their treatment journey.

Encourage your patients to receive support through Lighthouse

With the support of the Lighthouse Advocates and our patient resources, your patients will feel empowered to take ownership of their IMFINZI treatment experience.

Patient resources

Lighthouse support for your patients includes:

  • A Side Effects Monitoring Guide that educates patients on the types of immune-mediated adverse events (imAEs) they may experience while on IMFINZI
  • A Lighthouse Daily Tracker that encourages patients to log symptoms to better track and report any imAE symptoms
  • A Patient Wallet Card that contains oncologist contact information in case of emergencies
 

To better understand how Lighthouse can help support your patients, download the Lighthouse HCP Brochure

 

To learn more about how patients will experience the Lighthouse program,

visit www.LighthouseProgram.com or call 1-855-LHOUSE1 (1-855-546-8731).

 

Helping patients access the care they need

The AstraZeneca Access 360™ program provides personal support to connect patients to affordability programs and streamline access and reimbursement for IMFINZI. Access 360™ provides:

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

To learn more about the AstraZeneca Access 360™ program, please call 1-844-ASK-A360 (1-844-275-2360) Monday-Friday, 8 AM-8 PM ET, or visit www.MyAccess360.com.

How to enroll your patients in Access 360

To get your patients started, choose the most convenient method of enrollment:

Access360 logo Access360 logo

DOWNLOAD

the Enrollment Form

COMPLETE and FAX to

1-844-FAX-A360

(1-844-329-2360)

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

ProviderPortal.MyAccess360.com

NOTE:

For Access 360 to best support your patient, a Patient Authorization Form (PAF) is required. The PAF can be completed either by completing the Enrollment Form or online with the Electronic Patient Authorization Form (ePAF).

 

Oncology Access Services Enrollment Form

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Coding Resource

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Affordability Brochure (English)

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Affordability Brochure (Spanish)

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To learn more about the Access 360 program, please call 1-844-ASK-A360 (1-844-275-2360) Monday to Friday, 8 AM–8 PM EST or visit www.MyAccess360.com.

 

How to Order IMFINZI

IMFINZI is available through a controlled network of authorized distributors

IMFINZI Access and Reimbursement Guide

Download now

IMFINZI can be ordered from authorized specialty pharmacy providers (SPPs) who also provide support to help patients with their prescribed IMFINZI treatment

Specialty Pharmacy
Providers

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Oncology Nurse Educators

Oncology Nurse Educators offer live education and training

  • Provide onsite immuno-oncology education to patients and caregivers
  • Facilitate communications between patients and your office through a personalized patient care team
  • Help educate patients in early identification of immune-mediated adverse events
 

Resource Library

Healthcare professional resources

Dosing Guide

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imAE Management Handbook

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imAE Quick Reference Guide

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Lighthouse HCP Brochure

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PD-L1 Testing FAQ Brochure

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Patient and caregiver resources

Side Effects Monitoring Brochure

Download now

Side Effects Tracker

Download now

Immunotherapy Wallet Card

Download now

Lighthouse Patient Brochure

Download now

 

View additional video resources on
The IMFINZI YouTube channel

 

Important Safety Information

There are no contraindications for IMFINZI® (durvalumab).

IMFINZI can cause serious, potentially fatal adverse reactions including immune-mediated pneumonitis, hepatitis, colitis, endocrinopathies, nephritis, dermatologic reactions, other immune-mediated adverse reactions, infection, and infusion-related reactions. Please refer to the full Prescribing Information for important dosage modification and management information specific to adverse reactions.

Indication

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, defined as requiring use of corticosteroids. Fatal cases have been reported. Monitor patients for signs and symptoms of pneumonitis and evaluate with radiographic imaging when suspected. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold IMFINZI for Grade 2 pneumonitis; permanently discontinue for Grade 3 or 4 pneumonitis.

In clinical studies enrolling 1889 patients with various cancers who received IMFINZI, pneumonitis occurred in 5% of patients, including Grade 3 (0.8%), Grade 4 (<0.1%), and Grade 5 (0.3%) pneumonitis. Pneumonitis led to discontinuation of IMFINZI in 1.5% of the 1889 patients. The incidence of pneumonitis (including radiation pneumonitis) was higher in patients in the PACIFIC study who completed treatment with definitive chemoradiation within 42 days prior to initiation of IMFINZI (34%) compared to patients in other clinical studies (2.3%) in which radiation therapy was generally not administered immediately prior to initiation of IMFINZI. In the PACIFIC study, the incidence of Grade 3 pneumonitis was 3.4% and of Grade 5 pneumonitis was 1.1% in the IMFINZI arm. In the PACIFIC study, pneumonitis led to discontinuation of IMFINZI in 6% of patients.

The frequency and severity of immune-mediated pneumonitis were similar whether IMFINZI was given as a single agent in patients with various cancers or in combination with chemotherapy in patients with ES-SCLC.

Immune-Mediated Hepatitis

IMFINZI can cause immune-mediated hepatitis, defined as requiring use of corticosteroids. Fatal cases have been reported. Monitor patients for signs and symptoms of hepatitis during and after discontinuation of IMFINZI, including clinical chemistry monitoring. Administer corticosteroids for Grade 2 or higher elevations of ALT, AST, and/or total bilirubin. Withhold IMFINZI 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; permanently discontinue IMFINZI for 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.

In clinical studies enrolling 1889 patients with various cancers who received IMFINZI, hepatitis occurred in 12% of patients, including Grade 3 (4.4%), Grade 4 (0.4%), and Grade 5 (0.2%) hepatitis. Hepatitis led to discontinuation of IMFINZI in 0.7% of the 1889 patients.

Immune-Mediated Colitis

IMFINZI can cause immune-mediated colitis, defined as requiring use of corticosteroids. Administer corticosteroids for Grade 2 or greater colitis or diarrhea. Withhold IMFINZI for Grade 2 colitis or diarrhea; permanently discontinue for Grade 3 or 4 colitis or diarrhea.

In clinical studies enrolling 1889 patients with various cancers who received IMFINZI, colitis or diarrhea occurred in 18% of patients, including Grade 3 (1.0%) and Grade 4 (0.1%) immune-mediated colitis. Diarrhea or colitis led to discontinuation of IMFINZI in 0.4% of the 1889 patients.

Immune-Mediated Endocrinopathies

IMFINZI can cause immune-mediated endocrinopathies, including thyroid disorders, adrenal insufficiency, type 1 diabetes mellitus, and hypophysitis/hypopituitarism. Monitor patients for clinical signs and symptoms of endocrinopathies.

  • Thyroid disordersMonitor thyroid function prior to and periodically during treatment. Initiate hormone replacement therapy or medical management of hyperthyroidism as clinically indicated. Withhold IMFINZI for Grades 2–4 hyperthyroidism, until clinically stable. Continue IMFINZI for hypothyroidism.

    In clinical studies enrolling 1889 patients with various cancers who received IMFINZI, hypothyroidism occurred in 11% of patients, while hyperthyroidism occurred in 7% of patients. Thyroiditis occurred in 0.9% of patients, including Grade 3 (<0.1%) thyroiditis. Hypothyroidism was preceded by thyroiditis or hyperthyroidism in 25% of patients.

  • Adrenal insufficiencyAdminister corticosteroids as clinically indicated and withhold IMFINZI until clinically stable for Grade 2 or higher adrenal insufficiency. In clinical studies enrolling 1889 patients with various cancers who received IMFINZI, adrenal insufficiency occurred in 0.7% of patients, including Grade 3 (<0.1%) adrenal insufficiency.
  • Type 1 diabetes mellitusInitiate treatment with insulin as clinically indicated. Withhold IMFINZI for Grades 2–4 type 1 diabetes mellitus, until clinically stable. In clinical studies enrolling 1889 patients with various cancers who received IMFINZI, type 1 diabetes mellitus occurred in <0.1% of patients.
  • HypophysitisAdminister corticosteroids and hormone replacement as clinically indicated and withhold IMFINZI until clinically stable for Grade 2 or higher hypophysitis. Hypopituitarism leading to adrenal insufficiency and diabetes insipidus occurred in <0.1% of 1889 patients with various cancers who received IMFINZI.

Immune-Mediated Nephritis

IMFINZI can cause immune-mediated nephritis, defined as evidence of renal dysfunction requiring use of corticosteroids. Fatal cases have occurred. Monitor patients for abnormal renal function tests prior to and periodically during treatment with IMFINZI. Administer corticosteroids as clinically indicated. Withhold IMFINZI for creatinine greater than 1.5 to 3 times the ULN; permanently discontinue IMFINZI and administer corticosteroids in patients with creatinine greater than 3 times the ULN.

In clinical studies enrolling 1889 patients with various cancers who received IMFINZI, nephritis (reported as any of the following: increased creatinine or urea, acute kidney injury, renal failure, decreased glomerular filtration rate, tubulointerstitial nephritis, decreased creatinine clearance, glomerulonephritis, and nephritis) occurred in 6.3% of the patients including Grade 3 (1.1%), Grade 4 (0.2%), and Grade 5 (0.1%) nephritis. IMFINZI was discontinued in 0.3% of the 1889 patients.

Immune-Mediated Dermatologic Reactions

IMFINZI can cause immune-mediated rash. Stevens Johnson Syndrome (SJS)/toxic epidermal necrolysis (TEN) has occurred with other products in this class. Administer corticosteroids for Grade 2 rash or dermatitis lasting for more than 1 week or for Grade 3 or 4 rash or dermatitis. Withhold IMFINZI for Grade 2 rash or dermatitis lasting longer than 1 week or Grade 3 rash or dermatitis; permanently discontinue IMFINZI in patients with Grade 4 rash or dermatitis.

In clinical studies enrolling 1889 patients with various cancers who received IMFINZI, 26% of patients developed rash or dermatitis and 0.4% of the patients developed vitiligo. Rash or dermatitis led to discontinuation of IMFINZI in 0.1% of the 1889 patients.

Other Immune-Mediated Adverse Reactions

IMFINZI can cause severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system. While immune-mediated reactions usually manifest during treatment with IMFINZI, immune-mediated adverse reactions can also manifest after discontinuation of IMFINZI. For suspected immune-mediated adverse reactions, exclude other causes and initiate corticosteroids as clinically indicated. Withhold IMFINZI for Grade 3 immune-mediated adverse reactions, unless clinical judgment indicates discontinuation; permanently discontinue IMFINZI for Grade 4 adverse reactions.

The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in 1889 patients who received IMFINZI: aseptic meningitis, hemolytic anemia, immune thrombocytopenic purpura, myocarditis, myositis, and ocular inflammatory toxicity, including uveitis and keratitis. Additional clinically significant immune-mediated adverse reactions have been seen with other products in this class (see Warnings and Precautions Section 5.7 of IMFINZI full Prescribing Information).

Infection

IMFINZI can cause serious infections, including fatal cases. Monitor patients for signs and symptoms of infection and treat as clinically indicated. Withhold IMFINZI for Grade 3 or 4 infection, until clinically stable.

In clinical studies enrolling 1889 patients with various cancers who received IMFINZI, infections occurred in 43% of patients, including Grade 3 (8%), Grade 4 (1.9%), and Grade 5 (1.0%). The overall incidence of infections in IMFINZI-treated patients in the PACIFIC study (56%) was higher compared to patients in other clinical studies (38%) in which radiation therapy was generally not administered immediately prior to initiation of IMFINZI. In patients with UC in Study 1108 (n=182), the most common Grade 3 or higher infection was urinary tract infections, which occurred in 4% of patients. In patients with Stage III NSCLC in the PACIFIC study, the most common Grade 3 or higher infection was pneumonia, which occurred in 5% of patients.

Infusion-Related Reactions

IMFINZI can cause severe or life-threatening infusion-related reactions. Monitor patients for signs and symptoms of an infusion-related reaction. Interrupt or slow the rate of infusion for Grades 1–2 infusion-related reactions; permanently discontinue for Grades 3–4 infusion-related reactions.

In clinical studies enrolling 1889 patients with various cancers who received IMFINZI, infusion-related reactions occurred in 2.2% of patients, including Grade 3 (0.3%).

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. There are no data on the use of IMFINZI in pregnant women. Advise pregnant women of the potential risk to a fetus and advise women of reproductive potential to use effective contraception during treatment 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.

Most Common Adverse Reactions

  • In patients with extensive-stage SCLC in the CASPIAN study (n=265), the most common adverse reactions (≥20%) were nausea, fatigue/asthenia, and alopecia. 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 (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.

Indication

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.