MORE LESS
 
IMPORTANT SAFETY INFORMATION

Do not administer Fulphila® to patients with a history of serious allergic reactions, including anaphylaxis, to pegfilgrastim or filgrastim.

Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Fulphila.

Acute respiratory distress syndrome (ARDS) can occur in patients receiving pegfilgrastim products. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Fulphila for ARDS. Discontinue Fulphila in patients with ARDS.

Serious allergic reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products. The majority of reported events occurred upon initial exposure and can recur within days after discontinuation of initial anti-allergic treatment. Permanently discontinue Fulphila in patients with serious allergic reactions to any pegfilgrastim or filgrastim products.

Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products. Discontinue if sickle cell crisis occurs.

Glomerulonephritis has been reported in patients receiving pegfilgrastim products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after withdrawal of pegfilgrastim products. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of Fulphila.

White blood cell counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of CBCs during therapy with Fulphila is recommended.

Capillary leak syndrome has been reported after granulocyte colony-stimulating factor (G-CSF) administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.

The G-CSF receptor, through which pegfilgrastim and filgrastim products act, has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.

Aortitis has been reported in patients receiving pegfilgrastim products. It may occur as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without known etiology and discontinue Fulphila if aortitis is suspected.

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results.

The most common adverse reactions (≥5% difference in incidence) in placebo-controlled clinical trials are bone pain and pain in extremity.

INDICATION

Fulphila is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

The first
FDA-approved
biosimilar

for Neulasta® (pegfilgrastim)

INDICATION: Fulphila® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Helps protect your patients
at risk of febrile neutropenia

Fulphila® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive
anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.1

Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

LF Not Made With Natural Rubber Latex

Fulphila® is an effective treatment option for patients with febrile neutropenia

For FDA approval, Fulphila® had to demonstrate that it is highly similar to an existing FDA-approved biological product referred to as the reference product or reference biologic.

“FDA requires biosimilar…products meet the Agency’s rigorous approval standards. That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar…just as they would the reference product.”
— FDA2

In studies, Pegfilgrastim* demonstrated a
94% reduction in febrile neutropenia (FN) with patients
receiving chemotherapy for up to 4 cycles

Study design Phase 3, multicenter, multinational, double-blind, placebo-controlled trial of patients with breast cancer receiving 100 mg/m2 docetaxel for up to 4 cycles. Included 928 patients initially receiving placebo (n=465) or Neulasta® (n=463). Primary endpoint was the percentage of patients who developed FN.1,3

Efficacy at par with the reference product4

Confirmatory Phase III study demonstrated equivalent efficacy to the reference product4 in the reduction of chemotherapy-induced febrile neutropenia in breast cancer patients.

Study design: Randomized, double-blind, parallel-group trial evaluating equivalence of Fulphila® vs. reference pegfilgrastim in patients with breast cancer eligible to receive neoadjuvant or adjuvant TAC chemotherapy. The primary endpoint was the duration of severe neutropenia in cycle 1 defined as ANC < 0.5 x 109/L.

Mylan ADVOCATE® provides
Fulphila® patient access support

A team of dedicated patient access specialists is available to answer calls and address concerns or questions regarding:

Coding and billing information

Provide information about applicable coding for Fulphila® (pegfilgrastim-jmdb) and its administration

Note: Coding information is provided for informational purposes only and the physician must determine the appropriate code for each patient and payer

Benefit investigation

  • Research patient-specific insurance coverage, coding, and billing requirements for Fulphila® and its administration
  • Verify patient cost-sharing requirements including deductible, copay, coinsurance, and out-of-pocket maximum, and amounts met to date
  • Determine payer access requirements (eg, specialty pharmacy, in-office dispensing, etc)
  • Prepare Summary of Benefits that documents all findings

Coverage/claim appeal assistance & tracking

  • Verify appeal requirements
  • Track status and resolution of appeals

Patient Assistance

  • Patients without insurance coverage for Fulphila® who cannot afford their medication may be able to receive their medication free of charge
  • Eligibility requirements apply based on residency, income, and other factors. Contact Mylan ADVOCATE® for more information

Insurance coverage verification

Check patient insurance plan enrollment status

Prior authorization (PA)/ reauthorization assistance & tracking

  • Check PA requirements, submission details, and track status
  • Provide offices with payer-specific forms

Copay Assistance

  • Commercially insured patients may be able to access Fulphila® for a $0 copay
  • No income restrictions
  • Eligibility criteria apply; see below for additional details

Field Reimbursement Support

A reimbursement expert from your area can visit your practice or clinic for live educational programs on coverage and reimbursement information or to assist with questions related to Fulphila® access for patients

Alternate Coverage Identification

Mylan ADVOCATE® can help identify other resources, such as state programs or third-party charitable foundations, that may be able to assist your patients

  • Experienced and caring
    Mylan ADVOCATE® patient
    access specialists are available
  • Monday-Friday
    9:00 am to 8:00 pm ET
  • Phone: 1 (833) 695-2623
  • Fax: 1 (833) 247-2756
  • Patient support services and resources are available
    24 hours a day, 7 days a week, via the Mylan ADVOCATE®
    portal at www.mylanadvocate.com

Sign up to learn more about Fulphila® (pegfilgrastim-jmdb)

You are now leaving the Fulphila® website

You are now leaving this Mylan affiliate site. Mylan is not responsible for the content of the site you are about to visit.