Resources & Support for Releuko

Amneal PATHways® Patient Support Program

Helpful support for patients and HCP practices is available through the Amneal PATHways® Program.

Field Reimbursement Specialists

Provider
Portal

Benefits
Investigation

Co-pay Savings programs

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Our PATHways program is designed to help stay on track toward offering patients accessible treatment. With its full suite of services and dedicated program specialists, PATHways allows us to more easily map each patient’s personal treatment path together.

Materials

Releuko® Provider Brochure

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Releuko® Product Information Sheet

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Important Safety Information

Indications and Usage

RELEUKO® is a leukocyte growth factor 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 significant incidence of severe neutropenia with fever
Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML)
Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT)
Reduce the incidence and duration of sequelae of severe neutropenia‚ (e.g., fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia

RELEUKO® is not indicated to:

Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis
Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome)
Limitations of Use: ALYMSYS® is not indicated for adjuvant treatment of colon cancer.

Contraindications
Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim products. Before you take RELEUKO®, tell your healthcare provider if you are pregnant or plan to breast feed, and if you have sickle cell disorder, kidney problems or receiving radiation therapy.

Warnings and Precautions

Fatal splenic rupture: Patients may experience enlarged spleen which can rupture and cause death.
Acute respiratory distress syndrome (ARDS): Patients may develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue RELEUKO® in patients with ARDS.
Fatal sickle cell crises: Serious sickle cell crises have been reported in patients with sickle cell disorders receiving RELEUKO®. Discontinue RELEUKO® if sickle cell crisis occurs.
Serious allergic reactions, including anaphylaxis: Permanently discontinue RELEUKO® in patients with serious allergic reactions.
Kidney injury (Glomerulonephritis): Kidney injury have been reported in patients on RELEUKO®. Consider dose-reduction or interruption of RELEUKO® in patients with kidney injury.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using RELEUKO® in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.
Decreased platelet count (thrombocytopenia); increased white blood cell count (leukocytosis) and inflammation of your blood vessels (cutaneous vasculitis) have been reported. Monitor platelet counts and white blood cell count.

Adverse Reactions

Most common adverse reactions

With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs are pyrexia, pain, rash, cough, and dyspnea.
With AML are pain, epistaxis and rash.
With nonmyeloid malignancies undergoing myeloablative chemotherapy followed by Bone Marrow Transplant is rash.
With severe chronic neutropenia are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia.

IMPORTANT SAFETY INFORMATIONN