Patient Support-ZARXIO

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Patients can receive their first and subsequent doses of ZARXIO at no cost

Commercial Co-Pay Program for ZARXIO

The Sandoz One Source Commercial Co-Pay Program for ZARXIO supports eligible,* commercially insured patients with their out-of-pocket co-pay costs for ZARXIO.

Sandoz One Source co-pay details

Three ways to enroll

1. Instruct your patients to enroll in co-pay online.
2. Submit an online Sandoz One Source^® enrollment form.
3. Download and fax the Sandoz One Source enrollment form to 1-844-726-3695.

In-home Injection Training

Sandoz offers in-home visits where a nurse trainer can visit the patient at their home to provide instruction for administration of ZARXIO.^†

Sandoz One Source Injection Training Steps

Call 1-844-SANDOZ1 (1-844-726-3691) to request training for your patient.

Patient Support Services

Sandoz One Source provides comprehensive patient support services designed to help simplify and support patient access.

Benefit investigations
Prior authorization and appeals support
Commercial Co-Pay Program
In-home injection training

Independent foundation information
Patient Assistance Program
Billing and coding support
General payer policy information

ZARXIO Product Replacement Program

As a supplement to the Sandoz Returns Policy, Sandoz One Source offers a simple product replacement process for spoiled ZARXIO products under the following circumstances^‡:

Product was mishandled, dropped, or broken
Product was inappropriately stored or refrigerated, or was frozen
There was an admixture error
Product was reconstituted but not administered due to an unforeseen patient condition or because the patient missed the appointment

Contact a Sandoz One Source case manager at 1-844-SANDOZ1 (1-844-726-3691) to request replacement product.

Medical & Sandoz One Source Contact Card

Please see information about ZARXIO materials on the next page.

This website provides general information and is not intended to provide reimbursement or legal advice. Furthermore, it is not intended to increase or maximize payment by any payer. Because laws, regulations, and coverage policies are complex and updated frequently, you should check with your local Medicare carrier and payers often or go to www.cms.gov.

Nothing in the information provided shall be construed as a guarantee of Sandoz regarding levels of reimbursement, payment, or charge that reimbursement will be received. The ultimate responsibility for obtaining reimbursement lies with the physician, provider, or patient. Please consult with your counsel or reimbursement specialist for any practice-specific reimbursement or billing questions.

*Eligibility Requirements: Maximum benefit of $10,000 annually. Prescription must be for an approved indication. This program is not health insurance. This program is for insured patients only; cash-paying or uninsured patients are not eligible. Patients are not eligible if prescription for ZARXIO is paid, in whole or in part, by any state or federally funded programs, including but not limited to Medicare (including Part D, even in the coverage gap) or Medicaid, Medigap, VA, DOD, or TRICARE, or private indemnity plans that do not cover prescription drugs, or HMO insurance plans that reimburse the patient for the entire cost of their prescription drugs, or where prohibited by law. Co-Pay Program may apply to out-of-pocket expenses that occurred within 120 days prior to the date of the enrollment. Co-Pay Program may not be combined with any other rebate, coupon, or offer. Co-Pay Program has no cash value. Sandoz reserves the right to rescind, revoke, or amend this offer without further notice.

^†Training via video and telephone are also available.

^‡Additional conditions apply. Product shall be eligible for replacement only (no credit will be issued). Spoilage applies only to infused or injected Products. Samples are not eligible for spoilage replacement. Replacement is not available if Product has been administered. Sandoz can ship replacement Product only to licensed entities. All spoilage replacement requests are subject to review. If already billed or submitted to insurance, or a co-pay or co-insurance payment was received, replacement is not available. Replacement due to loss of refrigeration is limited to five (5) packs per incident, based on SKU dispensing pack quantity, unless the loss was caused by the failure of a Sandoz-provided refrigerator.

ZARXIO and Sandoz One Source are registered trademarks of Novartis AG.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ZARXIO is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim products.

WARNINGS AND PRECAUTIONS

Splenic rupture, including fatal cases, has been reported following the administration of filgrastim products. Patients who report left upper abdominal or shoulder pain should be evaluated.

Acute respiratory distress syndrome (ARDS) has been reported in patients receiving filgrastim products. Patients who develop fever and lung infiltrates or respiratory distress should be evaluated. Discontinue ZARXIO in patients with ARDS.

Serious allergic reactions, including anaphylaxis, have been reported in patients receiving filgrastim products. The majority of reported events occurred upon initial exposure. Provide symptomatic treatment for allergic reactions. Allergic reactions, including anaphylaxis, in patients receiving filgrastim products can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue ZARXIO in patients with serious allergic reactions.

Sickle cell crisis, in some cases fatal, has been reported with the use of filgrastim products in patients with sickle cell trait or sickle cell disease.

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

Alveolar hemorrhage manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization have been reported in healthy donors treated with filgrastim products undergoing peripheral blood progenitor cell (PBPC) collection mobilization. Hemoptysis resolved with discontinuation of filgrastim. The use of ZARXIO for PBPC mobilization in healthy donors is not an approved indication.

Capillary leak syndrome (CLS) has been reported after G-CSF administration, including filgrastim 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 appropriate treatment.

Confirm the diagnosis of severe chronic neutropenia (SCN) before initiating ZARXIO therapy. Myelodysplastic syndrome (MDS) and acute myelogenous leukemia (AML) have been reported to occur in the natural history of congenital neutropenia without cytokine therapy. Cytogenetic abnormalities, transformation to MDS, and AML have also been observed in patients treated with filgrastim products for SCN. Abnormal cytogenetics and MDS have been associated with the eventual development of myeloid leukemia. The effect of filgrastim products on the development of abnormal cytogenetics and the effect of continued filgrastim administration in patients with abnormal cytogenetics or MDS are unknown. If a patient with SCN develops abnormal cytogenetics or myelodysplasia‚ the risks and benefits of continuing ZARXIO should be carefully considered.

Thrombocytopenia has been reported in patients receiving filgrastim products. Monitor platelet counts.

Leukocytosis:

Patients with Cancer Receiving Myelosuppressive Chemotherapy: White blood cell counts of 100‚000/mm³ or greater were observed in approximately 2% of patients receiving filgrastim at dosages above 5 mcg/kg/day. In patients with cancer receiving ZARXIO as an adjunct to myelosuppressive chemotherapy‚ to avoid the potential risks of excessive leukocytosis‚ it is recommended that ZARXIO therapy be discontinued if the ANC surpasses 10‚000/mm³ after the chemotherapy-induced ANC nadir has occurred. Monitor CBCs at least twice weekly during therapy.
Peripheral Blood Progenitor Cell (PBPC) Collection and Therapy: During the period of administration of ZARXIO for PBPC mobilization in patients with cancer, discontinue ZARXIO if the leukocyte count rises to >100,000/mm³.

Cutaneous vasculitis has been reported in patients treated with filgrastim products. In most cases‚ the severity of cutaneous vasculitis was moderate or severe. Most of the reports involved patients with SCN receiving long-term filgrastim therapy. Hold ZARXIO therapy in patients with cutaneous vasculitis. ZARXIO may be started at a reduced dose when the symptoms resolve and the ANC has decreased.

The possibility that ZARXIO acts as a growth factor for any tumor type cannot be excluded. The safety of filgrastim products in chronic myeloid leukemia (CML) and myelodysplasia has not been established. When ZARXIO is used to mobilize PBPC‚ tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. Available data is limited and inconclusive.

The safety and efficacy of ZARXIO given simultaneously with cytotoxic chemotherapy have not been established. Do not use ZARXIO in the period 24 hours before through 24 hours after the administration of cytotoxic chemotherapy. The safety and efficacy of ZARXIO have not been evaluated in patients receiving concurrent radiation therapy. Avoid the simultaneous use of ZARXIO with chemotherapy and radiation therapy.

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging changes on nuclear imaging.

Aortitis has been reported in patients receiving filgrastim 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. Discontinue ZARXIO if aortitis is suspected.

ADVERSE REACTIONS

Most common adverse reactions in patients:

With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs (≥ 5% difference in incidence compared to placebo) are thrombocytopenia, nausea, pyrexia, chest pain, pain, fatigue, back pain, arthralgia, bone pain, pain in extremity, dizziness, cough, dyspnea, rash, blood lactate dehydrogenase increased and blood alkaline phosphatase increased

With AML (≥ 2% difference in incidence) are epistaxis, back pain, pain in extremity, erythema, and rash maculo-papular

With nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT (≥ 5% difference in incidence) are rash and hypersensitivity

Undergoing peripheral blood progenitor cell mobilization and collection (≥ 5% incidence) are bone pain, pyrexia, blood alkaline phosphatase increased and headache

With severe chronic neutropenia (SCN) (≥ 5% difference in incidence) are arthralgia, bone pain, back pain, muscle spasms, musculoskeletal pain, pain in extremity, splenomegaly, anemia, upper respiratory tract infection, urinary tract infection, epistaxis, chest pain, diarrhea, hypoesthesia, and alopecia

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

PATIENT SUPPORT