![]() The use of ZARXIO for PBPC mobilization in healthy donors is not an approved indication. Hemoptysis resolved with discontinuation of filgrastim. 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.If causality is likely, consider dose-reduction or interruption of ZARXIO. If glomerulonephritis is suspected, evaluate for cause. Generally, events of glomerulonephritis resolved after dose reduction or discontinuation of filgrastim products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Glomerulonephritis has occurred in patients receiving filgrastim products.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. Discontinue ZARXIO if sickle cell crisis occurs.Permanently discontinue ZARXIO in patients with serious allergic reactions. Allergic reactions, including anaphylaxis, in patients receiving filgrastim products can recur within days after the discontinuation of initial anti-allergic treatment. Provide symptomatic treatment for allergic reactions. The majority of reported events occurred upon initial exposure. Serious allergic reactions, including anaphylaxis, have been reported in patients receiving filgrastim products.Discontinue ZARXIO in patients with ARDS. Patients who develop fever and lung infiltrates or respiratory distress should be evaluated. Acute respiratory distress syndrome (ARDS) has been reported in patients receiving filgrastim products.Patients who report left upper abdominal or shoulder pain should be evaluated. Splenic rupture, including fatal cases, has been reported following the administration of filgrastim products.ZARXIO ® (filgrastim-sndz) is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim products. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS G-CSF=granulocyte colony-stimulating factor. 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. If already billed or submitted to insurance, or a co-pay or co-insurance payment was received, replacement is not available. All spoilage replacement requests are subject to review. Sandoz can ship replacement Product only to licensed entities. Replacement is not available if Product has been administered. Samples are not eligible for spoilage replacement. Spoilage applies only to infused or injected Products. Product shall be eligible for replacement only (no credit will be issued). †Training via video and telephone are also available. ![]() Sandoz reserves the right to rescind, revoke, or amend this offer without further notice. Co-Pay Program may not be combined with any other rebate, coupon, or offer. Co-Pay Program may apply to out-of-pocket expenses that occurred within 120 days prior to the date of the enrollment. 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. This program is for insured patients only cash-paying or uninsured patients are not eligible. Prescription must be for an approved indication. ![]() *Eligibility Requirements: Maximum benefit of $10,000 annually.
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