GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

CODING

J Code 1447 Injection, tbo-filgrastim, 1 microgram

Prefilled syringe without needle guard1

Thin blue syringes wit guard Thin white syringes without guard

300 mcg/0.5 mL, 63459-910-17 (1 pack) 63459-910-36 (5 pack)

480 mcg/0.8 mL, 63459-912-17 (1 pack) 63459-912-36 (5 pack)

For administration by patients, caregivers, and healthcare professionals

Prefilled syringe with needle guard1

Larger blue/white syringes with guard

300 mcg/0.5 mL prefilled syringe, 63459-910-11 (1 pack) 63459-910-15 (10 pack)

480 mcg/0.8 mL prefilled syringe, 63459-912-11 (1 pack) 63459-912-15 (10 pack)

For administration by healthcare professionals only


Vials1

300 vial 480 vial

300 mcg/1 mL vial, 63459-918-59

480 mcg/1.6 mL, 63459-920-59

Vials1

300 vial

300 mcg/1 mL vial, 63459-918-59 (10 pack)

480 vial

480 mcg/1.6 mL, 63459-920-59 (10 pack)

PATIENT ACCESS AND REIMBURSEMENT SERVICES

CORE services include:

  • Benefit verification and coverage determination

  • Precertification and prior authorization support

  • Coverage guidelines and claim requirements of payers

  • Support through the claims and appeals process

  • Templates for letters of medical necessity

  • Teva Cares Foundation Patient Assistance Program referrals

Teva Cares Foundation offers a Patient Assistance Program to provide FDA-approved products free of charge for patients who qualify.

Teva Oncology also provides support to patient advocacy organizations, such as the Leukemia & Lymphoma Society and others that have programs designed to help patients access the treatment they need.

Use of CORE services is not a guarantee of payment. Payments are based on medical necessity at the time a claim is received.

PATIENT SAVINGS PROGRAM

GRANIX injection Patient Savings Program

GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

$0 Out of pocket

Up to $14,000 savings per calendar year.

Financial assistance for GRANIX

Commercially insured and cash-paying patients may be eligible for GRANIX financial assistance
$0 Out of pocket

Up to $14,000 savings per calendar year.

Program benefits

  • No patient enrollment form required

  • Covers pharmacy benefit for GRANIX

  • This offer specifically applies to the syringe without needle guard
    300 mcg/0.5 mL, NDC 63459-910-17 (1 pack) NDC 63459-910-36 (5 pack)
    480 mcg/0.8 mL, NDC 63459-912-17 (1 pack) NDC 63459-912-36 (5 pack)

Find out more about the GRANIX Patient Savings Program or other available financial assistance.

Call 1-888-587-3263

For administration by patients, caregivers, and healthcare professionals. Available to specialty, retail, and mail-order pharmacies via national and regional wholesalers and distributors.

Terms and Conditions: Patients are not eligible if prescriptions are paid for in part or full by any state or federally funded programs, including but not limited to Medicare, Medicaid, Medigap, VA, DOD, TRICARE, or by private health benefit programs which reimburse patients for the entire cost of prescription drugs. This offer is not valid for patients who are Medicare eligible and are enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees (i.e., patients who are eligible for Medicare Part D but receive a prescription drug benefit through a former employer). By redeeming this offer, patients acknowledge that they are eligible and understand and agree to comply with the terms and conditions of this offer. Void if copied, transferred, purchased, altered or traded and where prohibited and restricted by law. This is not an insurance program. Teva Pharmaceuticals reserves the right to rescind, revoke, or amend this offer at any time without notice. This offer may not be used with any other discount, coupon or offer. Must be 18 years or older to participate.

Patient Implications: Patient must present their primary insurance card to the pharmacist along with their GRANIX prescription to participate in this program. Patients may opt out at any time.

Commercially Insured Patients: Patients will receive savings up to $14,000 on prescriptions of GRANIX per calendar year. Maximum reimbursement limits apply and patient out-of-pocket expenses may vary.

Cash-Paying Patients: Patients will receive savings up to $14,000 on prescriptions of GRANIX per calendar year.

Pharmacist Implications: When you use this program, you are certifying that you have not submitted and will not submit a claim for reimbursement under any federal, state, or other governmental program for this prescription. Void where prohibited by law. Pharmacists should no longer apply the program benefits when patients opt out of the program.

Pharmacy Instructions for Commercially Insured Patients: Submit this claim to Therapy First Plus. A valid Other Coverage Code (e.g., 8) is required. The patient is responsible for the first $0 and the program pays up to $14,000 in savings per calendar year. Reimbursement will be received from Therapy First Plus.

Pharmacy Instructions for Uninsured/Cash-Paying Patients: Submit this claim to Therapy First Plus. A valid Other Coverage Code (e.g., 1) is required. The program pays up to $14,000 in savings per calendar year. Reimbursement will be received from Therapy First Plus.

For questions regarding processing, please call the Help Desk at 1-800-422-5604. For questions regarding eligibility or benefits, please call 1-844-218-0443. Program managed by PSKW, LLC. on behalf of Teva Pharmaceuticals.

Medical Information

For healthcare professionals or patients with specific medical questions about GRANIX®, please contact:

Teva Medical Information

1-888-4TEVARX (1-888-483-8279)

To request more information about GRANIX, click here.

The information on this site is intended for healthcare professionals in the United States. Are you a healthcare professional in the United States?

Important Safety Information

  • Contraindication: GRANIX is contraindicated in patients with a history of serious allergic reactions to filgrastim or pegfilgrastim products.

  • Fatal Splenic Rupture: Splenic rupture, including fatal cases, can occur following the administration of filgrastim products. Evaluate patients who report upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. Discontinue GRANIX if splenic rupture is suspected or confirmed.

  • Acute respiratory distress syndrome (ARDS): ARDS can occur in patients receiving filgrastim products. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving GRANIX, for ARDS. Discontinue GRANIX in patients with ARDS.

  • Serious Allergic reactions: Serious allergic reactions, including anaphylaxis, can occur in patients receiving GRANIX. Reactions can occur on initial exposure. The administration of antihistamines‚ steroids‚ bronchodilators‚ and/or epinephrine may reduce the severity. Permanently discontinue GRANIX in patients with serious allergic reactions. Do not administer GRANIX to patients with a history of serious allergic reactions to filgrastim or pegfilgrastim.

  • Sickle Cell Disorders: Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim products. Discontinue GRANIX if sickle cell crisis occurs.

  • Glomerulonephritis: Glomerulonephritis can occur in patients receiving filgrastim products. The diagnoses were based on azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose reduction or discontinuation of the filgrastim product. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of GRANIX.

  • Capillary leak syndrome (CLS): CLS can occur in patients receiving 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 CLS should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.

  • Potential for tumor growth stimulatory effects on malignant cells: The granulocyte colony-stimulating factor (G-CSF) receptor, through which GRANIX acts, has been found on tumor cell lines. The possibility that GRANIX acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which GRANIX is not approved, cannot be excluded.

  • Leukocytosis: White blood cell counts of 100‚000/mm3 or greater were observed in approximately 2% of patients receiving filgrastim products at dosages above 5 mcg/kg/day. In patients with cancer receiving GRANIX as an adjunct to myelosuppressive chemotherapy‚ to avoid the potential risks of excessive leukocytosis‚ it is recommended that GRANIX 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. Dosages of GRANIX that increase the ANC beyond 10‚000/mm3 may not result in any additional clinical benefit. In patients with cancer receiving myelosuppressive chemotherapy‚ discontinuation of filgrastim products therapy usually resulted in a 50% decrease in circulating neutrophils within 1 to 2 days‚ with a return to pretreatment levels in 1 to 7 days.

  • Simultaneous Use with Chemotherapy and Radiation Therapy Not Recommended: The safety and efficacy of filgrastim products, including GRANIX, given simultaneously with cytotoxic chemotherapy have not been established. Because of the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ do not use GRANIX in the period 24 hours before through 24 hours after the administration of cytotoxic chemotherapy. The safety and efficacy of GRANIX have not been evaluated in patients receiving concurrent radiation therapy. Avoid the simultaneous use of GRANIX with chemotherapy and radiation therapy.

  • Nuclear Imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging changes. Consider this when interpreting bone-imaging results.

  • Aortitis: Aortitis has been reported in patients receiving another filgrastim product. 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 GRANIX if aortitis is suspected.

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

  • Most common treatment-emergent adverse reaction: Most common adverse reaction (≥1%) to GRANIX is bone pain.

Indication

GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

Please see Full Prescribing Information.

Reference: 1. GRANIX® (tbo-filgrastim) injection [Current Prescribing Information]. North Wales, PA: Teva Pharmaceuticals.