GRANIX 300 ug/mL
tbo-filgrastim · INJECTION, SOLUTION · Cephalon, LLC
GRANIX is a injection, solution containing tbo-filgrastim at 300 ug/mL, taken subcutaneous. Manufactured by Cephalon, LLC.
Key Facts
- Brand Name
- GRANIX
- Generic Name
- tbo-filgrastim
- NDC Code (Product)
63459-918- Manufacturer
- Cephalon, LLC
- Strength
- 300 ug/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA125294
- Drug Class
- Leukocyte Growth Factor [EPC]
- Marketing Start
- 11/07/2018
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. GRANIX (tbo-filgrastim) is a leukocyte growth factor indicated in adult and pediatric patients 1 month and older for reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended dose: 5 mcg/kg per day administered as a subcutaneous injection Administer the first dose no earlier than 24 hours following myelosuppressive chemotherapy. Do not administer within 24 hours prior to chemotherapy ( 2.1 ) 2.1 Recommended Dosage The recommended dose of GRANIX is 5 mcg/kg per day administered as a subcutaneous injection. Administer the first dose of GRANIX no earlier than 24 hours following myelosuppressive chemotherapy. Do not administer GRANIX within 24 hours prior to chemotherapy. Daily dosing with GRANIX should continue until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range. Monitor complete blood count (CBC) prior to chemotherapy and twice per week until recovery. 2.2 General Considerations for Administration GRANIX may be administered by either a healthcare professional, a patient or caregiver. Before a decision is made to allow GRANIX to be administered by a patient or caregiver, ensure that the patient is an appropriate candidate for self-administration or administration by a caregiver. Proper training on storage, preparation, and administration technique should be provide…
Contraindications
4 CONTRAINDICATIONS GRANIX is contraindicated in patients with a history of serious allergic reactions to filgrastim products or pegfilgrastim products [ see Warnings and Precautions (5.3) ]. Patients with a history of serious allergic reactions to filgrastim products or pegfilgrastim products. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following potential serious adverse reactions are discussed in greater detail in other sections of the labeling: Splenic Rupture [see Warnings and Precautions (5.1) ] Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.2) ] Serious Allergic Reactions [see Warnings and Precautions (5.3) ] Sickle Cell Disorders [see Warnings and Precautions (5.4) ] Glomerulonephritis [see Warnings and Precautions (5.5) ] Capillary Leak Syndrome [see Warnings and Precautions (5.6) ] Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions (5.7) ] Myelodysplastic Syndrome and Acute Myeloid Leukemia [see Warnings and Precautions (5.8) ] Leukocytosis [ see Warnings and Precautions ( 5.9 ) ] Simultaneous Use with Chemotherapy and Radiation Therapy Not Recommended [see Warnings and Precautions ( 5.10 ) ] Aortitis [see Warnings and Precautions ( 5.12 ) ] Alveolar Hemorrhage [see Warnings and Precautions (5.13) ] Most common adverse reaction (≥1%) to GRANIX is bone pain ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1 ‑ 866-832-8537 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Tri…
Frequently Asked Questions
What is GRANIX used for?
GRANIX contains tbo-filgrastim. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is GRANIX a controlled substance?
GRANIX is not classified as a controlled substance by the DEA.
What is the generic name for GRANIX?
The generic name for GRANIX is tbo-filgrastim. There are no other listed brand versions of tbo-filgrastim.
What is the NDC code for GRANIX 300 ug/mL?
The NDC (National Drug Code) for GRANIX 300 ug/mL is 63459-918, listed by Cephalon, LLC.
Other GRANIX Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)