Granix
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
GRANIX is indicated to reduce the duration of severe neutropenia in patients with non‑myeloid malignancies receiving myelosuppressive anti‑cancer drugs associated with a clinically significant incidence of febrile neutropenia.
History
There is currently no drug history available for this drug.
Other Information
Tbo-filgrastim is a non-glycosylated recombinant methionyl human granulocyte colony-stimulating growth factor (r-metHuG-CSF) manufactured by recombinant DNA technology using the bacterium strain E coli K802. It has a molecular weight of approximately 18.8 kDa and is composed of 175 amino acids. The endogenous human G-CSF is glycosylated and does not have the additional methionine amino acid residue in its NH2 terminal end.
The product is a sterile, clear, colorless, preservative-free solution containing tbo-filgrastim, glacial acetic acid, sorbitol, polysorbate 80, sodium hydroxide, and Water for Injection. The product is available in single-use prefilled syringes that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 0.5 mL or 0.8 mL, respectively. See table below for product composition of each single-use prefilled syringe.
| Product Composition |
||
| 300 mcg/0.5 mL Syringe |
480 mcg/0.8 mL Syringe |
|
| Tbo-filgrastim |
300 mcg |
480 mcg |
| Glacial Acetic Acid |
0.3 mg |
0.48 mg |
| Polysorbate 80 |
0.0275 mg |
0.044 mg |
| Sorbitol |
25 mg |
40 mg |
| Sodium Hydroxide |
q.s. to pH 4.2 |
q.s. to pH 4.2 |
| Water for Injection |
q.s. to 0.5 mL |
q.s. to 0.8 mL |
Sources
Granix Manufacturers
-
Cephalon, Inc.
![Granix (Tbo-filgrastim) Injection, Solution [Cephalon, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Granix | Cephalon, Inc.
2.1 DosageThe 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 [see Warnings and Precautions (5)].
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 AdministrationGRANIX may be administered by either a healthcare professional or by 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 provided. If a patient or caregiver is not an appropriate candidate for any reason, then in such patients, GRANIX should be administered by a healthcare professional.
Dispense only the pre-filled syringe without a safety needle guard device to patient or caregiver. Instruct patients and caregivers to follow the Instructions for Use provided with the GRANIX pre-filled syringe to properly administer an injection after training by a healthcare professional.
Visually inspect parenteral drug products for particulate matter and discoloration prior to administration.
Do not administer GRANIX if discoloration or particulates are observed.
The prefilled syringe is for single use only. Discard unused portions.
Recommended sites for subcutaneous GRANIX injections include the abdomen (except for the two-inch area around the navel), the front of the middle thighs, the upper outer areas of the buttocks, or the upper back portion of the upper arms. The injection site should be varied daily. GRANIX should not be injected into an area that is tender, red, bruised or hard, or that has scars or stretch marks.
2.3 Instructions for Use of the Safety Needle Guard Device by Healthcare ProfessionalsHold the syringe assembly by the open sides of the device and remove the needle shield.
Expel any extra volume depending on dose needed.
Inject GRANIX subcutaneously as recommended [see General Considerations for Administration (2.2)].
Push the plunger as far as it will go to inject all the medication. Injection of the entire prefilled syringe contents is necessary to activate the needle guard.
With the plunger still pressed all the way down, remove the needle from the skin.
Slowly let go of the plunger and allow the empty syringe to move up inside the device until the entire needle is guarded.
Discard the syringe assembly in approved containers.
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