Tbo-filgrastim 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.
DOSAGE AND ADMINISTRATION
The recommended dose of tbo-filgrastim is 5 mcg/kg per day administered as a subcutaneous injection. Administer the first dose of tbo-filgrastim no earlier than 24 hours following myelosuppressive chemotherapy. Do not administer tbo-filgrastim within 24 hours prior to chemotherapy [see WARNINGS AND PRECAUTIONS].
Daily dosing with tbo-filgrastim 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.
General Considerations for Administration
Tbo-filgrastim should be administered by a healthcare professional.
Visually inspect parenteral drug products for particulate matter and discoloration prior to administration. Do not administer tbo-filgrastim if discoloration or particulates are observed.
The prefilled syringe is for single use only. Discard unused portions.
Recommended sites for subcutaneous tbo-filgrastim 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. Tbo-filgrastim should not be injected into an area that is tender, red, bruised, or hard or that has scars or stretch marks.
Instructions for Use of the Safety Needle Guard Device
Hold the syringe assembly by the open sides of the device and remove the needle shield.
Expel any extra volume depending on dose needed.
Inject tbo-filgrastim subcutaneously as recommended [see General Considerations for Administration].
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.
Dosage Forms And Strengths
300 mcg/0.5 mL injection in single
use prefilled syringe
480 mcg/0.8 mL injection in single use prefilled syringe
Storage And Handling
Tbo-filgrastim solution for injection is supplied as a single-use, preservative-free, prefilled syringe of Type I glass which has a permanently attached stainless steel needle. Syringes may be supplied with or without an UltraSafe Passive® Needle Guard.
The active substance is tbo-filgrastim.
Tbo-filgrastim 300 mcg/0.5 mL: Each prefilled syringe contains 300 mcg of tbo-filgrastim in 0.5 mL solution with a blue plunger in:
Packs of 1 without a safety needle guard: NDC 63459-910-17
Packs of 5 without a safety needle guard: NDC 63459-910-36
Packs of 10 without a safety needle guard: NDC 63459-910-46
Packs of 1 with a safety needle guard in trays: NDC 63459-910-23
Packs of 5 with a safety needle guard in trays: NDC 63459-910-25
Packs of 10 with a safety needle guard in trays: NDC 63459-910-27
Packs of 1 with a safety needle guard in blisters: NDC 63459-910-11
Packs of 5 with a safety needle guard in blisters: NDC 63459-910-35
Packs of 10 with a safety needle guard in blisters: NDC 63459-910-15
Tbo-filgrastim 480 mcg/0.8 mL: Each prefilled syringe contains 480 mcg of tbo-filgrastim in 0.8 mL solution with a clear plunger in:
Packs of 1 without a safety needle guard: NDC 63459-912-17
Packs of 5 without a safety needle guard: NDC 63459-912-36
Packs of 10 without a safety needle guard: NDC 63459-912-46
Packs of 1 with a safety needle guard in trays: NDC 63459-912-23
Packs of 5 with a safety needle guard in trays: NDC 63459-912-25
Packs of 10 with a safety needle guard in trays: NDC 63459-912-27
Packs of 1 with a safety needle guard in blisters: NDC 63459-912-11
Packs of 5 with a safety needle guard in blisters: NDC 63459-912-35
Packs of 10 with a safety needle guard in blisters: NDC 63459-912-15
Tbo-filgrastim syringes should be stored in a refrigerator at 36° to 46° F (2° to 8° C). Protect from light. Within its shelf life, the product may be removed from 36° to 46° F (2° to 8° C) storage for a single period of up to 5 days between 73° to 81° F (23° to 27° C). If not used within 5 days, the product may be returned to 36° to 46° F (2° to 8° C) up to the expiration date.
Avoid shaking. The solution should be visually inspected prior to use. Only clear solutions without particles should be used. Exposure to 23° to 30° F (-1° to -5 °C) for up to 72 hours and temperatures as low as 5° to -13° F (-15 to -25° C) for up to 24 hours do not adversely affect the stability of tbo-filgrastim.
Single use syringe – discard unused portion. Any unused product or waste material should be disposed of in accordance with local requirements.
Manufactured by: Sicor Biotech UAB Vilnius, Lithuania, U.S. License No. 1803. Distributed by: Teva Pharmaceuticals USA, North Wales, PA 19454, Product of Israel. Revision 08/2012
Last reviewed on RxList: 10/12/2012
This monograph has been modified to include the generic and brand name in many instances.
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