Tbo-filgrastim

What is Tbo-filgrastim?

• Tbo-filgrastim (GRANIX) is a leukocyte growth factor used to treat severe neutropenia (a condition in which there is a lower-than-normal number of white blood cells) caused by some types of chemotherapy.

Filgrastim

What are the uses of this medicine?

This medicine:

• used in people with certain types of cancer (non-myeloid malignancies), who are receiving chemotherapy that affects the bone marrow
• given to help decrease the length of time that the number of certain white blood cells (neutrophils) are very low (severe neutropenia). Neutrophils are white blood cells that are important in fighting bacterial infections.

How does this medicine work?

• Tbo-filgrastim is a human granulocyte colony-stimulating factor (G-CSF) produced by recombinant DNA technology.
• Tbo-filgrastim binds to G-CSF receptors and stimulates proliferation of neutrophils.
• G-CSF is known to stimulate differentiation commitment and some end-cell functional activation, which increases neutrophil counts and activity.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have had a serious allergic reaction to filgrastim products or pegfligrastim products.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with GRANIX.

Is this medicine FDA approved?

• Initial U.S. Approval: 2012

How should this medicine be used?

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.

Administration:

• GRANIX is given by an injection under your skin (subcutaneous) by a healthcare provider. Your healthcare provider may decide injections can be given at home by you or your caregiver. If GRANIX is given at home, see the detailed “Instructions for Use” that comes with your GRANIX for information on how to prepare and inject a dose of GRANIX.
• Your healthcare provider will show you and your caregiver how to prepare and inject GRANIX before you use it.
• Your healthcare provider will tell you how much GRANIX to inject and when to inject it. Do not stop using GRANIX or change your dose unless your healthcare provider tells you to.
• GRANIX injections are usually given 1 time each day until your white blood cell count returns to normal.
• Your first dose of GRANIX is given at least 24 hours after you receive your chemotherapy.
• Do not inject GRANIX within 24 hours before your next dose of chemotherapy.
• Your healthcare provider will test your blood before your chemotherapy and during treatment with GRANIX.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Prefilled Syringe

• Injection: 300 mcg/0.5 mL solution in single-dose prefilled syringe
• Injection: 480 mcg/0.8 mL solution in single-dose prefilled syringe

Vial

• Injection: 300 mcg/1 mL solution in single-dose vials
• Injection: 480 mcg/1.6 mL solution in single-dose vials

This medicine is available in fallowing brand namesː

• GRANIX

What side effects can this medication cause?

The most common side effects of this medicine include:

• bone pain

Other possible side effects of other filgrastim products that may also happen with GRANIX may include muscle aches (myalgia), headache, weakness, diarrhea, fatigue, vomiting, inflamed blood vessels in the skin (cutaneous vasculitis), low platelet count (thrombocytopenia), and Sweet’s syndrome (a rare skin condition that mainly includes fever and painful skin lesions that appear mostly on the arms, neck, head and trunk).

GRANIX can cause serious side effects, including:

• Spleen rupture
• A serious lung problem called acute respiratory distress syndrome (ARDS)
• Serious allergic reactions
• Sickle cell crisis
• Kidney injury (glomerulonephritis)
• Capillary Leak Syndrome
• Inflammation of the aorta (aortitis)

What special precautions should I follow?

• Splenic rupture, including fatal cases, can occur following 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) 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, including anaphylaxis, can occur in patients receiving GRANIX. Permanently discontinue GRANIX in patients with serious allergic reactions .
• 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 can occur in patients receiving filgrastim products. Evaluate and consider dose-reduction or interruption of GRANIX if causality is likely.
• Capillary leak syndrome (CLS) can occur in patients receiving filgrastim products and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Monitor if symptoms develop and administer standard symptomatic treatment.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• The limited published data on filgrastim product use during pregnancy are insufficient to inform a drug-associated risk.
• GRANIX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• The safety and effectiveness of GRANIX have been established for pediatric patients 1 month to < 17 years old.

What are the active and inactive ingredients in this medicine?

• Active ingredient: tbo-filgrastim
• Inactive ingredients: glacial acetic acid, polysorbate 80, sorbitol, sodium hydroxide, and Water for Injection

Who manufactures and distributes this medicine?

• Manufactured by:

UAB Teva Baltics Vilnius, Lithuania

• Distributed by:

Teva Pharmaceuticals USA, Inc. North Wales, PA

What should I know about storage and disposal of this medication?

• Store GRANIX in the refrigerator between 36˚F to 46˚F (2˚C to 8˚C).
• Keep GRANIX way from light to protect it. If your GRANIX prefilled syringe or vial comes in a carton, keep it in the carton until you are ready to use it, to protect from light.
• Do not shake.
• Take GRANIX out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.
• GRANIX can be left at room temperature for up to 5 days. If not used within 5 days, return GRANIX back to the refrigerator. Throw away (dispose of) GRANIX that has been left at room temperature for more than 5 days.
• After you inject your dose, throw away (dispose of) any unused GRANIX left in the syringe or the vial. Do not save unused GRANIX in the syringe or vial for later use.

• Dailymed label info on Tbo-filgrastim
• FDA Tbo-filgrastim

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