Granix (tbo-filgrastim)
Generic name: tbo-filgrastim · Brand names: GRANIX
Quick facts
Common use one line
Reduce the duration of severe neutropenia in adults and children 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs (Section 1)
What it is used for
Granix is used to shorten how long severe neutropenia lasts in adults and children 1 month and older who have non-myeloid cancers and get chemotherapy that often causes febrile neutropenia.
Source text (exact source wording)
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. (Section 1)
How it works
Granix is a lab-made version of G-CSF. It attaches to G-CSF receptors and makes the body produce more neutrophils.
Source text (exact source wording)
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. (Section 12.1)
Dosage: adults
The label dose is 5 mcg/kg per day as an injection under the skin. The first dose is no earlier than 24 hours after chemotherapy, and not within 24 hours before chemotherapy. Daily dosing continues until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Source text (exact source wording)
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. (Section 2.1)
Dosage: children
The dose in the label text read is 5 mcg/kg per day. Safety and effectiveness are established for children 1 month to under 17 years old; there is no data under 1 month old.
Source text (exact source wording)
Section 2.1 gives one recommended dose (5 mcg/kg per day, subcutaneous) without a separate pediatric dose in the text read. Section 8.4: The safety and effectiveness of GRANIX have been established for pediatric patients 1 month to < 17 years old (no data for the age group < 1 month old).
Storage
Keep Granix in the refrigerator at 36°F to 46°F (2°C to 8°C), away from light. It may be out of the refrigerator once for up to 5 days at 73°F to 81°F (23°C to 27°C). Do not shake it.
Source text (exact source wording)
Store GRANIX in a refrigerator at 36°F to 46°F (2°C to 8°C). Protect from light. Within its shelf life, the product may be removed from 36°F to 46°F (2°C to 8°C) storage for a single period of up to 5 days between 73°F to 81°F (23°C to 27°C). If not used within 5 days, the product may be returned to 36°F to 46°F (2°C to 8°C) up to the expiration date. Dispose of syringes if stored at room temperature for more than 5 days. Avoid shaking. (Section 16)
Boxed warning
NONE found in the label text read (no boxed warning appeared)Contraindications
Do not use Granix if you ever had a serious allergic reaction to filgrastim products or pegfilgrastim products.
Source text (exact source wording)
GRANIX is contraindicated in patients with a history of serious allergic reactions to filgrastim products or pegfilgrastim products [see Warnings and Precautions (5.3)]. (Section 4)
Warnings and precautions
Filgrastim products can cause the spleen to rupture, including fatal cases.
Heading
5.1 Splenic Rupture
Source text (exact source wording)
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.
A serious breathing problem called ARDS can occur.
Heading
5.2 Acute Respiratory Distress Syndrome
Source text (exact source wording)
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 happen, even on the first dose. Granix is stopped permanently if a serious allergic reaction happens.
Heading
5.3 Serious Allergic Reactions
Source text (exact source wording)
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 of the reactions. Permanently discontinue GRANIX in patients with serious allergic reactions.
Heading
5.4-5.13
Pregnancy and breastfeeding
Source text (exact source wording)
8.1 Pregnancy, Risk Summary: The limited published data on filgrastim product use during pregnancy are insufficient to inform a drug-associated risk. 8.2 Lactation: No data are available regarding the presence of tbo-filgrastim in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. Another filgrastim product was detected in human milk for up to 3 days after filgrastim administration. Because of the potential for serious adverse reactions in the breastfed child, including splenic rupture, acute respiratory distress syndrome and serious allergic reactions, advise patients not to breastfeed during treatment with GRANIX and for 2 weeks after the last dose.
Side effects
Common
In children, the most common reactions (more than 5%) included thrombocytopenia (34%), pyrexia (8%), pain in extremity (6%), headache (6%) and diarrhea (6%).
Source text (exact source wording)
Pediatric (Section 6.1): The most common (>5%) adverse reactions included thrombocytopenia (34%), pyrexia (8%), pain in extremity (6%), headache (6%) and diarrhea (6%). Threshold: >5%.
Less common
In adults, bone pain was the most frequent reaction (3.4% with Granix, 1.4% with placebo). Other reactions known with filgrastim products include myalgia, headache, vomiting, cutaneous vasculitis and thrombocytopenia.
Source text (exact source wording)
Adults (Section 6.1): Bone pain was the most frequent treatment-emergent adverse reaction that occurred in at least 1% or greater in patients treated with GRANIX at the recommended dose and was numerically two times more frequent than in the placebo group. The overall incidence of bone pain in Cycle 1 of treatment was 3.4% (3.4% GRANIX, 1.4% placebo, 7.5% non-U.S.-approved filgrastim product). Other adverse reactions known to occur following administration of filgrastim products include myalgia, headache, vomiting, cutaneous vasculitis and thrombocytopenia.
Serious
Reported after approval: Sweet's syndrome, asthenia, diarrhea, and fatigue. Serious warnings are in the warnings list.
Source text (exact source wording)
Postmarketing (Section 6.2): Sweet’s syndrome (acute febrile neutrophilic dermatosis), asthenia, diarrhea, and fatigue. Leukocytosis (Section 6.1): In clinical studies, leukocytosis (WBC counts > 100,000 x 106/L) was observed in less than 1% patients with non-myeloid malignancies receiving GRANIX. [MedlinePlus: NOT FOUND for Granix]
Patient tips
Tell your provider if you have sickle cell disorder, kidney problems, or plan bone scans. Call right away for left upper belly or left shoulder pain, or for shortness of breath or trouble breathing. Stop Granix and get help right away for signs of a serious allergic reaction.
Source
DailyMed Patient Information (Granix)
Source text (exact source wording)
GRANIX is a prescription medicine: used in adults and children 1 month of age and older 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). ... Do not take GRANIX if you have had a serious allergic reaction to filgrastim products or pegfilgrastim products. Before you receive GRANIX, tell your healthcare provider about all of your medical conditions, including if you: have a sickle cell disorder; have kidney problems; plan to have bone scans or tests. ... Spleen rupture. ... Call your healthcare provider right away if you have pain in your left upper stomach (abdomen)-area or your left shoulder during treatment with GRANIX. A serious lung problem called acute respiratory distress syndrome (ARDS). Call your healthcare provider or get emergency medical help right away if you have shortness of breath with or without fever, trouble breathing, or a fast rate of breathing. Serious allergic reactions. ... If you have any of these symptoms, stop using GRANIX and call your healthcare provider or get emergency help right away.
Alternatives
NOT FOUNDFrequently asked questions
Question
What is Granix used for?
Answer
Granix is used to shorten how long severe neutropenia lasts in adults and children 1 month and older who have non-myeloid cancers and get chemotherapy that often causes febrile neutropenia.
Source section
1
Source
DailyMed GRANIX label
Question
How is Granix given?
Answer
It is given as an injection under the skin. The label dose is 5 mcg/kg per day.
Source section
2.1
Source
DailyMed GRANIX label
Question
When is the first dose given?
Answer
No earlier than 24 hours after chemotherapy, and not within 24 hours before chemotherapy.
Source section
2.1
Source
DailyMed GRANIX label
Question
How should Granix be stored?
Answer
Keep it in the refrigerator at 36°F to 46°F (2°C to 8°C), away from light. Do not shake it.
Source section
16
Source
DailyMed GRANIX label
Question
Can I breastfeed while using Granix?
Answer
The label advises not to breastfeed during treatment and for 2 weeks after the last dose.
Source section
8.2
Source
DailyMed GRANIX label
Question
Who should not use Granix?
Answer
People who ever had a serious allergic reaction to filgrastim products or pegfilgrastim products.
Source section
4
Source
DailyMed GRANIX label
Question
What are the most common side effects in children?
Answer
More than 5% of children had thrombocytopenia (34%), pyrexia (8%), pain in extremity (6%), headache (6%) and diarrhea (6%).
Source section
6.1
Source
DailyMed GRANIX label
Sources
- DailyMed GRANIX (TBO-FILGRASTIM) INJECTION, SOLUTION, Cephalon, LLC
Set id: df918ec2-0907-443f-a52a-b72866959644 · Label effective or revised date: Revised: 11/2023 · Dailymed version date: DailyMed spls.json published_date Nov 17, 2025; archive table shows version published Sep 24, 2026 (inconsistent, unresolved) · Fetched at: 2026-11-02 · Sections used: 1,2,4,5.1-5.3,6,8.2,12.1,16,Patient Information (verbatim via printer-friendly page; 5.4-5.13, 8.1 full text, 8.4/8.5 detail not re-read) - MedlinePlus
Set id: NOT FOUND · Label effective or revised date: NOT FOUND · Fetched at: 2026-11-02 · Sections used: No Granix page found (only a generic filgrastim page, different product, not used) - Drugs@FDA
Set id: NOT FOUND · Label effective or revised date: NOT FOUND · Fetched at: 2026-11-02 · Sections used: not checked: NOT FOUND
Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug