Granix

Last reviewed on RxList: 4/30/2019
Granix Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 4/30/2019

Granix (tbo-filgrastim) is a recombinant methionyl human granulocyte colony-stimulating growth factor (r-metHuG-CSF) used 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. Common side effects of Granix include:

Seek medical attention if you have signs of an allergic reaction after taking Granix, such as:

  • rash
  • shortness of breath
  • wheezing
  • dizziness
  • swelling of the face
  • fast heart rate
  • sweating

The recommended dose of Granix 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. Granix may interact with lithium. Tell your doctor all medications and supplements you use. During pregnancy, Tbo-filgrastim should be taken only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Granix (tbo-filgrastim) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

What is neutropenia? See Answer
Granix Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficult breathing; fast heart rate, sweating, feeling light-headed; swelling in your face, lips, tongue, or throat.

Capillary leak syndrome is a rare but serious side effect of tbo-filgrastim. Call your doctor right away if you have signs of this condition: stuffy or runny nose followed by weakness or tired feeling, and sudden swelling in your arms, legs and other parts of the body.

Call your doctor at once if you have:

  • stomach pain, back pain;
  • a general ill feeling;
  • signs of a kidney problem--blood in your urine, swelling in your face or ankles, little or no urination;
  • signs of infection--fever, redness, or swelling;
  • signs of acute respiratory distress syndrome--fever with shortness of breath or trouble breathing; or
  • signs of a ruptured spleen--pain in your upper stomach spreading to your left shoulder.

Common side effects may include:

  • bone pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Granix (Tbo-filgrastim Injection, for Subcutaneous Use)

Granix Professional Information

SIDE EFFECTS

The following potential serious adverse reactions are discussed in greater detail in other sections of the labeling:

  • Fatal Splenic Rupture [see WARNINGS AND PRECAUTIONS]
  • Acute Respiratory Distress Syndrome [see WARNINGS AND PRECAUTIONS]
  • Serious Allergic Reactions [see WARNINGS AND PRECAUTIONS]
  • Sickle Cell Disorders [see WARNINGS AND PRECAUTIONS]
  • Glomerulonephritis [see WARNINGS AND PRECAUTIONS]
  • Capillary Leak Syndrome [see WARNINGS AND PRECAUTIONS]
  • Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see WARNINGS AND PRECAUTIONS]
  • Leukocytosis [see WARNINGS AND PRECAUTIONS]
  • Simultaneous Use with Chemotherapy and Radiation Therapy Not Recommended [see WARNINGS AND PRECAUTIONS]
  • Aortitis [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Adverse Reactions In Adult Patients

GRANIX clinical trials safety data are based upon the results of three randomized clinical trials in patients receiving myeloablative chemotherapy for breast cancer (N=348), lung cancer (N=240) and non-Hodgkin’s lymphoma (N=92). In the breast cancer study, 99% of patients were female, the median age was 50 years, and 86% of patients were Caucasian. In the lung cancer study, 80% of patients were male, the median age was 58 years, and 95% of patients were Caucasian. In the non-Hodgkin’s lymphoma study, 52% of patients were male, the median age was 55 years, and 88% of patients were Caucasian. In all three studies a placebo (Cycle 1 of the breast cancer study only) or a non-US-approved filgrastim product were used as controls. Both GRANIX and the non-US-approved filgrastim product were administered at 5 mcg/kg subcutaneously once daily beginning one day after chemotherapy for at least five days and continued to a maximum of 14 days or until an ANC of ≥10,000 x 106/L after nadir was reached.

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-US-approved filgrastim product).

Leukocytosis

In clinical studies, leukocytosis (WBC counts > 100,000 x 106/L) was observed in less than 1% patients with non-myeloid malignancies receiving GRANIX. No complications attributable to leukocytosis were reported in clinical studies.

Additional Adverse Reactions

Other adverse reactions known to occur following administration of filgrastim products include myalgia, headache, vomiting, cutaneous vasculitis and thrombocytopenia.

Adverse Reactions In Pediatric Patients

GRANIX clinical trials safety data in pediatric patients are based upon the results of one single-arm clinical trial in 50 pediatric patients who received myelosuppressive chemotherapy for treatment of solid tumors without marrow involvement [see Use In Specific Populations]. In this study, GRANIX was administered at 5 mcg/kg subcutaneously once daily beginning one day after chemotherapy. The most common (>5%) adverse reactions included thrombocytopenia (34%), pyrexia (8%), pain in extremity (6%), headache (6%) and diarrhea (6%).

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay, and the observed incidence of antibody positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to GRANIX with the incidence of antibodies to other products may be misleading.

Binding antibodies to GRANIX were detected using a validated bridging immunoassay. Anti-drug antibodies to tbo-filgrastim occurred in 1.4 % of 486 adult and pediatric patients. None of these patients had cross-reactive antibodies to the native G-CSF. All antibody responses were transient and of low titers.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of GRANIX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Sweet’s syndrome (acute febrile neutrophilic dermatosis), asthenia, diarrhea, and fatigue

Read the entire FDA prescribing information for Granix (Tbo-filgrastim Injection, for Subcutaneous Use)

© Granix Patient Information is supplied by Cerner Multum, Inc. and Granix Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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