Granix 300mcg/0.5ml Inj, 0.5ml
It is used to lower the chance of getting an infection in people with bone marrow problems caused by chemo.It is used to raise the number of white blood cells in certain patients.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Hematopoietic agent
Pharmacologic Class
Granulocyte colony-stimulating factor (G-CSF)
Pregnancy Category
Category C
FDA Approved
Aug 2012
DEA Schedule
Not Controlled
Overview
What is this medicine?
Granix is a medicine that helps your body make more white blood cells, specifically a type called neutrophils. These cells are important for fighting infections. It is often used after chemotherapy to help prevent serious infections when your white blood cell count is low.
How to Use This Medicine
Proper Administration of This Medication
To ensure safe and effective use, follow your doctor's instructions and read all provided information carefully. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If someone else is giving you the injection, it may be administered in the buttocks or outer area of the upper arm.
Continue taking this medication as directed by your doctor or healthcare provider, even if you feel well. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Preparation and Administration
To minimize discomfort, remove the medication from the refrigerator and let it sit at room temperature for at least 30 minutes before use. Do not remove the cap or cover, and avoid heating the medication. Check the solution for cloudiness, leakage, or particles, and do not use if it has changed color. Do not shake the solution.
Wash your hands before and after administering the injection. Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Do not inject within 2 inches (5 cm) of the belly button. Rotate the injection site with each use.
Disposal and Safety
Each prefilled syringe is for single use only. Discard any remaining medication after administration, and dispose of needles in a designated sharps container. Do not reuse needles or other materials. When the container is full, follow local regulations for disposal. If you have questions, consult your doctor or pharmacist.
Do not use the medication if it has been dropped or damaged. If you accidentally get the medication on your skin, wash it off immediately with soap and water. If you get the medication in your eyes, flush with cool water and seek medical attention.
Storage and Handling
Store the medication in a refrigerator, but do not freeze. If you miss a dose, contact your doctor for guidance on what to do.
To ensure safe and effective use, follow your doctor's instructions and read all provided information carefully. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If someone else is giving you the injection, it may be administered in the buttocks or outer area of the upper arm.
Continue taking this medication as directed by your doctor or healthcare provider, even if you feel well. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Preparation and Administration
To minimize discomfort, remove the medication from the refrigerator and let it sit at room temperature for at least 30 minutes before use. Do not remove the cap or cover, and avoid heating the medication. Check the solution for cloudiness, leakage, or particles, and do not use if it has changed color. Do not shake the solution.
Wash your hands before and after administering the injection. Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Do not inject within 2 inches (5 cm) of the belly button. Rotate the injection site with each use.
Disposal and Safety
Each prefilled syringe is for single use only. Discard any remaining medication after administration, and dispose of needles in a designated sharps container. Do not reuse needles or other materials. When the container is full, follow local regulations for disposal. If you have questions, consult your doctor or pharmacist.
Do not use the medication if it has been dropped or damaged. If you accidentally get the medication on your skin, wash it off immediately with soap and water. If you get the medication in your eyes, flush with cool water and seek medical attention.
Storage and Handling
Store the medication in a refrigerator, but do not freeze. If you miss a dose, contact your doctor for guidance on what to do.
Lifestyle & Tips
- Practice good hand hygiene to prevent infections.
- Avoid crowded places and people who are sick.
- Report any signs of infection (fever, chills, sore throat) immediately to your doctor.
- Stay well-hydrated.
- Report any new or worsening pain, especially in your left upper abdomen or shoulder, as this could be a sign of a serious side effect (splenic rupture).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
5 mcg/kg/day administered subcutaneously
Dose Range:
5 - 10 mg
Condition-Specific Dosing:
chemotherapy-induced neutropenia:
Administer daily starting approximately 24 to 72 hours after completion of chemotherapy, and continue until the ANC has reached 10,000 cells/mm³ after the expected chemotherapy nadir.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Safety and efficacy not established in pediatric patients. Limited data suggest similar pharmacokinetics to adults, but specific dosing recommendations are not available.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment recommended.
Moderate:
No dose adjustment recommended.
Severe:
No dose adjustment recommended. Pharmacokinetics have not been formally studied in patients with severe renal impairment.
Dialysis:
No specific recommendations. Monitor ANC closely.
Hepatic Impairment:
Mild:
No dose adjustment recommended.
Moderate:
No dose adjustment recommended.
Severe:
No dose adjustment recommended. Pharmacokinetics have not been formally studied in patients with hepatic impairment.
Confidence:
Medium
Pharmacology
Mechanism of Action
Tbo-filgrastim is a recombinant human granulocyte colony-stimulating factor (G-CSF) that regulates the production and release of neutrophils from the bone marrow. It binds to specific G-CSF receptors on myeloid progenitor cells, stimulating their proliferation, differentiation, and functional activation, leading to an increase in neutrophil counts.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 30% (subcutaneous)
Tmax:
Approximately 3-8 hours (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 0.15-0.2 L/kg
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 3.2-5.4 hours
Clearance:
Approximately 0.4-0.9 mL/min/kg
ExcretionRoute:
Primarily via neutrophil-mediated degradation and renal excretion
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within 24 hours (increase in neutrophil counts)
PeakEffect:
Days 3-5 of daily administration
DurationOfAction:
Neutrophil counts return to baseline within 2-3 days after discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems: inability to pass urine, changes in urine output, blood in the urine, or significant weight gain
Signs of lung or breathing problems: shortness of breath, trouble breathing, cough, or fever
Signs of bleeding: vomiting or coughing up blood, vomit that resembles coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrolled bleeding
Dark urine
Rapid heartbeat
Dizziness or fainting
Excessive sweating
Rapid breathing
Chest pain
Purple spots or redness of the skin
Swelling
Numbness or tingling
Specific Warnings:
Enlarged and ruptured spleens have occurred with this medication, sometimes leading to fatal outcomes. If you experience left upper stomach pain or left shoulder pain, contact your doctor immediately.
Swelling of the aorta (the main blood vessel that arises from the heart) has occurred with this medication. If you feel extremely tired or weak, contact your doctor right away.
If you experience fever, stomach pain, or back pain, contact your doctor.
Rare but Serious Conditions:
A bone marrow disorder called myelodysplastic syndrome (MDS) and a type of leukemia have occurred in people taking this medication, particularly those with low white blood cell counts at birth or those undergoing chemotherapy or radiation for breast or lung cancer. If you experience fever, extreme fatigue, or unexplained bruising or bleeding, contact your doctor immediately.
Capillary leak syndrome (CLS) is a potentially life-threatening condition that has occurred with this medication. If you notice any of the following symptoms, contact your doctor right away: changes in urine output, inability to pass urine, blood in the urine, rapid or abnormal heartbeat, chest pain or pressure, dizziness or fainting, shortness of breath, significant weight gain, swelling, vomiting blood or coffee ground-like vomit, or black, tarry, or bloody stools.
Other Possible Side Effects:
While many people may not experience side effects or may only have mild side effects, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Back, bone, joint, or muscle pain
Pain in arms or legs
Headache
Diarrhea, upset stomach, or vomiting
Feeling tired or weak
Hair loss
Reporting Side Effects:
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems: inability to pass urine, changes in urine output, blood in the urine, or significant weight gain
Signs of lung or breathing problems: shortness of breath, trouble breathing, cough, or fever
Signs of bleeding: vomiting or coughing up blood, vomit that resembles coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrolled bleeding
Dark urine
Rapid heartbeat
Dizziness or fainting
Excessive sweating
Rapid breathing
Chest pain
Purple spots or redness of the skin
Swelling
Numbness or tingling
Specific Warnings:
Enlarged and ruptured spleens have occurred with this medication, sometimes leading to fatal outcomes. If you experience left upper stomach pain or left shoulder pain, contact your doctor immediately.
Swelling of the aorta (the main blood vessel that arises from the heart) has occurred with this medication. If you feel extremely tired or weak, contact your doctor right away.
If you experience fever, stomach pain, or back pain, contact your doctor.
Rare but Serious Conditions:
A bone marrow disorder called myelodysplastic syndrome (MDS) and a type of leukemia have occurred in people taking this medication, particularly those with low white blood cell counts at birth or those undergoing chemotherapy or radiation for breast or lung cancer. If you experience fever, extreme fatigue, or unexplained bruising or bleeding, contact your doctor immediately.
Capillary leak syndrome (CLS) is a potentially life-threatening condition that has occurred with this medication. If you notice any of the following symptoms, contact your doctor right away: changes in urine output, inability to pass urine, blood in the urine, rapid or abnormal heartbeat, chest pain or pressure, dizziness or fainting, shortness of breath, significant weight gain, swelling, vomiting blood or coffee ground-like vomit, or black, tarry, or bloody stools.
Other Possible Side Effects:
While many people may not experience side effects or may only have mild side effects, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Back, bone, joint, or muscle pain
Pain in arms or legs
Headache
Diarrhea, upset stomach, or vomiting
Feeling tired or weak
Hair loss
Reporting Side Effects:
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Fever (temperature 100.4°F or higher)
- Chills
- Sore throat
- Unusual bruising or bleeding
- Rash or hives
- Swelling of the face, lips, or tongue
- Difficulty breathing or wheezing
- Severe bone pain
- Left upper abdominal pain or shoulder pain
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are breastfeeding or plan to breastfeed. You should not breastfeed while taking this medication and for 2 weeks after your last dose.
To ensure safe treatment, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any health problems you have, as this medication may interact with other drugs or health conditions.
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are breastfeeding or plan to breastfeed. You should not breastfeed while taking this medication and for 2 weeks after your last dose.
To ensure safe treatment, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any health problems you have, as this medication may interact with other drugs or health conditions.
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To minimize potential interactions, do not take this drug at the same time as or within 24 hours before or after undergoing chemotherapy or radiation treatment. It is crucial to discuss this with your doctor to determine the best schedule for your treatment.
Regular blood work and other laboratory tests, as directed by your doctor, are necessary to monitor your condition while taking this medication. Additionally, be aware that this drug may interfere with certain lab tests, so it is vital to notify all your healthcare providers and laboratory personnel that you are taking this medication.
If you have sickle cell disease, it is crucial to be aware that this medication may cause your condition to worsen, which in some cases can be fatal. Therefore, it is essential to discuss this risk with your doctor.
If you are pregnant or planning to become pregnant, you must consult with your doctor to weigh the benefits and risks of using this medication during pregnancy. This discussion will help you make an informed decision about your treatment.
To minimize potential interactions, do not take this drug at the same time as or within 24 hours before or after undergoing chemotherapy or radiation treatment. It is crucial to discuss this with your doctor to determine the best schedule for your treatment.
Regular blood work and other laboratory tests, as directed by your doctor, are necessary to monitor your condition while taking this medication. Additionally, be aware that this drug may interfere with certain lab tests, so it is vital to notify all your healthcare providers and laboratory personnel that you are taking this medication.
If you have sickle cell disease, it is crucial to be aware that this medication may cause your condition to worsen, which in some cases can be fatal. Therefore, it is essential to discuss this risk with your doctor.
If you are pregnant or planning to become pregnant, you must consult with your doctor to weigh the benefits and risks of using this medication during pregnancy. This discussion will help you make an informed decision about your treatment.
Overdose Information
Overdose Symptoms:
- Extreme leukocytosis (very high white blood cell count)
- Bone pain
What to Do:
Treatment is generally supportive. Monitor white blood cell counts and discontinue the drug. Call 1-800-222-1222 (Poison Control) for further guidance.
Drug Interactions
Major Interactions
- Lithium: May potentiate the myeloproliferative effects of tbo-filgrastim. Monitor neutrophil counts more frequently.
Moderate Interactions
- Myelosuppressive antineoplastic agents: Do not administer tbo-filgrastim within 24 hours before or after administration of cytotoxic chemotherapy due to the potential for increased sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline neutrophil count and assess overall hematologic status before initiating therapy.
Timing: Prior to first dose of tbo-filgrastim
Routine Monitoring
Absolute Neutrophil Count (ANC)
Frequency: Daily or every other day
Target: Goal is to achieve ANC ≥ 10,000 cells/mm³ after the expected chemotherapy nadir.
Action Threshold: Discontinue tbo-filgrastim when ANC reaches target. If ANC > 10,000 cells/mm³ before nadir, consider holding dose.
CBC with differential
Frequency: Regularly during therapy (e.g., 2-3 times per week)
Target: Not applicable (monitoring for trends)
Action Threshold: Monitor for leukocytosis (WBC > 100,000 cells/mm³), which may warrant dose reduction or interruption.
Symptom Monitoring
- Fever or signs of infection (e.g., chills, sore throat)
- Bone pain (common side effect)
- Signs of allergic reaction (e.g., rash, urticaria, facial swelling, dyspnea)
- Signs of splenic rupture (e.g., left upper abdominal pain, shoulder pain)
- Signs of acute respiratory distress syndrome (ARDS) (e.g., fever, dyspnea, pulmonary infiltrates)
- Signs of glomerulonephritis (e.g., edema, proteinuria, hematuria)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for adverse developmental effects based on animal studies.
Second Trimester:
Potential for adverse developmental effects based on animal studies.
Third Trimester:
Potential for adverse developmental effects based on animal studies.
Lactation
It is not known whether tbo-filgrastim is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Not available (potential for serious adverse reactions)
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Limited data suggest similar pharmacokinetics to adults, but specific dosing recommendations are not available. Use is generally not recommended outside of specific clinical trials or compelling circumstances.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects. No dose adjustment is necessary based on age alone.
Clinical Information
Clinical Pearls
- Administer tbo-filgrastim at least 24 hours after chemotherapy and at least 24 hours before the next cycle of chemotherapy.
- Do not administer tbo-filgrastim within 24 hours before or after administration of cytotoxic chemotherapy.
- Patients should be instructed on proper subcutaneous injection technique if self-administering.
- Bone pain is a common side effect and can often be managed with non-opioid analgesics (e.g., acetaminophen, NSAIDs) or antihistamines (e.g., loratadine).
- Monitor for signs of splenic rupture (left upper abdominal pain, shoulder pain) and ARDS (fever, dyspnea, pulmonary infiltrates), though rare, these are serious adverse events.
- Granix is a biosimilar to filgrastim (Neupogen) but is not interchangeable with other filgrastim products without prescriber approval.
Alternative Therapies
- Filgrastim (e.g., Neupogen, Zarxio, Nivestym)
- Pegfilgrastim (e.g., Neulasta, Fulphila, Udenyca, Ziextenzo)
- Sargramostim (Leukine - GM-CSF)
Cost & Coverage
Average Cost:
Varies, typically several hundred to over a thousand USD per 0.5ml prefilled syringe
Insurance Coverage:
Specialty Tier (requires prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.