Granix 480mcg/1.6ml Inj 1.6ml
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 growth factor
Pharmacologic Class
Granulocyte colony-stimulating factor (G-CSF) analog
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 neutrophils. These white blood cells are important for fighting infections. It's often used after chemotherapy, which can lower your white blood cell count and make you more prone to infections.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. 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 the outer area of the upper arm.
Continue taking this medication as directed by your doctor or healthcare provider, even if you're feeling well. If you're self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Preparing the Injection
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 any signs of damage or contamination, such as cloudiness, leakage, particles, or a change in color. Do not use the medication if you notice any of these issues. Also, do not shake the solution.
Administering the Injection
Wash your hands before and after giving the injection. Choose a skin area that is not irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Avoid injecting within 2 inches (5 cm) of the belly button. Rotate the injection site with each use to minimize skin irritation.
Disposing of Used Needles and Syringes
Each prefilled syringe is for single use only. Discard any remaining medication after use and dispose of the needle in a sharps disposal container. Do not reuse needles or other materials. When the container is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Handling and Storage
Do not use this 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 it in your eyes, flush with cool water and seek medical attention.
Storage and Disposal
Store this medication in the refrigerator, but do not freeze. If you miss a dose, contact your doctor for guidance on what to do.
To use this medication correctly, follow your doctor's instructions and read all the information provided. 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 the outer area of the upper arm.
Continue taking this medication as directed by your doctor or healthcare provider, even if you're feeling well. If you're self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Preparing the Injection
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 any signs of damage or contamination, such as cloudiness, leakage, particles, or a change in color. Do not use the medication if you notice any of these issues. Also, do not shake the solution.
Administering the Injection
Wash your hands before and after giving the injection. Choose a skin area that is not irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks. Avoid injecting within 2 inches (5 cm) of the belly button. Rotate the injection site with each use to minimize skin irritation.
Disposing of Used Needles and Syringes
Each prefilled syringe is for single use only. Discard any remaining medication after use and dispose of the needle in a sharps disposal container. Do not reuse needles or other materials. When the container is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Handling and Storage
Do not use this 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 it in your eyes, flush with cool water and seek medical attention.
Storage and Disposal
Store this medication in the refrigerator, but do not freeze. If you miss a dose, contact your doctor for guidance on what to do.
Lifestyle & Tips
- Maintain good hygiene to reduce infection risk (e.g., frequent hand washing).
- Avoid crowded places or contact with sick individuals, especially during periods of low white blood cell counts.
- Report any signs of infection (fever, chills, sore throat) immediately to your healthcare provider.
- Stay well-hydrated as advised by your doctor.
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:
5 mcg/kg/day SC, starting 24-72 hours after chemotherapy, continued until ANC > 10,000 cells/mm³ after nadir.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
5 mcg/kg/day SC, starting 24-72 hours after chemotherapy, continued until ANC > 10,000 cells/mm³ after nadir.
Adolescent:
5 mcg/kg/day SC, starting 24-72 hours after chemotherapy, continued until ANC > 10,000 cells/mm³ after nadir.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended, but monitor ANC closely.
Dialysis:
No specific dose adjustment recommended, but monitor ANC closely.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
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:
4-6 hours (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
0.09 L/kg
ProteinBinding:
Low
CnssPenetration:
Limited
Elimination:
HalfLife:
3-4 hours
Clearance:
0.4-0.6 mL/min/kg
ExcretionRoute:
Renal and neutrophil-mediated degradation
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within 24 hours (increase in ANC)
PeakEffect:
2-5 days (peak ANC)
DurationOfAction:
ANC returns to baseline within 2-3 days after discontinuation.
Safety & Warnings
Side Effects
Serious 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 experience any of the following symptoms, contact your doctor immediately or seek medical attention:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of lung or breathing problems, such as:
+ Shortness of breath or difficulty breathing
+ Cough
+ Fever
Signs of bleeding, including:
+ 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
+ Uncontrollable 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
Additional Serious Side Effects
Enlarged and ruptured spleens have been reported with this medication, sometimes resulting in death. If you experience left upper stomach pain or left shoulder pain, contact your doctor immediately.
Swelling of the aorta (the main blood vessel that comes out of the heart) has been reported. If you feel extremely tired or weak, contact your doctor right away.
If you experience fever, stomach pain, or back pain, contact your doctor.
A bone marrow problem called myelodysplastic syndrome (MDS) and a type of leukemia have been reported 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 been reported with this medication. If you experience 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
+ Sudden weight gain
+ Swelling
+ Vomiting blood or coffee ground-like vomit
+ Black, tarry, or bloody stools
Other Side Effects
Not all medications cause side effects, and many people experience only minor or no side effects. However, if you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Back, bone, joint, or muscle pain
Pain in arms or legs
Headache
Diarrhea
Upset stomach
Vomiting
Fatigue
Weakness
* Hair loss
This is not an exhaustive list of potential 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 experience any of the following symptoms, contact your doctor immediately or seek medical attention:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of lung or breathing problems, such as:
+ Shortness of breath or difficulty breathing
+ Cough
+ Fever
Signs of bleeding, including:
+ 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
+ Uncontrollable 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
Additional Serious Side Effects
Enlarged and ruptured spleens have been reported with this medication, sometimes resulting in death. If you experience left upper stomach pain or left shoulder pain, contact your doctor immediately.
Swelling of the aorta (the main blood vessel that comes out of the heart) has been reported. If you feel extremely tired or weak, contact your doctor right away.
If you experience fever, stomach pain, or back pain, contact your doctor.
A bone marrow problem called myelodysplastic syndrome (MDS) and a type of leukemia have been reported 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 been reported with this medication. If you experience 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
+ Sudden weight gain
+ Swelling
+ Vomiting blood or coffee ground-like vomit
+ Black, tarry, or bloody stools
Other Side Effects
Not all medications cause side effects, and many people experience only minor or no side effects. However, if you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Back, bone, joint, or muscle pain
Pain in arms or legs
Headache
Diarrhea
Upset stomach
Vomiting
Fatigue
Weakness
* Hair loss
This is not an exhaustive list of potential 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 (100.4°F or higher)
- Chills
- Sore throat or mouth sores
- Unusual bruising or bleeding
- Severe bone pain that is not relieved by over-the-counter pain relievers
- Sudden severe pain in your left upper abdomen or shoulder (could be a sign of splenic rupture)
- Difficulty breathing, shortness of breath, or new cough (could be a sign of ARDS)
- Swelling of the face or lips, rash, or hives (signs of an allergic reaction)
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.
Potential Interactions with Other Medications or Health Conditions
This medication may interact with other medications or worsen certain health conditions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your health problems with your doctor, as they may affect the safety and efficacy of this medication.
* Before starting, stopping, or changing the dose of any medication, consult with your doctor to confirm that it is safe to do so in conjunction with 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.
Potential Interactions with Other Medications or Health Conditions
This medication may interact with other medications or worsen certain health conditions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your health problems with your doctor, as they may affect the safety and efficacy of this medication.
* Before starting, stopping, or changing the dose of any medication, consult with your doctor to confirm that it is safe to do so in conjunction with 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 understand the best timing for your treatment.
Regular monitoring of your blood work and other laboratory tests is necessary, as directed by your doctor. This medication may interfere with certain lab tests, so it is vital to notify all your healthcare providers and laboratory personnel that you are taking this drug.
If you have sickle cell disease, be aware that this medication may cause your condition to worsen, which in some cases can be fatal. It is crucial 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.
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 understand the best timing for your treatment.
Regular monitoring of your blood work and other laboratory tests is necessary, as directed by your doctor. This medication may interfere with certain lab tests, so it is vital to notify all your healthcare providers and laboratory personnel that you are taking this drug.
If you have sickle cell disease, be aware that this medication may cause your condition to worsen, which in some cases can be fatal. It is crucial 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.
Overdose Information
Overdose Symptoms:
- Exaggerated pharmacologic effects (e.g., extremely high white blood cell counts)
- Bone pain
What to Do:
Treatment is supportive. Monitor white blood cell counts and discontinue tbo-filgrastim. Call 1-800-222-1222 (Poison Control) for further guidance.
Drug Interactions
Major Interactions
- Lithium (may potentiate the myeloproliferative effects of tbo-filgrastim, requiring careful monitoring of neutrophil counts)
Moderate Interactions
- Chemotherapy (do not administer tbo-filgrastim within 24 hours before or after cytotoxic chemotherapy due to potential for increased myelosuppression)
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 during chemotherapy cycles, or as clinically indicated.
Target: Goal is to achieve ANC > 10,000 cells/mm³ after the chemotherapy-induced nadir.
Action Threshold: Discontinue tbo-filgrastim when ANC reaches target, or if ANC > 10,000 cells/mm³ after the expected nadir.
CBC with differential
Frequency: Regularly during therapy, especially during recovery phase.
Target: Not applicable (trend monitoring)
Action Threshold: Monitor for other cytopenias or unexpected changes.
Symptom Monitoring
- Bone pain (common, usually mild to moderate, can be managed with non-opioid analgesics)
- Fever or signs of infection (despite increased ANC, patients may still be immunocompromised)
- Left upper abdominal pain or shoulder pain (potential splenic rupture)
- Dyspnea, cough, fever (potential acute respiratory distress syndrome - ARDS)
- Rash, urticaria, facial swelling (allergic reactions)
- Hematuria, proteinuria (glomerulonephritis)
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 unknown whether tbo-filgrastim is excreted in human milk. Due to the potential for serious adverse reactions in breastfed 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:
Risk unknown; potential for adverse effects on infant hematopoiesis.
Pediatric Use
Safety and effectiveness have been established in pediatric patients 1 month to 17 years of age with chemotherapy-induced neutropenia. Dosing is weight-based (5 mcg/kg/day).
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects (≥65 years) and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. No specific dose adjustment is required.
Clinical Information
Clinical Pearls
- Administer tbo-filgrastim at least 24 hours after cytotoxic chemotherapy and at least 24 hours before subsequent chemotherapy.
- Do not administer tbo-filgrastim within 24 hours of radiation therapy.
- Patients should be instructed on proper subcutaneous injection technique if self-administering.
- Store refrigerated (2°C to 8°C / 36°F to 46°F). Do not freeze. Protect from light.
- Allow the syringe to reach room temperature for 30 minutes before injection.
- Discard any unused portion; Granix is a single-dose vial/syringe.
Alternative Therapies
- Filgrastim (Neupogen, Zarxio, Nivestym, etc.)
- Pegfilgrastim (Neulasta, Fulphila, Udenyca, etc.)
- Sargramostim (Leukine - GM-CSF)
Cost & Coverage
Average Cost:
High (typically several thousand dollars) per vial/syringe
Insurance Coverage:
Specialty Tier (requires prior authorization and often limited to specific indications)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.