Granix 480mcg/0.8ml Inj, 0.8ml
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
Not available
FDA Approved
Aug 2012
DEA Schedule
Not Controlled
Overview
What is this medicine?
Granix is a man-made protein similar to one your body naturally produces. It helps your body make more white blood cells called neutrophils. These cells are important for fighting infections, especially after certain types of chemotherapy that can lower your white blood cell count.
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 under 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 into 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'll be 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, and 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 dose 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 needles and syringes in a designated sharps 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 the medication 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 next.
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 under 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 into 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'll be 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, and 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 dose 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 needles and syringes in a designated sharps 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 the medication 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 next.
Lifestyle & Tips
- Report any new or worsening pain, especially in the left upper abdomen or shoulder, as this could be a sign of a serious spleen problem.
- Report any difficulty breathing, fever, or cough, as these could be signs of a serious lung problem.
- Avoid activities that could cause injury to the abdomen, especially if you experience spleen pain.
- Follow all instructions from your healthcare provider regarding administration and monitoring.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
5 mcg/kg/day administered subcutaneously
Dose Range:
5 - 5 mg
Condition-Specific Dosing:
chemotherapy-induced neutropenia:
Administer daily starting no earlier than 24 hours after chemotherapy, and continue until the Absolute Neutrophil Count (ANC) is >10,000 cells/mm3 after the expected nadir.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended
Moderate:
No specific dose adjustment recommended
Severe:
No specific dose adjustment recommended
Dialysis:
No specific dose adjustment recommended; monitor 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:
Not precisely quantified for subcutaneous, but well absorbed
Tmax:
3-8 hours (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 0.06 L/kg
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 3-4 hours
Clearance:
Not precisely quantified, but involves neutrophil-mediated degradation and renal excretion
ExcretionRoute:
Renal, neutrophil-mediated degradation
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within 24 hours (increase in neutrophil counts)
PeakEffect:
Days 3-5 after initiation of therapy
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, 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 other breathing difficulties
+ 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
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 comes out of the heart) has occurred with this medication. If you feel extremely tired or weak, contact your doctor right away.
If you have a fever, stomach pain, or back pain, contact your doctor.
Rare but Serious Conditions:
A bone marrow problem 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
+ Sudden weight gain
+ Swelling
+ Vomiting blood or coffee ground-like vomit
+ 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 contact your doctor if you notice any of the following:
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 about side effects or experience any side effects that bother you or do not go away, 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, 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 other breathing difficulties
+ 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
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 comes out of the heart) has occurred with this medication. If you feel extremely tired or weak, contact your doctor right away.
If you have a fever, stomach pain, or back pain, contact your doctor.
Rare but Serious Conditions:
A bone marrow problem 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
+ Sudden weight gain
+ Swelling
+ Vomiting blood or coffee ground-like vomit
+ 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 contact your doctor if you notice any of the following:
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 about side effects or experience any side effects that bother you or do not go away, 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:
- Severe bone pain
- Left upper abdominal pain or shoulder pain
- Shortness of breath, cough, fever (signs of ARDS)
- Swelling or puffiness, rapid weight gain, dizziness, lightheadedness (signs of capillary leak syndrome)
- Rash, hives, swelling of the face or mouth, difficulty breathing (signs of allergic reaction)
- Blood in urine or foamy urine (signs of glomerulonephritis)
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. Consult your doctor for personalized guidance.
Regular monitoring of your blood work and other laboratory tests is crucial, as directed by your doctor. Be aware that 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, it is crucial to be aware that this medication may exacerbate your condition, potentially leading to severe complications, including fatal outcomes. Discuss this risk with your doctor to understand the potential implications.
If you are pregnant or planning to become pregnant, consult 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 care.
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. Consult your doctor for personalized guidance.
Regular monitoring of your blood work and other laboratory tests is crucial, as directed by your doctor. Be aware that 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, it is crucial to be aware that this medication may exacerbate your condition, potentially leading to severe complications, including fatal outcomes. Discuss this risk with your doctor to understand the potential implications.
If you are pregnant or planning to become pregnant, consult 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 care.
Overdose Information
Overdose Symptoms:
- Increased white blood cell counts (leukocytosis)
- Bone pain
What to Do:
Treatment is generally supportive. Discontinuation of therapy usually results in a return of white blood cell counts to baseline. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Moderate Interactions
- Lithium (may potentiate the myeloproliferative effects of tbo-filgrastim; monitor neutrophil counts more frequently)
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: >10,000 cells/mm3 after expected nadir (for discontinuation)
Action Threshold: Discontinue when ANC is >10,000 cells/mm3 after the expected nadir following chemotherapy.
CBC with differential
Frequency: Regularly during therapy
Target: Not applicable (monitoring for trends)
Action Threshold: Monitor for signs of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) in patients with breast or lung cancer, or for other hematologic abnormalities.
Symptom Monitoring
- Bone pain
- Fever or other signs of infection
- Shortness of breath, cough, or fever (signs of Acute Respiratory Distress Syndrome - ARDS)
- Left upper abdominal pain or shoulder pain (signs of splenic rupture)
- Swelling or puffiness (signs of capillary leak syndrome)
- Rash, urticaria, facial swelling (signs of allergic reaction)
- Hematuria, proteinuria (signs of glomerulonephritis)
Special Patient Groups
Pregnancy
Tbo-filgrastim is classified as Pregnancy Category C (older classification). 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. Consider the potential for fetal harm.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm, but human data are limited.
Second Trimester:
Potential for fetal harm, but human data are limited.
Third Trimester:
Potential for fetal harm, but human data are limited.
Lactation
It is not known 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 cannot be excluded (L3 - Moderate risk)
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use is not recommended.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly (âĨ65 years) and younger patients. Dose adjustment is generally not required based on age alone.
Clinical Information
Clinical Pearls
- Granix should not be administered within 24 hours before or after cytotoxic chemotherapy.
- Do not administer Granix if the patient has a known history of serious allergic reactions to G-CSFs.
- Monitor for signs and symptoms of splenic rupture (left upper abdominal pain, shoulder pain) and ARDS (fever, dyspnea, pulmonary infiltrates).
- Patients with sickle cell trait or disease may be at increased risk of sickle cell crisis; monitor closely.
- Tbo-filgrastim is a G-CSF, similar to filgrastim, but it is not interchangeable unit-for-unit with other G-CSF products without consulting specific dosing guidelines.
Alternative Therapies
- Filgrastim (Neupogen, Zarxio, Nivestym, etc.)
- Pegfilgrastim (Neulasta, Fulphila, Udenyca, Ziextenzo, etc.)
- Sargramostim (Leukine - GM-CSF)
Cost & Coverage
Average Cost:
Varies widely, typically several thousand USD per 0.8ml 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 happened.