Granix 480mcg/1.6ml Inj 10x1.6ml
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 agent
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 medicine that helps your body make more white blood cells called neutrophils. These cells are important for fighting infections, especially after you've had 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 also be given 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'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, such as cloudiness, leakage, or particles, and do not use it if you notice any of these issues. Also, do not use the medication if the solution has changed color. Gently handle the syringe to avoid shaking 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 Syringes and Needles
Each prefilled syringe is for single use only. Discard any remaining medication after use and dispose of the syringe and needle in a designated sharps disposal container. Do not reuse needles or other items. 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 also be given 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'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, such as cloudiness, leakage, or particles, and do not use it if you notice any of these issues. Also, do not use the medication if the solution has changed color. Gently handle the syringe to avoid shaking 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 Syringes and Needles
Each prefilled syringe is for single use only. Discard any remaining medication after use and dispose of the syringe and needle in a designated sharps disposal container. Do not reuse needles or other items. 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
- Maintain good hygiene to reduce infection risk (e.g., frequent hand washing).
- Avoid crowded places or contact with sick individuals, especially when white blood cell counts are low.
- Report any signs of infection (fever, chills, sore throat) immediately to your healthcare provider.
- Report any new or worsening pain in your left upper abdomen or shoulder, as this could be a sign of a serious spleen problem.
- Stay well-hydrated.
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 administered subcutaneously, starting no earlier than 24 hours after chemotherapy and no later than 72 hours after chemotherapy. Continue daily until the ANC has reached 10,000 cells/mm³ after the expected chemotherapy-induced neutrophil nadir.
Pediatric Dosing
Neonatal:
Not established
Infant:
Safety and efficacy established in pediatric patients 1 month to 21 years for chemotherapy-induced neutropenia, dosing is typically 5 mcg/kg/day.
Child:
Safety and efficacy established in pediatric patients 1 month to 21 years for chemotherapy-induced neutropenia, dosing is typically 5 mcg/kg/day.
Adolescent:
Safety and efficacy established in pediatric patients 1 month to 21 years for chemotherapy-induced neutropenia, dosing is typically 5 mcg/kg/day.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment recommended.
Moderate:
No dosage adjustment recommended.
Severe:
No dosage adjustment recommended.
Dialysis:
No specific dosage adjustment recommendations; monitor ANC closely.
Hepatic Impairment:
Mild:
No dosage adjustment recommended.
Moderate:
No dosage adjustment recommended.
Severe:
No dosage 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 33% (subcutaneous)
Tmax:
3-6 hours (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Not available
ProteinBinding:
Not available
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 3-4 hours (subcutaneous)
Clearance:
Not available (primarily receptor-mediated and renal)
ExcretionRoute:
Renal and receptor-mediated uptake
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within 24 hours (neutrophil increase)
PeakEffect:
Days 3-5 of treatment
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 or seek immediate 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 on the skin
Swelling
Numbness or tingling
Additional Serious Side Effects
Enlarged and ruptured spleens have been reported 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 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.
Rare but Serious Conditions
A bone marrow disorder called myelodysplastic syndrome (MDS) and a type of leukemia have been reported in people taking this medication, particularly those with pre-existing low white blood cell counts 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
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 do not resolve, contact your doctor:
Back, bone, joint, or muscle pain
Pain in arms or legs
Headache
Diarrhea
Upset stomach or vomiting
Fatigue or weakness
* 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 or seek immediate 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 on the skin
Swelling
Numbness or tingling
Additional Serious Side Effects
Enlarged and ruptured spleens have been reported 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 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.
Rare but Serious Conditions
A bone marrow disorder called myelodysplastic syndrome (MDS) and a type of leukemia have been reported in people taking this medication, particularly those with pre-existing low white blood cell counts 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
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 do not resolve, contact your doctor:
Back, bone, joint, or muscle pain
Pain in arms or legs
Headache
Diarrhea
Upset stomach or vomiting
Fatigue or weakness
* 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 (100.4°F or higher)
- Chills or shaking
- Sore throat or mouth sores
- Unusual bruising or bleeding
- Severe bone pain
- Left upper abdominal pain or shoulder pain
- Difficulty breathing or shortness of breath
- Rash or hives
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. Be sure to describe the allergic reaction and its symptoms.
If you are breastfeeding, as 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 drugs, natural products, and vitamins.
Any existing health problems, 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. Be sure to describe the allergic reaction and its symptoms.
If you are breastfeeding, as 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 drugs, natural products, and vitamins.
Any existing health problems, 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 blood tests and other laboratory assessments are crucial while taking this medication. Adhere to the schedule recommended by your doctor for these tests.
This drug may interfere with the accuracy of certain laboratory tests. Therefore, it is vital to disclose that you are taking this medication to all your healthcare providers and laboratory personnel.
If you have sickle cell disease, 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 implications.
If you are pregnant or planning to become pregnant, consult your doctor to weigh the benefits and risks associated with using this drug 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 blood tests and other laboratory assessments are crucial while taking this medication. Adhere to the schedule recommended by your doctor for these tests.
This drug may interfere with the accuracy of certain laboratory tests. Therefore, it is vital to disclose that you are taking this medication to all your healthcare providers and laboratory personnel.
If you have sickle cell disease, 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 implications.
If you are pregnant or planning to become pregnant, consult your doctor to weigh the benefits and risks associated with using this drug during pregnancy. This discussion will help you make an informed decision about your care.
Overdose Information
Overdose Symptoms:
- Symptoms of overdose are not well-established but may include exaggerated pharmacological effects such as marked leukocytosis (extremely high white blood cell count) and bone pain.
What to Do:
Treatment is supportive. Monitor white blood cell counts and manage symptoms. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Moderate Interactions
- Chemotherapy and radiation therapy: Do not administer tbo-filgrastim in the period 24 hours before through 24 hours after cytotoxic chemotherapy or radiation therapy 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
Complete Blood Count (CBC) with differential
Frequency: Daily or every other day
Target: ANC > 10,000 cells/mm³ after nadir (for discontinuation)
Action Threshold: Discontinue when ANC reaches target after nadir.
Platelet count
Frequency: Regularly during treatment
Target: Normal range
Action Threshold: Monitor for thrombocytopenia, especially in patients receiving myelosuppressive chemotherapy.
Signs and symptoms of splenic rupture
Frequency: Throughout treatment
Target: Absence of symptoms
Action Threshold: Prompt evaluation for left upper abdominal pain or shoulder pain.
Signs and symptoms of Acute Respiratory Distress Syndrome (ARDS)
Frequency: Throughout treatment
Target: Absence of symptoms
Action Threshold: Prompt evaluation for fever, lung infiltrates, or respiratory distress.
Symptom Monitoring
- Fever
- Signs of infection (e.g., chills, sore throat)
- Bone pain
- Left upper abdominal pain or shoulder pain (splenic rupture)
- Shortness of breath, cough, fever (ARDS)
- Rash, urticaria, facial swelling (allergic reactions)
- Hematuria or dark urine (glomerulonephritis)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of tbo-filgrastim in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Risk unknown; animal studies have shown adverse effects at high doses.
Second Trimester:
Risk unknown; animal studies have shown adverse effects at high doses.
Third Trimester:
Risk unknown; animal studies have shown adverse effects at high doses.
Lactation
It is unknown whether tbo-filgrastim is excreted in human milk. The decision to discontinue nursing or to discontinue the drug should take into account the importance of the drug to the mother.
Infant Risk:
Risk unknown; potential for serious adverse reactions in breastfed infants.
Pediatric Use
Safety and efficacy have been established in pediatric patients 1 month to 21 years of age with chemotherapy-induced neutropenia. Dosing is typically 5 mcg/kg/day. The safety and effectiveness in neonates (less than 1 month of age) have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects (≥65 years) and younger subjects. Dosage adjustment is generally not required based on age alone.
Clinical Information
Clinical Pearls
- Administer tbo-filgrastim no earlier than 24 hours after cytotoxic chemotherapy and no later than 72 hours after chemotherapy.
- Do not administer tbo-filgrastim concurrently with chemotherapy or radiation therapy.
- Monitor CBC with differential regularly until ANC has recovered to target levels.
- Educate patients on symptoms of splenic rupture (left upper abdominal pain, shoulder pain) and ARDS (fever, shortness of breath, cough) and to seek immediate medical attention if they occur.
- 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) for some patients.
Alternative Therapies
- Filgrastim (Neupogen, Zarxio, Nivestym, Releuko, etc.)
- Pegfilgrastim (Neulasta, Fulphila, Udenyca, Ziextenzo, Nyvepria, Stimufend, etc.)
- Sargramostim (Leukine) - GM-CSF
Cost & Coverage
Average Cost:
Highly variable, typically several hundred to over a thousand USD per dose per 1.6ml vial
Insurance Coverage:
Tier 3 or 4 (Specialty Drug)
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 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 details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.