Granix 300mcg/1ml Inj Sol 10x1ml
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
Colony-Stimulating Factor
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 cells are crucial for fighting infections. It's often used after certain cancer treatments (chemotherapy) that can lower your white blood cell count, making you more susceptible 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 feel well. If you will 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 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 needles in a designated 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 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 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 feel well. If you will 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 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 needles in a designated 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 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
- Practice good hand hygiene frequently.
- Avoid contact with people who are sick or have infections.
- Report any signs of infection (fever, chills, sore throat) to your healthcare provider immediately.
- Do not shake the syringe; shaking may damage the protein.
- Store in the refrigerator, protect from light, and do not freeze.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
5 mcg/kg/day administered subcutaneously
Condition-Specific Dosing:
chemotherapy-induced neutropenia:
Initiate no less than 24 hours after cytotoxic chemotherapy. Continue daily until ANC is >10,000 cells/mm3 after 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, monitor closely
Moderate:
No specific dose adjustment recommended, monitor closely
Severe:
No specific dose adjustment recommended, monitor closely
Dialysis:
No specific dose adjustment recommended, monitor closely
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, monitor closely
Moderate:
No specific dose adjustment recommended, monitor closely
Severe:
No specific dose adjustment recommended, monitor closely
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:
3-8 hours (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 150 mL/kg
ProteinBinding:
Not significant
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 3-4 hours (range 2.1-7.7 hours)
Clearance:
Dose-dependent, primarily via neutrophil-mediated degradation and renal excretion
ExcretionRoute:
Renal
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within 24 hours (increase in neutrophil count)
PeakEffect:
Days 3-5 (peak ANC)
DurationOfAction:
Dependent on duration of therapy and underlying condition; neutrophil counts return to baseline within 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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate
+ 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 or 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 or ruptured spleen: If you experience left upper stomach pain or left shoulder pain, contact your doctor immediately, as ruptured spleens can be life-threatening.
Swelling of the aorta (main blood vessel): If you feel extremely tired or weak, contact your doctor right away.
Fever, stomach pain, or back pain: Contact your doctor if you experience any of these symptoms.
Myelodysplastic syndrome (MDS) or leukemia: If you have a fever, feel extremely tired, or experience unexplained bruising or bleeding, contact your doctor immediately, as these conditions can be associated with this medication.
Capillary leak syndrome (CLS): This is a rare but potentially life-threatening condition. If you experience any of the following symptoms, contact your doctor right away:
+ Changes in urine output
+ Inability to urinate
+ 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 everyone will experience side effects, and many people may only have mild symptoms. However, if you notice any of the following side effects or if they persist or bother you, contact your doctor:
Back, bone, joint, or muscle pain
Pain in the arms or legs
Headache
Diarrhea, upset stomach, or vomiting
Feeling tired or weak
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 notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate
+ 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 or 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 or ruptured spleen: If you experience left upper stomach pain or left shoulder pain, contact your doctor immediately, as ruptured spleens can be life-threatening.
Swelling of the aorta (main blood vessel): If you feel extremely tired or weak, contact your doctor right away.
Fever, stomach pain, or back pain: Contact your doctor if you experience any of these symptoms.
Myelodysplastic syndrome (MDS) or leukemia: If you have a fever, feel extremely tired, or experience unexplained bruising or bleeding, contact your doctor immediately, as these conditions can be associated with this medication.
Capillary leak syndrome (CLS): This is a rare but potentially life-threatening condition. If you experience any of the following symptoms, contact your doctor right away:
+ Changes in urine output
+ Inability to urinate
+ 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 everyone will experience side effects, and many people may only have mild symptoms. However, if you notice any of the following side effects or if they persist or bother you, contact your doctor:
Back, bone, joint, or muscle pain
Pain in the arms or legs
Headache
Diarrhea, upset stomach, or vomiting
Feeling tired or weak
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
- Unusual bleeding or bruising
- Severe bone pain
- Sudden left upper abdominal pain or shoulder pain (may indicate splenic rupture)
- Difficulty breathing, shortness of breath, cough, or fever (may indicate ARDS)
- Rash, hives, swelling of the face, lips, tongue, or throat (signs of 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.
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 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 life-threatening. 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 life-threatening. 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 pharmacological effects such as severe bone pain
- Marked leukocytosis (extremely high white blood cell count)
What to Do:
Management is supportive. Discontinuation of therapy and close monitoring of white blood cell counts are recommended. Call 1-800-222-1222 (Poison Control Center) for further guidance.
Drug Interactions
Moderate Interactions
- Chemotherapy agents (administer Granix no less than 24 hours after chemotherapy)
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline neutrophil count and assess overall hematologic status.
Timing: Prior to initiation of therapy
Routine Monitoring
Absolute Neutrophil Count (ANC)
Frequency: Daily or every other day during chemotherapy cycles
Target: Guidance for continuation or discontinuation of therapy (e.g., >10,000 cells/mm3 after expected nadir)
Action Threshold: Discontinue when ANC reaches target or as clinically indicated.
Complete Blood Count (CBC) with differential
Frequency: Regularly during therapy
Target: Not applicable
Action Threshold: Monitor for leukocytosis (WBC >100,000 cells/mm3) and other cytopenias.
Symptom Monitoring
- Fever (signs of infection)
- Chills
- Sore throat
- Severe bone pain
- Left upper abdominal pain or shoulder pain (possible splenic rupture)
- Difficulty breathing, cough, fever (possible Acute Respiratory Distress Syndrome - ARDS)
- Rash, urticaria, facial swelling (allergic reactions)
Special Patient Groups
Pregnancy
Category C. 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:
Potential risk to fetus, but human data are lacking.
Second Trimester:
Potential risk to fetus, but human data are lacking.
Third Trimester:
Potential risk to fetus, but human data are lacking.
Lactation
L3 (Moderate Risk). No human data are available on the presence of tbo-filgrastim in human milk, the effects on the breastfed infant, or the effects on milk production. Due to its large protein nature, transfer into milk is likely low, and oral absorption by the infant is unlikely. Caution should be exercised when tbo-filgrastim is administered to a nursing mother.
Infant Risk:
Low systemic exposure expected in breastfed infant due to large molecular weight and poor oral bioavailability.
Pediatric Use
Safety and effectiveness of Granix have not been established in pediatric patients. While G-CSFs are used in pediatric oncology, specific dosing and safety for tbo-filgrastim in this population are not fully established in the prescribing information.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects (âĨ65 years) and younger subjects. No specific dose adjustment is required based on age alone, but monitor for adverse effects.
Clinical Information
Clinical Pearls
- Granix should not be administered within 24 hours before or after cytotoxic chemotherapy due to the potential for increased myelosuppression.
- Administer Granix by subcutaneous injection. Do not shake the syringe.
- Monitor Absolute Neutrophil Count (ANC) closely to guide the duration of therapy and ensure appropriate response.
- Educate patients on the importance of reporting any signs of infection (fever, chills) or symptoms of splenic rupture (left upper abdominal pain, shoulder pain) immediately.
- Bone pain is a common side effect and can often be managed with non-opioid analgesics.
Alternative Therapies
- Filgrastim (e.g., Neupogen, Zarxio, Nivestym)
- Pegfilgrastim (e.g., Neulasta, Fulphila, Udenyca, Ziextenzo)
- Sargramostim (Leukine)
Cost & Coverage
Average Cost:
$2,000 - $4,000+ per 10x1ml (300mcg) prefilled syringes
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, consult 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 overdose, including the medication taken, the amount, and the time it occurred.