Granix 300mcg/1ml Inj Sol 1ml
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
Category C
FDA Approved
Aug 2012
DEA Schedule
Not Controlled
Overview
What is this medicine?
Granix is a medication 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 to help prevent serious infections when your white blood cell count is low.
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 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, 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 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 them 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 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 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, 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 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 them 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
- Follow all instructions for administration carefully, including proper injection technique if self-administering.
- Do not shake the syringe, as this can damage the medication.
- Store in the refrigerator, protect from light, and do not freeze.
- Report any signs of infection (fever, chills, sore throat) immediately.
- Report any new or worsening pain in your left upper abdomen or shoulder, as this could be a sign of a serious spleen problem.
- Report any difficulty breathing, cough, or fever, as these could be signs of a serious lung problem.
- Avoid receiving Granix within 24 hours before or after your chemotherapy dose.
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 once daily for at least 2 weeks or until the absolute neutrophil count (ANC) has reached 10,000 cells/mm³ following the expected chemotherapy nadir. Do not administer within 24 hours before or after cytotoxic chemotherapy.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (safety and efficacy not established in pediatric patients)
Adolescent:
Not established (safety and efficacy not established in pediatric patients)
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment recommended
Moderate:
No dose adjustment recommended
Severe:
No dose adjustment recommended (monitor closely)
Dialysis:
No specific dose adjustment recommended; monitor ANC closely.
Hepatic Impairment:
Mild:
No dose adjustment recommended
Moderate:
No dose adjustment recommended
Severe:
No 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 hematopoietic stem cells, progenitor cells, and mature neutrophils, stimulating their proliferation, differentiation, commitment, and functional activation.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 30% (subcutaneous)
Tmax:
3-5 hours (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Not available (primarily distributed to hematopoietic tissues)
ProteinBinding:
Not available
CnssPenetration:
Limited
Elimination:
HalfLife:
3-4 hours (subcutaneous)
Clearance:
0.5-0.7 mL/min/kg
ExcretionRoute:
Renal clearance and neutrophil-mediated degradation
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within 24 hours (increase in neutrophil count)
PeakEffect:
Days 3-5 (peak ANC after chemotherapy nadir)
DurationOfAction:
Until ANC recovers to target levels (typically 2 weeks or more)
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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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 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.
A bone marrow disorder called myelodysplastic syndrome (MDS) and a type of leukemia have been reported in people with low white blood cell counts at birth, as well as in those with breast or lung cancer undergoing chemotherapy or radiation. 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 side effects are severe, and many people may not experience any side effects or only mild ones. However, if you experience 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
Fatigue or weakness
* Hair loss
This is not an exhaustive list of possible 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 or seek medical attention immediately:
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 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.
A bone marrow disorder called myelodysplastic syndrome (MDS) and a type of leukemia have been reported in people with low white blood cell counts at birth, as well as in those with breast or lung cancer undergoing chemotherapy or radiation. 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 side effects are severe, and many people may not experience any side effects or only mild ones. However, if you experience 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
Fatigue or weakness
* Hair loss
This is not an exhaustive list of possible 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 bruising or bleeding
- Severe bone pain
- Left upper abdominal pain or shoulder pain
- Shortness of breath or difficulty breathing
- Swelling of the face, lips, or tongue
- Rash or hives
- Dark or foamy urine, swelling (signs of kidney problems)
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 and pharmacist to determine if it is safe to take this medication.
* Never start, stop, or change the dose of any medication without first consulting your doctor to avoid potential interactions or adverse effects.
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 and pharmacist to determine if it is safe to take this medication.
* Never start, stop, or change the dose of any medication without first consulting your doctor to avoid potential interactions or adverse effects.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To minimize potential interactions, do not take this drug at the same time as or within 24 hours before or after undergoing chemotherapy or radiation treatment. It is crucial to discuss this with your doctor to determine the best schedule for your treatment.
Regular blood work and other laboratory tests, as directed by your doctor, are necessary to monitor your condition while taking this medication. Additionally, be aware that this drug may interfere with certain lab tests, so it is vital to notify all your healthcare providers and laboratory personnel that you are taking this medication.
If you have sickle cell disease, it is crucial to be aware that this medication may cause your condition to worsen, which in some cases can be fatal. Therefore, it is essential to discuss this risk with your doctor.
If you are pregnant or planning to become pregnant, you must consult with your doctor to weigh the benefits and risks of using this medication during pregnancy. This discussion will help you make an informed decision about your treatment.
To minimize potential interactions, do not take this drug at the same time as or within 24 hours before or after undergoing chemotherapy or radiation treatment. It is crucial to discuss this with your doctor to determine the best schedule for your treatment.
Regular blood work and other laboratory tests, as directed by your doctor, are necessary to monitor your condition while taking this medication. Additionally, be aware that this drug may interfere with certain lab tests, so it is vital to notify all your healthcare providers and laboratory personnel that you are taking this medication.
If you have sickle cell disease, it is crucial to be aware that this medication may cause your condition to worsen, which in some cases can be fatal. Therefore, it is essential to discuss this risk with your doctor.
If you are pregnant or planning to become pregnant, you must consult with your doctor to weigh the benefits and risks of using this medication during pregnancy. This discussion will help you make an informed decision about your treatment.
Overdose Information
Overdose Symptoms:
- Increased white blood cell count (leukocytosis)
- Bone pain
- Splenomegaly
What to Do:
In case of overdose, supportive care is recommended. Monitor white blood cell counts and discontinue tbo-filgrastim. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.
Drug Interactions
Major Interactions
- Myelosuppressive antineoplastic agents (do not administer within 24 hours before or after chemotherapy)
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: >1,500 cells/mm³ (or >10,000 cells/mm³ after nadir for discontinuation)
Action Threshold: Discontinue when ANC reaches 10,000 cells/mm³ after the expected chemotherapy nadir.
CBC with differential
Frequency: Regularly during therapy
Target: Not applicable (monitor trends)
Action Threshold: Significant changes in other cell lines (e.g., thrombocytopenia, anemia) may warrant further investigation.
Spleen size
Frequency: Periodically, especially if abdominal pain or left upper quadrant pain occurs
Target: Normal
Action Threshold: Splenomegaly or splenic rupture symptoms (e.g., left upper abdominal pain, shoulder pain) require immediate medical attention.
Symptom Monitoring
- Fever
- Signs of infection (e.g., chills, sore throat, cough)
- Bone pain
- Left upper quadrant abdominal pain or shoulder pain (potential splenic rupture)
- Shortness of breath, cough, fever (potential acute respiratory distress syndrome - ARDS)
- Allergic reactions (e.g., rash, urticaria, facial swelling, dyspnea)
- Glomerulonephritis symptoms (e.g., edema, dark urine, foamy urine)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at clinically relevant doses. There are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Potential for adverse developmental effects based on animal data.
Second Trimester:
Potential for adverse developmental effects based on animal data.
Third Trimester:
Potential for adverse developmental effects based on animal data.
Lactation
It is not known whether tbo-filgrastim is excreted in human milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Granix and any potential adverse effects on the breastfed infant from Granix or from the underlying maternal condition.
Infant Risk:
Low to moderate risk. Large protein molecules like tbo-filgrastim are generally poorly absorbed orally by infants. However, potential for adverse effects on infant hematopoiesis cannot be excluded.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Use in pediatric patients with severe chronic neutropenia has been studied with other filgrastim products, but not specifically tbo-filgrastim.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects (≥65 years) and younger subjects. Dose adjustment is generally not required based on age alone, but monitor for age-related decreases in renal function.
Clinical Information
Clinical Pearls
- Tbo-filgrastim is a G-CSF that helps reduce the incidence of febrile neutropenia in patients receiving myelosuppressive chemotherapy.
- It is crucial to administer tbo-filgrastim at least 24 hours after chemotherapy to avoid exacerbating myelosuppression.
- Patients should be educated on proper subcutaneous injection technique if self-administering and on symptoms requiring immediate medical attention (e.g., fever, severe bone pain, left upper quadrant pain).
- Bone pain is a common side effect, often manageable with non-opioid analgesics.
- Monitor ANC regularly to guide discontinuation of therapy once recovery is achieved.
- Splenic rupture is a rare but serious adverse event; educate patients on symptoms like left upper abdominal pain or shoulder pain.
Alternative Therapies
- Filgrastim (Neupogen, Zarxio, Nivestym, Releuko, etc.)
- Pegfilgrastim (Neulasta, Fulphila, Udenyca, Ziextenzo, etc.)
- Sargramostim (Leukine - GM-CSF)
Cost & Coverage
Average Cost:
$300-$600 per 300mcg/1ml syringe
Insurance Coverage:
Tier 3 / Specialty drug (requires prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, do not 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 overdose, including the medication taken, the amount, and the time it occurred.