Fulphila 6/0.6ml Inj. 0.6ml
It is used to lower the chance of getting an infection in people with bone marrow problems caused by chemo.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Hematopoietic Agent; Granulocyte Colony-Stimulating Factor (G-CSF)
Pharmacologic Class
Granulocyte Colony-Stimulating Factor (G-CSF) Analog
Pregnancy Category
Not available
FDA Approved
Jun 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fulphila 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 received 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. If you are self-administering the injection, your doctor or nurse will instruct you on the proper technique.
Continue taking this medication as directed by your doctor or healthcare provider, even if you are feeling well. Before using the medication, remove it from the refrigerator and let it reach room temperature for at least 30 minutes. Do not heat the medication.
Preparation and Administration
Do not remove the cap or cover until you are ready to use the medication. Check the solution for any signs of 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. Avoid shaking the medication.
Wash your hands before and after administering the injection. Choose a site on the skin that is not irritated, bruised, red, infected, hard, or scarred, and avoid areas within 2 inches (5 cm) of the belly button. Rotate the injection site with each use.
After administering the dose, discard any remaining medication and dispose of the device properly. Do not reuse the device or any of its components. Dispose of used needles in a designated needle/sharp disposal box, and follow local regulations for disposing of the box when it is full.
Storage and Disposal
Store this medication in a refrigerator at a temperature between 2°C and 8°C (36°F and 46°F). Do not freeze the medication.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
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. If you are self-administering the injection, your doctor or nurse will instruct you on the proper technique.
Continue taking this medication as directed by your doctor or healthcare provider, even if you are feeling well. Before using the medication, remove it from the refrigerator and let it reach room temperature for at least 30 minutes. Do not heat the medication.
Preparation and Administration
Do not remove the cap or cover until you are ready to use the medication. Check the solution for any signs of 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. Avoid shaking the medication.
Wash your hands before and after administering the injection. Choose a site on the skin that is not irritated, bruised, red, infected, hard, or scarred, and avoid areas within 2 inches (5 cm) of the belly button. Rotate the injection site with each use.
After administering the dose, discard any remaining medication and dispose of the device properly. Do not reuse the device or any of its components. Dispose of used needles in a designated needle/sharp disposal box, and follow local regulations for disposing of the box when it is full.
Storage and Disposal
Store this medication in a refrigerator at a temperature between 2°C and 8°C (36°F and 46°F). Do not freeze the medication.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Maintain good hygiene (frequent hand washing) to reduce infection risk.
- Avoid contact with sick individuals.
- Report any signs of infection (fever, chills, sore throat) immediately to your healthcare provider.
- Stay well-hydrated.
- Avoid shaking the prefilled syringe vigorously, as this can damage the medication.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
6 mg (0.6 mL) subcutaneous injection once per chemotherapy cycle
Dose Range:
6 - 6 mg
Condition-Specific Dosing:
chemotherapy_induced_neutropenia:
Administer approximately 24 hours after cytotoxic chemotherapy and at least 14 days before administration of subsequent chemotherapy.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants < 2 kg. For infants/children > 2 kg, weight-based dosing applies.
Child:
Weight-based dosing for patients weighing less than 45 kg: 0.1 mg/kg subcutaneous injection once per chemotherapy cycle. For patients weighing 45 kg or more, use adult dose (6 mg).
Adolescent:
For patients weighing 45 kg or more, use adult dose (6 mg). For patients weighing less than 45 kg, use weight-based dosing (0.1 mg/kg).
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Dialysis:
No dose adjustment necessary; pegfilgrastim is not renally cleared.
Hepatic Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Pharmacology
Mechanism of Action
Pegfilgrastim is a pegylated form of recombinant human granulocyte colony-stimulating factor (G-CSF). It binds to G-CSF receptors on myeloid progenitor cells, stimulating their proliferation, differentiation, commitment, and functional activation. It also enhances the phagocytic activity and cytotoxicity of mature neutrophils.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly quantified as a percentage, but well absorbed after subcutaneous administration.
Tmax:
16 to 120 hours (median 30-42 hours) after subcutaneous administration.
FoodEffect:
No known food effect.
Distribution:
Vd:
Not widely reported, but generally low due to large molecular size.
ProteinBinding:
Low protein binding.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 15 to 80 hours (variable, dependent on dose and neutrophil count).
Clearance:
Neutrophil-mediated clearance, which becomes saturated at higher doses, leading to non-linear pharmacokinetics.
ExcretionRoute:
Primarily non-renal (cellular degradation).
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Increase in neutrophil counts typically observed within 24 hours.
PeakEffect:
Peak neutrophil count usually occurs 4-5 days after administration.
DurationOfAction:
Neutrophil counts remain elevated until they return to baseline, typically within 1-2 weeks, depending on the chemotherapy regimen.
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
+ Difficulty 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
Dark urine
Excessive sweating
Rapid breathing
Abdominal swelling
Feeling full
Left upper stomach pain or left shoulder pain, which may indicate an enlarged or ruptured spleen (a potentially life-threatening condition)
Signs of a swollen aorta (the main blood vessel that comes out of the heart), such as feeling extremely tired or weak
Fever, stomach pain, or back pain
Capillary leak syndrome (CLS), a potentially life-threatening condition, characterized by:
+ Changes in urine output
+ Inability to pass urine
+ Blood in the urine
+ Abnormal heartbeat
+ Chest pain or pressure
+ Dizziness or fainting
+ Shortness of breath
+ Sudden weight gain
+ Swelling
+ Vomiting blood or coffee ground-like material
+ Black, tarry, or bloody stools
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's 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 go away, contact your doctor:
Bone, joint, or muscle pain
Pain in arms or legs
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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
+ Difficulty 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
Dark urine
Excessive sweating
Rapid breathing
Abdominal swelling
Feeling full
Left upper stomach pain or left shoulder pain, which may indicate an enlarged or ruptured spleen (a potentially life-threatening condition)
Signs of a swollen aorta (the main blood vessel that comes out of the heart), such as feeling extremely tired or weak
Fever, stomach pain, or back pain
Capillary leak syndrome (CLS), a potentially life-threatening condition, characterized by:
+ Changes in urine output
+ Inability to pass urine
+ Blood in the urine
+ Abnormal heartbeat
+ Chest pain or pressure
+ Dizziness or fainting
+ Shortness of breath
+ Sudden weight gain
+ Swelling
+ Vomiting blood or coffee ground-like material
+ Black, tarry, or bloody stools
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's 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 go away, contact your doctor:
Bone, joint, or muscle pain
Pain in arms or legs
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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)
- Severe bone or joint pain
- Difficulty breathing, shortness of breath, cough
- Swelling of the face or throat, rash, hives (signs of allergic reaction)
- Severe pain in the upper left side of your stomach or left shoulder (signs of possible splenic rupture)
- Dizziness, lightheadedness, swelling in hands/feet, rapid weight gain (signs of Capillary Leak Syndrome)
- Blood in urine or foamy urine (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 symptoms you experienced.
Your weight, particularly if you weigh less than 99 pounds (45 kilograms), as this may be relevant to your treatment.
Potential interactions with other medications or health conditions. To ensure safe use, disclose all your medications, including:
+ Prescription and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
Any existing health problems, as these may affect the safety and efficacy of this medication.
Remember to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug. This will help ensure your safety and the effectiveness of your treatment.
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 symptoms you experienced.
Your weight, particularly if you weigh less than 99 pounds (45 kilograms), as this may be relevant to your treatment.
Potential interactions with other medications or health conditions. To ensure safe use, disclose all your medications, including:
+ Prescription and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
Any existing health problems, as these may affect the safety and efficacy of this medication.
Remember to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug. This will help ensure your safety and the effectiveness of your treatment.
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 within 14 days before or 24 hours after receiving chemotherapy.
Regular blood work and laboratory tests are crucial while taking this medication. Your doctor will guide you on the frequency of these tests. It is also important to notify all your healthcare providers and laboratory personnel that you are taking this drug, as it may affect the results of certain lab tests.
There is a rare risk of low platelet counts associated with this medication, which can increase the likelihood of bleeding. If you experience any unexplained bruising or bleeding, contact your doctor immediately.
If you have sickle cell disease, it is crucial to discuss the potential risks of this medication with your doctor, as it may worsen your condition. In some cases, this has been fatal.
In patients with breast or lung cancer who are undergoing chemotherapy or radiation, there is a risk of developing myelodysplastic syndrome (MDS), a bone marrow disorder, or a type of leukemia. If you experience symptoms such as fever, extreme fatigue, or unexplained bruising or bleeding, contact your doctor right away.
If you are pregnant, planning to become pregnant, or breastfeeding, it is essential to discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
To minimize potential interactions, do not take this drug within 14 days before or 24 hours after receiving chemotherapy.
Regular blood work and laboratory tests are crucial while taking this medication. Your doctor will guide you on the frequency of these tests. It is also important to notify all your healthcare providers and laboratory personnel that you are taking this drug, as it may affect the results of certain lab tests.
There is a rare risk of low platelet counts associated with this medication, which can increase the likelihood of bleeding. If you experience any unexplained bruising or bleeding, contact your doctor immediately.
If you have sickle cell disease, it is crucial to discuss the potential risks of this medication with your doctor, as it may worsen your condition. In some cases, this has been fatal.
In patients with breast or lung cancer who are undergoing chemotherapy or radiation, there is a risk of developing myelodysplastic syndrome (MDS), a bone marrow disorder, or a type of leukemia. If you experience symptoms such as fever, extreme fatigue, or unexplained bruising or bleeding, contact your doctor right away.
If you are pregnant, planning to become pregnant, or breastfeeding, it is essential to discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Not well-defined, 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) or seek immediate medical attention.
Drug Interactions
Major Interactions
- Cytotoxic Chemotherapy: Do not administer pegfilgrastim within 14 days before or 24 hours after cytotoxic chemotherapy due to potential for increased myelosuppression.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline neutrophil count and assess overall hematopoietic status before chemotherapy and pegfilgrastim administration.
Timing: Prior to each chemotherapy cycle and before pegfilgrastim administration.
Routine Monitoring
Complete Blood Count (CBC) with differential (specifically Absolute Neutrophil Count - ANC)
Frequency: As clinically indicated, typically before subsequent chemotherapy cycles or if fever/infection is suspected.
Target: ANC > 1.5 x 10^9/L (to proceed with chemotherapy), or as per clinical guidelines.
Action Threshold: ANC < 0.5 x 10^9/L (severe neutropenia) warrants close monitoring and management of infection risk.
Signs and symptoms of adverse reactions (e.g., bone pain, fever, rash, dyspnea, abdominal pain)
Frequency: Daily during treatment period and as needed.
Target: Absence of severe symptoms.
Action Threshold: Development of severe or persistent symptoms (e.g., severe bone pain, signs of allergic reaction, splenic rupture, ARDS, glomerulonephritis) requires immediate medical evaluation.
Symptom Monitoring
- Bone pain (mild to moderate, common)
- Fever
- Rash, urticaria, facial swelling (signs of allergic reaction)
- Dyspnea, cough, fever (signs of Acute Respiratory Distress Syndrome - ARDS)
- Left upper abdominal pain, shoulder pain (signs of splenic rupture)
- Hematuria, proteinuria (signs of glomerulonephritis)
- Fatigue, dizziness (signs of anemia, thrombocytopenia)
- Capillary leak syndrome symptoms (hypotension, hypoalbuminemia, edema)
Special Patient Groups
Pregnancy
Limited human data on pegfilgrastim use in pregnant women are insufficient to inform a drug-associated risk for major birth defects or miscarriage. Animal reproduction studies have shown no evidence of adverse developmental outcomes. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk low based on mechanism.
Second Trimester:
Limited data, theoretical risk low.
Third Trimester:
Limited data, theoretical risk low.
Lactation
It is unknown whether pegfilgrastim is excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant, including neutropenia, 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:
Unknown; potential for adverse effects on infant hematopoiesis.
Pediatric Use
Approved for pediatric patients > 2 kg. Dosing is weight-based for patients weighing less than 45 kg. Safety and effectiveness in neonates and infants weighing less than 2 kg have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between patients 65 years and older and younger patients. No dose adjustment is necessary based on age alone, but monitor for age-related comorbidities and adverse effects.
Clinical Information
Clinical Pearls
- Administer pegfilgrastim approximately 24 hours after cytotoxic chemotherapy and at least 14 days before administration of subsequent chemotherapy to avoid potential for increased myelosuppression.
- Store in the refrigerator (2°C to 8°C / 36°F to 46°F). Do not freeze. If frozen, thaw in the refrigerator. Do not refreeze. Protect from light.
- Allow the prefilled syringe to reach room temperature for 30 minutes prior to injection.
- Do not shake the syringe, as this can denature the protein.
- Patients should be instructed on proper subcutaneous injection technique if self-administering.
- Bone pain is a common side effect; it can often be managed with non-opioid analgesics (e.g., NSAIDs, acetaminophen) or antihistamines (e.g., loratadine).
Alternative Therapies
- Filgrastim (Neupogen, Zarxio, Nivestym)
- Other pegfilgrastim biosimilars (e.g., Udenyca, Ziextenzo, Nyvepria, Stimufend, Fylnetra)
Cost & Coverage
Average Cost:
Highly variable, typically > $4,000 - $6,000 per 6 mg/0.6 mL prefilled syringe
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (Tier 4 or higher) for most commercial and Medicare Part D plans. 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 this 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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.