Ziextenzo 6mg/0.6ml Pf Inj, 0.6ml
It is used to lower the chance of getting an infection in people with bone marrow problems caused by chemo.It is used in patients who have been exposed to certain doses of radiation.
Drug Class
Hematopoietic growth factor
Pharmacologic Class
Granulocyte colony-stimulating factor (G-CSF) analog
Pregnancy Category
Not available
FDA Approved
Nov 2019
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ziextenzo is a medicine that helps your body make more white blood cells, called neutrophils. These white blood cells are important for fighting infections, especially when you are receiving chemotherapy for cancer, which 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 will be 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. The solution should be colorless to faintly yellow; do not use it if the color has changed. Do not shake the medication.
Wash your hands before and after administering the injection. Avoid injecting into skin that is irritated, bruised, red, infected, hard, or scarred. Do not inject 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. Do not reuse the device or any of its components. Dispose of needles and other sharp objects in a designated needle/sharp disposal box. When the box is full, follow local regulations for disposal. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in the refrigerator, but do not freeze it.
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 will be 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. The solution should be colorless to faintly yellow; do not use it if the color has changed. Do not shake the medication.
Wash your hands before and after administering the injection. Avoid injecting into skin that is irritated, bruised, red, infected, hard, or scarred. Do not inject 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. Do not reuse the device or any of its components. Dispose of needles and other sharp objects in a designated needle/sharp disposal box. When the box is full, follow local regulations for disposal. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in the refrigerator, but do not freeze it.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Store the prefilled syringe in the refrigerator (2°C to 8°C / 36°F to 46°F) in its original carton to protect from light. Do not freeze. If frozen, thaw in the refrigerator. Do not shake.
- Allow the syringe to reach room temperature for at least 30 minutes before injecting. Do not warm it in any other way.
- Do not use if the solution is cloudy, discolored, or contains particles.
- Do not administer within 24 hours before or after chemotherapy.
- Report any new or worsening symptoms to your doctor immediately, especially severe bone pain, left upper abdominal pain, or difficulty breathing.
- Avoid activities that could cause injury if you experience splenic enlargement or rupture (e.g., contact sports).
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
6 mg 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 the next dose of chemotherapy.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children weighing less than 45 kg: 0.1 mg/kg subcutaneous injection once per chemotherapy cycle. For children weighing 45 kg or more: 6 mg subcutaneous injection once per chemotherapy cycle.
Adolescent:
For adolescents weighing less than 45 kg: 0.1 mg/kg subcutaneous injection once per chemotherapy cycle. For adolescents weighing 45 kg or more: 6 mg subcutaneous injection once per chemotherapy cycle.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment recommended
Moderate:
No dose adjustment recommended
Severe:
No dose adjustment recommended
Dialysis:
No specific dose adjustment recommended; pegfilgrastim is primarily cleared by neutrophils, not renal excretion.
Hepatic Impairment:
Mild:
No dose adjustment recommended
Moderate:
No dose adjustment recommended
Severe:
No dose adjustment recommended
Pharmacology
Mechanism of Action
Pegfilgrastim is a covalent conjugate of recombinant methionyl human G-CSF (filgrastim) and a 20 kDa polyethylene glycol (PEG) molecule. It binds to G-CSF receptors on myeloid progenitor cells, stimulating their proliferation, differentiation, commitment, and some end-cell functional activation. It also enhances the phagocytic activity of mature neutrophils and their cytotoxic capabilities. The PEGylation prolongs its half-life by reducing renal clearance and extending its systemic residence time.
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, depending on dose and patient population.
FoodEffect:
Not applicable (parenteral administration).
Distribution:
Vd:
Not typically reported for biologics in the same manner as small molecules; distribution is primarily to hematopoietic tissues.
ProteinBinding:
Not applicable (biologic, not protein-bound in the traditional sense).
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 15 to 80 hours (variable, dependent on dose and neutrophil count; half-life decreases as neutrophil count recovers).
Clearance:
Neutrophil-mediated clearance (saturable process).
ExcretionRoute:
Not renally or hepatically excreted in significant amounts; primarily catabolized by neutrophils.
Unchanged:
Not applicable (cleared by cellular uptake and degradation).
Pharmacodynamics
OnsetOfAction:
Increase in neutrophil count typically observed within 1-2 days.
PeakEffect:
Peak absolute neutrophil count (ANC) typically occurs 4-5 days after administration.
DurationOfAction:
Duration of neutrophil elevation is sustained until neutrophil counts return to normal, typically lasting for up to 2 weeks.
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 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 or fever
Dark urine
Excessive sweating
Rapid breathing
Abdominal swelling
Feeling full or bloated
Left upper stomach pain or left shoulder pain, which can be symptoms of an enlarged or ruptured spleen (a potentially life-threatening condition)
Swelling of the aorta (the main blood vessel that comes out of the heart), which can cause symptoms such as:
+ Extreme fatigue or weakness
+ Fever
+ Stomach pain
+ Back pain
Capillary leak syndrome (CLS), a rare but serious condition that can cause:
+ Changes in urine output
+ Inability to pass urine
+ Blood in the urine
+ Abnormal heartbeat or chest pain
+ 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, contact your doctor for advice:
Bone, joint, or muscle pain
* Pain in the arms or legs
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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 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 or fever
Dark urine
Excessive sweating
Rapid breathing
Abdominal swelling
Feeling full or bloated
Left upper stomach pain or left shoulder pain, which can be symptoms of an enlarged or ruptured spleen (a potentially life-threatening condition)
Swelling of the aorta (the main blood vessel that comes out of the heart), which can cause symptoms such as:
+ Extreme fatigue or weakness
+ Fever
+ Stomach pain
+ Back pain
Capillary leak syndrome (CLS), a rare but serious condition that can cause:
+ Changes in urine output
+ Inability to pass urine
+ Blood in the urine
+ Abnormal heartbeat or chest pain
+ 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, contact your doctor for advice:
Bone, joint, or muscle pain
* Pain in the arms or legs
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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:
- Severe bone pain (especially in arms, legs, back, or chest)
- Pain in the upper left side of your stomach or shoulder pain (could be a sign of a ruptured spleen)
- Shortness of breath, cough, fever (could be signs of a serious lung problem)
- Swelling or puffiness, rapid weight gain, dizziness (could be signs of Capillary Leak Syndrome)
- Rash, hives, swelling of the face or mouth, difficulty breathing (signs of an allergic reaction)
- 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 treatment, disclose all of your:
+ Prescription and over-the-counter (OTC) medications
+ Natural products
+ Vitamins
+ Health problems
Your doctor and pharmacist will assess whether it is safe to take this medication in combination with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting 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 treatment, disclose all of your:
+ Prescription and over-the-counter (OTC) medications
+ Natural products
+ Vitamins
+ Health problems
Your doctor and pharmacist will assess whether it is safe to take this medication in combination with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
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 other 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, and in rare instances, this has been fatal.
In patients with breast or lung cancer who are undergoing chemotherapy or radiation, there is a risk of developing a bone marrow disorder called myelodysplastic syndrome (MDS) or a type of leukemia. Be vigilant for symptoms such as fever, extreme fatigue, or unexplained bruising or bleeding, and contact your doctor right away if you experience any of these.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is essential to discuss the benefits and risks of this medication with your doctor to make an informed decision about your treatment.
To minimize potential interactions, do not take this drug within 14 days before or 24 hours after receiving chemotherapy.
Regular blood work and other 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, and in rare instances, this has been fatal.
In patients with breast or lung cancer who are undergoing chemotherapy or radiation, there is a risk of developing a bone marrow disorder called myelodysplastic syndrome (MDS) or a type of leukemia. Be vigilant for symptoms such as fever, extreme fatigue, or unexplained bruising or bleeding, and contact your doctor right away if you experience any of these.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is essential to discuss the benefits and risks of this medication with your doctor to make an informed decision about your treatment.
Overdose Information
Overdose Symptoms:
- Exaggerated pharmacological effects (e.g., extreme leukocytosis, bone pain)
What to Do:
No specific antidote. Management should consist of supportive care and monitoring of white blood cell counts. Call 1-800-222-1222 (Poison Control) or seek emergency medical attention.
Drug Interactions
Major Interactions
- Chemotherapy (do not administer within 14 days before or 24 hours after cytotoxic chemotherapy due to potential for increased myelosuppression or reduced efficacy of pegfilgrastim).
Moderate Interactions
- Lithium (may potentiate the myeloproliferative effects of pegfilgrastim, leading to increased neutrophil counts; monitor CBC).
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline neutrophil count and assess overall hematopoietic status before initiating therapy.
Timing: Before each chemotherapy cycle and prior to pegfilgrastim administration.
Routine Monitoring
Complete Blood Count (CBC) with differential (especially Absolute Neutrophil Count - ANC)
Frequency: As clinically indicated, typically before subsequent chemotherapy cycles or if fever/infection develops.
Target: ANC > 1.5 x 10^9/L (to ensure recovery before next chemotherapy cycle)
Action Threshold: If ANC remains low, consider delaying next chemotherapy cycle or investigating other causes of neutropenia.
Signs and symptoms of adverse reactions
Frequency: Regularly throughout treatment and follow-up.
Target: Absence of severe adverse effects.
Action Threshold: Development of severe bone pain, left upper abdominal pain, fever, rash, dyspnea, swelling, or signs of allergic reaction requires immediate medical evaluation.
Symptom Monitoring
- Bone pain (especially in long bones, sternum, pelvis)
- Left upper abdominal pain or shoulder pain (may indicate splenic rupture)
- Fever, chills, signs of infection
- Shortness of breath, cough, fever (signs of Acute Respiratory Distress Syndrome - ARDS)
- Swelling of face, hands, or feet; rapid weight gain; dizziness; shortness of breath (signs of Capillary Leak Syndrome - CLS)
- Rash, urticaria, facial swelling, dyspnea (signs of allergic reaction)
- Hematuria, proteinuria (signs of glomerulonephritis)
Special Patient Groups
Pregnancy
Limited data on pegfilgrastim use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies have not shown evidence of adverse developmental outcomes. Due to its large molecular weight, pegfilgrastim is not expected to cross the placenta. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited human data, animal data suggest no direct harm. Large molecule, unlikely to cross placenta.
Second Trimester:
Limited human data, animal data suggest no direct harm. Large molecule, unlikely to cross placenta.
Third Trimester:
Limited human data, animal data suggest no direct harm. Large molecule, unlikely to cross placenta.
Lactation
There is no information regarding the presence of pegfilgrastim in human milk, the effects on the breastfed infant, or the effects on milk production. Due to its large molecular weight, pegfilgrastim is unlikely to be excreted in human milk or absorbed by a breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Ziextenzo and any potential adverse effects on the breastfed infant from Ziextenzo or from the underlying maternal condition.
Infant Risk:
Low (due to large molecular weight, unlikely to be excreted in significant amounts or absorbed by infant).
Pediatric Use
Safety and effectiveness have been established in pediatric patients aged 0 to 16 years for chemotherapy-induced neutropenia. Dosing is weight-based for children weighing less than 45 kg (0.1 mg/kg) and 6 mg for those 45 kg or more.
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.
Clinical Information
Clinical Pearls
- Ziextenzo is a biosimilar to Neulasta. Ensure correct product is dispensed and administered.
- Administer the dose at least 24 hours after cytotoxic chemotherapy and at least 14 days before the next planned dose of chemotherapy.
- Do not administer pegfilgrastim during the 14-day period before or 24 hours after administration of cytotoxic chemotherapy.
- Store in the refrigerator (2°C to 8°C / 36°F to 46°F). Protect from light. Do not freeze. If frozen, thaw in the refrigerator. Do not shake the syringe.
- Allow the prefilled syringe to reach room temperature for at least 30 minutes before injection. Do not use external heat sources.
- Patients should be instructed on proper subcutaneous injection technique if self-administering. Rotate injection sites.
- Monitor for signs of splenic rupture (left upper abdominal pain, shoulder pain) and ARDS (fever, dyspnea, cough).
- Severe bone pain can be managed with non-opioid analgesics (e.g., NSAIDs, acetaminophen) or, if severe, opioids.
Alternative Therapies
- Filgrastim (Neupogen, Zarxio, Nivestym, Releuko)
- Other pegfilgrastim biosimilars (e.g., Fulphila, Udenyca, Nyvepria, Stimufend, Fylnetra)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per 6 mg prefilled syringe
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.