Q: What is Udenyca used for?

Udenyca is used to treat decrease of infection risk ( febrile neutropenia ) in patients receiving myelosuppressive chemotherapy.

Q: How does Udenyca work?

Mechanism of Action Udenyca belongs to a class of medications known as colony-stimulating factors. It is a man-made version of a protein naturally produced in the body that regulates the production of white blood cells. Many chemotherapy treatments can suppress the bone marrow, leading to a decrease in white blood cells. This condition, called neutropenia, makes it harder for the body to fight off infections. Udenyca helps address this by: Stimulating cell production: The medication binds to specific receptors in the bone marrow, signaling it to produce and release more neutrophils, a type of white blood cell. Supporting immune defense: By increasing the number of neutrophils in the bloodstream, the drug helps reduce the risk of developing a fever or serious infection while the immune system is weakened by chemotherapy. Udenyca is a pegylated form of filgrastim. This means the medication has been modified to stay in the body longer than standard filgrastim. Because it is cleared from the system more slowly, it typically only requires one dose per chemotherapy cycle to maintain white blood cell levels.

Q: What are the active ingredients in Udenyca?

The active ingredient in Udenyca is pegfilgrastim .

Q: What are the side effects of Udenyca?

Common side effects of Udenyca may include: Bone pain Pain in extremity Always consult with a healthcare professional about potential side effects.

Q: What drug class is Udenyca?

Udenyca belongs to the colony stimulating factor drug class.

Q: What is the dosage of Udenyca and how do I take it?

How Udenyca is Given Udenyca is administered as an injection under the skin (subcutaneously). It is typically given once during each chemotherapy cycle. It is important to follow the specific timing schedule provided by your healthcare team. This medication must not be administered within 14 days before you receive chemotherapy or within 24 hours after your chemotherapy treatment has ended. Administration Methods Udenyca may be delivered in several ways: A prefilled syringe or autoinjector used for manual injection. An on-body injector that is applied to the skin by a healthcare professional. This device is programmed to deliver the medication automatically about 27 hours after it is applied. Preparation and Use If you are administering the injection yourself, keep the following in mind: Take the medication out of the refrigerator and let it reach room temperature for about 30 minutes before injecting. Do not shake the medication. Visually inspect the liquid; it should be clear and colorless. Do not use it if it looks cloudy or has visible particles. Use a new needle and syringe for every injection. Missed Dose If you miss a scheduled dose, contact your doctor right away to discuss when you should receive your next injection.

Q: Is Udenyca safe during pregnancy and breastfeeding?

Pregnancy There are no adequate or well-controlled studies of Udenyca use in pregnant women. In animal studies, pegfilgrastim was associated with an increase in embryo-fetal loss and structural abnormalities when administered at doses significantly higher than the recommended human dose. Because the effects on a developing fetus are not fully known, Udenyca should be used during pregnancy only if a healthcare provider determines that the potential benefit justifies the potential risk to the fetus. Breastfeeding It is not known whether Udenyca passes into human breast milk. Because many medications are excreted in human milk, caution should be exercised when Udenyca is administered to someone who is breastfeeding. Patients should discuss the potential risks and benefits with their healthcare provider before breastfeeding while using this medication.

Q: What forms and strengths does Udenyca come in?

Available Forms Udenyca is provided as a clear, colorless, preservative-free solution for injection. It is available in the following delivery systems: Single-dose prefilled syringe: Used for manual subcutaneous injection. Autoinjector: A single-dose prefilled syringe integrated into a handheld autoinjector device. On-body injector: A system consisting of a prefilled syringe and an on-body injector that is applied to the skin to deliver the dose automatically.

Q: What is the FDA approval status of Udenyca?

FDA Approval and Biosimilar Status Udenyca (pegfilgrastim-cbqv) was approved by the U.S. Food and Drug Administration (FDA) as a biosimilar to the reference product Neulasta. A biosimilar is a biological product that is highly similar to an already approved biological medicine, with no clinically meaningful differences in safety, purity, or potency. Approved Indications The FDA has approved Udenyca for the following clinical uses: Febrile Neutropenia Prevention: To decrease the incidence of infection, manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Acute Radiation Syndrome: To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). Regulatory Safety Information Udenyca does not currently have a Boxed Warning or a Risk Evaluation and Mitigation Strategy (REMS) program. However, the FDA monitors the safety of all pegfilgrastim products through the FDA Adverse Event Reporting System (FAERS). Regulatory reviews have identified potential signals for serious risks associated with pegfilgrastim products, including large vessel vasculitis (aortitis). Healthcare providers are required to monitor for serious regulatory-noted risks such as splenic rupture, acute respiratory distress syndrome (ARDS), and potential sickle cell crises in patients with sickle cell disorders. The FDA also requires labeling to include warnings regarding the risk of capillary leak syndrome and potential glomerulonephritis.

Question 1

What is Udenyca?

Accepted Answer

Udenyca is a leukocyte growth factor that works by signaling the bone marrow to increase the production of neutrophils, which are a specific type of white blood cell.

These cells are a vital part of the immune system that help the body fight off infections. By increasing the neutrophil count, the medication supports the body's ability to maintain its natural immune defenses.

Question 2

What is Udenyca used for?

Accepted Answer

Udenyca is used to treat decrease of infection risk (febrile neutropenia) in patients receiving myelosuppressive chemotherapy.

Question 3

How does Udenyca work?

Accepted Answer

Mechanism of Action

Udenyca belongs to a class of medications known as colony-stimulating factors. It is a man-made version of a protein naturally produced in the body that regulates the production of white blood cells.

Many chemotherapy treatments can suppress the bone marrow, leading to a decrease in white blood cells. This condition, called neutropenia, makes it harder for the body to fight off infections. Udenyca helps address this by:

Stimulating cell production: The medication binds to specific receptors in the bone marrow, signaling it to produce and release more neutrophils, a type of white blood cell.
Supporting immune defense: By increasing the number of neutrophils in the bloodstream, the drug helps reduce the risk of developing a fever or serious infection while the immune system is weakened by chemotherapy.

Udenyca is a pegylated form of filgrastim. This means the medication has been modified to stay in the body longer than standard filgrastim. Because it is cleared from the system more slowly, it typically only requires one dose per chemotherapy cycle to maintain white blood cell levels.

Question 4

What are the active ingredients in Udenyca?

Accepted Answer

The active ingredient in Udenyca is pegfilgrastim.

Question 5

What are the side effects of Udenyca?

Accepted Answer

Common side effects of Udenyca may include:

Bone pain
Pain in extremity

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Udenyca?

Accepted Answer

Udenyca belongs to the colony stimulating factor drug class.

Question 7

What is the dosage of Udenyca and how do I take it?

Accepted Answer

How Udenyca is Given

Udenyca is administered as an injection under the skin (subcutaneously). It is typically given once during each chemotherapy cycle. It is important to follow the specific timing schedule provided by your healthcare team.

This medication must not be administered within 14 days before you receive chemotherapy or within 24 hours after your chemotherapy treatment has ended.

Administration Methods

Udenyca may be delivered in several ways:

A prefilled syringe or autoinjector used for manual injection.
An on-body injector that is applied to the skin by a healthcare professional. This device is programmed to deliver the medication automatically about 27 hours after it is applied.

Preparation and Use

If you are administering the injection yourself, keep the following in mind:

Take the medication out of the refrigerator and let it reach room temperature for about 30 minutes before injecting.
Do not shake the medication.
Visually inspect the liquid; it should be clear and colorless. Do not use it if it looks cloudy or has visible particles.
Use a new needle and syringe for every injection.

Missed Dose

If you miss a scheduled dose, contact your doctor right away to discuss when you should receive your next injection.

Question 8

Is Udenyca safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

There are no adequate or well-controlled studies of Udenyca use in pregnant women. In animal studies, pegfilgrastim was associated with an increase in embryo-fetal loss and structural abnormalities when administered at doses significantly higher than the recommended human dose. Because the effects on a developing fetus are not fully known, Udenyca should be used during pregnancy only if a healthcare provider determines that the potential benefit justifies the potential risk to the fetus.

Breastfeeding

It is not known whether Udenyca passes into human breast milk. Because many medications are excreted in human milk, caution should be exercised when Udenyca is administered to someone who is breastfeeding. Patients should discuss the potential risks and benefits with their healthcare provider before breastfeeding while using this medication.

Question 9

What forms and strengths does Udenyca come in?

Accepted Answer

Available Forms

Udenyca is provided as a clear, colorless, preservative-free solution for injection. It is available in the following delivery systems:

Single-dose prefilled syringe: Used for manual subcutaneous injection.
Autoinjector: A single-dose prefilled syringe integrated into a handheld autoinjector device.
On-body injector: A system consisting of a prefilled syringe and an on-body injector that is applied to the skin to deliver the dose automatically.

Question 10

What is the FDA approval status of Udenyca?

Accepted Answer

FDA Approval and Biosimilar Status

Udenyca (pegfilgrastim-cbqv) was approved by the U.S. Food and Drug Administration (FDA) as a biosimilar to the reference product Neulasta. A biosimilar is a biological product that is highly similar to an already approved biological medicine, with no clinically meaningful differences in safety, purity, or potency.

Approved Indications

The FDA has approved Udenyca for the following clinical uses:

Febrile Neutropenia Prevention: To decrease the incidence of infection, manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Acute Radiation Syndrome: To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).

Regulatory Safety Information

Udenyca does not currently have a Boxed Warning or a Risk Evaluation and Mitigation Strategy (REMS) program. However, the FDA monitors the safety of all pegfilgrastim products through the FDA Adverse Event Reporting System (FAERS). Regulatory reviews have identified potential signals for serious risks associated with pegfilgrastim products, including large vessel vasculitis (aortitis).

Healthcare providers are required to monitor for serious regulatory-noted risks such as splenic rupture, acute respiratory distress syndrome (ARDS), and potential sickle cell crises in patients with sickle cell disorders. The FDA also requires labeling to include warnings regarding the risk of capillary leak syndrome and potential glomerulonephritis.

Question 11

What should I know about Udenyca and cost?

Accepted Answer

Factors Influencing Cost

Several factors can affect the out-of-pocket cost for Udenyca, including:

Insurance Coverage: Most private insurance plans and Medicare cover Udenyca, but the amount you pay depends on your specific plan's deductible, copayments, or coinsurance requirements.
Delivery Method: Udenyca is available in different formats, such as a prefilled syringe, an autoinjector, or an on-body injector. The price may vary between these options.
Administration Setting: Costs may differ if the medication is administered in a hospital, a doctor's office, or at home.

Biosimilar Pricing

Udenyca is a biosimilar medication. Biosimilars are highly similar to an already approved biological product and are often introduced to provide more affordable treatment options. Because it is a biosimilar, it may be less expensive than the original brand-name drug.

Financial Assistance

Patients who are uninsured or underinsured may be eligible for patient assistance programs or manufacturer coupons that can help reduce the cost of the medication. It is recommended to speak with a healthcare provider or pharmacist to explore these options and to check with your insurance provider for a specific cost estimate.

Udenyca

📋Overview

How It Works

Uses

Active Ingredients

Common Side Effects

Warnings & Precautions

Dosage

Pregnancy & Breastfeeding

Frequently Asked Questions

📚References

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