Udenyca

Infection Prevention During Chemotherapy

Udenyca is primarily used to lower the risk of infection in patients with non-myeloid cancers who are receiving strong chemotherapy. Some chemotherapy drugs can significantly decrease the number of neutrophils, a type of white blood cell that helps the body fight off bacteria. When these levels are too low, a condition called neutropenia occurs, making the patient more vulnerable to life-threatening infections and fever.

Radiation Exposure

This medication is also approved to increase the chance of survival in adults and children who have been exposed to high doses of radiation, such as during a radiological or nuclear emergency. High-dose radiation can cause severe damage to the bone marrow, leading to a dangerous drop in white blood cell counts.

How It Helps

Udenyca works by stimulating the bone marrow to produce more white blood cells. By maintaining or increasing these cell counts, the medication helps the body:

• Reduce the incidence of infection manifested by febrile neutropenia.
• Decrease the time spent in the hospital due to infection-related complications.
• Support the immune system during intensive medical treatments.

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.

Common Side Effects

The most frequently reported side effects of Udenyca include:

• Bone pain
• Pain in the arms or legs
• Redness, swelling, or bruising at the injection site

Serious Side Effects

While less common, some side effects can be severe. Seek medical attention immediately if you experience:

• Spleen problems: Pain in the left upper stomach area or the tip of the left shoulder, which may indicate an enlarged or ruptured spleen.
• Lung issues: Shortness of breath, wheezing, or fever, which could be signs of acute respiratory distress syndrome.
• Allergic reactions: Skin rash, itching, swelling of the face or throat, dizziness, or a fast heart rate.
• Kidney injury: Dark-colored urine, blood in the urine, or swelling in the face and ankles.
• Capillary leak syndrome: Sudden swelling, puffiness, or a feeling of fullness, often accompanied by difficulty breathing and decreased urination.
• Aortitis: Inflammation of the aorta, which may cause fever, abdominal pain, or extreme fatigue.
• High white blood cell count: Your healthcare provider will monitor your blood levels during treatment to check for leukocytosis.

Serious Allergic Reactions

Severe allergic reactions, including anaphylaxis, can occur with Udenyca. These reactions may happen during the first dose or subsequent treatments. Symptoms may include rash, swelling, shortness of breath, and low blood pressure. If a serious allergic reaction occurs, the medication should be permanently discontinued.

Splenic Rupture

Spleen rupture, which can be fatal, has been reported in patients receiving pegfilgrastim products. Medical evaluation is necessary if there is pain in the left upper abdomen or the left shoulder tip.

Acute Respiratory Distress Syndrome (ARDS)

ARDS is a serious lung condition that can occur. Symptoms include fever, shortness of breath, or a cough. Healthcare providers may monitor for signs of lung inflammation or respiratory distress.

Sickle Cell Crisis

Severe and sometimes fatal sickle cell crises can occur in people with sickle cell disorders. It is important to discuss the risks with a healthcare provider before starting treatment.

Kidney Injury (Glomerulonephritis)

Inflammation of the kidneys has been observed in patients. Symptoms may include puffiness in the face or ankles, blood in the urine, or dark-colored urine. This condition usually improves if the dose is reduced or the medication is stopped.

Capillary Leak Syndrome

This condition causes fluid to leak from blood vessels into body tissues. Symptoms include swelling, puffiness, decreased urination, and feeling lightheaded or tired.

Aortitis

Inflammation of the aorta (the main artery leaving the heart) can occur. Symptoms may include fever, abdominal pain, feeling tired, or back pain.

Risk of Blood Cancers

In patients with certain types of cancer (such as breast or lung cancer) receiving chemotherapy or radiation, there may be an increased risk of developing myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

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.

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.

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.

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.