UDENYCA Sample Claim Form 1450

What is UDENYCA?

UDENYCA (pegfilgrastim-cbqv) is a prescription medicine used to help reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer (non-myeloid), who receive anti-cancer medicines (chemotherapy) that can cause fever and low

IMPORTANT SAFETY INFORMATION

Do not take UDENYCA if you have had a serious allergic reaction to pegfilgrastim or filgrastim products.

Before taking UDENYCA, tell your healthcare provider about all of your medical conditions, including if you:

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What is UDENYCA?

IMPORTANT SAFETY INFORMATION

Do not take UDENYCA if you have had a serious allergic reaction to pegfilgrastim or filgrastim products.

Before taking UDENYCA, tell your healthcare provider about all of your medical conditions, including if you:

Have a sickle cell disorder
Have had severe skin reactions to acrylic adhesives
Have kidney problems
Are pregnant or plan to become pregnant. It is not known if UDENYCA will harm your unborn baby
Are breastfeeding or plan to breastfeed. It is not known if UDENYCA passes into your breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of UDENYCA?

UDENYCA can cause serious side effects, including:

Spleen rupture: Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach (abdomen) area or your left shoulder.

A serious lung problem called acute respiratory distress syndrome (ARDS): Call your healthcare provider or get emergency medical help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.

Serious allergic reactions: UDENYCA can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using UDENYCA and call your healthcare provider or get emergency medical help right away.

Sickle cell crisis: You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive UDENYCA. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.

Kidney injury (glomerulonephritis): UDENYCA can cause kidney injury. Call your healthcare provider right away if you experience swelling of your face or ankles, blood in your urine (or dark-colored urine), or you urinate less than usual.

Increased white blood cell count (leukocytosis): Your healthcare provider will check your blood during treatment with UDENYCA.

Decreased platelet count (thrombocytopenia): Your healthcare provider will check your blood during treatment with UDENYCA. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with UDENYCA. This could be a sign of decreased platelet counts, which may reduce your blood’s ability to clot.

Capillary leak syndrome: Pegfilgrastim products can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:

Swelling or puffiness and urinating less than usual
Trouble breathing
Swelling of your stomach area (abdomen) and feeling of fullness
Dizziness or feeling faint
A general feeling of tiredness

Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML): If you have breast cancer or lung cancer and are receiving UDENYCA in combination with chemotherapy and radiation therapy, or radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called MDS or a blood cancer called AML. Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with UDENYCA.

Inflammation of the aorta (aortitis): Inflammation of the aorta (the large blood vessel that transports blood from the heart to the body) has been reported in patients who received pegfilgrastim products. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.

Allergies to acrylics (UDENYCA ONBODY® only): The on-body injector (OBI) for UDENYCA uses acrylic adhesive. If you have had reactions to acrylic adhesives, use of this product may result in a significant reaction.

The most common side effects of UDENYCA are pain in the bones, arms, and legs.

These are not all the possible side effects of UDENYCA. Tell your healthcare provider about any side effect you experience. For additional information, see the full Prescribing Information or ask your healthcare provider or pharmacist.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

UDENYCA is supplied as:

Prefilled syringe: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only.
Autoinjector: 6 mg/0.6 mL in a single-dose prefilled autoinjector.
UDENYCA ONBODY®: 6 mg/0.6 mL in a single-dose prefilled syringe co-packaged with the on-body injector for UDENYCA®.

For more information, please see the full Prescribing Information and Patient Information.

IMPORTANT SAFETY INFORMATION

UDENYCA (pegfilgrastim-cbqv) is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis.

Splenic rupture: Splenic rupture, including fatal cases, can occur following administration of pegfilgrastim products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.

Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA in patients with ARDS.

Serious allergic reactions, including anaphylaxis: The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue UDENYCA in patients with serious allergic reactions.

Allergies to acrylics (UDENYCA ONBODY® only): The on-body injector (OBI) for UDENYCA uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction.

Sickle cell disorders: Severe and sometimes fatal crises have occurred in patients with sickle cell disorders. Discontinue UDENYCA if sickle cell crisis occurs.

Glomerulonephritis: The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events resolved after dose reduction or discontinuation. Evaluate and consider dose-reduction or interruption of UDENYCA if causality is likely.

Leukocytosis: White blood cell (WBC) counts of 100 x 10⁹/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count during UDENYCA therapy is recommended.

Thrombocytopenia: Thrombocytopenia has been reported in patients receiving pegfilgrastim products. Monitor platelet counts.

Capillary leak syndrome: Has been reported after granulocyte colony stimulating factor (G-CSF) administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency and severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care.

Potential for tumor growth stimulatory effects on malignant cells: The G-CSF receptor through which pegfilgrastim products and filgrastim products act has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.

Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with breast or lung cancer: MDS and AML have been associated with the use of pegfilgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast or lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.

Potential device failures (UDENYCA ONBODY® only): Missed or partial doses have been reported in patients receiving UDENYCA via the OBI due to the device not performing as intended. In the event of a missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered. Instruct patients using the OBI to notify their healthcare professional immediately to determine the need for a replacement dose of UDENYCA if they suspect that the device may not have performed as intended.

Aortitis: Has been reported in patients receiving pegfilgrastim products, occurring as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (eg, c-reactive protein and WBC count). Consider aortitis when signs and symptoms develop without known etiology. Discontinue UDENYCA if aortitis is suspected.

Nuclear imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. Consider when interpreting bone imaging results.

The most common adverse reactions (≥5% difference in incidence compared to placebo) are bone pain and pain in extremity.

INDICATION

UDENYCA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitation of Use
UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

UDENYCA® is supplied as:

Prefilled syringe: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only
Autoinjector: 6 mg/0.6 mL in a single-dose prefilled autoinjector
UDENYCA ONBODY®: 6 mg/0.6 mL in a single-dose prefilled syringe co-packaged with the on-body injector for UDENYCA®

For more information, please see the full Prescribing Information.

References: 1. UDENYCA (pegfilgrastim-cbqv) Prescribing Information. Accord BioPharma, Inc. 2. Neulasta^® (pegfilgrastim) Prescribing Information. Amgen Inc.

References: 1. UDENYCA (pegfilgrastim-cbqv) Prescribing Information. Accord BioPharma, Inc. 2. Neulasta® (pegfilgrastim) Prescribing Information. Amgen Inc. 3. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. US Food and Drug Administration. Published April 2015. Updated April 24, 2020. Accessed January 26, 2024. https://www.fda.gov/media/82647/download. 4. Clinical pharmacology data to support a demonstration of biosimilarity to a reference product: guidance for industry. US Food and Drug Administration. Published December 2016. Accessed January 26, 2024. https://www.fda.gov/media/88622/download. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hematopoietic Growth Factors V.3.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed February 14, 2024. To view the most recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

References: 1. Klastersky J, de Naurois J, Rolston K, et al. Management of febrile neutropenia: ESMO clinical practice guidelines. Ann Oncol. 2016;27:111-V118. https://www.annalsofoncology.org/article/S0923-7534(19)31643-6/fulltext. 2. Weycker D, Li X, Edelsberg, et al. Risk and consequences of chemotherapy-induced febrile neutropenia in patients with metastatic solid tumors. Oncol Pract. 2015;11:47-54. https://pubmed.ncbi.nlm.nih.gov/25491042/. 3. Culakova E, Thota R, Poniewierski MS, et al. Patterns of chemotherapy-associated toxicity and supportive care in US oncology practice: a nationwide prospective cohort study. Cancer Med. 2014;3:434-444. https://doi.org/10.1002/cam4.200. 4. Boccia R, Glaspy J,Crawford J, et al. Chemotherapy-induced neutropenia and febrile neutropenia in the US: a beast of burden that needs to be tamed? The Oncologist. 2022;27(8):625-636. https://pubmed.ncbi.nlm.nih.gov/35552754/. 5. Pathak R, Giri S, Aryal MR, et al. Mortality, length of stay, and healthcare costs of febrile neutropenia-related hospitalizations among patients with breast cancer in the United States. Support Care Cancer. 2015;23:615-617. https://pubmed.ncbi.nlm.nih.gov/25556610/. 6. Tai E, Guy GP, Dunbar A, et al. Cost of cancer-related neutropenia or fever hospitalizations, United States, 2012. Oncol Pract. 2017;13:552-561. https://pubmed.ncbi.nlm.nih.gov/28437150/#:~:text=For%20adults%2C%20the%20mean%20length,cost%20of%20%2426%2C000%20per%20stay. 7. Li S, Liu J, Bowers C, et al. Febrile neutropenia-related care and associated costs in elderly patients with breast cancer, lung cancer, or non-Hodgkin lymphoma. Support Care Cancer. 2020;28:113-122. https://doi.org/10.1007/s00520-019-04795-0. 8. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hematopoietic Growth Factors V.3.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed February 14, 2024. To view the most recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 9. Kuderer, M. Impact of primary prophylaxis with granulocyte colony-stimulating factor on febrile neutropenia. Clin Oncol. 2007;25(21):1-10. 10. UDENYCA (pegfilgrastim-cbqv) Prescribing Information. Accord BioPharma, Inc. 11. Neulasta® (pegfilgrastim) Prescribing Information. Amgen Inc.

References: 1. UDENYCA ONBODY HCP Instructions for Use. Accord BioPharma, Inc. 2. UDENYCA (pegfilgrastim-cbqv) Prescribing Information. Accord BioPharma, Inc. 3. Neulasta® (pegfilgrastim) Prescribing Information. Amgen Inc. 4. Neulasta® Onpro® Instructions for Use. Amgen, Inc. 5. Data on file. Accord BioPharma, Inc. 6. UDENYCA Autoinjector Instructions for Use. Accord BioPharma, Inc.

References: 1. UDENYCA® (pegfilgrastim-cbqv) Prescribing Information. Accord BioPharma, Inc. 2. Neulasta® (pegfilgrastim) Prescribing Information. Amgen Inc.