Nyvepria (Pegfilgrastim-apgf) - Subcutaneous

Warning:

Allergic reactions in people taking Nyvepria have happened. These included severe and life-threatening allergic reactions. Rupturing of the spleen (an organ in the abdomen) has occurred. This could lead to significant pain and bleeding and be potentially life-threatening.

Acute Respiratory Distress Syndrome (ARDS) occurred in some people taking Nyvepria. Signs of ARDS can include cough, fever, difficulty breathing, or chest pain.

What Is Nyvepria?

Nyvepria (pegfilgrastim-apgf) is a medication used to decrease the risk of infection in people receiving chemotherapy. It is in a class of medications called granulocyte-colony stimulating factors (G-CSF).

Certain chemotherapy medications reduce how many infection-fighting white blood cells are in the body. Nyvepria works by stimulating the bone marrow, the tissue inside the bones where the blood cells are made, to make more white blood cells.

This medication is biosimilar to Neulasta (pegfilgrastim). Biosimilars are biologic products manufactured through complex processes that involve living organisms. This makes them work the same way as the original drug, often called the reference product. Biosimilars must be as effective and safe as the original medication to be approved by the Food and Drug Administration (FDA).

Nyvepria is given subcutaneously (under the skin) through a single-dose prefilled syringe. You may receive this injection in an infusion center or administer it to yourself at home.

Drug Facts

Generic Name: Pegfilgrastim-apgf

Brand Name(s): Nyvepria

Drug Availability: Prescription

Administration Route: Subcutaneous

Therapeutic Classification: Hematopoietic

Available Generically: No

Controlled Substance: N/A

Active Ingredient: Pegfilgrastim

Dosage Form(s): Solution for injection

What Is Nyvepria Used For?

The FDA approved Nyvperia to prevent febrile neutropenia in people receiving a type of chemotherapy that may significantly decrease their white blood cell counts. Febrile neutropenia is a condition that can occur when there are low levels of white blood cells after chemotherapy. A low white blood cell count can cause fevers and heighten infection risk.

To be eligible for this treatment, people must receive chemotherapy for solid tumor cancer, such as breast or lung cancer, and not a blood cancer like leukemia.

How to Take Nyvepria

Nyvepria is given through a subcutaneous (under the skin) injection. You will usually receive the injection at the same infusion center where the chemotherapy is given. However, it is also possible to be prescribed a syringe to self-inject at home.

Nyvperia is typically administered once during a chemotherapy cycle at the instruction of the ordering oncologist. It should not be given within 14 days before or 24 hours after chemotherapy. The dose is prefilled, so there is no need for any measuring if self-injecting. Do not shake this medication. Check this product visually for any particles or discoloration before using it. Do not use the liquid if either is present.

Storage

Nyvperia should be kept in its original packaging and stored in the refrigerator, where it will not be exposed to light. The medication should be taken out of the refrigerator about 30 minutes before the injection to allow it to come to room temperature.

What Are the Side Effects of Nyvepria?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

The most common side effect of Nyvepria is bone pain, typically in the arms and legs. Injection site reactions, such as redness, can occur as well.

Severe Side Effects

Call your healthcare provider immediately if you have serious side effects, or call 911 if you feel your side effects are life-threatening or an emergency. Serious side effects and their symptoms can include:

  • Spleen rupture: Symptoms can include pain in the left shoulder or left side of the abdomen
  • Acute respiratory distress syndrome: Symptoms include shortness of breath, cough, and chest pain
  • Kidney changes: Symptoms include blood in the urine or not being able to urinate
  • Decreased platelet count: Symptoms may include bleeding or easy bruising
  • Capillary leak syndrome: Symptoms may include trouble breathing, swelling to the abdomen, and feeling dizzy
  • Aorta inflammation: Symptoms include fever, feeling tired, abdominal pain, and back pain

Long-Term Side Effects

Nyvperia may increase the risk of developing blood cancer, such as acute myeloid leukemia, or a precancerous condition called myelodysplastic syndrome. People who received Nyvepria and radiation treatments for their cancer were at the highest risk.

Report Side Effects

Nyvperia may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Nyvepria Should I Take?

Drug Content Provided and Reviewed by IBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injectable dosage form (solution):
    • To increase white blood cell count:
      • Adults—6 milligrams (mg) as a single injection under the skin once every cancer treatment cycle.
      • Children weighing less than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor:
        • Weighing 31 kg to 44 kg—4 milligrams (mg) as a single injection under the skin once every cancer treatment cycle.
        • Weighing 21 kg to 30 kg—2.5 mg as a single injection under the skin once every cancer treatment cycle.
        • Weighing 10 kg to 20 kg—1.5 mg as a single injection under the skin once every cancer treatment cycle.
        • Weighing less than 10 kg—0.1 mg per kg body weight as a single injection under the skin once every cancer treatment cycle.

Modifications

Dosing for children weighing less than 45 kilograms (approximately 99 pounds) should be dependent on their weight.

Missed Dose

If you miss a dose of Nyvepria, contact your oncologist immediately for instructions. Whether or not you should take it will be based on the dates of your chemotherapy treatments.

Overdose: What Happens If I Take Too Much Nyvepria?

If you administer Nyvepria more than prescribed, contact your oncology team immediately. Too much Nyvepria may increase white blood cell counts and cause bone pain.

What Happens If I Overdose on Nyvperia?

If you think you or someone else may have overdosed on Nyvperia, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Nyvperia, call 911 immediately.

Precautions

Drug Content Provided and Reviewed by IBM Micromedex®

It is very important that your doctor check you or your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

If you or your child have left upper stomach pain or shoulder pain, contact your doctor right away. This could be a symptom of a serious side effect with the spleen.

Check with your doctor right away at the first sign of any infection, including fever, chills, cough, sore throat, or redness, swelling, or pain around a cut or sore.

Check with your doctor right away if you or your child develop a fever, chest pain or tightness, fast breathing, or trouble breathing. These could be symptoms of a serious lung condition called acute respiratory distress syndrome (ARDS).

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine may increase the risk of having sickle cell crises, especially in patients with sickle cell disease. Check with your doctor right away if you have pain in the arms, legs, chest, or lower back, extreme tiredness or weakness, yellow skin, or difficulty breathing.

This medicine may cause kidney problems. Call your doctor right away if you or your child has swelling in the face or ankles, blood in the urine, or a decrease in how much or how often you urinate.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed more easily. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Check with your doctor right away if you or your child has black or tarry stools, bleeding gums, blood in the urine or stools, pinpoint red spots on the skin, or unusual bleeding or bruising after receiving this medicine.

This medicine may cause a condition called capillary leak syndrome. It can cause fluid to leak from the blood vessels into your body's tissues. Call your doctor right away if you have swelling or puffiness and are urinating less often, trouble breathing, feeling of fullness, dizziness, or feeling faint.

This medicine may cause blood or bone marrow problems (eg, myelodysplastic syndrome, acute myeloid leukemia) in patients with breast or lung cancer. Check with your doctor right away if you have chest pain, chills, cough or hoarseness, fever, lower back or side pain, painful or difficult urination, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

This medicine may cause aortitis (inflammation of the aorta, the largest artery in the body). Check with your doctor right away if you have fever, stomach pain, unusual tiredness or weakness, or back pain.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests (eg, bone imaging tests).

What Are Reasons I Shouldn’t Take Nyvepria?

You should not take Nyvepria if you are allergic to it, similar medications such as Neulasta, or other forms of pegfilgrastim or filgrastim.

What Other Medications Interact With Nyvepria?

There are no medications that interact with Nyvepria.

What Medications Are Similar?

Nyvepria is the fourth biosimilar for Neulasta that has been approved.

The other Neulasta biosimilar medications are:

  • Fulphila (pegfilgrastim-jmdb)
  • Udenyca (pegfilgrastim-cbqv)
  • Ziextenzo (pegfilgrastim-bmez)

These medications are all approved for the same use as Nyvepria but should not be taken along with Nyvepria.

Frequently Asked Questions

  • What is Nyvepria used for?

    Nyvepria is used to prevent febrile neutropenia in people getting chemotherapy to treat their cancer. Febrile neutropenia is a condition in which the risk for infection is high after getting chemotherapy.

  • How does Nyvepria work?

    Nyvepria works by stimulating the cells in the bone marrow to make more white blood cells, which are the infection-fighting cells. Chemotherapy can reduce the amount of white blood cells in the body.

  • What are the side effects of Nyvepria?

    The most common side effect of Nyvepria is bone pain, usually in the arms or legs. 

    There can be some severe side effects, which are not as common. These can include:

    • Spleen rupture
    • Respiratory distress
    • Capillary leak syndrome
    • Inflammation of the aorta
  • Is Nyvepria less effective than Neulasta?

    No, Nypveria (pegfilgrastim-apgf) is just as effective and safe as Neulasta (pegfilgrastim). Nyvepria is a biosimilar to Neulasta. A biosimilar is a biological drug highly similar to its reference product (the original drug). The FDA conducts rigorous evaluation and testing to ensure no clinically meaningful differences in safety and effectiveness between the biosimilar and the reference product. Therefore, you should not be concerned about using a biosimilar medication if it is prescribed to you.

How Can I Stay Healthy While Taking Nyvepria?

If you’re receiving Nyvepria, you are also undergoing chemotherapy, potentially decreasing your body’s ability to fight off an infection. Taking care of yourself and your health is important to prevent infection. Good hand-washing practices and staying away from sick people can help reduce your risk of catching an infection.

You may also feel tired and lack energy, but this is normal. Get as much rest as possible, but also try to engage in some activity daily. Talk to your cancer care team about what to expect and communicate any questions or concerns.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

4 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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  2. National Cancer Institute. Biosimilar drug.

  3. Selby C, Peyton-Thomas B, Eslami P. Pegfilgrastim Biosimilars: where are we now? J Adv Pract Oncol. 2021;12(5):541-547. doi:10.6004/jadpro.2021.12.5.9

  4. Food and Drug Administration. What is a biosimilar?