Udenyca (pegfilgrastim-cbqv)

What is Udenyca?

Udenyca is a brand-name prescription medication. It’s FDA-approved to reduce the risk of infection in people receiving chemotherapy for non-myeloid* cancer.

Chemotherapy may cause neutropenia, which is a low level of white blood cells called neutrophils. These cells help fight infection. With too few of the cells, your risk of infection may increase.

Udenyca is used to help prevent febrile neutropenia. This condition occurs when you have a fever in combination with neutropenia.

Udenyca has a limitation of use. For more information, see the “Udenyca uses” section below.

* Non-myeloid cancers are cancers that do not affect your bone marrow. This is the soft inner lining of bones that makes blood cells.

Udenyca injection details

Udenyca is approved for use in adults and children.

Udenyca belongs to a class of drugs called granulocyte colony-stimulating factors (G-CSFs). A G-CSF is a type of protein called a growth factor that your immune system makes naturally. Udenyca contains the active ingredient pegfilgrastim, which is a slightly modified version of the G-CSF protein.

Udenyca comes as a clear solution in a prefilled syringe. The drug is given as a subcutaneous injection, typically the day after chemotherapy. A healthcare professional will give you this injection. They can also show you how to self-inject Udenyca at home.

Udenyca is available in one strength: 6 milligrams (mg) in 0.6 milliliters (mL) of solution.

FDA approval

The Food and Drug Administration (FDA) approved Udenyca in 2018.

Effectiveness

For information about the effectiveness of Udenyca, see the “Udenyca uses” section below.

Udenyca generic or biosimilar

Udenyca contains the active drug pegfilgrastim-cbqv. This is a biosimilar version of pegfilgrastim (Neulasta).

A biosimilar is a drug that’s similar to a brand-name biologic drug (the parent drug). Udenyca is a biologic medication, which is also called a biologic.

Biologic drugs are made from living cells. It’s not possible to copy these drugs exactly. A generic, on the other hand, refers to drugs made from chemicals. A generic is an exact copy of the active drug in a brand-name medication.

Biosimilars are considered to be just as safe and effective as their parent drug. And like generics, biosimilars tend to cost less than brand-name medications.

The reason “-cbqv” appears at the end of the drug’s name is to show that the drug is distinct from similar medications. Examples include:

• pegfilgrastim-jmdb (Fulphila)
• pegfilgrastim-apgf (Nyvepria)
• pegfilgrastim-bmez (Ziextenzo)

If you’re interested in a medication that’s similar to Udenyca, talk with your doctor. They can tell you if it comes in forms and strengths that can be used for your condition.

Udenyca side effects

Udenyca can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Udenyca. These lists do not include all possible side effects.

For more information about the possible side effects of Udenyca, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you’d like to notify the FDA about a side effect you’ve had with Udenyca, you can do so through MedWatch.

Mild side effects

Mild side effects* of Udenyca can include:

• bone pain
• pain in your arms and legs

Most of these side effects may go away within a few days to a couple of weeks. If they become more severe or do not go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Udenyca. To learn about other mild side effects, talk with your doctor or pharmacist, or view Udenyca’s prescribing information.

Serious side effects

Serious side effects from Udenyca are not common, but they can occur. It’s important to note that the side effects listed below were not reported in clinical trials of the drug. Rather, they were reported after Udenyca was approved and made available to the public. It’s unclear how often the serious side effects occurred and whether Udenyca was the cause. To learn more, see the medication’s prescribing information.

Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects of Udenyca and their symptoms can include:

• Ruptured spleen (the breaking open of the spleen). Symptoms can include:
  • pain in the upper left abdomen
  • left shoulder pain that gets worse when you inhale
  • lightheadedness
  • fainting
• Acute respiratory distress syndrome (a type of lung problem). Symptoms can include:
  • fever
  • coughing
  • trouble breathing
  • breathing faster than usual
  • bluish nails or lips
• Glomerulonephritis (a group of conditions that affect small blood vessels in the kidneys). Symptoms can include:
  • swelling of your ankles or face due to fluid retention
  • producing less urine than usual
  • bloody or dark-colored urine
• Low level of platelets (blood cells involved in clotting). Symptoms may include:
  • unusual bruising
  • nosebleeds
  • bleeding gums
• Capillary leak syndrome (a condition in which blood from tiny blood vessels leaks into surrounding tissues). Symptoms may include:
  • fluid retention
  • bloating
  • fatigue
  • sudden weight gain
  • increased thirst
• Inflammation of the aorta (the main artery that carries blood from your heart to your body). Symptoms may include:
  • back pain
  • fever
  • pain in your abdomen
  • generally not feeling well
• Cancers of the blood or bone marrow, such as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).† Symptoms of MDS or AML may include:
  • tiredness
  • fever
  • chills
  • unusual bleeding or bruising
• Leukocytosis (high level of leukocytes, a type of white blood cell). Leukocytosis typically does not cause symptoms and is often discovered in a blood test.
• Allergic reaction.*

* For details, see “Allergic reaction” below.
† These cancers were reported in people with breast cancer or lung cancer.

Side effects in children

Udenyca may cause the same side effects in children as in adults.

If you have any questions about Udenyca side effects in children, talk with your child’s doctor.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after receiving Udenyca. This side effect was not reported in clinical trials of the drug. However, it has occurred since Udenyca was approved and made available to the public.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have an allergic reaction to Udenyca, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Udenyca cost

As with all medications, Udenyca injection costs can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use. The price may also depend on the cost of the visits to your doctor’s office to receive Udenyca injections.

Keep in mind that you may be able to get a 90-day supply of Udenyca. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor, pharmacist, or insurance company.

It’s important to note that you may have to get Udenyca at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.

Before approving coverage for Udenyca, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Udenyca, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Udenyca, or if you need help understanding your insurance coverage, help is available.

A program called Coherus Complete is available for Udenyca. For more information and to find out if you’re eligible for support, call 844-4-UDENYCA (844-483-3692) or visit the program website.

To learn more about saving money on prescriptions, check out this article.

Mail-order pharmacies

Udenyca may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Udenyca, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor, pharmacist, or insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you do not have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Biosimilar version

Udenyca is a biosimilar version of pegfilgrastim (Neulasta). A biosimilar is a drug that’s similar to a brand-name biologic drug (the parent drug). Udenyca is a biologic medication, which is also called a biologic.

Biologic drugs are made from living cells. It’s not possible to copy these drugs exactly. Biosimilars are considered to be just as safe and effective as their parent drug. Like generic drugs, biosimilars tend to cost less than brand-name medications.

You may also be interesting in comparing the cost of other Neulasta biosimilars, which include Fulphila, Nyvepria, and Ziextenzo.

If your doctor has prescribed Udenyca and you’re interested in using Neulasta instead, talk with your doctor. They may have a preference for one version or another. You’ll also need to check your insurance plan, as it may only cover a particular version.

Udenyca dosage

The Udenyca dosage your doctor prescribes, including how often Udenyca is given, will depend on factors such as:

• body weight (for children)
• the dosing schedule for your specific chemotherapy regimen

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug form and strength

Udenyca comes as a clear solution in a prefilled syringe. The drug is given as a subcutaneous injection. A healthcare professional will give you this injection. They can also show you how to self-inject Udenyca at home.

Udenyca is available in one strength: 6 milligrams (mg) in 0.6 milliliters (mL) of solution.

Dosage for lowering risk of infection during chemotherapy

The usual dosage of Udenyca is 6 mg given once per chemotherapy cycle. This is equal to 0.6 mL (the contents of one Udenyca prefilled syringe).

Udenyca is typically given a day after chemotherapy. (If you receive chemotherapy for more than 1 day in a row, Udenyca is usually given 24 hours after the last dose.)

You should not receive or inject a dose of Udenyca between 14 days before and 24 hours after receiving chemotherapy.

Exactly how often you’ll have a dose of Udenyca depends on your specific chemotherapy regimen.

Children’s dosage

The dosage of Udenyca for children depends on their weight in kilograms (kg). One kg equals about 2.2 pounds (lb).

If your child weighs 45 kg (about 99 lb) or more, they’ll likely receive the adult dose of 6 mg. This is equal to 0.6 mL, which is the contents of one Udenyca prefilled syringe.

The chart below summarizes Udenyca dosing for children who weigh less than 45 kg.

These smaller doses (which are less than 0.6 mL) cannot be accurately measured with a Udenyca prefilled syringe. Because of this, a healthcare professional will prepare and administer your child’s doses.

Children will likely receive Udenyca once per chemotherapy cycle. The drug is typically given a day after chemotherapy.

Your child should not receive a dose of Udenyca between 14 days before and 24 hours after receiving chemotherapy. Exactly how often your child will receive a dose depends on their specific chemotherapy regimen.

What if I miss a dose?

If you miss giving yourself a dose of Udenyca, talk with your doctor right away. They can advise you on when you should have your next dose.

If you miss an appointment for a Udenyca injection, call your doctor’s office as soon as possible. They can reschedule your appointment. Missing or rescheduling doses of Udenyca may also impact your chemotherapy treatment schedule.

You should not receive or inject Udenyca between 14 days before and 24 hours after receiving chemotherapy.

To help make sure that you do not miss a dose, try setting a reminder on your phone. You can also keep track of all of your appointments on a calendar.

Will I need to use this drug long term?

Udenyca is meant to help lower the risk of infection during chemotherapy. You and your doctor will determine if Udenyca is safe and effective for you. If it is, your Udenyca treatment will likely last for as long as you’re at risk of infection due to chemotherapy.

How to use Udenyca

You should use Udenyca according to the administration instructions your doctor gives you.

Udenyca is given as a subcutaneous injection, typically a day after chemotherapy. This type of injection is administered just under the skin.

A healthcare professional will give you this injection. They can also show you how to self-inject the medication. Instructions for injecting Udenyca are available online as well.

Udenyca is injected in the thighs or abdomen (avoiding the 2-inch area around the belly button). If someone else gives you Udenyca doses, they can also inject the medication into two other spots. These are the back of your upper arm or the outside upper area of your buttocks.

When to use

Your doctor will tell you exactly when Udenyca should be given during each chemotherapy cycle.

You should not receive or inject Udenyca between 14 days before and 24 hours after receiving chemotherapy.

To help make sure that you do not miss a dose, try setting a reminder on your phone. You can also keep track of all of your appointments on a calendar.

Common questions about Udenyca

Here are answers to some frequently asked questions about Udenyca.

Does Udenyca cause injection-related side effects?

Possibly. Udenyca is given as a subcutaneous injection. As with most other injections, you may have discomfort at or around the injection site. Symptoms generally include pain, swelling, and itching. Other possible symptoms include bruising, redness, or discoloration. Injection site reactions usually go away within a few days.

Injection site reactions were not reported in clinical trials of Udenyca. However, the reactions have been reported since the drug was approved and made available to the public.

If you’re concerned about side effects from Udenyca injections, talk with your doctor or pharmacist. They may be able to suggest ways to help prevent and ease any reactions.

Can older people use Udenyca?

Yes, doctors may prescribe Udenyca to people of any age. This includes older adults (ages 65 years and older).

In clinical trials, the drug was just as safe and effective in older adults as it was in younger adults.

If you’re an older adult interested in Udenyca treatment, talk with your doctor. They can advise you on the right medication for you.

How does Udenyca affect my immune system?

Udenyca is meant to strengthen your immune system. The drug boosts your body’s production of neutrophils (a type of white blood cell). Neutrophils are made in bone marrow, which is the soft inner lining of your bones.

Neutrophils are an important part of your immune system. They’re one of the first immune system cells to respond when a pathogen enters your body. (A pathogen is a germ, such as bacteria or a virus, that can cause infection.) Neutrophils search out and destroy the pathogen, fighting off the infection. Neutrophils also signal other immune system responses.

Chemotherapy drugs are used to kill cancer cells. However, in the process, these drugs often damage other types of cells, such as neutrophils. Udenyca is given to people receiving chemotherapy to help lower the risk of infection.

To learn more, see the “How Udenyca works” section below. You can also talk with your doctor and pharmacist.

Alternatives to Udenyca

Other drugs are available that can lower the risk of infection during chemotherapy. Some may be a better fit for you than others. If you’re interested in finding an alternative to Udenyca, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when a drug that’s approved by the Food and Drug Administration (FDA) is prescribed for a purpose other than what it’s approved for.

Alternatives for lowering risk of infection during chemotherapy

Examples of other drugs that may be used to help prevent infections during chemotherapy include:

• pegfilgrastim (Neulasta)
• pegfilgrastim-jmdb (Fulphila)
• pegfilgrastim-apgf (Nyvepria)
• pegfilgrastim-bmez (Ziextenzo)
• filgrastim (Neupogen)
• filgrastim-aafi (Nivestym)
• filgrastim-ayow (Releuko)
• filgrastim-sndz (Zarxio)
• tbo-filgrastim (Granix)

Udenyca uses

The Food and Drug Administration (FDA) approves prescription drugs such as Udenyca to treat certain conditions. Udenyca may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Udenyca for lowering risk of infection during chemotherapy

Udenyca is approved to reduce the risk of infection in people receiving chemotherapy for non-myeloid* cancer.

Specifically, Udenyca is used to help prevent febrile neutropenia. This condition occurs when you have a fever along with neutropenia (low level of neutrophils).

Udenyca has a limitation of use. This drug is not used to increase the number of stem cells that move out of bone marrow into blood for a hematopoietic stem cell transplant.

* Non-myeloid cancers are cancers that do not affect your bone marrow. This is the soft inner lining of bones that makes blood cells.

Febrile neutropenia explained

Chemotherapy drugs are used to kill cancer cells. In the process, many of these medications often damage or kill other types of cells. This includes white blood cells such as neutrophils.

Neutrophils are an important part of your immune system, helping to fight infection. Without enough neutrophils, your risk of developing an infection can increase.

When the level of neutrophils in your blood becomes lower than normal, a condition called neutropenia occurs. If you have neutropenia and develop a fever, it’s known as febrile neutropenia.

Neutropenia itself typically does not cause symptoms. Your doctor is likely to notice it in a blood test. The definition of febrile neutropenia can vary. In general, doctors define the condition as:

• a temperature greater than 100.3°F and
• fewer than 500 neutrophils per microliter (mcL) of blood

A fever can mean that you have an infection. Symptoms of infection may vary based on the type of infection and where it occurs. You can find some common symptoms here.

Febrile neutropenia can be a serious and sometimes life threatening complication of chemotherapy.

Effectiveness for lowering risk of infection during chemotherapy

Pegfilgrastim (the active drug in Udenyca) has been shown to be effective in lowering the risk of infection in people receiving chemotherapy. National Comprehensive Cancer Network treatment guidelines recommend pegfilgrastim.

For information on how the drug performed in clinical trials, see Udenyca’s prescribing information.

Udenyca and children

The FDA approves Udenyca to reduce the risk of infection in people receiving chemotherapy. This includes children of all ages.

Udenyca use with other drugs

Udenyca is used to lower the risk of infection in people receiving chemotherapy.

Chemotherapy drugs are used to kill cancer cells. In the process, many of these medications often damage or kill healthy cells. This can lead to low levels of certain blood cells, such as neutrophils. (A neutrophil is a type of white blood cell that’s important in fighting infection.)

Udenyca is given after each cycle of chemotherapy to help boost the production of neutrophils.

Examples of chemotherapy drugs that may cause low levels of neutrophils include:

• carboplatin
• cisplatin
• oxaliplatin (Eloxatin)
• paclitaxel
• docetaxel (Taxotere)
• doxorubicin (Doxil)
• 5-fluorouracil

Keep in mind that the timing of Udenyca treatment is important. You should not receive or inject a dose of Udenyca between 14 days before and 24 hours after receiving a dose of chemotherapy. Your doctor will tell you exactly when you’ll receive Udenyca during each chemotherapy cycle.

Udenyca interactions

Udenyca is not known to interact with other medications, herbs, supplements, or foods. The manufacturer of Udenyca did not look at interactions in clinical trials of the drug.

However, this doesn’t mean that interactions won’t be recognized in the future. For example, new drugs could be approved that interact with Udenyca.

Before starting Udenyca treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist.

Udenyca and alcohol

Udenyca is not known to interact with alcohol.

Udenyca is used to lower the risk of infection during chemotherapy. Some chemotherapy drugs interact with alcohol. Drinking alcohol may also worsen certain side effects of chemotherapy drugs, such a sore and dry mouth.

If you drink alcohol, talk with your doctor about how much (if any) is safe during your treatment.

How Udenyca works

Chemotherapy can decrease the level of neutrophils in your body. Neutrophils are a type of white blood cell that’s important in fighting infection.

Udenyca belongs to a class of drugs called granulocyte colony-stimulating factors (G-CSFs). A G-CSF is a type of protein called a growth factor. Your immune system naturally makes G-CSF. It’s a hormone that signals your bone marrow to make neutrophils.

Udenyca contains the active ingredient pegfilgrastim, which is a slightly modified version of G-CSF. It mimics your body’s natural G-CSF, telling your bone marrow to ramp up neutrophil production.

How long does it take to work?

Udenyca begins working right away to help your body make more neutrophils. One dose typically works for 10 to 14 days.

Udenyca and pregnancy

It’s not known whether treatment with pegfilgrastim (the active drug in Udenyca) is safe during pregnancy. The drug’s clinical trials didn’t include pregnant people.

One study looked at the medical records of pregnant people who took pegfilgrastim or a similar drug during chemotherapy. The researchers did not find an increased risk of harm. This was compared with people who received chemotherapy alone during pregnancy.

Keep in mind that most chemotherapy drugs are not safe to take during pregnancy.

If you’re pregnant or trying to become pregnant, talk with your doctor. They can help you decide on the right way to treat your condition during this time.

Udenyca and birth control

It’s not known if Udenyca treatment is safe during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Udenyca.

For more information about taking Udenyca during pregnancy, see the “Udenyca and pregnancy” section above.

Udenyca and breastfeeding

It’s not known whether Udenyca treatment is safe while breastfeeding. Research has not been done to learn about the drug’s effects on breast milk or a breastfed child.

If you’re breastfeeding or considering it, talk with your doctor before starting Udenyca treatment. They’ll likely recommend another feeding option for your child during chemotherapy.

Udenyca precautions

Before taking Udenyca, talk with your doctor about your health history. Udenyca may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

• Sickle cell disease. If you have sickle cell disease (SCD), Udenyca treatment may worsen your condition. Sickle cell crisis has been reported in people who received Udenyca and had a type of SCD called sickle cell anemia. Talk with your doctor to determine whether it’s safe for you to take Udenyca if you have SCD.
• Allergic reaction. If you’ve had an allergic reaction to Udenyca or any of its ingredients, your doctor will likely not prescribe Udenyca. Your doctor will also not likely prescribe Udenyca if you’re allergic to filgrastim. This is a type of drug called a granulocyte colony stimulating factor. Ask them what other medications may be better options for you.
• Pregnancy. It’s not known if Udenyca is safe to take during pregnancy. For more information, see the “Udenyca and pregnancy” section above.
• Breastfeeding. It’s not known if Udenyca is safe to take while breastfeeding. For more information, see the “Udenyca and breastfeeding” section above.

Note: For more information about the potential negative effects of Udenyca, see the “Udenyca side effects” section above.

Udenyca overdose

Using more than the recommended dosage of Udenyca can lead to serious side effects. Do not use more Udenyca than your doctor recommends.

Overdose symptoms

Symptoms of an overdose can include:

• leukocytosis (high levels of leukocytes, a type of white blood cell)
• bone pain
• edema (swelling due to fluid buildup)
• trouble breathing
• pleural effusion (fluid buildup around the lungs)

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.