Udenyca (Subcutaneous)

Pegfilgrastim-cbqv injection is used to treat neutropenia (low white blood cells) caused by cancer medicines. It is a synthetic (man-made) version of a substance that your body normally produces called a colony stimulating factor. Pegfilgrastim-cbqv helps the bone marrow produce new white blood cells.

When certain cancer medicines are used to fight cancer cells, they can also affect the white blood cells that help fight infections. Pegfilgrastim-cbqv is used to reduce the risk of getting an infection while you are receiving cancer treatments.

This medicine is available only with your doctor's prescription.

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

Check with your doctor right away at the first sign of an infection, including fever, chills, cough, sore throat, or unusual tiredness or weakness.

Check with your doctor immediately if you or your child are experiencing pain in the upper left part of your stomach or at the tip of the left shoulder. This could be a symptom of a serious side effect involving the spleen.

Check with your doctor right away if you or your child develop a fever, chest pain or tightness, 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 require immediate medical attention. Tell your doctor right away if you or your child has a rash, itching skin, dizziness, lightheadedness, or fainting, swelling of the face, tongue, or throat, trouble breathing, or chest pain after receiving the medicine.

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

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

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 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.

This medicine may cause blood or bone marrow problems (e.g., 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.

Before you have any medical tests, inform the medical doctor in charge that you are using this medicine. The results of some tests (e.g., bone tests) may be affected by this medicine.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies conducted so far have not shown any specific problems in children that would limit the usefulness of pegfilgrastim-cbqv injection in the pediatric population.

Geriatric

Studies conducted so far have not shown any specific problems in older adults that would limit the usefulness of pegfilgrastim-cbqv injection in the elderly.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if an interaction may happen. In such cases, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Glomerulonephritis (kidney disease) or
• Leukocytosis (high white blood cell count) or
• Lung disease or breathing problems or
• Sickle cell disease (red blood cell disease)—Use with caution. May worsen these conditions.

Along with its beneficial effects, this medicine can cause some unwanted effects. Not all of these side effects will happen, but if they do, you may need medical help.

Contact your doctor right away if any of the following side effects occur:

More common

• Bone pain
• Pain in the arms or legs

Incidence not known

• Back pain
• Black, tarry stools
• Bleeding gums
• Blood in the urine or stools
• Blue lips, fingernails, or skin
• Blurred vision
• Change in the amount of urine
• Chest pain or tightness
• Chills
• Cloudy or bloody urine
• Cough
• Difficulty or rapid breathing
• Difficulty swallowing
• Dizziness
• Eye pain
• Fainting or feeling lightheaded
• Fast heartbeat
• Feeling of fullness
• Fever
• Fever sores on the skin
• General feeling of discomfort or illness
• Headache
• Hives, itching, skin rash
• Lower back or side pain
• Nausea
• Nervousness
• Pain spreading to the left shoulder
• Painful or difficult urination
• Pale skin
• Pinpoint red spots on the skin
• Pounding in the ears
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Redness, soreness, or itching of the skin
• Slow or fast heartbeat
• Sore throat
• Sores, welts, or blisters
• Stomach pain
• Swelling of the hands, ankles, feet, or lower legs
• Trouble breathing
• Ulcers or white spots on the lips or in the mouth
• Unusual bleeding or bruising
• Unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your healthcare professional may also know ways to prevent or lessen some of these side effects. Talk to your healthcare professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Udenyca

Available Dosage Forms:

• Solution

Therapeutic Class: Hematopoietic

Pharmacologic Class: Pegfilgrastim

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Udenyca.

Neulasta (pegfilgrastim) - Amgen Inc.

View Neulasta information in detail.

Neulasta Onpro (pegfilgrastim) - Amgen Inc.

View Neulasta Onpro information in detail.

Neulasta, Neulasta Onpro biosimilar products

Biosimilar products can only be given instead of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by state.

Armlupeg (pegfilgrastim-unne) - Lupin Limited (Biotech Division)

View Armlupeg information in detail.

Ennumo (pegfilgrastim-pccg) - Accord BioPharma Inc.

View Ennumo information in detail.

Fulphila (pegfilgrastim-jmdb) - Biocon Biologics Inc.

View Fulphila information in detail.

Fylnetra (pegfilgrastim-pbbk) - Kashiv BioSciences, LLC

View Fylnetra information in detail.

Nyvepria (pegfilgrastim-apgf) - Hospira Inc., a Pfizer Company

View Nyvepria information in detail.

Stimufend (pegfilgrastim-fpgk) - Fresenius Kabi USA, LLC

View Stimufend information in detail.

Udenyca (pegfilgrastim-cbqv) - Accord BioPharma Inc.

View Udenyca information in detail.

Udenyca Onbody (pegfilgrastim-cbqv) - Accord BioPharma Inc.

View Udenyca Onbody information in detail.

Ziextenzo (pegfilgrastim-bmez) - Sandoz Inc.

View Ziextenzo information in detail.

A nurse or other trained health professional may give you this medicine. It is given as a shot under the skin of your upper arm, upper outer buttock, stomach, or thigh. You or your caregiver may be trained to prepare and inject this medicine at home. Be sure that you understand how to use it.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that are tender, red, bruised, hard, or has scars, moles, or birthmarks.

Pegfilgrastim-cbqv comes in 2 forms: a prefilled autoinjector and a prefilled syringe. Your doctor will tell you which dosage form you should use.

This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions about:

• How to prepare the injection.
• The proper use of the prefilled autoinjector and prefilled syringe.
• How to give the injection.
• How long the injection can be stored at home.

Allow the medicine to warm to room temperature for 30 minutes before you inject it. If the medicine in the prefilled autoinjector or prefilled syringe has changed color, looks cloudy, or if you see particles in it, do not use it. Do not shake. Use the prefilled autoinjector or prefilled syringe only once. Do not save leftover medicine.

Do not use this medicine between 14 days before and 24 hours after receiving chemotherapy.

Dosing

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 (prefilled autoinjector or prefilled syringe):For neutropenia: Adults—6 milligrams (mg) as a single injection under the skin once every cancer treatment cycle. Children weighing more than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. It is usually 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 as a single injection under the skin once every cancer treatment cycle.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Protect from light. If it is frozen, thaw it in the refrigerator before using it. Throw this medicine away if it has been frozen more than once or if it has been left at room temperature for longer than 48 hours.

Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.

• Biosimilars vs Biologics: What are they and how do they compare?
• What is the difference between Udenyca and Neulasta?
• How is Fulphila injected / administered?
• What is the difference between Udenyca and Fulphila?
• What does cbqv stand for in pegfilgrastim?
• What biosimilars have been approved in the United States?
• What is the difference between Fulphila and Neulasta?

View more FAQ