Udenyca

Generic name: pegfilgrastim
Brand names: Fulphila, Neulasta, Neulasta Onpro Kit, Nyvepria, Udenyca, Ziextenzo
Drug class: Colony stimulating factors

Medically reviewed by  A Ras MD.

What is Udenyca used for?

Udenyca is a prescription medicine that is used to lower the chance of getting an infection in people with bone marrow problems caused by chemo. Udenyca may be given to you for other reasons.

Description

Pegfilgrastim-cbqv is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble, 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kDa). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene.

During the pegfilgrastim-cbqv manufacturing process, fermentation is carried out in nutrient medium containing the antibiotic kanamycin. However, kanamycin is cleared in the manufacturing process and is not detectable in the final product. To produce pegfilgrastim-cbqv, a 20 kDa monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF. The average molecular weight of pegfilgrastim-cbqv is approximately 39 kDa.

UDENYCA (pegfilgrastim-cbqv) injection is supplied in 0.6 mL prefilled syringes for manual subcutaneous injection. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL).

Each syringe contains 6 mg pegfilgrastim-cbqv (based on protein weight) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), polysorbate 20 (0.02 mg), sodium (0.02 mg), and sorbitol (30 mg) in Water for Injection, USP.

Mechanism of Action

Pegfilgrastim products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

Before taking Udenyca, tell your doctor:

• If you are allergic to Udenyca; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you weigh less than 99 pounds (45 kilograms), talk with your doctor.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Udenyca with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Udenyca?

• Tell all of your health care providers that you take Udenyca. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take Udenyca within 14 days before or on the same day that you get chemo.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Udenyca.
• Some people with sickle cell disease have had times where the sickle cell disease has gotten worse when taking Udenyca. Sometimes, this has been deadly. Talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Udenyca best taken?

Use Udenyca as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Keep taking Udenyca as you have been told by your doctor or other health care provider, even if you feel well.
• Leave Udenyca at room temperature for at least 30 minutes before using. Do not remove the cap or cover until ready to use. Do not heat Udenyca.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Do not shake.
• Wash your hands before and after use.
• Do not give into skin that is irritated, bruised, red, infected, or scarred.
• Move the site where you give the shot with each shot.
• Throw away any part left over after the dose is given.
• Throw syringe away after use. Do not use the same syringe more than one time.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Udenyca that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
• Dark urine.
• Sweating a lot.
• Fast breathing.
• Swelling of belly.
• Feeling full.
• Enlarged and ruptured spleens have happened with Udenyca. Sometimes, ruptured spleens have been deadly. Call your doctor right away if you have left upper stomach pain or left shoulder pain.
• Swelling of the main blood vessel that comes out of the heart (aorta) has happened with Udenyca. Call your doctor right away if you feel very tired or weak. Call your doctor if you have fever, stomach pain, or back pain.
• Capillary leak syndrome (CLS) is a very bad health problem that has happened with Udenyca. Sometimes, CLS can be deadly. Tell your doctor right away if you get signs of CLS like change in how much urine is passed; not able to pass urine; blood in the urine; a fast or abnormal heartbeat; chest pain or pressure; dizziness or passing out; shortness of breath; a big weight gain; swelling; throwing up blood or throw up that looks like coffee grounds; or if you have black, tarry, or bloody stools.

What are some other side effects of Udenyca?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Bone pain.
• Muscle pain.
• Pain in arms or legs.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Udenyca?

• Store in a refrigerator. Do not freeze.
• Store in the original container to protect from light.
• If Udenyca freezes, let it thaw in the refrigerator before use.
• Do not use if Udenyca has been frozen more than once.
• Do not use Udenyca if it has been dropped or if it is broken.
• If needed, Udenyca can be left out at room temperature for up to 48 hours. Throw away unopened drug if left at room temperature for more than 48 hours.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL

• Carton Label – One 6 mg/0.6 mL Single-Dose Prefilled Syringe – UDENYCA
• PRINCIPAL DISPLAY PANEL
• Coherus
  BioSciences
• 6 mg/
  0.6 mL
• NDC 70114-101-01
• UDENYCA®
  pegfilgrastim-cbqv
  Injection
• Rx Only
• 6 mg in 0.6 mL Single-Dose Prefilled
  Syringe
  For Subcutaneous Use
  Sterile Solution – No Preservative
• Pegylated Recombinant
  Methionyl Human Granulocyte
  Colony-Stimulating Factor
  (PEG-r-metHuG-CSF) derived
  from E. coli
• One 6 mg/0.6 mL single-dose
  Prefilled Syringe

SRC: NLM .