Pegfilgrastim Biosimilars: What to Know About Fulphila and Other Neulasta Look-Alikes
Pegfilgrastim biosimilars are used to prevent infection following chemotherapy. Examples of pegfilgrastim biosimilars include Fulphila, Udenyca, and Ziextenzo.
Udenyca
Used for Neutropenia
Used for Neutropenia
Udenyca (pegfilgrastim or pegfilgrastim-cbqv) is a biosimilar to Neulasta (pegfilgrastim). It's an injection used in adults and children to lower infection risk during certain cancer treatments and improve survival after harmful radiation exposure. The medication is available as a prefilled syringe, autoinjector, and Udenyca on-body injector, and is given as an injection under the skin. Common side effects include bone pain and pain in the arms or legs.
What is Udenyca (pegfilgrastim)?
What is Udenyca (pegfilgrastim) used for?
- Lower the risk of infection in adults and children receiving certain cancer treatments that can lower white blood cell levels (febrile neutropenia)
- Increase survival in adults and children exposed to high doses of radiation that severely damage the bone marrow
How Udenyca (pegfilgrastim) works
Udenyca (pegfilgrastim) is a granulocyte colony-stimulating factor (G-CSF), a type of leukocyte growth factor. It works like G-CSF, a protein your body naturally makes. G-CSF triggers your bone marrow to make more neutrophils, a type of white blood cell that helps fight infections.
When does Udenyca (pegfilgrastim) start working?Time passed since treatment started:
Drug facts
| Common Brands | Udenyca |
|---|---|
| Drug Class | Colony-stimulating factor |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
More on Udenyca (pegfilgrastim) essentials
Side effects of Udenyca (pegfilgrastim)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Bone pain (31%)
- Pain in arms or legs (9%)
Less Common Side Effects
- Injection site reactions
- Rash
- Hives
Udenyca (pegfilgrastim) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Spleen rupture: pain in your left upper stomach, pain in your left shoulder
- Lung problem: shortness of breath, fever, trouble breathing, fast rate of breathing
- Serious allergic reaction: rash, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, sweating
- Kidney problems: swelling of your face or ankles, urinating less than usual, blood in your urine or dark colored urine
- Capillary leak syndrome: swelling of your stomach, dizziness or feeling faint, trouble breathing, urinating less than usual, tiredness
- Blood vessel inflammation: fever, stomach pain, back pain, headache, neck pain, generally feeling unwell
When do Udenyca (pegfilgrastim) possible side effects begin and end?
Time passed since treatment started:
H
D
W
M
Bone pain
Back pain
The following Udenyca (pegfilgrastim) side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
Black, tarry stools
bleeding gums
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
blisters in the skin
blood in the urine or stools
cloudy urine
decrease in how much or how often you urinate
difficulty with swallowing
dizziness
fainting or lightheadedness
fast heartbeat
flushing or redness of the skin
hives or welts, skin rash
itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
lower back or side pain
painful or difficult urination
pinpoint red spots on the skin
sores on the skin
stomach pain
swelling of the hands, ankles, feet, or lower legs
swollen glands
unusual bleeding or bruising
unusual tiredness or weakness
unusually warm skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Belching
change in sense of taste
cracked lips
hair loss or thinning of the hair
indigestion
joint pain
lack or loss of strength
loss of appetite
muscle soreness
swelling or inflammation of the mouth
trouble sleeping
vomiting
weakness, generalized
Incidence not known
Body produces substance that can bind to drug making it less effective or cause side effects
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 may report side effects to the FDA at 1-800-FDA-1088.
Get your GoodRx coupon
N/A
GoodRx discount
$4014.25
Pros and cons of Udenyca (pegfilgrastim)
Pros
- Long-lasting and only needs to be given once per chemotherapy cycle
- Available as a prefilled syringe, autoinjector, and on-body injector
- Udenyca on-body injector delivers the dose in 5 minutes
Cons
- Commonly causes bone pain and back pain
- Requires frequent lab work
- Must be timed carefully around chemotherapy
Pharmacist tips for Udenyca (pegfilgrastim)
- If you're receiving chemotherapy, Udenyca (pegfilgrastim) shouldn't be given within 14 days before or 24 hours after chemotherapy. Getting it too close to chemotherapy can affect how well treatment works.
- Keep all blood test appointments while receiving Udenyca (pegfilgrastim). Your care team will check your white blood cells to make sure they're in a safe range.
- Bone pain is common with Udenyca (pegfilgrastim). Ask your care team which pain relievers are safe for you before taking anything on your own.
- Contact your care team right away if you have pain in the upper left side of your stomach or left shoulder while receiving Udenyca (pegfilgrastim). This could be a sign of a serious spleen problem.
- Storage: Keep Udenyca (pegfilgrastim) in the refrigerator and protect it from light. Don't freeze or shake the medication.
- After using Udenyca (pegfilgrastim), put the syringe, autoinjector, or on-body injector in a sharps container. This helps prevent accidental needlestick injuries.
Udenyca prefilled syringe and autoinjector:
- If injecting at home, your care team will show you or your caregiver how to give the shot safely. Follow the Instructions for Use and ask your care team if you have questions.
- Take the syringe or autoinjector out of the refrigerator at least 30 minutes before your injection and let it reach room temperature. Throw it away if it's been left at room temperature for more than 48 hours.
- The medication can be injected under the skin of your upper arm, stomach, thigh, or buttocks.
For Udenyca on-body injector
- A healthcare professional will place the on-body injector on your skin, usually on the same day as chemotherapy.
- The on-body injector starts delivering the medication about 27 hours after it's placed on your skin. It takes about 5 minutes to deliver the full dose.
- Review the Instructions for Use to check that it's working. A green light means it's working properly; if the light turns red, contact your care team because you might need a replacement dose.
- If the on-body injector falls off, contact your oncology care team right away. Don't try to put the device back on yourself.
- Avoid driving, traveling, or using heavy machinery 26 to 29 hours after the on-body injector is placed. This is when the device delivers your dose, and you'll need to make sure you receive the full amount.
- Keep the on-body injector dry for about 3 hours before your dose and avoid baths, hot tubs, saunas, and direct sunlight while wearing it. Contact your oncology care team if you notice leaking because you might not receive your full dose.
- Keep the on-body injector at least 4 inches away from electrical devices, such as cell phones and microwaves. Avoid airport X-rays and certain medical imaging scans while wearing it because they can interfere with the device.
Risks and warnings for Udenyca (pegfilgrastim)
Udenyca (pegfilgrastim) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Spleen rupture
Rarely, Udenyca (pegfilgrastim) can cause your spleen to become enlarged. In serious cases, the spleen can rupture (break open), which can be life-threatening. Get medical help right away if you have pain in the upper left side of your stomach or in your left shoulder.
Lung problem
Udenyca (pegfilgrastim) can cause acute respiratory distress syndrome (ARDS), a serious lung condition that makes it hard to breathe and get enough oxygen. Get medical help right away if you develop trouble breathing or shortness of breath, especially if you also have a fever.
Serious allergic reactions
- Risk factors: Allergy to Udenyca (pegfilgrastim) or similar medications | Allergy to acrylics
Udenyca (pegfilgrastim) can cause serious allergic reactions that can be life-threatening if not treated. These reactions are more likely after your first dose, but symptoms can return days after the first reaction is treated.
You shouldn't receive Udenyca (pegfilgrastim) if you've had a serious allergic reaction to it or a similar medication, such as Neupogen (filgrastim). The on-body injector uses acrylic adhesive, so tell your prescriber if you have an acrylic allergy. Get medical help right away if you have trouble breathing, swelling of your face or throat, hives, or severe dizziness.
Sickle cell crisis in people with sickle cell anemia
- Risk factors: Sickle cell anemia
In people with sickle cell anemia, Udenyca (pegfilgrastim) can trigger a serious and sometimes life-threatening sickle cell crisis. Symptoms can include severe pain, trouble breathing, chest pain, fever, or extreme tiredness. If a sickle cell crisis happens, the care team will stop the medication and provide treatment.
Kidney problems
Udenyca (pegfilgrastim) can rarely cause glomerulonephritis, a condition where the tiny filters in the kidneys become inflamed. Signs can include blood in the urine, dark colored urine, swelling, or urinating less than usual. If this happens, the care team might lower the dose or stop the medication.
Changes in blood cell counts
Udenyca (pegfilgrastim) can cause your white blood cell count to become too high. Your care team will check your complete blood count (CBC) during treatment to make sure your levels stay in a safe range.
Udenyca (pegfilgrastim) can also lower your platelet count, which can raise your risk of bruising or bleeding. Tell your care team if you notice unusual bruising, nosebleeds, or bleeding that's hard to stop.
Capillary leak syndrome
Colony-stimulating factor medications like Udenyca (pegfilgrastim) can rarely cause capillary leak syndrome (CLS). This is a serious condition where fluid leaks out of small blood vessels into nearby tissues. It can cause low blood pressure, swelling, dizziness, or weakness and can be life-threatening without quick treatment. Get medical help right away if these symptoms develop.
Risk of certain cancers
Udenyca (pegfilgrastim) is a growth factor that mainly helps your body make more white blood cells. But there's a possibility it could also promote the growth of certain cancer cells.
Rarely, people with breast or lung cancer have developed blood cancers or bone marrow problems while receiving Udenyca (pegfilgrastim) with chemotherapy or radiation. Your care team will monitor your blood tests and might stop the medication if the risks become greater than the benefits.
Problems with the on-body injector
Sometimes the Udenyca on-body injector might not deliver the full dose. Missing some or all of the dose can raise the risk of low white blood cell levels, fever, and infection. Contact your oncology care team right away if the device falls off, leaks, shows a red light, or doesn't seem to work correctly because a replacement dose might be needed.
Blood vessel inflammation
Udenyca (pegfilgrastim) can rarely cause serious inflammation of large or medium-sized blood vessels. This can happen as early as the first week of treatment. Contact your oncology care team right away if you develop an unexplained fever, stomach or back pain, headache, neck pain, or feel unusually unwell.
Udenyca (pegfilgrastim) dosage
The average cost for 1 syringe of 6mg/0.6ml of Udenyca (pegfilgrastim) is $4,014.25 with a free GoodRx coupon.
Syringe
Syringe| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 6mg/0.6ml | 1 syringe | $4,014.25 | $4,014.25 |
Typical dosage for Udenyca (pegfilgrastim)
Udenyca (pegfilgrastim) is given as an injection under the skin using a syringe, autoinjector, or Udenyca on-body injector. The Onbody injector is placed on your skin by a member of your oncology care team.
Lower risk the risk of infection during chemotherapy
- Adults and children weighing 45 kg (99 lbs) or more
- The typical dose is 6 mg once per chemotherapy cycle.
- It shouldn't be given within 14 days before or 24 hours after chemotherapy.
After high-dose radiation exposure
- Adults and children weighing 45 kg (99 lbs) or more
- The typical dose is 6 mg as soon as possible after radiation exposure, followed by another 6 mg dose one week later.
Interactions between Udenyca (pegfilgrastim) and other drugs
Udenyca (pegfilgrastim) may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking. The list below does not include all possible drug interactions with Udenyca (pegfilgrastim). Please note that only the generic name of each medication is listed below.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
How much does Udenyca (pegfilgrastim) cost?
To access savings, use a GoodRx coupon and pay just a fraction of the retail price.
Neulasta (brand)
$4,014.25
Udenyca (pegfilgrastim) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Udenyca (pegfilgrastim) will not be safe for you to take.
- Allergy to pegfilgrastim medications
- Allergy to filgrastim medications (e.g. Neupogen (filgrastim))
What are alternatives to Udenyca (pegfilgrastim)?
There are a number of medications that your doctor can prescribe in place of Udenyca (pegfilgrastim). Compare a few possible alternatives below.
Used for:
Prevention of low neutrophil-related complications in:
Preparation for blood collection for your own stem cell transplant (Neupogen, Nivestym, and Zarxio only)
Increase survival in people exposed to bone marrow-suppressing radiation (Neupogen only)
$333.75View prices
News about Udenyca (pegfilgrastim)
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Udenyca (pegfilgrastim) images
