Fulphila
Generic name: pegfilgrastim [ PEG-fil-GRAS-tim ]
Brand names: Fulphila, Fylnetra, Neulasta, Neulasta Onpro Kit, Nyvepria,
... show all 8 brands
Drug class: Colony stimulating factors
What is Fulphila?
Fulphila is used to prevent neutropenia (a lack of certain white blood cells) that is caused by receiving chemotherapy.
Fulphila is a form of a protein that stimulates the growth of white blood cells that help your body fight against infection.
Fulphila may also be used for purposes not listed in this medication guide.
Fulphila side effects
Get emergency medical help if you have signs of an allergic reaction: hives, skin rash, sweating, warmth or tingly feeling; dizziness, fast heartbeats; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.
Capillary leak syndrome is a rare but serious side effect of pegfilgrastim. Call your doctor right away if you have signs of this condition, which may include: decreased urination, tiredness, dizziness or light-headed feeling, trouble breathing, and sudden swelling, puffiness, or feeling of fullness.
Fulphila may cause serious side effects. Call your doctor at once if you have:
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sudden or severe pain in your left upper stomach spreading up to your shoulder;
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sudden and severe pain in your chest, stomach, or back;
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severe or ongoing pain anywhere in your body;
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fever, tiredness;
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shortness of breath, rapid breathing;
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easy bruising, unusual bleeding, purple or red spots under your skin;
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bruising, swelling, or a hard lump where the medicine was injected; or
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kidney problems--little or no urination, pink or dark urine, swelling in your face or lower legs.
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects of Fulphila may include:
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bone pain; or
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pain in your arms or legs.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Warnings
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Before taking this medicine
You should not use Fulphila if you are allergic to Fulphila or filgrastim (Neupogen).
Tell your doctor if you have ever had:
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sickle cell disorder;
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kidney disease;
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radiation treatment;
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myelodysplastic syndrome (also called "preleukemia"); or
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a latex allergy.
Treatment with Fulphila and radiation with or without chemotherapy for breast or lung cancer, you could develop a blood disorder or blood cancer (leukemia). Ask your doctor about this risk.
Tell your doctor if you are pregnant or breastfeeding.
How should I use Fulphila?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Fulphila should not be given within 14 days before or 24 hours after you receive chemotherapy.
Fulphila is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.
Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.
Your blood may need to be tested often.
Carefully follow your doctor's instructions when giving Fulphila to a child who weighs less than 99 pounds (45 kilograms). The correct dose for a child this size cannot be accurately measured using the prefilled syringe.
You may need medical tests to help your doctor determine how long to treat you with Fulphila.
Store the prefilled syringe in its original package in the refrigerator, protected from light. Do not shake or freeze.
Take the syringe out of the refrigerator and let it reach room temperature for 15 to 30 minutes before injecting your dose. If a syringe has become frozen, thaw it in a refrigerator. Do not use any syringe that has been frozen more than one time.
Do not use a Neulasta or Udenyca syringe that has been left at room temperature for longer than 48 hours. Do not use a Fylnetra, Fulphila, o Stimufend syringe that has been left at room temperature for longer than 72 hours. Do not use a Ziextenzo syringe that has been left at room temperature for longer than 5 days.
The Neulasta Onpro Injector is a special device placed on the skin that delivers your Fulphila dose at a specific time. You will need to wear the device for 27 hours before the dose begins. The timed dose will then be released from the device slowly over a 45-minute period.
Keep Neulasta Onpro refrigerated until you are ready to wear it. Do not use an Neulasta Onpro device that has been left out of a refrigerator for longer than 12 hours. Do not use Nyvepria prefilled syringe that has been left out of the refrigerator for longer than 15 days.
While wearing Neulasta Onpro, you or a caregiver will need to check the device to make sure it is working properly.
Each prefilled syringe or Onpro Injector is for one use only. Throw it away after one use, even if there is still medicine left inside.
Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.
Related/similar drugs
filgrastim, Zarxio, Neupogen, pegfilgrastim, Neulasta, Granix
What happens if I miss a dose?
Call your doctor for instructions if you miss an injection, or if you have a problem with the Neulasta Onpro device.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms include bone pain, pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, cold, clammy skin, anxiety, rapid heartbeats.
What should I avoid while using Fulphila?
When using Neulasta Onpro: Avoid traveling, driving, or operating machinery while wearing the device.
What other drugs will affect Fulphila?
Other drugs may affect Fulphila, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Fulphila Biosimilars
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 Fulphila.
Neulasta (pegfilgrastim) - Amgen Inc.
Formulation type | Strength |
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Pre-Filled Syringe | 6 mg/0.6 mL |
View Neulasta information in detail.
Neulasta Onpro (pegfilgrastim) - Amgen Inc.
Formulation type | Strength |
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Pre-Filled Syringe | 6 mg/0.6 mL |
View Neulasta Onpro information in detail.
Neulasta, Neulasta Onpro biosimilar products
Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.
Pharmacy laws for biosimilar prescribing may vary by state
Fulphila (pegfilgrastim-jmdb) - Biocon Biologics Inc.
Formulation type | Strength |
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Pre-Filled Syringe | 6 mg/0.6 mL |
Fylnetra (pegfilgrastim-pbbk) - Kashiv BioSciences, LLC
Formulation type | Strength |
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Pre-Filled Syringe | 6 mg/0.6 mL |
View Fylnetra information in detail.
Nyvepria (pegfilgrastim-apgf) - Hospira Inc., a Pfizer Company
Formulation type | Strength |
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Pre-Filled Syringe | 6 mg/0.6 mL |
View Nyvepria information in detail.
Stimufend (pegfilgrastim-fpgk) - Fresenius Kabi USA, LLC
Formulation type | Strength |
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Pre-Filled Syringe | 6 mg/0.6 mL |
View Stimufend information in detail.
Udenyca (pegfilgrastim-cbqv) - Coherus BioSciences, Inc.
Formulation type | Strength |
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Autoinjector | 6 mg/0.6 mL |
Pre-Filled Syringe | 6 mg/0.6 mL |
View Udenyca information in detail.
Udenyca Onbody (pegfilgrastim-cbqv) - Coherus BioSciences, Inc.
Formulation type | Strength |
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Pre-Filled Syringe | 6 mg/0.6 mL |
View Udenyca Onbody information in detail.
Ziextenzo (pegfilgrastim-bmez) - Sandoz Inc.
Formulation type | Strength |
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Pre-Filled Syringe | 6 mg/0.6 mL |
View Ziextenzo information in detail.
Popular FAQ
What are biosimilar drugs and how do they compare to biologics?
A biosimilar is a biological product that is similar to a reference biologic (usually the originally approved product) and for which there are no clinically meaningful differences in terms of safety, purity, and potency. One example is Amjevita (adalimumab-atto), the first biosimilar approved for Humira (adalimumab) in 2016. Continue reading
What is the difference between Fulphila and Neulasta?
Fulphila (pegfilgrastim-jmbd), is a biosimilar to Neulasta (pegfilgrastim). A biosimilar is a biological product that is highly similar to a biologic already approved by the FDA (known as the reference product) and has no clinically meaningful differences in terms of safety, purity and potency from the reference product. Biosimilars can provide cost effective treatment options to already approved biologics. Continue reading
How is Fulphila injected / administered?
Fulphila is injected into the area just under your skin (subcutaneous injection). It is given by a healthcare provider. You, or your caregiver, may be able to give these injections at home, after training from a healthcare provider. Continue reading
Is Fulphila a chemo drug?
No, Fulphila is a prescription medicine used to boost the number of white blood cells in cancer patients receiving chemo. Fulphila is a man-made form of a protein known as a colony stimulating factor used to help prevent neutropenia (low white blood cells) caused by chemotherapy. Continue reading
What is the difference between Udenyca and Fulphila?
Udenyca (pegfilgrastim-cbqv) and Fulphila (pegfilgrastim-jmdb) are both biological drugs containing pegfilgrastim. Udenyca and Fulphila are biosimilars of the reference product Neulasta (pegfilgrastim).
Udenyca and Fulphila are highly similar to, and have no clinically meaningful differences from Neulasta - they are as safe and effective and are used in the same way, but they are not interchangeable. Continue reading
What does cbqv stand for in pegfilgrastim?
The “cbqv” suffix is found in the biosimilar name for Udenyca (pegfilgrastim-cbqv), a biologic drug used to prevent neutropenia (a lack of certain white blood cells) caused by receiving chemotherapy. The suffix is used to distinguish its name from the original reference product, in this case Neulasta (pegfilgrastim), which has no suffix. The suffix on biosimilars helps healthcare providers and patients realize the medicine is an approved biosimilar, but the suffix has no specific meaning itself. Continue reading
What is the difference between Udenyca and Neulasta?
Udenyca (pegfilgrastim-cbqv) and Neulasta (pegfilgrastim) are both biological drugs containing pegfligrastim.
The US Food and Drug Administration (FDA) has approved Udencya as a biosimilar of Neulasta, which means it is "highly similar to, and has no clinically meaningful differences from" Neulasta - it is just as safe and effective and used in the same way. The two drugs, however, are not interchangeable. Continue reading
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- Fulphila (Pegfilgrastim Subcutaneous) advanced reading
- Fulphila (Pegfilgrastim-jmdb Subcutaneous) (Advanced Reading)
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Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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