Fulphila

Fulphila is used to prevent neutropenia (a lack of certain white blood cells) caused by chemotherapy.

Fulphila is a type of protein that helps stimulate the growth of white blood cells, which are important for fighting infection.

Fulphila may also be used for reasons not mentioned in this medication guide.

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.

You should not use Fulphila if you are allergic to Fulphila or filgrastim (Neupogen).

Tell your doctor if you have ever had:

• sickle cell disorder;
• kidney disease;
• acute myeloid leukemia;
• radiation treatment;
• myelodysplastic syndrome (also called "preleukemia"); or
• a latex allergy.

If you are treated with Fulphila and receive 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.

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:

• sudden or severe pain in your left upper stomach spreading up to your shoulder;
• sudden and severe pain in your chest, stomach, or back;
• severe or ongoing pain anywhere in your body;
• fever, tiredness;
• shortness of breath, rapid breathing;
• easy bruising, unusual bleeding, purple or red spots under your skin;
• bruising, swelling, or a hard lump where the medicine was injected; or
• 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:

• bone pain; or
• 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.

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.

Call your doctor for guidance if you miss an injection or if you have an issue with the Neulasta Onpro Kit device.

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.

When using Neulasta Onpro: Do not travel, drive, or operate machinery while wearing the device.

Other drugs may affect Fulphila, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all your current medicines and any medicine you start or stop using.

Biosimilar and interchangeable products are biological products that are very similar to and have no important clinical differences from the reference product.

Reference products

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

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.

Fulphila (pegfilgrastim-jmdb) - Biocon Biologics Inc.

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.