How is Fulphila injected / administered?
- Fulphila is injected into the area just under your skin (subcutaneous injection). It is given by a healthcare provider.
- It can be injected into the thigh area, stomach area, upper and outer area around your buttocks, or the outer area of the upper arm.
- You, or your caregiver (such as a family member), may also be able to give these injections at home, after training from a healthcare provider.
Before you inject each dose, always follow the detailed “Instructions for Use'' that comes with your Fulphila. These instructions provide information on how to prepare and inject a dose of Fulphila.
If you are receiving Fulphila because you are also receiving chemotherapy, the last dose of Fulphila should be injected at least 14 days before and 24 hours after your dose of chemotherapy.
You should not inject a dose of Fulphila to children weighing less than 45 kg (99 lb) from a Fulphila prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the Fulphila prefilled syringe.
What is Fulphila used for?
Fulphila is used in cancer patients to increase the production of white blood cells to help prevent infections and neutropenia due to cancer treatment (chemotherapy).
Neutropenia occurs when there is a low amount of the white blood cells known as neutrophils. Lower levels of these white blood cells can increase your risk for infection and fever, especially during chemotherapy.
Is Fulphila a biosimilar?
Yes, Fulphila (pegfilgrastim-jmdb), from Mylan, was the first biosimilar to Neulasta (pegfilgrastim) and was approved by the FDA in June 2018.
A biosimilar is a biological product that is highly similar to a biologic already approved by the FDA (known as the reference product). It has no clinical differences in terms of safety, purity and potency from the reference product. Biosimilars can provide cost-effective treatment options to biologics that are already approved.
The FDA has approved four biosimilars to Neulasta (pegfilgrastim), including:
- Fulphila (pegfilgrastim-jmdb)
- Udenyca (pegfilgrastim-cbqv)
- Nyvepria (pegfilgrastim-apgf)
- Ziextenzo (pegfilgrastim-bmez)
More information: What Are Biosimilars? Top Facts You May Not Know
Does Fulphila come as an on-body injector (OBI) device?
Fulphila is NOT given using an on-body injector (OBI) device for use at home.
- OBIs are attached to your arm to allow the injection at a specific time at home. This helps to prevent a return trip to the clinic the day after chemotherapy. Neulasta Onpro is one pegfilgrastim brand name on-body injector device available in the US.
- No biosimilars for pegfilgrastim are available with an on-body injector device at this time, which means you may need to go back to the clinic the next day for your injection.
- If your doctor approves, you (or a caregiver or family member) may be able to learn how to give the Fulphila under-the-skin (subcutaneous) injection at home.
This is not all the information you need to know about Fulphila (pegfilgrastim-jmdb) for safe and effective use and does not take the place of talking to your doctor about your treatment. Review the full Fulphila information here, and discuss this information and any questions you have with your doctor or other health care provider.
- Fulphila (pegfilgrastim-jmdb) Prescribing Information. March 2021. Mylan. Morgantown, WV. Accessed June 28, 2021 at https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3ea915d7-2feb-4e75-91f7-913c965b7d8a&type=display
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