Understanding Fulphila and Its Role in Treatment
Fulphila is a leukocyte growth factor indicated to decrease the incidence of infection, particularly febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. Chemotherapy can damage the bone marrow, leading to a drop in infection-fighting white blood cells (neutrophils). Fulphila works by stimulating the bone marrow to produce new neutrophils, which helps reduce the risk of serious infection.
Fulphila is available as a single-dose prefilled syringe containing 6 mg/0.6 mL of pegfilgrastim-jmdb for manual subcutaneous use. It is administered once per chemotherapy cycle, typically at least 24 hours after a chemotherapy dose and no sooner than 14 days before the next cycle. Unlike its reference product, Neulasta, Fulphila does not offer an on-body injector option.
A Step-by-Step Guide: How do you administer Fulphila?
For patients and caregivers trained in home administration, the process of injecting Fulphila requires careful adherence to the manufacturer's instructions. These steps ensure the medication is delivered safely and effectively.
Preparing for the Injection
Before starting, gather all necessary supplies and prepare the medication and the injection site.
Required supplies:
- One Fulphila prefilled syringe
- Alcohol wipes
- Cotton ball or gauze pad
- Adhesive bandage
- Sharps disposal container
Preparation steps:
- Remove from refrigerator: Take the Fulphila syringe out of the refrigerator and allow it to sit at room temperature for at least 30 minutes. Do not use any heat sources to warm the syringe.
- Wash hands: Wash your hands thoroughly with soap and water.
- Inspect the syringe: Check the syringe for any damage, such as cracks or a missing needle cap. Visually inspect the solution inside; it should be clear and colorless. Do not use the syringe if the liquid is cloudy, discolored, or contains particles.
- Do not shake: Shaking the syringe can damage the medication. If it has been shaken, it may appear foamy and should not be used.
The Injection Process
Once prepared, follow these steps for the subcutaneous injection.
Injection site selection and cleaning:
- Choose an injection site from the following areas: the front of the middle thighs, the abdomen (at least two inches from the belly button), or the back of the upper arm or upper buttocks (if a caregiver is administering).
- Rotate the injection site with each dose to prevent irritation and ensure proper absorption.
- Clean the chosen site with an alcohol wipe and allow it to air dry completely before injecting.
- Do not inject into skin that is bruised, tender, red, hard, or has scars or stretch marks.
Performing the injection:
- Pinch a 1 to 2-inch fold of skin at the injection site to create a firm surface.
- With your other hand, hold the syringe like a pen or dart and carefully pull the needle cap straight off. Do not twist or bend it.
- Insert the entire needle straight into the pinched-up fold of skin in one smooth, quick motion.
- Once the needle is inserted, release the pinched skin. Use your thumb to slowly and steadily push the plunger all the way down until all the medication is injected.
- When the syringe is empty, pull it straight out of your skin.
After the Injection
Proper post-injection care is important for safety and comfort.
- Needle Safety: After releasing the plunger, the safety guard on the syringe will automatically cover the needle. Do not attempt to recap the used syringe.
- Site Care: Press a cotton ball or gauze pad over the injection site for a few seconds if there is any bleeding. Do not rub the area, as this can cause bruising or affect absorption.
- Disposal: Immediately place the used syringe and needle cap into an approved, puncture-resistant sharps disposal container. Dispose of the full sharps container according to local regulations.
Comparison: Fulphila Prefilled Syringe vs. Other Pegfilgrastim Devices
Fulphila is administered exclusively via a manual prefilled syringe. This contrasts with other pegfilgrastim brands like Neulasta, which may offer an on-body injector (OBI). Understanding the differences is key for patients and providers.
| Feature | Fulphila (Prefilled Syringe) | Neulasta (On-body Injector - OBI) |
|---|---|---|
| Delivery Method | Manual subcutaneous injection by a healthcare provider, patient, or caregiver. | Hands-free, programmed subcutaneous delivery via an attached device. |
| Delivery Time | Administered manually over a few seconds by pushing the plunger. | Dose delivered automatically over 45 minutes, approximately 27 hours after application. |
| Flexibility | Allows for immediate injection by trained individuals, with no waiting period after application. | Requires wearing the device for an extended period before the timed delivery begins. |
| Monitoring | Requires direct administration and immediate disposal. | Requires monitoring the device for proper function and completion of delivery. |
| Cost | Can vary depending on insurance and local pharmacy agreements. | Can vary depending on insurance and local pharmacy agreements. |
| Availability | Available as a single-dose prefilled syringe only. | Available with both a prefilled syringe and an on-body injector option. |
Important Safety and Administrative Considerations
- Allergy Warning: Do not take Fulphila if you have a history of serious allergic reactions to pegfilgrastim or filgrastim products.
- Dosing for Children: For pediatric patients weighing less than 45 kg, the standard 6 mg/0.6 mL prefilled syringe is not designed to accurately measure and deliver partial doses. A different administration method is needed, as instructed by a healthcare provider.
- Overdose: Injecting more Fulphila than prescribed can lead to complications such as high white blood cell counts (leukocytosis) and bone pain. If an overdose occurs, contact a healthcare provider immediately.
- Missed Dose: Missing a dose can affect treatment efficacy. Contact a healthcare provider as soon as possible if a dose is missed to determine the next steps.
Conclusion
Administering Fulphila is a straightforward process when following proper technique for the prefilled syringe. Key steps include allowing the syringe to reach room temperature, inspecting the solution, selecting and cleaning a rotation injection site, and carefully injecting the medication subcutaneously. Proper disposal of the used syringe is critical for safety. For home administration, patient training by a healthcare provider is essential to ensure the procedure is performed correctly. Unlike some other pegfilgrastim products, Fulphila is only available via a manual prefilled syringe, which offers an immediate injection process once the syringe is ready. Always consult a healthcare provider for any questions or concerns regarding Fulphila administration.
