Fulphila

Fulphila is a prescription medication used to prevent infection (demonstrated by fever and low white blood cell count) in patients receiving anti-cancer drugs (chemotherapy) that have a high risk of causing infections.

Fulphila is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.

This medication comes in an injectable form to be given directly under the skin (subcutaneous injection) by you, your caregiver, or a healthcare professional once per chemotherapy cycle.  

Common side effects of Fulphila include pain in the bones, arms and legs.

Fulphila is a prescription medication used to decrease the chances of infection in patients with non-myeloid malignancies (cancers that do not involve or affect bone marrow) who are receiving anti-cancer drugs that decrease bone marrow activity.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Fulphila. See the “Fulphila Precautions” section.

Common side effects of Fulphila include the following:

• Bone pain
• Pain in arms and legs

This is not a complete list of Fulphila side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Fulphila including the following:

• Spleen rupture. Your spleen can become enlarged and rupture, which can lead to death. Tell your healthcare provider right away if you have the following symptoms:
  • Pain in the left upper stomach area or your left shoulder.
• Serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Tell your healthcare provider or get emergency care right away if you have the following symptoms:
  • Shortness of breath with or without fever
  • Trouble breathing
  • Fast rate of breathing
• Serious allergic reactions. Tell your healthcare provider or get emergency care right away if you have the following symptoms:
  • Rash over your whole body
  • Shortness of breath
  • Wheezing
  • Dizziness
  • Swelling around your mouth or eyes
  • Fast heart rate
  • Sweating
• Sickle cell crises. Serious sickle cell crises have happened in people with sickle cell disorders receiving Fulphila that have sometimes led to death. Tell your healthcare provider right away if you have these symptoms of sickle cell crises:
  • Pain
  • Difficulty breathing
• Kidney injury. Fulphila can cause kidney injury. Call your healthcare provider right away if you have any of these symptoms:
  • Swelling of your face or ankles
  • Blood in your urine or dark colored urine
  • You urinate less than usual
• Increased white blood cell count. Your healthcare provider will check your blood during treatment with Fulphila.
• Capillary Leak Syndrome. Fulphila can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:
  • Swelling or puffiness and are urinating less than usual
  • Trouble breathing
  • Swelling of your stomach area and feeling full
  • Dizziness or feeling faint
  • Tiredness
• Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received pegfilgrastim products. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.

Do not take Fulphila if you:

• are allergic to Fulphila or to any of its ingredients
• have had a serious allergic reaction to pegfilgrastim or filgrastim products.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Fulphila, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Fulphila, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Fulphila or to any of its ingredients
• have a sickle cell disorder
• have kidney problems
• are pregnant or plan to become pregnant. It is not known if Fulphila will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if pegfilgrastim passes into your breast milk.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. It is not known if Fulphila will harm your unborn baby. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Fulphila crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Fulphila.

Take Fulphila exactly as prescribed.

• Fulphila is given as an injection under your skin (subcutaneous injection) by a healthcare provider. If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, follow the detailed “Instructions for Use” that comes with your Fulphila for information on how to prepare and inject a dose of Fulphila. 
• You and your caregiver will be shown how to prepare and inject Fulphila before you use it. 

• You should not inject a dose of Fulphila to children weighing less than 45 kg from a Fulphila prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the Fulphila prefilled syringe. 

• 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. 

• If you miss a dose of Fulphila, talk to your healthcare provider about when you should give your next dose.

Steps for administration (by you or your caregiver):

• Remove the carton from refrigerator and allow the Fulphilla prefilled syringe to reach room temperature for at least 30 minutes.
• Wash your hands thoroughly with soap and water.
• Make sure the syringe is clear and colorless.
• Clean the injection site with an alcohol wipe and let skin dry. These are the 4 sites you can use:
  • Thigh
  • Stomach area, except for a 2 inch area right around the belly button
  • Upper outer area of the buttocks (only if someone else is giving you the injection)
  • Outer area of the upper arm (only if someone else is giving you the injection)
• Hold the syringe by the needle safety guard. Pull the gray needle cap straight off and away from the body.
• Pinch and hold the cleaned injection site.
• Insert the needle into the skin between 45 to 90 degrees,
• Use slow and constant pressure to push the plunger rod until it reaches the bottom.
• Once the entire dose has been injected, release the plunger so that the needle safety guard can come out and cover the needle.
• If there is blood, press a cotton ball on the injection site. Do not rub. Use a bandage if needed.
• Throw away used syringe in a sharps disposal container or a household container that is:
  • Made of heavy-duty plastic
  • Can be closed with a tight-fitting, puncture-resistant lid without sharps being able to come out
  • Upright and stable during use
  • Leak-resistant
  • Properly labeled to warn of hazardous waste inside the container

Do not use Fulphila between 14 days before and 24 hours after receiving chemotherapy.

If you miss a dose, talk to your healthcare provider about when you should give your next dose.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose/dose range of Fulphila for the prevention of infection in patients with cancer receiving chemotherapy is 6 mg once per chemotherapy cycle.

The Fulphila prefilled syringe is not designed to allow dosing for children weighing less than 45 kg.

If you take too much Fulphila, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Fulphila in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC).
• DO NOT freeze. If Fulphila is accidentally frozen, allow the prefilled syringe to thaw in the refrigerator before injecting.
• DO NOT use a Fulphila prefilled syringe that has been frozen more than 1 time. Use a new Fulphila prefilled syringe.
• Throw away any Fulphila that has been left at room temperature 68ºF to 77ºF (20ºC to 25ºC) for more than 72 hours or frozen more than 1 time.
• Keep the prefilled syringe in the original carton to protect from light.
• DO NOT shake the prefilled syringe.
• Take Fulphila out of the refrigerator 30 minutes before use and allow it to reach room temperature before injecting.
• Keep this and all medicines out of the reach of children.