PegaGen®


(Pegylated Filgrastim)

Bone Pain Flies Away ...


Overview

  • Pre-filled syringe: 6 mg / 0.6 ml in single use Pre-filled syringe
  • Automatic injection: 6 mg / 0.6 ml in single use Pre-filled syringe in autoinjector (Physioject™)

Overview

PegaGen® contains Pegfilgrastim. Pegfilgrastim 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.

 

Indications and Usage

  • It is used to lower the chance of getting an infection in cancer patients who have had very bad bone marrow problems caused by chemotherapy.
  • It is used to lower the chance of getting an infection in patients who receive radiotherapy.

What should I know BEFORE taking PegaGen?

Tell your doctor BEFORE you take this drug:

  • If you have an allergy to pegfilgrastim, filgrastim, or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances.  
  • Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • Tell your doctor if you have sickle cell disease.
  • If you are allergic to acrylics, talk with your doctor.
  • This drug may interact with other drugs or health problems. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breastfeeding.

How should I take this drug?

  • PegaGen® should be administered in a hospital or a clinic under the supervision of a doctor.
  • PegaGen® is provided in a prefilled syringe and autoinjector. It is given as a shot into the fatty part of the skin.
  • To gain the most benefit, do not miss doses.
  • Do not shake the solution.
  • Before giving the shot, let it come to room temperature. Do not heat this drug.
  • Wash your hands before and after use.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Do not use if this drug has been frozen more than once.
  • Do not give into the red or irritated skin.
  • Move the site where you give the shot with each shot.
  • Throw syringe away after use. Do not use more than one time.
  • Store in a refrigerator (2-8°C). Do not freeze.
  • You can store Pre-filled syringe at room temperature for 2 days.
  • PegaGen® should be stored in its carton to protect from light until use.
  • Keep all drugs out of the reach of children and pets.
  • Throw out unused drugs.

What should I know DURING treatment?

  • Tell dentists, surgeons, and other doctors that you use this drug.
  • Sometimes pain and redness occur at the injection site. Tell your doctor if you have swelling, bumps, and bruises after injection that have not been removed.
  • If you have a latex allergy, talk with your doctor.
  • This drug should not be injected within 14 days before and also until approximately 24 hours after receiving chemotherapy.
  • If you have a sickle cell disorder, make sure that your doctor knows about it before you start using this drug. If you have a sickle cell crisis after getting PegaGen®, tell your doctor right away.
  • PegaGen® can cause serious allergic reactions. These reactions can cause the rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. If you have an allergic reaction during the injection of PegaGen®, stop the injection. Call your doctor right away.
  • If you have pain in upper left part of your abdomen or pain in your shoulder after PegaGen® administration tell your doctor.
  • Monitor your white blood cells on a regular basis.
  • Tell your doctor if you have a problem in urination, blood in the urine or sudden weight gain.
  • Tell your doctor if you have a fever and painful skin lesions that mostly occurs on the arms, neck, head, and trunk.
  • Tell your doctor if you missed one dose.
  • Administration with autoinjector takes about 10 seconds. During this time and for 24 hours avoid moving a lot, driving or moving heavy equipment.
  • First time administration with autoinjector should be performed in a hospital or a clinic.
  • Tell your doctor if you see drug leakage surrounding autoinjector.
  • Keep the part of the body which is planned to be injected dry for 3 hours before drug injection.
  • Do not apply pressure on the injection site.
  • The most common side effect you may experience is aching in the bones and muscles. If this happens, it can usually be relieved with a non-aspirin pain reliever, such as acetaminophen.

Pregnancy and Lactation

  • C/ Use with caution.
  • It is not recommended during breast feeding because the probability of secreting in breast milk.

How Supplied / Storage and Handling

  • PegaGen® should be stored in the refrigerator at 2 to 8°C (36° to 46°F), but not in the freezer.
  • PegaGen® should be protected from light, so you should keep it in its carton until you are ready to use it.
  • Avoid shaking PegaGen®.
  • If PegaGen® is accidentally frozen, allow it to thaw in the refrigerator before injecting. However, if it is frozen a second time, do not use it.
  • PegaGen® Pre-filled syringe can be left out at room temperature for up to 48 hours. 

Do not leave PegaGen® in direct sunlight.

FAQs

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