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Fylnetra (pegfilgrastim-jmdb) (Generic Pegfilgrastim Injection)

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Why is this medication prescribed?

People with certain types of cancer who are receiving chemotherapy drugs that may lower the number of neutrophils (a type of blood cell needed to fight infection) can use pegfilgrastim injection products to lower their risk of infection. Injections of pegfilgrastim (Neulasta) are also used to improve survival rates in patients who have been exposed to dangerous levels of radiation, which can seriously and fatally destroy bone marrow. Colony stimulating factors are a class of medicines that includes pegfilgrastim. It functions by enhancing the body’s production of neutrophils.

How should this medicine be used?

Products for injecting pegfilgrastim are available as a solution (liquid) in prefilled injection syringes for subcutaneous (under the skin) injection and in prefilled automatic injection devices (on-body injectors) for topical application. Pegfilgrastim injections are typically administered as a single dose for each chemotherapy cycle, no earlier than 24 hours following the administration of the cycle’s final dose of chemotherapy and no sooner than 14 days prior to the start of the subsequent cycle. Pegfilgrastim injection is typically administered in two single doses, spaced one week apart, if it is being used to treat radiation exposure. When specifically you should use pegfilgrastim injection products will be specified by your doctor.

A nurse or other healthcare professional may give you pegfilgrastim injection products, instruct you to administer the medication yourself at home, or give you a prefilled automatic injection device that will administer the medication automatically for you at home. A healthcare provider will demonstrate how to administer the drug or operate the device if you will be injecting pegfilgrastim injectable products yourself at home or if you obtain the prefilled automatic injection device. You will also receive information from the manufacturer for the patient from your healthcare professional. If there is anything you don’t understand, ask your healthcare professional to clarify it. Follow a pegfilgrastim injection product’s instructions to the letter. Use it only as directed by your doctor, neither more nor less often.

Syringes containing pegfilgrastim solution shouldn’t be shaken. Before injecting, always check the pegfilgrastim solution. If the pegfilgrastim solution includes particles, is murky, or is discolored, it has beyond its expiration date and should not be used.

The device will typically be attached to your belly or the back of your arm by a nurse or other healthcare professional the day before you will get the dosage of pegfilgrastim if your pegfilgrastim solution comes in a prefilled automated injection device. The dose of pegfilgrastim solution will be automatically given subcutaneously over the course of 45 minutes the next day (about 27 hours after the prefilled automated injection device was attached to your skin).

When the automated injection device with prefilled pegfilgrastim is in position;

  • The first time you take a dosage of pegfilgrastim and every time the prefilled automated injection device is placed on the back of your arm, you should have a caregiver present.
  • You must avoid activities and environments that could interfere with monitoring throughout the administration of the full dose of pegfilgrastim and for an hour afterward. You will need to keep an eye on the prefilled automatic injection device during this time.
  • One hour before and two hours after receiving your dosage of pegfilgrastim via the prefilled automated injection device (about 26 to 29 hours after the application), you should avoid driving, operating machinery, or traveling.
  • Make sure to keep electric devices and equipment, such as cordless phones, microwaves, and cell phones, at least 4 inches away from the prefilled automatic injection device.
  • After the prefilled automatic injection device is applied to your body and before you receive your dose of pegfilgrastim, you should avoid airport x-rays and request a manual pat down if you must travel.
  • If you experience an allergic reaction while taking your dose of pegfilgrastim, you should stop the prefilled automated injection device right away by gripping the edge of the adhesive pad and peeling it off. Make a doctor’s appointment right away and seek emergency care.
  • If the adhesive gets noticeably moist, if you see dripping from the device, if the status light flashes red, or if the prefilled automatic injection device comes off of your skin, you should call your doctor right away. To help you catch a leak if it occurs when you are administering your dose of pegfilgrastim, you should keep the prefilled automated injection device dry for three hours prior to doing so.
  • You should stay away from oxygen-rich environments like hyperbaric chambers as well as medical imaging tests like X-rays, MRIs, CT scans, and ultrasounds.
  • Sleeping or putting strain on the prefilled automated injection device are not recommended.
  • Direct sunshine, whirlpools, saunas, and hot tubs should all be avoided.
  • The area of your skin closest to the prefilled automatic injection device should not be exposed to lotions, oils, creams, or cleaners.

Call your doctor straight away if the prefilled automatic injection device flashes red, falls off before the entire dose is administered, or if there is leaking or the adhesive on the device becomes moist. Pegfilgrastim may not have been administered in its entirety, and you may require an additional dose.

Put used needles, syringes, and equipment in a container that won’t puncture. How to get rid of the puncture-resistant container should be discussed with your doctor or pharmacist.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before using pegfilgrastim injection products,

  • If you have any allergies to any medications, including pegfilgrastim, filgrastim (Granix, Neupogen, Nivestym, Releuko, Zarxio), any foods, or any of the substances in pegfilgrastim injection products, notify your doctor and pharmacist right away. Additionally, let your doctor know if you or the person administering the pegfilgrastim injection have a latex, rubber, or acrylic adhesive allergy.
  • Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Inform your doctor if you have or have ever had kidney issues, myelodysplasia (issues with bone marrow cells that may evolve into leukemia), or cancer of the blood or bone marrow.
  • Inform your doctor if you have sickle cell disease, a blood condition that can lead to excruciating crises, a deficiency in red blood cells, infection, and internal organ damage. The likelihood of experiencing a crisis while receiving treatment with a pegfilgrastim injectable product may increase if you have sickle cell disease. If you experience a sickle cell crisis while undergoing therapy, contact your doctor immediately.
  • Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Call your doctor right away if you become pregnant while using a pegfilgrastim injectable product.
  • It’s important to understand that while pegfilgrastim injectable medicines reduce the risk of infection, they do not always ward against infections that can arise during or after treatment. If you experience any infection-related symptoms, including fever, chills, rash, sore throat, diarrhea, or redness, swelling, or pain around a cut or sore, call your doctor right once.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

Ask your doctor what to do if you forget to administer the medication on time if you will be injecting a pegfilgrastim injection product at home.

What side effects can this medication cause?

Products for injecting pegfilgrastim may have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Bone ache
  • Pain in the legs or arms

Some adverse effects can be very harmful. Call your doctor right away if any of these symptoms occur to you:

  • The left upper area of your stomach or the left shoulder’s tip hurts
  • Fever, respiratory difficulties, shortness of breath, and rapid breathing
  • Swelling of the face, throat, lips, or eyes; hives; rash; itching; difficulty breathing; a quick heartbeat; or excessive perspiration
  • Swollen ankles or face, crimson or dark urine, and reduced urination
  • Unexpected bruising or bleeding, fever, or exhaustion
  • Fever, discomfort in the abdomen, back, and general malaise
  • Stomach swelling or other swellings, decreased urination, breathing difficulties, lightheadedness, and exhaustion

Other side effects from pegfilgrastim injection products are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

What should I know about storage and disposal of this medication?

Keep this medication tightly packed in the carton it was packaged in and out of the reach of children. Products for injecting pegfilgrastim should not be frozen; instead, store them in the refrigerator. You can let the medication thaw in the fridge if you accidently freeze it. However, you should discard the medication syringe if you freeze it again after the first freezing. Neulasta prefilled syringe and Nyvepria are examples of pegfilgrastim injection products that can be stored at room temperature for up to 48 hours. Fulphila and Fylnetra are examples of pegfilgrastim injection products that can be stored at room temperature for up to 72 hours. Ziextenzo and Nyvepria are examples of pegfilgrastim injection products that can be stored at room temperature for up to 5 days. Products for injecting pegfilgrastim should not be exposed to direct sunlight.

To make sure that pets, kids, and other people cannot take leftover pharmaceuticals, they should be disposed of in a specific manner. You shouldn’t flush this medication down the toilet, though. The best option to get rid of your medication is instead through a medication take-back program. To find out about take-back initiatives in your neighborhood, speak with your pharmacist or get in touch with your city’s waste/recycling department. If you do not have access to a take-back program, you can find more information at the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p).

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Bone ache
  • Swelling
  • Breathing difficulty

What other information should I know?

Keep all of your appointments with your physician and the lab. To determine how your body is reacting to a pegfilgrastim injectable product, your doctor will request a few lab tests.

Inform your doctor and the technician that you are using a pegfilgrastim injection product before undergoing a bone imaging study. The outcomes of this kind of investigation may be impacted by pegfilgrastim.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Fylnetra®(pegfilgrastim-pbbk)
  • Fulphila®(pegfilgrastim-jmdb)
  • Neulasta®(pegfilgrastim)
  • Nyvepria®(pegfilgrastim-apgf)
  • Udenyca®(pegfilgrastim-cbqv)
  • Ziextenzo (pegfilgrastim-bmez)
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