Fulphila 6 mg/0.6 mL subcutaneous syringe

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Medication name

Generic name:
Pegfilgrastim-jmdb - injection

Pronunciation
(PEG-fil-GRA-stim)

Brand name(s)
Fulphila

Uses

Pegfilgrastim-jmdb is a man-made version of a certain natural substance made in your body. It is used to help your body make more white blood cells. White blood cells are important to help you fight off infections. Pegfilgrastim-jmdb is given to people whose ability to make white blood cells is reduced (for instance, due to chemotherapy).

Other uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to increase low white blood cell counts caused by certain other conditions (such as exposure to large amounts of radiation).

How to use

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using pegfilgrastim-jmdb and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

For use during chemotherapy, it is usually given once during each chemotherapy cycle. However, it should not be given within 14 days before or 24 hours after chemotherapy. Ask your doctor for specific directions about when to use this medication.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Before use, take pegfilgrastim-jmdb out of the refrigerator. Let it warm up to room temperature for at least 30 minutes. Do not heat this medication any other way, such as by heating in the microwave or placing in hot water. Do not shake this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Inject this medication under the skin of the thigh, abdomen, upper outer area of the buttocks, or upper arm as directed by your doctor. The dosage is based on your medical condition and response to treatment. For children, the dosage may be based on their weight.

Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject pegfilgrastim-jmdb into skin that is tender, bruised, red, hard, or that has scars or stretch marks.

Learn how to store and discard medical supplies safely.

Side effects

Aching or pain in the bones and muscles may occur. Taking a non-aspirin pain reliever such as acetaminophen may help relieve pain. Ask your doctor or pharmacist for more details. Redness, swelling, itching, or bruising at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

  • pink/bloody urine
  • fever
  • fast heartbeat
  • purple or red spots on your skin
  • back pain

Get medical help right away if you have any very serious side effects, including:

  • breathing problems (such as trouble breathing, shortness of breath, fast breathing)
  • unusual decrease in urination
  • unusual tiredness
  • swelling/puffiness of the body

Rarely, serious (possibly fatal) damage to the spleen may occur. Get medical help right away if you develop stomach/abdominal pain or shoulder pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using pegfilgrastim-jmdb, tell your doctor or pharmacist if you are allergic to it; or to pegfilgrastim, pegfilgrastim-cbqv, filgrastim, filgrastim-aafi, filgrastim-sndz, or tbo-filgrastim; or if you have any other allergies. This product may contain inactive ingredients (such as dry natural rubber/latex in the needle cover on the prefilled syringe), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • sickle cell disease
  • spleen problems

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication may pass into breast milk. Consult your doctor before breast-feeding.

Drug interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Pegfilgrastim-jmdb is very similar to pegfilgrastim, pegfilgrastim-cbqv, filgrastim, filgrastim-aafi, filgrastim-sndz, and tbo-filgrastim. Do not use pegfilgrastim, pegfilgrastim-cbqv, filgrastim, filgrastim-aafi, filgrastim-sndz, or tbo-filgrastim while using pegfilgrastim-jmdb.

This medication may interfere with certain lab tests (such as bone imaging tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, kidney function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.

Storage

Store in the refrigerator. Keep the medication in the original package to protect from light. Do not freeze or shake. If this medication is taken out of the refrigerator, use or discard within 72 hours. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised August 2019.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.