What is Fulphila used for?

Fulphila is a prescription medicine that is used to lower the chance of getting an infection in people with bone marrow problems caused by chemo. Fulphila may be given to you for other reasons.

Description

Pegfilgrastim-jmdb is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim-jmdb a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF. The average molecular weight of pegfilgrastim-jmdb is approximately 39 kD.

Fulphila (pegfilgrastim-jmdb) injection is intended for subcutaneous use only and is supplied in a single-dose prefilled syringe with a 29 gauge needle, with UltraSafe Passive Plus™ Needle Guard. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL).

The delivered 0.6 mL dose from the prefilled syringe contains 6 mg pegfilgrastim-jmdb (based on protein mass only) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.7 mg), D-sorbitol (30 mg), polysorbate 20 (0.024 mg) and sodium (0.01 mg) in Water for Injection, USP.

Mechanism of Action

Pegfilgrastim products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

Before taking Fulphila, tell your doctor:

• If you are allergic to Fulphila; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you weigh less than 99 pounds (45 kilograms), talk with your doctor.

This medicine 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 Fulphila with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Fulphila?

• Tell all of your health care providers that you take Fulphila. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take Fulphila within 14 days before or on the same day that you get chemo.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Fulphila.
• Some people with sickle cell disease have had times where the sickle cell disease has gotten worse when taking Fulphila. Sometimes, this has been deadly. Talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Fulphila best taken?

Use Fulphila as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Keep taking Fulphila as you have been told by your doctor or other health care provider, even if you feel well.
• Leave Fulphila at room temperature for at least 30 minutes before using. Do not remove the cap or cover until ready to use. Do not heat Fulphila.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Do not shake.
• Wash your hands before and after use.
• Do not give into skin that is irritated, bruised, red, infected, or scarred.
• Move the site where you give the shot with each shot.
• Throw away any part left over after the dose is given.
• Throw syringe away after use. Do not use the same syringe more than one time.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Fulphila that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
• Dark urine.
• Sweating a lot.
• Fast breathing.
• Swelling of belly.
• Feeling full.
• Enlarged and ruptured spleens have happened with Fulphila. Sometimes, ruptured spleens have been deadly. Call your doctor right away if you have left upper stomach pain or left shoulder pain.
• Swelling of the main blood vessel that comes out of the heart (aorta) has happened with Fulphila. Call your doctor right away if you feel very tired or weak. Call your doctor if you have fever, stomach pain, or back pain.
• Capillary leak syndrome (CLS) is a very bad health problem that has happened with Fulphila. Sometimes, CLS can be deadly. Tell your doctor right away if you get signs of CLS like change in how much urine is passed; not able to pass urine; blood in the urine; a fast or abnormal heartbeat; chest pain or pressure; dizziness or passing out; shortness of breath; a big weight gain; swelling; throwing up blood or throw up that looks like coffee grounds; or if you have black, tarry, or bloody stools.

What are some other side effects of Fulphila?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Bone pain.
• Muscle pain.
• Pain in arms or legs.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Fulphila?

• Store in a refrigerator. Do not freeze.
• Store in the original container to protect from light.
• If Fulphila freezes, let it thaw in the refrigerator before use.
• Do not use if Fulphila has been frozen more than once.
• Do not use Fulphila if it has been dropped or if it is broken.
• If needed, Fulphila can be left out at room temperature for up to 72 hours. Throw away unopened drug if left at room temperature for more than 72 hours.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

• NDC 67457-833-06   Rx only
• Fulphila®
  (pegfilgrastim-jmdb)
  Injection
  6 mg/0.6 mL
• Single-Dose Prefilled Syringe
• Pegylated Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor (PEG-r-metHuG-CSF) derived from E Coli
• For Subcutaneous Use Only
• Sterile Solution – No Preservative
• One 0.6 mL Single-Dose
  Prefilled Syringe
• Each 0.6 mL prefilled syringe contains: 6 mg pegfilgrastim (based on protein mass only) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.7 mg), D-sorbitol (30 mg), polysorbate 20 (0.024 mg), and sodium (0.01 mg) in water for injection, USP.
• No U.S. standard of potency
• Store refrigerated at 2° to 8°C (36° to 46°F) in original carton to Protect from Light. Do Not Freeze or Shake.
• Keep this and all medication out of the reach of children.
• Dosage: See prescribing information for dosage and instructions for use.
• Manufactured by:
  Mylan Pharmaceuticals Inc.
  Morgantown, WV 26505 U.S.A.
• U.S. License No. 2210
• Distributed by:
  Mylan Institutional LLC
  Rockford, IL 61103 U.S.A.
• Product of India
• B:833:1C:R10
• KR/DRUGS/KTK/28D/07/2006
• Mylan.com