Fulphila Injection

Name: Fulphila Injection

Dosage Forms and Strengths

• Injection: 6 mg/0.6 mL clear, colorless solution of Fulphila in a single-dose prefilled syringe for manual use only.

Warnings and Precautions

Splenic Rupture

Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Fulphila.

Acute Respiratory Distress Syndrome

Acute respiratory distress syndrome (ARDS) can occur in patients receiving pegfilgrastim products. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Fulphila, for ARDS. Discontinue Fulphila in patients with ARDS.

Serious Allergic Reactions

Serious allergic reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Fulphila in patients with serious allergic reactions. Do not administer Fulphila to patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products.

Use in Patients with Sickle Cell Disorders

Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products.

Glomerulonephritis

Glomerulonephritis has occurred in patients receiving pegfilgrastim products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose reduction or discontinuation of pegfilgrastim products. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of Fulphila.

Leukocytosis

White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during therapy with Fulphila is recommended.

Capillary Leak Syndrome

Capillary leak syndrome has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.

Potential for Tumor Growth Stimulatory Effects on Malignant Cells

The granulocyte colony-stimulating factor (G-CSF) receptor through which pegfilgrastim products and filgrastim products act has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.

Overdosage

Overdosage of pegfilgrastim products may result in leukocytosis and bone pain. Events of edema, dyspnea, and pleural effusion have been reported in a single patient who administered pegfilgrastim on 8 consecutive days in error. In the event of overdose, the patient should be monitored for adverse reactions [see Adverse Reactions (6)].

How Supplied/Storage and Handling

Fulphila single-dose prefilled syringe for manual use

Fulphila (pegfilgrastim-jmdb) Injection is a clear, colorless solution supplied in a prefilled single-dose syringe for manual use containing 6 mg pegfilgrastim-jmdb, supplied with a 29 gauge, 1/2-inch needle with an UltraSafe Passive Plus™ Needle Guard.

Fulphila is provided in a dispensing pack containing one sterile 6 mg/0.6 mL prefilled syringe.

NDC 67457-833-06

Fulphila prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (6 mg/0.6 mL) for direct administration. Use of the prefilled syringe is not recommended for direct administration for pediatric patients weighing less than 45 kg who require doses that are less than the full contents of the syringe.

Store refrigerated between 2° to 8°C (36° to 46°F) in the carton to protect from light. Do not shake. Discard syringes stored at room temperature for more than 72 hours. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once.

Patient Information

Fulphila™ (FULL-fil-ah)
(pegfilgrastim-jmdb)
Injection
Single-Dose Prefilled Syringe

What is Fulphila?

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.

Do not take Fulphila if you have had a serious allergic reaction to pegfilgrastim or filgrastim products.

Before you receive Fulphila, tell your healthcare provider about all of your medical conditions, including if you:

• 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 healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive Fulphila?

• 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.

What are possible side effects of Fulphila?

Fulphila may cause serious side effects, including:

• Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach area or your left shoulder. • A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency care right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing. • Serious allergic reactions. Fulphila can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using Fulphila and call your healthcare provider or get emergency medical help right away. • Sickle cell crises. You may have a serious sickle cell crisis if you have a sickle cell disorder and receive Fulphila. Serious sickle cell crises have happened in people with sickle cell disorders receiving Fulphila that has sometimes led to death. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing. • Kidney injury (glomerulonephritis). Fulphila can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms: o swelling of your face or ankles o blood in your urine or dark colored urine o you urinate less than usual • Increased white blood cell count (leukocytosis). 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: o swelling or puffiness and are urinating less than usual o trouble breathing o swelling of your stomach-area (abdomen) and feeling of fullness o dizziness or feeling faint o a general feeling of tiredness

The most common side effects of Fulphila are pain in the bones, arms, and legs.

These are not all the possible side effects of Fulphila.

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

How should I store Fulphila?

• Store Fulphila in the refrigerator between 36°F to 46°F (2°C to 8°C). • Do not freeze. If Fulphila is accidently 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 (dispose of) any Fulphila that has been left at room temperature, 68°F to 77ºF (20°C 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 preparing an injection.

Keep the Fulphila prefilled syringe out of the reach of children.

General information about the safe and effective use of Fulphila.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Fulphila for a condition for which it was not prescribed. Do not give Fulphila to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Fulphila that is written for health professionals.

What are the ingredients in Fulphila?

Active ingredient: pegfilgrastim-jmdb

Inactive ingredients: acetate, D-sorbitol, polysorbate 20, and sodium in Water for Injection.

Manufactured by: Mylan GmbH, Zurich, Switzerland, CH-8050 U.S. License No. 2062

Product of India. Code No.: KR/DRUGS/KTK/28D/7/2006 Distributed by: Mylan Institutional LLC, Rockford, IL 61103 U.S.A.

 

For more information, go to www.fulphila.com or call 1-833-695-2623.

This Patient Information has been approved by the U.S. Food and Drug Administration.      Issued: 6/2018

Manufactured by:
Mylan GmbH
Zurich, Switzerland, CH-8050
U.S. License No. 2062

Product of India

Code No.: KR/DRUGS/KTK/28D/7/2006

Distributed by:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.

Revised: 6/2018
B:PEGFIL:R1

 

 

Instructions for Use

FULPHILATM (FULL-fil-ah)

(pegfilgrastim-jmdb)

injection, for subcutaneous use

Single-Dose Prefilled Syringe

Guide to Parts

Before Use

After Use

Important: The needle is covered by the gray needle cap before use.

Important Information

Read the Patient Information for important information you need to know about Fulphila before using these Instructions for Use.

 

Storing the Fulphila prefilled syringe

• 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 (dispose of) 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. See Step 4: Disposing of used prefilled syringes. • Keep the prefilled syringe in the original carton to protect from light. • For questions about storage, contact your healthcare provider or pharmacist. • Keep the Fulphila prefilled syringe out of the reach of children.

Before you use a Fulphila prefilled syringe, read this important information:

• It is important that you do not try to give yourself the injection unless you have received training from your healthcare provider. • The prefilled syringe has a needle safety guard that will be activated to cover the needle after the injection is given. The needle guard will help prevent needlestick injuries to anyone who handles the prefilled syringe after the injection has been given. • Make sure that the name Fulphila appears on the carton and prefilled syringe label.
 
Fulphila is given as an injection into the tissue just under the skin (subcutaneous injection). • 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. • Do not use a prefilled syringe after the expiration date on the label. • Do not shake the prefilled syringe. • Do not use the prefilled syringe if the carton is open or damaged. • Do not remove the gray needle cap from the prefilled syringe until you are ready to inject. • Do not use the prefilled syringe if it has been dropped on a hard surface. The syringe may be broken even if you cannot see the break. Use a new prefilled syringe. • Do not attempt to activate the prefilled syringe prior to injection. • Do not attempt to remove the needle safety guard from the prefilled syringe. • Do not attempt to remove the label from the prefilled syringe barrel before injecting your dose of Fulphila.

Call your healthcare provider if you have any questions.

Step 1: Gather supplies

A - Find a clean, well-lit and flat work surface, such as a table.

 

B - Take the prefilled syringe carton out of the refrigerator and place it on your clean work surface. Allow it to reach room temperature for 30 minutes before giving an injection.

 

C - Remove the prefilled syringe tray from the carton.

 

D - Wash your hands thoroughly with soap and water.

 

E - Gather the supplies for the injection:

• 1 alcohol wipe • 1 cotton ball or gauze pad • 1 adhesive bandage • an FDA-cleared sharps disposal container

Step 2: Prepare for injection

F - Open the tray by peeling away the cover. Grab the
needle safety guard to remove the prefilled
syringe from the tray.

 

 

For safety reasons:

• Do not grab the plunger rod. • Do not grasp the gray needle cap.

G - Inspect the medicine and prefilled syringe.

 
      Make sure the medicine in the prefilled syringe is clear and colorless.

 

Do not use the prefilled syringe if:

• The medicine is cloudy or discolored, or contains flakes or particles. • The prefilled syringe has been dropped. • Any part appears cracked or broken. • The gray needle cap is missing or not securely attached. • The expiration date printed on the label has
passed.

In all cases, use a new prefilled syringe and call your healthcare provider.

H - Prepare and clean the injection site.
      There are 4 injection sites that you can use:

• thigh • stomach area (abdomen), except for a 2-inch area right around the navel (belly button) • upper outer area of the buttocks (only if someone else is giving you the injection), and • the outer area of the upper arm (only if someone else is giving you the injection).

Clean the injection site with an alcohol wipe. Let the skin dry.

• Do not touch this area again before injecting. • Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks. • If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.

I - Hold the prefilled syringe by the needle safety guard.
When ready, carefully pull the gray needle cap straight off and away from the body.

• Do not twist or bend the gray needle cap. • Do not hold the prefilled syringe by the plunger rod. • Do not put the gray needle cap back onto the prefilled syringe. Dispose of (throw away) the gray needle cap in your household trash.

Step 3: Inject the dose

J - Pinch the cleaned injection site to create a firm surface.

  ! Keep skin pinched   while injecting.

K - Hold the pinch. Insert the needle into the skin between 45 to 90 degrees.

• Do not touch the cleaned area
of the skin

L - Using slow and constant pressure, push the plunger rod until it reaches the bottom.

  ! The plunger must be pushed fully in   order to inject the full dose.

M - Once the entire dose has been injected, the needle safety guard will be triggered. You can do either of the following:

• Release the plunger until the entire needle is covered and then remove the needle from the injection site.

or

• Gently remove the needle from the injection site and release the plunger until the entire needle is covered by the needle safety guard.

After releasing the plunger, the needle safety guard will safely cover the injection needle.

• Once the needle has been removed from the injection site, dispose of the syringe and needle in your sharps disposal container right away. See “Step 4: Disposing of used prefilled syringes”. o If the needle safety guard is not activated or only partially activated, discard the product (without replacing the needle cap). See “Step 4: Disposing of used prefilled syringes”. o If your injection is given by another person, they should also be careful when removing the needle from your skin in order to prevent accidental needlestick injury and possible infections. o When you remove the syringe, if it looks like the medicine is still in the syringe barrel, this means you have not received the full dose. Call your healthcare provider right away.

N - Examine the injection site. If there is blood, press a cotton ball or gauze pad on the injection site. Do not rub the injection site. Apply an adhesive bandage if needed.

Step 4: Disposing of used prefilled syringes
• Put the used prefilled syringe in an FDA-cleared sharps disposal container right away after use. Do not throw away the syringe in the household trash. • If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: o made of heavy-duty plastic o can be closed with a tight-fitting, puncture-resistant lid without sharps being able to come out o upright and stable during use o leak-resistant o properly labeled to warn of hazardous waste inside the container • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at http://www.fda.gov/safesharpsdisposal.

Important: Keep the sharps disposal container out of the reach of children.

• Do not reuse the prefilled syringe. • Do not recycle prefilled syringes or throw them into household waste.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured by:
Mylan GmbH
Zurich, Switzerland CH-8050
U.S. License No. 2062

Code No.: KR/DRUGS/KTK/28D/7/2006

BF1638/01

Revised: 6/2018
B:IFU:PEGFIL:R1

BF1638/01

PRINCIPAL DISPLAY PANEL – 6 mg/0.6 mL

NDC 67457-833-06   Rx only

Fulphila™
(pegfilgrastim-jmdb)
Injection
6 mg/0.6 mL

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 GmbH
Zurich, Switzerland CH-805
U.S. License No. 2062

Distributed by:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.

Product of India

Mylan.com

B:833:1C:R4
Code No.: KR/DRUGS/KTK/28D/7/2006

FULPHILA 
pegfilgrastim injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67457-833
Route of Administration SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PEGFILGRASTIM (PEGFILGRASTIM) PEGFILGRASTIM 6 mg  in 0.6 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID  
POLYSORBATE 20  
SODIUM HYDROXIDE  
SORBITOL  
WATER  
Packaging
# Item Code Package Description
1 NDC:67457-833-06 1 SYRINGE in 1 CARTON
1 0.6 mL in 1 SYRINGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761075 06/25/2018
Labeler - Mylan Institutional LLC (790384502)
  Mylan Institutional LLC

Medical Disclaimer

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