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FULPHILA- pegfilgrastim injection


  1. Patient Information
  2. What Is Fulphila?
  3. Before You Receive Fulphila, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  4. How Will I Receive Fulphila?
  5. Fulphila May Cause Serious Side Effects, Including:
  6. How Should I Store Fulphila?
  7. Active Ingredient:
  8. Inactive Ingredients:
  9. Important:
  10. Before You Use A Fulphila Prefilled Syringe, Read This Important Information:
  11. For Safety Reasons:
  12. There Are 4 Injection Sites That You Can Use:
  13. If You Do Not Have An Fda-cleared Sharps Disposal Container, You May Use A Household Container That Is:
  14. Advise Patients Of The Following Risks And Potential Risks With Fulphila:
  15. Instruct Patients Who Self-administer Fulphila Using The Single-dose Prefilled Syringe Of The:

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 Fulphilaif you have had a serious allergic reaction to pegfilgrastim products 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 Fulphila 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.

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 pegfilgrastim 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:
swelling of your face or ankles
blood in your urine or dark colored urine
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:
swelling or puffiness and are urinating less than usual
trouble breathing
swelling of your stomach-area (abdomen) and feeling of fullness
dizziness or feeling faint
a general feeling of tiredness
Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received pegfilgrastim. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.

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 health care provider 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).
Take Fulphila out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.
Avoid freezing. If Fulphila is accidently frozen, allow the prefilled syringe to thaw in the refrigerator before injecting.
Do notuse a Fulphila prefilled syringe that has been frozen more than 1 time. Use a new Fulphila prefilled syringe.
Keep the prefilled syringe in the original carton to protect from light or physical damage.
Do not shake the prefilled syringe.
Throw away (dispose of) any Fulphila that has been left at room temperature, 68 F to 77 F (20 C to 25 C) for more than 72 hours or frozen more than 1 time.

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.

Active Ingredient: 

pegfilgrastim-jmdb

Inactive Ingredients: 

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

Manufactured by:Mylan GmbH,Turmstrasse 24, 6312 Steinhausen, Switzerland 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. Revised: 3/2019

Manufactured by:
Mylan GmbH
Turmstrasse 24
6312 Steinhausen, Switzerland

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: 5/2019
B:PEGFIL:R3

Instructions for Use

FULPHILA(FULL-fil-ah)

(pegfilgrastim-jmdb)

injection, for subcutaneous use

Single-Dose Prefilled Syringe

Guide to Parts

Before Use

After Use

Instructions for Use Syringe Before UseInstructions for Use Syringe 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 36 F to 46 F (2 C to 8 C).
Take Fulphila out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.
Avoid freezing. If Fulphila is accidentally frozen, allow the prefilled syringe to thaw in the refrigerator before injecting.
Do notuse 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 77 F (20 C to 25 C) for more than 72 hours or frozen more than 1 time. SeeStep 4: Disposing of used prefilled syringes.
Keep the prefilled syringe in the original carton to protect from light or physical damage.
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 safety 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 notuse a prefilled syringe after the expiration date on the label.
Do notshake the prefilled syringe.
Do notuse the prefilled syringe if the carton is open or damaged.
Do notremove the gray needle cap from the prefilled syringe until you are ready to inject.
Do notuse 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 notattempt to activate the prefilled syringe prior to injection.
Do notattempt to remove the needle safety guard from the prefilled syringe.
Do notattempt 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 for30minutes 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
Instructions for Use Figure 01

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 notgrab the plunger rod.
Do notgrasp the gray needle cap.
Instructions for Use Figure 02

G -Inspect the medicine and prefilled syringe.


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

Do notuse 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.

Instructions for Use Figure 03

H -Prepare and clean the injection site.

There Are 4 Injection Sites That You Can Use: 

thigh
stomach area (abdomen), except for a2-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).
Instructions for Use Figure 04

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

Do nottouch this area again before injecting.
Do notinject 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 nottwist or bend the gray needle cap.
Do nothold the prefilled syringe by the plunger rod.
Do notput the gray needle cap back onto the prefilled syringe. Dispose of (throw away) the gray needle cap in your household trash.
Instructions for Use Figure 05

Step 3: Inject the dose

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

! Keep skin pinched
while injecting.
Instructions for Use Figure 06

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

Do nottouch the cleaned area
of the skin
Instructions for Use Figure 07

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.
Instructions for Use Figure 08

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.
Instructions for Use Figure 09

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.
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 .
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.
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 notthrow 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: 

made of heavy-duty plastic
can be closed with a tight-fitting, puncture-resistant lid without sharps being able to come out
upright and stable during use
leak-resistant
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.
Instructions for Use Figure 10

Advise Patients Of The Following Risks And Potential Risks With Fulphila: 

Splenic rupture and splenomegaly[seeWarnings and Precautions (5.1)]
Acute Respiratory Distress Syndrome[seeWarnings and Precautions (5.2)]
Serious allergic reactions[seeWarnings and Precautions (5.3)]
Sickle cell crisis[seeWarnings and Precautions (5.4)]
Glomerulonephritis[seeWarnings and Precautions (5.5)]
Capillary Leak Syndrome[seeWarnings and Precautions (5.7)]
Aortitis[seeWarnings and Precautions (5.9)]

Instruct Patients Who Self-administer Fulphila Using The Single-dose Prefilled Syringe Of The: 

Importance of following the Instructions for Use.
Dangers of reusing syringes.
Importance of following local requirements for proper disposal of used syringes.

Manufactured by:
Mylan GmbH
Turmstrasse 24
6312 Steinhausen, Switzerland

U.S. License No. 2062



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