Udenyca - patient leaflet, side effects, dosage

What UDENYCA is and what it is used for

UDENYCA contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli followed by conjugation with polyethylene glycol (PEG) It belongs to a group of proteins called cytokines. The protein part is very similar to a natural protein produced by your own body.

ed to reduce the duration of low white blood cell count (neutropenia) and blood cell count with a fever (febrile neutropenia) which can be caused by otherapy (medicines that destroy rapidly growing cells). White blood cells

help your body fight infection. These cells are very sensitive to the effects of

chemotherapy which can cause the number of these cells in your body to decrease. If white blood cells fall to a low level there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.

Your doctor has given you UDENYCA to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.

2. What you need to know before you use UDENYCADo not use UDENYCA- if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using UDENYCA if you:

• experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and itchy skin
• experience a cough, fever and difficulty breathing. This can be a sign of Acute Respiratory Distress Syndrome (ARDS)
• have any of the following or combination of the following side effects:

– swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness

These could be symptoms of condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body. See section 4.

get left upper abdominal pain or pain at the tip of your shoulder. This may be a sign of a problem with your spleen (splenomegaly)

have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung infiltration) are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) or decreased blood platelet counts, which reduces the ability of your blood to clot (thrombocytopenia). Your doctor may want to monitor you more closely

have sickle cell anaemia. Your doctor may monitor your condition more closely

have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing. These could be signs of a severe allergic reaction

Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely in cancer patients and healthy donors. The symptoms can include fever, abdominal pain, malaise, back pain and increased inflammatory markers. Tell your doctor if you experience these symptoms

Your doctor will check your blood and urine regularly as your kidneys (glomerulonep­hritis).

Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of UDENYCA. Stop using UDENYCA and seek medical attention immediately if you notice any of the symptoms described in section 4.

r risks of developing cancers of the blood. If you develop or , you should not use UDENYCA, unless instructed by your

Loss of response to pegfilgrastim

If you experience a loss of response or decrease in response with pegfilgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise pegfilgrastim’s ac­tivity.

Other medicines and UDENYCA

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast -feeding

• Ask your doctor or pharmacist for advice before taking any medicine. UDENYCA has not been tested in pregnant women. It is important to tell your doctor if you: are pregnant
• think you may be pregnant
• are planning to have a baby

If you become pregnant during UDENYCA treatment, please inform your doctor.

Unless your doctor directs you otherwise, you must stop breast-feeding if you use UDENYCA.

Driving and using machines

UDENYCA has no or negligible effect on the ability to drive or use machines.

UDENYCA contains sorbitol (E420) and sodium acetate

UDENYCA contains sorbitol (a type of sugar). Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially ‘sodium-free’.

3. How to use UDENYCA

UDENYCA is for use in adults aged 18 and over.

Always take UDENYCA exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.

Dose

The usual dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe. It should be given at least 24 hours after your last dose of chemotherapy, at the end of each chemotherapy cycle.

Do not shake UDENYCA vigorously as this may affect its activity.

Injecting UDENYCA yourself

Your doctor may decide that it would be more convenient for you to inject UDENYCA yourself. Your doctor or nurse will show you how to inject yourself. Do not try to inject yourself if you have not been trained.

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For further instructions on how to inject yourself with UDENYCA, please read the section at the end of this leaflet.

If you use more UDENYCA than you should

If you have forgotten a dose of UDENYCA, you should contact your doctor to discuss when you should inject the next dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Please tell your doctor immediately if you have any of the following or combination of the following side effects:

• swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. These symptoms generally develop in a rapid fashion.

These could be symptoms of an uncommon condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.

Very common side effects (may affect more than 1 in 10 people):

• bone pain. Your doctor will tell you what you can take to ease the bone pain
• nausea and headaches

Common side effects (may affect up to 1 in 10 people):

• pain at the site of injection
• general aches and pains in the joints and muscles
• some changes may occur in your blood, but these will be detected by routine blood tests. Your white blood cell count may become high for a short period of time. Your platelet count may become low which might result in bruising.

Uncommon side effects (may affect up to 1 in 100 people):

• allergic-type reactions, including redness and flushing, skin rash, and raised areas of the skin that itch.
• serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).
• increased spleen size
• spleen rupture. Some cases of splenic rupture were fatal. It is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen.
• breathing problems. If you have a cough, fever and difficulty breathing please tell your doctor.
• Sweet’s syndrome – plum-coloured, raised, painful lesions on the limbs and sometimes the face and neck with fever has occurred but other factors may play a role.
• inflammation of the blood vessels in the skin (cutaneous vasculitis)
• damage to the tiny filters inside your kidneys (glomerulonep­hritis)
• redness at the site of injection
• coughing up blood (haemoptysis)

Rare side effects (may affect up to 1 in 1,000 people)

• Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2
• bleeding from the lung (pulmonary haemorrhage)
• Stevens-Johnson syndrome, which can appear as reddish target-like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. Stop using UDENYCA if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store UDENYCA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the carton and on the syringe label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).

You may take UDENYCA out of the refrigerator and keep it at room temperature (not above 30°C) for no longer than 72 hours. Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30°C) it must either be used within 72 hours or disposed of.

Do not freeze. UDENYCA may be used if it is accidentally frozen for a single period of less than 24 hours.

Keep the container in the outer carton in order to protect from light.

Do not use this medicine if you notice it is cloudy or there are particles in it.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other informationWhat UDENYCA contains- The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml of solution.

• – The other ingredients are acetic acid and sodium acetate (for pH adjustment), sorbitol (E420), polysorbate 20 and water for injections. See section 2.

What UDENYCA

looks like and contents of the pack

UDENYCA is a clear, colourless solution for injection in a pre-filled syringe (6 mg/0.6 ml).

Each pack contains 1 glass pre-filled syringe with an attached stainless steel needle and needle cap.

The syringes are provided with an automatic needle guard.

Marketing Authorisation Holder

ERA Consulting GmbH

Lange Strasse 70

29664 Walsrode

Germany

Tel: +49 (0) 5161 9890 0

Fax: +49 (0) 5161 9890 18

E-mail:

Manufacturer

Millmount Healthcare Limited

Block 7, City North Business Campus, Stamullen Co. Meath, K32 YD60 Ireland

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http : //

Instructions for use

This section contains information on how to give yourself an injection of UDENYCA. It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse or pharmacist. If you have questions about how to inject, please ask your doctor, nurse or pharmacist for assistance.

About this pre - filled syringe with automatic needle guard

• It is important that you read the instructions before using the syringe so you understand how to administer the injection.
• This medicine comes as a one-time use pre-filled safety syringe that contains a single dose. The syringe should be disposed of after giving the injection.
• The syringe has an automatic needle guard that covers the needle after administering the medicine and designed to prevent needle stick injury

Storage information

Store the pre-filled syringes in the refrigerator between 2° to 8° C in its original carton.

DO NOT freeze or shake the pre-filled syringe. If frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once.

• Store the pre-filled syringe in its original carton to protect from light until you are ready to use it.

DO NOT use the pre-filled syringe if it has been left out at room temperature for more than 72 hours.

DO NOT shake the pre-filled syringe. If shaken vigorously, the solution may appear foamy and should not be used.

DO NOT use this medicine if you are:

- Allergic to pegfilgrastim or any of its ingredients.

Prepare the injection

• 1 Remove carton from refrigerator and check expiry date.

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• A: Remove the carton from the refrigerator and check the expiry date printed on the carton. (see Figure 1).

DO NOT use if the expiry date has passed. The expiry date refers to the last day of that month.

• B: Open the carton and remove the sealed syringe tray (see Figure 2).

FIGURE 2

• 2 Allow medicine to reach room temperature and gather supplies.

• A: Place the sealed syringe tray on a flat, clean surface and allow it to sit at room temperature for at least 30 minutes (see Figure 3).

  FIGURE 3

  
  

DO NOT attempt to warm up the syringe in any other way, such as a microwave, hot water, or direct sunlight.

• B: Gather the following

Sharps

3 Wash your hands and remove syringe from tray.

• A: Wash your hands with soap and warm water (see Figure 5).

FIGURE 5

• B: Remove the syringe from the sealed tray as follows: peel the cover off the tray, remove the syringe by grasping the middle of the syringe body (see Figure 6)

DO NOT handle the syringe by the plunger, plunger head, or needle cap.

£ UDENYCA Pegfilgrastim

FIGURE 6

• 4 Inspect the syringe and solution.

Check the solution through the inspection window. The solution should be clear and colourless. It is normal to see one or more air bubbles in the syringe. Removal of the air is not needed (see Figure 7).

FIGURE 7

DO NOT use if the solution appears discoloured or cloudy.

DO NOT use if the solution contains lumps, flakes, or particles.

DO NOT use the syringe if it appears used or damaged.

Select and clean the injection site

5 Select the injection site.

The recommended injection sites for a subcutaneous injection are the:

• Abdomen (except for a two-inch area surrounding the navel)
• Thighs
• Back of Arms
• Buttocks

(see Figure 8)

Back of Arms

Abdomen Buttocks

Thighs

• FIGURE 8

DO NOT inject into moles, scars, birthmarks, or areas where the skin is tender, bruised, red, or hard.

• 6 Clean the injection site.

Clean the injection site with an alcohol swab (see Figure 9).

• FIGURE 9

Inject the dose

7 Remove needle cap.

Pull the needle cap straight off (see Figure 10).

• FIGURE 10

DO NOT recap the syringe.

DO NOT use the pre-filled syringe if it has been dropped with the needle cap removed.

• 8 Position fingers.

Grasp the body of the syringe like a dart (just under the finger grips) with your thumb and index fingers (see Figure 11).

FIGURE 11

DO NOT touch the plunger or grasp the syringe above the finger grips.

• 9 Pinch the skin and insert the needle.

• A: Use your free hand to gently pinch the skin around the injection site (see Figure 12).

FIGURE 12

• B: Insert the needle into the pinched area of the skin at a 45 to 90 degree angle (see Figure 13)

FIGURE 13

DO NOT touch the plunger head while inserting the needle into the skin.

• C: After fully inserting the needle, release the pinched skin and use your free hand to stabilise the bottom of the syringe.

Then move your other hand into injection position with your thumb on the plunger head (see Figure 14).

10 Push plunger head down to deliver dose.

• A: Using your thumb, slowly and steadily push the plunger head down until it will go no further. This will ensure you have received the full dose (see Figure 15).

  FIGURE 15

  
  

• B: While the needle is still inserted, slowly move your thumb back, allowing the plunger to rise. This will retract the needle and secure it inside the syringe body. Then remove the syringe from the injection site (see Figure 16).

  FIGURE 16

  C: If you see dro needed