Nyvepria - patient leaflet, side effects, dosage

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Nyvepria is and what it is used for

• 2. What you need to know before you use Nyvepria

• 3. How to use Nyvepria

• 4. Possible side effects

• 5. How to store Nyvepria

• 6. Contents of the pack and other information

1. What Nyvepria is and what it is used for

Nyvepria contains the active substance pegfilgrastim. It is used in patients treated with cytotoxic chemotherapy (medicines that destroy rapidly growing cells) to reduce the duration of neutropenia (low neutrophil count, a type of white blood cell) and to help prevent febrile neutropenia (low white blood cell count with a fever). Nyvepria is for use in adults aged 18 years and over.

White blood cells are important for fighting off infection. If the white blood cell count to fall too low, due to your cytotoxic chemotherapy, your body may not be able to fight off microorganisms and this will increase the chances of an infection. Pegfilgrastim, is very similar to a natural protein in the body called granulocyte colony stimulating factor and it works by encouraging your bone marrow to produce more white blood cells that help your body fight off infections.

2. What you need to know before you use Nyvepria

Do not use Nyvepria

• if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine

(listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Nyvepria:

• If you 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).
• If you are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) or decreased blood platelet counts (thrombocytopenia), which reduces the ability of your blood to clot. Your doctor may want to monitor you more closely.
• If you have sickle cell anaemia. Your doctor may monitor your condition more closely.

Talk to your doctor, pharmacist or nurse while using Nyvepria:

• If you are a patient with breast cancer or lung cancer, pegfilgrastim in combination with chemotherapy and/or radiation therapy may increase your risk of a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukaemia (AML). Symptoms may include tiredness, fever, and easy bruising or bleeding.
• If you get an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face, lips, tongue or other parts of the body (anaphylaxis), redness and flushing, skin rash or hives on the skin and areas of the skin that itch.
• If you get a cough or fever, and have difficulty breathing. This can be a sign of acute respiratory distress syndrome (ARDS).
• If you have any of the following side effects:

• – swelling or puffiness, passing urine less frequently, difficulty breathing, abdominal (belly) 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.

• If you 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).
• If you get fever, abdominal pain, malaise, and back pain as these may be symptoms of inflammation of the aorta (the large blood vessel which transports blood from the heart to the body). This disorder can occur rarely in cancer patients and healthy donors.

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

Severe skin reactions (Stevens-Johnson syndrome; a skin condition that causes painful blisters and sores of the skin and mucous membranes, especially in the mouth) have been reported with the use of pegfilgrastim. Stop using Nyvepria and get medical attention immediately if you notice any of these symptoms: reddish target like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes possibly with fever and flu-like symptoms beforehand. See section 4.

You should talk to your doctor about your risks of developing cancers of the blood. If you have a cancer of the blood or have been told by your doctor that you are at risk of one, you should not use Nyvepria, unless instructed by your doctor.

Loss of response to pegfilgrastim

If pegfilgrastim treatment does not work or stops working, your doctor will investigate why this has happened including whether you have developed antibodies which neutralise pegfilgrastim’s ac­tivity.

Children and adolescents

Nyvepria is not recommended for use in children and adolescents because there is insufficient information on its safety and effectiveness.

Other medicines and Nyvepria

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Nyvepria has not been studied in pregnant women. Therefore, your doctor may decide that you should not use this medicine.

If you become pregnant during Nyvepria treatment, speak with your doctor.

Unless your doctor tells you otherwise, you must stop breast-feeding if you use Nyvepria.

Driving and using machines

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

Nyvepria contains sorbitol (E420) and sodium

This medicine contains 30 mg sorbitol in each pre-filled syringe which is equivalent to 50 mg/mL. The additive effect of concomitantly administered medicines containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.

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

3. How to use Nyvepria

Nyvepria is for use in adults aged 18 years and over.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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

Injecting Nyvepria yourself

Your doctor may decide that you can inject Nyvepria yourself. Your doctor or nurse will show you how to inject it yourself. Do not try to inject it yourself if you have not been trained.

For instructions on how to inject Nyvepria, read the section at the end of this leaflet.

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

If you use more Nyvepria than you should

If you use more Nyvepria than you should contact your doctor, pharmacist or nurse for advice.

If you forget to inject Nyvepria

If you have forgotten a dose of Nyvepria, 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.

Tell your doctor immediately if you have any of the following side effects:

• swelling or puffiness, passing urine less frequently, difficulty breathing, abdominal (belly) swelling and feeling of fullness, and a general feeling of tiredness. These symptoms generally develop quickly.

They could be symptoms of an uncommon (may affect up to 1 in 100 people) condition called capillary leak syndrome which causes blood to leak from the small blood vessels into your body and needs urgent treatment.

Very common: 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: 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. Your platelet count may become low which might result in bruising.
• chest pain not related to heart disorders.

Uncommon: 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 (the spleen is an organ located in the belly to the left of the stomach involved in the production and removal of blood cells and forming part of the immune system). Tell your doctor if you have an increase of volume in the upper left side of your abdomen.
• spleen rupture, which can be fatal. It is important that you contact your doctor immediately if you get 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 tell your doctor.
• Sweet’s syndrome (plum-coloured, raised, painful damage on the limbs and sometimes the face and neck with fever).
• cutaneous vasculitis (inflammation of the blood vessels in the skin).
• damage to your kidneys (called glomerulonephri­tis).
• redness at the site of injection.
• coughing up blood (haemoptysis).
• blood disorders (myelodysplastic syndrome [MDS] or acute myeloid leukaemia [AML]).

Rare: may affect up to 1 in 1000 people

• inflammation of 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 possibly with fever and flu-like symptoms beforehand. Stop using Nyvepria if you develop these symptoms and contact your doctor or get 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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nyvepria

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 Nyvepria out of the refrigerator and keep it at room temperature (not above 25°C) for no longer than 15 days. Once a syringe has been removed from the refrigerator and has reached room temperature (not above 25°C) it must either be used within 15 days or disposed of.

Do not freeze. Nyvepria 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 information

What Nyvepria 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 sodium acetate trihydrate, glacial acetic acid, sorbitol (E420), polysorbate 20 and water for injections (see section 2 “Nyvepria contains sorbitol (E420) and sodium acetate”).

What Nyvepria looks like and contents of the pack

Nyvepria is a clear, colourless, free from visible particles, 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, needle cover and an automatic needle guard.

Marketing Authorisation Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Manufacturer

Hospira Zagreb d.o.o.

Prudnicka cesta 60

10291 Prigorje Brdovecko

Croatia

Danmark Pfizer ApS Tlf: +45 44 20 11 00	Malta Drugsales Ltd Tel: +356 21 419 070/1/2
Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055–51000	Nederland Pfizer bv Tel: +31 (0)10 406 43 01
B'ixiiapiiH n<|)aÜ3ep ^æKceMÔypr C’APÆ KnoH Btnrapua	Norge Pfizer AS Tlf: +47 67 52 61 00

Ten: +359 2 970 4333

Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500	Österreich Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15–0
EZZàôa PFIZER EAAAE A.E. TnÀ.: +30 210 67 85 800	Polska Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 00
España Pfizer, S.L. Tel: +34 91 490 99 00	Portugal Laboratórios Pfizer, Lda. Tel: +351 21 423 5500
France Pfizer Tél: +33 (0)1 58 07 34 40	România Pfizer Romania S.R.L Tel: +40 (0) 21 207 28 00
Hrvatska Pfizer Croatia d.o.o. Tel: +385 1 3908 777	Slovenija Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: +386 (0) 1 52 11 400
Ireland Pfizer Healthcare Ireland Tel: +1800 633 363 (toll free) Tel: +44 (0)1304 616161	Slovenská Republika Pfizer Luxembourg SARL, organizačná zložka Tel: +421 2 3355 5500
Ísland Icepharma hf. Tel: +354 540 8000	Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 040
Italia Pfizer S.r.l. Tel: +39 06 33 18 21	Sverige Pfizer AB Tel: +46 (0)8 550 520 00
Latvija Pfizer Luxembourg SARL filiäle Latvijä Tel. +371 67035775	United Kingdom (Northern Ireland) Pfizer Limited Tel: +44 (0)1304 616161

Lietuva

Pfizer Luxembourg SARL filialas Lietuvoje

Tel. +3705 2514000

This leaflet was last revised in

Other sources of information

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

Important

Before you use a Nyvepria pre-filled syringe with automatic needle guard, read this important information:

It is important that you do not give yourself the injection unless you have received training from your doctor or healthcare provider. If you have questions about how to inject, please ask your doctor or healthcare provider for help.

Make sure the name Nyvepria appears on the carton and pre-filled syringe label.

Check the carton and pre-filled syringe label to make sure the dose strength is 6 mg (6 mg/0.6 mL).

Nyvepria is given as an injection into the tissue just under the skin (subcutaneous injection).

X

Do not use the pre-filled syringe if the date has passed the last day of the month shown.

X

Do not remove the needle cover from the pre-filled syringe until you are ready to inject.

X

Do not use the pre-filled syringe if it has been dropped on a hard surface. Use a new prefilled syringe and call your doctor or healthcare provider.

X

Do not activate the pre-filled syringe before injection.

X

Do not remove the clear automatic needle guard from the pre-filled syringe.

X Do not remove the peelable label on the pre-filled syringe barrel before injecting the medicine.

Call your doctor or healthcare provider if you have any questions.

Step 1: Prepare
A	Remove the pre-filled syringe carton from the refrigerator. Remove the pre-filled syringe inner carton from the outer carton by peeling away the cover and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included).
For a more comfortable injection, leave the pre-filled syringe at room temperature (not above 25°C) for about 30 minutes before injecting. Wash your hands thoroughly with soap and water. On a clean, well-lit work surface, place the new pre-filled syringe and the other supplies. X Do not warm the syringe by using a heat source such as hot water or microwave. X Do not leave the pre-filled syringe exposed to direct sunlight. X Do not shake the pre-filled syringe. Keep pre-filled syringes out of the sight and reach of children.

B

For safety reasons:

X Do not grasp the plunger rod.

X Do not grasp the needle cover.

C I Inspect the medicine and pre-filled syringe.

• X Do not use the pre-filled syringe if:

• The medicine is cloudy or there are particles in it. It must be a clear and colourless liquid.
• Any part appears cracked or broken.
• The needle cover is missing or not securely attached.
• The expiry date printed on the label has passed the last day of the month shown.

In all cases, call your doctor or healthcare provider.

_____________­________________________­_Step 2: Get ready ___________

A | Wash your hands thoroughly. Prepare and clean your injection site.

You can use:

• Upper part of your thigh.
• Belly, except for a 5 cm (2-inch) area right around your belly button.
• Outer area of upper arm (only if someone else is giving you the injection).