Mediclarum
Medicine guide

Nyvepria

  • Prescription status not stated
  • Cancer treatments and immune-system medicines
Active substance
Pegfilgrastim
Made by
Pfizer Europe MA EEIG

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

What it is 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.

From the package leaflet in EMA’s product information, p. 23 · 2026-01-20

How it works

From the US prescribing label for the same active substance (Neulasta). It describes the substance, not this exact product.

Pegfilgrastim is a colony-stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

Half-life15–80 h
Mostly cleared after≈ 10 daysfive half-lives — our arithmetic

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-10

Do not take it if

• if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine (listed in section 6).

From the package leaflet in EMA’s product information, p. 23.

How to take it

These directions are for this exact strength and form. Another one is different.

  • 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.

From the package leaflet in EMA’s product information, p. 25.

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.

From the package leaflet in EMA’s product information, p. 23–24.

Pregnancy and breastfeeding

  • 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.

From the package leaflet in EMA’s product information, p. 24.

Other medicines

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

From the package leaflet in EMA’s product information, p. 24.

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’.

From the package leaflet in EMA’s product information, p. 25.

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 1 000 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 safety of this medicine.the

From the package leaflet in EMA’s product information, p. 25–26.

How to store it

  • 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 pre-filled syringe 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.

From the package leaflet in EMA’s product information, p. 26–27.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

United StatesNo exact match for this strength and form

Every strength and form (4)

SpainNo exact match for this strength and form

Every strength and form (10)

FranceNo exact match for this strength and form

Every strength and form (12)

CanadaNo exact match for this strength and form

Every strength and form (10)

NetherlandsNo exact match for this strength and form

Every strength and form (13)

SwitzerlandNo exact match for this strength and form

Every strength and form (6)

Details

Made byPfizer Europe MA EEIG
Active substancePegfilgrastim
Used inCancer treatments and immune-system medicines
ClassificationL03AA13 · Cancer treatments and immune-system medicines
BiosimilarYes — a biosimilar medicine, according to the register
Authorised on2020-11-18
Last updated by the regulator2026-01-20
EMA product numberEMEA/H/C/005085

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

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Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

GrasustekEU authorisation Juta Pharma GmbH · Pegfilgrastim · L03AA13FulphilaEU authorisation Biosimilar Collaborations Ireland Limited · Pegfilgrastim · L03AA13DyrupegEU authorisation CuraTeQ Biologics (Malta) Limited · Pegfilgrastim · L03AA13PelgrazEU authorisation Accord Healthcare S.L.U. · Pegfilgrastim · L03AA13ZiextenzoEU authorisation Sandoz GmbH · Pegfilgrastim · L03AA13Cegfila (previously Pegfilgrastim Mundipharma)EU authorisation Mundipharma Corporation (Ireland) Limited · Pegfilgrastim · L03AA13

See every product with Pegfilgrastim