Dyrupeg

Do not take it if

From the package leaflet in EMA’s product information, p. 22.

How to take it

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

• Always use Dyrupeg exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. 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 Dyrupeg yourself Your doctor may decide that it would be more convenient for you to inject Dyrupeg yourself. Your doctor or nurse will show you how to inject yourself. Do not try to inject yourself if you have not been trained.
• For further instructions on how to inject yourself with Dyrupeg, please read the section at the end of this leaflet.
• Do not shake Dyrupeg vigorously, as this may affect its activity.
• If you use more Dyrupeg than you should If you use more Dyrupeg, then you should contact your doctor, pharmacist, or nurse.
• If you forget to inject Dyrupeg If you are injecting yourself and have forgotten a dose of Dyrupeg, you should contact your doctor to discuss when you should inject the next dose. If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

From the package leaflet in EMA’s product information, p. 24–25.

Warnings and precautions

From the package leaflet in EMA’s product information, p. 22–23.

Pregnancy and breastfeeding

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

Other medicines

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

Driving and using machines

• Dyrupeg has no or negligible effect on the ability to drive or use machines.
• Dyrupeg contains sorbitol (E420)
• This medicine contains 30 mg sorbitol in each pre-filled syringe, which is equivalent to 50 mg/mL.
• Dyrupeg contains sodium This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, that is to say, essentially ‘sodium-free.’ Dyrupeg contains polysorbate 20 (E432)
• This medicine contains 0.02 mg of polysorbate 20 in each pre-filled syringe. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

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

Side effects

• Like all medicine , this medicine can cause side effects, although not everybody gets them.
• Please tell your doctor immediately if you have any of the following or a combination of the following side effects:
• Swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling, feeling fullness, and a general feeling of tiredness. These symptoms generally develop in a rapid fashion.
• These could be symptoms of an uncommon condition (which may affect up to 1 in 100 people)
• 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-colored, raised, painful lesions on the limbs and sometimes the face and neck with fever) has occurred, but other factors may play a role.
• cutaneous vasculitis (inflammation of the blood vessels in the skin).
• damage to the tiny filters inside your kidneys (glomerulonephritis).
• redness at the site of injection.
• coughing up blood (haemoptysis).
• blood disorders (myelodysplastic syndrome [MDS] or acute myeloid leukaemia [AML]).
• Rare side effects (may affect up to 1 in 1 000 people):
• inflammation of the aorta (the large blood vessel that 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 Dyrupeg 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 Appendix V. By reporting side effects, you can provide more information on the safety of this medicine.

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 Dyrupeg out of the refrigerator and keep it at room temperature (not above 25 °C) for no longer than three days. Once a syringe has been removed from the refrigerator and has reached room temperature (not above 25 °C), it must be used within three days.
• Do not freeze. Dyrupeg may be used if it is accidentally frozen for a single period of less than 72 hours.
• Keep the pre-filled syringe in the outer carton in order to protect it from light.
• Do not use this medicine if you notice it is cloudy or there are particles in it.
• Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicine no longer use. These measures will help protect the environment.

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

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.

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Details

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

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