Possible side effects

POSSIBLE SIDE EFFECTS

Like all medicines, Neupogen® can cause side effects, although not everybody gets them.
Please tell your doctor immediately during treatment:
if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), skin rash, itchy rash (urticaria), swelling of the face lips, mouth, tongue or throat (angioedema) and shortness of breath (dyspnoea).
if you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Acute Respiratory Distress Syndrome (ARDS).
if you experience kidney injury (glomerulonephritis). Kidney injury has been seen in patients who received Neupogen®. Call your doctor right away if you experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual.
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 a condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.
if you have a combination of any of the following symptoms:
  • fever, or shivering, or feeling very cold, high heart rate, confusion or disorientation, shortness of breath, extreme pain or discomfort and clammy or sweaty skin.
    These could be symptoms of a condition called “sepsis” (also called "blood poisoning"), a severe infection with whole-body inflammatory response which can be life threatening and needs urgent medical attention.
if you get left upper belly (abdominal) pain, pain below the left rib cage or pain at the tip of your shoulder, as there may be a problem with your spleen (enlargement of the spleen (splenomegaly) or rupture of the spleen).
if you are being treated for severe chronic neutropenia and you have blood in your urine (haematuria). Your doctor may regularly test your urine if you experience this side effect or if protein is found in your urine (proteinuria).
if you notice unusual bleeding or bruising (these may be symptoms of a decrease in blood platelets (thrombocytopenia), with a reduced ability of your blood to clot).
Inflammation of 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 those symptoms.
A common side effect of Neupogen® use is pain in your muscles or bones (musculoskeletal pain), which can be helped by taking standard pain relief medicines (analgesics). In patients undergoing a stem cell or bone marrow transplant, Graft versus host disease (GvHD) may occur- this is a reaction of the donor cells against the patient receiving the transplant; signs and symptoms include rash on the palms of your hands or soles of your feet and ulcer and sores in your mouth, gut, liver, skin, or your eyes, lungs, vagina and joints.
In normal stem cell donors an increase in white blood cells (leukocytosis) and a decrease of platelets may be seen this reduces the ability of your blood to clot (thrombocytopenia), these will be monitored by your doctor.
Very common side effects (may affect more than 1 in 10 people):
  • Decrease of platelets which reduces the ability of blood to clot (thrombocytopenia)
  • Low red blood cell count (anaemia)
  • Headache
  • Diarrhoea
  • Vomiting
  • Nausea
  • Unusual hair loss or thinning (alopecia)
  • Tiredness (fatigue)
  • Soreness and swelling of the digestive tract lining which runs from the mouth to the anus (mucosal inflammation)
  • Fever (pyrexia)
Common side effects (may affect up to 1 in 10 people):
  • Inflammation of the lung (bronchitis)
  • Upper respiratory tract infection
  • Urinary tract infection
  • Decreased appetite
  • Trouble sleeping (insomnia)
  • Dizziness
  • Decreased feeling of sensitivity, specially in the skin (hypoaesthesia)
  • Tingling or numbness of the hands or feet (paraesthesia)
  • Low blood pressure (hypotension)
  • High blood pressure (hypertension)
  • Cough
  • Coughing up blood (haemoptysis)
  • Pain in your mouth and throat (oropharyngeal pain)
  • Nose bleeds (epistaxis)
  • Constipation
  • Oral pain
  • Enlargement of the liver (hepatomegaly)
  • Rash
  • Redness of the skin (erythema)
  • Muscle spasm
  • Pain when passing urine (dysuria)
  • Chest pain
  • Pain
  • Generalised weakness (asthenia)
  • Generally feeling unwell (malaise)
  • Swelling in the hands and feet (oedema peripheral)
  • Increase of certain enzymes in the blood
  • Changes in blood chemistry
  • Transfusion reaction
THIS IS NOT A FULL LIST OF POSSIBLE SIDE EFFECTS. Please refer to the Patient Information Leaflet found in your Neupogen® pack for a complete list of possible side effects. If you have any questions or concerns about side effects, please talk to your doctor, nurse or pharmacist.
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 the package leaflet. Side effects can be reported directly to the Health Products Regulatory Authority (HPRA) using the available methods via www.hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine. Side effects should also be reported to Amgen Limited on +44 (0) 1223 436441 or Freephone 1800 535 160.
Please report any potential quality issue with the Amgen product you have received, by calling us on +44 (0) 1223 436441 or Freephone 1800 535 160 and providing us with the details. Please ensure that you keep your packaging, so we are able to identify your product

References:

Neupogen® (filgrastim). Patient Information Leaflet. [Available at: www.medicines.ie/medicines/list/all/page-1/per-page-25?query=neupogen]

This site is intended for patients in Ireland who are being treated with an Amgen® product and for Irish Healthcare Professionals (HCPs).

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IE-CBU-0820-00002 August 2020