Neupogen 30 MU (0.3 mg/ml) solution for injection

filgrastim

Neupogen is a white blood cell growth factor (granulocyte-colony stimulating factor) and belong to a group of medicines called cytokines. Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine. Neupogen works by encouraging the bone marrow to produce more white blood cells.

A reduction in the number of white blood cells (neutropenia) can occur for several reasons and makes your body less able to fight infection. Neupogen stimulates the bone marrow to produce new white cells quickly.

Neupogen can be used:

• to increase the number of white blood cells after treatment with chemotherapy to help prevent infections;
• to increase the number of white blood cells after a bone marrow transplant to help prevent infections;
• before high-dose chemotherapy to make the bone marrow produce more stem cells which can be collected and given back to you after your treatment. These can be taken from you or from a donor. The stem cells will then go back into the bone marrow and produce blood cells;
• to increase the number of white blood cells if you suffer from severe chronic neutropenia to help prevent infections;
• in patients with advanced HIV infection which will help reduce the risk of infections.

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

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

Like all medicines, this medicine 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).

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 (leucocytosis) 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, especially 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

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

• increase in white blood cells (leucocytosis)
• allergic reaction (hypersensitivity)
• rejection of transplanted bone marrow (graft versus host disease)
• high uric acid levels in the blood, which may cause gout (hyperuricaemia) (Blood uric acid increased)
• liver damage caused by blocking of the small veins within the liver (veno-occlusive disease)
• lungs do not function as they should, causing breathlessness (respiratory failure)
• swelling and/or fluid in the lungs (pulmonary oedema)
• inflammation of the lungs (interstitial lung disease)
• abnormal x-rays of the lungs (lung infiltration)
• bleeding from the lung (pulmonary haemorrhage)
• lack of absorption of oxygen in the lung (hypoxia)
• bumpy skin rash (rash maculo-papular)
• disease which causes bones to become less dense, making them weaker, more brittle and likely to break (osteoporosis)
• injection site reaction

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

• severe pain in the bones, chest, gut or joints (sickle cell anaemia with crisis)
• sudden life-threatening allergic reaction (anaphylactic reaction)
• pain and swelling of the joints, similar to gout (pseudogout)
• a change in how your body regulates fluids within your body and may result in puffiness (fluid volume disturbances)
• inflammation of the blood vessels in the skin (cutaneous vasculitis)
• plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with a fever (Sweets syndrome)
• worsening of rheumatoid arthritis
• unusual change in the urine
• bone density decreased
• inflammation of aorta (the large blood vessel which transports blood from the heart to the body), see section 2
• formation of blood cells outside of the bone marrow (extramedullary haematopoiesis).

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

Store in a refrigerator (2°C – 8°C).

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

Accidental freezing will not harm Neupogen.

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

Do not use this medicine if you notice discolouration, cloudiness or particles, it should be a clear, colourless liquid.

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

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the name Neupogen, except in Cyprus, Greece and Italy where it is called Granulokine.