Neupogen

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How does it work?

Neupogen injection contains the active ingredient filgrastim, which is a type of medicine called a recombinant human granulocyte-colony stimulating factor (G-CSF). G-CSF is a substance produced naturally by the body that stimulates the bone marrow to produce white blood cells known as neutrophils. Filgrastim is a man-made version of G-CSF.

Neutrophils, like all blood cells, are produced naturally by the bone marrow. They play a cental role in the body's immune system because they help defend the body from infections. A low level of neutrophils in the blood (neutropenia), leaves a person very susceptible to life threatening infections.

Neutropenia can be caused by a number of factors, including cancer chemotherapy, which often kills normal healthy cells such as blood cells as well as the cancer cells. Neutropenia also often occurs in people who have recently had a bone marrow transplant or who are suffering from AIDS.

Filgrastim is used to correct low neutrophil levels in the blood and thereby reduce the duration and severity of neutropenia. As a result, filgrastim minimises the need for antibiotic treatment, the risk of complications due to infections and length of time spent in hospital.

The injection is given on a daily basis, with the length of treatment depending on the reason the medicine is being given and the results of blood cell counts. It is given either under the skin (subcutaneous injection), most often of the thigh, arm or abdomen, or as a drip into a vein (intravenous infusion).

What is it used for?

- Reducing the duration of neutropenia and risk of infection in people treated with chemotherapy for cancer (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
- Reducing duration of neutropenia in people who have had a bone marrow transplant.
- Reducing the risk of infections in people with advanced HIV infection and persistant neutropenia.
- Long-term therapy to increase neutrophil counts and reduce the number and duration of infections in people with low neutrophil counts from birth (severe congenital neutropenia), low neutrophil counts that recur at regular intervals (cyclic neutropenia), or low neutrophil counts with no known cause (idiopathic neutropenia).
- To increase production of immature blood cells (stem cells or progenitor cells) that are then collected by drawing blood, so the patient can receive transfusions of their own stem cells, for example following high-dose chemotherapy treatment. The stem cells go back into the bone marrow and produce blood cells. (This medicine can also be given to a stem cell donor, eg brother or sister of the patient, to stimulate the production of their stem cells before donation.)

Warning!

- Neupogen should be stored in the refrigerator at 2 to 8°C.

- You will need to have regular blood tests to monitor the numbers of blood cells in your blood while you are receiving treatment with this medicine.
- This medicine may enlarge the spleen and on very rare occasions may cause the spleen to rupture. It is recommended that the spleen size of people receiving this medicine should be regularly monitored. Tell your doctor if you experience upper left sided abdominal pain or pain at the tip of your left shoulder after receiving this medicine, as this could indicate a problem with your spleen.
- This medicine may rarely have side effects on the lungs. For this reason, you should let your doctor know if you get a cough, fever, shortness of breath, or difficulty breathing while receiving treatment with this medicine.
- It is recommended that people with osteoporosis should have their bone density regularly monitored if they have treatment with this medicine for more than six months.
- People receiving long-term treatment with this medicine for neutropenia present from birth (congenital neutropenia) should have regular bone marrow examinations to check for any abnormal changes in the bone marrow or blood cells. This is recommended approximately every 12 months.
- The manufacturer of this medicine has not studied its safety and efficacy for stimulating stem cell production in healthy stem cell donors aged under 16 years or over 60 years, or for treating babies less than one month old, or for treating people with neutropenia caused by the body's immune system attacking the white blood cells (autoimmune neutropenia).

Use with caution in

.

- Acute myeloid leukaemia
- Osteoporosis
- People who have recently had pneumonia
- Hereditary fructose intolerance
- Sickle cell disease.

Not to be used in

- Severe congenital neutropenia (Kostman's syndrome) with abnormal chromosomes.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

- There safety of this medicine during pregnancy has not been established, therefore it is not recommended for use during pregnancy, unless considered essential by your doctor. Seek medical advice from your doctor.
- There is no information available about the safety of this medicine during breastfeeding. For this reason it is not recommended for women who are breastfeeding. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine.

Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

- Pain in muscles or bones (musculoskeletal pain)
- Disturbances of the gut, such as nausea, vomiting, diarrhoea, constipation
- Enlargement of the spleen
- Fatigue
- Weakness
- Headache
- Loss of appetite
- Hair loss (alopecia)
- Cough
- Skin rash
- Alteration in results of liver function tests
- Nosebleeds (epistaxis)
- Difficulty or pain on passing urine (dysuria)
- Protein or blood in the urine
- Decrease in the number of platelets in the blood (thrombocytopenia)
- Decrease in the number of red blood cells in the blood (anaemia)
- Injection site reaction
- Worsening of arthritis
- Fluid on the lungs (pulmonary oedema)
- Pneumonia
- A sudden inability to breath (adult respiratory distress syndrome, ARDS)

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. . For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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