Neulastim 6 mg Solution

NEULASTIM ® contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli. It belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.

NEULASTIM ® is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells). White blood cells are important as they help your body fight infection. These cells are very sensitive to the effects of chemotherapy which can cause the number of these cells in your body to decrease. If white blood cells fall to a low level there may not be enough left in the body to fight bacteria and you may have an increased risk of infection. Your doctor has given you NEULASTIM ® to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body to fight infection.

Do not use NEULASTIM ® if you are allergic to pegfilgrastim, filgrastim or any of the other ingredients of NEULASTIM ®.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using NEULASTIM ®:

• if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and areas of the skin that itch.
• if you have an allergy to latex. The needle cover on the pre-filled syringe contains a derivative of latex and may cause severe allergic reactions.
• if you experience a cough, fever and difficulty in breathing. This can be a sign of Acute Respiratory Distress Syndrome (ARDS).
• 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 could be symptoms of a 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 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, which reduces the ability of your blood to clot (thrombocytopenia). Your doctor may want to monitor you more closely.
• if you have sickle cell anaemia. Your doctor may monitor your condition more closely.
• if you are a patient with breast cancer or lung cancer, NEULASTIM ® 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 have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing these could be signs of a severe allergic reaction.
• if you have symptoms of 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.

Your doctor will check your blood and urine regularly as NEULASTIM ® can harm the tiny filters inside your kidneys (glomerulonephritis). Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of NEULASTIM ®. Stop using NEULASTIM ® and seek medical attention immediately if you notice any of the symptoms described in section 4.

You should talk to your doctor about your risks of developing cancers of the blood. If you develop or are likely to develop cancers of the blood, you should not use NEULASTIM ®, unless instructed by your doctor.

Loss of response to pegfilgrastim If you experience a loss of response or failure to maintain a response with NEULASTIM ® treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise NEULASTIM ®’s activity.

Other medicines and NEULASTIM ®

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

Pregnancy and Breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine. NEULASTIM ® has not been tested in pregnant women. It is important to tell your doctor if you:

• are pregnant;
• think you may be pregnant; or
• are planning to have a baby.

Unless your doctor directs you otherwise, you must stop breastfeeding if you use NEULASTIM ®.

Driving and using machines

NEULASTIM ® has no or negligible effect on the ability to drive or use machines.

NEULASTIM ® contains sorbitol (E420) and sodium NEULASTIM ® contains 30 mg sorbitol in each pre-filled syringe which is equivalent to 50 mg/ml. This medicine contains less than 1 mmol sodium (23 mg) per 6 mg dose, that is to say essentially ‘sodium-free’.

NEULASTIM ® is for use in adults aged 18 and over. Always take NEULASTIM ® exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. The usual dose is one 6 mg subcutaneous injection (injection under your skin) and it should be given at least 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.

Injecting NEULASTIM ® yourself Your doctor may decide that it would be more convenient for you to inject NEULASTIM ® 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 NEULASTIM ®, please read the section at the end of this leaflet.

Do not shake NEULASTIM ® vigorously as this may affect its activity.

If you use more NEULASTIM ® than you should

If you use more NEULASTIM ® than you should, contact your doctor, pharmacist or nurse.

If you forget to inject NEULASTIM ®

If you are injecting yourself and have forgotten your dose of NEULASTIM ®, you should 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.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Please tell your doctor immediately 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 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 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-coloured, 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 1000 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 and can be preceded by fever and flu-like symptoms. Stop using NEULASTIM ® if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.

It you notice any side effect not mentioned in this leaflet. please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of NEULASTIM ®. Alternatively, suspected side effects can be reported via our distributor, Aspen Pharmacare (Pty) Ltd, to: Tel: +27 800 118 088 Email: [email protected] / [email protected]

Keep this medicine out of 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 NEULASTIM ® out of the refrigerator and keep it at room temperature (not above 30 °C) for no longer than 3 days. Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30 °C) it must either be used within 3 days or disposed of. Do not freeze. NEULASTIM ® may be used if it is accidentally frozen for a single period of less than 24 hours. Keep the container 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.