Filgrastim Teva 0,5 ml Solution

FILGRASTIM TEVA contains filgrastim, a white blood cell growth factor (granulocyte colony stimulating factor [G-CSF]). FILGRASTIM TEVA works by stimulating the bone marrow (the tissue where new blood cells are made) to produce more white blood cells. White blood cells are important as they help your body fight infection.

FILGRASTIM TEVA is used to increase the number of white blood cells after treatment with to help prevent infections.

Do not use FILGRASTIM TEVA:

• If you are hypersensitive (allergic) to filgrastim or any of the other ingredients of FILGRASTIM TEVA (listed in section 6).
• If you have severely low white blood cell levels that were detected soon after your birth (Kostmann’s syndrome) with abnormal cell structure or function.
• If you have kidney or liver problems.
• If you are pregnant or breastfeeding your baby.

Warnings and precautions

Tell your doctor or healthcare provider before being given the injection if:

• Special care should be taken with FILGRASTIM TEVA:
• You have a history sickle cell disease, because FILGRASTIM TEVA can cause sickle cell crisis (a painful episode that occurs in people who have sickle cell anaemia. Sickle shaped red blood cells block blood vessels. Blood and oxygen cannot get to the tissues, causing pain).
• If you have osteoporosis (bone disease). Your doctor will monitor your bone mineral density if you are receiving FILGRASTIM TEVA for more than 6 months.

If you have symptoms of cough, fever, shortness of breath or trouble breathing because these may be signs of a serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Stop treatment with FILGRASTIM TEVA immediately and consult your doctor if you have any of these symptoms (see Possible side effects).

Other medicines and FILGRASTIM TEVA

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before using FILGRASTIM TEVA. FILGRASTIM TEVA has not been tested in pregnant women. You should not be given FILGRASTIM TEVA if you are pregnant or breastfeeding. It is unknown whether FILGRASTIM TEVA passes into the breast milk. You should not use FILGRASTIM TEVA if you are breastfeeding.

Do not share medicines prescribed for you with any other person. Always use FILGRASTIM TEVA exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose: FILGRASTIM TEVA is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection). It can also be given as a daily slow injection into the vein (known as an intravenous infusion). The dosage will vary depending on your illness and weight. Your doctor will tell you how much FILGRASTIM TEVA you will be administered. You will be given FILGRASTIM TEVA until your white blood cell count is normal. Regular blood tests will be taken to monitor the number of white blood cells in your body.

If you have the impression that the effect of FILGRASTIM TEVA is too strong or too weak, tell your doctor or pharmacist. It is quite normal to have a number of courses of FILGRASTIM TEVA treatment.

The usual dose is 0,5 million international units (MIU) per kilogram of body weight each day. Your treatment will usually last for about 14 days. In some disease types however, longer treatment lasting up to one month may be required.

Method of administration: If you are receiving this medicine by subcutaneous injection, your doctor may suggest that you learn how to give yourself the injection. Your doctor or nurse will give you instructions on how to do this. Do not attempt to self-administer without this training. Some of the information you require is given at the end of this package leaflet, but proper treatment of your disease requires close and constant co-operation with your doctor. Keep all your appointments for your FILGRASTIM TEVA injections and blood tests.

Each pre-filled syringe is for single use only.

If you use more FILGRASTIM TEVA than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to use FILGRASTIM TEVA: Do not use a double dose to make up for a forgotten injection.

If you stop using FILGRASTIM TEVA: Before you stop using FILGRASTIM TEVA, talk to your doctor.

FILGRASTIM TEVA can have side effects. Not all side effects reported for FILGRASTIM TEVA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using this medicine, please consult your healthcare provider for advice.

If any of the following happens, stop using FILGRASTIM TEVA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis).
• Skin rash, itchy rash (urticarial).
• Swelling of the face, lips, mouth, tongue or throat (angioedema).
• Shortness of breath (dyspnoea).

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to FILGRASTIM TEVA. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Cough, fever and difficulty breathing as this can be a sign of Acute Respiratory Distress Syndrome (ARDS).
• Severe pain in the bones, chest, gut or joints (sickle cell crisis).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Nausea (feeling sick).
• Vomiting.
• Constipation.
• Diarrhoea.
• Lack of appetite (anorexia).
• Headache.
• Sore throat.
• Extreme tiredness (fatigue), general weakness.
• Hair loss.
• Chest pain.
• Musculoskeletal pain.

Tell your doctor if you notice any of the following:

Less frequent side effects:

• Any of the following or combination of the following adverse 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 an uncommon condition called ‘Capillary Leak Syndrome’, which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.
• Vascular disorder (a disorder that affects the blood vessels)
• Pseudogout (a form of arthritis that causes pain, stiffness, tenderness, redness, warmth, and swelling in some joints).
• Abnormal X-rays of the lung (Pulmonary infiltrates).
• Inflammation of the blood vessels in the skin (cutaneous vasculitis).
• Sweets syndrome (plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with a fever).
• Worsening of rheumatoid arthritis.
• Painful or difficult urination or urinary problems.

If you notice any side effects 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 FILGASTRIM TEVA.

Store between 2 °C – 8 °C in a refrigerator. Within its shelf-life and for ambulatory use, the product may be removed from the refrigerator (2 °C – 8 °C) and stored at a temperature up to 25 °C for one single period of up to 4 days. If not used within 4 days, the product may be returned to the refrigerator (2 °C – 8 °C) up to the expiry date. Dispose of syringes if stored above 8 °C for more than 4 days.

Store all medicines out of reach of children. Do not use FILGRASTIM TEVA after the expiry date which is stated on the outer carton and on the pre-filled syringe. The expiry date refers to the last day of that month. Do not use FILGRASTIM TEVA if you notice it is cloudy or there are particles in it. Each pre-filled syringe is for single use only.

Accidental exposure to freezing temperatures does not adversely affect the stability of FILGRASTIM TEVA. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.