Zefylti 48 MU/0.5 ml solution for injection/infusion in pre filled syringe

Zefylti^® 30 MU/0.5 mL solution for injection/infusion in pre-filled syringe

Zefylti^® 48 MU/0.5 mL solution for injection/infusion in pre-filled syringe

filgrastim

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Zefylti is a white blood cell growth factor (granulocyte colony-stimulating factor) and belongs 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. Zefylti 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. Zefylti stimulates the bone marrow to produce new white cells quickly.

Zefylti 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.

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 filgrastim. 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 filgrastim 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 1000 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 the 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.

Do not use this medicine after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP. The expiry date refers to the last day of that month.

Store and transport refrigerated (2 °C – 8 °C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light.

Within its shelf -life and for the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25 °C) for one single period of up to 72 hours. At the end of this period, the product should not be put back in the refrigerator and should be disposed of.

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 protect the environment.

This section contains information on how to give yourself an injection of Zefylti. It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse. Zefylti is provided with a needle safety guard, and you will be shown how to use this by your doctor or nurse. If you are not sure about giving the injection or you have any questions, please ask your doctor or nurse for help.

1. Wash your hands.
2. Remove the syringe from the pack and remove the protective cap from the injection needle. Syringes are embossed with graduation rings in order to enable partial use if required. Each graduation ring corresponds to a volume of 0.025 mL. If partial use of a syringe is required, remove unwanted solution before injection.
3. Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed the last day of the month shown.
4. Check the appearance of Zefylti. It must be a clear and colourless liquid. If there is discolouration, cloudiness or particles in it, you must not use it.
5. Clean the skin at the injection site using an alcohol wipe.
6. Form a skin fold by pinching the skin between thumb and forefinger.
7. Insert the needle into the skin fold with a quick, firm action.
8. Keeping your skin pinched, depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further. Do not release the pressure on the plunger.
9. After injecting the liquid, remove the syringe from your skin while maintaining pressure on the plunger and then let go of your skin.
10. Let go of the plunger. The needle safety guard will rapidly move to cover the needle.
11. Discard any unused product or waste material. Only use each syringe for one injection.