6 mg solution for injection in a pre-filled syringe
What Ziextenzo is and what it is used for
Extenze contains the active substance pegfilgrastim. Pegfilgrastim is a protein that, with the help of biotechnology, is produced in a bacterium called E. coli. It belongs to a group of proteins called cytokines and it is very similar to a natural protein (granulocyte colony-stimulating factor) produced in the body.
Extenze 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 concomitant fever) that may result from the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells). The white blood cells are important because they help your body fight infection. These blood cells are very sensitive to chemotherapy and this treatment can lead to a decrease in their number in the body. About the number of white blood cells drops to a low level, there may not be enough left in the body to fight bacteria, and then you may become more susceptible to infection.
Your doctor has given you Ziextenzo to help your bone marrow (the part of the bone where blood cells are made) make more white blood cells to help your body fight infection.
What you need to know before you use Ziextenzo
Do not use Ziextenzo
- if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Ziextenzo:
- if you suffer from an allergic reaction, which may manifest as a feeling of weakness, drop in blood pressure, difficulty breathing, swelling of the face ( anaphylaxis ), redness and swelling, rash, and itchy skin areas.
- if you have a cough, fever, and breathing difficulties. This may be a sign of acute respiratory distress syndrome.
- if you suffer from one or more of the following side effects:
- swelling or fluid retention, which may occur while you urinate less often than usual; difficulty breathing; swollen abdomen and a feeling of oversaturation; general feeling of tiredness there may be symptoms of a condition called capillary leak syndrome, which causes blood to leak out of the small blood vessels. See section 4.
- if you suffer from pain in the upper part of the abdomen on the left side of the tip of the left shoulder blade. This may be a sign of spleen problems ( splenomegaly ).
- if you have recently had a serious lung infection ( pneumonia ), fluid in the lungs ( pulmonary edema), inflammation of the lungs (interstitial lung disease), or abnormal chest X-ray results (pulmonary infiltration).
- if you know that you have changed the number of blood cells (e.g. increased number of white blood cells or anemia ) or decreased the number of platelets, which reduces the blood’s ability to clot ( thrombocytopenia ). The doctor may want to check this more often than usual.
- if you have sickle cell anemia. The doctor may want to check this more often than usual.
- if you are a patient with breast cancer or lung cancer, then Ziextenzo in combination with chemotherapy and/or radiotherapy may increase the risk of a pre-cancer called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms may include fatigue, fever, and easy bruising and bleeding.
- if you experience sudden signs of allergy, such as rash, itching or hives, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, wheezing, or difficulty breathing. These may be signs of a severe allergic reaction.
- if you have symptoms indicating inflammation of the aorta (the large blood vessel that transports blood from the heart to the body). This has been reported with a frequency of “rare” in cancer patients and healthy donors. Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers. Tell your doctor if you experience these symptoms.
You will have regular blood and urine tests because pegfilgrastim can damage the tiny filters in your kidneys (glomerulonephritis).
Serious skin reactions (Stevens-Johnson syndrome) have been reported with the use of Ziextenzo. Stop using Ziextenzo and seek medical attention immediately if you experience any of the symptoms described in section 4.
Talk to your doctor about your risk of developing blood cancer. If you develop or are at high risk of developing blood cancer, you should not use Ziextenzo unless your doctor tells you to.
Impaired treatment response to pegfilgrastim
If you stop responding to treatment with pegfilgrastim or if the response to treatment decreases, your doctor will investigate the reasons for this. Among other things, your doctor will check whether you have developed antibodies that neutralize pegfilgrastim’s activity.
Other medicines and Ziextenzo
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. Pegfilgrastim has not been tested in pregnant women. You must tell your doctor if you:
- is pregnant,
- think you are pregnant or,
- planning to have children.
If you become pregnant while being treated with Ziextenzo, talk to your doctor.
Driving ability and use of machinery
Extenze has no or negligible effect on the ability to drive or use machines.
Extenze contains sorbitol (E 420) and sodium
This medicine contains 30 mg of sorbitol per pre-filled syringe corresponding to 50 mg/ml.
This medicine contains less than 1 mmol (23 mg) of sodium per 6 mg dose, i.e. it is almost “sodium-free”.
How to use Ziextenzo
Extenze is intended for use by adults aged 18 and over.
Always use Ziextenzo as directed by your doctor. Ask your doctor or pharmacist if you are unsure. The usual dose is a 6 mg subcutaneous injection ( injection under the skin) with a pre-filled syringe. Does one should be given at least 24 hours after your last dose of chemotherapy at the end of each cycle of chemotherapy.
How to inject yourself with Ziextenzo
Your doctor may decide that you should inject Ziextenzo yourself. Your doctor or nurse will show you how to give yourself an injection. Do not try to inject yourself unless the doctor or nurse has shown you how to do it.
More information about how to inject yourself with Ziextenzo can be found at the end of this leaflet.
If you have used too much Ziextenzo
If you use more Ziextenzo than you should, contact your doctor, pharmacist, or nurse.
If you forget to take Ziextenzo
If you inject Ziextenzo yourself and forget your dose, you should contact your doctor to discuss when you should inject your next dose.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, contact your doctor immediately:
- swelling or fluid retention, which may occur while urinating less often than usual; difficulty breathing; swollen abdomen and a feeling of oversaturation; and a general feeling of tiredness. These symptoms often develop quickly.
These symptoms may be signs of a less common condition (which may affect up to 1 in 100 people) called ‘capillary leak syndrome, which causes blood to leak from small blood vessels into the body. This condition must be treated immediately.
Very common side effects ( may affect more than 1 in 10 users):
- bone pain. Your doctor can recommend what you can take to relieve the bone pain.
- headache and nausea.
Common side effects ( may affect up to 1 in 10 users):
- pain at the injection site.
- general joint and muscle pain.
- some changes in blood values may occur, but these are detected during routine blood tests. Your white blood cell count may increase for a limited period. The number of platelets may decrease which may lead to bruising.
Uncommon side effects ( may affect up to 1 in 100 users):
- allergy-like reactions, including redness and swelling, rash, and raised itchy areas of skin.
- severe allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).
- increased spleen size.
- splenic hernia. Some cases of splenic rupture were fatal. You must contact your doctor immediately if you experience pain in the upper left side of the abdomen or above the left shoulder, as this may indicate a problem with the spleen.
- breathing problems. If you have a cough, fever, and breathing difficulties, contact a doctor.
- Sweet’s syndrome (plum-colored, raised, painful skin changes on the arms and legs and sometimes on the face and neck with fever) has occurred, but other factors may play a role.
- cutaneous vasculitis ( inflammation of the skin’s blood vessels).
- damage to the small filters in the kidneys ( glomerulonephritis ).
- redness at the injection site.
- coughing up blood (hemoptysis)
- blood disorders ( myelodysplastic syndrome [MDS] or acute myeloid leukemia [AML]).
Rare side effects ( may affect up to 1 in 1,000 users):
- inflammation of the aorta (the large blood vessel that transports blood from the heart to the body), see section 2.
- bleeding from the lungs ( pulmonary hemorrhage).
- Stevens-Johnson syndrome may begin as reddish, target-like, or round spots on the trunk, often with blisters in the center. Skin peeling and sores in the mouth, throat, nose, genitals, and eyes can also occur. These reactions are often preceded by fever and flu-like symptoms. If you develop any of these symptoms, stop using Ziextenzo and contact your doctor or seek medical attention immediately. See also section 2.
How to store Ziextenzo
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and syringe label (EXP). The expiration date is the last day of the specified month.
Store in a refrigerator (2 °C‑8 °C).
You can take Ziextenzo out of the refrigerator and store it at room temperature (maximum 35 °C) for a maximum of 120 hours. Once a syringe has been removed from the refrigerator and reached room temperature (maximum 35 °C), it must be used within 120 hours or discarded.
Do not freeze. Extenze can be used if the solution has been accidentally frozen for less than 24 hours at one time.
Store in the outer carton. Light sensitive.
Do not use this medicine if it is cloudy or contains particles.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
- The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg pegfilgrastim in 0.6 ml solution.
- Other ingredients are concentrated acetic acid, sorbitol (E 420), polysorbate 20, sodium hydroxide, and water for injections. See section 2 “Ziextenzo contains sorbitol (E 420) and sodium”.
Appearance and package sizes of the medicine
Extenze is a clear, colorless slightly yellowish solution for injection in a pre-filled syringe (6 mg/0.6 ml).
Each pack contains 1 glass pre-filled syringe with a rubber plunger stopper, a plunger rod, and an attached stainless steel cannula with a needle sleeve. The syringes are supplied with an automatic needle guard.
Marketing Authorisation Holder