Silapo
epoetin zeta
epoetin zeta
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What Silapo is and what it is used for
What you need to know before you use Silapo
How to use Silapo
Possible side effects
How to store Silapo
Contents of the pack and other information
Silapo contains the active substance epoetin zeta – a protein, that stimulates the bone marrow to produce more red blood cells, which carry haemoglobin (a substance that transports oxygen). Epoetin zeta is a copy of the human protein erythropoietin (ee-rith-roe-po-eh-tin) and acts in the same way.
in children on haemodialysis
in adults on haemodialysis or peritoneal dialysis
in severely anaemic adults not yet undergoing dialysis
If you have kidney disease, you may be short of red blood cells if your kidney does not produce enough erythropoietin (necessary for red cell production). Silapo is prescribed to stimulate your bone marrow to produce more red blood cells.
Silapo is used in moderately anaemic adults about to have major orthopaedic surgery (for example hip or knee replacement operations), to reduce the potential need for blood transfusions.
To stimulate the production of your red blood cells (so that doctors can take more blood from you) if you cannot have transfusions with your own blood during or after surgery.
have severe heart disease
have severe disorders of the veins and arteries
have recently had a heart attack or stroke
can’t take medicines to thin the blood
Silapo may not be suitable for you. Please discuss with your doctor. While on Silapo, some people need medicines to reduce the risk of blood clots. If you can’t take medicines that prevent blood clotting, you must not have Silapo.
Talk to your doctor, pharmacist or nurse before using Silapo.
Silapo and other products that stimulate red cell production may increase the risk of developing blood clots in all patients. This risk may be higher if you have other risk factors for developing blood clots (for example, if you have had a blood clot in the past or are overweight, have diabetes, have heart disease or you are off your feet for a long time because of surgery or illness). Please tell your doctor about any of these things. Your doctor will help you to decide if Silapo is suitable for you.
Silapo if you are not responding to treatment may increase the risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.
SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blisters on the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications.
If you develop a serious rash or another of these skin symptoms, stop taking Silapo and contact your doctor or seek medical attention immediately.
Silapo is one of a group of products that stimulate the production of red blood cells like the human
protein erythropoietin does. Your healthcare professional will always record the exact product you are using.
If you are given a product in this group other than Silapo during your treatment, speak to your doctor or pharmacist before using it.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No data on the effects of Silapo on fertility are available.
No studies on the effects on the ability to drive and use machines have been performed.
This medicine contains up to 0.5 mg phenylalanine in each dosage unit. Phenylalanine may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because
the body cannot remove it properly.
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially
‘sodium-free’.
Your doctor will decide how Silapo will be injected. Usually the injections will be given to you by a doctor, nurse or other health care professional. Some people, depending on why they need Silapo treatment, may later learn how to inject themselves under the skin: see Instructions on how to inject Silapo yourself.
Silapo should not be used:
after the expiry date on the label and outer carton
if you know, or think that it may have been accidentally frozen, or
if there has been a refrigerator failure.
The dose of Silapo you receive is based on your bodyweight in kilograms. The cause of your anaemia is also a factor in your doctor deciding the correct dose.
Your doctor will maintain your haemoglobin level between 10 and 12 g/dL as a high haemoglobin level may increase the risk of blood clots and death. In children the haemoglobin level should be maintained between 9.5 and 11 g/dL.
For patients on peritoneal dialysis Silapo may be given twice a week.
For adults and children Silapo is given as an injection either into a vein (intravenously) or a tube that goes into a vein. When this access (via a vein or tube) is not readily available, your doctor
may decide that Silapo should be injected under the skin (subcutaneously). This includes
patients on dialysis and patients not yet on dialysis.
Your doctor will order regular blood tests to see how your anaemia is responding and may adjust the dose, usually no more frequently than every four weeks. A rise in haemoglobin of greater than 2 g/dL over a four week period should be avoided.
Once your anaemia has been corrected, your doctor will continue to check your blood regularly.
Your Silapo dose and frequency of administration may be further adjusted to maintain your response to treatment. Your doctor will use the lowest effective dose to control the symptoms of your anemia.
If you do not respond adequately to Silapo, your doctor will check your dose and will inform you if you need to change doses of Silapo.
If you are on a more extended dosing interval (greater than once weekly) of Silapo, you may not maintain adequate haemoglobin levels and you may require an increase in Silapo dose or frequency of administration.
You may be given iron supplements before and during Silapo treatment to make it more effective.
If you are having dialysis treatment when you begin treatment with Silapo, your dialysis regime may need to be adjusted. Your doctor will decide this.
Your doctor may initiate treatment with Silapo if your haemoglobin is 10 g/dL or less.
Your doctor will maintain your haemoglobin level between 10 and 12 g/dL as a high haemoglobin level may increase the risk of blood clots and death.
The recommended starting dose is either 150 IU per kilogram bodyweight three times a week or 450 IU per kilogram bodyweight once a week.
Silapo is given by injection under the skin.
Your doctor will order blood tests, and may adjust the dose, depending on how your anaemia responds to Silapo treatment.
You may be given iron supplements before and during Silapo treatment to make it more effective.
You will usually continue Silapo treatment for one month after the end of chemotherapy.
The recommended dose is 600 IU per kilogram bodyweight twice a week.
Silapo is given by injection into a vein immediately after you have donated blood for 3 weeks before your surgery.
You may be given iron supplements before and during Silapo treatment to make it more effective.
The recommended dose is 600 IU per kilogram bodyweight once a week.
Silapo is given by injection under the skin each week for three weeks before surgery and on the day of surgery.
If there is a medical need to reduce the time before your operation, you will be given a daily dose of 300 IU/kg for up to ten days before surgery, on the day of surgery and for four days immediately afterwards.
If blood tests show your haemoglobin is too high before the operation, the treatment will be stopped.
You may be given iron supplements before and during Silapo treatment to make it more effective.
Your doctor may initiate treatment with Silapo if your haemoglobin is 10 g/dL or less. The aim of treatment is to maintain your haemoglobin level between 10 and 12 g/dL as a higher
haemoglobin level may increase the risk of blood clots and death.
Silapo is given by injection under the skin.
The starting dose is 450 IU per kilogram bodyweight once a week.
Your doctor will order blood tests, and may adjust the dose, depending on how your anaemia responds to Silapo treatment.
When treatment starts, Silapo is usually injected by medical or nursing staff. Later, your doctor may suggest that you or your caregiver learn how to inject Silapo under the skin (subcutaneously) yourself.
If Silapo is injected under the skin (subcutaneously), the amount injected is not normally more than one millilitre (1 mL) in a single injection.
Silapo is given alone and not mixed with other liquids for injection.
Take a syringe out of the refrigerator. The liquid needs to come to room temperature. Do not remove the syringe’s needle cover while allowing it to reach room temperature.
Check the syringe, to make sure it is the right dose, has not passed its expiry date, is not damaged, and the liquid is clear and not frozen.
Choose an injection site. Good sites are the top of the thigh and around the tummy (abdomen) but away from the navel. Vary the site from day to day.
Wash your hands. Use an antiseptic swab on the injection site, to disinfect it.
Hold the pre-filled syringe by the body of the syringe with the covered needle pointing upward.
Do not hold by the plunger head, plunger or needle cover.
Do not pull back on the plunger at any time.
Do not remove the needle cover from the pre-filled syringe until you are ready to inject Silapo.
Take the needle cover off the syringe by holding the barrel and pulling the needle cover off carefully without twisting it. Don’t push the plunger, touch the needle or shake the syringe.
Pinch a fold of skin between your thumb and index finger. Don’t squeeze it.
Push the needle in fully. Your doctor or nurse may have shown you how to do this.
Push the plunger with your thumb as far as it will go to inject the entire amount of liquid. Push it slowly and evenly, keeping the skin fold pinched.
When the plunger is pushed as far as it will go, take out the needle and let go of the skin.
When the needle is pulled out of your skin, there may be a little bleeding at the injection site.
This is normal. You can press an antiseptic swab over the injection site for a few seconds after the injection.
Dispose of your used syringe in a sharps container. Do not try to replace the needle cover.
Never put used syringes into your normal household waste bin.
Your pre-filled syringe has a passive needle guard device attached to it in order to protect you from needle stick injury.
Take a syringe out of the refrigerator. The liquid needs to come to room temperature. Do not remove the syringe’s needle cover while allowing it to reach room temperature.
Check the syringe, to make sure it is the right dose, has not passed its expiry date, is not damaged, and the liquid is clear and not frozen.
Choose an injection site. Good sites are the top of the thigh and around the tummy (abdomen) but away from the navel. Vary the site from day to day.
Wash your hands. Use an antiseptic swab on the injection site, to disinfect it.
Hold the pre-filled syringe by the body of the syringe with the covered needle pointing upward.
Do not hold by the plunger head, plunger or needle cover.
Do not pull back on the plunger at any time.
Do not remove the needle cover from the pre-filled syringe until you are ready to inject Silapo.
Take the needle cover off the syringe by holding the barrel and pulling the needle cover off carefully without twisting it. Don’t push the plunger, touch the needle or shake the syringe.
Pinch a fold of skin between your thumb and index finger. Don’t squeeze it.
Push the needle in fully. Your doctor or nurse may have shown you how to do this.
Depress the plunger while grasping the finger flange until the entire dose has been given. The needle guard will NOT activate unless the ENTIRE dose has been given.
When the plunger is pushed as far as it will go, take out the needle and let go of the skin.
Let go of the plunger and allow the syringe to move up until the entire needle is guarded and locks into place.
When the needle is pulled out of your skin, there may be a little bleeding at the injection site.
This is normal. You can press an antiseptic swab over the injection site for a few seconds after the injection.
Dispose of your used syringe in a sharps container. Do not try to replace the needle cover.
Never put used syringes into your normal household waste bin.
Tell the doctor or nurse immediately if you think too much Silapo has been injected. Side effects from
an overdose of Silapo are unlikely.
Make the next injection as soon as you remember. If you are within a day of your next injection, forget
the missed one and carry on with your normal schedule. Do not double up the injections to make up for a forgotten dose.
You should discuss this with your doctor because a combination of Silapo with interferon and
ribavirin has led to a loss of effect and development of a condition called pure red cell aplasia (PRCA), a severe form of anaemia, in rare cases. Silapo is not approved in the management of anaemia associated with hepatitis C.
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.
Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with epoetin treatment. These can appear as reddish target-like macules 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 Silapo if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.
Verycommon: mayaffectmorethan1in10people
Common: mayaffectupto1in10people
adjustment to any medicines you already take for high blood pressure).
You may have chest pain, breathlessness, and painful swelling and redness, usually in the leg as symptoms.
them in the future.
Uncommon: mayaffectupto1in100people
Rare:mayaffectupto1in1000people
PRCA means the bone marrow does not make enough red blood cells. PRCA causes sudden and severe anaemia. The symptoms are:
PRCA has been very rarely reported mostly in patients with kidney disease after months to years of treatment with Silapo and other products that stimulate red blood cell production.
An increase in levels of small blood cells (called platelets), which are normally involved in the formation of a blood clot may occur, particularly when starting treatment. Your doctor will check on this.
Severe allergic reaction that may include:
a swollen face, lips, mouth, tongue or throat
difficulty swallowing or breathing
itchy rash (hives).
Problem with the blood that may cause pain, dark coloured urine or increased sensitivity of the skin to sunlight (porphyria).
If you are receiving haemodialysis:
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via thenationalreporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 box and on the 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 Silapo out of the refrigerator and keep it at room temperature (up to 25 °C) for no longer than 3 days. Once a syringe has been removed from the refrigerator and has reached room temperature (up to 25 °C) it must either be used within 3 days or disposed of.
Do not freeze or shake.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Do not use this medicine if you notice that the seal is broken or if the liquid is coloured or you can see particles floating in it. In the event of either being observed, discard the medicinal product.
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.
The active substance is epoetin zeta (produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line).
Silapo 1 000 IU/0.3 mL solution for injection in pre-filled syringe
1 pre-filled syringe with 0.3 mL solution for injection contains 1 000 international units (IU) epoetin zeta (recombinant human erythropoietin). The solution contains 3 333 IU epoetin zeta
per mL.
Silapo 2 000 IU/0.6 mL solution for injection in pre-filled syringe
1 pre-filled syringe with 0.6 mL solution for injection contains 2 000 international units (IU) epoetin zeta (recombinant human erythropoietin). The solution contains 3 333 IU epoetin zeta
per mL.
Silapo 3 000 IU/0.9 mL solution for injection in pre-filled syringe
1 pre-filled syringe with 0.9 mL solution for injection contains 3 000 international units (IU) epoetin zeta (recombinant human erythropoietin). The solution contains 3 333 IU epoetin zeta
per mL.
Silapo 4 000 IU/0.4 mL solution for injection in pre-filled syringe
1 pre-filled syringe with 0.4 mL solution for injection contains 4 000 international units (IU) epoetin zeta (recombinant human erythropoietin). The solution contains 10 000 IU epoetin zeta
per mL.
Silapo 5 000 IU/0.5 mL solution for injection in pre-filled syringe
1 pre-filled syringe with 0.5 mL solution for injection contains 5 000 international units (IU) epoetin zeta (recombinant human erythropoietin). The solution contains 10 000 IU epoetin zeta
per mL.
Silapo 6 000 IU/0.6 mL solution for injection in pre-filled syringe
1 pre-filled syringe with 0.6 mL solution for injection contains 6 000 international units (IU) epoetin zeta (recombinant human erythropoietin). The solution contains 10 000 IU epoetin zeta per mL.
Silapo 8 000 IU/0.8 mL solution for injection in pre-filled syringe
1 pre-filled syringe with 0.8 mL solution for injection contains 8 000 international units (IU) epoetin zeta (recombinant human erythropoietin). The solution contains 10 000 IU epoetin zeta per mL.
Silapo 10 000 IU/1 mL solution for injection in pre-filled syringe
1 pre-filled syringe with 1 mL solution for injection contains 10 000 international units (IU) epoetin zeta (recombinant human erythropoietin). The solution contains 10 000 IU epoetin zeta per mL.
Silapo 20 000 IU/0.5 mL solution for injection in pre-filled syringe
1 pre-filled syringe with 0.5 mL solution for injection contains 20 000 international units (IU) epoetin zeta (recombinant human erythropoietin). The solution contains 40 000 IU epoetin zeta per mL.
Silapo 30 000 IU/0.75 mL solution for injection in pre-filled syringe
1 pre-filled syringe with 0.75 mL solution for injection contains 30 000 international units (IU) epoetin zeta (recombinant human erythropoietin). The solution contains 40 000 IU epoetin zeta per mL.
Silapo 40 000 IU/1 mL solution for injection in pre-filled syringe
1 pre-filled syringe with 1 mL solution for injection contains 40 000 international units (IU) epoetin zeta (recombinant human erythropoietin). The solution contains 40 000 IU epoetin zeta per mL.
The other ingredients are disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).
Silapo is presented as a clear and colourless solution for injection in a pre-filled syringe with a fixed injection needle.
The pre-filled syringes contain between 0.3 and 1 mL solution, depending on the content of epoetin zeta (see “What Silapo contains”).
One pack contains 1, 4 or 6 pre-filled syringes with or without a needle guard device.
STADA Arzneimittel AG Stadastrasse 2-18
D-61118 Bad Vilbel
Germany
STADA Arzneimittel AG Stadastrasse 2-18
D-61118 Bad Vilbel
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
STADAPHARM GmbH
Stadastraße 2-18
D-61118 Bad Vilbel Tel: +49 (0) 6101 603-0
Fax: +49 (0) 6101 603-3888