Abseamed

Package leaflet: Information for the patient

Abseamed 1 000 IU/0.5 mL solution for injection in pre-filled syringe, 2 000 IU/1 mL solution for injection in pre-filled syringe, 3 000 IU/0.3 mL solution for injection in pre-filled syringe, 4 000 IU/0.4 mL solution for injection in pre-filled syringe, 5 000 IU/0.5 mL solution for injection in pre-filled syringe, 6 000 IU/0.6 mL solution for injection in pre-filled syringe, 7 000 IU/0.7 mL solution for injection in pre-filled syringe, 8 000 IU/0.8 mL solution for injection in pre-filled syringe, 9 000 IU/0.9 mL solution for injection in pre-filled syringe, 10 000 IU/1 mL solution for injection in pre-filled syringe, 20 000 IU/0.5 mL solution for injection in pre-filled syringe, 30 000 IU/0.75 mL solution for injection in pre-filled syringe, 40 000 IU/1 mL solution for injection in pre-filled syringe

epoetin alfa
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Abseamed is and what it is used for
2. What you need to know before using Abseamed
3. How to use Abseamed
4. Possible side effects
5. How to store Abseamed
6. Contents of the pack and other information

1. What Abseamed is and what it is used for

Abseamed contains the active substance epoetin alfa, a protein that stimulates the bone marrow to produce more red blood cells, which carry haemoglobin (a substance that transports oxygen).
Epoetin alfa is a copy of the human protein erythropoietin and acts in the same way.
Abseamed is used to treat symptomatic anaemia caused by kidney disease:

• in children undergoing haemodialysis
• in adults undergoing haemodialysis or peritoneal dialysis
• in adults who are severely anaemic but not yet on dialysis

In kidney disease, a shortage of red blood cells may occur if the kidney does not produce enough erythropoietin (which is necessary for red blood cell production). Abseamed is prescribed to stimulate the bone marrow to produce more red blood cells.
Abseamed is used to treat anaemia in adults undergoing chemotherapy for solid tumours, malignant lymphoma, or multiple myeloma (a tumour of the bone marrow) who might otherwise require blood transfusions. Abseamed may reduce the need for blood transfusions in these patients.
Abseamed is used in moderately anaemic adults who donate part of their own blood before surgery, so that the collected blood can be given back to them during or after the surgical procedure. Because Abseamed stimulates red blood cell production, doctors can collect more blood from these individuals.
Abseamed is used in moderately anaemic adults who are about to undergo major orthopaedic surgery (e.g. hip or knee replacement surgery) to reduce the potential need for blood transfusions.
Abseamed is used to treat anaemia in adults with a bone marrow disorder that causes a severe disturbance in blood cell formation (myelodysplastic syndromes). Abseamed may reduce the need for blood transfusions.

2. What you must know before using Abseamed

Do not use Abseamed

• if you are allergic to epoetin alfa or to any of the other ingredients of this medicine (listed in section 6).
• if you have been diagnosed with pure red cell aplasia (the bone marrow fails to produce enough red blood cells) following treatment with any medicine that stimulates red blood cell production (including Abseamed). See section 4.
• if you have high blood pressure that is not adequately controlled with medication.
• to stimulate red blood cell production (so that doctors can collect more of your blood) if you cannot receive transfusions with your own blood during or after surgery.
• if you are about to undergo elective major orthopaedic surgery (such as hip or knee surgery) and:
• you have severe heart disease
• you have serious disorders of veins or arteries
• you recently had a heart attack or stroke
• you cannot take medicines to make your blood less likely to clot. Abseamed may not be suitable for you. Discuss this with your doctor. During treatment with Abseamed, some people need medication to reduce the risk of blood clots. If you cannot take medicines that prevent blood clots, you must not take Abseamed.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Abseamed.
Abseamed and other products that stimulate red blood cell production can increase the risk of blood
clots in all patients. This risk may be higher if you have other risk factors for developing blood clots
(e.g. if you have previously had a blood clot, or if you are overweight, have diabetes, have heart disease,
or need to remain lying down for a prolonged period due to surgery or illness). Inform your doctor of
any such conditions. Your doctor will help you decide whether Abseamed is suitable for you.
It is important that you inform your doctor if any of the following apply to you. You may still be able
to use Abseamed, but you should discuss this with your doctor first.
If you know you have or have previously had:

• high blood pressure;
• seizures or epileptic fits;
• liver disease;
• anaemia due to other causes;
• porphyria (a rare blood disorder).

If you are a patient with chronic renal failure, and particularly if you do not respond adequately to
Abseamed, your doctor will monitor the dose of Abseamed you receive, because repeatedly increasing
the dose of Abseamed when you do not respond to treatment may increase the risk of heart or blood
vessel problems, as well as the risk of myocardial infarction, stroke, and death.
If you are a cancer patient, please note that medicines that stimulate red blood cell production (such
as Abseamed) may act as growth factors and could theoretically influence tumour progression.
Depending on your individual situation, a blood transfusion may be preferable. Discuss this with your
doctor.
If you are a cancer patient, please note that Abseamed has been associated with shorter survival and
a higher rate of death in patients with head and neck cancer and metastatic breast cancer undergoing
chemotherapy.
Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis
(TEN), have been reported with epoetin treatment.
SJS and TEN may initially appear as red target-like spots or circular patches, often with central blisters on the trunk. Mouth, throat, nose, genital, and eye ulcers (red, swollen eyes) may also occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. The skin rashes may progress to widespread skin peeling and life-threatening complications.
If you develop a severe skin rash or any of these other skin symptoms, stop taking Abseamed and contact your doctor immediately.
Exercise particular caution with other products that stimulate red blood cell production:
Abseamed belongs to a group of products that, like the human protein erythropoietin, stimulate red blood cell production. Your healthcare provider will always record the specific product you are using. If during treatment you are given a medicine from this group different from Abseamed, talk to your doctor or pharmacist before using it.
Other medicines and Abseamed
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
If you are a patient with hepatitis C and are receiving interferon and ribavirin
You should discuss this with your doctor, because a combination of epoetin alfa with interferon and ribavirin has rarely led to loss of effect and development of a condition called pure red cell aplasia (PRCA), a serious form of anaemia. Abseamed is not approved for the management of anaemia associated with hepatitis C.
If you are taking a medicine called ciclosporin (used, for example, after kidney transplants), your doctor may perform blood tests to monitor ciclosporin levels while you are taking Abseamed.
Iron supplements and other blood stimulants may increase the effectiveness of Abseamed. Your doctor will decide whether it is appropriate for you to take them.
If you go to hospital, clinic, or visit your family doctor, inform them that you are being treated with Abseamed. This may affect other treatments or test results.
Pregnancy, breast-feeding, and fertility
It is important to inform your doctor if any of the following apply to you. You may still be able to use Abseamed, but you should discuss this with your doctor first:

• If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breast-feeding
  with breast milk, consult your doctor or pharmacist before taking this medicine.

There are no data available on the effects of Abseamed on fertility.
Abseamed contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to use Abseamed

Use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.
Your doctor has performed blood tests and has decided that you need Abseamed.
Abseamed can be administered by injection:

• into a vein or into a tube going into a vein (intravenous route)
• or under the skin (subcutaneous route).

Your doctor will decide how Abseamed will be injected. Usually, injections are given by a doctor, nurse, or other healthcare professional. Some people, depending on the reason they require treatment with Abseamed, may later be trained to self-inject under the skin: see Instructions for self-injection of Abseamed at the end of this leaflet.

Abseamed must not be used:

• after the expiry date stated on the label and on the outer packaging
• if you know or suspect that it has been accidentally frozen, or
• if there has been a refrigerator malfunction.

The dose of Abseamed you will be given depends on your body weight in kilograms. The cause of the anemia is also important for your doctor to determine the correct dose.
Your doctor will regularly monitor your blood pressure during treatment with Abseamed.

Patients with kidney disease

• Your doctor will maintain your hemoglobin level between 10 and 12 g/dL, as a high hemoglobin level may increase the risk of blood clots and death. In children, the hemoglobin level should be maintained between 9.5 and 11 g/dL.
• The usual starting dose of Abseamed in adults and children is 50 International Units (IU) per kilogram (/kg) of body weight, administered three times a week. In patients undergoing peritoneal dialysis, Abseamed may be given twice a week.
• In adults and children, Abseamed is administered as an injection into a vein (intravenous route) or into a tube leading into a vein. When this access (via a vein or tube) is not readily available, your doctor may decide to inject Abseamed under the skin (subcutaneous route). This applies to patients on dialysis and those not yet on dialysis.
• Your doctor will regularly order blood tests to monitor how your anemia responds to treatment and may adjust the dose, usually no more frequently than every four weeks. An increase in hemoglobin greater than 2 g/dL within four weeks should be avoided.
• Once the anemia has been corrected, your doctor will continue to monitor your blood regularly. The dose and frequency of Abseamed administration may be further adjusted to maintain treatment response. Your doctor will use the lowest effective dose to control anemia symptoms.
• If you do not respond adequately to Abseamed, your doctor will review the dose you are receiving and inform you if adjustments to Abseamed doses are needed.
• If you are using a longer interval (more than once a week) between Abseamed doses, you may not be able to maintain adequate hemoglobin levels and may require an increase in dose or frequency of Abseamed administration.
• Before and during treatment with Abseamed, you may also receive iron supplementation to enhance treatment effectiveness.
• If you are on dialysis when starting Abseamed treatment, your dialysis schedule may need to be adjusted. Your doctor will make this decision.

Adults undergoing chemotherapy

• Your doctor may start treatment with Abseamed if your hemoglobin is ≤10 g/dL.
• Your doctor will maintain your hemoglobin level between 10 and 12 g/dL, as a high hemoglobin level may increase the risk of blood clots and death.
• The usual starting dose is 150 IU per kilogram of body weight three times a week or 450 IU per kilogram of body weight once a week.
• Abseamed is administered by subcutaneous injection.
• Your doctor will prescribe regular blood tests and may adjust the dose depending on how your anemia responds to treatment.
• Before and during treatment with Abseamed, you may also receive iron supplementation to enhance treatment effectiveness.
• Treatment with Abseamed usually continues for one month after completion of chemotherapy.

Adults donating their own blood

• The usual dose is 600 IU per kilogram of body weight, twice a week.
• Abseamed is administered by intravenous injection immediately after donating blood, for 3 weeks before surgery.
• Before and during treatment with Abseamed, you may also receive iron supplementation to enhance treatment effectiveness.

Adults awaiting major orthopedic surgery

• The recommended dose is 600 IU per kilogram of body weight once a week.
• Abseamed is administered by subcutaneous injection once a week for three weeks before surgery and on the day of surgery.
• If there is a need to shorten the time before surgery, a daily dose of 300 IU/kg may be given for up to ten days before surgery, on the day of surgery, and for four days after surgery.
• If blood tests show excessively high hemoglobin levels before surgery, treatment will be discontinued.
• Before and during treatment with Abseamed, you may receive iron supplementation to enhance treatment effectiveness.

Adults with myelodysplastic syndromes

• Your doctor may start treatment with Abseamed if your hemoglobin is ≤10 g/dL. The goal of treatment is to maintain hemoglobin levels between 10 and 12 g/dL, as higher levels may increase the risk of blood clots and death.
• Abseamed is administered by subcutaneous injection.
• The starting dose is 450 IU per kilogram of body weight once a week.
• Your doctor will prescribe blood tests and may adjust the dose depending on how anemia responds to Abseamed treatment.

Instructions for self-injection of Abseamed
At the beginning of treatment, Abseamed is usually injected by medical or nursing staff.
Later, your doctor may suggest that you, or a caregiver, learn to self-inject
Abseamed under the skin ( subcutaneously ).

• Do not attempt to self-inject the medicine unless your doctor or nurse has shown you how to do it.
• Always use Abseamed exactly as instructed by your doctor or nurse.
• Make sure you inject only the amount of liquid specified by your doctor or nurse.
• Use Abseamed only if it has been stored correctly – see section 5, How to store Abseamed.
• Before use, allow the Abseamed syringe to rest until it reaches room temperature. This usually takes 15–30 minutes. Use the syringe within 3 days after removing it from the refrigerator.

Use only one dose of Abseamed from each syringe.
If Abseamed is injected subcutaneously, the injected volume generally does not exceed one milliliter (1 mL) per single injection.
Abseamed must be administered alone and must not be mixed with other injectable liquids.
Do not shake Abseamed syringes. Prolonged vigorous shaking may damage the product.
If the product has been shaken vigorously, do not use it.
Instructions for self-injection of Abseamed are provided at the end of this leaflet.

If you use more Abseamed than you should
Inform your doctor or nurse immediately if you think too much Abseamed has been injected. Adverse effects due to overdose with Abseamed are unlikely.

If you forget to use Abseamed
Administer the missed injection as soon as you remember. If less than one day remains until the next scheduled injection, skip the missed dose and continue with your regular schedule. Do not use a double dose to make up for a forgotten dose.

If you have any questions about the use of this medicine, consult your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor or nurse immediately if you notice any of the side effects listed below.
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with treatment with epoetin. These may appear as red target-like spots or circular patches, often with central blisters on the trunk, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms. Stop using Abseamed if you develop any of these symptoms and contact your doctor immediately. See also section 2.

Very common side effects
May affect more than 1 in 10 people.

• Diarrhoea
• Nausea
• Vomiting
• Fever
• Respiratory congestion, such as nasal congestion and sore throat, has been reported in patients with kidney disease who are not yet on dialysis.

Common side effects
May affect up to 1 in 10 people.

• Increased blood pressure. The following signs may indicate a sudden rise in blood pressure: headache, particularly if sudden in onset and stabbing in nature like a migraine, confusion or seizures. These signs require urgent treatment. Increased blood pressure may require treatment with medicines (or adjustment of the dosage of medicines you are already taking for high blood pressure).
• Blood clots (including deep vein thrombosis and embolism), which may require urgent intervention. Symptoms may include chest pain, shortness of breath, and swelling with pain and redness, usually in the legs.
• Cough.
• Skin rashes, which may be due to an allergic reaction.
• Bone or muscle pain.
• Flu-like symptoms, such as headache, joint pain and aching, feeling weak, chills, fatigue and dizziness. These symptoms may be more common at the beginning of treatment. If you experience these symptoms during intravenous injection, a slower injection may help prevent them in the future.
• Redness, burning, and pain at the injection site.
• Swelling of the ankles, feet, or fingers.
• Pain in the arm or leg.

Uncommon side effects
May affect up to 1 in 100 people.

• High levels of potassium in the blood, which may cause irregular heart rhythms (this is a very common side effect in patients on dialysis).
• Seizures.
• Nasal or airway congestion.
• Allergic reaction.
• Hives (urticaria).

Rare side effects
May affect up to 1 in 1,000 people.

• Symptoms of pure red cell aplasia (PRCA)

Pure red cell aplasia (PRCA) means that the bone marrow does not produce enough red blood cells. PRCA causes sudden and severe anaemia. Symptoms include:

• unusual tiredness,
• dizziness,
• shortness of breath.

PRCA has been reported very rarely, particularly in patients with kidney disease, after months or years of treatment with epoetin alfa and other medicines that stimulate red blood cell production.

• An increase in the number of certain small blood cells (called platelets), normally involved in clot formation, may occur, particularly at the beginning of treatment. Your doctor will carry out appropriate monitoring.
• Severe allergic reaction which may include:
• swelling of the face, lips, mouth, tongue or throat,
• difficulty swallowing or breathing,
• itchy skin rash (urticaria).
• A blood disorder that may cause pain, dark-coloured urine, or increased sensitivity of the skin to sunlight (porphyria).

If you are on haemodialysis:

• Blood clots (thrombosis) may form in the dialysis fistula. This is more likely to occur if you have low blood pressure or complications affecting the fistula.
• Clots may also form in the haemodialysis system. Your doctor may decide to increase the dose of heparin during dialysis.

Contact your doctor or nurse immediately if you notice any of these side effects or any other side effect during treatment with Abseamed.
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor, nurse or pharmacist.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Abseamed

• 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 label after “EXP” and on the carton after “Scad.”. The expiry date refers to the last day of that month.
• Store and transport in a refrigerator (2 °C - 8 °C).
• You may remove Abseamed from the refrigerator and store it at room temperature (up to 25 °C) for a maximum of 3 days. Once the syringe has been removed from the refrigerator and has reached room temperature (up to 25 °C), it must be used within 3 days or discarded.
• Do not freeze or shake.
• Store in the original packaging to protect the medicine from light.

Do not use this medicine if you notice

• that it has been accidentally frozen, or
• that there has been a refrigerator malfunction,
• that the liquid is discolored or if you see particles floating in it,
• that the seal is broken.

Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines
you no longer use. This will help protect the environment.

6. Package contents and other information

What Abseamed contains

• The active substance is epoetin alfa (for the amount, see the table below).
• The other components are sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.

Description of the appearance of Abseamed and contents of the pack
Abseamed is a clear, colourless injectable solution in a pre-filled syringe. The syringes are sealed in blisters.

Packages containing 1, 4 or 6 pre-filled syringes, with or without needle safety device.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
Medice Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn
Germany
Manufacturer
Sandoz GmbH
Biochemiestr. 10
6336 Langkampfen
Austria
More detailed information on this medicinal product is available on the European Medicines Agency
website: http://www.ema.europa.eu.

Instructions for self-injection (for patients with symptomatic anaemia due to renal disease,
chemotherapy-treated adult patients, adult patients awaiting orthopaedic surgery, or adult patients
with myelodysplastic syndromes)
This section contains information on how to self-administer Abseamed. It is important that you do
not attempt to inject the medicine yourself unless you have been specifically trained by your doctor
or nurse. Abseamed is supplied with or without a needle safety device; your doctor or nurse will
show you how to use it. If you have any doubts or questions about self-injection, please consult your
doctor or nurse.
WARNING: Do not use if the syringe has fallen on a hard surface or has been dropped after removing
the needle cap. Do not use the pre-filled syringe of Abseamed if it is damaged. Return the pre-filled
syringe and its original packaging to the pharmacy.

1. Wash your hands.
2. Remove one syringe from its packaging and take off the protective needle cap. The syringes are marked with raised graduations, allowing partial use if necessary. Each graduation corresponds to a volume of 0.1 mL. If partial use of the syringe is required, discard the unused solution before administering the injection.
3. Disinfect the skin at the injection site using an alcohol swab.
4. Pinch a skin fold between your thumb and index finger.
5. With a quick, firm motion, insert the needle into the skin fold. Inject the Abseamed solution as shown to you by your doctor. If in doubt, consult your doctor or pharmacist.

Pre-filled syringe without needle safety device

6. While keeping the skin fold pinched between your fingers, slowly and evenly press the plunger.
7. After injecting the liquid, withdraw the needle and release the skin. Apply gentle pressure to the injection site with a dry sterile gauze pad.
8. Dispose of any unused medicine and waste material from this medicine. Use each syringe only once.

Pre-filled syringe with needle safety device

6. While keeping the skin fold pinched between your fingers, slowly and steadily

press the plunger until the full dose has been delivered and the plunger can no longer be depressed. Do not release pressure on the plunger!

7. After injecting the liquid, withdraw the needle while maintaining pressure on the plunger, then release the skin. Apply gentle pressure to the injection site with a dry sterile gauze pad.
8. Release the plunger. The safety device will automatically cover the needle immediately.
9. Dispose of any unused medicine and waste material from this medicine. Use each syringe only once.