UK/Ireland
SUMMARY OF PRODUCT CHARACTERISTICS
NeoRecormon®
1. NAME OF THE MEDICINAL PRODUCT
NeoRecormon Multidose Powderpowder and solvent for solution for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
NeoRecormon Multidose 50,000 Powderpowder and solvent for solution for injection:
1One vial contains 50,000 international units (IU) corresponding to 415 micrograms epoetin beta* (recombinant human erythropoietin).
1One ampoule contains 10ml solvent (water for injection with benzyl alcohol and benzalkonium chloride as preservatives).
1One ml of reconstituted solution contains 5000 IU epoetin beta.
NeoRecormon Multidose 100,000 Ppowder and solvent for solution for injection:
1One vial contains 100,000 international units (IU) corresponding to 830 micrograms epoetin beta* (recombinant human erythropoietin).
1One ampoule contains 5ml solvent (water for injection with benzyl alcohol and benzalkonium chloride as preservatives).
1One ml of reconstituted solution contains 20,000 IU epoetin beta.
*ProducedRecombinant human erythropoietin produced by recombinant DNA technology in CHO cell line.
Excipients:
Phenylalanine (up to 5.0 mg/vial)
For a full list of excipients, see 6.1.
4.1 Therapeutic indications
- Treatment of symptomatic anaemia in adult patients with with all non-myeloid malignancies solid tumours receiving chemotherapy.
- Treatment of symptomatic anaemia in adult patients with multiple myeloma, low grade non-Hodgkin’s lymphoma or chronic lymphocytic leukaemia, who have a relative erythropoietin deficiency and are receiving anti-tumour therapy. Deficiency is defined as an inappropriately low serum erythropoietin level in relation to the degree of anaemia.
are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
4.2 Posology and method of administration
Treatment of symptomatic anaemia in cancer patients with solid tumours:
The reconstituted solution is administered subcutaneously; the weekly dose can be given as one injection per week or in divided doses 3 to 7 times per week.
The recommended initial dose is 30,000 IU per week (corresponding to approximately 450 IU/kg body weight per week, based on an average weighted patient).
NeoRecormon treatment is indicated if the haemoglobin value is £ 11 g/dl (6.83 mmol/l). Haemoglobin levels should not exceed 13 g/dl (8.07 mmol/l) (see section 5.1).
The reconstituted solution is administered subcutaneously; the weekly dose can be divided into 3 to 7 single doses.
NeoRecormon treatment is indicated if the haemoglobin value is £ 11 g/dl (6.83 mmol/l). The recommended initial dose is 450 IU/kg body weight per week.
Haemoglobin level should not exceed 13 g/dl (8.07 mmol/l) (see section 5.1).
If, after 4 weeks of therapy, the haemoglobin value has increased by at least 1 g/dl (0.62 mmol/l), the current dose should be continued. If the haemoglobin value has not increased by at least 1 g/dl (0.62 mmol/l), a doubling of the weekly dose should be considered. If, after 8 weeks of therapy, the haemoglobin value has not increased by at least 1 g/dl (0.62 mmol/l), response is unlikely and treatment should be discontinued.
The therapy should be continued up to 4 weeks after the end of chemotherapy.
The maximum dose should not exceed 60,000 IU per week.
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50 % in order to maintain haemoglobin at that level. If required, further dose reduction may be instituted to ensure that haemoglobin level does not exceed 13 g/dl.
If the rise in haemoglobin is greater than 2 g/dl (1.3 mmol/l) in 4 weeks, the dose should be reduced by 25 to 50 %.
If, after 4 weeks, a patient does not show a satisfactory response in terms of haemoglobin values, then the dose should be doubled. The therapy should be continued up to 3 weeks after the end of chemotherapy.
If haemoglobin falls by more than 1 g/dl (0.62 mmol/l) in the first cycle of chemotherapy despite concomitant NeoRecormon therapy, further therapy may not be effective.
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50% in order to maintain haemoglobin at that level. If required, further dose reduction may be instituted to ensure that haemoglobin level does not exceed 13 g/dl.
If the rise in haemoglobin is greater than 2 g/dl (1.3 mmol/l) in 4 weeks, the dose should be reduced by 25 to 50%.
Treatment of symptomatic anaemia in patients with multiple myeloma, low-grade non-Hodgkin’s lymphoma or chronic lymphocytic leukaemia
Patients with multiple myeloma, non-Hodgkin’s lymphoma or chronic lymphocytic leukaemia should have a relative erythropoietin deficiency. Deficiency is defined as an inappropriately low serum erythropoietin level in relation to the degree of anaemia:
serum erythropoietin level of £ 100 mU/ml at a haemoglobin of > 9 to < 10 g/dl
(> 5.58 to < 6.21 mmol/l)
serum erythropoietin level of £ 180 mU/ml at a haemoglobin of > 8 to £ 9 g/dl
(> 4.96 to £ 5.58 mmol/l)
serum erythropoietin level of £ 300 mU/ml at a haemoglobin of £ 8 g/dl (£ 4.96 mmol/l)
The above values should be measured at least 7 days after the last blood transfusion and the last cycle of cytotoxic chemotherapy.
The reconstituted solution is administered subcutaneously; the weekly dose can be given as one injection per week or in divided doses 3 to 7 times per week.
The recommended initial dose is 450 IU/kg body weight per week.
Haemoglobin level should not exceed 13 g/dl (8.07 mmol/l) (see section 5.1).
If, after 4 weeks of therapy, the haemoglobin value has increased by at least 1 g/dl (0.62 mmol/l), the current dose should be continued. If the haemoglobin value has not increased by at least 1 g/dl (0.62 mmol/l), a dose increase to 900 IU/kg body weight, given in divided doses 2 to 7 times per week, may be considered. If, after 8 weeks of therapy, the haemoglobin value has not increased by at least 1 g/dl (0.62 mmol/l), response is unlikely and treatment should be discontinued.
Clinical studies have shown that response to epoetin beta treatment is delayed by about 2 weeks in chronic lymphocytic leukaemia patients, as compared with patients with multiple myeloma,
non-Hodgkin’s lymphoma and solid tumours. The therapy should be continued up to 4 weeks after the end of chemotherapy.
The maximum dose should not exceed 900 IU/kg body weight per week.
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50% in order to maintain haemoglobin at that level. If required, further dose reduction may be instituted to ensure that haemoglobin level does not exceed 13 g/dl.
If the rise in haemoglobin is greater than 2 g/dl (1.3 mmol/l) in 4 weeks, the dose should be reduced by 25 to 50%.
Therapy should only be reintroduced if the erythropoietin deficiency is the most likely cause of the anaemia.
4.3 Contraindications
Hypersensitivity to the active substance or any of the excipients.
Poorly controlled hypertension.
In the indication "increasing the yield of autologous blood": myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease.
NeoRecormon must not be used in the presence of poorly controlled hypertension and known hypersensitivity to the active substance or to any of the excipients of NeoRecormon Multidose or benzoic acid, a metabolite of benzyl alcohol.
In the indication "increasing the yield of autologous blood", NeoRecormon must not be used in patients who, in the month preceding treatment, have suffered a myocardial infarction or stroke, patients with unstable angina pectoris, or patients who are at risk of deep venous thrombosis such as those with a history of venous thromboembolic disease.
4.5 Interaction with other medicinal products and other forms of interaction
The clinical results obtained so far do not indicate any interaction of NeoRecormon with other medicinal productssubstances.
Animal experiments revealed that epoetin beta does not increase the myelotoxicity of cytostatic medicinal productsdrugs like etoposide, cisplatin, cyclophosphamide, and fluorouracil.
4.6 Pregnancy and lactation
For epoetin beta no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see 5.3).
Caution should be exercised when prescribing to pregnant women.
Animal experiments have yielded no indications of teratogenic effects of epoetin beta in dosing regimens that do not lead to an unphysiologically high PCV. No adequate experience in human pregnancy and lactation has been gained, but a potential risk appears to be minimal under therapeutic conditions.
4.7 Effects on ability to drive and use machines
NeoRecormon has no influence on the ability to drive and use machines.
No effects on ability to drive and use machines have been observed.
4.8 Undesirable effects
· Cardiovascular system
- Patients with cancersolid tumours, multiple myeloma, non-Hodgkin’s lymphoma or chronic lymphocytic leukaemia
· Blood
- Patients with solid tumours, multiple myeloma, non-Hodgkin’s lymphoma or chronic lymphocytic leukaemiacancer
6.4 Special precautions for storage
Store in a refrigerator (2°C – 8°C).
Store at 2°C – 8°C (in a refrigerator).
6.5 Nature and contents of container
The stopper of the vial is made of teflonised rubber material. The disposable syringe is made of polypropylene and polyethylene.
1 vial with powder for solution for injection and 1 ampoule with preserved solvent
(10 10 ml) (vial and ampoule of type I glass) with one reconstitution and withdrawal device with 1 needle 21G2, and 1 disposable syringe (10 10 ml).
The stopper of the vial is made of teflonised rubber material. The disposable syringe is made of polypropylene and polyethylene.
10. DATE OF REVISION OF THE TEXT
4 January 2007
LEGAL STATUS
POM
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
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