Drugs List

Therapeutic Indications

Uses

Reduction of exposure to allogeneic blood transfusions
Reduction of transfusion requirements in patients receiving chemotherapy
Symptomatic anaemia - due to chronic renal failure
Symptomatic anaemia - if severe in patients not yet undergoing dialysis
Symptomatic anaemia in adults with malignant lymphoma on chemotherapy
Symptomatic anaemia in adults with multiple myeloma receiving chemotherapy
Symptomatic anaemia in adults with solid tumours receiving chemotherapy
Symptomatic anaemia: Adults at low/int-1 risk of myelodysplastic syndromes
To increase yield of autologous blood in predonation programmes

Symptomatic anaemia associated with chronic renal failure in children and adults on haemodialysis and adults on peritoneal dialysis.

Severe symptomatic anaemia of renal origin in adult patients with renal impairment not yet undergoing dialysis.

Symptomatic anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).

To increase the yield of autologous blood from patients in a predonation programme. Treatment should only be given to patients with moderate anaemia (Hb 10g/dL to 13g/dL, no iron deficiency), if blood conserving procedures are insufficient or when scheduled major elective surgery requires a large volume of blood (4 or more units for females, 5 or more units for males). The use of epoetin alfa in this indication must be balanced against the reported risk of thrombo-embolic events.

To reduce exposure to allogeneic blood transfusions in adult non-iron deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. Use should be restricted to patients with moderate anaemia (e.g. Hb 10g/dL to 13g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900ml to 1800ml).

Symptomatic anaemia in adults with a low serum erythropoietin who have low or intermediate-1-risk of primary myelodysplastic syndromes (MDS).

Administration

For administration by intravenous injection or subcutaneous injection.

Check that there are no particles in the solution or change in colour. This product is for single use only. Any unused portion should be discarded.

Intravenous injection
The required dose is administered by slow intravenous injection over at least one to five minutes, depending on the total dose. A slower injection is preferable in patients who react to treatment with 'flu-like' symptoms.
In patients receiving haemodialysis, a bolus injection may be administered through a suitable venous port in the dialysis line. Alternatively, the injection may be administered at the end of the dialysis session via fistula needle tubing and the tubing should then be flushed with 10ml of isotonic sodium chloride injection.

Subcutaneous injection
Generally, the maximum volume per injection site should not exceed 1ml. Where larger volumes are required, administer the dose at multiple injection sites. The required dose is administered via the subcutaneous route in the limbs or the anterior abdominal wall.

Contraindications

Inadequate antithrombotic prophylaxis
Pure red cell aplasia following previous erythropoietic therapy
Breastfeeding - if used in an autologous blood predonation programme
Cardiovascular disorder - if used before orthopaedic surgery
Pregnancy - if used in an autologous blood predonation programme
Uncontrolled hypertension

Precautions and Warnings

Children under 18 years
Predisposition to seizures
Predisposition to thromboembolic disease
Breastfeeding
Chronic hepatic impairment
Chronic renal failure
Epileptic disorder
History of seizures
Ischaemic heart disease
Porphyria
Pregnancy
Sickle cell disease

Blood transfusion is preferred treatment for anaemia in cancer patients
Ensure adequate antithrombotic prophylaxis in surgical patients
Correct hyperkalaemia before starting treatment
Exclude other causes of anaemia before treatment
Not all routes are licensed for all indications
Treatment to be initiated and supervised by a specialist
Do not mix with other injections or infusions prior to administration
Record name and batch number of administered product
Monitor haemoglobin prior to initiating therapy and periodically thereafter
Monitor iron status before and during treatment
Avoid haemoglobin level >12g/dl
Consider discontinuing treatment until hyperkalaemia has been corrected
Haemoglobin should not increase by more than 2g/dl per month
Increased risk of thrombotic events if haemoglobin >13g/dl
Investigate patients developing a sudden lack of response to treatment
Monitor platelet counts for first 8 weeks of therapy
Monitor reticulocyte count at regular intervals
Monitor serum electrolytes in chronic renal failure
Advise patient to contact their physician if worsening of anaemia symptoms
Iron supplements may be required if iron deficiency occurs
May act as growth factor for any tumour type
Discontinue and do not restart if severe cutaneous adverse reactions occur
Discontinue if blood pressure cannot be controlled
Discontinue if pure red cell aplasia is diagnosed
Not licensed for all indications in all age groups
Optimise heparin dose in chronic renal failure patients on haemodialysis

Monitor closely and control blood pressure in all patients.

Pure Red Cell Aplasia (PRCA)
A reticulocyte count should be obtained in patients who develop a sudden decrease in haemoglobin (1g/dL to 2g/dL a month) and an increased need for transfusions. Similarly if the reticulocyte count corrected for anaemia is low (less than 20,000 per microlitre) and platelet and white cell counts are normal, typical causes of non-response should be investigated (e.g. iron, folate, or vitamin B12 deficiency, aluminium intoxication, infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, and bone marrow fibrosis of any origin). If no typical cause is identified a bone marrow investigation and testing for antibodies should be considered. If antibody-mediated PRCA is suspected, therapy with epoetin alfa must be discontinued immediately. Patients must not be switched to other erythropoietin products.

Chronic renal failure patients
Chronic renal failure patients treated by the subcutaneous route should be monitored regularly for loss of efficacy. This can be detected by a sustained decrease in haemoglobin despite an increase in epoetin alfa dosage.

Shunt thromboses may occur in haemodialysis patients, particularly in patients who have a tendency to hypotension or whose arteriovenous fistula exhibit complications, such as aneurysms. Additional management may be required.

Hyperkalaemia has been observed in isolated cases. In chronic renal failure patients, correction for anaemia may lead to increased appetite, and potassium and protein intake. Dialysis prescriptions may have to be adjusted periodically to maintain urea, creatinine and potassium in the desired range. If an elevated (or rising) serum potassium level is detected then consideration should be given to ceasing epoetin alfa administration until hyperkalaemia has been corrected.

An increase in heparin dose during haemodialysis is frequently required during the course of therapy with epoetin alfa as a result of the increased packed cell volume. Occlusion of the dialysis system is possible if heparinization is not optimum.

Cancer patients receiving chemotherapy
Epoetin alfa is a growth factor that primarily stimulates red blood cell production. Erythropoietin receptors may be present on the surface of a variety of tumour cells. As with all growth factors, there is a possibility that erythropoietins may stimulate the growth of any type of malignancy. The role of ESAs on tumour progression or progression-free survival cannot be excluded.
Clinical studies have suggested, that when ESAs were administered to patients with various cancers (including head, neck and breast cancer) there was an associated negative effect on progression-free survival, a reduction in locoregional tumour control and decreased overall survival. The MHRA therefore suggest that blood transfusion should be the preferred treatment for anaemia in cancer patients. The decision to administer erythropoietins to cancer patients should be made after an informed risk benefit assessment which takes into account: tumour type and stage; degree of anaemia; life expectancy; the treatment environment and the patient's preference.

The 2 to 3 week delay between erythropoietin administration and the appearance of erythropoietin-induced red cells should be taken into account when assessing if epoetin alfa therapy is appropriate (patient at risk of being transfused).

An increased incidence of thrombotic vascular events has been seen in cancer patients receiving erythropoietins. The risk should be carefully considered, especially in those with risk factors for thrombotic events such as obese patients and those with a history of thrombotic events. In order to minimise the risk for thrombotic events the haemoglobin level and rate of increase should not exceed the haemoglobin limits.

Major elective orthopaedic surgery
The cause of anaemia should be established and treated, if possible, before the start of epoetin alfa treatment. Thrombotic events can be a risk in this population and this possibility should be carefully weighed against the benefit to be derived from the treatment in this patients group.

Patients should receive adequate antithrombotic prophylaxis, as thrombotic and vascular events may occur in surgical patients, especially in those with underlying cardiovascular disease. In addition, special caution is required in patients with predisposition for development of deep vein thrombosis. Epoetin alfa treatment may be associated with an increased risk of postoperative thrombotic/vascular events in patients with a baseline haemoglobin of greater than 13g/dL.

Pregnancy and Lactation

Pregnancy

Use epoetin alfa with caution during pregnancy.

In pregnant surgical patients participating in an autologous blood predonation programme, the use of epoetin alfa is contraindicated.

At the time of writing there is limited published information regarding the use epoetin alfa during pregnancy in humans. Animal studies have shown foetal toxicity including delayed ossification, decreased growth and delayed eyelid opening when used during pregnancy, however the doses studied were up to five times the recommended human dose (Briggs et al, 2015).

Limited studies in human pregnancies have shown complications with severe hypertension and in pre-existing renal disease. The high molecular weight of recombinant glycoprotein erythropoietin alpha does not appear to cross the human placenta (Schaefer et al, 2015).

The manufacturer suggests to avoid the use of epoetin alfa during pregnancy unless the potential benefit to the mother outweighs any potential risks to the foetus.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use epoetin alfa with caution during breastfeeding.

In breastfeeding surgical patients participating in an autologous blood predonation programme, the use of epoetin alfa is contraindicated.

At the time of writing there is limited published information regarding the use of epoetin alfa during breastfeeding. It is not known whether epoetin is excreted in human breast milk, however due to the 165 amino acid glycoprotein number it is strongly suggested epoetin alfa is not excreted in breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Aggravation of existing hypertension
Anaphylactic reaction
Angioedema
Anti-erythropoietin antibody
Arterial thrombosis
Arthralgia
Cerebral haemorrhage
Cerebral infarct
Cerebrovascular accident
Deep vein thrombosis (DVT)
Diarrhoea
Encephalopathy-like symptoms
Fever
Headache
Hyperkalaemia
Hypersensitivity reactions
Hypertensive crisis in some patients (with normal or low blood pressure)
Increased blood pressure
Influenza-like symptoms
Local reaction at injection site
Migraine-like headache
Myalgia
Myocardial infarction
Myocardial ischaemia
Nausea
Peripheral oedema
Porphyria
Pulmonary embolism
Rash
Red cell aplasia
Retinal vein thrombosis
Seizures
Shunt thrombosis
Stevens-Johnson syndrome
Thrombocythaemia
Thromboembolic disorders
Toxic epidermal necrolysis
Transient ischaemic attack
Upper respiratory tract congestion
Urticaria
Vascular disorders
Vomiting

Presentation

Parenteral formulations of epoetin alfa.

Drugs List

Therapeutic Indications

Uses

Reduction of exposure to allogeneic blood transfusions
Reduction of transfusion requirements in patients receiving chemotherapy
Symptomatic anaemia - due to chronic renal failure
Symptomatic anaemia - if severe in patients not yet undergoing dialysis
Symptomatic anaemia in adults with malignant lymphoma on chemotherapy
Symptomatic anaemia in adults with multiple myeloma receiving chemotherapy
Symptomatic anaemia in adults with solid tumours receiving chemotherapy
Symptomatic anaemia: Adults at low/int-1 risk of myelodysplastic syndromes
To increase yield of autologous blood in predonation programmes

Symptomatic anaemia associated with chronic renal failure in children and adults on haemodialysis and adults on peritoneal dialysis.

Severe symptomatic anaemia of renal origin in adult patients with renal impairment not yet undergoing dialysis.

Symptomatic anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).

To increase the yield of autologous blood from patients in a predonation programme. Treatment should only be given to patients with moderate anaemia (Hb 10g/dL to 13g/dL, no iron deficiency), if blood conserving procedures are insufficient or when scheduled major elective surgery requires a large volume of blood (4 or more units for females, 5 or more units for males). The use of epoetin alfa in this indication must be balanced against the reported risk of thrombo-embolic events.

To reduce exposure to allogeneic blood transfusions in adult non-iron deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. Use should be restricted to patients with moderate anaemia (e.g. Hb 10g/dL to 13g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900ml to 1800ml).

Symptomatic anaemia in adults with a low serum erythropoietin who have low or intermediate-1-risk of primary myelodysplastic syndromes (MDS).

Dosage

Treatment should only be carried out by a specialist.

Patients should be monitored closely and the lowest approved dose of epoetin alfa should be used to provide adequate control of anaemia and the symptoms of anaemia.

Adults

Elderly

Children

Administration

For administration by intravenous injection or subcutaneous injection.

Check that there are no particles in the solution or change in colour. This product is for single use only. Any unused portion should be discarded.

Intravenous injection
The required dose is administered by slow intravenous injection over at least one to five minutes, depending on the total dose. A slower injection is preferable in patients who react to treatment with 'flu-like' symptoms.
In patients receiving haemodialysis, a bolus injection may be administered through a suitable venous port in the dialysis line. Alternatively, the injection may be administered at the end of the dialysis session via fistula needle tubing and the tubing should then be flushed with 10ml of isotonic sodium chloride injection.

Subcutaneous injection
Generally, the maximum volume per injection site should not exceed 1ml. Where larger volumes are required, administer the dose at multiple injection sites. The required dose is administered via the subcutaneous route in the limbs or the anterior abdominal wall.

Contraindications

Inadequate antithrombotic prophylaxis
Pure red cell aplasia following previous erythropoietic therapy
Breastfeeding - if used in an autologous blood predonation programme
Cardiovascular disorder - if used before orthopaedic surgery
Pregnancy - if used in an autologous blood predonation programme
Uncontrolled hypertension

Precautions and Warnings

Children under 18 years
Predisposition to seizures
Predisposition to thromboembolic disease
Breastfeeding
Chronic hepatic impairment
Chronic renal failure
Epileptic disorder
History of seizures
Ischaemic heart disease
Porphyria
Pregnancy
Sickle cell disease

Blood transfusion is preferred treatment for anaemia in cancer patients
Ensure adequate antithrombotic prophylaxis in surgical patients
Correct hyperkalaemia before starting treatment
Exclude other causes of anaemia before treatment
Not all routes are licensed for all indications
Treatment to be initiated and supervised by a specialist
Do not mix with other injections or infusions prior to administration
Record name and batch number of administered product
Monitor haemoglobin prior to initiating therapy and periodically thereafter
Monitor iron status before and during treatment
Avoid haemoglobin level >12g/dl
Consider discontinuing treatment until hyperkalaemia has been corrected
Haemoglobin should not increase by more than 2g/dl per month
Increased risk of thrombotic events if haemoglobin >13g/dl
Investigate patients developing a sudden lack of response to treatment
Monitor platelet counts for first 8 weeks of therapy
Monitor reticulocyte count at regular intervals
Monitor serum electrolytes in chronic renal failure
Advise patient to contact their physician if worsening of anaemia symptoms
Iron supplements may be required if iron deficiency occurs
May act as growth factor for any tumour type
Discontinue and do not restart if severe cutaneous adverse reactions occur
Discontinue if blood pressure cannot be controlled
Discontinue if pure red cell aplasia is diagnosed
Not licensed for all indications in all age groups
Optimise heparin dose in chronic renal failure patients on haemodialysis

Monitor closely and control blood pressure in all patients.

Pure Red Cell Aplasia (PRCA)
A reticulocyte count should be obtained in patients who develop a sudden decrease in haemoglobin (1g/dL to 2g/dL a month) and an increased need for transfusions. Similarly if the reticulocyte count corrected for anaemia is low (less than 20,000 per microlitre) and platelet and white cell counts are normal, typical causes of non-response should be investigated (e.g. iron, folate, or vitamin B12 deficiency, aluminium intoxication, infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, and bone marrow fibrosis of any origin). If no typical cause is identified a bone marrow investigation and testing for antibodies should be considered. If antibody-mediated PRCA is suspected, therapy with epoetin alfa must be discontinued immediately. Patients must not be switched to other erythropoietin products.

Chronic renal failure patients
Chronic renal failure patients treated by the subcutaneous route should be monitored regularly for loss of efficacy. This can be detected by a sustained decrease in haemoglobin despite an increase in epoetin alfa dosage.

Shunt thromboses may occur in haemodialysis patients, particularly in patients who have a tendency to hypotension or whose arteriovenous fistula exhibit complications, such as aneurysms. Additional management may be required.

Hyperkalaemia has been observed in isolated cases. In chronic renal failure patients, correction for anaemia may lead to increased appetite, and potassium and protein intake. Dialysis prescriptions may have to be adjusted periodically to maintain urea, creatinine and potassium in the desired range. If an elevated (or rising) serum potassium level is detected then consideration should be given to ceasing epoetin alfa administration until hyperkalaemia has been corrected.

An increase in heparin dose during haemodialysis is frequently required during the course of therapy with epoetin alfa as a result of the increased packed cell volume. Occlusion of the dialysis system is possible if heparinization is not optimum.

Cancer patients receiving chemotherapy
Epoetin alfa is a growth factor that primarily stimulates red blood cell production. Erythropoietin receptors may be present on the surface of a variety of tumour cells. As with all growth factors, there is a possibility that erythropoietins may stimulate the growth of any type of malignancy. The role of ESAs on tumour progression or progression-free survival cannot be excluded.
Clinical studies have suggested, that when ESAs were administered to patients with various cancers (including head, neck and breast cancer) there was an associated negative effect on progression-free survival, a reduction in locoregional tumour control and decreased overall survival. The MHRA therefore suggest that blood transfusion should be the preferred treatment for anaemia in cancer patients. The decision to administer erythropoietins to cancer patients should be made after an informed risk benefit assessment which takes into account: tumour type and stage; degree of anaemia; life expectancy; the treatment environment and the patient's preference.

The 2 to 3 week delay between erythropoietin administration and the appearance of erythropoietin-induced red cells should be taken into account when assessing if epoetin alfa therapy is appropriate (patient at risk of being transfused).

An increased incidence of thrombotic vascular events has been seen in cancer patients receiving erythropoietins. The risk should be carefully considered, especially in those with risk factors for thrombotic events such as obese patients and those with a history of thrombotic events. In order to minimise the risk for thrombotic events the haemoglobin level and rate of increase should not exceed the haemoglobin limits.

Major elective orthopaedic surgery
The cause of anaemia should be established and treated, if possible, before the start of epoetin alfa treatment. Thrombotic events can be a risk in this population and this possibility should be carefully weighed against the benefit to be derived from the treatment in this patients group.

Patients should receive adequate antithrombotic prophylaxis, as thrombotic and vascular events may occur in surgical patients, especially in those with underlying cardiovascular disease. In addition, special caution is required in patients with predisposition for development of deep vein thrombosis. Epoetin alfa treatment may be associated with an increased risk of postoperative thrombotic/vascular events in patients with a baseline haemoglobin of greater than 13g/dL.

Pregnancy and Lactation

Pregnancy

Use epoetin alfa with caution during pregnancy.

In pregnant surgical patients participating in an autologous blood predonation programme, the use of epoetin alfa is contraindicated.

At the time of writing there is limited published information regarding the use epoetin alfa during pregnancy in humans. Animal studies have shown foetal toxicity including delayed ossification, decreased growth and delayed eyelid opening when used during pregnancy, however the doses studied were up to five times the recommended human dose (Briggs et al, 2015).

Limited studies in human pregnancies have shown complications with severe hypertension and in pre-existing renal disease. The high molecular weight of recombinant glycoprotein erythropoietin alpha does not appear to cross the human placenta (Schaefer et al, 2015).

The manufacturer suggests to avoid the use of epoetin alfa during pregnancy unless the potential benefit to the mother outweighs any potential risks to the foetus.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use epoetin alfa with caution during breastfeeding.

In breastfeeding surgical patients participating in an autologous blood predonation programme, the use of epoetin alfa is contraindicated.

At the time of writing there is limited published information regarding the use of epoetin alfa during breastfeeding. It is not known whether epoetin is excreted in human breast milk, however due to the 165 amino acid glycoprotein number it is strongly suggested epoetin alfa is not excreted in breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Aggravation of existing hypertension
Anaphylactic reaction
Angioedema
Anti-erythropoietin antibody
Arterial thrombosis
Arthralgia
Cerebral haemorrhage
Cerebral infarct
Cerebrovascular accident
Deep vein thrombosis (DVT)
Diarrhoea
Encephalopathy-like symptoms
Fever
Headache
Hyperkalaemia
Hypersensitivity reactions
Hypertensive crisis in some patients (with normal or low blood pressure)
Increased blood pressure
Influenza-like symptoms
Local reaction at injection site
Migraine-like headache
Myalgia
Myocardial infarction
Myocardial ischaemia
Nausea
Peripheral oedema
Porphyria
Pulmonary embolism
Rash
Red cell aplasia
Retinal vein thrombosis
Seizures
Shunt thrombosis
Stevens-Johnson syndrome
Thrombocythaemia
Thromboembolic disorders
Toxic epidermal necrolysis
Transient ischaemic attack
Upper respiratory tract congestion
Urticaria
Vascular disorders
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: July 2017

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Eprex 2,000 IU/ml solution for injection in pre-filled syringes. Janssen-Cilag Ltd. Revised March 2017.

Summary of Product Characteristics: Eprex 4,000 IU/ml solution for injection in pre-filled syringes. Janssen-Cilag Ltd. Revised March 2017.

Summary of Product Characteristics: Eprex 10,000 IU/ml solution for injection in pre-filled syringes. Janssen-Cilag Ltd. Revised March 2017.

Summary of Product Characteristics: Eprex 40,000 IU/ml solution for injection in pre-filled syringes. Janssen-Cilag Ltd. Revised March 2017.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 05 July 2017

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Last revised: 07 September 2013
Last accessed: 05 July 2017