Epoetin beta interacts in the following cases:
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment. More severe cases have been observed with long-acting epoetins. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, epoetin beta should be withdrawn immediately and an alternative treatment considered. If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of epoetin beta, treatment with ESA must not be restarted in this patient at any time.
Pure Red Cell Aplasia (PRCA) caused by anti-erythropoietin antibodies has been reported in association with all ESAs, including epoetin beta. These antibodies have been shown to cross-react with all ESAs, and patients suspected or confirmed to have antibodies to erythropoietin should not be switched to epoetin beta.
PRCA in patients with Hepatitis C: A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin and perform anti-erythropoietin antibody testing. Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly. Epoetins are not approved in the management of anaemia associated with hepatitis C.
There are no data from the use of epoetin beta in pregnant women. Animal studies do not indicate direct harmful effects with respect to pregnancy, embryofoetal development, parturition or postnatal development but indicate a class-related reversible reduction in foetal weight. Caution should be exercised when prescribing to pregnant women.
It is unknown whether epoetin beta is excreted in human breast milk. One animal study has shown excretion of methoxy polyethylene glycol-epoetin beta in maternal milk. A decision on whether to continue or discontinue breast-feeding or to continue or discontinue therapy with epoetin beta should be made taking into account the benefit of breast-feeding to the child and the benefit of epoetin beta therapy to the woman.
Studies in animals have shown no evidence of impaired fertility. The potential risk for humans is unknown.
Epoetin beta has no or negligible influence on the ability to drive and use machines.
The safety data base from clinical trials comprised 3,042 CKD patients, including 1,939 patients treated with epoetin beta and 1,103 with another ESA. Approximately 6% of patients treated with epoetin beta are expected to experience adverse reactions. The most frequent reported adverse reaction was hypertension (common).
Adverse reactions are listed according to MedDRA system organ class and frequency category. Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Table 2. Adverse reactions attributed to the treatment with epoetin beta in CKD patients. Adverse reactions observed only during post-marketing are marked (*):
Uncommon: Thrombocytopenia*
Not known: Pure red cell aplasia*
Rare: Hypersensitivity
Not known: Anaphylactic reaction*
Uncommon: Headache
Rare: Hypertensive encephalopathy
Common: Hypertension
Rare: Hot flush
Uncommon: Thrombosis*
Rare: Pulmonary embolism*
Rare: Rash, maculopapular
Not known: Stevens-Johnson syndrome/toxic epidermal necrolysis*
Uncommon: Vascular access thrombosis
Cases of thrombocytopenia have been reported from post-marketing setting. A slight decrease in platelet counts remaining within the normal range was observed in clinical studies.
Platelet counts below 100 × 109/l were observed in 7% of patients treated with epoetin beta and 4% of patients treated with other ESAs during clinical development. In a post-authorisation safety study with long treatment exposure of up to 8.4 years, baseline platelet counts below 100 × 109/l was present in 2.1% of patients in the epoetin beta group and 2.4% of patients in other ESAs group. During the study, platelet counts below 100 × 109/l were observed yearly in 1.5% to 3.0% of patients treated with epoetin beta and 1.6% to 2.5% of patients treated with other ESAs.'
Data from a controlled clinical trial with epoetin alfa or darbepoetin alfa reported an incidence of stroke as common. A post-authorisation safety study showed similar incidence of stroke between epoetin beta (6.3%) and reference ESAs groups (epoetin alfa, darbepoetin alfa and epoetin beta) (7%).
As with other ESAs, cases of thrombosis, including pulmonary embolism, have been reported in the post-marketing setting.
Neutralising anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA) has been reported, frequency unknown. In case PRCA is diagnosed, therapy with epoetin beta must be discontinued, and patients should not be switched to another recombinant erythropoietic protein.
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