Epoetin Theta

Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Genes that may be involved
  • Drug Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names


Austria: Biopoin, Eporatio; Bulgaria: Biopoin, Eporatio; Czech Republic: Biopoin, Eporatio; Estonia: Biopoin, Eporatio; Finland: Eporatio; France: Eporatio; Germany: Biopoin, Eporatio; Greece: Eporatio; Hungary: Eporatio; Ireland: Biopoin, Eporatio; Italy: Eporatio; Latvia: Biopoin, Eporatio; Lithuania: Biopoin, Eporatio; Luxembourg: Biopoin, Eporatio; Malta: Biopoin, Eporatio; Netherlands: Biopoin, Eporatio; Poland: Biopoin, Eporatio; Portugal: Biopoin, Eporatio; Romania: Eporatio; Slovakia: Biopoin, Eporatio; Slovenia: Biopoin, Eporatio; Spain: Eporatio; Sweden: Biopoin, Eporatio; UK: Eporatio.

Drug combinations


Epoetin Theta: Recombinant human erythropoietin produced in Chinese Hamster Ovary cells (CHO-K1) by recombinant DNA technology. The first 27 aa (signal peptide) and the last aa (terminal arginine) are cleaved during translation to result in the 165 aa polypeptide. Three N-linked oligosaccharide chains are linked to aa positions Asn-24, Asn-38 and Asn-83 and one O-linked oligosaccharide chain is linked to Ser-126. Disulfide bridges between cysteines Cys-7 and Cys-161 as well as between Cys-29 and Cys-33 stabilize the higher order protein structure (secondary, tertiary). Mw: 30.6 (glycosylated protein).

Pharmacologic Category

Antianemia Drugs. Hematopoietic Agents; Recombinant Human Erythropoietin. (ATC-Code: B03XA01).

Mechanism of action

Human erythropoietin is an endogenous glycoprotein hormone that is the primary regulator of erythropoiesis through specific interaction with the erythropoietin receptor on the erythroid progenitor cells in the bone marrow. It acts as a mitosis-stimulating factor and differentiation hormone. The production of erythropoietin primarily occurs in and is regulated by the kidney in response to changes in tissue oxygenation. Production of endogenous erythropoietin is impaired in patients with chronic renal failure and the primary cause of their anemia is erythropoietin deficiency. In patients with cancer receiving chemotherapy the etiology of anemia is multifactorial. In these patients, erythropoietin deficiency and a reduced response of erythroid progenitor cells to endogenous erythropoietin both contribute significantly towards their anemia. Epoetin theta is identical in its amino acid sequence and similar in its carbohydrate composition (glycosylation) to endogenous human erythropoietin.

Therapeutic use

Treatment of symptomatic anemia associated with chronic renal failure in adult patients. Treatment of symptomatic anemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

Pregnancy and lactiation implications

Caution should be exercised when prescribing to pregnant women. Not recommended during lactation.

Unlabeled use


Hypersensitivity to the active substance, other epoetins and derivatives or to any of the excipients. Uncontrolled hypertension.

Warnings and precautions

Epoetin theta treatment should be initiated by physicians experienced in the above-mentioned indications. Non-response to therapy with epoetin theta should prompt a search for causative factors. Deficiencies of iron, folic acid or vitamin B~12~ reduce the effectiveness of epoetins and should therefore be corrected. Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, hemolysis, aluminium intoxication, underlying hematological diseases or bone marrow fibrosis may also compromise the erythropoietic response. A reticulocyte count should be considered as part of the evaluation. Pure red cell aplasia (PRCA) caused by neutralizing anti-erythropoietin antibodies has been reported in association with erythropoietin therapy. Epoetins are not approved in the management of anemia associated with hepatitis C. Patients on epoetin theta therapy can experience an increase in blood pressure or aggravation of existing hypertension particularly during the initial treatment phase (monitor closely and control blood pressure; a reduction of the administered dose of epoetin theta or temporary interruption of epoetin theta therapy may be required). Misuse of epoetin theta by healthy persons may lead to an excessive increase in hemoglobin and hematocrit (associated with life-threatening cardiovascular complications). The use of epoetin theta in nephrosclerotic patients not yet undergoing dialysis should be defined individually, as a possible accelerated progression of renal failure cannot be ruled out with certainty. During hemodialysis, patients treated with epoetin theta may require increased anticoagulation treatment to prevent clotting of the arterio-venous shunt. As with all growth factors, there is a concern that epoetins could stimulate the growth of any type of malignancy (in some clinical situations blood transfusion should be the preferred treatment for the management of anemia in patients with cancer. The decision to administer recombinant erythropoietins should be based on a benefit-risk assessment).



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