Recormon

Recormon

epoetin beta

Manufacturer:

Roche

Distributor:

DKSH
Concise Prescribing Info
Contents
Epoetin β
Indications/Uses
Symptomatic anemia associated w/ chronic kidney disease (CKD) in patients on dialysis; symptomatic renal anemia in patients not yet undergoing dialysis & adult patients w/ non-myeloid malignancies receiving chemotherapy; symptomatic anemia associated w/ myelodysplastic syndromes (MDS) patients, including other ineffective erythropoiesis. Prevention of anemia of prematurity in infants w/ a birth wt of 750-1,500 g & a gestational age of <34 wk. Increase yield of autologous blood from patients in a pre-donation program.
Dosage/Direction for Use
Anemia due to CKD Correction phase: Max: 720 IU/kg/wk. SC Initially 3 x 20 IU/kg/wk. May be increased every 4 wk by 3 x 20 IU/kg/wk if increase of Hb is not adequate. Maintenance phase: Administer wkly dose as a single inj or in 3 or 7 divided doses, may be switched to once every 2 wk. IV Initially 3 x 40 IU/kg/wk. May be raised after 4 wk to 80 IU/kg 3 times/wk & by further increments of 20 IU/kg 3 times/wk at mthly intervals, if needed. Maintenance phase: Initially reduce to ½ of the previously administered amount, then adjust individually at 2-4 wk intervals. Symptomatic anemia in cancer patients receiving chemotherapy Administer wkly dose as a single inj or in 3-7 divided doses SC. Initially 30,000 IU/wk or approx 450 IU/kg/wk. Double wkly dose if Hb value has not increased by at least 1 g/dL. Max: 60,000 IU/wk. Increasing the amount of autologous blood Single dose administered twice wkly over 4 wk. Max: 1,600 IU/kg/wk for IV or 1,200 IU/kg/wk for SC. Prevention of anemia of prematurity 3 x 250 IU/kg/wk SC, starting as early as day 3 of life for 6 wk. Anemia in myelodysplastic syndromes including other ineffective erythropoiesis Initially 30,000 IU/wk SC. Treatment is indicated if Hb value ≤10 g/dL. Hb levels should not exceed 12 g/dL. Double wkly dose (60,000 IU wkly), if Hb level increase <1 g/dL from baseline Hb level & Hb level <12 g/dL after 6-8 wk.
Contraindications
Hypersensitivity. Poorly controlled HTN. MI or stroke, unstable angina pectoris. History of venous thromboembolic disease. Infants or childn up to 3 yr.
Special Precautions
Presence of refractory anemia w/ excess blasts in transformation, epilepsy, thrombocytosis, & chronic liver failure. Rule out folic acid & vit B12 deficiencies. Evaluate Fe status prior to & during treatment. Consider bone marrow exam for pure red cell aplasia diagnosis if sudden drop of Hb associated w/ reticulocytopenia & anti-erythropoietin antibodies occur. Do not switch to Recormon in patients suspected or confirmed to have neutralising Ab to erythropoietin. May stimulate growth of any type of malignancy. Risk of BP increase (hypertensive episodes) or existing HTN aggravation in cases of rapid Hb increase. Monitor BP regularly including between dialyses in patients w/ renal anemia. Hypertensive crisis w/ encephalopathy-like symptoms may occur. Severe Al overload due to treatment of renal failure. Shunt thrombosis. Discontinue if there is increase in platelets of >150 x 109/L or platelets rise above normal. Patients in whom it is considered of particular importance to avoid homologous blood transfusion. Regularly monitor platelet counts during the first 8 wk of therapy; haematocrit/Hb levels. Interrupt therapy if serum K elevation occur in patients w/ CKD. Severe forms of phenylketonuria. Pregnancy & lactation. Infants (anemia due to CKD); ped patients (anemia in cancer patients receiving chemotherapy & treatment for increasing amount of autologous blood) is not indicated.
Adverse Reactions
HTN; headache; thromboembolic event; fall in serum ferritin values.
ATC Classification
B03XA01 - erythropoietin ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.
Presentation/Packing
Form
Recormon pre-filled inj 3000 IU/0.3 mL
Packing/Price
6 × 1's
Form
Recormon pre-filled inj 10000 IU/0.6 mL
Packing/Price
1's
Form
Recormon pre-filled inj 2000 IU/0.3 mL
Packing/Price
6 × 1's
Form
Recormon pre-filled inj 30000 IU/0.6 mL
Packing/Price
1's
Form
Recormon pre-filled inj 5000 IU/0.3 mL
Packing/Price
6 × 1's
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