Recormon

Recormon

epoetin beta

Manufacturer:

Roche

Distributor:

Globo Asiatico
Concise Prescribing Info
Contents
Epoetin β
Indications/Uses
Symptomatic anemia associated w/ CKD in patients on dialysis; symptomatic renal anemia in patients not yet undergoing dialysis; symptomatic anemia in adults w/ non-myeloid malignancies receiving chemotherapy. Increasing yield of autologous blood from patients in pre-donation program. Prevention of anemia of prematurity in infants w/ birth wt of 750-1,500 g & gestational age <34 wk.
Dosage/Direction for Use
Anemia due to CKD SC/IV Inj over approx 2 min in case of IV. Administer SC in non-hemodialysis patient. Correction phase: Max: Not to exceed 720 IU/kg wkly. SC Initially 3 x 20 IU/kg wkly, may be increased every 4 wk by 3 x 20 IU/kg wkly if Hb increase is inadequate (<0.25 g/dL wkly). Wkly dose can be divided into daily doses. IV Initially 3 x 40 IU/kg wkly, may be increased after 4 wk to 80 IU/kg 3 times wkly & by further increment of 20 IU/kg 3 times wkly if needed at mthly interval. Maintenance phase: Initially reduced to ½ of previously administered amount. Adjust dose subsequently at 2-4 wk interval individually. SC Wkly dose can be given as 1 inj wkly or in divided doses 3 or 7 times wkly, may be switched to once every 2 wk in patient stable on a once wkly dosing regimen. Symptomatic anemia in cancer patient receiving chemotherapy SC Wkly dose can be given as 1 inj wkly or in divided doses 3-7 times wkly. Initially 30,000 IU wkly (approx 450 IU/kg wkly). If after 4 wk Hb value has increased by at least 1 g/dL, continue current dose; if not, double wkly dose. If after 8 wk Hb value has not increased by at least 1 g/dL, discontinue treatment. Continue therapy up to 4 wk after end of chemotherapy. Max: Not to exceed 60,000 IU wkly. Increasing amount of autologous blood SC/IV Individualized dosage. Single dose IV over approx 2 min or SC twice wkly over 4 wk. Max: Not to exceed 1,600 IU/kg wkly for IV or 1,200 IU/kg wkly for SC. Prevention of anemia of prematurity SC 3 x 250 IU/kg wkly starting as early as possible, preferably by day 3, for 6 wk.
Contraindications
Hypersensitivity. Poorly controlled HTN. Not to be used in increasing yield of autologous blood in patients who in the mth preceding treatment have suffered MI or stroke, patients w/ unstable angina pectoris or patients at increased risk of DVT eg, those w/ history of venous thromboembolic disease.
Special Precautions
Discontinue use if pure red cell aplasia is diagnosed; there is increase in platelets of >150 x 109/L or platelets rise above normal. 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. Chronic inflammation eg, due to uremia or advanced metastatic cancer; chronic blood loss, bone marrow fibrosis, severe Al overload due to renal failure treatment, hemolysis. Consider bone marrow exam for pure red cell aplasia diagnosis if sudden drop of Hb associated w/ reticulocytopenia & anti-erythropoietin Abs 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. Increased BP (hypertensive episodes) or aggravation of existing HTN especially in cases of rapid Hb increase. Regularly monitor BP including between dialyses in patients w/ renal anemia particularly at beginning of therapy. Hypertensive crisis w/ encephalopathy-like symptom; sudden stabbing migraine-like headaches. Risk of shunt thrombosis. Regularly monitor platelet counts & hematocrit/Hb levels in all patients. Interrupt therapy if serum K elevation occur in patients w/ CKD. Misuse by non-anemic persons may lead to excessive Hb increase. Patients w/ severe forms of phenylketonuria. Pregnancy & lactation. Not to be used in infants <2 yr w/ anemia due to CKD & not indicated in ped population w/ anemia receiving chemotherapy for cancer & for treatment for increasing amount of autologous blood.
Adverse Reactions
HTN; headache; thromboembolic event.
MIMS Class
Haematopoietic Agents
ATC Classification
B03XA01 - erythropoietin ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.
Presentation/Packing
Form
Recormon inj 10,000 IU/0.6 mL
Packing/Price
6 × 1's (P21,780/pack)
Form
Recormon inj 2,000 IU/0.3 mL
Packing/Price
6 × 1's (P3,958/pack)
Form
Recormon inj 30,000 IU/0.6 mL
Packing/Price
1's (P11,411/pack)
Form
Recormon inj 5,000 IU/0.3 mL
Packing/Price
6 × 1's (P9,501/pack)
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