RPO 2000IU

Epoetin alfa sold under brand name of RPO 2000IU and which is a 165-amino acid erythropoiesis-stimulating glycoprotein manufactured by recombinant DNA technology. RBCs (Red blood cells) are originated in the bone marrow (the spongy tissue inside the bone). To make red blood cells, the body regulate a sufficient supply of erythropoietin (EPO), a hormone which is formed by the kidney. It helps to make red blood cells. When have more red blood cells increases the haemoglobin levels. Haemoglobin is the protein in red blood cells which is needed for blood carry oxygen throughout the body. Anaemia is a disorder which arise when there is not sufficient haemoglobin in a person's blood. There are different causes of anaemia. For instance, Anemia can be caused by the body's impotence to produce sufficient EPO to make red blood cells. In case, the person may have to undergo blood transfusion to cure this type of anaemia. If you have anaemia, your physician can determine the cause.

Erythropoietin

RPO

2000IU

RPG Life science




INDICATION OF RPO 2000IU INJECTION

RPO 2000IU injection is indicated for the treatment of following conditions Anemia due to chronic kidney disease including patients on dialysis or without dialysis to reduce the requirement of RBC transfusion Anemia due to Zidovudine given ≤ 4200 mg/week in HIV infection patients with levels of erythropoietin endogenous serum of ≤ munits/mL.

Anemia due to effect of concomitant myelosuppressive chemotherapy RPO 2000IU is indicated to decrease the uses for allogeneic RBC transfusions among patients with perioperative haemoglobin > 10 to ≤ 13 g/dL who are at serious risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. RPO 2000IU is not used for patients who are willing to donate autologous blood pre-operatively.

PHARMACOLOGICAL ACTION OF RPO 2000IU INJECTION

Erythropoietin controls erythropoiesis by stimulating the differentiation and replication of erythroid precursors, stimulating the release of reticulocytes into the circulation, and synthesis of cellular haemoglobin.

Recombinant human erythropoietin is available as epoetin alfa and epoetin beta which are required in the management of anaemia’s along with CRF, cancer chemotherapy and anti-aids drug zidovudine.



Pharmacokinetic

Time to peak plasma concentration of RPO 2000IU is 20 to 25 hours and bioavailability of SC injectable RPO 2000IU is much lower than IV injection and is 20-24%. Adult and paediatric with CRF peak plasma level is 5 to 24 hours

Volume of distribution is range of 40-63.80 ml/kg and RPO 2000IU has no plasma protein binding

Bounding of erythropoietin and epoetin alfa to EPO-R causes to cellular internalization, which includes the degradation of the ligand. Erythropoietin and epoetin alfa may also be disgraced by the reticuloendothelial scavenging pathway or lymphatic system

RPO 2000IU injection are cleared through uptake and degradation via the EPO-R-expressing cells and may also involve other cellular pathways in the interstitium. Only a little amount of unchanged epoetin alfa is found in the urine. Half-life in adult is 4 hours and for children is approx. 6 hours Adult and paediatric with CRF the half-life is 4 to 13 hours




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RPO 2000IU
Brand RPO
Ingredients Erythropoietin
Strength 2000IU
Manufactured RPG Life science
Rating

Zidovudine-treated Patients with HIV-infection
Starting Dose The prescribed initial dose in adults is 100 Units/kg as an IV or SC injection 3 times per week. Discontinue RPO if an increase in haemoglobin is not achieved at a dose of 300 Units/kg for 8 weeks.

Patients on Cancer Chemotherapy
Start RPO in patients on cancer chemotherapy only if the haemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned chemotherapy. Use the less dose of RPO needed to avoid RBC transfusions. Usually Starting Dose For Adults administer the dose of 150 Units/kg subcutaneously 3 times per week until completion of a chemotherapy course or 40,000 Units subcutaneously weekly until completion of a chemotherapy course. Paediatric Patients (5 to 18 years): 600 Units/kg intravenously weekly until completion of a chemotherapy course.

Patients with Chronic Kidney Disease
For all patients with CKD
When starting or adjusting therapy, monitor haemoglobin levels at least weekly until stable, then monitor at least monthly. Avoid rises of the dose more frequently than once every 4 weeks. Reduces in dose can occur more frequently. Avoid frequent dose adjustments. If the haemoglobin increases rapidly, decrease the dose of RPO by 25% or more as required to reduce fast responses.

For adult patients with CKD on dialysis
Start RPO therapy when the haemoglobin level is less than 10 g/dL. If the haemoglobin level approaches or exceeds 11 g/dL, decrease the dose of RPO. The usual starting dose for adult patients is 50 to 100 Units/kg 3 times weekly IV or SC. The intravenous route is prescribed for patients on haemodialysis.

For paediatric patients with CKD
Start RPO therapy only when the haemoglobin level is less than 10 g/dL. If the haemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of RPO. The usual starting dose for paediatric patients (ages 1 month or older) is 50 Units/kg 3 times weekly intravenously or subcutaneously.

Surgery Patients
The prescribed RPO injections are: 300 Units/kg per day subcutaneously (SC) for 15 days total: given daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery. 600 Units/kg subcutaneously (SC) in 4 doses given the patients 21, 14, and 7 days before surgery and on the day of surgery.

Over dosage

RPO 2000IU overdose can cause by above the desired level of haemoglobin levels, which must be controlled with discontinuation or reduction of RPO 2000IU dosage with phlebotomy.

SIDE EFFECTS CAUSED DUE TO RPO 2000IU INJECTION

The injection RPO 2000IU has some serious side effects like

Increase mortality, Myocardial infarction, stroke and thromboembolism Increased mortality/ risk of tumor progression or recurrence in patients. Hypertension, Seizures, PRCA, Serious allergic reactions, Severe cutaneous reaction

Precautions

  • High incidence of death, myocardial infarction (MI), stroke, and thromboembolism: while Using ESAs to aim hemoglobin level of >11 g/dL rises risk of severe adverse cardiovascular reactions
  • Special caution usage in hypertension, iron deficiency, folate or B12 deficiency, congestive heart failure (CHF), coronary artery disease (CAD), seizure disorder, sickle-cell disease, haemolytic Anemia, porphyria, hematologic disorders
  • Cancer patients will Increased tumor development rate when dosed to achieve haemoglobin level of >12 mg/ld.
  • In Chronic renal failure patients at starting of treatment, transferrin saturation should be ≥20% and ferritin ≥100 mg/mL
  • Patients go through surgery are at high risk for DVT; concomitant DVT prophylaxis is strongly recommended In Zidovudine-treated patients may have response only when zidovudine dosage <4200 mg/wk and endogenous epoetin <500 U/mL
  • In Dialysis patients having IV administration recommended to decrease red-cell aplasia risk; rises anticoagulation with heparin may be needed to prohibit clotting of extracorporeal circuit during haemodialysis
  • Avoid increase dose more frequently than once monthly.
  • Patients Contains albumin; may carry extremely specific risk for transmission or viral diseases or Creutzfeldt-Jakob disease.
  • In Cases of PRCA and of severe Anemia, with or without other cytopenia’s that appears following the growth of neutralizing antibodies to erythropoietin resulted in patients treated with epoetin alfa

DRUG – DRUG INTERACTION

  • Concomitant use with dichlorphenamide and RPO 2000IU both reduces serum potassium use with caution and monitor
  • RPO 2000IU interaction with methyltestosterone will increase effects of epoetin alfa by pharmacodynamic synergism. Because of potential adverse effects of drug combination should be avoided
  • Combination with danazol and fluoxymesterone, oxandrolone, oxymetholone will increase effects of epoetin alfa by pharmacodynamic synergism. Androgens used will reduce needed dose of epoetin alfa.

Contraindications

RPO 2000IU injection contraindicated to Uncontrolled hypertension, Pure red cell aplasia which started after treatment with RPO 2000IU, Serious allergic reactions



The limited available data on pregnancy women have insufficient to describe a drug associated risk of adverse development outcomes. RPO 2000IU from multiple dose which contains benzyl alcohol is contraindicated to pregnant women. If pregnant women needed treatment with RPO 2000IU then use benzyl alcohol free formulation to avoid harm to foetus.

RPO 2000IU from multiple dose which contains benzyl alcohol is contraindicated to lactating women Advise the breast-feeding women not to feed for at least 2 weeks after the last dose. Possible similar harm to infants exposed to benzyl alcohol through human milk.

Store at 2°C to 8°C Do not freeze the injection Avoid using of shaken or frozen RPO 2000IU injection, do not shake Store the injection in original container until use to away from light

If dose is missed then immediately take the dose you remember before next dose otherwise skip the missed, if next dose time reached. Do not take extra dose at a time. Take advice of the doctor about missed dose

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