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Recombinant Human Erythropoietin

Erythropoietin or EPO, is a glycoprotein hormone that controls erythropoiesis or red blood cell production. Recombinant human erythropoietin production has revolutionized the treatment of anemia associated with chronic renal failure. In the past years, however, EPO has been approved for prevention/treatment of anemia during chemotherapy, prematurity and during the therapy in HIV-infected patients. Hindustan Biosciences Ltd obtained its Import license from Genetic Engineering Approval Committee (GEAC) in 2007 and has been a leader in the Recombinant Human Erythropoietin market ever since. We have an extensive distribution network all over the country. We sell the EPO product at various dosages:

STRENGTH VOLUME
2000iu 1
4000iu 1
6000iu 1
10000iu 1


For more information regarding Recombinant Human Erythropoietin please refer:

http://www.ncbi.nlm.nih.gov/pubmed/9570702
http://www.ncbi.nlm.nih.gov/pubmed/16555732


Symptoms


The early symptoms of chronic kidney disease are also symptoms of other illnesses. These symptoms may be the only signs of kidney disease until the condition is more advanced.


Symptoms may include:
  • Appetite loss
  • General ill feeling and fatigue
  • Headaches
  • Itching (pruritus) and dry skin
  • Nausea
  • Weight loss without trying to lose weight

Other symptoms that may develop, especially when kidney function has gotten worse, include:

  • Abnormally dark or light skin
  • Bone pain
  • Brain and nervous system symptoms:
    • Drowsiness and confusion
    • Problems concentrating or thinking
    • Numbness in the hands, feet, or other areas
    • Muscle twitching or cramps
  • Breath odor
  • Easy bruising, bleeding, or blood in the stool
  • Excessive thirst
  • Frequent hiccups
  • Low level of sexual interest and impotence
  • Menstrual periods stop (amenorrhea)
  • Shortness of breath
  • Sleep problems, such as insomnia, restless leg syndrome, and obstructive sleep apnea
  • Swelling of the feet and hands (edema)
  • Vomiting, typically in the morning

Chronic kidney disease is the slow breakdown of kidney function. One who has been diagnosed with chronic kidney disease, has been unwell for a long time.


The symptoms may not be noticed until a significant loss of kidney function occurs. When kidney function is at 50-75% of normal, no symptoms may show. When the kidney function is at 20-50% of normal, you may only notice symptoms at times of high stress.


When patients finally feel the effects of their damaged kidneys, they will experience an overall ill feeling. This is called uremia.


Uremia.

Uremia occurs, when less than 15% of kidney function remains. Too much fluid and waste will build up as toxins in the bloodstream. This condition leads to weight gain, high blood pressure, edema, and shortness of breath. Sufferers also develop fatigue, nausea, loss of appetite, vomiting, and seizures in the progression of uremia.


Edema

Chronic kidney disease is a slow process. Chronic kidney failure silently creeps up over a long period, but is devastating nonetheless. There are millions of nephrons in each kidney, and a person may not notice when a few nephrons become damaged. The remaining healthy nephrons normally are able to expel and filter salts, so the symptoms of edema (bloating) and high blood pressure are not readily apparent. However, when nephron damage reaches the last stage of chronic kidney failure, most patients build up sodium, as intake is greater than output. When lesions occur in the heart, the feet are first to bloat. Swelling of the face and eyelids is a symptom of infected kidneys, and it leads to edema and less urination than usual.


Albuminuria

When lesions develop in the kidney nephrons, the tissue fills up, narrowing the filter area and changing the character of the filter. When functioning properly, protein (albumin-a) that has not passed through is also filtered. This protein normally stabilizes water in the bloodstream. When the protein flows into the urine, the water in the bloodstream destabilizes, and the urine may be "frothy."


Signs and tests


High blood pressure is almost always present during all stages of chronic kidney disease. A nervous system exam may show signs of nerve damage. The health care provider may hear abnormal heart or lung sounds when listening with a stethoscope.

A urinalysis may show protein or other changes. These changes may appear 6 months to 10 or more years before symptoms appear.


Tests that check how well the kidneys are working include:
  • Creatinine clearance
  • Creatinine levels
  • BUN

Chronic kidney disease changes the results of several other tests. Every patient needs to have the following checked regularly, as often as every 2 - 3 months when kidney disease gets worse:

  • Albumin
  • Calcium
  • Cholesterol
  • Complete blood count (CBC)
  • Electrolytes
  • Magnesium
  • Phosphorous
  • Potassium
  • Sodium
Causes of chronic kidney disease may be seen on:
  • Abdominal CT scan
  • Abdominal MRI
  • Abdominal ultrasound
  • Kidney biopsy
  • Kidney scan
  • Kidney ultrasound
This disease may also change the results of the following tests:
  • Erythropoietin
  • PTH
  • Bone density test
  • Vitamin D

Precaution & Care

Unfortunately, chronic kidney failure often cannot be cured. Dialysis and/or a kidney transplant may be needed when the kidneys do not work well enough after treatments with medications and a proper diet.


1.Hemodialysis

  • Blood is sent through a filter called an artificial kidney, or a hemodialyzer, that removes waste products. The clean blood is returned to the body.
  • Hemodialysis is usually performed three times per week, for 3 to 4 hours at a time.

2.Peritoneal dialysis

  • A cleansing solution called dialysate travels through a special tube known as a catheter into the abdomen.
  • Fluid, waste, and chemicals pass from tiny blood vessels in the peritoneal membrane to the dialysate solution.
  • After several hours, the dialysate drains from the abdomen, taking the wastes from the blood with it. Then the abdomen is refilled with fresh dialysate and the cleaning process begins again.

3. Diet

  • Limited sodium intake Avoid salt. Salty food promotes thirst and causes the body to retain water, which can lead to edema, weight gain and high blood sugar.
  • Limited fluid intake. Limit the amount you drink. Fluid builds up quickly in the body when the kidneys aren't functioning well. Too much fluid swells the tissues swell and can cause hypertension, weight gain, heart trouble and shortness of breath due to edema of the lungs. Patients must control the consumption soup, soft drinks, milk, teas, ice, and ice cream as well.
  • Proper protein intake. Excessive intake of protein when on hemodialysis will exacerbate uremia, while insufficient protein will bring on anemia or nutrition deficiency. Quality animal protein (eggs, meat, fish, milk) should be eaten in the right amounts at every meal.
  • Adequate caloric intake Insufficient calories will weaken the muscles and waste them away, and waste will build up. After dialysis the patient must check his/her weight and get the extra calories if needed from sources such as candy, jelly, and honey.
  • Limited phosphorus intake Diseased kidneys are unable to remove phosphorus from the blood sufficiently. Too much phosphorus in the blood may lead to loss of calcium in the bones, causing them to weaken, become brittle and break easily. High phosphorus levels in the blood can affect the heart rhythm, and lead to stroke. Phosphorus comes from many foods in the diet. However, proper food handling can remove phosphorus prior to consumption, such as soaking vegetables in water for more than 2 hours or to blanching them in boiling water before eating.
  • Water-soluble vitamins The patient who is on dialysis should take water-soluble vitamins, especially folic acid and iron, because they are removed from the body by the dialysis procedure.
  • Recommended foods
    * For calories: honey, candy, white sugar, jelly, vegetable oil, syrup, flour with low protein.
    * For flavor: hot pepper, black pepper, curry, vinegar, vanilla, mustard.
  • Foods to limit or avoid MSG, baking powder, chocolate, cocoa, brown and dark sugar, orange juice, instant coffee, tomato ketchup.

Treatment of anemia


Healthy kidneys make the hormone EPO, which stimulates the bones to make more red blood cells. When diseased kidneys do not make enough EPO, treatment with a genetically engineered form of EPO may be needed to supplement the function of EPO. The injection dosage will depending on tests results for hemoglobin (Hgb) count and hematocrit (Hct). If the iron level is low, iron pills may be taken or iron given intravenously in cases of chronic kidney failure.


Eposino



Available in

STRENGTH VOLUME
2000iu 1ml
4000iu 1ml
6000iu 1ml
10000iu 1ml

Indications


Treatment of anemia, especially in renal anemia resulting from renal functioninsufficiency, including hemodialysis and non- hemodialysis of chronic renal failure.



Dosage

Eposino should be administered through SC and IV 2-3 times/week under physician's direction. Dosage can be changed according to anemia status, age and other related factors of patients.


Treatment Period:

The initial dosage for the patients receiving hemodialysis is 100-150 iu/ kg, and for those not on hemodialysis is 75- 100 iu/kg/week. If hematocrit increase is not as expected (<0.5 vol/week), the dosage can be changed after 4 weeks of initial treatment to increase the dose to 15-30 iu/kg/week but not more than 30 iu/kg/week. The expected rise of hematocrit should be in range of 30-33% v/v, not higher than 34% v/v.


Maintenance Period:

If the hematocrit has reached to 30-33% v/v and/or the hemoglobin has reached 100-110 g/L, the maintenance treatment starts. The dosage should be 2/3 of the initial dosage on this stage. The hematocrit should be monitored once every 2-4 weeks so as to adjust the dosage to maintain hematocrit and hemoglobin at the proper level as well as to avoid erythropoesis to be formed too quickly. Eposino is usually for long-term use, however, the therapy with Eposino might be stopped for special cases.


Precaution


During the treatment with epoetin a, the hematocrit should be checked regularly (once a week at the early stage and once every 2 weeks in the maintenance period). The hematocrit should be maintained <30% volume to avoid the formation of extraordinary erythropoiesis. Should extraordinary erythropoiesis happen, suitable treatment shall be taken eg, temporarily discontinuing the use of epoetin a.


Hyperkalemia may appear during the course of treatment, diet should be adjusted or the Eposino should be stopped for use when hyperkalemia occurs until the normal level is recovered.


Eposino should be used carefully for patients with myocardial infarction or to pulmonary infarction or those with allergic history or tendency.


During the treatment with recombinant human erythropoietin a, iron concentration in serum usually decreases. Therefore, it is necessary to provide iron to meet the body's need. If serum ferric concentration is <100 mg/ mL or the transfer in saturation falls <20%, daily ferrotherapy should be adopted.


Folic and vitamin B12 insufficiency and ultra-high aluminum may reduce efficacy or Eposino. Use in pregnancy & lactation: The safety for pregnant women or in lactation is not certain. Use in children: The safety for children is not certain. Use in the elderly: For aged patients with complications of hypertension or circulation system because of hypo- function, the blood pressure and hematocrit should be monitored frequently when epoetin a is used. The dosage and times of administration should be adjusted accordingly.



Contraindications


Patients with uncontrollable severe hypertension; those allergic to epoetin a or to other erythropoietin agents. Those with combined infections should be cured before Eposino is administered.


Adverse Drug Reactions


Common:
A few may have headache, low fever and fatigue, muscle pain and anthralgia at the initial state of drug administration. But most of the adverse reactions may be relieved upon duration of treatment accordingly and there is no need to discontinue the use of Eposino. If the previously-mentioned symptoms still exist, discontinuance of the drug may be considered.

Allergic Reactions:
Allergic reactions eg, skin rashes or urticaria, including allergic shock may occur rarely, therefore, it is advised that a small dosage of Eposino should be used as an initial dose as well as in the beginning of reuse of Eposino, make sure that there are no abnormal reactions that occur before the use of full dose as prescribed. If they do occur, Eposino should be stopped immediately and the proper treatment provided.

Cardiovascular System:
Hypertension or other symptoms caused by the exacerbation of existing hypertension and hypertensive encephalopathy may occur eg, headache, disturbance of consciousness, convulsion and sometimes even encephalorrhagia. Therefore, blood pressure should be monitored periodically, dosage may be decreased or stopped and the depressor drug may also be adjusted.

Hematological System:
The blood viscosity may increase as hematocrit rises. For some patients receiving hemodialysis, the heparin dosage should be increased whenever necessary to prevent artificial renal hemoagglutination. Accordingly, patients who tend to have hypotension or suffer from artriovenous fistulae occlusion, should use acetylsalicylic acid or aspirin to prevent the hemo-occlusion.

Liver:
Hepatic function impairment may occur, GOP and GPT may sometimes rise.

Gastrointestinal System:
Nausea, vomiting, anorexia and diarrhea may happen occasionally when Eposino is used.


Storage:
Store at 2-8C. Protect from light. Do not freeze nor shake.

Poison Schedule: Rx

Shelf Life:2 years