Anemia associated with chronic renal failure ( CRF )

Adverse reactions-

Cardiovascular-       arteriovenous fistula site complication  5%
                                   arteriovenous fistula thrombosis  5%
                                   hypertension  13%
                                   procedural hypotension  8%
                                  

CNS-                         headache  9%

GI-                             constipation  5%        diarrhea  11%          vomiting  6%

GU-                           urinary tract infection  5%

Metabolic/nutrional -       fluid overload  7%

Muculoskeletal -             back pain 6%      Muscle spasms    8%

Respiratory -                  cough  6%            nasophryngitis  11%      
                                       upper respiratory tract infection     9%

Miscellaneous-         pain in extremity    5%      

Special precautions- 

Anemia caused by other conditions-  the safety and efficacy of methoxy polythene glycol
epoetin-beta  have not been established for use among patients with anemia
caused by cancer chemotherapy or for reduction  in the need for allogeneic red blood cell
transfusion in perisurgical setting.

Hypotension-  take care to closely monitor and control blood pressure during methoxy polythene glycol epoetin-beta therapy, especially in patients with a history of cardio-vascular disease or hypertension.

Seizures-  sieizure have occurred in patients participating in methoxy polythene glycol
epoetin-beta clinical studies. During the first several months of therapy, closely monitor blood pressure and presence of monitory neurological symptoms.
Decrease or withhold the dose if the memoglobin  increases more than 1g/dL in any 2 week period.

Lack or loss of response-  the lack of response or failure to maintain  a hemoglobin response with methoxy polythene glycol epoetin beta within the recommended dose range  should prompt for a search for causative factors. Exclude or correct deficiencies of iron, folic acid, and Vitamin B12.

Allergic reactions- serious allergic reactions consisting of tachycardia, pruritus and rash have been reported in patients treated with drug.. If a serious allergic or anaphylactic reaction occurs, permanently discontinue treatment and administer appropiate therapy

Pregnancy- should be administered during pregnancy only if the benefits justifies the risk
to the fetus.

Lactation- excercise caution while administering the drug to breast feeding woman.

Children- safety and efficacy in children have not been established

Elderly- start with a low end of the dosing schedule, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomittant disease or other drug therapy.

Monitoring-  to ensure effective erythropoiesis evaluate the status of all patients before and
during treatment. Provide supplementary iron therapy in patients whose serum ferritin is
below  100mcg/L or whose serum transferrin is below 20%
 

Indication-
Anemia associated with chronic renal failure ( CRF )

Dosage-
The dose of methoxy polythene glycol -epoetin beta should be reduced as the hemoglobin 
approaches 12g/dL or increases by more than 1g/dL in any two week period.

Recommended starting dose- in adult CRF patients who are not currently treated with an ESA is
0.6mcg/kg body weight administered as a single intravenous IV  or subcutaneous  injection 
once every two weeks. 

1. Inform patients of the need for regular blood pressure monitoring and laboratory tests for
    haemoglobin to lessen the risks of mortality and serious cardiovascular events

2. Inform patients of the possible adverse reactions of methoxy polythelene glycol epoetin beta,
    including injection site reactions, allergic reactions, and potential problems due to excesive
    increases in hemoglobin levels.

3. Inform patients of the signs and symptoms of injection site and allergic reactions

4. Inform patients of the imprtance of compliance with prescribed dietary restrictions,
   dialysis regimens, or medications including antihypertensive medications.

Pharmacology-
Methoxy polythene glycol epoetin beta is erythropoetin receptor activator with greater activity
in vivo as well as increased half life in contrast to erythropoietin.

A primary growth factor for erythroid  development, erythropoietin is produced in the kidney
and released into the blood stream.

Pregnancy-
Should be administered during pregnancy only if the benefits justifies the risk
to the fetus.

Lactation-
Excercise caution while administering the drug to breast feeding woman.

Children-
Safety and efficacy in children have not been established

Elderly-
Start with a low end of the dosing schedule, reflecting the greater frequency of decreased
hepatic, renal or cardiac function and of concomittant disease or other drug therapy.