Drug interactions-

Insulin/oral hypoglycemic agents  -
patients with diabetes mellitus treated with insulin may require dose reductions after initiation of
therapy with pegvisomant

Opoids-
patients on opioids often needed higher pegovisomant concentrations to acheive appropiate
IGI -I suppression compared with patients not receiving opiods.

Acromegaly

Acromegaly-
When growth hormones- secreting tumors develop after puberty , acromegaly results. The disorder
occurs equally in men and women. Approximately  10 to 15 perecent of all large pitutiary  tumors
secrete growth hormone and cause acromegaly.

Because of the slow progression of the disease the changes in physical features, which often
begin between second and fourth decade are frrqeuntly not recongnized for 10 to 20 years

Adverse reactions were mild to moderate intensity and limited duration. most advere reactions
did not appear to be dose dependent

CNS -       dizziness 4%      

GI -         abnormal liver function tests 4%           nausea  8%

Miscellaneous -        pain  4%    injection site reaction  4%     accidental injury  4%
                                   flu syndrome 12%       chest pain  8%

Special precautions-
Tumor growth- tumors that secrete growth hormone GH may expand and cause serious
complications. Therefore all patients with these tumors including those who are receiving
pegovisomant should be carefully monitered with periodic imaging scans of sella turcica

Glucose metabolism- Patients  with diabetic mellitus treated with pegvisomant had  clinically
relevant hypoglycemia. These patients should be monitored and doses of antidiabetic
drugs reduced as necesary

GH deficiency- a state functional H deficiency may result from administration of pegvisomant.
Therefore patients should  be carefully observed for clinical symptoms of GH deficiency and
serum IGI -I concentration should be monitored and maintained within the age-adjusted normal
range

Pregnancy- pegvisomant should be used during pregnancy only if required

Lactation- caution should be excercised when pegvisomant is administred to a breast feeding
woman

Children- safety and efficacy of pegvisomant in children have not been established

Elderly- dose selection in an elderly patient should be cautious, usually starting at a low
end of dosing schedule, because of greater frequency of decreased hepatic, renal or
cardiac function and concomittant disease or other drug therapy
 

Indication-
Acromegaly

Dosage-
A loading dose of 40mg should be administred subcutaneously under physician supervision.
Patients should then be instructed to to begin daily subcutaneous injection of 10mg

1. Patients and other persons who may administer pegvisomant should be carefully instructed
    by a health care professional on how to properly reconstitute and inject the product

2. Patients should be informed for serial monitoring of LTs and told to immediately discontinue
    therapy and contact their physician if tey become jaundiced

3. Patients should be made aware that serial iGF-I levels will need to be obtained to allow
    physician to properly adjust the dose of pegvisomant

Pregnancy-
Pegvisomant should be used during pregnancy only if required

Lactation-
Caution should be excercised when pegvisomant is administred to a breast feeding
woman

Children-
Safety and efficacy of pegvisomant in children have not been established

Elderly-
Dose selection in an elderly patient should be cautious, uusually starting at a low
end of dosing schedule, because of greater frequency of decreased hepatic, renal or
cardiac function and concomittant disease or other drug therapy