Adjunctive diagnostic tool for serum throglobulin (Tg ) testing

Most common adverse reactions-

Nausea 10% , headache  6%

CNS -    dizziness 2%   headache  6%

GI -       nausea 10%     vomiting 2%

Miscellaneous -   fatigue   3%

Not known

Special Precautions/Warnings-

Administration-   administer thyrotropin alfa  IM  , do not administer  IV

Pretreatment with glucocorticoids -  it is recommended that  treatment with
 glucocorticooids  be considered for patients in whom local tumor expansion may
compromise vital anatomic structures  eg trachea, CNS, or extensive ,microscopic
lung metastases.

Antibodies -  Tg antibodies confound the Tg assay and render Tg levels uninterpretable.
Even with negative or lower stage thyrotropin alfa radioiodine scan , consider evaluating
patients further with a confirmatory thyroid hormone withdrawal scan to determine  the
location of thyroid cancer.

Renal function impairment -  elimination of thyrotropin alfa is significantly slower  in
 dialysis -dependent  end stage renal disease ESRD  patients  resulting in prolonged
elevation of thyroid stimulating hormone levels. ESRD patients who receive throtropin alfa
 may have markedly elevated thyroid-stimulating hoemone levels for several days  after
treatment which may lead to increased risk of headache and nausea.

Special risk - excercise caution in patients with a known history of heart disease  and
significant residual thyroid tissue.

Pregnancy- give thyrotropin alfa to a pregnant womwn only if clearly needed.

Lacation-  excercise caution when administering thyrotropin alfa to a breast-feeding woman

Children- safety and efficacy in pediatric patients younger than 16 years of age have not
been established

Elderly -  no differences in the safety and efficacy of thyroptropin alfa between patients
younger than 65 years of age and older than 65 years of age reported.

Indication-

Adjunctive diagnostic tool for serum throglobulin (Tg ) testing

Dosage-

Usual dose - a  2-injection regimen recommended for thyrotropin alfa injection.

The 2-injection regimen  is thyrotropin alfa ( 1ml ) intramuscularly ( IM )  into the buttock , followed by a second 0.9mg ( 1ml ) IM injection 24 hours later.

Pregnancy-
Give thyrotropin alfa to a pregnant womwn only if clearly needed.

Lacation- 
Excercise caution when administering thyrotropin alfa to a breast-feeding woman

Children-
Safety and efficacy in pediatric patients younger than 16 years of age have not
been established

Elderly -                                                                                                                                       No differences in the safety and efficacy of thyroptropin alfa between patients
younger than 65 years of age and older than 65 years of age reported.