Indication:
Adjunctive diagnostic tool for serum throglobulin (Tg ) testing
Adverse Reaction:
Most common adverse reactions-
Nausea 10% , headache 6%
CNS - dizziness 2% headache 6%
GI - nausea 10% vomiting 2%
Miscellaneous - fatigue 3%
Contra-Indications:
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.
Dosages/ Overdosage Etc:
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.
Patient Information:
Ref - USP PDI Vol II 17th Edition (1997)
THYROTROPIN- SYSTEMIC
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
Tyrotropin. Also tell your healthcare care professional if you are allergic
to any other substances such as foods. preservatives or dyes.
2.Pregnancy-
Studies have not been done in humans or animals.
3. Breast-feeding-
It is not known whether thyrotropin passes into breast milk. However,
this medicine has not been reported to cause problems in nursing babies.
4.Children-
This medicine has been tested in a limited number of children and has
not been shown to cause different side effects or problems than it
does in adults.
5.Older adults-
Although there is no specific information comparing use of thyrotropin
in the elderly with use in other age groups, this medicine is not expected
to cause different side effects or problems in older people.
6. Other medicines-
When you are taking thyrotropin, it is important that your doctor should
know if you taking-
Thyroid hormones- you may not respond as strongly as thyrotropin if you
have been taking thyroid hormones regularly.
7. Other medical problems-
The presence of other medical problems may affect the use of thyrotropin.
Make sure you tell your doctor if you have any other medical problems
especially-
Hardening of the arteries or
Heart disease or
High blood pressure - thyrotropin increase body metabolism and
cause the heart to work harder, which may make the condition
worse
Untreated underactive adrenal gland or
Untreated underactive pitutiary gland- use of thyrotropin may
severely worsen the conditions
Pregnancy and lactation:
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.
Manufacturer Details