Data from FDA - Curated by EPG Health - Last updated 19 December 2016

Indication(s)

INDICATIONS AND USAGE TRH is indicated as an adjunctive agent in the diagnostic assessment of thyroid function.

As an adjunct to other diagnostic procedures, testing with TRH (protirelin) may yield useful information in patients with pituitary or hypothalamic dysfunction.

TRH is indicated as an adjunct to evaluate the effectiveness of thyrotropin suppression with a particular dose of T4 in patients with nodular or diffuse goiter.

A normal TSH baseline value and a minimal difference between the 30 minute and baseline response to TRH injection would indicate adequate suppression of the pituitary secretion of TSH. TRH may be used, adjunctively, for adjustment of thyroid hormone dosage given to patients with primary hypothyroidism.

A normal or slightly blunted TSH response, thirty minutes following TRH injection, would indicate adequate replacement therapy.

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Advisory information

Special warnings and precautions

PRECAUTIONS General: Thyroid hormones reduce the TSH response to TRH.

Accordingly, patients in whom TRH is to be used diagnostically should be taken off liothyronine (T3) approximately seven days prior to testing and should be taken off thyroid medications containing levothyroxine (T4), e.g., desiccated thyroid, thyroglobulin, or liotrix, at least 14 days before testing.

Hormone therapy is NOT to be discontinued when the test is used to evaluate the effectiveness of thyroid suppression with a particular dose of T4 in patients with nodular or diffuse goiter, or for adjustment of thyroid hormone dosage given to patients with primary hypothyroidism.

Chronic administration of levodopa has been reported to inhibit the TSH response to TRH.

It is not advisable to withdraw maintenance doses of adrenocortical drugs used in the therapy of known hypopituitarism.

Several published reports have shown that prolonged treatment with glucocorticoids at physiologic doses has no significant effect on the TSH response to thyrotropin releasing hormone, but that the administration of pharmacologic doses of steroids reduces the TSH response.

Therapeutic doses of acetylsalicylic acid (2 to 3.6 g/day) have been reported to inhibit the TSH response to protirelin.

The ingestion of acetylsalicylic acid caused the peak level of TSH to decrease approximately 30 % as compared to values obtained without acetylsalicylic acid administration.

In both cases, the TSH peak occurred 30 minutes post-administration of protirelin.

Adverse reactions

ADVERSE REACTIONS Side effects have been reported in about 50 % of the patients tested with TRH.

Generally, the side effects are moor, have occurred promptly, and have persisted for only a few minutes following injection.

Cardiovascular reactions: Marked changes in blood pressure, including both hypertension and hypotension with or without syncope, have been reported in a small number of patients.

Endocrine reaction: Breast enlargement and leakage in lactating women for up to two or three days.

Other reactions: Headaches, sometimes severe, and transient amaurosis in patients with pituitary tumors.

Rarely, convulsions may occur in patients with predisposing conditions, e.g., epilepsy, brain damage.

Nausea; urge to urinate; flushed sensation; light-headedness; bad taste in mouth; abdominal discomfort; and dry mouth.

Less frequently reported were: Anxiety; sweating; tightness in the throat; pressure in the chest; tingling sensation; drowsiness; and allergic reactions.

Pituitary apoplexy requiring acute neurosurgical intervention has been reported infrequently for patients with pituitary macroadenomas following the acute administration of protirelin injection in the setting of combined anterior pituitary function testing in conjunction with LHRH and insulin.

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION TRH is intended for intravenous administration with the patient in the supine position.

The drug is administered as a bolus over a period of 15 to 30 seconds, with the patient remaining supine until all scheduled post injection blood samples have been taken.

Blood pressure should be measured before TRH is administered and at frequent intervals during the first 15 minutes thereafter (see WARNINGS).

Have the patient urinate before injecting TRH. Adults: 500?

g.

Doses between 200 and 500?g have been used.

500?g is considered the optimum dose to give the maximum response in the greatest number of patients.

Doses greater than 500 ?g are unlikely to elicit a greater TSH response.

Children age 6 to 16 years: 7?g/ kg body weight up to a dose of 500?

g.

Infants and children up to 6 years: Experience is limited in this age group; doses of 7?g/ kg have been administered.

One blood sample for TSH assay should be drawn immediately prior to the injection of TRH, and a second sample should be obtained 30 minutes after injection.

The TSH response to TRH is reduced by repetitive administration of the drug.

Accordingly, if the TRH test is repeated, an interval of seven days before testing is recommended.

Elevated serum lipids may interfere with the TSH assay.

Thus, fasting (except in patients with hypopituitarism) or a low-fat meal is recommended prior to the test.

More information

Category Value
Orphan designation No
Product NDC 51808-209
Date Last Revised 19-06-2012
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder AnazaoHealth Corporation