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Thyrogen

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Overview

What is Thyrogen?

Each vial of THYROGEN contains 1.1 mg thyrotropin alfa, 36 mg Mannitol, 5.1 mg Sodium Phosphate, and 2.4 mg Sodium Chloride

THYROGEN (thyrotropin alfa for injection) contains recombinant human thyroid stimulating hormone (TSH). Thyrotropin alfa is synthesized in a genetically modified Chinese hamster ovary cell line.

Thyrotropin alfa is a heterodimeric glycoprotein comprised of two non-covalently linked subunits, an alpha subunit of 92 amino acid residues containing two N-linked glycosylation sites and a beta subunit of 118 residues containing one N-linked glycosylation site. The amino acid sequence of thyrotropin alfa is identical to that of human pituitary TSH.

Both thyrotropin alfa and naturally occurring human pituitary TSH are synthesized as a mixture of glycosylation variants. Unlike pituitary TSH, which is secreted as a mixture of sialylated and sulfated forms, thyrotropin alfa is sialylated but not sulfated. The biological activity of thyrotropin alfa is determined by a cell-based bioassay. In this assay, cells expressing a functional TSH receptor and a cAMP-responsive element coupled to a heterologous reporter gene, luciferase, enable the measurement of thyrotropin alfa activity by measuring the luciferase response. The specific activity of thyrotropin alfa is determined relative to an internal Genzyme reference standard that was calibrated against the World Health Organization (WHO) human TSH reference standard.



What does Thyrogen look like?



What are the available doses of Thyrogen?

Lyophilized powder containing 1.1 mg of thyrotropin alfa for single use after reconstitution with Sterile Water for Injection. ()

What should I talk to my health care provider before I take Thyrogen?

Renal Impairment: Elimination of THYROGEN is significantly slower in dialysis-dependent end stage renal disease patients, resulting in prolonged elevation of TSH levels. ()

How should I use Thyrogen?

THYROGEN is indicated for use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy.

THYROGEN should be used by physicians knowledgeable in the management of patients with thyroid cancer.

THYROGEN is indicated as a two-injection regimen. The recommended dosage of THYROGEN is a 0.9 mg intramuscular injection to the buttock followed by a second 0.9 mg intramuscular injection to the buttock 24 hours later.

THYROGEN should be administered intramuscularly only. THYROGEN should not be administered intravenously.

Pretreatment with glucocorticoids should be considered for patients in whom tumor expansion may compromise vital anatomic structures [].

Routine measurement of serum TSH levels is not recommended after THYROGEN use.


What interacts with Thyrogen?

Sorry No Records found


What are the warnings of Thyrogen?

Sorry No Records found


What are the precautions of Thyrogen?

Sorry No Records found


What are the side effects of Thyrogen?

Sorry No records found


What should I look out for while using Thyrogen?

None


What might happen if I take too much Thyrogen?

In clinical trials of THYROGEN, three patients experienced symptoms after receiving THYROGEN doses higher than those recommended. Two patients had nausea after a 2.7 mg IM dose (3 times the recommended dose), and in one of these patients, the event was accompanied by weakness, dizziness and headache. Another patient experienced nausea, vomiting and hot flashes after a 3.6 mg IM dose (4 times the recommended dose). There is no specific therapy for THYROGEN overdose. Supportive care is recommended.


How should I store and handle Thyrogen?

THYROGEN (thyrotropin alfa for injection) is supplied as a sterile, non-pyrogenic, lyophilized product. It is available as a two-vial kit. containing 1.1 mg of THYROGEN. NDC 58468-0030-2 (2-vial kit)THYROGEN is for intramuscular injection to the buttock. The lyophilized powder should be reconstituted immediately prior to use with 1.2 mL of Sterile Water for Injection, USP Each vial of THYROGEN and each vial of diluent, if provided, is intended for single use.THYROGEN (thyrotropin alfa for injection) is supplied as a sterile, non-pyrogenic, lyophilized product. It is available as a two-vial kit. containing 1.1 mg of THYROGEN. NDC 58468-0030-2 (2-vial kit)THYROGEN is for intramuscular injection to the buttock. The lyophilized powder should be reconstituted immediately prior to use with 1.2 mL of Sterile Water for Injection, USP Each vial of THYROGEN and each vial of diluent, if provided, is intended for single use.THYROGEN (thyrotropin alfa for injection) is supplied as a sterile, non-pyrogenic, lyophilized product. It is available as a two-vial kit. containing 1.1 mg of THYROGEN. NDC 58468-0030-2 (2-vial kit)THYROGEN is for intramuscular injection to the buttock. The lyophilized powder should be reconstituted immediately prior to use with 1.2 mL of Sterile Water for Injection, USP Each vial of THYROGEN and each vial of diluent, if provided, is intended for single use.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Thyrotropin (TSH) is a pituitary hormone that stimulates the thyroid gland to produce thyroid hormone. Binding of thyrotropin alfa to TSH receptors on normal thyroid epithelial cells or on well-differentiated thyroid cancer tissue stimulates iodine uptake and organification, and synthesis and secretion of thyroglobulin (Tg), triiodothyronine (T3) and thyroxine (T4).

The effect of thyroid stimulating hormone activation of thyroid cells is to increase uptake of radioiodine to allow scan detection or radioiodine killing of thyroid cells. TSH activation also leads to the release of thyroglobulin by thyroid cells. Thyroglobulin functions as a tumor marker which is detected in blood specimens.

Non-Clinical Toxicology
None

When given to patients who have substantial thyroid tissue still or functional thyroid cancer metastases, THYROGEN is known to cause a transient (over 7 to 14 days) but significant rise in serum thyroid hormone concentration. There have been reports of death in non-thyroidectomized patients and in patients with distant metastatic thyroid cancer in which events leading to death occurred within 24 hours after administration of THYROGEN. Patients with residual thyroid tissue at risk for THYROGEN-induced hyperthyroidism include the elderly and those with a known history of heart disease. Hospitalization for administration of THYROGEN and post-administration observation in patients at risk should be considered.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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