thyrotropin alfa (Rx)

Brand and Other Names:Thyrogen
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 1.1mg/vial
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Serum Thyroglobulin Testing

Indicated 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

2 dose regimen: 0.9 mg IM in buttock, followed by 2nd 0.9 mg IM injection 24 hr later

Obtain serum Tg sample 72 hr after final injection

If indicated, oral radioiodine should be given 24 hr after the second injection

Diagnostic scanning should be performed 48 hr after the radioiodine administration

Limitations of use

  • Thyrotropin-stimulated Tg levels are generally lower than, and do not correlate with Tg levels after thyroid hormone withdrawal
  • Even when thyrotropin-Tg testing is performed in combination with radioiodine imaging, there remains a risk of missing a diagnosis of thyroid cancer or underestimating the extent of the disease
  • Anti-Tg antibodies may confound the Tg assay and render Tg levels uninterpretable

Remant Thyroid Tissue Ablation

Indicated as adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer

2 dose regimen: 0.9 mg IM in buttock, followed by 2nd 0.9 mg IM injection 24 hr later

Oral radioiodine should be given 24 hr after the second injection

<16 years: Safety and efficacy not established

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Adverse Effects

>10%

Nausea (11%)

1-10%

Headache (6%)

Fatigue (2%)

Vomiting (2%)

Dizziness (2%)

Asthenia (1%)

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Warnings

Contraindications

None

Cautions

Known to cause a transient (over 7 to 14 days) but significant rise in serum thyroid hormone concentration when given to patients who have substantial thyroid tissue still in situ or functional thyroid cancer metastases

Sudden, rapid and painful tumor enlargement reported

CHF, hypopituitarism, concurrent use of corticosteroids

Anaphylactic reaction may occur after repeated use of thyrotropin

Radioiodine testing 24 hr after final thyrotropin dose

Reports of death within 24 hr after administration; patients for whom thyrotropin-induced hyperthyroidism could have serious consequences (eg, heart disease, extensive metastatic disease), consider hospitalization for administration and postadministration observation

Reports of neurologic events, including acute hemiplegia or hemiparesis, occurring 1-3 days after administration to patients with CNS metastases; these events associated with sudden rapid tumor enlargement

Postmarketing reports of stroke or unilateral weakness occurring within 72 hr (range 20 minutes to 3 days) of administration to women without known CNS metastases

Tumor enlargement that is sudden, rapid and painful reported within 12-48 hr of administration; symptoms include dyspnea, stridor, or dysphonia; rapid clinical improvement occurred following glucocorticoid therapy (consider pretreatment with glucocorticoids if local tumor expansion may compromise vital anatomic structures)

Use caution in patients with known history of heart disease

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: Unknown if distributed in human milk; use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Recombinant thyroid stimulating hormone (TSH); increases iodine uptake by thyroid & formation, secretion, or release of thyroid hormones; stimulates the secretion of Tg from any remaining thyroid tissue remenants; elevated Tg levels suggest the presence of remmnant thyroid tissues

Pharmacokinetics

Half-life: 15-35 hr

Peak plasma time: 3-24 hr after injection

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Administration

IM Preparation

Add 1.2 mL of sterile water for injection to the vial containing lyophilized powder

Do not shake the solution; swirl the contents of the vial until all the material is dissolved

Reconstituted solution concentration is 0.9 mg/mL

IM Administration

Visually inspect the reconstituted solution for particulate matter and discoloration prior to administration; it should be clear and colorless (do not use if particulate matter present, or solution is cloudy or discolored)

Inject 1 mL (0.9 mg) IM in the buttocks

Discard unused portions

Do not mix with other substances

Storage

Protect from light

Refrigerate at 2-8ºC (36-46ºF)

Reconstituted vial

  • Room temperature: Use within 3 hr
  • Refrigerated (2-8ºC [36-46ºF]): Use within 24 hr
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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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