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Thyrotropin alfa (recombinant human thyrotropin): Drug information

Thyrotropin alfa (recombinant human thyrotropin): Drug information
(For additional information see "Thyrotropin alfa (recombinant human thyrotropin): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Thyrogen
Brand Names: Canada
  • Thyrogen
Pharmacologic Category
  • Diagnostic Agent
Dosing: Adult

Note: Consider pretreatment with glucocorticoids for patients in whom local tumor expansion may compromise vital anatomic structures. Oral radioiodine should be administered 24 hours following the second thyrotropin alfa injection (for diagnostic scanning and remnant ablation). Perform diagnostic scanning 48 hours after radioiodine administration (72 hours after the second thyrotropin alfa injection).

Diagnostic imaging

Diagnostic imaging: IM: 0.9 mg, followed 24 hours later by a second 0.9 mg dose; obtain serum Tg sample 72 hours after the second thyrotropin alfa injection.

Thyroid tissue remnant ablation

Thyroid tissue remnant ablation: IM: 0.9 mg, followed 24 hours later by a second 0.9 mg dose.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, elimination is significantly slower in dialysis-dependent end-stage renal disease and TSH level elevation may be prolonged.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Gastrointestinal: Nausea (11%)

1% to 10%:

Central nervous system: Headache (6%), dizziness (2%), fatigue (2%)

Gastrointestinal: Vomiting (2%)

Neuromuscular & skeletal: Weakness (1%)

Frequency not defined: Endocrine & metabolic: Altered thyroid hormone levels (increased)

<1%, postmarketing, and/or case reports: Cerebrovascular accident (with and without physiologic symptoms like unilateral weakness), flu-like symptoms (transient; including arthralgia, chills, fever, malaise, myalgia, shivering), hypersensitivity reaction (including dyspnea, flushing, pruritus, skin rash, urticaria), injection site reaction (including bruising, erythema, pain, and pruritus)

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Hypersensitivity to thyrotropin alfa or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Hyperthyroidism: Thyrotropin alfa use may cause a transient (over 7 to 14 days) and significant rise in serum thyroid hormone concentration in patients with substantial in situ thyroid tissue or with functional thyroid cancer metastases. Thyrotropin alfa-induced hyperthyroidism may result in serious complications in patients with certain risk factors (heart disease, advanced age, extensive metastatic disease, or with underlying serious illness); consider hospitalization for administration and subsequent observation. Deaths within 24 hours of thyrotropin alfa administration have been reported.

• Stroke: Postmarketing reports of stroke or symptoms suggestive of stroke (eg, unilateral weakness) have occurred within 3 days (range: 20 minutes to 3 days) of thyrotropin alfa administration in patients without known CNS metastases. The majority of these patients had risk factors for stroke (eg, smokers, history of migraine) or were young females taking oral contraceptives. Patients should be well hydrated prior to thyrotropin alfa administration.

• Tumor growth: Sudden, rapid, and painful growth of residual thyroid tissue or distant metastases may occur following thyrotropin alfa administration. Symptoms are associated with tissue location and include acute hemiplegia, hemiparesis, and vision loss 1 to 3 days after administration. Laryngeal edema, pain at site of distant metastases, and respiratory distress requiring tracheotomy have also been reported. Consider glucocorticoid premedication in patients where local tumor enlargement may compromise vital structures.

Disease-related concerns:

• Cardiovascular disease: Patients with known history of heart disease in the presence of significant residual thyroid tissue are at increased risk for thyrotropin alfa-induced hyperthyroidism.

• Renal impairment: Thyrotropin alfa elimination is significantly reduced in dialysis-dependent end-stage renal disease, leading to prolonged elevation of TSH levels.

Special populations:

• Older adult: Elderly patients with residual thyroid tissue are at increased risk for thyrotropin alfa-induced hyperthyroidism.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intramuscular [preservative free]:

Thyrogen: 0.9 mg (1 ea)

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Thyrogen Intramuscular)

0.9 mg (per each): $2,372.69

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intramuscular:

Thyrogen: 0.9 mg (1 ea)

Administration: Adult

IM: Administer only by IM injection into the buttock. Do not administer IV.

Use: Labeled Indications

Diagnostic imaging: Adjunctive diagnostic tool for serum thyroglobulin (Tg) testing (with or without radioiodine imaging) in follow-up of patients with well-differentiated thyroid cancer (DTC) who have previously undergone thyroidectomy.

Limitations of use: Thyrotropin alfa-stimulated Tg levels are generally lower than and do not correlate with Tg levels after thyroid hormone withdrawal; even when thyrotropin alfa-stimulated Tg testing is performed in combination with radioiodine imaging, there is a risk of missing a thyroid cancer diagnosis or of underestimating disease extent. Anti-Tg antibodies may confound Tg assay and render Tg levels uninterpretable; in such cases, even with a negative or low-stage thyrotropin alfa radioiodine scan, consider further patient evaluation.

Thyroid tissue remnant ablation: Adjunctive treatment for radioiodine ablation of thyroid tissue remnants after total or near-total thyroidectomy in patients with well-differentiated thyroid cancer without evidence of metastatic disease.

Limitations of use: The effect of thyrotropin alfa on thyroid cancer recurrence >5 years postremnant ablation has not been evaluated.

Guideline recommendations: The American Thyroid Association guidelines recommend thyrotropin alfa as a reasonable alternative to thyroid hormone withdrawal prior to remnant ablation or adjuvant therapy in patients with low- or intermediate-risk DTC without extensive lymph node involvement. Thyrotropin alfa may also be considered in intermediate-risk DTC with extensive lymph node disease (but without distance metastases), though the evidence is of lower quality (ATA [Haugen 2016).

Medication Safety Issues
Sound-alike/look-alike issues:

Thyrogen may be confused with Thyrolar

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Reproductive Considerations

Evaluate pregnancy status prior to use in females of reproductive potential when thyrotropin alfa is administered with radioiodine (ATA [Haugen 2016]).

Pregnancy Considerations

Use of thyrotropin alfa administered with radioiodine is contraindicated during pregnancy.

Breastfeeding Considerations

It is not known if thyrotropin alfa is present in breast milk.

According to the manufacturer, the decision to continue or discontinue breastfeeding following diagnostic testing with thyrotropin alfa should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of testing to the mother. Thyrotropin alfa administered with radioiodine is contraindicated in breastfeeding women.

Monitoring Parameters

Monitor for neurologic adverse events (hemiplegia, hemiparesis, stroke, weakness); dyspnea, dysphonia, stridor or other symptoms of local tumor growth, signs/symptoms of hyperthyroidism

Reference Range

In preparation for radioactive iodine (RAI) remnant ablation or diagnostic testing a goal TSH of >30 milliunits/L is recommended (ATA [Haugen 2016])

Mechanism of Action

Thyrotropin alfa, derived from a recombinant DNA source, has the identical amino acid sequence as endogenous human thyroid stimulating hormone (TSH). As a diagnostic tool in conjunction with serum thyroglobulin (Tg) testing, thyrotropin alfa stimulates the secretion of Tg from any remaining thyroid tissues (remnants). Under conditions of successful thyroidectomy and complete ablation, very little serum Tg should be detected under TSH stimulatory conditions; conversely, elevated Tg levels suggest the presence of remnant thyroid tissues. Since the source of TSH is exogenous, stimulation of Tg synthesis can be achieved in euthyroid patients, avoiding the need for thyroid hormone withdrawal.

As an adjunctive agent for radioiodine ablation treatment of thyroid cancer tissue remnants, thyrotropin alfa binds to TSH receptors on these tissues, stimulating the uptake and organification of iodine, including radiolabeled iodine (I131). Cancerous tissue is destroyed via gamma emission from the radioiodine concentrated in these tissues.

Pharmacokinetics (Adult Data Unless Noted)

Half-life elimination: 25 ± 10 hours

Time to peak: Median: 10 hours (range: 3 to 24 hours)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Thyrogen;
  • (AT) Austria: Thyrogen;
  • (AU) Australia: Thyrogen;
  • (BE) Belgium: Thyrogen;
  • (BG) Bulgaria: Thyrogen;
  • (BR) Brazil: Thyrogen;
  • (CL) Chile: Thyrogen;
  • (CO) Colombia: Thyrogen;
  • (CZ) Czech Republic: Thyrogen;
  • (DE) Germany: Thyrogen;
  • (DO) Dominican Republic: Thyrogen;
  • (EC) Ecuador: Thyrogen;
  • (EE) Estonia: Thyrogen;
  • (FI) Finland: Thyrogen;
  • (FR) France: Thyrogen;
  • (HK) Hong Kong: Thyrogen;
  • (HR) Croatia: Thyrogen;
  • (HU) Hungary: Thyrogen;
  • (IE) Ireland: Thyrogen;
  • (IL) Israel: Thyrogen;
  • (IT) Italy: Thyrogen;
  • (JP) Japan: Thyrogen;
  • (KR) Korea, Republic of: Thyrogen;
  • (LB) Lebanon: Thyrogen;
  • (LT) Lithuania: Thyrogen;
  • (LV) Latvia: Thyrogen;
  • (MX) Mexico: Thyrogen | Tirotropina;
  • (MY) Malaysia: Thyrogen;
  • (NL) Netherlands: Thyrogen;
  • (NO) Norway: Thyrogen;
  • (PE) Peru: Thyrogen;
  • (PK) Pakistan: Thyrogen;
  • (PL) Poland: Thyrogen;
  • (PR) Puerto Rico: Thyrogen;
  • (PT) Portugal: Thyrogen;
  • (QA) Qatar: Thyrogen;
  • (RO) Romania: Thyrogen;
  • (RU) Russian Federation: Thyrogyn;
  • (SE) Sweden: Thyrogen;
  • (SG) Singapore: Thyrogen;
  • (SI) Slovenia: Thyrogen;
  • (SK) Slovakia: Thyrogen;
  • (TW) Taiwan: Thyrogen;
  • (ZA) South Africa: Thyrogen
  1. Haugen BR, Alexander EK, Bible KC, et al. 2015 American Thyroid Association management guidelines for adult patients with thyroid nodules and differentiated thyroid cancer: the American Thyroid Association guidelines task force on thyroid nodules and differentiated thyroid cancer. Thyroid. 2016;26(1):1-133. doi:10.1089/thy.2015.0020 [PubMed 26462967]
  2. Mallick U, Harmer C, Yap B, et al, “Ablation With Low-Dose Radioiodine and Thyrotropin Alfa in Thyroid Cancer,” N Engl J Med, 2012, 366(18):1674-85. [PubMed 22551128]
  3. Pacini F, Ladenson PW, Schlumberger M, et al, “Radioiodine Ablation of Thyroid Remnants After Preparation With Recombinant Human Thyrotropin in Differentiated Thyroid Carcinoma: Results of an International, Randomized, Controlled Study,” J Clin Endocrinol Metab, 2006, 91(3):926-32. [PubMed 16384850]
  4. Schlumberger M, Catargi B, Borget I, et a, “Strategies of Radioiodine Ablation In Patients With Low-Risk Thyroid Cancer,” N Engl J Med, 2012, 366(18):1663-73. [PubMed 22551127]
  5. Thyrogen (thyrotropin alfa) [prescribing information]. Cambridge, MA: Genzyme Corporation; February 2023.
  6. Thyrogen (thyrotropin alfa) [product monograph]. Toronto, Ontario, Canada: Sanofi Genzyme Canada; May 2023.
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