Drug Detail:Thyrotropin alfa (Thyrotropin alfa [ thye-roe-troe-pin-al-fa ])
Drug Class: In vivo diagnostic biologicals Thyroid drugs
Usual Adult Dose for Thyroid Cancer
Two 1 mL (0.9 mg thyrotropin alpha) intramuscular injections into the buttock
- Administer second dose 24 hours after first
Comments:
- Drug stimulated thyroglobulin (Tg) levels are usually lower than, and do not correlate with, thyroid hormone withdrawal Tg levels.
- A missed thyroid cancer diagnosis or underestimation of disease extent can occur despite combination testing with radioiodine imaging.
- Anti-Tg antibodies may lead to uninterpretable Tg levels from Tg assays; consider further evaluating patients with negative or low-stage radioiodine scans.
Use: Adjunctive treatment for ablation in well differentiated thyroid cancer after thyroidectomy and without distant metastases
Usual Adult Dose for Diagnostic
Two 1 mL (0.9 mg thyrotropin alpha) intramuscular injections into the buttock
- Administer second dose 24 hours after first
Comments:
- Long term effects on thyroid cancer outcomes by use of this drug have not been determined.
- There is too little clinical data on use in remnant ablation to say if long term outcomes are equal to those of thyroid hormone withholding prior to ablation.
Use: Adjunctive diagnostic tool for serum thyroglobulin testing in well differentiated thyroid cancer after thyroidectomy
Renal Dose Adjustments
The manufacturer makes no recommendation regarding use in renal impairment.
- Elimination is significantly slower in dialysis dependent end stage renal disease.
- Thyroid stimulating hormone levels may be elevated for a prolonged time.
Liver Dose Adjustments
Data not available
Precautions
CONTRAINDICATIONS: None
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
The manufacturer makes no recommendation regarding use in dialysis.
- Elimination is significantly slower in dialysis dependent end stage renal disease.
- Thyroid stimulating hormone levels may be elevated for a prolonged time.
Other Comments
Administration advice:
- For intramuscular administration only.
- Do not administer intravenously.
- Consider corticosteroid pretreatment if tumor expansion could compromise vital organs.
Storage requirements:
- Refrigerate; protect from light
Reconstitution/preparation techniques:
- Add 1.2 mL sterile water for injection into vial.
- Swirl contents until completely dissolved; do not shake
- Use within 3 hours of reconstitution.
- Reconstituted product may be refrigerated for not more than 24 hours; avoid microbial contamination.
- Solution should be clear.
- Do not use if solution is discolored, cloudy, or has particulates.
IV compatibility:
- Do not mix with other substances.
General:
- Only for use by physicians knowledgeable in thyroid cancer treatment.
Monitoring:
- Routine TSH monitoring is NOT recommended after treatment.
