Thyrotropin alfa
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From MedlinePlus, U.S. National Library of Medicine
Thyroid Stimulating Hormone
Dosing in kidney impairment
Renal Impairment Elimination of THYROGEN is significantly slower in dialysis-dependent end-stage renal disease (ESRD) patients, resulting in prolonged elevation of TSH levels.
Preparation and administration
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Reconstitution, Preparation, and Administration of THYROGEN The supplied lyophilized powder must be reconstituted with Sterile Water for Injection, USP. THYROGEN should be prepared, and administered in the following manner: Reconstitute each 0.9 mg vial of THYROGEN with 1.2 mL of Sterile Water for Injection, USP to yield a single-dose solution containing 0.9 mg/mL of thyrotropin alfa that delivers 1 mL (0.9 mg).
Gently swirl the contents of the vial until all the material is dissolved. Do not shake the solution. Visually inspect the reconstituted solution for particulate matter and discoloration prior to administration. The reconstituted THYROGEN solution should be clear and colorless. Do not use if the solution has particulate matter or is cloudy or discolored.
Withdraw 1 mL of the reconstituted THYROGEN solution (0.9 mg of thyrotropin alfa) and inject intramuscularly in the buttocks. Discard any unused portions. The reconstituted THYROGEN solution must be injected within 3 hours unless refrigerated. If necessary, the reconstituted solution can be stored refrigerated at a temperature between 2°C and 8°C (36°F to 46°F) for up to 24 hours, while avoiding microbial contamination.
Do not mix with other substances.
Timing of Serum Thyroglobulin Testing Following THYROGEN Administration For serum thyroglobulin testing, the serum sample should be obtained 72 hours after the final injection of THYROGEN [see Clinical Studies ] .
Timing for Remnant Ablation and Diagnostic Scanning Following THYROGEN Administration Oral radioiodine should be given 24 hours after the second injection of THYROGEN in both remnant ablation and diagnostic scanning. The activity of 131 I is carefully selected at the discretion of the nuclear medicine physician. Diagnostic scanning should be performed 48 hours after the radioiodine administration.
Contraindications
If THYROGEN is administered with radioiodine, the contraindications to radioiodine also apply to this combination regimen. Refer to the radioiodine prescribing information for a list of contraindications for radioiodine. If THYROGEN is administered with radioiodine, the contraindications to radioiodine also apply to this combination regimen. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary THYROGEN may be used in combination with radioiodine (RAI). If THYROGEN is administered with RAI, the combination regimen is contraindicated in pregnant women because fetal exposure to RAI can lead to neonatal hypothyroidism, which in some cases is severe and irreversible. Refer to the RAI prescribing information for more information on use during pregnancy. Available data from case reports and postmarketing experience with THYROGEN use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with THYROGEN.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
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Therapeutic equivalence (Orange Book)
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