DOSAGE AND ADMINISTRATION
Recommended Dosage
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 [
see
Warnings and Precautions
(
5.3
)].
Routine
measurement of serum TSH levels is not recommended after
THYROGEN use.
Reconstitution, Preparation, and Administration of THYROGEN
The supplied lyophilized powder must be reconstituted
with Sterile Water for Injection. THYROGEN should be
prepared, and administered in the following
manner:
- Add 1.2 mL of Sterile Water for Injection to the vial
containing the THYROGEN lyophilized powder.
- Swirl the contents of the vial until all the material is
dissolved. Do not shake the solution. The
reconstituted THYROGEN solution has a concentration of 0.9
mg of thyrotropin alfa per mL.
- 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.
- The reconstituted THYROGEN solution must be injected
within 3 hours unless refrigerated; if refrigerated, the
reconstituted solution may be kept for up to 24
hours.
- Discard unused portions. 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
(
14.1
)
].
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 131I is
carefully selected at the discretion of the nuclear medicine
physician.
Diagnostic scanning should be
performed 48 hours after the radioiodine
administration.
DOSAGE FORMS AND STRENGTHS
THYROGEN is a lyophilized powder containing 1.1 mg of
thyrotropin alfa for single use after reconstitution with Sterile Water
for Injection.
Supplied as:
- Two vial kit (two vials of lyophilized thyrotropin alfa).
- Four vial kit (two vials of lyophilized thyrotropin alfa) and two
vials of 10 mL vials of Sterile Water for Injection).
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