Thyrogen (thyrotropin alfa for injection)
FDA approval for a supplemental indication for Thyrogen to be used in combination with radioiodine to ablate, or destroy, the remaining thyroid tissue in patients who have had their cancerous thyroids removed. The product was initially approved in the United States in 1998 for use as an adjunctive diagnostic tool for serum thyroglobulin testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer. A 2-injection regimen is recommended. The 2-injection regimen is Thyrogen 0.9 mg intramuscularly (IM), followed by a second 0.9-mg IM injection 24 hours later. After reconstitution with 1.2 mL sterile water for injection, a 1.0-mL solution (0.9 mg thyrotropin alfa) is administered by IM injection to the buttock. For radioiodine imaging or remnant ablation, radioiodine should be administered 24 hours following the final Thyrogen injection. The product is supplied as a sterile, nonpyrogenic, lypophilized product. It is available in a 2- or 4-vial kit. The 2-vial kit contains two 1.1-mg vials of Thyrogen. The 4-vial kit contains two 1.1-mg vials of Thyrogen as well as two 10-mL vials of sterile water for injection USP.
Thyrogen (α-促甲状腺素)，既可作为辅助诊断工具又可用于治疗甲状腺癌[肌内(IM)注射]。
Generic Name for THYROGEN
Thyrotropin alfa 1.1mg/vial; lyophilized pwd for IM inj after reconstitution; contains mannitol.
Legal Classification:
Rx
Pharmacological Class for THYROGEN
Thyroid stimulating hormone (recombinant).
Manufacturer of THYROGEN
Genzyme Corporation
Indications for THYROGEN
Adjunctive diagnostic tool for serum thyroglobin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer. 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 metastatic thyroid cancer.
Adult dose for THYROGEN
≥16yrs: Give by IM inj into the buttock. 0.9mg, followed by a second 0.9mg injection 24 hours later. For radioiodine imaging or remnant ablation, give radioiodine 24 hours after the final thyrogen injection.
Children's dosing for THYROGEN
<16yrs: not recommended.
Precautions for THYROGEN
See literature. Heart disease, extensive metastatic disease, or other serious underlying illnesses; increased risk of Thyrogen-induced hyperthyroidism, consider hospitalization for administration and post-administration observation. Thyroglobulin (Tg) antibodies may render Tg levels uninterpretable; consider further evaluation with thyroid hormone withdrawal scan. Previous bovine TSH treatment. Residual thyroid tissue. End-stage renal disease. Elderly (increased risk of cardiac effects). Pregnancy (Cat.C). Nursing mothers.
Adverse Reactions for THYROGEN
Nausea, headache, fatigue, influenza-like symptoms.
How is THYROGEN supplied?
2-vial kit—2 vials of Thyrogen
4-vial kit—2 vials of Thyrogen + 2 vials of diluent
FDA 批准Thyrogen用于去除甲状腺癌的治疗
Genzyme 公司宣布FDA已同意批准注射用促甲状腺素α（thyrotropin alfa，Thyrogen）与射碘（radioiodine）联合用于已施手术的甲状腺癌患者去除、破环残余甲状腺组织的补充适应证。清除残余甲状腺是治疗甲状腺癌的必要措施。
本品的新增适应证对于已经过初步治疗的甲状腺癌患者而言具有显著的意义，目前本品不但可以在诊断甲状腺癌复发中使用，且可在清除残余甲状腺放疗手术中使用。
美国癌症协会2007年评估了在美国诊断出33550 甲状腺新病例， 大约90%的甲状腺患者的分化程度很高，这些患者为甲状腺残余清除手术的候选者。研究结果表明本品显著提高了患者在治疗期间及治疗后的生活质量。开发新的治疗药物对甲状腺的治疗来说是当务之急，因为在美国所有的女性癌症患者中，甲状腺癌的发病率急速上升。
1998年本品首先在美国获准用于高分化甲状腺癌复发情况的诊断试剂，随后于2001年在欧盟获准。本品增加了诊断的灵敏度，此外，Genzyme 公司的Thyrogen于2005年在欧盟被批准用于甲状腺残余手术中的治疗。