THYROTROPIN ALFA

Thyrotropin alfa is a recombinant form of thyroid-stimulating hormone belonging to the class of diagnostic agents. It received FDA approval on 30 November 1998 for medical use.

Thyrotropin alfa is available as an injection. It is used in people who have had their thyroid gland removed and are taking thyroid hormones to detect certain types of thyroid cancer. It is also used with radioiodine treatment to eliminate the thyroid tissue which is left over after surgical removal of the thyroid gland in patients who do not have secondary cancer growths and in those who are taking thyroid hormone.

Thyrotropin Alfa will be administered to you by a doctor or other healthcare professional in a hospital setting trained in cancer chemotherapy. Your doctor will decide the dose, route of administration, and duration of the therapy based on your disease status, severity, and other factors such as body weight, other disease conditions, and age. This medicine will be given intramuscularly. Do not self-administer the injection.

The common side effects of thyrotropin alfa are headache, nausea, and vomiting. Other serious side effects include hyperthyroidism, severe skin hypersensitivity, and CNS problem.

This injection may cause drug-induced thyroid. Check your thyroid levels regularly. Stroke has been reported in patients receiving this injection. Report any symptoms of face drooping, arm weakness, or speaking difficulties immediately to your physician.

Inform your physician if you have heart, kidney, or liver disease before initiating the treatment. Due to limited data, the medicine's safety in children is not well established. No special precautions are needed for elderly patients taking this medicine. Do not breastfeed or become pregnant during the treatment with this medicine. Inform your doctor if you are pregnant, suspecting, or planning for pregnancy before receiving this medicine. Inform your healthcare provider about all the medicines you take, including prescription medications, over-the-counter medications, nutritional and vitamin supplements, and herbal products. Certain medications interact with thyrotropin alfa and reduce its effectiveness by causing undesirable side effects. Inform your doctor if you are using birth control pills.

Store in a refrigerator between 2°C and 8°C. Protect from light and excessive moisture. Keep out of reach of children and pets. If you miss a scheduled dose, inform your healthcare professional immediately to reschedule. A healthcare professional will administer this medicine intramuscularly and monitor you throughout treatment. Drink extra fluids before treatment with this medicine. You may receive additional medication prior to starting treatment. Inform your doctor if you are taking birth control pills. This medicine may be administered together with radioiodine. You will be exposed to radiation during radioiodine treatment. Discuss with your doctor the precautions you and people around you should take.

Thyrogen 0.9 mg powder for solution for injection - Summary of Product Characteristics (SmPC) - (emc). www.medicines.org.uk. Published September 2022. Accessed May 5, 2023. http://www.medicines.org.uk/emc/product/235/smpc Genzyme Corporation, US Food and Drug Administration, [ Accessed on may 5, 2023], https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020898s051lbl.pdf Ujjal Mallick et al; Ablation with low-dose radioiodine and thyrotropin alfa in thyroid cancer; The New England Journal of Medicine; Published on May 2012; Accessed on 05/05/2023; https://pubmed.ncbi.nlm.nih.gov/22551128/