Thyrotropin alfa


Generic Medicine Info
Indications and Dosage
Intramuscular
Adjunctive diagnostic tool with serum thyroglobulin testing in post-thyroidectomy patients for remnant thyroid tissue and well differentiated thyroid cancer
Adult: 2 doses of 0.9 mg at 24-hour intervals into the gluteal muscle.

Intramuscular
Adjunct to radioiodine ablation of thyroid remnants in post-thyroidectomy patients for well differentiated thyroid cancer
Adult: In patients who do not have evidence of distant metastatic thyroid cancer: 2 doses of 0.9 mg at 24-hour intervals into the gluteal muscle.
Reconstitution
Reconstitute vial with 1.2 mL of sterile water for inj to provide a solution containing 0.9 mg/mL.
Special Precautions
Patient with risk factors for hyperthyroidism (e.g. significant residual thyroid tissue, history of cardiac disease); CNS metastases, risk factors for stroke (e.g. history of migraine, smoker). Renal impairment. Elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Transient increase in serum thyroid hormone, stroke or symptoms predictive of stroke (e.g. unilateral weakness); enlargement of residual thyroid tissue or metastases.
Cardiac disorders: Palpitations.
Gastrointestinal disorders: Nausea, vomiting, diarrhea.
General disorders and administration site conditions: Injection site reactions, fatigue, asthenia.
Musculoskeletal and connective tissue disorders: Neck pain, back pain.
Nervous system disorders: Headache, dizziness, paraesthesia.
Skin and subcutaneous tissue disorders: Urticaria, rash, pruritus.
Potentially Fatal: Drug-induced hyperthyroidism.
IM/Parenteral: C
Patient Counseling Information
This drug may cause dizziness and headache, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor neurologic adverse events (e.g. hemiplegia, hemiparesis, stroke, weakness); dyspnoea, dysphonia, stridor; other symptoms of local tumour growth; signs and symptoms of hyperthyroidism.
Overdosage
Symptoms: Nausea, weakness, dizziness, headache, vomiting, hot flushes. Management: Supportive treatment.
Lab Interference
Thyroglobulin assay may be confounded by thyroglobulin antibodies, leading to misinterpreted thyroglobulin levels.
Action
Description:
Mechanism of Action: Thyrotropin alfa is a recombinant TSH which binds to TSH receptors on thyroid epithelial cells stimulating iodine uptake and organification, and synthesis and release of thyroglobulin (Tg), triiodothyronine (T3), and thyroxine (T4).
Pharmacokinetics:
Absorption: Time to peak plasma concentration: Median: 10 hours (range: 3-24 hours).
Excretion: Elimination half-life: 25 ± 10 hours.
Storage
Store between 2-8°C. Do not freeze. Protect from light.
MIMS Class
Radiographic & Diagnostic Agents / Trophic Hormones & Related Synthetic Drugs
ATC Classification
H01AB01 - thyrotropin alfa ; Belongs to the class of thyrotropin. Used in anterior pituitary lobe hormone and analogue preparations.
References
Anon. Thyrotropin Alfa. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 27/06/2023.

Anon. Thyrotropin Alfa. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 27/06/2023.

Buckingham R (ed). Thyrotrophin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 27/06/2023.

Joint Formulary Committee. Thyrotropin Alfa. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 27/06/2023.

Thyrogen 0.9 mg Powder for Solution for Injection (Aventis Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 27/06/2023.

Thyrogen for Injection (Sanofi-Aventis [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 27/06/2023.

Thyrogen Injection, Powder, Lyophilized, for Solution (Genzyme Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 27/06/2023.

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