Thyrotropin Alfa

Registered South African indications: 

• Thyroid cancer

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Breastfeeding
• Renal impairment
• Elderly
• Intravenous administration
• Substantial thyroid disease still in situ
• Metastatic thyroid cancer
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: inj

Thyroid cancer
- An adjunctive diagnostic tool for serum thyroglobulin testing for the detection of thyroid remnants and differentiated thyroid cancer in post-thyroidectomy patients maintained on thyroid hormone suppression therapy
- An 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 distant metastatic thyroid cancer

• IM: Intial: 0.9mg, as a single; THEN 0.9mg 24hrs later

After reconstitution with 1.2ml sterile water for injection, 1.0 ml solution (0.9mg thyrotropin alfa) is administered by intramuscular injection to the buttock

For radioiodine imaging or treatment, radioiodine should be administered 24hrs following the final injection

For serum thyroglobulin testing, the serum sample should be obtained 72 hours after the final injection

Not established for use in children below 18 years

Pregnancy

• Caution
• Safety in pregnancy has not been established

Breastfeeding

• Caution

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Central Nervous System Disorders

• Dizziness
• Headache
• Ageusia
• Dysgeusia
• Paraesthesia
• Stroke
• Tremor
• Fatigue

Cardiovascular Disorders

• Palpitations
• Flushing

Respiratory Disorders

• Dyspnoea

Gastrointestinal Disorders

• Nausea and vomiting
• Diarrhoea

Endocrine and Metabolic Disorders

• Feeling hot
• Decreased thyroid stimulation hormone

Musculoskeletal Disorders

• Neck pain
• Back pain
• Arthralgia
• Myalgia

Skin and Subcutaneous Tissue Disorders

• Urticaria
• Rash
• Pruritus
• Hyperhidrosis 

Immune, Blood and Lymphatic System Disorders

• Influenza
• Neoplasm swelling
• Metastatic pain
• Influenza like illness
• Pyrexia
• Chills

No information available

None routine

Thyrotropin alfa is a recombinant human thyroid stimulating hormone. Binding of thyrotropin alfa to thyroid stimulation hormone receptors on normal thyroid epithelial cells or on well-differentiated thyroid cancer tissue stimulates iodine uptake and organification, and synthesis and secretion of thyroglobulin, T3 and T4.

Injection (per ml) 0.9mg

• Thyrogen (Sanofi) originator