Land: Israel
Sprog: engelsk
Kilde: Ministry of Health
THYROTROPIN ALFA
SANOFI ISRAEL LTD
V04CJ01
POWDER FOR SOLUTION FOR INJECTION
THYROTROPIN ALFA 0.9 MG/ML
I.M
Required
GENZYME EUROPE B.V., THE NETHERLANDS
THYROTROPIN
THYROTROPIN
Adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy. 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.
2020-03-31
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ )תוחיטב )תוחיטב ןולעב ןולעב אפורל אפורל :ךיראת 5.8.2014 םש רישכת :תילגנאב THYROGEN רפסמ :םושיר 117 91 29910 00 םש לעב :םושירה SANOFI AVENTIS ISRAEL LTD . ספוט הז דעוימ טוריפל תורמחה !דבלב תורמחהה תושקובמה קרפ ןולעב טסקט יחכונ טסקט שדח WARNINGS AND PRECAUTIONS STROKE There are postmarketing reports of radiologically- confirmed stroke and neurological findings suggestive of stroke unconfirmed radiologically (e.g., unilateral weakness) occurring within 72 hours (range 20 minutes to three days) of THYROGEN administration in patients without known central nervous system metastases. The majority of such patients were young women taking oral contraceptives at the time of their event or had other risk factors for stroke, such as smoking or a history of migraine headaches. The relationship between THYROGEN administration and stroke is unknown. Patients should be well- hydrated prior to treatment with THYROGEN. 6.Adverse Reactions 6.1Clinical Trials Experience Table 4 PREFERRED TERM THYROGE N (N=481) N %) THYROID HORMONE WITHDRAWAL (N=418) N (%) Nausea 57 (11.9) 13 (3.1) Headache 35 (7.3) 5 (1.2) Fatigue 16 (3.3) 4 (1.0) Hyperchole sterolemia 0 (0.0) 13 (3.1) Vomiting 14 (2.9) 3 (0.7) Dizziness 12 (2.5) 0 (0.0) Paraesthesi a 8 (1.7) 0 (0.0) Asthenia 7 (1.5) 0 (0.0) Insomnia 7 (1.5) 0 (0.0) Blood Cholesterol Abnormal 0 (0.0) 6 (1.4) Diarrhea 6 (1.2) 0 (0.0) Nasophary ngitis 5 (1.0) 0 (0.0) Thyroglob ulin Present 5 (1.0) 0 (0.0) TABLE 1 PREFERRED TERM THYROGEN (N=481) N (%) THYROID HORMONE WITHDRAWAL (N=418) N (%) Nausea 53 (11) 2 (<1) Headache 29 (6) 0 Fatigue 11 (2) 2 (<1) Vomiting 11 (2) 0 Dizziness 9 (2) 0 (0.0) Asthenia 5 (1) 1 (<1) TABULATED LIST OF ADVERSE EVENTS The most commonly reported adverse events are nausea and headache, occurring in approximately 12%, and 7% of patients, respectively. The adverse eve Læs hele dokumentet
07.2020, VERSION _THYR-IM-0.9MG-SPC-12.0_- update according to the USPI Updated 03.2020 FULL PRESCRIBING INFORMATION THYROGEN (THYROTROPIN ALFA 0.9 MG/ML) POWDER FOR SOLUTION INJECTION 1 INDICATIONS AND USAGE 1.1 ADJUNCTIVE DIAGNOSTIC TOOL FOR SERUM THYROGLOBULIN TESTING IN WELL DIFFERENTIATED THYROID CANCER THYROGEN ® is indicated for use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy. Limitations of Use: • THYROGEN-stimulated Tg levels are generally lower than, and do not correlate with, Tg levels after thyroid hormone withdrawal [ _see_ _Clinical _ _Studies_ ( _14.1_ )]. • Even when THYROGEN-stimulated Tg testing is performed in combination with radioiodine imaging, there remains a risk of missing a diagnosis of thyroid cancer or of underestimating the extent of disease. • Anti-Tg antibodies may confound the Tg assay and render Tg levels uninterpretable [ _see Clinical Studies _ ( _14.1_ )]. Therefore, in such cases, even with a negative or low-stage THYROGEN radioiodine scan, consideration should be given to further evaluating patients. 1.2 ADJUNCT TO TREATMENT FOR ABLATION IN WELL DIFFERENTIATED THYROID CANCER THYROGEN is indicated for use as 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. Limitations of Use: • The effect of THYROGEN on long-term thyroid cancer outcomes has not been determined. Due to the relatively small clinical experience with THYROGEN in remnant ablation, it is not possible to conclude whether long-term thyroid cancer outcomes would be equivalent after use of THYROGEN or use of thyroid hormone withholding for TSH elevation prior to remnant ablation. 2 DOSAGE AND ADMINISTRATION 2.1 RECOMMENDED DOSAGE THYROGEN shou Læs hele dokumentet