THYROGEN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

THYROTROPIN ALFA

Available from:

SANOFI ISRAEL LTD

ATC code:

V04CJ01

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

THYROTROPIN ALFA 0.9 MG/ML

Administration route:

I.M

Prescription type:

Required

Manufactured by:

GENZYME EUROPE B.V., THE NETHERLANDS

Therapeutic group:

THYROTROPIN

Therapeutic area:

THYROTROPIN

Therapeutic indications:

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.

Authorization date:

2020-03-31

Patient Information leaflet

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

Summary of Product characteristics

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