16.07.2024-Gadolinyum-Ajanlarini-Iceren-Ilaclar-Acil-Guvenlilik-Kisitlamasi-Gorus-katki_EN-1

Turkish Ministry of Health Turkish Medicines and Medical Devices Agency

Number: E-24931227-510.01.04-1536596 16.07.2024 Subject: Gadolinium agents – Urgent Safety Restriction

DOSSIER

The Agency has given consideration to the decisions taken by the European Medicines Agency regarding intratracheal and pregnancy use of gadolinium agents (PSUSA/00001500/202304, PSUSA/00001502/202304, PSUSA/00001504/202304, PSUSA/00001506/202304 and PSUSA/00001509/202304) and decided that the wording provided in the attachment must be incorporated in the local summary of product characteristics (KÜB) and local package leaflet (KÜB) of the aforesaid products. Please forward any opinions, views and suggestions regarding the foregoing decision to the Pharmacovigilance Risk Management Unit at the Pharmacovigilance and Controlled Substances Department within 15 days of this announcement, and refrain from making any submissions to the Pharmacologic Assessment Unit in the mean time. For your information and appropriate action.

Dr. Asım Hocaoğlu Agency President

Attachment: Wording to be included in KÜBs/KTs

Distribution: Turkish Pharmaceutical Manufacturers’ Association Association of Research-Based Pharmaceutical Companies Pharmaceutical Manufacturers’ Association of Türkiye Health Products Association

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Amendments to be included in the relevant sections of the Product Information (new text underlined and in bold, deleted text strike through).

For gadobenic Acid-containing products

Local Summary of Product Characteristics (KÜB)

4.4 Special Warnings and Precautions for Use

Gadobenic acid must not be used intrathecally. Serious, life-threatening and fatal cases, primarily with neurological reactions (e.g. coma, encephalopathy, seizures), have been reported with intrathecal use.

4.6 Pregnancy and lactation

Pregnancy There is no data on the use of gadobenate dimeglumine in pregnant women. Data on the use of gadolinium-based contrast agents including gadobenic acid in pregnant women is limited. Gadolinium can cross the placenta. It is unknown whether exposure to gadolinium is associated with adverse effects in the fetus. […]

Local Package Leaflet (KT)

2. What you need to know before taking ……

Pregnancy Gadobenic acid can cross the placenta. It is not known whether it affects the baby.

For gadobutrol-containing products

Local Summary of Product Characteristics (KÜB)

4.4 Special Warnings and Precautions for Use

Gadobutrol must not be used intrathecally. Serious, life-threatening and fatal cases, primarily with neurological reactions (e.g. coma, encephalopathy, seizures), have been reported with intrathecal use.

4.6 Pregnancy and lactation

Pregnancy There is no data on the use of gadobutrol in pregnant women. Data on the use of gadolinium-based contrast agents including gadobutrol in pregnant women is limited. Gadolinium can cross the placenta. It is unknown whether exposure to gadolinium is associated with adverse effects in the fetus. […]

Local Package Leaflet (KT)

2. What you need to know before taking ……

Pregnancy Gadobutrol can cross the placenta. It is not known whether it affects the baby.

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For gadopentetic acid-containing products

Local Summary of Product Characteristics (KÜB)

4.4 Special Warnings and Precautions for Use

Gadopentetic acid must not be used intrathecally. Serious, life-threatening and fatal cases, primarily with neurological reactions (e.g. coma, encephalopathy, seizures), have been reported with intrathecal use.

4.6 Pregnancy and lactation

Pregnancy There is no data on the use of Xxx in pregnant women. Data on the use of gadolinium-based contrast agents including gadopentetic acid in pregnant women is limited. Gadolinium can cross the placenta. It is unknown whether exposure to gadolinium is associated with adverse effects in the fetus. […]

Local Package Leaflet (KT)

2. What you need to know before taking ……

Pregnancy Gadopentetic acid can cross the placenta. It is not known whether it affects the baby.

For gadoteric acid-containing products

Local Summary of Product Characteristics (KÜB)

4.4 Special Warnings and Precautions for Use

Not for intratracheal use. Care must be taken to ensure intravenous injection is maintained until complete. Gadoteric acid must not be used intrathecally. Serious, life-threatening and fatal cases, primarily with neurological reactions (e.g. coma, encephalopathy, seizures), have been reported with intrathecal use. Extravasation may result in local intolerance reactions, requiring the usual local care.

4.6 Pregnancy and lactation

Pregnancy Animal studies have shown absence of any teratogenic effects. Nevertheless, caution must be exercised when treating women who may be pregnant, weighing benefits against risks. While no teratogenic effects were observed in animals with Xxx, the data available is not sufficient to evaluate potential teratogenic or fetotoxic effects of gadoteric acid during pregnancy. Accordingly, Xxx should be only used in pregnant women when absolutely necessary.

Data from the use of gadolinium-based contrast agents including gadoteric acid in pregnant women is limited. Gadolinium can cross the placenta. It is unknown whether exposure to gadolinium is associated with adverse effects in the fetus. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Gadoteric acid must not be used during pregnancy unless the patient’s clinical condition requires use of gadoteric acid.

Local Package Leaflet (KT)

2. What you need to know before taking ……

Pregnancy Gadopentetic acid can cross the placenta. It is not known whether it affects the baby.

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For gadoxetic acid-containing products

Local Summary of Product Characteristics (KÜB)

4.6 Pregnancy and lactation

Pregnancy There is no data on the use of gadoxetate in pregnant women. Data on the use of gadolinium-based contrast agents is limited. Gadolinium can cross the placenta. It is unknown whether exposure to gadolinium is associated with adverse effects in the fetus. […]

Local Package Leaflet (KT)

2. What you need to know before taking ……

Pregnancy Xxx must not be used during pregnancy unless absolutely necessary. Gadoxetic acid can cross the placenta. It is unknown whether it affects the fetus. Because Xxx must not be used during pregnancy unless absolutely necessary, be sure to tell your doctor that you are pregnant or may conceive.

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