Dear Healthcare Professional Letter on association of Scintimun (besilesomab) with potential risk of human anti-mouse antibody (HAMA) forming by hypersensitivity reaction and acute hypotension
01.07.2014
CIS bio international and Marti Farm d.o.o. have in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals about important information associated with the use of Scintimun (besilesomab).
Summary
- Due to potential risk of human anti-mouse antibody forming (HAMA) that may lead to a type III hypersensitivity reaction, HAMA test should be carried out in all patients before use of Scintimun. The positive result is contraindicated for use of this medicine.
- Hypersensitive reactions may be in the whole range from mild allergic reactions to those life-threatening (including anaphylactic and anaphylactoid reactions).
- Due to acute hypotension risk, adequate therapeutic measures should be available in place in case the acute hypotension occurs as an individual reactions or associated with any clinical sign of the hypersensitivity reaction. The reanimation equipment should be available in the immediate proximity (i.e. ambulance, intensive care unit, etc.).
Further information on safety issues
The frequency of HAMA forming is 14 % after the first administration of Scintimun vs frequency of 35 in general population not being exposed to Scintimun. Patients who receive this medicine may develop a type III hypersensitivity reaction within a few days after administration. The reaction may appear as increased body temperature, astralgi a, lymphadenopathy, and skin rushes. Those symptoms may be preceded by itching, pain or swelling on the application site of Scintimun. Patients receiving this medicine should be instructed to immediately seek advice from their doctors if the above mentioned signs and symptoms appear after injection.
The acute hypotension (i.e.) mild blood pressure drop) in a short time period after receiving a Scintimun injection is an expected adverse raction (frequency ≥ 1:100 to ˂1:10) that may appear few minutes after administration, without additional clinical symptoms or possible etiological factors.
HALMED has not received any adverse reaction report to Scintimun by now, which would be associated with human anti-mouse antibody forming, hypersensitivity reaction or acute hypotension. HALMED will continue to closely monitor the safe use of this medicine and will inform the public promptly about any new information.
Here you may view the Dear Healthcare Professional Letter.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
