Techspec schreef op 14 december 2018 16:53:
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Wat denk je van een mogelijke anafylactische shock bij het gebruik van Lanadelumab?
Ik hoef jou toch niet uit te gaan leggen hoe gevaarlijk dit kan zijn.
Kijk ook nog even op de Lanadelumab website van Tahkzyro zelf wat men reeds geconstateerd heeft t.a.v. de impact op het immunogeniciteitsgebied, Coagulatie, Overgevoeligheidsreacties,
(Het is maar wat je niet ernstig noemt)
IMMUNOGENICITY
Treatment with lanadelumab has been associated with development of treatment emergent anti-drug antibodies (ADA) in 11.9% (10/84) of subjects.
COAGULATION
Interference with coagulation test: Lanadelumab can increase activated partial thromboplastin time (aPTT) due to an interaction of lanadelumab with the aPTT assay. The reagents used in the aPTT laboratory test initiate intrinsic coagulation through the activation of plasma kallikrein in the contact system. Inhibition of plasma kallikrein by lanadelumab can increase aPTT in this assay. Er waren nog geen patiënten met inwendige bloedingen maar hierdoor kan het dus wel!
HYPERSENSITIVITY
Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, administration of TAKHZYRO must be stopped immediately and appropriate treatment must be initiated.
Ook niet geheel onbelangrijk;
Pregnancy
There are no or limited data from the use of lanadelumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive or developmental toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of lanadelumab during pregnancy.
Breast-feeding
It is unknown whether lanadelumab is excreted in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed child cannot be excluded during this short period. Afterwards, lanadelumab could be used during breast-feeding if clinically needed.