LANADELUMAB Drug Interactions: What You Need to Know

INTERACTIONS No dedicated drug interaction studies have been conducted [see Clinical Pharmacology (12.3) ]. No dedicated drug interaction studies have been conducted. ( 7 )

7.1 Drug-Laboratory Test Interactions Coagulation tests TAKHZYRO can increase activated partial thromboplastin time (aPTT) due to an interaction of TAKHZYRO 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 TAKHZYRO can increase aPTT in this assay.

In Trial

1, prolongation of aPTT (>1× ULN) was observed at one or more time points in 3, 9, and 11 patients treated with TAKHZYRO 150 mg q4wks, 300 mg q4wks, and 300 mg q2wks, respectively, compared to 5 placebo-treated patients. Only one patient in the 300 mg q2wks treatment group experienced transient aPTT prolongation ≥1.5x ULN which was confounded by ongoing heparin therapy. None of the increases in aPTT in patients treated with TAKHZYRO were associated with abnormal bleeding adverse events. There were no differences in INR values between treatment groups.

None. None. ( 4 )

AND PRECAUTIONS Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment. ( 5.1 )

5.1 Hypersensitivity Reactions Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment.