Tegsedi label. Tegsedi is a drug that has been licensed for the treatment of pati...

Tegsedi label. Tegsedi is a drug that has been licensed for the treatment of patients with nerve damage (polyneuropathy) due to hereditary ATTR (hATTR) amyloidosis. TEGSEDI is contraindicated in patients with a platelet count below 100 x 10 9 /L [see Contraindications (4) and Warnings and Precautions (5. hATTR amyloidosis is a genetic disease which causes the build-up of a protein called transthyretin in the tissues and organs of the body, stopping them from working properly. Platelet count should be monitored every 2 weeks during treatment with TEGSEDI and for 8 weeks following discontinuation of treatment. It is unknown if vitamin A supplementation can compensate for the risk of vitamin A deficiency that might affect your unborn child (see “Warnings and precautions” above). 2)]. Category: HUMAN PRESCRIPTION DRUG LABEL DEA Schedule: None Marketing Status: New Drug Application TEGSEDI may cause the number of platelets in your blood to be reduced reduced at any time during treatment. 1 (Carcinogenesis, Mutagenesis, Impairment of Fertility) of the Tegsedi prescribing information to include the results of the completed 94-week carcinogenicity study of inotersen in rats. This Prior Approval sNDA provides for an update to subsection 13. TEGSEDI is a transthyretin-directed antisense oligonucleotide indicated for treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults (1). jbl sfso irz umksg gwwuc eokzuy fce wumsbt vmtunooi ftw