sp; Remove from refrigerated storage at least 30 minutes prior to use.
- Other warming methods should not be used.
Use each prefilled syringe only once.
2.3 Assessment Prior to Initiating TEGSEDI
Measure platelet count, serum creatinine, estimated glomerular filtration rate (eGFR), urine protein to creatinine ratio (UPCR), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin, and perform urinalysis prior to treatment with TEGSEDI and as directed following treatment initiation [see Dosage and Administration (2.4) and Warnings and Precautions (5.1 and 5.2)].
2.4 Laboratory Testing and Monitoring to Assess Safety after Initiating TEGSEDI
Monitor platelet count, serum creatinine, estimated glomerular filtration rate (eGFR), urinalysis, urine protein to creatinine ratio (UPCR), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin during treatment with TEGSEDI, and for 8 weeks following discontinuation of treatment.
Platelet Count
Do not initiate TEGSEDI in patients with a platelet count less than 100 x 109/L. Recommendations for platelet monitoring frequency and TEGSEDI dosing are specified in TABLE 1. If a patient develops signs or symptoms of thrombocytopenia, obtain a platelet count as soon as possible, and hold dosing until platelet count is confirmed. Recheck the platelet count as soon as possible if a platelet measurement is uninterpretable (e.g., clumped sample) [see Warnings and Precautions (5.8].
Table 1: TEGSEDI Monitoring and Treatment Recommendations for Platelet Count
* It is strongly recommended that, unless the patient has a medical contraindication to receiving glucocorticoids, the patient receive glucocorticoid therapy to reverse the platelet decline [see Warnings and Precautions (5.1)].
# Additional risk factors for bleeding include age >60 years, receiving anticoagulant or antiplatelet medicinal products,or prior history of major bleeding events.
†Patients who discontinue therapy with TEGSEDI because of platelet counts below 25 x109/L should not reinitiate therapy.
Platelet count (x109/L) Monitoring Frequency Dosing
At least 100 Weekly Continue to dose weekly.
At least 75 to less than 100 Weekly Stop treatment. Do not restart unless platelet count is greater than 100.
At least 50 to less than 75 Twice weekly until 3 successive values above 75; then weekly monitoring. Stop treatment. Do not restart TEGSEDI in patients with thrombocytopenia, unless there have been 3 successive values above 100 and the benefit of TEGSEDI outweighs the risk of thrombocytopenia and potential bleeding.
At least 25 to less than 50*
Twice weekly until 3 successive values above 75; then weekly monitoring.
Consider more frequent monitoring if additional risk factors for bleeding are present.#
Stop treatment. Do not restart TEGSEDI in patients with thrombocytopenia, unless there have been 3 successive values above 100 and the benefit of TEGSEDI outweighs the risk of thrombocytopenia and potential bleeding.
Corticosteroids recommended.
Consider discontinuation of any antiplatelet agents or anticoagulants.
Less than 25*† Daily until 2 successive values above 25. Then monitor twice weekly until 3 successive values above 75. Then weekly monitoring until stable.
Stop TEGSEDI.
Corticosteroids recommended.
Consider di |
