Avatrombopag

PRIOR VERIFY CARRY-FORWARD: the previous draft of this file was HELD because its card contradicted itself - it showed the chronic liver disease dose (60 mg once daily) while its maxDose gave the chronic ITP ceiling (40 mg/day), i.e. a stated maximum LOWER than the stated dose, with two indications collapsed into one field. That is fixed here: both indications are labelled explicitly in the dose field and the maxDose field now names the ceiling for each. The verify's second point stands unchanged - the only provider in this bundle is the US SPRINKLE label, so the entire regimen is US-only with no UK SPC cross-check. || INDICATION MATCH: the page is the thrombopoietin receptor agonist for (1) thrombocytopenia in chronic liver disease before an elective procedure and (2) chronic immune thrombocytopenia, given orally - and the fetched label doses BOTH of those indications by that route, so both are published above, each labelled with its own indication. || VERBATIM - CHRONIC LIVER DISEASE (section 2.2): 'Begin DOPTELET tablets dosing 10 days to 13 days prior to the scheduled procedure. The recommended daily dose of DOPTELET is based on the patient's platelet count prior to the scheduled procedure. Patients should undergo their procedure 5 days to 8 days after the last dose of DOPTELET. DOPTELET tablets should be taken orally once daily for 5 consecutive days with food. All 5 days of dosing should be completed.' Table 1: platelet count 'Less than 40x10 9 /L' - '60 mg (3 tablets) orally once daily' for 5 days; '40x10 9 /L to less than 50x10 9 /L' - '40 mg (2 tablets) orally once daily' for 5 days. Also: 'DOPTELET tablets have been investigated only as a single 5-day once daily dosing regimen in clinical trials in patients with chronic liver disease' and 'DOPTELET should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts.' || VERBATIM - CHRONIC ITP IN ADULTS (section 2.3): 'Use the lowest dose of DOPTELET needed to achieve and maintain a platelet count greater than or equal to 50x10 9 /L as necessary to reduce the risk for bleeding. Dose adjustments are based on platelet count response. Do not use DOPTELET to normalize platelet counts. Initial Dosage: Begin DOPTELET tablets at an initial dosage of 20 mg (1 tablet) orally once daily with food... Do not exceed a DOPTELET daily dose of 40 mg (2 tablets).' Dose adjustment rules (Table 2): platelet count less than 50x10 9 /L after at least 2 weeks - increase one dose level and wait 2 weeks; between 200 and 400x10 9 /L - decrease one dose level and wait 2 weeks; greater than 400x10 9 /L - 'Stop DOPTELET tablets. Increase platelet monitoring to twice weekly. When platelet count is less than 150x10 9 /L, decrease One Dose Level per Table 3 and reinitiate therapy'; less than 50x10 9 /L after 4 weeks of 40 mg once daily - discontinue; greater than 400x10 9 /L after 2 weeks of 20 mg weekly - discontinue. Table 3 (the full dose-level ladder) is truncated at the source-fetch limit - what survives is dose level 6 = '40 mg (2 tablets) orally Once Daily' and a partial next level '40 mg (2 tablets) orally Three Times a Week AND 20 mg (1 tablet)...'. || COUNTS ARE STRENGTH-PINNED: section 3 states DOPTELET tablets are 20 mg and DOPTELET SPRINKLE capsules are 10 mg, so the '3 tablets'/'2 tablets'/'1 tablet' and '1 capsule'/'2 capsules' counts above resolve to definite milligram doses. || SWITCHING PRESENTATIONS (2.1): 'The mixture prepared from the granules in DOPTELET SPRINKLE capsules is more bioavailable than DOPTELET tablets. There is no experience from clinical trials in switching between dosing with the granules and the tablet. If the formulation is switched, monitor platelet counts weekly until stable platelet counts are obtained and adjust dosing as needed before resuming monthly monitoring.' || INTERACTIONS AFFECTING THE STARTING DOSE (7.1), ITP only: 'Reduce the starting dosage of DOPTELET when used concomitantly with a moderate or strong dual inhibitor of CYP2C9 and CYP3A4' and 'Increase the recommended starting dosage of DOPTELET when used concomitantly with a moderate or strong dual inducer of CYP2C9 and CYP3A4' - the numeric tables (Table 4 and Table 7) were NOT retrieved in this bundle, so no adjusted starting doses are published here. || ELDERLY (8.5): no dose adjustment is given; 71 (23%) of treated patients were 65 or older and 12 (4%) were 75 or older, and 'Clinical studies of DOPTELET did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.'

NOT A PER-KILOGRAM DOSE - this is a fixed, age-banded oral regimen, so dosePerKg is null by design and no weight calculation applies. INDICATION: persistent or chronic immune thrombocytopenia only (the chronic liver disease pre-procedure regimen is not a paediatric indication in this label). VERBATIM (section 2): 'Adult Patients with Chronic Immune Thrombocytopenia and Pediatric Patients 6 Years and Older with Persistent or Chronic Immune Thrombocytopenia: Initiate DOPTELET tablets at 20 mg (1 tablet) orally once daily. Adjust the dose or frequency of dosing to maintain platelet count greater than or equal to 50x10 9 /L. Do not exceed 40 mg (2 tablets) per day. Pediatric Patients 1 Year to Less than 6 Years with Persistent or Chronic Immune Thrombocytopenia: Initiate DOPTELET SPRINKLE oral granules at 10 mg (content of 1 capsule) orally once daily. Adjust the dose or frequency of dosing to maintain platelet count greater than or equal to 50x10 9 /L. Do not exceed 20 mg (content of 2 capsules) per day.' The strengths are pinned in section 3 (tablets 20 mg; SPRINKLE capsules 10 mg). AGE LIMITS (8.4): effectiveness is established for DOPTELET tablets from 6 years and for DOPTELET SPRINKLE in children aged 1 to under 6 years; the two presentations 'are not substitutable on a mg-to-mg basis'. The paediatric titration tables (Tables 5, 6 and 7) were NOT retrieved in this bundle. This is US labelling - verify the dose, the presentation and the age bands against the UK SPC and a children's formulary before prescribing for anyone under 18.