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The recommended dosage of odevixibat is 40 mcg/kg administered orally once daily in the morning with food. The recommended once-daily dosage based on body weight is as follows:
For patients weighing 7.4 kg or less: 200 mcg.
For patients weighing 7.5–12.4 kg: 400 mcg.
For patients weighing 12.5–17.4 kg: 600 mcg.
For patients weighing 17.5–25.4 kg: 800 mcg.
For patients weighing 25.5–35.4 kg: 1200 mcg.
For patients weighing 35.5–45.4 kg: 1600 mcg.
For patients weighing 45.5–55.4 kg: 2000 mcg.
For patients weighing 55.5 kg or more: 2400 mcg.
If pruritus does not improve after 3 months, the dosage may be increased in increments of 40 mcg/kg up to a maximum of 120 mcg/kg once daily, with the total daily dose not exceeding 6 mg/day.
Odevixibat oral granules are indicated for patients weighing less than 19.5 kg.Odevixibat capsules are indicated for patients weighing 19.5 kg or more.
The recommended dosage of odevixibat is 120 mcg/kg administered orally once daily in the morning with food. The recommended once-daily dosage based on body weight is as follows:
For patients weighing 7.4 kg or less: 600 mcg.
For patients weighing 7.5–12.4 kg: 1200 mcg.
For patients weighing 12.5–17.4 kg: 1800 mcg.
For patients weighing 17.5–25.4 kg: 2400 mcg.
For patients weighing 25.5–35.4 kg: 3600 mcg.
For patients weighing 35.5–45.4 kg: 4800 mcg.
For patients weighing 45.5–55.4 kg: 6000 mcg.
For patients weighing 55.5 kg or more: 7200 mcg.
Odevixibat oral granules are indicated for patients weighing less than 19.5 kg.Odevixibat capsules are indicated for patients weighing 19.5 kg or more.
If tolerability issues occur without other identifiable causes, consider reducing the dosage to 40 mcg/kg per day. Once the tolerability issues resolve, the dosage may be increased back to 120 mcg/kg per day.
Prior to initiating odevixibat treatment, establish a baseline pattern of liver function test results to facilitate identification of potential signs of liver injury. Monitor liver function tests during odevixibat treatment. If new-onset abnormal liver function tests occur or symptoms consistent with clinical hepatitis are observed, discontinue odevixibat treatment.
Once the abnormal liver function tests return to baseline levels or stabilize at a new baseline, consider reinitiating odevixibat treatment at the recommended dosage. If abnormal liver function tests recur, consider permanently discontinuing odevixibat.
If a patient experiences a hepatic decompensation event (e.g., variceal bleeding, ascites, hepatic encephalopathy), permanently discontinue odevixibat.
FDA，2025.03
