Bylvay (odevixibat)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Odevixibat sesquihydrate is an ileal bile acid transporter (IBAT) inhibitor.
Odevixibat is a reversible inhibitor of the ileal bile acid transporter (IBAT). Odevixibat decreases the reabsorption of bile acids (primarily the salt forms) from the terminal ileum. Pruritus is a common symptom in patients with PFIC and ALGS; the pathophysiology of pruritus in patients with PFIC and ALGS has not been fully elucidated.
Although the mechanism by which odevixibat improves pruritus in PFIC and ALGS patients is unknown, inhibition of IBAT results in decreased reuptake of bile salt and a subsequent decrease in serum bile acid levels.
Odevixibat is minimally absorbed following oral administration. No accumulation of odevixibat was observed in healthy adults following once daily administration. The time to peak plasma concentration was 1-5 hours following a single oral dose in healthy adults.
When odevixibat pellets were opened and sprinkled on applesauce, peak plasma concentration and AUC decreased by 39% and 35%, respectively, and the median time to peak plasma concentration was delayed by 1.5 hours (from 3 to 4.5 hours) compared to administration under fasting conditions; these changes are not considered clinically important. When odevixibat was administered with a high-fat meal, peak plasma concentration and AUC decreased by 72% and 62%, respectively, and the median time to peak plasma concentration was delayed by 1.5 hours (from 3 to 4.5 hours) compared to administration under fasting conditions; these changes are not considered clinically important. Odevixibat is more than 99% bound to plasma proteins in vitro.
Following a single 3-mg oral dose of radiolabeled odevixibat in healthy adults, 82.9% of the dose was recovered in feces (97% as unchanged drug), and less than 0.002% was recovered in the urine (no unchanged drug). The half-life of odevixibat is approximately 2.36 hours in healthy adults. Odevixibat is metabolized in vitro by mono-hydroxylation.
USES: Depending on your brand, this medication is used to treat skin itching caused by certain inherited liver conditions (progressive familial intrahepatic cholestasis-PFIC or Alagille syndrome-ALGS). In PFIC and ALGS, a substance that your body normally makes (bilirubin) builds up in the liver and results in jaundice. Odevixibat belongs to a class of drugs known as ileal bile acid transporter inhibitors.
It helps to lessen symptoms of jaundice such as itching, yellowing eyes/skin, dark urine, and pale colored stools.
Generic name: odevixibat
Pronunciation: (OH-de-VIX-i-bat)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
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Indications
The following indications are listed for Bylvay:
- Cholestatic Pruritus In Patients With Alagille Syndrome
- Pruritus Due To Progressive Familial Intrahepatic Cholestasis
Also known as: Cholestatic Pruritus In Patients With Algs, Pruritus Due To Pfic.
Dosing
Dosage of odevixibat sesquihydrate is expressed in terms of odevixibat.
Administer odevixibat orally once daily in the morning with a meal.
Odevixibat is commercially available as capsules and pellets for oral administration. The oral pellets are intended for use by patients weighing <19.5 kg and the capsules are intended for use by patients weighing >=19.5 kg.
The drug should be taken with food.
Odevixibat should be administered at least 4 hours before or after administration of bile acid sequestrants.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
In vitro, odevixibat does not inhibit cytochrome P-450 (CYP) isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, or 2D6, or induce CYP isoenzymes 1A2, 2B6, or 3A4.
Odevixibat is a substrate of P-glycoprotein (P-gp), but is not a substrate of breast cancer resistance protein (BCRP).
In vitro, odevixibat did not inhibit P-gp, BCRP, organic anion transporter polypeptide (OATP) 1B1 or OATP1B3, organic anion transporter (OAT)1, OAT3, organic cation transporter 2 (OCT2), or multidrug and toxin extrusion exporter 1 (MATE1) and MATE2K.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Prior or active hepatic decompensation events (e.g., variceal hemorrhage, ascites, hepatic encephalopathy).
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Most common adverse reactions (>2%) reported in patients with PFIC receiving odevixibat include liver test abnormalities, diarrhea, abdominal pain, vomiting, and fat-soluble vitamin deficiency.
Most common adverse reactions (>5%) reported in patients with ALGS receiving odevixibat include diarrhea, abdominal pain, hematoma, and weight loss.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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Safety and efficacy of odevixibat have been established in pediatric patients 3 months to 17 years of age for the treatment of pruritus due to PFIC. Use of odevixibat in this age group is supported by data from a 24-week, randomized, double-blind, placebo-controlled trial conducted in 62 patients with a confirmed diagnosis of PFIC type 1 or type 2 (Trial 1) and an open-label, 72-week, extension trial in patients with PFIC (Trial 2).
Safety and efficacy of odevixibat have been established in pediatric patients 12 months to 17 years of age for the treatment of pruritus due to ALGS. Use of odevixibat in this age group is supported by data from a randomized, double-blind, placebo-controlled trial conducted in 52 patients with a confirmed diagnosis of ALGS and one open-label extension trial in ALGS patients.
Safety and efficacy of odevixibat for the treatment of pruritus in pediatric patients <3 months of age with PFIC have not been established. Safety and efficacy of odevixibat for the treatment of pruritus in pediatric patients <12 months of age with ALGS have not been established.
There are insufficient human data on use of odevixibat in pregnant women to establish a drug-associated risk of major birth defects, miscarriage, or adverse developmental outcomes. In animal studies, increased incidence of malformations in fetal heart, great blood vessels, and other vascular sites were reported in pregnant rabbits receiving odevixibat at all dosages during organogenesis; maternal systemic exposure at the lowest dose was 2.1 times the maximum recommended human dosage. Since odevixibat may inhibit the absorption of fat-soluble vitamins, which are necessary for normal fetal growth and development, clinicians should monitor pregnant patients for a deficiency and supplement as needed. Pregnancy may require increased fat-soluble vitamin supplementation.
A pregnancy safety study that monitors outcomes in women exposed to odevixibat during pregnancy is available. Pregnant women exposed to odevixibat, or their healthcare providers, should report odevixibat exposure by calling 1-855-463-5127.
Odevixibat is minimally absorbed following oral administration; therefore, breast-feeding is not expected to result in exposure to the infant at the recommended dosage. It is not known whether odevixibat is distributed into human milk. The effects of the drug on breast-fed infants or on milk production are unknown. Consider the developmental and health benefits of breast-feeding along with the mother's need for odevixibat and any potential adverse effects on the breast-fed child from the drug or underlying maternal condition.
Patients with PFIC or ALGS may also have concomitant fat-soluble vitamin deficiency. Because odevixibat may further reduce absorption of fat-soluble vitamins, monitor fat-soluble vitamin levels and provide supplementation if a deficiency is diagnosed during lactation.
The manufacturer makes no specific dosage recommendations for geriatric patients.
The manufacturer states that PFIC and ALGS are largely diseases of pediatric and young adult patients. Clinical studies with odevixibat did not include patients >=65 years of age.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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