Is Maralixibat approved by the FDA?
Yes, maralixibat is FDA approved. Maralixibat, marketed under the brand name Livmarli, received FDA approval on September 29, 2021. It is used to treat itching due to liver problems in people with a genetic condition called Alagille syndrome.
What is Maralixibat?
Maralixibat is an oral solution (9.5 mg/mL) that belongs to the drug class of miscellaneous gastrointestinal (GI) agents. It is specifically used to treat pruritus (itching) in patients with Alagille syndrome, a condition where there are not enough bile ducts to properly drain bile from the liver, leading to liver damage. Maralixibat helps to reduce itching but is not a cure for Alagille syndrome.
How to Take Maralixibat
Maralixibat is typically taken once daily, 30 minutes before a meal. The dosage should be measured with the supplied device and taken exactly as directed by your healthcare provider. Frequent blood tests are necessary to monitor liver function during treatment.
Precautions and Warnings
Before taking maralixibat, inform your healthcare provider if you have ever had cirrhosis. Maralixibat can reduce the absorption of certain vitamins, so your doctor may recommend specific vitamin supplements during treatment, especially if you are pregnant or breastfeeding. It should not be given to children under one year old.
Side Effects
Maralixibat can cause side effects, some of which may be serious. These include:
- Severe ongoing nausea, vomiting, or diarrhea
- Stomach pain or bloody diarrhea
- Sudden pain or trouble moving limbs
- Liver problems (e.g., loss of appetite, upper right stomach pain, tiredness, dark urine, jaundice)
- Dehydration (e.g., dizziness, confusion, extreme thirst)
- Stomach bleeding
Common side effects include:
- Stomach pain, vomiting, diarrhea
- Stomach bleeding
- Vitamin deficiencies (A, D, E, K)
- Abnormal liver function tests
Drug Interactions
Certain medications should be taken either 4 hours before or 4 hours after maralixibat to avoid interactions. These include:
- Colesevelam
- Colestipol
- Cholestyramine
Additionally, maralixibat may interact with statin cholesterol medications such as atorvastatin, simvastatin, and others.
Storage and Disposal
Store maralixibat tightly closed at room temperature away from moisture and heat. Unused maralixibat should be discarded 45 days after opening the bottle. For disposal, mix leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw it in the trash or consult a drug take-back program.
Conclusion
Maralixibat (Livmarli) is FDA-approved for treating itching due to liver problems in Alagille syndrome patients. It provides symptomatic relief but does not cure the underlying condition. Proper administration, awareness of side effects, and adherence to storage guidelines are essential for effective treatment. Always follow your healthcare provider’s instructions and discuss any other medications you are taking to avoid potential interactions.
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