Obetee

Obetee Uses, Dosage, Side Effects, Mechanism of Action, How Long Does it Take to Work? Obetee is a brand name. Its generic name is Obeticholic Acid.

Introduction

Obeticholic acid (brand name Ocaliva) is a semisynthetic bile acid analog and a member of the farnesoid X receptor (FXR) agonist family of drugs. It is an orally administered FXR agonist and is used to treat primary biliary cholangitis (PBC).

Uses for

Obeticholic acid is used to treat primary biliary cholangitis (PBC), a progressive disorder of the bile ducts in the liver. It works by blocking the abnormal buildup of bile, slowing down the growth of the cells, and reducing inflammation.

Mechanism Of Action

The primary mechanism by which obeticholic acid works is through the farnesoid X receptor (FXR). FXR is a nuclear receptor involved in the regulation of bile acid synthesis and metabolism. When activated, it increases the expression of small-hormone receptors involved in the production and excretion of bile acids from the liver. It also decreases the expression of bile acid transporters involved in reabsorption of bile acids and increases the expression of several bile acid synthesis enzymes. Obeticholic acid also has anti-inflammatory and anti-oxidant effects, which can help reduce the damage and inflammation caused by PBC.

How Long Does It Take To Work?

Obeticholic acid typically takes several weeks to become effective. Most patients begin to see an improvement in liver enzyme levels within 4-6 weeks, although the degree of improvement can vary from person to person. It is important to continue taking the medication even if no improvement is noticed, as it may take several months for the drug to reach its maximum effect.

Absorption

Obeticholic acid is easily absorbed from the gastrointestinal tract into the systemic circulation. It has an estimated bioavailability of 45%.

Route Of Elimination

Obeticholic acid is primarily eliminated via the feces. It is also metabolized by the liver and excreted in the urine.

Dosage

The recommended adult dose of obeticholic acid is 10 mg once daily with food. This dose can be increased to 10 mg twice daily by the physician based on individual needs, such as the degree of liver enzyme elevation. The maximum daily dose should not exceed 20 mg.

Administration

Obeticholic acid should be taken with food to facilitate absorption. It is available as a tablet or oral suspension and should be taken as directed by the physician.

Side Effect

Common side effects of obeticholic acid include nausea, diarrhea, increased liver enzymes, fatigue, and itching. Serious side effects, such as liver damage and jaundice, have been reported in rare cases.

Toxicity

Obeticholic acid is not known to be toxic, although long-term use can lead to elevated liver enzymes. Patients should discuss any signs or symptoms of liver toxicity with their doctor. Additionally, obeticholic acid should not be given to patients with severe liver disease.

Precautions

Obeticholic acid should not be taken by patients with severe hepatic impairment, as it may aggravate liver failure. Patients with a history of gallstones should also exercise caution when taking obeticholic acid, as it may increase the risk of gallstone formation. Additionally, pregnant and breastfeeding women should consult their doctor before taking obeticholic acid.

Interaction

Obeticholic acid may interact with certain other medications, including antifungal drugs, antibiotics, uricosuric agents, and statins. Patients should discuss all medications with their doctor before taking obeticholic acid. Additionally, obeticholic acid may interact with grapefruit juice and alcohol, and these products should be avoided while taking the medication.

Disease Interactions

Obeticholic acid should not be used in patients with severe liver impairment or hepatic failure. Patients with a history of gallstones should exercise caution when taking the drug, as it may increase the risk of gallstone formation. Patients with active infections, such as HIV and hepatitis, should also exercise caution.

Drug Interactions

Obeticholic acid can interact with certain other medications, including antifungal drugs, antibiotics, uricosuric agents, and statins. Patients should discuss all medications with their doctor before taking obeticholic acid.

Food Interactions

Grapefruit juice and alcohol should be avoided while taking obeticholic acid, as these can interact with the drug and cause adverse effects. Additionally, the drug should be taken with food to facilitate absorption.

Pregnancy Use

Obeticholic acid is classified as a Pregnancy Category C medication, meaning it may or may not be safe to use during pregnancy. Patients should discuss the risks and benefits with their doctor before taking the drug during pregnancy or when planning to become pregnant.

Lactation Use

Obeticholic acid is not recommended for use in breastfeeding women, as it could pass into the milk and harm a nursing infant. Patients should discuss the risks and benefits with their doctor before taking the drug when breastfeeding.

Acute Overdose

Symptoms of an obeticholic acid overdose may include nausea, vomiting, diarrhea, and abdominal pain. Patients should seek medical attention immediately if these symptoms occur.

Contraindication

Obeticholic acid should not be used in patients with severe hepatic impairment or hepatic failure. Patients with active infections, such as HIV and hepatitis, should also exercise caution. Additionally, the drug should not be used during pregnancy or when planning to become pregnant.

Use Direction

Obeticholic acid should be taken with food to facilitate absorption. The recommended adult dose is 10 mg once daily, with the maximum daily dose not exceeding 20 mg. The dose may be increased to 10 mg twice daily based on individual needs, such as the degree of liver enzyme elevation.

Storage Condition

Obeticholic acid should be stored at room temperature between 15-30°C (59-86°F). It should be protected from light, heat, and moisture. The tablets should not be crushed or chewed.

Volume Of Distribution

The volume of distribution of obeticholic acid is approximately 24 liters.

Half Life

The half-life of obeticholic acid is approximately 1.2 hours.

Clearance

The clearance of obeticholic acid is approximately 5.1 L/hour.

Here you find in details version of Obetee

Some Frequently Asked Questions About Obetee

What is Obetee?

Obeticholic acid is a therapeutic agent used to treat primary biliary cholangitis (PBC). It is a hydrophilic bile acid derivative administered as oral tablets and can be prescribed in combination with ursodeoxycholic acid for patients with PBC.

What is the mechanism of action of Obetee?

Obeticholic acid acts as a farnesoid X receptor (FXR) agonist, a nuclear receptor that helps to regulate the body’s metabolism of bile acids, glucose and lipids. By binding to FXR, obeticholic acid activates genes that reduce liver inflammation and fibrosis caused by PBC.

What is Primary Biliary Cholangitis (PBC)?

Primary Biliary Cholangitis (PBC) is an autoimmune liver disease characterized by progressive inflammation and destruction of the intrahepatic bile ducts, leading to bile stasis and eventual cirrhosis.

Who can take Obetee?

Obetee is indicated for the treatment of adults with primary biliary cholangitis (PBC). Patients should not use Obetee if they have severe liver impairment (Child-Pugh C). Obetee is not indicated for those with other liver diseases (such as hemochromatosis, primary sclerosing cholangitis, or biliary obstruction).

How long does Obetee take to work?

The effects of Obetee in patients with PBC vary. Some patients may start to see improved liver enzyme levels as soon as 2-3 months after beginning Obetee treatment, however, it can take up to 6 months to see the full benefits. It is important to take Obetee as directed by a doctor and follow-up regularly for blood testing.

How is Obetee administered?

Obetee is a tablet taken orally with or without food. It is important to take Obetee as prescribed by a doctor and not to exceed the recommended dose.

How long do I take Obetee?

Obetee is intended for long-term therapy and should be taken as directed by a doctor. Patients should not stop taking Obetee without first consulting their healthcare provider.

What are the possible side effects of Obetee?

The most common side effects of Obetee include joint and muscle pain, upper respiratory tract infection, headache, and nausea. More serious side effects include decreased kidney function, pancreatitis, and liver injury. Patients should report any side effects to their doctor.

Can Obetee be used in combination with other drugs?

Obetee may interact with some medications, including oral contraceptive drugs and cholesterol-lowering medications. Obetee is not recommended for use with drugs that reduce the activity of liver enzymes (CYP enzymes). Patients should always consult with their doctor before taking Obetee with any other medication.

Is Obetee safe for pregnant women?

Obetee is not recommended for use in pregnant women. Animal studies have demonstrated fetal toxicity with obeticholic acid. Pregnant women should consult with their doctor before taking Obetee.

Does Obetee cause weight gain?

Obetee is not known to cause weight gain in patients. If patients experience sudden weight changes while taking Obetee, they should talk to their doctor.

Does Obetee cause itching?

Itching is a possible side effect of Obetee. Patients experiencing itching should tell their doctor right away.

Does Obetee interact with alcohol?

Alcohol should be avoided if taking Obetee, as it may increase the risk of liver injury. Patients should consult with their doctor if considering drinking alcohol while taking Obetee.

Does Obetee interact with grapefruit?

Grapefruit and grapefruit juice may potentially interact with Obetee and should be avoided or taken with caution. It is important to discuss any dietary or supplement changes with a doctor before starting Obetee.

How long does Obetee stay in your system?

The half-life of Obetee is about 6.5 hours. Therefore, it takes approximately 32 hours for Obetee to be eliminated from the body.

Does Obetee affect blood sugar levels?

Obetee may cause a decrease in fasting blood sugar levels but does not typically cause an increase. Patients should monitor their blood sugar levels and consult their doctor if they experience any changes.

Does Obetee cause hair loss?

Hair loss is a rare side effect of Obetee. Patients should tell their doctor right away if they experience any hair loss while taking Obetee.

Is Obetee covered by insurance?

Insurance coverage for Obetee depends on the patient's individual plan and varies by region.

Does Obetee cause joint pain?

Joint pain is a common side effect of Obetee. Patients should tell their doctor right away if they experience joint pain while taking Obetee.

Can Obetee be taken with food?

Obetee can be taken with or without food, however, it is important to maintain consistent dosing and take Obetee as directed by a doctor.

What dose of Obetee is typically prescribed?

The recommended dose of Obetee for the treatment of PBC is 10mg taken once daily. Patients should always take Obetee as prescribed by their doctor.

Are there any other therapeutic options for PBC?

Yes, in addition to Obetee, your treating physician may prescribe ursodeoxycholic acid, antivirals, and probiotics. Additionally, lifestyle modifications such as avoiding alcohol and certain foods, as well as exercise, can help support the management of PBC.

Does Obetee cause diarrhea?

Diarrhea is a possible side effect of Obetee. Patients should tell their doctor right away if they experience diarrhea while taking Obetee.

Is there an alternative to Obetee?

Currently, there is no approved alternative to Obetee for the treatment of primary biliary cholangitis (PBC). Other treatments prescribed may include ursodeoxycholic acid, antivirals, and probiotics.

Can Obetee cause mood swings?

Mood swings are a rare side effect of Obetee. Patients should tell their doctor right away if they experience mood swings while taking Obetee.

Does Obetee need to be taken with other drugs?

Obetee may be prescribed in combination with ursodeoxycholic acid for patients with PBC. Other drugs may be prescribed depending on the individual patient's needs. It is important to talk to your doctor before taking any other medication with Obetee.

How does Obetee reduce inflammation?

Obeticholic acid acts as a farnesoid X receptor (FXR) agonist. By binding to FXR, obeticholic acid activates genes that reduce inflammation and fibrosis in the liver caused by primary biliary cholangitis (PBC).

Does Obetee need to be taken on an empty stomach?

Obetee can be taken with or without food, however, it is important to maintain consistent dosing and take Obetee as directed by a doctor.

Does Obetee cause fatigue?

Fatigue is a possible side effect of Obetee. Patients should tell their doctor right away if they experience fatigue while taking Obetee.

Can Obetee be used to treat conditions other than PBC?

No, Obetee is currently only approved for the treatment of primary biliary cholangitis (PBC) and should not be used to treat other conditions.

What other medications may interact with Obetee?

Will Obetee cure my PBC?

Obetee is not a cure for primary biliary cholangitis (PBC). It is used to reduce inflammation and decrease liver enzymes in order to slow the progression of the disease, but it does not cure PBC.

Is Obetee the same as bile acids?

Obetee is a type of bile acid derivative. It is a therapeutic agent used to treat primary biliary cholangitis (PBC) and works by activating the farnesoid X receptor (FXR).

Does Obetee require labs to be monitored?

Yes, Obetee may require regular blood tests to monitor safety and effectiveness. Patients should check with their doctor to determine the frequency with which they should get their labs.

Can Obetee cause rash?

Rash is a rare side effect of Obetee. Patients should tell their doctor right away if they experience a rash while taking Obetee.

Does Obetee cause stomach pain?

Stomach pain is a possible side effect of Obetee. Patients should tell their doctor right away if they experience stomach pain while taking Obetee.

How do I know if Obetee is working for me?

The effects of Obetee in patients with PBC vary. Patients may start to see improved liver enzyme levels as soon as two to three months after beginning treatment, however, it can take up to six months to see the full benefits. It is important to take Obetee as directed by a doctor and follow up regularly for blood testing.