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Obeticholic acid

Generic Name: Obeticholic acid [ oh-BET-i-KOE-lik-AS-id ]
The Brand Name: Ocaliva.
Dosage Format: Oral tablet (10 mg, 5 mg)
Drug Class: Miscellaneous GI agents

What is Obeticholic Acid?

Primary biliary cholangitis (PBC) is an ongoing chronic liver disorder that may cause the destruction of the bile ducts that run through the liver. This can result in liver cirrhosis (scarring in the lining of your liver) and liver failure. PBC is a progressive illness that can go undetected for several years. Obeticholic acid is a drug used to treat PBC in adult patients who have not yet developed liver cirrhosis. Obeticholic acid can be used in conjunction with a different drug known as ursodeoxycholic acid (UDCA). Obeticholic acid could be used to treat other conditions not covered in this medication guide.

Side Effects

Contact a medical professional immediately. Get medical attention immediately if you notice symptoms that indicate an allergic reaction, such as hives, difficulty breathing, or swelling of your lips, face, and tongue.

Obeticholic acid could cause severe adverse effects. Contact your physician immediately if you suffer from:

  • Feeling of tiredness, weakness, dizziness, apathy, or sleepiness;
  • Anxiety, mood shifts, and slurred speech
  • Intense burning;
  • Fever, chills, and less urination;
  • Stomach discomfort, nausea, vomiting, diarrhea, and loss of appetite.
  • Bloody or tarry stool that coughs up blood or vomit that resembles coffee grounds
  • Jaundice (yellowing of the eyes or skin) or
  • The stomach is stuffed with fluids, which can cause bloating or weight gain, problems breathing, and swelling of your legs or stomach.

Your dosages could be shortened or discontinued permanently in the event of some side effects.

Common negative side effects of obeticholic acids could include:

  • Skin eruptions: dryness, itching, oozing, or crusting
  • Dizziness, fever, feeling exhausted;
  • Stomach discomfort, constipation;
  • Discomfort in your throat or mouth;
  • Heart rate that is irregular or fast;
  • An increase in swelling on your hands or legs;
  • Joint pain,
  • Thyroid function that is abnormal.

This isn't a complete list of all the side effects. Others could happen. Contact your doctor to seek medical advice on adverse effects. You may report any adverse reactions to the FDA at 1-800-FDA-1088.

Warnings

Contact your doctor immediately if you experience mood changes, swelling, itching, extreme weight gain, difficulty breathing, or stomach pains. more urination, less eyes that are yellow, eyes that are bloody, tarry stool, or when you are coughing out the blood of your vomit or puke that appears similar to coffee grinds.

You'll need liver function tests. You might have to stop using obeticholic acid in accordance with the results. Don't stop taking the medication without consulting your physician.

Prior to Use this Drug

Obeticholic acid, if your body is allergic to it or suffers from:

  • Advanced liver cirrhosis or
  • Total blockage in the bile ducts.

The doctor will conduct tests to ensure that you are receiving the correct option for you. Speak to your doctor if you've experienced liver issues, particularly the condition known as cirrhosis.

Consult your physician if you are nursing or pregnant.

How to Take Obeticholic?

Follow the instructions on the label of your prescription and study all medication guides or instruction sheets. Your doctor may alter the dosage. Make sure you take the medicine exactly as prescribed. Take it with or without. It is possible to receive medications to stop itching, which is a typical side effect of obeticholic acids. Contact your physician when itching becomes excessive.

There will be liver function tests, and you might need to discontinue the obeticholic acids based on the results, even if you've had no signs. Don't stop using obeticholic acids without the advice of your physician. Place it in a cool, dry place free of heat and moisture.

Details on Dosage

Usual Adult Dose for Biliary Cirrhosis:

Initial dose: 5 mg taken orally at least once per day.
Maintenance dosage: 5 mg taken orally every day. If a sufficient reduction in alkaline phosphatase (ALP) or total bilirubin levels is not achieved after 3 months, increase the dosage to 10 mg every day.
Maximum dose: 10 mg/day

Comments:
This drug was approved through the expedited approval process due to ALP reductions. However, an improvement in survival or related symptoms was not proven.
Patients and prescribers must be aware that approval for continued use may be dependent on verification and the clinical benefits of additional confirmation trials.
Health care providers should determine the Child-Pugh classification for any patient suspected of having ascites prior to initiating treatment.

Uses:
To treat primary biliary cholangitis (PBC):
In patients with no cirrhosis, in combination with ursodeoxycholic acids (UDCA) who are intolerant to UDCA or monotherapy in patients
in patients who have compensated cirrhosis but no evidence of portal hypertension, together with UDCA in patients who are not able to take UDCA, or as monotherapy for patients

What Happens If I Miss the Dose?

Do not take the medicine for as long as you are able, but avoid your missed dose if you are nearing the time to take the next dose. Don't take two doses at once.

What Happens If I Overdose?

Get medical attention in an emergency or contact the poison help line at 1-800-222-1222.

What Should be Avoided?

Follow your doctor's advice regarding any restrictions on your food, drink, or activities.

Interaction with Other Drugs

You should take your dose of obeticholic acids four hours before or four hours following taking one of these:

  • Colesevelam
  • Cholestyramine
  • Colestipol

Other medications can alter the obeticholic acids, such as prescription and over-the-counter medicines, vitamins, and herbal products. Discuss with your doctor all other medications you take.

 

 

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*

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