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Ocaliva

Generic Name: Obeticholic acid [ oh-BET-i-KOE-lik-AS-id ]
Drug Class: Miscellaneous GI agents

What is Ocaliva?

Ocaliva is a prescription medication for treating primary biliary cholangitis (PBC) in conjunction with ursodeoxycholic acid (UDCA) for adults who haven't adequately responded to UDCA or by itself for adults who are unable to endure UDCA.

Primary biliary cholangitis (PBC) is a persistent liver condition that gradually damages the bile ducts that are located in the liver. These ducts carry bile into the small intestines to aid in the digestion of fats and other nutrients. When PBC damages these ducts, the bile is stored in the liver and causes damage to the cells of the liver. This could lead to the conditions known as cirrhosis (scarring on the liver) and liver failure. PBC is a chronic disease that may not show any symptoms for a long time. The treatment of PBC will help to maintain the liver's normal functioning.

Ocaliva is accepted from The US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical trials, a few patients with PBC have responded to the medicine. However, further research is required.It isn't clear whether taking Ocaliva increases your odds of survival or reduces the signs of PBC.

Warnings

Consult your physician immediately. If you notice mood swings or severe itching, swelling, and weight gain, problems breathing and stomach pains, fewer urinations, a yellowing of your eyes or skin, bloody or tarry stool, or if you vomit in the blood of your vomit or vomit that appears as coffee ground,

You'll need tests for liver function, and according to the results, you may have to stop taking obeticholic acids. Don't stop taking the medication without consulting your physician.

Don't take Ocaliva. If you suffer from primary biliary cholangitis that has liver cirrhosis that manifests as symptoms like gastric fluid as well as confusion (decompensated liver cirrhosis), or if you have abnormalities on certain tests that test your liver,

Before you Take this Drug

It is not recommended to take Ocaliva in the event that you are allergic to obeticholic acids or if you suffer from:

  • Advanced liver cirrhosis;
  • Complete blockage of the bile ducts.

The doctor will conduct tests to determine if Ocaliva is the correct therapy for you. Inform your doctor about liver issues, particularly cirrhosis.Inform your doctor if you are nursing or pregnant.

How to Take Ocaliva?

Use Ocaliva exactly as directed by your physician. Follow the directions on your prescription label and review all medication manuals or instruction sheets. The doctor might alter your dosage.Eat with or withoutYou might be prescribed medications to reduce itching, a typical adverse result of Ocaliva. Contact your physician when itching becomes excessive.

You'll need liver function tests, and you might need to discontinue taking Ocaliva according to the results, even if there are no signs.Don't stop using this medication without consulting your doctor.Keep at room temperature, away from heat and moisture.

Details on Dosage

Usual Adult Dose for Biliary Cirrhosis:

Initial dose: 5 mg taken orally every day.
Maintenance dose: 5 mg every day. If an adequate reduction in alkaline phosphatase (ALP) or total bilirubin does not occur after 3 months, increase the dose to 10 mg taken orally at least once per day.
Maximum dose: 10 mg/day
Comments:
Uses: In the treatment of primary biliary cholangitis
As monotherapy for adults who are unable to tolerate ursodeoxycholic acids (UDCA).
In combination with UDCA in adults who have an insufficient response to UDCA

What Happens if I Miss the Dose?

Do not take the medicine for as long as you can. However, avoid any missed doses if you are close to the time of the next dose. Don't take two doses at a time.

What Happens If I Overdose?

For medical emergencies, seek emergency medical attention or contact the Poison Help line at 1-800-222-1222.

What Should be Avoided?

Follow your doctor's advice regarding any limitations on foods, drinks, or any activity.

Side effects of Ocaliva

See a doctor immediately. If you show symptoms that indicate an allergy reaction (ocaliva): hives, breathing problems, or swelling of your lips, face, tongue, throat, or face,

See your doctor right away. If you suffer from:

  • New or worsening symptoms of fatigue, weakness, dizziness, or drowsiness
  • Anxiety, mood changes, slurred or confused speech;
  • Extreme itching;
  • Fever, chills, and less urination;
  • Stomach discomfort, nausea, vomiting, diarrhoea, nausea, vomiting, and loss of appetite
  • Bloody or tarry stool that coughs up blood or vomit that looks similar to coffee grounds
  • Jaundice (yellowing of the eyes or skin)
  • Fluid build-up around your stomach It can cause stomach bloating, weight gain, difficulty breathing, and swelling in your legs or stomach.

Your dosages could be shortened or discontinued permanently when you experience certain adverse reactions.

Common ocaliva adverse effects could include:

  • Skin rash: dryness, itching, redness, oozing, or crusting
  • Dizziness, fever, feeling exhausted;
  • Stomach discomfort, constipation;
  • The throat or mouth;
  • Rapid or irregular heart rate;
  • An increase in swelling on your hands and lower legs;
  • Joint pain,
  • Thyroid function that is abnormal.

This is not a comprehensive list of all the side effects. Other side effects could occur. Contact your doctor for advice regarding medical effects. You can report adverse reactions to the FDA at 1-800-FDA-1088.

Interaction with Other Drugs

You should take your Ocaliva dose at least 4 hours prior to or 4 hours following the time you take any of the following medications:

  • Colesevelam;
  • Cholestyramine;
  • Colestipol.

Other medications can interfere with obeticholic acids, such as prescription and over-the-counter medications, vitamins, and herbal products. Inform your physician about any other medications you take.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*

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