Obeticholic Acid (Oral)

Obeticholic acid is a semi-synthetic bile acid analogue that is used either alone or with other treatments to treat patients with primary biliary cholangitis.

Overview

Obeticholic acid is a semi-synthetic bile acid analogue. It is either used alone or in combination with ursodeoxycholic acid in the treatment of primary biliary cholangitis.

Primary biliary cholangitis (PBC) is a developing liver disease that can lead to liver failure. Commonly there are no symptoms of this condition, but the liver function will gradually decrease and significant problems will develop if left untreated.

This medication is available only with a prescription and is administered as Ocaliva tablets.

Condition treated

  • Primary biliary cholangitis

Type Of Medicine

  • Selective farnesoid X receptor

Side Effects

In addition to the desired effects of using obeticholic acid, other unwanted side effects from use may also occur. While not all of the following side effects may occur, in some cases where they do they may require you to seek medical attention.

You should consult your doctor immediately if you experience any of the following side effects:

Occurring commonly:

  • Feverishness
  • Severe itching of the skin

Frequency of occurrence not known:

  • Abdominal pains
  • Changed breath odor
  • Chills
  • Darkened urine
  • Dizziness
  • Headaches
  • Lost appetite
  • Nausea
  • Rash
  • Stomach pain
  • Stomach pain with bloating
  • Stools with a clay-like coloration
  • Unusual tiredness
  • Unusual weakness
  • Vomiting up of blood
  • Yellowing of the eyes
  • Yellowing of the skin

Obeticholic acid may also cause other unwanted side effects that would not normally require that you seek medical attention. These side effects are usually milder, may abate over time and are not indications that other, more serious, conditions may be developing. If these side effects do begin to bother you or if they are continuing, however, then you should contact your doctor for advice on how to alleviate them:

Occurring commonly:

  • Abdominal pain
  • Bloated or swollen face, arms, hands, lower legs or feet
  • Difficulty passing a bowel movement
  • Difficulty with moving
  • Fast or pounding heartbeat or pulse
  • Irregularity of heartbeat
  • Muscle pain
  • Muscle stiffness
  • Pain in the joints
  • Rapid weight gain
  • Soreness of the throat
  • Stomach discomfort
  • Tingling in the feet or hands
  • Unusual weight gain
  • Unusual weight loss

Occurring less commonly:

  • Encrusting of the skin
  • Oozing of the skin
  • Scaling of the skin
  • Skin rash

Other side effects could also occur that have not been listed herein. If you experience other side effects then you should contact your healthcare professional to seek their advice. If you believe your immediate health is at risk, however, always contact the emergency services.

Dosage

Obeticholic acid should be taken only as you have been directed to by your doctor. You should not take more of this medication than you have been prescribed and should not take it more often than ordered. Doing so will increase the risk of side effects and increase the severity of side effects that occur.

You can take this medication either with or without food. You should take it with food if it upsets your stomach.

If you're also being treated with Cholestyramine, colestipol or colesevelam, you must leave a gap between these and your dose of Obeticholic acid. Take Obeticholic acid either four hours before or after taking these other treatments.

The dose of this medication will differ for each patient depending on a range of factors. Significant factors include the strength of the medication, the condition being treated, your body weight and your tolerance to the treatment. You should not make any changes to your dosing for any reason. The following information is to serve as a guideline only and should never be used to make changes to your own dosing with this medication:

  • Adults should be treated with an initial dose of 5 mg taken once per day. This dose can be adjusted if the patient can tolerate it up to a maximum dose of 10 mg given once daily.
  • The use of this medication in children must only ever be carried out under direct instruction from a doctor.

If you miss a dose of this medication then you should take it as soon as possible. If you are close to your next dose or if you are within 4 hours of being due to take a dose of Cholestyramine, colestipol or coleseveleam, however, then you should skip the dose entirely and return to your normal schedule. You should never take a double dose of this treatment and should never take this treatment within four hours of the other listed medications.

Interactions

Some medications should never be used in conjunction with one another. This is because they can interact in the body with severe side effects. In the most serious cases the effects may be life-threatening and in other cases, drugs may prevent each other from working or may expose the patient to more serious side effects. When taking this medication it is essential that your doctor is fully aware of all other medications that you are taking so that interactions can be avoided. This includes all prescribed medications, over the counter treatments and any other substances that you take.

Obeticholic acid is not recommended for use with the following medication. If you are already taking one then the other treatment may not be prescribed due to the severity of interactions. If both are prescribed, however, then changes will be made to the dose given or to the frequency of use:

  • Warfarin

Certain interactions can also occur with the foods, drinks and tobacco products that you consume. As Obeticholic acid acts on the liver it is unwise to consume alcohol when you are taking this medication. You should discuss your use of alcohol with your doctor before beginning treatment.

Certain medical problems can also impact on the use of this treatment. You must inform your doctor of all medical conditions from which you are suffering so that interactions can be avoided. Some medical conditions can be worsened by the use of this treatment and others may intensify the effects of it. It is especially important that you inform your doctor if you have any of the following medical problems:

  • Patients with a biliary blockage should not be treated with this medication.
  • Patients with hyperlipidemia may experience a worsening of condition when using Obeticholic acid.
  • The effects of Obeticholic acid may be increased when other moderate to severe diseases of the liver a present.

Other medical conditions can also impact the use of Obeticholic acid. You must inform your doctor of all other conditions from which you suffer before beginning treatment.

Warnings

Before you begin use of Obeticholic acid you should consider the potential risks and side effects in relation to the benefits of use. This decision to take Obeticholic acid should be made with your doctor having considered all of the following:

Allergies: You must inform your doctor if you have ever suffered from an allergic reaction to any medications in the past. You should also inform them of any other allergies you have suffered to dyes, foods, preservatives and other substances too. Certain allergies may prohibit the use of Obeticholic acid.

Pediatric: The safety and effectiveness of use in children for this medication has not been established. You should discuss this with your doctor before use.

Geriatric: There are no known limitations to the use in elderly patients. Elderly patients are, however, more likely to have other medical conditions that may limit the usefulness of Obeticholic acid as a treatment.

Pregnancy: The risk of use during pregnancy is unknown. You should discuss this with your doctor before use and must inform the doctor if you are pregnant.

Breastfeeding: There are known adequate studies that enable risk to be calculated in breastfeeding an infant while using this medication. You should consider the benefits and risks and make a decision with your doctor about whether or not to continue breastfeeding.

Your doctor will need to check your development regularly when you are taking this treatment. This will enable them to check that the medication is working properly and blood tests may also need to be taken to check that no unwanted side effects are occurring.

Serious liver problems can develop while you are using this treatment. If you experience any symptoms of liver problems then you should contact your doctor straight away. Symptoms can include:

  • Darkened coloration of urine
  • Paling of stools
  • Nausea
  • Vomiting
  • Lost appetite
  • Pain in the stomach
  • Yellowing of the skin
  • Yellowing of the eyes

An increase in cholesterol levels may occur from the use of this treatment. In these cases, you may then be given a medication to help to control your cholesterol levels. You should discuss this with your doctor if you have any concerns about this.

You should not take any other medications in conjunction with this treatment unless you have discussed this use with your doctor. Your doctor will be able to help you in preventing drug interactions from occurring but you must consult them before use.

Storage

You can store this medication at room temperature but should prevent it from freezing and keep it away from heat at all times.

You should store it out of the reach of children and should dispose of any unwanted medication promptly and safely.

Summary

Obeticholic acid is used in the treatment of primary biliary cholangitis. This is a developing liver problem that will eventually lead to liver failure if it is untreated.

Obeticholic acid is prescribed in tablet form that should be taken daily. Patients should develop a habit of use and should take it in the same manner each day to ensure that the treatment is delivered effectively and has the desired impact.

You should not take any other medications in conjunction with Obeticholic acid unless they have been approved by your doctor.