Ocaliva

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

• yellowing of the skin or eyes
• dark colored urine
• loss of appetite
• pain in the upper right part of the stomach
• nausea
• vomiting
• swelling in the area around the stomach

• Ocaliva^®

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Ocaliva crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with the use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Ocaliva.

• Store at 20°C-25°C (68°F-77°F)
• Do not keep medicine that is out of date or that you no longer need.
• Keep Lipitor and all medicines out of the reach of children. Be sure that if you throw medicine away, it is out of the reach of children.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe itching;
• rapid weight gain, especially in your face and midsection;
• swelling in your ankles;
• dark urine, clay-colored stools;
• nausea, vomiting;
• jaundice (yellowing of the skin or eyes);
• tiredness, joint pain;
• dry eyes or mouth;
• darkening of your skin; or
• puffiness around your eyes.

Common side effects may include:

• itching, rash;
• feeling tired;
• sore throat;
• stomach pain, constipation;
• dizziness; or
• joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe itching;

• rapid weight gain, especially in your face and midsection;

• swelling in your ankles;

• dark urine, clay-colored stools;

• nausea, vomiting;

• jaundice (yellowing of the skin or eyes);

• tiredness, joint pain;

• dry eyes or mouth;

• darkening of your skin; or

• puffiness around your eyes.

Common side effects may include:

• itching, rash;

• feeling tired;

• sore throat;

• stomach pain, constipation;

• dizziness; or

• joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Distribution of obeticholic acid is restricted.12 (See Restricted Distribution Program under Dosage and Administration.)

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you have dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellow skin or eyes. These may be symptoms of a serious liver problem.

This medicine may increase the level of cholesterol and fats in your blood. If this condition occurs, your doctor may give you a medicine to lower the cholesterol and fats. Talk to your doctor if you have concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

• Tell all of your health care providers that you take Ocaliva. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Other drugs will be given with this medicine to help avoid side effects.
• Do not take colesevelam, colestipol, or cholestyramine within 4 hours of Ocaliva.
• This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Ocaliva while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Ocaliva (obeticholic acid) is used to treat primary biliary cholangitis (PBC). This medicine is sometimes used together with another drug called ursodeoxycholic acid (UDCA).

Primary biliary cholangitis is a chronic type of liver disease that can gradually destroy bile ducts. These ducts deliver bile from the liver to the small intestines, to help your body digest fats and certain vitamins. When bile ducts are destroyed by PBC, bile stays in the liver and damages liver cells, which can cause cirrhosis (scarring of the liver) and lead to liver failure. PBC is a slow progressive disease that may have no symptoms for many years. Treating PBC to keep the liver functioning normally can allow for a normal life expectancy.

Ocaliva was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis.

In clinical studies, patients with PBC responded to Ocaliva. However, further studies are needed to determine if this medicine can improve survival or disease-related symptoms.

Use Ocaliva exactly as it was prescribed for you Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Ocaliva is usually taken once per day, with or without food.

To be sure this medicine is helping your condition, you may need frequent blood tests. You may not notice any change in your symptoms, but your blood work will help your doctor determine how best to treat you with Ocaliva.

You may be given other medications to treat itching that may be caused by Ocaliva.

If you stop taking Ocaliva for any reason, you may need to use a lower dose when you start taking it again. Follow your doctor's dosing instructions carefully.

Call your doctor if your symptoms do not improve, or if they get worse. The most common symptoms of PBC is intense itching, especially in your arms, legs, and back.

Store Ocaliva at room temperature away from moisture and heat.