Ocaliva (Page 6 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

OCALIVA tablets are packaged in a 40 mL high density polyethylene bottle closed with a 33 mm polypropylene child resistant cap containing an induction seal. Each bottle contains 30 tablets.

5 mg Tablets

OCALIVA tablets are available as off-white to yellow, round tablets debossed with INT on one side and 5 on the other side. Each tablet contains 5 mg of obeticholic acid.

NDC 69516-005-30

5 mg tablets in a bottle (30 count)

10 mg Tablets

OCALIVA tablets are available as off-white to yellow, triangular tablets debossed with INT on one side and 10 on the other side. Each tablet contains 10 mg of obeticholic acid.

NDC 69516-010-30

10 mg tablets in a bottle (30 count)

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Hepatic Decompensation and Failure in PBC Patients with Cirrhosis

• Instruct patients and caregivers to immediately contact their healthcare provider if they experience:
  • Symptoms of disease progression or worsening liver function, such as ascites, jaundice, variceal bleeding, or hepatic encephalopathy.
  • Symptoms of complete biliary obstruction [see Contraindications (4), Warnings and Precautions (5.1)].
  • Severe or persistent non-specific signs and symptoms of impaired health:
    • nausea, vomiting, abdominal pain, diarrhea, weight loss, fever and chills, worsening or new fatigue, weakness, loss of appetite, or dehydration.
• Inform patients that they will need to undergo laboratory testing periodically while on OCALIVA treatment to assess liver function.

Severe Pruritus

• Advise patients to contact their healthcare provider if they experience new onset or worsening severe pruritus [see Warnings and Precautions (5.2)].

Reduction in HDL-C

• Advise patients that they may need to undergo laboratory testing to check for changes in lipid levels while on treatment with OCALIVA [see Warnings and Precautions (5.3)].

Administration

Advise patients to take:

• OCALIVA with or without food.
• OCALIVA at least 4 hours before or 4 hours after taking a bile acid binding resin, or at as great an interval as possible [see Drug Interactions (7.1)].

OCALIVA is a registered trademark of Intercept Pharmaceuticals, Inc.

Distributed by:

Intercept Pharmaceuticals, Inc.

305 Madison AvenueMorristown, NJ 07960

This Medication Guide has been approved by the U.S. Food and Drug Administration.				Revised: April 2022
MEDICATION GUIDEOCALIVA® (o-CAL-eh-vah)(obeticholic acid) tablets
What is the most important information I should know about OCALIVA? Before you start OCALIVA, and during your treatment with OCALIVA, your healthcare provider will do tests to check your liver. These tests will help your healthcare provider decide if it is safe for you to start taking OCALIVA and safe for you to continue taking OCALIVA. OCALIVA can cause serious side effects including:Worsening of liver problems or liver failure, in some cases leading to liver transplant or death, has happened in people with primary biliary cholangitis (PBC) with liver cirrhosis when taking OCALIVA. Tell your healthcare provider right away if you have any of the following symptoms of worsening liver problems during treatment with OCALIVA:
	swelling of your stomach-area from a build-up of fluid yellowing of your skin or the whites of your eyes black, tarry, or bloody stools coughing up or vomiting blood, or your vomit looks like “coffee grounds”		mental changes such as confusion, sleepier than usual or harder to wake up, slurred speech, mood swings, or changes in personality
Tell your healthcare provider right away if you have any of the following symptoms during treatment with OCALIVA and they are severe or do not go away:
	stomach-area pain nausea, vomiting, or diarrhea loss of appetite or weight loss new or worsening fatigue		weakness fever and chills light-headedness less frequent urination
What is OCALIVA? OCALIVA is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well enough to UDCA, or alone in adults who cannot tolerate UDCA.It is not known if taking OCALIVA will improve your chance of survival or improve your symptoms of PBC.It is not known if OCALIVA is safe and effective in children.
Do not take OCALIVA if you: have PBC with liver cirrhosis with symptoms such as fluid in the stomach-area or confusion (decompensated liver cirrhosis) or with abnormalities in certain tests that check your liver. have a complete blockage of the bile ducts in your liver or gallbladder.
Before taking OCALIVA, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant. It is not known if OCALIVA will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if OCALIVA passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you take OCALIVA. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. OCALIVA can affect the way certain medicines work. Certain other medicines may affect the way OCALIVA works.
How should I take OCALIVA? Take OCALIVA exactly as your healthcare provider tells you to. Do not take more OCALIVA than your healthcare provider tells you to. Take OCALIVA with or without food. If you take a bile acid binding resin, take OCALIVA at least 4 hours before or 4 hours after you take your bile acid binding resin. If this is not possible, space the time between taking OCALIVA and your bile acid binding resin as far apart as possible. If you take too much OCALIVA, call your healthcare provider or get emergency medical help right away.
What are the possible side effects of OCALIVA?OCALIVA can cause serious side effects, including: See “What is the most important information I should know about OCALIVA?“ Severe itching (pruritus). Itching is a common side effect of OCALIVA and can sometimes become severe (intense itching or itching over much of your body). Severe itching can cause discomfort, problems sleeping, and problems doing daily activities and usually needs to be treated. Tell your healthcare provider if you get severe itching or if your itching gets worse. Lower HDL-C (“good” cholesterol). OCALIVA can lower high levels of HDL-C. Your healthcare provider will check your cholesterol levels during your treatment with OCALIVA. The most common side effects of OCALIVA include:
	tiredness stomach pain and discomfort rash joint pain mouth and throat pain	dizziness constipation swelling in your hands, ankles, or feet fast or irregular heartbeat		fever changes in how your thyroid gland works dryness, irritation, redness, crusting or drainage of the skin (eczema)
These are not all the possible side effects of OCALIVA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store OCALIVA? Store OCALIVA at room temperature between 68°F to 77°F (20°C to 25°C). Keep OCALIVA and all medicines out of the reach of children.
General information about the safe and effective use of OCALIVA. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use OCALIVA for a condition for which it was not prescribed. Do not give OCALIVA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about OCALIVA that is written for health professionals.
What are the ingredients in OCALIVA?Active ingredient: obeticholic acidInactive ingredients: microcrystalline cellulose, sodium starch glycolate, magnesium stearateFilm coating: Opadry II (Yellow) containing polyvinyl alcohol-part hydrolyzed, titanium dioxide, macrogol (polyethylene glycol 3350), talc, iron oxide yellowDistributed by: Intercept Pharmaceuticals, Inc., Morristown, NJ 07960OCALIVA is a registered trademark of Intercept Pharmaceuticals, Inc.For more information, go to www.OCALIVA.com or call 1-844-782-4278.