INTRODUCTION

INOCA 5 contains Obeticholic acid which belongs to the group of medicines called Farnesoid X receptor agonists. It is used to treat primary biliary cholangitis (also known as primary biliary cirrhosis) in adults, either by itself or together with other medicine (called ursodeoxycholic acid).

Primary biliary cholangitis is a chronic disorder in which the bile ducts in your liver are slowly destroyed. When these ducts are destroyed, bile (fluid that aids in digestion and absorption of vitamins) builds up in the liver leading to inflammation and scarring. It is also known as primary biliary cirrhosis.

INOCA 5 is not recommended for use in pregnant women and consult your doctor before taking INOCA 5 if you are breast-feeding women. INOCA 5 is not recommended for use in children and adolescents (under 18 years of age) and should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before taking INOCA 5.

Prior to treatment with INOCA 5 your doctor may advice you to take blood test to understand your existing condition like liver function. The most common side effects of taking INOCA 5 are stomach pain, tiredness, dizziness, constipation, dry skin and fast or irregular heartbeat. Consult your doctor if any of the symptom worsens.

USES OF INOCA 5

• Treats primary biliary cholangitis in adults

HOW INOCA 5 WORKS

INOCA 5 works by reducing the production and build-up of bile in the liver and also reduces the inflammation of the liver. Therefore, as a result it helps to improve liver function.

DIRECTIONS FOR USE

Take INOCA 5 as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF INOCA 5

HOW TO MANAGE SIDE EFFECTS

Stomach pain:

Try to take rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. If the symptom does not improve, contact your doctor.

Constipation:

Take fiber rich foods in your diet such as fresh fruits, vegetables and whole grain cereals, and drink plenty of fluids. Exercise more regularly and stay active. Consult your doctor if the symptom gets worse.

Dizziness:

Try to rest and relax and get enough sleep. Try to avoid driving or operating any tools or machines while you are feeling dizzy. Limit your consumption of alcohol, as it can aggravate your dizziness. Consult and inform your doctor if the symptom does not improve.

Tiredness:

Drink plenty of fluids and eat balanced diet and frequent meals. Do regular minimal exercise and follow regular sleep schedule. Consult your doctor if the symptom does not improve.

Skin rash:

Do not scratch the affected area. Wear protective clothing while going outdoors. Regularly moisturize your skin after consulting the doctor. Consult your doctor if the symptom worsens.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before taking INOCA 5, inform your doctor if you are taking any of the following medicines:

• bile acid binding resins such as cholestyramine, colestipol, colesevelam (used to lower blood cholesterol levels)
• theophylline (used to prevent and treat wheezing)
• tizanidine (used to relieve the stiffness and restriction of muscles)
• warfarin (used to prevent and treat blood clots)

Overdosage:

If you or anyone else accidentally take too much of INOCA 5, consult your doctor immediately or visit the nearby hospital. Symptoms of overdosage include yellowing of the skin.

SYNOPSIS

MORE INFORMATION

• Keep INOCA 5 out of reach of children
• Store at room temperature

FAQs ABOUT INOCA 5

Is INOCA 5 safe to use in patients with liver problems?

INOCA 5 is not recommended for use in patients with complete blockage of the biliary tract (liver, gall bladder and bile ducts). Consult your doctor before taking INOCA 5.

What is INOCA 5 used for?

INOCA 5 is used to treat primary biliary cholangitis (also known as primary biliary cirrhosis) in adults, either by itself or together with other medicine (called ursodeoxycholic acid).

What common side effects are seen with INOCA 5?

The most common side effects of taking INOCA 5 are stomach pain, tiredness, dizziness, constipation, dry skin, fast or irregular heartbeat, fever, swelling in hands and feet, throat and mouth pain, skin rash and itching, joint pain and fever. Consult your doctor if any of the symptom worsens.

Is INOCA 5 safe to use in pregnant and breast-feeding women?

INOCA 5 is not recommended for use in pregnant women and it is not known whether INOCA 5 passes through breast milk. Consult your doctor before taking INOCA 5 if you are planning to get pregnant or breast-feeding women.

Does INOCA 5 cause constipation?

Yes, INOCA 5 may cause constipation in some individuals. To manage this side effect, try taking fiber rich foods in your diet such as fresh fruits, vegetables and whole grain cereals, and drink plenty of fluids. Exercise more regularly and stay active. Consult your doctor if the symptom gets worse.

REFERENCES

1. James E. Barrett. Handbook of Experimental Pharmacology. The pharmacology of bile acids and their receptors. 1st edition. 2019. Page – 13.

2. Frederik Nevens, Pietro Andreone, Giuseppe Mazzella, Simone I Strasser, Christopher Bowlus, Pietro Invernizzi, Joost P H Drenth, Paul J Pockros, Jaroslaw Regula, Ulrich Beuers 1, Michael Trauner, David E Jones, Annarosa Floreani, Simon Hohenester, Velimir Luketic, Mitchell Shiffman, Karel J van Erpecum, Victor Vargas, Catherine Vincent, Gideon M Hirschfield, Hemant Shah, Bettina Hansen, Keith D Lindor, Hanns-Ulrich Marschall, Kris V Kowdley, Roya Hooshmand-Rad, Tonya Marmon, Shawn Sheeron, Richard Pencek, Leigh MacConell, Mark Pruzanski, David Shapiro, POISE Study Group. A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis. NIH. National Library of Medicine, National center for biotechnology information. Pubmed.gov. August 2016. [Accessed on 8th August 2022] https://pubmed.ncbi.nlm.nih.gov/27532829/

3. Intercept Pharmaceuticals. Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (REVERSE). NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on March 2008] [Accessed on 8th August 2022] https://clinicaltrials.gov/ct2/show/NCT03439254

4. Almac Pharma Services. Electronic Medicines Compendium (EMC). [Revised in March 2018] [Accessed on 8th August 2022] https://www.medicines.org.uk/emc/files/pil.2561.pdf

5. Intercept Pharmaceuticals, Inc. U.S. Food & Drug Administration. [Revised in January 2018] [Accessed on 8th August 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207999s003lbl.pdf