(BPT) - This is the real-life experience of one individual's experience living with primary biliary cholangitis (PBC). This is not representative of all experiences. The information provided is not intended to be a substitute for professional medical advice, diagnosis, or treatment.
Wendy built a career in human resources making sure employees had the information and support they needed to be successful in their roles. Almost 30 years later, Wendy is using that same passion for helping others to raise awareness of a rare liver disease called primary biliary cholangitis (PBC).
PBC is a progressive, cholestatic autoimmune disease that causes chronic inflammation and can lead to irreversible scarring of the liver. Over time, PBC progressively destroys liver bile ducts and can cause bile and toxins to build-up (cholestasis) which can lead to scarring of the liver (cirrhosis), and eventually liver failure.[i] It is also a disease that predominantly affects women.[ii]
Life with PBC for Wendy has had its challenges. She was always very active and kept busy, so never felt that anything was 'off' with her health. It wasn't until she had routine blood work done and had higher-than-normal liver enzymes that her doctor recommended she see a liver specialist, a hepatologist.
A liver biopsy confirmed the diagnosis of PBC and Wendy's doctor started her on a treatment for PBC. But when her alkaline phosphatase (ALP) levels did not improve, she decided to seek out a second opinion to get the answers she needed.
'It was important to me that my concerns were being heard by my doctor,' Wendy recalls. 'I advocated for myself and found a new hepatologist - one that respected my needs and goals for managing PBC.'
Advances in PBC Research
For people living with PBC, there has been a significant unmet need for new treatment options, particularly for people who have an inadequate response to first-line treatment or are intolerant to treatment.[iii] However, research in PBC is continuing and there have been advancements in medicine that may help meet the current needs of people living with this disease.[i],[iv]
For Wendy, PBC treatment options are important, especially since she did not respond to initial treatment.
Moving Forward
While certain aspects of this progressive autoimmune disease have not allowed Wendy to continue with a traditional career path, she's taken on a new role as the 'CEO of her family.' And while she knows that life may never be 'normal' with PBC, she is going to do everything she can to be as healthy as possible for her family.
Wendy hopes that by sharing her story, she can inspire others who are living with PBC to feel empowered to advocate for themselves and their liver health. 'Although this disease may be challenging and life will be different, you can choose to be an optimist.'
Learn more about Iqirvo® (elafibranor) 80 mg tablets, including full Prescribing Information and Important Safety Information at www.Iqirvo.com.
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IMPORTANT SAFETY INFORMATION
-What is IQIRVO® used for?
IQIRVO is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well to UDCA, or used alone in patients unable to tolerate UDCA.
IQIRVO is not recommended for use in people who have symptoms or signs of advanced liver disease. It is not known if taking IQIRVO will improve your chance of survival or prevent liver decompensation.
It is not known if IQIRVO is safe and effective in children under 18 years of age.
-What Warnings should I know about IQIRVO?
- IQIRVO can cause muscle problems (myalgia, myopathy, rhabdomyolysis) and muscle pain that can be severe. Treatment with IQIRVO may cause muscle pain or worsen existing pain and can increase the level of an enzyme in your blood called creatine phosphokinase (CPK); both can be a sign of muscle damage. If there is new or worsening muscle pain, your healthcare provider may examine you and perform a blood test. Stop taking IQIRVO and call your healthcare provider right away if you have any of the following signs or symptoms: severe muscle pain, unexplained soreness, unexplained muscle weakness, or dark, reddish urine.
- IQIRVO may increase the risk of bone fractures. Tell your healthcare provider about any bone fractures, or if you develop pain, or have changes in your ability to move around.
- IQIRVO may cause harm to an unborn baby when taken during pregnancy. Women taking IQIRVO who can become pregnant should use effective birth control during treatment and for 3 weeks after the last dose of IQIRVO. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant or think you may be pregnant.
- IQIRVO can cause liver problems and abnormal liver blood test results. Your healthcare provider should do tests before starting and during treatment with IQIRVO to check your liver function. Tell your healthcare provider right away if you experience any of the following during treatment with IQIRVO: swelling of your stomach-area (abdomen), yellowing of your skin or whites of your eyes, black, tarry, or bloody stools, mental changes such as confusion, being sleepier than usual or harder to wake up, slurred speech, mood swings, or changes in personality, or coughing up or vomiting blood, or your vomit looks like coffee grounds. If you have severe stomach-area (abdomen) pain, nausea, vomiting, diarrhea, loss of appetite or weight loss, new or worsening fatigue, weakness, fever and chills, light-headedness, or less frequent urination, tell your healthcare provider right away.
- Some people taking IQIRVO had allergic reactions, which may include rash, trouble breathing, itching, or swelling of your face, lips, tongue, or throat. If you experience any of these, stop taking IQIRVO, call your healthcare provider right away or go to the nearest hospital emergency room.
- IQIRVO can cause blockage of the bile duct and may increase your risk of gallstones. Call your healthcare provider right away if you develop pain in the upper right stomach area or yellowing of the skin.
-You should not use IQIRVO if you:
- Have advanced liver disease.
- Are pregnant or plan to become pregnant. IQIRVO can harm your unborn baby. You should not become pregnant during treatment with IQIRVO.
- Are breastfeeding or plan to breastfeed. It is not known if IQIRVO passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you take IQIRVO.
-What are the side effects of IQIRVO?
The most common side effects of IQIRVO include weight gain, diarrhea, stomach pain, nausea, vomiting, joint pain, constipation, muscle pain, bone fractures, gastroesophageal reflux disease (GERD), dry mouth, weight loss, and rash. These are not all of the possible side effects of IQIRVO. Call your doctor for medical advice about side effects.
-What other medications might interact with IQIRVO?
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. IQIRVO can affect the way certain medicines work. Certain medicines may affect the way IQIRVO works. If you take a bile acid binding resin, take IQIRVO at least 4 hours before or after you take your bile acid resin.
You are encouraged to report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. You may also report side effects to Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127.
Please click here for full Prescribing Information.
IQIRVO is a registered trademark of Genfit, S.A.
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[i] European Association for the Study of the Liver. EASL clinical practice guidelines: the diagnosis and management of patients with primary biliary cholangitis. J Hepatol. 2017;67(1):145-172.
[ii] Galoosian A, et al. 2020. Clinical updates in primary biliary cholangitis: trends, epidemiology, diagnostics, and new therapeutic approaches. J Clin Transl Hepatol. 8(1), pp. 49-60.
[iii] Huang YQ. Recent advances in the diagnosis and treatment of primary biliary cholangitis. World J Hepatol. 2016 Nov 28;8(33):1419-1441. doi: 10.4254/wjh.v8.i33.1419. PMID: 27957241; PMCID: PMC5124714.
[iv] Medford A, Childs J, Little A, Chakraborty S, Baiocchi L, Alpini G, Glaser S. Emerging Therapeutic Strategies in The Fight Against Primary Biliary Cholangitis. J Clin Transl Hepatol. 2023 Aug 28;11(4):949-957. doi: 10.14218/JCTH.2022.00398. Epub 2023 Mar 16. PMID: 37408803; PMCID: PMC10318288.
