A change today that could transform tomorrow
What does the IQIRVO Effect mean to you? See the impact IQIRVO is making in the lives of people with primary biliary cholangitis (PBC).
Cecilia’s IQIRVO Effect
Meet Cecilia, who advocated for care that was right for her and chose IQIRVO as the next step in her PBC journey.
My name is Cecilia, I’m a mom of two girls, a psychologist, and I choose to transform my PBC treatment journey with IQIRVO.
I was diagnosed with PBC in 2021, but my journey began in 2014. Following the birth of my second daughter, I started experiencing itching, fatigue, and pain that I never had before. Even when bloodwork found I had elevated liver enzymes, my primary care doctor dismissed both my symptoms and labs. Specialist after specialist, I was met with the same dismissal. I had followed every suggestion from my medical team, yet my liver enzymes were still elevated. I knew something was wrong, and I knew that no one was listening. At that point, I decided to seek out an entirely new medical team.
I prepared binders of my previous labs and medical history, and my primary care doctor finally referred me to a hepatologist. But finding the right hepatologist wasn’t that easy, and I was once again left without answers. I took matters into my own hands, researching and booking consultations with hepatologists across the country, and, finally, I found one that was right for me. I was so nervous for my first appointment, but when we met, I immediately felt seen and heard in a way I hadn’t before. He took the time to understand and consider what I had experienced, and a liver biopsy confirmed a diagnosis of PBC.
When I started treatment with UDCA, I was already 7 years into my journey. My ALP levels decreased slightly, but I was considered a partial responder and knew that I needed more from my treatment. My hepatologist is passionate about rare liver disease, and he knew that a change in PBC treatment was coming. When IQIRVO became available, it took just days for him and I to agree that it was the next step in my journey.
When I received my lab results after 5 weeks, I couldn’t believe that my ALP level was normal. My itching has also improved. IQIRVO has helped me to achieve results that I couldn’t before on just UDCA.
To me, the IQIRVO Effect is finding joy in the face of change. At the nail salon, at amusement parks, at the beach, instead of watching my family and wondering if they’re having fun, I’m truly enjoying it with them.
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 see full Prescribing Information for IQIRVO.
Christine’s IQIRVO Effect
Meet Christine, who reevaluated her PBC treatment plan with her doctor and discovered a different treatment approach with IQIRVO.
My name is Christine, I’m a wife, mother, and avid hiker, and I choose to transform my PBC treatment journey with IQIRVO.
17 years ago, a routine blood test found that I had high liver enzyme levels. At the time, my doctor dismissed the results, and I decided to make a list of anything I could find that may be related to my high ALP level.
For weeks, I advocated for additional tests, going line by line on my list of possibilities. Finally, my doctor referred me to a hepatologist, who confirmed a diagnosis of primary biliary cholangitis. I learned that while it can be slow moving, PBC is still progressive, and so I started treatment with UDCA right away.
For 12 years, I responded well to my PBC treatment, but then I saw my ALP levels start to increase. My doctor suggested an additional treatment, but it wasn’t right for me and I was left waiting for a different option.
That different treatment option came when my doctor told me about a clinical trial for IQIRVO. I learned everything I could about the treatment and was so excited to enter the trial. That was over 3 years ago, and I’ve chosen to continue taking IQIRVO. It is helping me meet my treatment goal of getting my ALP back to normal.
Before, I didn’t feel like other treatments were an option for me, but I remained determined to not let PBC stop me from doing so many of the things that I love.
The IQIRVO Effect, to me, means hope.
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 see full Prescribing Information for IQIRVO.