The International Society on Thrombosis and Haemostasis (ISTH) Guidelines

A global organization of experts recommends using CABLIVI, plasma exchange, and immunosuppression based on lab testing and diagnosis

CABLIVI, in combination with PEX and immunosuppression, is the only FDA-approved treatment for acquired/immune-mediated thrombotic thrombocytopenic purpura (aTTP/iTTP*) recommended by ISTH

A guideline-recommended treatment for aTTP

The ISTH Treatment Guidelines suggest using CABLIVI with PEX and immunosuppression for people experiencing their first episode or another aTTP/iTTP episode

  • The ISTH created a guideline for the treatment of aTTP/iTTP
  • The ISTH is a global, not-for-profit organization of experts in this field. It has more than 5000 members in 100 countries
  • The guideline helps doctors and other healthcare professionals make informed treatment decisions for patients with aTTP/iTTP

Recommendation based on laboratory testing and diagnosis.

CABLIVI is the first and only FDA-approved therapy for adults with aTTP/iTTP designed to work with plasma exchange (PEX) and immunosuppression

CABLIVI is a prescription treatment used in combination with PEX and immunosuppression to treat adults with acquired/immune-mediated thrombotic thrombocytopenic purpura (aTTP/iTTP*).

CABLIVI was tested in a clinical study of 145 adults with aTTP/iTTP

72

72 people were given
CABLIVI + PEX +
immunosuppression

vs


 

73

73 people were given a placebo
(an injection without any medicine) +
PEX + immunosuppression

During PEX and 30 days after PEX: Both groups received either CABLIVI (caplacizumab-yhdp) or placebo after their daily PEX, and then for 30 days after. Additional treatment time: Some people received more treatment (up to 28 additional days) based on their doctor's decision.

After treatment was stopped, everyone was followed by their doctor for 28 more days.

CABLIVI CONFIDENCE—In the clinical study, the CABLIVI difference was clear

Faster return to normal platelet counts in combination with PEX and immunosuppressive therapy

CABLIVI helped return platelet counts to normal significantly faster when added to PEX and immunosuppression.

67% fewer patients relapsed requiring restarting PEX during treatment and for 28 days after

67% fewer patients in the CABLIVI group relapsed, where a drop in platelets required restarting PEX, during treatment and for 28 days after.

Significantly fewer people had another episode of aTTP/iTTP that required starting PEX again within the full study period (while taking CABLIVI and 28 days after stopping CABLIVI) in the CABLIVI group vs the placebo group: 13% receiving CABLIVI (9 people) vs 38% receiving placebo (28 people).

How real people took on aTTP/iTTP with CABLIVI confidence

See the stories of real people, real patients treated with CABLIVI. Follow their personal journey from diagnosis to living with aTTP/iTTP. Every experience is unique and individual results with CABLIVI may vary.

Meet Alex

“My main concern was bringing up my platelet counts. So learning that CABLIVI, along with immunosuppressive therapy and plasma exchange, could [potentially] help bring my platelet count to a normal level faster, it’s like, ‘OK, let’s do this.’”

Alex, real patient. Individual results may vary. Alex is being compensated by Sanofi.

    CABLIVI (caplacizumab-yhdp) is a prescription medicine used for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy. Please stay tuned for the Important Safety Information at the end of this video.

    My name is Alex.

    *Alex was compensated for his time in the creation of this video.*

    I am a husband, I’m a father, I’m a musician. And two years ago, I was diagnosed with aTTP.

    My first experience with aTTP was pretty scary. I was on my way to work, and then half of my body went numb. So, I drove myself to the urgent care, and they basically said, “It sounds like you had a ministroke. You might want to go to the ER because there’s nothing we can do for you.”

    The first time I was in the hospital, I had a very extended stay. Not knowing what’s wrong with you is just so frightening. You know they’re testing for so many things, and everything comes back negative.

    My platelet count kept going down, it just wasn’t improving. Having all these doctors around you, that look kind of concerned because they can’t figure out what’s wrong with you. You sort of want to keep hope, but you somehow also start beginning to lose hope. All you can do is just be patient and hope they figure it out.

    They finally diagnosed me with aTTP. I just felt so relieved that they finally figured out what was wrong. On my second experience with aTTP, my new doctor mentioned that there was a medication that could be helpful for me called CABLIVI.

    Once I had aTTP again, my main concern was bringing up my platelet counts. So, learning that CABLIVI, along with immunosuppressants and plasma exchange, could help platelet count to a normal level faster, it’s like OK, let’s do this. What do we do? What’s the treatment plan?

    The only thing I could think about then was just being home with my family, with my music career. I just wanted things back the way they were.

    Within 3 days of starting CABLIVI, my platelet count returned to a normal level. After 7 days, I was well enough to go home.

    *CABLIVI was tested in a clinical study of 145 adults with aTTP/iTTP. 72 people were given CABLIVI, plasma exchange (PEX), and immunosuppressive therapy vs 73 people who were given placebo (an injection without any medicine), PEX, and immunosuppressive therapy. Both groups received either CABLIVI or placebo after their daily PEX, and then for 30 days after. Some people received more treatment (up to 28 additional days) based on their doctor’s decision. After treatment was stopped, everyone was followed by their doctor for 28 more days.*

    My doctor explained that taking CABLIVI had certain side effects, but thankfully I didn’t experience any.

    *The most common side effects include nosebleed, headache and bleeding gums. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CABLIVI. Call your doctor for medical advice about side effects.*

    Once I was released from the hospital and I continued my medication at home, I had no issues with self-injecting, the nurses at the hospital showed me how to do it, and I was confident that I could do it at home.

    I didn’t have any relapses during my CABLIVI treatment, or for 28 days after.

    *Significantly fewer people had another episode of aTTP/iTTP that required starting PEX again within the full study period (while taking CABLIVI and 28 days after stopping CABLIVI) in the CABLIVI group vs the placebo group: 13% receiving CABLIVI (9 people) vs 38% receiving placebo (28 people). Individual results may vary.*

    So my life today is just staying on top of my symptoms. I just feel more confident and I was ready to move forward with my life. Appreciate my family, and my music career. I can do the things that I wanted to do, and still live a fulfilling life. Even if I'm living with aTTP.

    This was Alex's personal experience with CABLIVI. Every patient's experience is unique and individual results will vary. If you're interested in learning more, please speak with your doctor about the potential benefits and risks of treatment with CABLIVI and whether CABLIVI may be right for you.

    INDICATION AND IMPORTANT SAFETY INFORMATION
    What is CABLIVI?
    CABLIVI (caplacizumab-yhdp) is a prescription medicine used for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

    Who should not take CABLIVI?
    Do not take CABLIVI if you've had an allergic reaction to caplacizumab-yhdp or to any of the ingredients in CABLIVI.

    What should I tell my healthcare team before starting CABLIVI?
    Tell your doctor if you have a medical condition including if you have a bleeding disorder. Tell your doctor about any medicines you take, including medicines that increase your risk of bleeding such as anti-coagulants and anti-platelet agents.

    Talk to your doctor before scheduling any surgery, medical or dental procedure.

    What are the possible side effects of CABLIVI?
    CABLIVI can cause severe bleeding. In clinical studies, severe bleeding adverse reactions of nosebleed, bleeding from the gums, bleeding in the stomach or intestines, and bleeding from the uterus were each reported in 1% of subjects. In the post-marketing setting, cases of life-threatening and fatal bleeding were reported in patients receiving CABLIVI. Contact your doctor immediately if symptoms of excessive bruising, excessive bleeding, or major bleeding occur. Signs and symptoms of bleeding include: pain, swelling or discomfort, prolonged bleeding from cuts, increased menstrual flow or vaginal bleeding, nosebleeds, bleeding of gums from brushing, unusual bleeding or bruising, red or dark brown urine, red or tar black stools, headache, dizziness, or weakness.

    You may have a higher risk of bleeding if you have a bleeding disorder (i.e. hemophilia) or if you take other medicines that increase your risk of bleeding such as anti-coagulants and anti-platelet agents.

    CABLIVI should be stopped for 7 days before surgery or any medical or dental procedure. Talk to your doctor before you stop taking CABLIVI.

    The most common side effects include nosebleed, headache and bleeding gums.

    Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CABLIVI. Call your doctor for medical advice about side effects.

    Please see accompanying full Prescribing Information.

Meet Heather

“Even though I know a relapse is possible at any time, I’m confident in knowing that CABLIVI will be there.”

Heather, real patient. Individual results may vary. Heather is being compensated by Sanofi.

    CABLIVI (caplacizumab-yhdp) is a prescription medicine used for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy. Please stay tuned for the Important Safety Information at the end of this video.

    My name is Heather and this is my aTTP journey.

    *Heather was compensated for her time in the creation of this video.*

    I’m a teacher’s assistant. A softball coach for the girl’s 7th- and 8th-grade teams.

    I really love camping. It gives me a sense of enjoying the outdoors. I spend as much time outside as I can.

    In 2007, I became ill. It was a very long, hard diagnosis. I had a very bad menstrual cycle. I went to the doctor and had some tests. They said everything was fine and put me on birth control to stop the bleeding.

    A few days later the bleeding had still not stopped. I went out to the local hospital, had labs again. My platelet level was at 9,000, which is extremely low.

    They had said that I was going to need to stay in the hospital for a while and get some more tests.

    I was very frightened. I wondered if I was going to make it. I didn’t know what I was going to do for living my life.

    So it was very, very discouraging for my family and I to wake up every day and not get the answers that we needed.

    I had been there for a week and I took a nap. When I woke up from my nap I could not hear. I could not speak. I could not see, and I could not walk.

    So I was transported to the larger hospital. I was diagnosed with aTTP.

    The treatment for aTTP is very stressful and it takes a lot out of you, especially the older you get.

    I was released and sent home. At my 6-month check-up everything was fine. But unfortunately, a week later, I relapsed.

    Relapsing 4 or 5 times in 1 year, that was difficult on my body. Difficult on my family. Difficult on my emotions.

    And every time you have a relapse it just makes you a little more anxious knowing that it’s happening all over again.

    In 2019, I relapsed again. My doctor and I had talked about CABLIVI and thought that I should give it a shot if I was okay with that.

    With the CABLIVI, my platelet level came up within 4 days. I don’t like being in the hospital, just like everyone else. My stay at the hospital was only for 6 days.

    *CABLIVI was tested in a clinical study of 145 adults with aTTP/iTTP. 72 people were given CABLIVI, plasma exchange (PEX), and immunosuppressive therapy vs 73 people who were given placebo (an injection without any medicine), PEX, and immunosuppressive therapy. Both groups received either CABLIVI or placebo after their daily PEX, and then for 30 days after. Some people received more treatment (up to 28 additional days) based on their doctor’s decision. After treatment was stopped, everyone was followed by their doctor for 28 more days.*

    Once you leave the hospital, having to take CABLIVI at home, I felt confident doing it at home because of the training that I got while in the hospital.

    *Injection site reactions such as rash, bleeding, and itching may occur. Please remember that this video shares only Heather’s experience and that every patient’s experience is unique.*

    The only side effects were a little bruising on the belly from the injection site.

    *The most common side effects include nosebleed, headache, and bleeding gums. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CABLIVI. Call your doctor for medical advice about side effects.*

    While taking CABLIVI, I did not experience any relapses, and I have not experienced any relapses 28 days after taking CABLIVI.

    *Significantly fewer people had another episode of aTTP/iTTP that required starting PEX again within the full study period (while taking CABLIVI and 28 days after stopping CABLIVI) in the CABLIVI group vs the placebo group: 13% receiving CABLIVI (9 people) vs 38% receiving placebo (28 people). Individual results may vary.*

    So I’ve lived with aTTP since 2007 and as long as I’m feeling good and can do things, I want to be out, enjoying the outdoors, sitting outside underneath the stars, and getting back to my girls.

    Even though I know a relapse is possible at any time, I’m confident in knowing that CABLIVI will be there.

    This was Heather’s personal experience with CABLIVI. Every patient’s experience is unique and individual results will vary. If you’re interested in learning more, please speak with your doctor about the potential benefits and risks of treatment with CABLIVI and whether CABLIVI may be right for you.

    INDICATION AND IMPORTANT SAFETY INFORMATION
    What is CABLIVI?
    CABLIVI (caplacizumab-yhdp) is a prescription medicine used for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

    Who should not take CABLIVI?
    Do not take CABLIVI if you've had an allergic reaction to caplacizumab-yhdp or to any of the ingredients in CABLIVI.

    What should I tell my healthcare team before starting CABLIVI?
    Tell your doctor if you have a medical condition including if you have a bleeding disorder. Tell your doctor about any medicines you take, including medicines that increase your risk of bleeding such as anti-coagulants and anti-platelet agents.

    Talk to your doctor before scheduling any surgery, medical or dental procedure.

    What are the possible side effects of CABLIVI?
    CABLIVI can cause severe bleeding. In clinical studies, severe bleeding adverse reactions of nosebleed, bleeding from the gums, bleeding in the stomach or intestines, and bleeding from the uterus were each reported in 1% of subjects. In the post-marketing setting, cases of life-threatening and fatal bleeding were reported in patients receiving CABLIVI. Contact your doctor immediately if symptoms of excessive bruising, excessive bleeding, or major bleeding occur. Signs and symptoms of bleeding include: pain, swelling or discomfort, prolonged bleeding from cuts, increased menstrual flow or vaginal bleeding, nosebleeds, bleeding of gums from brushing, unusual bleeding or bruising, red or dark brown urine, red or tar black stools, headache, dizziness, or weakness.

    You may have a higher risk of bleeding if you have a bleeding disorder (i.e. hemophilia) or if you take other medicines that increase your risk of bleeding such as anti-coagulants and anti-platelet agents.

    CABLIVI should be stopped for 7 days before surgery or any medical or dental procedure. Talk to your doctor before you stop taking CABLIVI.

    The most common side effects include nosebleed, headache and bleeding gums.

    Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CABLIVI. Call your doctor for medical advice about side effects.

    Please see accompanying full Prescribing Information.

Like any medication, side effects are possible with CABLIVI

 

CABLIVI Patient Solutions is dedicated to your needs, from starting CABLIVI in the hospital to continuing at home
 

*aTTP is also known as iTTP. You and your healthcare team can use either term.
aTTP/iTTP=acquired/immune-mediated thrombotic thrombocytopenic purpura.

IMPORTANT SAFETY INFORMATION AND INDICATIONS