If an organ in your body (such as the heart, kidneys, or liver) is not working well enough because of an illness or injury, you may need an organ transplant. An organ transplant involves surgically removing an organ from one person (who could be someone living or someone who has died) and placing it in your body.
After a transplant, organ transplant rejection can happen if your body’s immune system recognizes the new organ as “foreign” and attacks it. Normally, your immune system protects you from harmful substances by recognizing and destroying things that do not belong in your body, like bacteria or viruses. These harmful substances have special proteins called antigens on their surfaces. Once they enter the body, the immune system recognizes their antigens as foreign and attacks them.
Every person’s organs have unique antigens on their surface. If you get a transplanted organ from another person, your immune system may recognize those antigens as different. As a result, your immune system may respond, causing inflammation and damage to the transplanted organ. To prevent transplant rejection, people who receive a transplant take immunosuppressive (anti-rejection) medicines that calm down the immune response so the body will not attack the new organ.
Myhibbin (mycophenolate mofetil) is an immunosuppressive medicine. It was approved by the FDA in May 2024 to prevent transplant rejection in people who have had a heart, kidney, or liver transplant. Myhibbin is used along with other immunosuppressive medicines.
How Do I Take Myhibbin?
Myhibbin is an oral suspension (liquid) that is taken by mouth two times per day. Your dose will depend on which type of organ transplant you had (heart, kidney, or liver) and your age. In younger people, the dose also depends on your body surface area (a number that is calculated by your health care provider based on your height and weight).
Shake Myhibbin well before each dose. Take each dose without food unless your health care provider tells you otherwise. Do not mix Myhibbin with any other liquids before you take it. Once the bottle is opened, throw it away after 60 days.
Handle this medicine carefully so that you do not get any on your skin. If Myhibbin gets on you, wash the area well with soap and water. If you get Myhibbin in your eyes, rinse them well with plain water.
The main ingredient of Myhibbin, mycophenolate mofetil, has been used to prevent transplant rejection for almost 30 years. Your body changes mycophenolate mofetil into mycophenolic acid (MPA), which is the active ingredient. Myhibbin is one form (liquid) of MPA. This medicine comes in other forms like tablets, capsules, and slow-release tablets. If you have different forms of MPA on hand, do not substitute one form for another. Carefully follow your health care provider’s instructions about what to take.
What Monitoring or Blood Tests May I Need Before Starting and During Treatment?
Your health care provider will perform blood tests regularly. These tests are needed to monitor your health and assess how your body responds to the medicine. It is important to keep all of your scheduled lab tests while taking Myhibbin. Your health care provider will check to make sure the medicine is working and hopefully catch any early signs of infection or side effects before they cause problems.
For example, if your white blood cell counts go too low during treatment, your health care provider may pause or stop Myhibbin or lower your dose. Myhibbin works by suppressing your immune system (making it less active). As a result, the medicine can cause a lowering of your blood cell counts. If your white blood cell count drops too low (also called neutropenia), you are more likely to get infections, including serious infections.
How Was Myhibbin Studied and What Benefits Were Seen?
Myhibbin was approved by the FDA based on several clinical studies that were done in the past using other mycophenolate mofetil (MMF) medicines that are taken by mouth, such as tablets or capsules. In these studies, people who had kidney, heart, or lung transplants were given MMF by mouth twice daily with other immunosuppressive medicines. The regimen was compared to a placebo (containing no medicine) or another immunosuppressive medicine, such as azathioprine with other immunosuppressive medicines.
The main outcome that the researchers in these studies looked at was transplant rejection (or sometimes treatment failure, which included transplant rejection and a few other signs that treatment was not working) after six to 12 months. Across the studies, MMF with other immunosuppressive medicines was at least as good as, and often better than, the other treatment it was compared to at preventing transplant rejection.
Your results may differ from what was seen in clinical studies.
What Types of Interactions Can Happen?
Many medicines can lower the amount of Myhibbin in your body. Lowered amounts of Myhibbin may mean that you could lose your transplanted organ. It is very important that you never take anything without first talking with your health care provider. Many over-the-counter (OTC) products and prescription medicines could cause problems for you.
What Should I Know if I Can Become Pregnant?
Myhibbin can cause serious harm to a fetus, including a higher risk of miscarriage and birth defects if taken during pregnancy. If you can become pregnant, talk with your health care provider about what you will do to prevent pregnancy. If you will use a hormone method like a birth control pill, patch, vaginal ring, injection, or implant, you will also need to use a barrier method, like a condom.
Getting Your Medicine: What to Expect
Medicines that contain mycophenolate mofetil, including Myhibbin, are part of the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program. This is a program required by the FDA for medicines that have potentially serious side effects. The goal is to inform you and your health care provider about the risks and how to manage and check for these symptoms during treatment.
If you can become pregnant, you and your health care provider will need to be educated about the risks of using Myhibbin in pregnancy before it can be prescribed. The drugmaker has a program to help support the process and may require that you use a specific pharmacy.
Health care provider training. Your health care provider will need to complete training on the risks of Myhibbin and submit proof that the training has been completed before they can prescribe it.
Safety information and monitoring. If you can become pregnant, your health care provider will give you an overview of the safety concerns when using Myhibbin during pregnancy and will provide you with a brochure with information.
You will need to be tested for pregnancy right before you start Myhibbin, about eight to 10 days later, and during regular visits with your health care provider.
Cost assistance. The drugmaker offers a patient support program that may help to lower your monthly copay to as little as $0. For questions or more information, you can call 800-461-7449 or visit myhibbin.azuritysolutions.com.