Myfortic

The active ingredient in Myfortic is mycophenolic acid (MPA). It belongs to a class of medications known as immunosuppressants. More specifically, it works by acting as an inhibitor for an enzyme known as IMPDH, which is responsible for DNA production in immune cells known as T and B lymphocytes. Without DNA synthesis, these cells are unable to grow and proliferate, calming the immune response. As a result, the body is less likely to react to a foreign entity (like an organ) being introduced to it. On the other hand, using immunosuppressive agents does put you at an increased risk for infection.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Myfortic. However, the following is a synopsis of the general guidelines for the use of Myfortic:

• Myfortic should be used exactly as prescribed.
• Typically, Myfortic is taken twice daily on an empty stomach, either 1 hour before or 2 hours after eating. The dose you take will be decided on by your transplant team. Take the tablet whole. Do not split, crush, or chew Myfortic when taking. Doing so could damage the enteric coating of the tablet, altering its absorption and effectiveness.
• Women of childbearing age should use an effective form of birth control while using Myfortic and for 6 weeks after stopping due to the potential for birth defects in the baby. Your doctor may repeat pregnancy routines during routine follow-ups to ensure no pregnancy is on board. Males using Myfortic and who are sexually active should use effective contraception if their partner is of childbearing age during use and for 90 days after stopping. If you do become pregnant while taking Myfortic, do not immediately stop use. Doing so can greatly increase your risk of organ transplant rejection, putting both you and the baby at risk. Contact your prescriber for further information on how to proceed.
• Myfortic may increase your risk of skin cancer. Minimize exposure to sunlight and avoid using tanning beds and sunlamps. Use a broad-spectrum sunscreen with at least SPF 30 daily and opt for protective clothing whenever going outdoors, especially for long periods of time.
• Do not donate blood while taking Myfortic and for at least 6 weeks after stopping use.
• Do not donate sperm while taking Myfortic and for 90 days after stopping use.
• If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a missed one.

The most common side effects of Myfortic seen in clinical trials include:

• Anemia (low red blood cells), neutropenia, or leukopenia (low white blood cells). Your blood tests will be monitored routinely for these blood abnormalities.
• Constipation or diarrhea
• Nausea
• Vomiting
• Indigestion and heartburn
• Infections, including UTIs and CMV infection
• Insomnia
• Headache
• Back pain

Some individuals may experience serious side effects while using Myfortic. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of a gastrointestinal or stomach bleed, such as blood in your vomit, vomit that resembles coffee grounds, blood in your stools, or stools that appear dark and tarry.
• Onset of excessive inflammation, such as a fever, joint stiffness, joint pain, and muscle pain. You may need to be hospitalized for such a reaction.
• Signs and symptoms of a serious infection such as a high fever (temperature ≥100.5°F), runny nose, sore throat, fatigue, stomach pain, vomiting, diarrhea, ear pain, headache, pain during urination, white patches in the mouth or throat, unexpected bleeding or bruising, and any cuts, scrapes, or incisions that become red, warm, and ooze pus.
• Signs and symptoms of progressive multifocal leukoencephalopathy (PML) such as weakness on one side of the body, a general sense of apathy, confusion, problems thinking, and a lack of control over your muscles. This is a kind of brain infection that could cause death if it is not addressed right away.
• Signs and symptoms of cancer such as a persistent fever with no exact cause, unusual fatigue, unexplained weight loss, swelling of the lymph nodes, a new skin lesion or bump, a change in your skin appearance or any existing moles or marks on the skin, and any other changes in your health for which you cannot find a cause for.
• Signs of a severe allergic reaction such as hives, rash, difficulty breathing, chest pain, or swelling of the face, lips, eyes, or tongue.

These are not all of the possible side effects of Myfortc. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Myfortic, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Problems with digestion
• A history of ulcers
• Plans to receive any vaccine, especially live vaccines
• Lesch-Nyhan or Kelley Seegmiller syndrome, or any other condition where you are deficient in HGPRT
• Are pregnant or planning to become pregnant
• Are breastfeeding or planning to breastfeed

Boxed Warning

• Myfortic, if used during pregnancy, can increase the risk of miscarriage and birth defects in the baby. If used by females of childbearing potential, ensure an effective form of contraception is in place. Before starting Myfortic, a pregnancy test must be done and repeated 8 to 10 days after starting.
• Myfortic can increase the risk of lymphomas and other cancers, especially those involving the skin.
• Myfortic suppresses your immune system. As a result, using Myfortic increases your susceptibility to bacterial, fungal, protozoal, and viral infections. Certain infections could lead the transplanted kidney to fail.
• Viral infections can include shingles, herpes, cytomegalovirus (CMV), BK virus, hepatitis B and C, and COVID-19.

Do not use Myfortic if you have an allergy to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or any of the other ingredients in Myfortic.

It can take several weeks of regular use before Myfortic can have its full effect.

When Myfortic is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Antacids with magnesium and aluminum
• Azathioprine
• Cholestyramine
• Bile acid sequestrants
• Activated charcoal
• Sevelamer
• Cyclosporine
• Norfloxacin
• Ciprofloxacin
• Metronidazole
• Rifampin
• Hormonal contraceptives
• Acyclovir
• Valacyclovir
• Ganciclovir
• Valganciclovir
• Amoi-Clav

Myfortic is available as 180 mg and 360 mg tablets.

Although Myfortic is available in other dosage forms, such as suspensions or immediate release formulations, do not switch between formulations without asking your transplant team first. Each works a little bit differently in the body, and switching can greatly impact how effective the medication will be.

Myfortic should be stored at room temperature, in a tightly closed container to protect from heat and moisture, and out of reach of children.

Myfortic is manufactured by the pharmaceutical company Novartis.

Yes, there is a generic available for the brand-name Myfortic.

Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Myfortic.

Myfortic can be harmful to use during pregnancy and can raise your risk for miscarriage (pregnancy loss) and birth defects. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is unknown if Myfortic passes into the breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.