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Myhibbin is the only
READY-TO-USEa
mycophenolate oral suspension

aMyhibbin must be shaken before administering.

Mycophenolate mofetil has been a vital part of transplant maintenance therapy for nearly 30 years.

Myhibbin is a reliable and ready-to-use mycophenolate mofetil formulation. No preparation needed.

Myhibbin is a prescription medicine to prevent rejection (antirejection medicine) in people who have received a kidney, heart, or liver transplant. Rejection is when the body’s immune system perceives the new organ as a “foreign” threat and attacks it. Myhibbin is used with other antirejection medicines.

NDC: 24338-018-01

Product labeling, packaging, and imagery are for representation purposes only.

Myhibbin:
Ask your provider for it by name.

Did you know? Other mycophenolate oral suspensions must be prepared by a pharmacist. Anyone who prepares or mixes mycophenolate mofetil could be exposed to a hazardous powder.

Do not let Myhibbin come in contact with your skin or mucous membranes.

  • If you accidentally get the oral suspension on your skin, wash the area well with soap and water
  • If you accidentally get the oral suspension in your eyes or other mucous membranes, rinse with plain water

A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately.
A household teaspoon or tablespoon is not an adequate measuring device.

If you miss a dose of Myhibbin, or you are not sure when you took your last dose, take your prescribed dose of Myhibbin as soon as you remember. If your next dose is less than 2 hours away, skip the missed dose and take your next dose at your normal scheduled time. Do not take 2 doses at the same time. Call your doctor if you are not sure what to do.

Myhibbin doesn’t need to be refrigerated. Once opened, Myhibbin should be discarded after 60 days.

Prescription coverage doesn’t have to be complicated. We’re by your side.

At a time when rising costs may put even routine necessities out of reach, Azurity Solutions is committed to helping to keep the Azurity medications your doctor prescribes affordable and convenient.

  • Eligibleb patients may
    • Receive 1 freeb 30-day supply of Myhibbin
    • Pay as little as $0b out of pocket per 30-day supply of Myhibbin
    • Participate in the Patient Assistance Program, which provides a potential safety net for uninsured patients

Visit Azurity Solutions

bView Eligibility Restrictions, Terms, and Conditions at AzuritySolutions.com.

IMPORTANT SAFETY INFORMATION

INDICATION

  • MYHIBBINTM (mycophenolate mofetil oral suspension) is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart, or liver transplants, in combination with other immunosuppressants.

WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES, and SERIOUS INFECTIONS

  • Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1), Use in Special Populations (8.1, 8.3)].
  • Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2)].
  • Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections and viral reactivation of hepatitis B and C, which may lead to hospitalizations and fatal outcomes [see Warnings and Precautions (5.3)].

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT MYHIBBIN?

MYHIBBIN can cause serious side effects, including:

Increased risk of loss of a pregnancy (miscarriage) and higher risk of birth defects. Females who take MYHIBBIN during pregnancy have a higher risk of miscarriage during the first 3 months (first trimester), and a higher risk that their baby will be born with birth defects.

  • If you are a female who can become pregnant, your doctor must talk with you about acceptable birth control methods (contraceptive counseling) to use while taking MYHIBBIN. You should have 1 pregnancy test immediately before starting MYHIBBIN and another pregnancy test 8 to 10 days later. Pregnancy tests should be repeated during routine follow-up visits with your doctor. Talk to your doctor about the results of all your pregnancy tests. You must use acceptable birth control during your entire MYHIBBIN treatment and for 6 weeks after stopping MYHIBBIN, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely. MYHIBBIN decreases blood levels of the hormones in birth control pills that you take by mouth. Birth control pills may not work as well while you take MYHIBBIN, and you could become pregnant. If you take birth control pills while using MYHIBBIN you must also use another form of birth control. Talk to your doctor about other birth control methods that you can use while taking MYHIBBIN.
  • If you are a sexually active male whose female partner can become pregnant while you are taking MYHIBBIN, use effective contraception during treatment and for at least 90 days after stopping MYHIBBIN.
  • If you plan to become pregnant, talk with your doctor. Your doctor will decide if other medicines to prevent rejection may be right for you.
  • If you become pregnant while taking MYHIBBIN, do not stop taking MYHIBBIN. Call your doctor right away. You and your doctor may decide that other medicines to prevent rejection may be right for you. You and your doctor should report your pregnancy to the Mycophenolate Pregnancy Registry either:
    • By phone at 1-800-617-8191 or
    • By visiting the Risk Evaluation and Mitigation Strategy (REMS) website at www.mycophenolateREMS.com
  • The purpose of this registry is to gather information about the health of you and your baby.

Increased risk of getting certain cancers. People who take MYHIBBIN have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Tell your doctor if you have:

  • Unexplained fever, prolonged tiredness, weight loss, or lymph node swelling
  • A brown or black skin lesion with uneven borders or one part of the lesion does not look like the other
  • A change in the size and color of a mole
  • A new skin lesion or bump
  • Any other changes to your health

Increased risk of getting serious infections. MYHIBBIN weakens the body's immune system and affects your ability to fight infections. Serious infections can happen with MYHIBBIN and can lead to hospitalizations and death. These serious infections can include:

  • Viral infections. Certain viruses can live in your body and cause active infections when your immune system is weak. Viral infections that can happen with MYHIBBIN include:
    • Shingles, other herpes infections, and cytomegalovirus (CMV). CMV can cause serious tissue and blood infections.
    • BK virus. BK virus can affect how your kidney works and cause your transplanted kidney to fail.
    • Hepatitis B and C viruses. Hepatitis viruses can affect how your liver works. Talk to your doctor about how hepatitis viruses may affect you.
    • COVID-19
  • A brain infection called Progressive Multifocal Leukoencephalopathy (PML). In some patients, MYHIBBIN may cause an infection of the brain that may cause death. You are at risk for this brain infection because you have a weakened immune system. Call your doctor right away if you have any of the following symptoms:
    • Weakness on one side of your body
    • You do not care about things you usually care about (apathy)
    • You are confused or have problems thinking
    • You cannot control your muscles
  • Fungal infections. Yeasts and other types of fungal infections can happen with MYHIBBIN and can cause serious tissue and blood infections (See “What are the possible side effects of MYHIBBIN?”).

Call your doctor right away if you have any of the following signs and symptoms of infection:

  • Temperature of 100.5°F or greater
  • Cold symptoms, such as a runny nose or sore throat
  • Flu symptoms, such as an upset stomach, stomach pain, vomiting, or diarrhea
  • Earache or headache
  • Pain during urination
  • White patches in the mouth or throat
  • Unexpected bruising or bleeding
  • Cuts, scrapes, or incisions that are red, warm, and oozing pus

See “What are the possible side effects of MYHIBBIN?” for information about other serious side effects.

WHO SHOULD NOT TAKE MYHIBBIN?

Do not take MYHIBBIN if you are allergic to mycophenolate mofetil or any of the ingredients in MYHIBBIN.

WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING MYHIBBIN?

Tell your doctor about all of your medical conditions, including if you:

  • Have any digestive problems, such as ulcers
  • Have Lesch-Nyhan syndrome, Kelley-Seegmiller syndrome, or another rare inherited deficiency hypoxanthine-guanine phosphoribosyl-transferase (HGPRT). You should not take MYHIBBIN if you have one of these disorders
  • Plan to receive any vaccines. People taking MYHIBBIN should not receive live vaccines. Some vaccines may not work as well during treatment with MYHIBBIN
  • Are pregnant or plan to become pregnant. See “What is the most important information I should know about MYHIBBIN?”
  • Are breastfeeding or plan to breastfeed. It is not known if MYHIBBIN passes into breast milk. You and your doctor will decide if you will take MYHIBBIN or breastfeed

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Some medicines may affect the way MYHIBBIN works, and MYHIBBIN may affect how some medicines work. Especially tell your doctor if you take:

  • Birth control pills (oral contraceptives). See “What is the most important information I should know about MYHIBBIN?”
  • Sevelamer (Renagel, Renvela). These products should be taken at least 2 hours after taking MYHIBBIN
  • Acyclovir (Zovirax), valacyclovir (Valtrex), ganciclovir (CYTOVENE-IV, Vitrasert), valganciclovir (Valcyte)
  • Rifampin (Rifater, Rifamate, Rimactane, Rifadin)
  • Antacids that contain magnesium and aluminum (MYHIBBIN and the antacid should not be taken at the same time)
  • Proton pump inhibitors (PPIs) (Prevacid, Protonix)
  • Sulfamethoxazole/trimethoprim (Bactrim, Bactrim DS)
  • Norfloxacin (Noroxin®) and metronidazole (Flagyl, Flagyl ER, Flagyl IV, Metro IV, Helidac, Pylera).
  • Ciprofloxacin (Cipro, Cipro XR, Ciloxan, Proquin XR) and amoxicillin plus clavulanic acid
  • (Augmentin, Augmentin XR)
  • Azathioprine (Azasan, Imuran)
  • Cholestyramine (Questran Light, Questran, Locholest Light, Locholest, Prevalite)

Know the medicines you take. Keep a list of them to show to your doctor or nurse and pharmacist when you get a new medicine. Do not take any new medicine without talking with your doctor.

HOW SHOULD I TAKE MYHIBBIN?

  • Take MYHIBBIN exactly as prescribed.
  • Do not stop taking MYHIBBIN or change the dose unless your doctor tells you to.
  • If you miss a dose of MYHIBBIN, or you are not sure when you took your last dose, take your prescribed dose of MYHIBBIN as soon as you remember. If your next dose is less than 2 hours away, skip the missed dose and take your next dose at your normal cheduled time. Do not take 2 doses at the same time. Call your doctor if you are not sure what to do.
  • Take MYHIBBIN on an empty stomach, unless your doctor tells you otherwise.
  • Do not mix MYHIBBIN with any other medicine. MYHIBBIN should not be mixed with any type of liquids before taking the dose.
  • Do not let MYHIBBIN come in contact with your skin or mucous membranes.
    • If you accidentally get the oral suspension on your skin, wash the area well with soap and water.
    • If you accidentally get the oral suspension in your eyes or other mucous membranes, rinse with plain water.
  • If you take too much MYHIBBIN, call your doctor or the poison control center right away.

WHAT SHOULD I AVOID WHILE TAKING MYHIBBIN?

  • Avoid becoming pregnant. See “What is the most important information I should know about MYHIBBIN?”
  • Limit the amount of time you spend in sunlight. Avoid using tanning beds or sunlamps. People who take MYHIBBIN have a higher risk of getting skin cancer. (See “What is the most important information I should know about MYHIBBIN?”) Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen with a high protection factor. This is especially important if your skin is very fair or if you have a family history of skin cancer.
  • You should not donate blood while taking MYHIBBIN and for at least 6 weeks after stopping MYHIBBIN.
  • You should not donate sperm while taking MYHIBBIN and for 90 days after stopping MYHIBBIN.
  • MYHIBBIN may influence your ability to drive and use machines (See “What are the possible side effects of MYHIBBIN?”). If you experience drowsiness, confusion, dizziness, tremor, or low blood pressure during treatment with MYHIBBIN, you should be cautious about driving or using heavy machines.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF MYHIBBIN?

MYHIBBIN may cause serious side effects, including:

  • Side effects listed in the section “What is the most important information I should know about MYHIBBIN?”
    Please see this section.
  • Low blood cell counts. People taking high doses of MYHIBBIN each day may have a decrease in blood counts, including:
    • White blood cells, especially neutrophils. Neutrophils fight against bacterial infections. You have a higher chance of getting an infection when your white blood cell count is low. This is most common from 1 month to 6 months after your transplant.
    • Red blood cells. Red blood cells carry oxygen to your body tissues. You have a higher chance of getting severe anemia when your red blood cell count is low.
    • platelets. Platelets help with blood clotting.

Your doctor will do blood tests before you start taking MYHIBBIN and during treatment with MYHIBBIN to check your blood cell counts. Tell your doctor right away if you have any signs of infection (see “What is the most important information I should know about MYHIBBIN?”), including any unexpected bruising or bleeding. Also, tell your doctor if you have unusual tiredness, lack of energy, dizziness, or fainting.

  • Stomach problems. Stomach problems including intestinal bleeding, a tear in your intestinal wall (perforation) or stomach ulcers can happen in people who take MYHIBBIN. Bleeding can be severe and you may have to be hospitalized for treatment. Call your doctor right away if you have sudden or severe stomach-area pain or stomach-area pain that does not go away, or if you have diarrhea.
  • Inflammatory reactions. Some people taking MYHIBBIN may have an inflammatory reaction with fever, joint stiffness, joint pain, and muscle pain. Some of these reactions may require hospitalization. This reaction could happen within weeks to months after your treatment with MYHIBBIN starts or if your dose is increased. Call your doctor right away if you experience these symptoms.

The most common side effects of MYHIBBIN include:

  • Diarrhea
  • Blood problems including low white and red blood cell counts
  • Infections
  • Blood pressure problems
  • Fast heartbeat
  • Swelling of the lower legs, ankles, and feet
  • Changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia)
  • Stomach problems including diarrhea, constipation, nausea, and vomiting
  • Rash
  • Nervous system problems such as headache, dizziness, and tremor

Side effects that can happen more often in children than in adults taking MYHIBBIN include:

  • Stomach area pain
  • Fever
  • Infection
  • Pain
  • Blood infection (sepsis)
  • Diarrhea
  • Vomiting
  • Sore throat
  • Colds (respiratory tract infections)
  • High blood pressure
  • Low white blood cell count
  • Low red blood cell count

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

The Important Safety Information does not include all the information needed to use MYHIBBIN safely and effectively. Please see the full Prescribing Information for MYHIBBIN.

To Report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

© 2024 Azurity Pharmaceuticals, Inc.

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