Myhibbin
Pronunciation: my-hib-in
Generic name: mycophenolate mofetil
Dosage form: oral suspension
Drug class: Selective immunosuppressants
What is Myhibbin?
Myhibbin is a ready-to-use oral suspension of mycophenolate mofetil that may be used to prevent organ rejection in adults and children aged 3 months and older who have received an allogenic kidney, heart, or liver transplant.
- Myhibbin is used in combination with other immunosuppressants.
Myhibbin works in several different ways to prevent organ rejection by slowing down the body's immune system so it doesn't attack the new organ. Myhibbin does this by interfering with how cells grow and divide. Myhibbin (mycophenolate mofetil) belongs to the class of medicines known as antimetabolite immunosuppressants.
Myhibbin, the first ready-to-use oral suspension of mycophenolate, gained FDA approval on May 1, 2024. Oral mycophenolate tablets have been FDA-approved since May 3, 1995.
Myhibbin side effects
The most common side effects of Myhibbin affecting adults include:
- diarrhea
- changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia)
- blood problems including low white and red blood cell counts
- stomach problems including diarrhea,
- constipation, nausea, and vomiting
- infections
- blood pressure problems
- a rash
- fast heartbeat
- nervous system problems such as headaches,
- swelling of the lower legs, ankles, and feet
- dizziness and tremor.
The most common side effects of Myhibbin in children include:
- stomach area pain
- vomiting
- fever
- sore throat
- infection
- colds (respiratory tract infections)
- pain
- high blood pressure
- blood infection (sepsis)
- low white blood cell count
- diarrhea
- low red blood cell count.
Serious side effects and warnings
Myhibbin carries a Boxed Warning for an increased risk of pregnancy loss (miscarriage), a higher risk of birth defects (see Pregnancy below), and an increased risk of cancer and serious infections.
An increased risk of cancer, including lymphoma, and other cancers, especially skin cancer. Tell your healthcare provider if you have unexplained fever, prolonged tiredness, weight loss, a change in the size and color of a mole, a brown or black skin lesion with uneven borders, a new skin lesion or bump or one part of the lesion does not look like the other, lymph node swelling, and any other changes to your health.
An increased risk of serious infections. Myhibbin weakens the body’s immune system and affects your ability to fight infections. Serious, potentially fatal, infections can happen such as:
- Reactivation of 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, cytomegalovirus (CMV), BK virus, hepatitis B and C virus, and COVID-19. Some of these can cause serious tissue and blood infections, may cause your transplanted organ to fail, or affect how your organ works
- 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 healthcare provider right away if you have any of the following symptoms:
- weakness on one side of the body
- you are confused or have problems thinking
- you do not care about things you usually care about (apathy)
- you cannot control your muscles
- Fungal and yeast infections, which can be serious. Call your healthcare provider right away if you have any of the following signs and symptoms of infection:
- temperature of 100.5°F or greater
- pain during urination
- cold symptoms, such as a runny nose or sore throat
- white patches in the mouth or throat
- flu symptoms, such as an upset stomach, stomach pain, vomiting, or diarrhea
- unexpected bruising or bleeding
- earache or headache
- cuts, scrapes, or incisions that are red, warm, and oozing pus.
Myhibbin can also cause the following serious side effects.
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 healthcare provider will do blood tests before you start taking Myhibbin and during treatment to check your blood cell counts. Tell your healthcare provider right away if you have any signs of infection (see above) or unexpected bruising or bleeding. Also, tell your doctor if you have unusual tiredness, lack of energy, dizziness, or fainting.
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 starts or if your dose is increased. Call your healthcare provider right away if you experience these symptoms.
Do not donate blood while receiving Myhibbin and for 6 weeks afterward. Males should not donate sperm during treatment and for 90 days afterward.
Myhibbin may influence your ability to drive and use machinery.
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. You may report side effects to the FDA at 1-800-FDA1088. You may also report side effects to Liqmeds Worldwide Limited at 1-800-461-7449.
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Before taking
Do not take Myhibbin if you are allergic to mycophenolate mofetil or any of the ingredients in Myhibbin (see the end of this guide for a complete list of ingredients).
Before taking Myhibbin tell your healthcare provider 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 of 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 and some vaccines may not work as well during treatment
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
Pregnancy [Boxed Warning]
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 healthcare provider 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 healthcare provider. Talk to your healthcare provider about the results of all of 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 healthcare provider about other birth control methods that you can use while taking Myhibbin.
If you plan to become pregnant, talk with your healthcare provider. Your healthcare provider will decide if other medicines to prevent rejection may be right for you.
If you become pregnant while taking Myhibbin, do not stop taking it. Call your healthcare provider right away. You and your healthcare provider may decide that other medicines to prevent rejection may be right for you. You and your healthcare provider should report your pregnancy to the Mycophenolate Pregnancy Registry either by phoning 1-800-617-8191 or by visiting the REMS website at: www.mycophenolateREMS.com The purpose of this registry is to gather information about the health you and your baby.
Sexually active males
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.
Breastfeeding
There is no data on the presence of Myhibbin in human milk or its effects on milk production. There may be potential risks to a breastfed infant. Talk to your healthcare provider about the best way to feed your baby if you are taking Myhibbin.
How should I take Myhibbin?
Take Myhibbin exactly as prescribed. Do not stop taking it or change the dose unless your healthcare provider tells you to.
- Myhibbin is a liquid form of mycophenolate mofetil. It is usually taken twice a day.
- Your healthcare provider will tell you the exact dose to take. This depends on your age, the type of transplant you have had, your levels of white blood cells, and if you have kidney disease.
- Take Myhibbin on an empty stomach, unless your healthcare provider tells you otherwise.
- Do not mix Myhibbin with any other medicine or any other 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
- in your eyes or other mucous membranes, rinse with plain water.
What should I avoid while taking Myhibbin?
Avoid becoming pregnant (see warnings above).
Limit the amount of time you spend in the sun. Avoid using tanning beds or sunlamps. People who take Myhibbin have a higher risk of getting skin cancer. Wear protective clothing when you are in the sun and use a broadspectrum 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.
Do not donate blood while taking Myhibbin and for at least 6 weeks after stopping it.
Males should not donate sperm while taking Myhibbin and for 90 days after stopping it.
Myhibbin may influence your ability to drive and use machinery. If you experience drowsiness, confusion, dizziness, tremors, or low blood pressure during treatment with Myhibbin, you should be cautious about driving or using heavy machines.
What happens if I miss a dose?
If you miss a dose of Myhibbin, or you are not sure when you took your last dose, take your prescribed dose 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 healthcare provider if you are not sure what to do.
What happens if I overdose?
If you take too much Myhibbin, call your healthcare provider or the poison control center right away.
What other drugs will affect Myhibbin?
Tell your healthcare provider about all 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 healthcare provider if you take:
- birth control pills (oral contraceptives)
- sevelamer (Renagel, Renvela). These products should be taken at least 2 hours after taking Myhibbin.
- antivirals, such as acyclovir (Zovirax), valacyclovir (Valtrex), ganciclovir (Cytovene-IV, Vitrasert), or 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)
- antibiotics, such as 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).
- immunosuppressants such as azathioprine (Azasan, Imuran).
- cholestyramine (Questran Light, Questran, Locholest Light, Locholest, Prevalite).
Know the medicines you take. Keep a list of all your medicines. Show them to your healthcare provider or pharmacist when you get a new medicine. Do not take any new medicine without talking with your doctor.
Storage
Store Myhibbin at room temperature 68°F to 77°F (20°C to 25°C); excursions permitted to 59°F to 86°F (15°C to 30°C).
Do not freeze.
Wear gloves when wiping the Myhibbin bottle and bottle cap.
Keep out of the reach of children.
Myhibbin oral suspension ingredients
Active ingredient: mycophenolate mofetil 200 mg/mL.
Inactive ingredients: dibasic sodium phosphate, glycerin, methylparaben, monobasic sodium phosphate, polysorbate 80, propylparaben, purified water, raspberry flavor, simethicone emulsion, sorbitol solution, and xanthan gum.
Who makes Myhibbin?
Azurity Pharmaceuticals Inc. manufactures Myhibbin.
References
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