Monomethyl Fumarate
NA
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Drug Status
Government Approvals
US(FDA)
WHO Essential Medicine
NO
Known Teratogen
NO
Pharmaceutical Class
NA
Controlled Drug Substance
No
Summary
Monomethyl fumarate is used to treat type 2 diabetes, which is a condition where blood sugar levels are too high, heart failure, which is when the heart can't pump blood effectively, and chronic kidney disease, which is damage to organs that filter waste from the blood.
Monomethyl fumarate works by blocking a kidney protein called SGLT2, which helps the body remove excess sugar through urine. This process lowers blood sugar levels and reduces sodium reabsorption, which helps improve heart health by lowering blood pressure.
Monomethyl fumarate is taken as a once-daily pill, usually in the morning, with or without food. Adults typically start with a 10 mg dose, which can be increased to 25 mg if needed. Children 10 years and older may also start with 10 mg daily.
Common side effects of monomethyl fumarate include urinary tract infections, which are infections in the system that removes urine, and genital yeast infections, which cause itching and irritation. Increased urination and dehydration, which means the body doesn't have enough fluids, can also occur.
Monomethyl fumarate can increase the risk of diabetic ketoacidosis, which is a dangerous buildup of acids in the blood. It should not be used by people with type 1 diabetes or severe kidney problems. Avoid during pregnancy, especially in later months, as it may harm the baby.
Indications and Purpose
How does monomethyl fumarate work?
Monomethyl fumarate belongs to a medication group called SGLT2 inhibitors, which work in your kidneys to lower blood sugar. Normally, your kidneys filter sugar from your blood but then reabsorb it back into your body. Monomethyl fumarate blocks this reabsorption process. Think of it like changing the settings on a water filter. The medication adjusts your kidney's "filter settings" so excess sugar gets flushed out in your urine instead of being recycled into your bloodstream. This medicine also reduces sodium reabsorption, which helps improve heart health by lowering pressure in your blood vessels.
Is monomethyl fumarate effective?
Monomethyl fumarate treats type 2 diabetes, chronic kidney disease, which is damage to organs that filter waste from your blood, and heart failure, which is when your heart can't pump blood effectively. This medication works by blocking a kidney protein called SGLT2. This blocking action causes your body to remove more sugar through urine, which lowers blood sugar levels. Clinical studies show monomethyl fumarate significantly improves blood sugar control in diabetes patients, lowering HbA1c levels, body weight, and blood pressure. For heart failure patients, the medication reduced the risk of hospitalization and death from heart problems by 25% compared to placebo.
What is monomethyl fumarate?
Monomethyl fumarate is a medication for type 2 diabetes that helps control blood sugar when you also follow a healthy diet and exercise plan. This medication works by blocking a kidney protein called SGLT2, which causes your body to remove more sugar through urine. Beyond managing diabetes, monomethyl fumarate can reduce the risk of dying from heart disease in adults who have both type 2 diabetes and heart problems. It may also lower your chances of being hospitalized for heart failure, which is when your heart can't pump blood effectively. Additionally, monomethyl fumarate can slow the progression of kidney disease, which is damage to the organs that filter waste from your blood.
Directions for Use
For how long do I take monomethyl fumarate?
Monomethyl fumarate is usually a long-term medication for managing ongoing health conditions like type 2 diabetes, heart failure, and chronic kidney disease, which is damage to organs that filter waste from your blood. For diabetes management, you'll typically take monomethyl fumarate every day as a lifelong treatment unless your doctor suggests otherwise. The same applies when it's prescribed for heart failure, which is when your heart can't pump blood effectively, or for kidney disease. Stopping this medication without medical advice could cause your conditions to worsen. Always talk with your doctor before changing or stopping your monomethyl fumarate treatment.
How do I dispose of monomethyl fumarate?
If you can, bring unused medicines to a drug take-back program or collection site at a pharmacy or hospital. They will dispose of this medicine properly so it doesn't harm people or the environment. If you can't find a take-back program, you can throw most medicines in the trash at home. But first, take them out of their original containers, mix them with something undesirable like used coffee grounds, seal the mixture in a plastic bag, and throw it away.
How do I take monomethyl fumarate?
Monomethyl fumarate is a once-daily pill you should take each morning, with or without food. It can be crushed or mixed with water or food. If you miss a dose, take it when you remember unless it's almost time for your next dose. Then just skip the missed dose and continue your normal schedule. Never take two doses at once. While taking monomethyl fumarate, you don't need to avoid specific foods, but drinking enough water is important to prevent dehydration, which means your body doesn't have enough fluids. Try to avoid alcohol while on this medication. Alcohol can increase your risk of ketoacidosis, which is a serious condition where harmful acid levels build up in your blood.
How long does it take for monomethyl fumarate to start working?
Monomethyl fumarate begins working in your body shortly after you take it, reaching its highest levels in your blood about 1.5 hours later. The medication immediately starts helping your body remove more sugar through urine. However, you may not notice all the benefits right away. For type 2 diabetes, you might see some improvement in blood sugar levels within days, but more significant changes typically take several weeks. If you're taking monomethyl fumarate for heart failure, which is when your heart can't pump blood effectively, or for chronic kidney disease, which is damage to organs that filter waste from your blood, the full benefits may take months to appear.
How should I store monomethyl fumarate?
Keep monomethyl fumarate tablets at room temperature between 68°F to 77°F, though brief exposure to temperatures between 59°F and 86°F is acceptable. Store the medication in a tightly closed container to protect it from moisture and light that could damage it. Don't keep your medicine in humid places like bathrooms, where moisture in the air could affect how well the medication works. If your pills came in packaging that isn't child-resistant, transfer them to a container that children can't easily open. Always store monomethyl fumarate out of children's reach to prevent accidental swallowing.
What is the usual dose of monomethyl fumarate?
Adults typically start monomethyl fumarate with a 10 mg pill once each morning, which you can take with or without food. Your doctor may increase your dose to 25 mg daily if you need better blood sugar control and handle the starting dose well. Children 10 years and older with type 2 diabetes also begin with 10 mg daily, which can be increased to 25 mg if needed. Elderly patients and those with kidney problems, which affect organs that filter waste from your blood, need careful monitoring when taking this medication. Always follow your doctor's specific dosing instructions for your personal health needs.
Warnings and Precautions
Can I take monomethyl fumarate with other prescription drugs?
Monomethyl fumarate can interact with certain prescription drugs, increasing the risk of adverse effects or reducing its effectiveness. For example, combining it with other medications that lower blood sugar, like insulin or sulfonylureas, can increase the risk of hypoglycemia, which is when your blood sugar drops too low. This can cause symptoms like dizziness, confusion, or fainting. Additionally, taking monomethyl fumarate with diuretics, which are medications that help remove excess fluid from your body, can increase the risk of dehydration, which means your body doesn't have enough fluids. Always inform your doctor about all medications you're taking to avoid potential interactions.
Can monomethyl fumarate be taken safely while breastfeeding?
Monomethyl fumarate is not recommended while breastfeeding. We don't have much information about whether this medication passes into human breast milk. However, animal studies show it does appear in rat milk and can build up over time. This raises concerns because a baby's kidneys, which are organs that filter waste from the blood, continue developing during the first two years of life. The medication might affect this development. While we don't have specific reports of harm to breastfed babies from monomethyl fumarate, we can't rule out potential risks to their developing kidneys. We also don't know how this medication might affect your milk production.
Can monomethyl fumarate be taken safely while pregnant?
Monomethyl fumarate isn't recommended during pregnancy, especially in the middle and final months. Animal studies show this medication can affect kidney development in unborn babies. These effects included changes to kidney structure that were reversible. We don't have much information about monomethyl fumarate use in pregnant women. However, uncontrolled diabetes during pregnancy can cause serious problems for both mother and baby. These problems include diabetic ketoacidosis, which is a dangerous buildup of acids in your blood, and preeclampsia, which is high blood pressure during pregnancy. Babies may face birth defects or be born too early.
Does monomethyl fumarate have adverse effects?
Monomethyl fumarate can cause unwanted reactions, though most people tolerate it well. Urinary tract infections, which are infections in the system that removes urine from your body, affect up to 9% of people taking this medication. Genital yeast infections are common, especially in women. These infections cause itching and unusual discharge. The medication increases urination and can lead to dehydration, which means your body doesn't have enough fluids. This might make you feel dizzy. A rare but serious effect is ketoacidosis, which is a dangerous buildup of acid in your blood. This requires immediate medical attention. Always tell your doctor about any new or worsening symptoms while taking monomethyl fumarate.
Does monomethyl fumarate have any safety warnings?
Monomethyl fumarate has important safety warnings you should know about. This medication can increase your risk of diabetic ketoacidosis, which is a dangerous buildup of acids in your blood. This can happen even when your blood sugar is normal, especially if you miss insulin doses or get sick. If you experience nausea, vomiting, stomach pain, or breathing problems, get emergency help. Monomethyl fumarate can cause dehydration, which means your body doesn't have enough fluids. This may lead to low blood pressure or kidney problems. Drink plenty of water while taking this medicine. Serious urinary tract infections can occur. Watch for painful urination, fever, or back pain.
Is it safe to drink alcohol while taking monomethyl fumarate?
It's best to avoid alcohol while taking monomethyl fumarate. Drinking alcohol while on this medication can increase your risk of diabetic ketoacidosis, which is a dangerous buildup of acids in your blood. This serious condition requires emergency medical treatment. Alcohol can also cause dehydration, which means your body doesn't have enough fluids. This may worsen side effects of monomethyl fumarate like dizziness or low blood pressure. If you do choose to drink occasionally, limit how much alcohol you consume and watch for warning signs like nausea, vomiting, stomach pain, or trouble breathing. These symptoms could indicate ketoacidosis and require immediate medical attention.
Is it safe to exercise while taking monomethyl fumarate?
You can exercise while taking monomethyl fumarate, but keep a few things in mind. This medication increases urination and can cause dehydration, which means your body doesn't have enough fluids. This might make you feel dizzy or lightheaded during exercise, especially in hot weather. Monomethyl fumarate can also lower your blood sugar, which is called hypoglycemia, particularly if you take insulin or certain other diabetes medications. Low blood sugar might make you feel weak during workouts. To exercise safely, drink plenty of water before, during, and after physical activity. Watch for signs of dizziness, unusual fatigue, or low blood sugar.
Is it safe to stop monomethyl fumarate?
Stopping monomethyl fumarate suddenly can cause serious problems for your health conditions. If you're taking it for type 2 diabetes, your blood sugar levels might rise quickly when you stop. For heart failure, which is when your heart can't pump blood effectively, or kidney disease, which is damage to organs that filter waste from your blood, stopping could make these conditions worse. A dangerous complication called diabetic ketoacidosis might occur if you suddenly stop taking monomethyl fumarate. This condition, which causes harmful acids to build up in your blood, can cause nausea, vomiting, stomach pain, and breathing problems. Always talk with your doctor before stopping monomethyl fumarate.
Is monomethyl fumarate addictive?
Monomethyl fumarate is not addictive or habit-forming. This medication doesn't cause dependency or withdrawal symptoms when you stop taking it. Monomethyl fumarate works by affecting your kidneys to help remove sugar through urine. This mechanism doesn't affect brain chemistry in ways that could lead to addiction. You won't experience cravings for this medication or feel compelled to take more than prescribed. Unlike some medications that can cause psychological or physical dependence, monomethyl fumarate doesn't create these effects. If you have concerns about medication dependence, you can feel confident that monomethyl fumarate doesn't carry this risk while managing your health condition.
Is monomethyl fumarate safe for the elderly?
The elderly are more vulnerable to safety risks of medicines due to age-related changes in their bodies, such as slower metabolism and decreased kidney function. Monomethyl fumarate is generally safe for elderly patients, but they may be at higher risk for dehydration, which means their body doesn't have enough fluids, and low blood pressure. These risks can lead to dizziness or fainting. Elderly patients should be monitored closely by their healthcare provider while taking this medication. It's important for them to stay well-hydrated and report any unusual symptoms to their doctor promptly.
What are the most common side effects of monomethyl fumarate?
Side effects are unwanted reactions that can happen when taking a medication. With monomethyl fumarate, these effects vary from person to person. The most common side effect is urinary tract infections, which affect about 8-9% of people taking this medication. Women may experience genital yeast infections, which occur in about 2-5% of female patients. Men can also get genital yeast infections, but this happens less frequently. Some people notice they urinate more often when taking monomethyl fumarate, which happens in about 1-3% of patients. Upper respiratory infections, which affect your nose, throat, and airways, occur in about 4% of people taking this medication.
Who should avoid taking monomethyl fumarate?
Don't take monomethyl fumarate if you're allergic to it or its ingredients. Serious allergic reactions, which cause rash, hives, or swelling that makes breathing difficult, require immediate medical help. This medication isn't for people with type 1 diabetes because it increases the risk of diabetic ketoacidosis, which is a dangerous buildup of acid in your blood. Monomethyl fumarate shouldn't be used by people with severe kidney problems, which affect organs that filter waste from your blood, as it won't work well and might worsen kidney function. Avoid this medication during pregnancy, especially in the later months, as it may harm your baby.
