Acoramidis
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Drug Status
Government Approvals
US(FDA)
WHO Essential Medicine
NO
Known Teratogen
No
Pharmaceutical Class
None
Controlled Drug Substance
No
Acoramidis
Summary
Acoramidis is used to treat a condition called cardiomyopathy associated with wild-type or variant transthyretin-mediated amyloidosis (ATTRCM) in adults. This condition involves the buildup of harmful protein deposits, called amyloid, in the heart.
Acoramidis works by stabilizing a protein called transthyretin. This protein can form harmful amyloid deposits in the heart. Acoramidis binds to this protein and slows down its breakdown, which reduces the formation of these deposits.
The usual dose for adults is 712 mg of Acoramidis taken orally twice daily. The tablets should be swallowed whole and can be taken with or without food. It's important to follow your healthcare provider's advice on how to take this medication.
The most commonly reported side effects of Acoramidis are gastrointestinal, including diarrhea (11.6%) and upper abdominal pain (5.5%). These side effects are generally mild and resolve without stopping the medication.
Patients should avoid using Acoramidis with UGT inducers and strong CYP3A inducers, as these can decrease its effectiveness. Also, it's important to monitor for changes in serum creatinine and eGFR, as these can occur with treatment initiation. Always consult your healthcare provider for personalized advice.
Indications and Purpose
How does Acoramidis work?
Acoramidis 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. Acoramidis 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. These effects make Acoramidis helpful for people with type 2 diabetes, heart failure, which is when your heart can't pump blood effectively, and chronic kidney disease, which is damage to organs that filter waste from your blood.
Is Acoramidis effective?
Acoramidis 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 Acoramidis 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. In people with chronic kidney disease, Acoramidis lowered the risk of worsening kidney function or death from heart problems by 28%. These results show Acoramidis effectively manages blood sugar, improves heart health, and helps preserve kidney function.
What is Acoramidis?
Acoramidis 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, Acoramidis 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, Acoramidis 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 Acoramidis?
Acoramidis 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 Acoramidis 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. How long you'll need this medication depends on your body's response, any side effects you experience, and changes in your overall health. Always talk with your doctor before changing or stopping your Acoramidis treatment.
How do I dispose of Acoramidis?
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 Acoramidis?
Acoramidis is a once-daily pill you should take each morning, with or without food. Acoramidis 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 Acoramidis, 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, and can worsen dehydration. Always follow your doctor's specific advice about diet and fluid intake while taking this medication.
How long does it take for Acoramidis to start working?
Acoramidis 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 Acoramidis 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 quickly the medication works can depend on your kidney function, age, and overall health. Take it exactly as prescribed for the best results.
How should I store Acoramidis?
Keep Acoramidis 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 Acoramidis out of children's reach to prevent accidental swallowing. Remember to check the expiration date regularly and properly dispose of any unused or expired medication.
What is the usual dose of Acoramidis?
Adults typically start Acoramidis 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 Acoramidis be taken safely while breastfeeding?
Acoramidis 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 Acoramidis, we can't rule out potential risks to their developing kidneys. We also don't know how this medication might affect your milk production. If you're taking Acoramidis and want to breastfeed, talk with your doctor about safer medication options that would allow you to nurse your baby safely.
Can Acoramidis be taken safely while pregnant?
Acoramidis 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 Acoramidis 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. If you're pregnant or planning to become pregnant, talk with your doctor about the safest way to manage your blood sugar during this important time. Your doctor can help create a pregnancy-specific treatment plan that protects both you and your baby.
Can I take Acoramidis with other prescription drugs?
Acoramidis is metabolized by UGT enzymes, so using it with UGT inducers can decrease its exposure. Strong CYP3A inducers can also affect UGT enzymes. Acoramidis inhibits CYP2C9, which may increase concentrations of CYP2C9 substrates. Patients should be monitored for signs of increased exposure when taking these drugs together.
Does Acoramidis have adverse effects?
Acoramidis 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. Very rarely, people develop severe allergic reactions, kidney problems, or Fournier's gangrene, which is a serious infection of the genital area. Always tell your doctor about any new or worsening symptoms while taking Acoramidis.
Does Acoramidis have any safety warnings?
Acoramidis 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. Acoramidis 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, which are infections in the system that removes urine from your body, can occur. Watch for painful urination, fever, or back pain. Although rare, this medication can cause necrotizing fasciitis, which is a serious bacterial infection in the genital area requiring immediate medical attention. Genital yeast infections are common with Acoramidis. Regular foot care is important as this medicine may increase amputation risk in some patients. Stop taking the medicine and seek help if you develop signs of an allergic reaction.
Is Acoramidis addictive?
Acoramidis is not addictive or habit-forming. This medication doesn't cause dependency or withdrawal symptoms when you stop taking it. Acoramidis 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, Acoramidis doesn't create these effects. If you have concerns about medication dependence, you can feel confident that Acoramidis doesn't carry this risk while managing your health condition.
Is Acoramidis safe for the elderly?
No dosage adjustment is required for elderly patients (65 years and older). In clinical studies, 97% of participants were 65 years and over, with a median age of 78 years. However, elderly patients should still be monitored closely for any adverse effects or interactions with other medications they may be taking.
Is it safe to drink alcohol while taking Acoramidis?
It's best to avoid alcohol while taking Acoramidis. 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 Acoramidis 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. Talk with your doctor about alcohol use while taking Acoramidis to get personalized advice based on your specific health situation.
Is it safe to exercise while taking Acoramidis?
You can exercise while taking Acoramidis, 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. Acoramidis 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. If you notice these symptoms, slow down or stop exercising and rest. Most people can maintain their regular exercise routine while taking Acoramidis, but check with your doctor if you have concerns about your specific situation.
Is it safe to stop Acoramidis?
Stopping Acoramidis 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 Acoramidis. This condition, which causes harmful acids to build up in your blood, can cause nausea, vomiting, stomach pain, and breathing problems. This risk continues for several days after stopping the medication. Always talk with your doctor before stopping Acoramidis. They might suggest gradually reducing your dose or switching to a different medication to keep your condition under control. Your doctor will help you make any medication changes safely to protect your health.
What are the most common side effects of Acoramidis?
Side effects are unwanted reactions that can happen when taking a medication. With Acoramidis, 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 Acoramidis, 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. If you notice new symptoms after starting Acoramidis, they might be temporary or unrelated to the medication. Talk with your doctor before stopping any medication.
Who should avoid taking Acoramidis?
Don't take Acoramidis 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. Acoramidis 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. Breastfeeding mothers shouldn't take it either, as it may pass into breast milk. Older adults have higher risks of dehydration, which means your body doesn't have enough fluids. Be careful when taking Acoramidis with water pills, as this combination increases dehydration risk. Always consult your doctor about these concerns.
