Lomitapide
Hypercholesterolemia
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Drug Status
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
NO
Known Teratogen
Possible
Pharmaceutical Class
Microsomal Triglyceride Transfer Protein Inhibitor
Controlled Drug Substance
No
Lomitapide
Summary
Lomitapide is used to treat a rare genetic disorder called homozygous familial hypercholesterolemia (HoFH). This condition causes extremely high cholesterol levels.
Lomitapide works by inhibiting a protein in the liver and intestines called microsomal triglyceride transfer protein (MTP). This reduces the production of low-density lipoprotein (LDL) cholesterol, which helps prevent cholesterol buildup in the arteries.
The usual starting dose for adults is 5 mg once daily. This can be increased gradually based on safety and tolerability to a maximum of 60 mg daily. Lomitapide is taken orally, typically once daily with a glass of water at least 2 hours after the evening meal and on an empty stomach.
Common side effects of Lomitapide include diarrhea, nausea, vomiting, and abdominal pain. Some patients may also experience fatigue, weight loss, and headaches.
Lomitapide can cause serious liver problems. It is not recommended for patients with moderate or severe liver impairment or those taking certain other medications. It is also not recommended during pregnancy due to potential harm to the fetus. Patients should avoid alcohol and grapefruit juice while taking this medication.
Indications and Purpose
How does Lomitapide work?
Lomitapide works by inhibiting the microsomal triglyceride transfer protein, which is involved in the production of cholesterol in the liver. This inhibition reduces the amount of cholesterol released into the bloodstream. Think of it like turning down the volume on a speaker to reduce noise. By lowering cholesterol production, Lomitapide helps decrease LDL cholesterol levels, reducing the risk of heart disease in people with homozygous familial hypercholesterolemia.
Is Lomitapide effective?
Lomitapide is effective in treating homozygous familial hypercholesterolemia, which is a genetic condition causing high cholesterol levels. It works by reducing the production of cholesterol in the liver. Clinical studies show Lomitapide significantly lowers LDL cholesterol levels in patients with this condition. This reduction helps decrease the risk of heart disease. Always follow your doctor's instructions to achieve the best results with Lomitapide.
What is Lomitapide?
Lomitapide is a medication used to treat homozygous familial hypercholesterolemia, which is a genetic condition causing high cholesterol levels. It belongs to the class of drugs called microsomal triglyceride transfer protein inhibitors. Lomitapide works by reducing the production of cholesterol in the liver. This helps lower LDL cholesterol levels, reducing the risk of heart disease. It's used alongside a low-fat diet and other lipid-lowering treatments.
Directions for Use
For how long do I take Lomitapide?
Lomitapide is usually a long-term medication for managing homozygous familial hypercholesterolemia, which is a genetic condition causing high cholesterol levels. You'll typically take Lomitapide every day as a lifelong treatment unless your doctor suggests otherwise. Stopping this medication without medical advice could cause your cholesterol levels to rise. Always talk with your doctor before changing or stopping your Lomitapide treatment.
How do I dispose of Lomitapide?
To dispose of Lomitapide, bring unused medicines to a drug take-back program or collection site at a pharmacy or hospital. They will dispose of this medicine properly to prevent harm to people or the environment. If you can't find a take-back program, you can throw most medicines in the trash at home. Mix them with something undesirable like used coffee grounds, seal in a plastic bag, and throw it away.
How do I take Lomitapide?
Take Lomitapide once daily, preferably in the evening, without food. Swallow the capsule whole; do not crush or chew it. Avoid grapefruit juice while on this medication. If you miss a dose, take it as soon as you remember unless it's close to your next dose. In that case, skip the missed dose. Never take two doses at once. Follow your doctor's specific advice about diet and fluid intake while taking Lomitapide.
How long does it take for Lomitapide to start working?
Lomitapide begins working in your body shortly after you take it, but it may take several weeks to see significant changes in cholesterol levels. The full therapeutic effect can take a few months to achieve. Individual factors like liver function and adherence to a low-fat diet can affect how quickly Lomitapide works. Take it exactly as prescribed for the best results and follow up with your doctor to monitor progress.
How should I store Lomitapide?
Store Lomitapide at room temperature, between 68°F to 77°F, in a tightly closed container to protect it from moisture and light. Do not refrigerate or freeze the medication. Avoid storing it in humid places like bathrooms, where moisture could affect its effectiveness. Keep Lomitapide out of children's reach to prevent accidental ingestion. Regularly check the expiration date and properly dispose of any unused or expired medication.
What is the usual dose of Lomitapide?
The usual starting dose of Lomitapide for adults is 5 mg once daily. Your doctor may gradually increase your dose based on your response and tolerance. The maximum recommended dose is 60 mg daily. Always follow your doctor's specific dosing instructions. Dose adjustments may be necessary for special populations, such as those with liver problems. Consult your doctor for personalized advice.
Warnings and Precautions
Can I take Lomitapide with other prescription drugs?
Lomitapide can interact with certain medications, increasing the risk of liver damage or reducing its effectiveness. Major interactions include strong CYP3A4 inhibitors, which can increase Lomitapide levels and risk of side effects. Moderate interactions include other lipid-lowering agents. Always inform your doctor about all medications you take to prevent interactions and ensure safe treatment with Lomitapide.
Can Lomitapide be taken safely while breastfeeding?
Lomitapide is not recommended while breastfeeding. There is limited information on whether this medication passes into human breast milk. However, due to potential risks to the breastfed infant, it's best to avoid Lomitapide while nursing. If you're taking Lomitapide and want to breastfeed, talk with your doctor about safer medication options that would allow you to nurse your baby safely.
Can Lomitapide be taken safely while pregnant?
Lomitapide is not safe to use during pregnancy. It can harm the unborn baby, leading to birth defects. There is limited evidence on the safety of most medicines during pregnancy, but Lomitapide is known to be harmful. If you're pregnant or planning to become pregnant, talk with your doctor about safer alternatives to manage your condition. Your doctor can help create a treatment plan that protects both you and your baby.
Does Lomitapide have adverse effects?
Adverse effects are unwanted reactions to a medication. Lomitapide can cause liver problems and gastrointestinal issues like diarrhea and nausea. These effects vary in frequency and severity. Serious side effects include liver damage, requiring immediate medical attention. If you notice any new or worsening symptoms while taking Lomitapide, contact your doctor. They can help determine if these symptoms are related to the medication and suggest appropriate actions.
Does Lomitapide have any safety warnings?
Lomitapide has important safety warnings. It can cause liver problems, so regular liver function tests are necessary. Not adhering to these warnings can lead to serious liver damage. Lomitapide can also cause gastrointestinal side effects. It's crucial to follow dietary restrictions to minimize these effects. Always discuss any concerns or symptoms with your doctor to ensure safe use of Lomitapide.
Is it safe to drink alcohol while taking Lomitapide?
It's best to avoid alcohol while taking Lomitapide. Alcohol can increase the risk of liver damage, which is a serious side effect of Lomitapide. Drinking alcohol may also worsen gastrointestinal side effects like nausea and diarrhea. If you do choose to drink occasionally, limit your alcohol intake and monitor for any symptoms. Talk with your doctor about alcohol use while taking Lomitapide for personalized advice.
Is it safe to exercise while taking Lomitapide?
You can exercise while taking Lomitapide, but be mindful of potential side effects. Lomitapide can cause gastrointestinal issues like nausea and diarrhea, which might affect your exercise capacity. To exercise safely, stay hydrated and avoid strenuous activities if you experience symptoms. Most people can maintain their regular exercise routine while taking Lomitapide, but check with your doctor if you have concerns about your specific situation.
Is it safe to stop Lomitapide?
Stopping Lomitapide suddenly can lead to a rapid increase in cholesterol levels, which may increase the risk of heart problems. It's important to talk with your doctor before stopping Lomitapide. They might suggest gradually reducing your dose or switching to a different medication to manage your condition safely. Your doctor will help you make any medication changes safely to protect your health.
Is Lomitapide addictive?
Lomitapide is not addictive or habit-forming. This medication doesn't cause dependency or withdrawal symptoms when you stop taking it. Lomitapide works by affecting lipid metabolism, which doesn't involve brain chemistry changes that could lead to addiction. You won't experience cravings for this medication or feel compelled to take more than prescribed. If you have concerns about medication dependence, Lomitapide doesn't carry this risk.
Is Lomitapide safe for the elderly?
Elderly individuals may be more vulnerable to the side effects of Lomitapide, such as liver problems and gastrointestinal issues. While Lomitapide can be used by the elderly, careful monitoring is necessary. Regular liver function tests and adherence to dietary restrictions are important to minimize risks. Always consult your doctor about any concerns or symptoms while taking Lomitapide to ensure safe use.
What are the most common side effects of Lomitapide?
Side effects are unwanted reactions to a medication. Common side effects of Lomitapide include gastrointestinal issues like diarrhea, nausea, and abdominal pain. These occur in more than 10% of people taking the medication. If you notice new symptoms after starting Lomitapide, they might be temporary or unrelated to the medication. Talk with your doctor before stopping any medication to ensure safe and effective treatment.
Who should avoid taking Lomitapide?
Lomitapide should not be used by people with liver problems or those who are pregnant, as it can harm the liver and the unborn baby. These are absolute contraindications. Relative contraindications include using Lomitapide with certain medications that affect liver enzymes. Always consult your doctor about any concerns or medications you are taking to ensure safe use of Lomitapide.
