Berotralstat
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Drug Status
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
NO
Known Teratogen
No
Pharmaceutical Class
Plasma Kallikrein Inhibitor
Controlled Drug Substance
No
berotralstat
Summary
Berotralstat is used to prevent attacks of hereditary angioedema, which is a condition causing sudden swelling in various parts of the body.
Berotralstat works by inhibiting an enzyme called kallikrein, which is involved in the process that leads to hereditary angioedema attacks, helping to reduce their frequency.
The usual dose of Berotralstat for adults is 150 mg taken once daily as an oral capsule, which means it is swallowed whole with water.
Common side effects of Berotralstat include abdominal pain, diarrhea, and headache, which are generally mild and temporary.
Berotralstat may cause liver problems, so liver function should be monitored. It is not recommended for people with severe liver issues and should not be taken if allergic to its ingredients.
Indications and Purpose
How does Berotralstat work?
Berotralstat works by inhibiting an enzyme called kallikrein, which is involved in the process that leads to hereditary angioedema attacks. Think of it like turning off a faucet to stop water from overflowing. By blocking this enzyme, Berotralstat helps prevent the sudden swelling associated with the condition. This makes it effective in reducing the frequency of attacks and improving quality of life for those affected.
Is Berotralstat effective?
Yes, Berotralstat is effective in preventing attacks of hereditary angioedema, which is a condition causing sudden swelling. Clinical studies show that Berotralstat significantly reduces the frequency of these attacks. It works by inhibiting a specific enzyme involved in the disease process. If you have questions about its effectiveness for your condition, discuss them with your healthcare provider.
What is Berotralstat?
Berotralstat is a medication used to prevent attacks of hereditary angioedema, which is a condition causing sudden swelling. It belongs to a class of drugs called kallikrein inhibitors, which work by blocking an enzyme involved in the disease process. This helps reduce the frequency of swelling attacks. Berotralstat is taken as a once-daily oral capsule and is used as a long-term treatment.
Directions for Use
For how long do I take Berotralstat?
Berotralstat is usually taken long-term to manage hereditary angioedema, which is a condition causing sudden swelling. You'll typically take Berotralstat every day as a lifelong treatment unless your doctor suggests otherwise. How long you'll need this medication depends on your body's response and any side effects you experience. Always talk with your doctor before changing or stopping your Berotralstat treatment.
How do I dispose of Berotralstat?
To dispose of Berotralstat, take it to a drug take-back program or collection site at a pharmacy or hospital. If you can't find a take-back program, you can throw it in the trash at home. First, mix it with something undesirable like used coffee grounds, seal it in a plastic bag, and throw it away. This helps prevent harm to people and the environment.
How do I take Berotralstat?
Take Berotralstat once daily with food to help your body absorb it better. Swallow the capsule whole; do not crush or chew it. If you miss a dose, take it as soon as you remember unless it's almost time for your next dose. In that case, skip the missed dose and continue your regular schedule. Do not take two doses at once. Always follow your doctor's specific instructions for taking Berotralstat.
How long does it take for Berotralstat to start working?
Berotralstat begins working in your body shortly after you start taking it, but it may take several weeks to see a reduction in the frequency of hereditary angioedema attacks. The time it takes to achieve full therapeutic effect can vary based on individual factors like your overall health. Take Berotralstat exactly as prescribed for the best results. If you have concerns about how quickly it's working, talk with your doctor.
How should I store Berotralstat?
Store Berotralstat at room temperature, away from moisture and light. Keep it in its original container with the lid tightly closed. Do not store it in humid places like bathrooms. Always keep Berotralstat out of reach of children to prevent accidental ingestion. Check the expiration date regularly and properly dispose of any unused or expired medication.
What is the usual dose of Berotralstat?
The usual dose of Berotralstat for adults is 150 mg once daily. This medication is taken to prevent attacks of hereditary angioedema, which is a condition causing sudden swelling. Always follow your doctor's specific dosing instructions, as they may adjust your dose based on your health needs. If you have any questions about your dosage, consult your healthcare provider.
Warnings and Precautions
Can Berotralstat be taken safely while breastfeeding?
The safety of Berotralstat while breastfeeding is not well-established. It's unclear if this medication passes into breast milk. If you're breastfeeding or planning to breastfeed, talk with your doctor about the safest options for managing your condition. Your doctor can help determine the best treatment plan for you and your baby.
Can Berotralstat be taken safely while pregnant?
The safety of Berotralstat during pregnancy is not well-established. There is limited information on its use in pregnant women. If you're pregnant or planning to become pregnant, talk with your doctor about the safest way to manage your condition. Your doctor can help create a treatment plan that protects both you and your baby.
Can I take Berotralstat with other prescription drugs?
Berotralstat is a moderate inhibitor of CYP2D6 and CYP3A4, which can affect the metabolism of other drugs. It may increase the concentration of medications metabolized by these enzymes, such as thioridazine, pimozide, cyclosporine, and fentanyl. Berotralstat is also a weak inhibitor of P-gp, which can affect drugs like digoxin. Patients should inform their healthcare provider of all medications they are taking to avoid potential interactions.
Does Berotralstat have adverse effects?
Adverse effects are unwanted reactions to a medication. Common adverse effects of Berotralstat include abdominal pain, diarrhea, and headache. These effects are generally mild. Serious side effects are rare but can include liver problems. If you notice any new or worsening symptoms, contact your doctor. They can help determine if these symptoms are related to Berotralstat and advise on the best course of action.
Does Berotralstat have any safety warnings?
Yes, Berotralstat has safety warnings. It may cause liver problems, so your doctor will monitor your liver function. If you experience symptoms like yellowing of the skin or eyes, dark urine, or severe fatigue, contact your doctor immediately. Not adhering to these warnings can lead to serious health issues. Always follow your doctor's advice and report any unusual symptoms.
Is Berotralstat addictive?
Berotralstat is not addictive or habit-forming. It doesn't cause dependency or withdrawal symptoms when you stop taking it. This medication works by inhibiting a specific enzyme to prevent hereditary angioedema attacks. It doesn't affect brain chemistry in ways that could lead to addiction. If you have concerns about medication dependence, you can feel confident that Berotralstat doesn't carry this risk.
Is Berotralstat safe for the elderly?
The safety and effectiveness of Berotralstat have been evaluated in elderly patients aged 65 years and older. The results were consistent with the overall study results, indicating no specific dosage adjustments are necessary for elderly patients. However, as with any medication, elderly patients should be monitored closely for any adverse effects or interactions with other medications they may be taking.
Is it safe to drink alcohol while taking Berotralstat?
It's best to avoid alcohol while taking Berotralstat. Alcohol can increase the risk of side effects like dizziness or liver problems. If you choose to drink occasionally, limit your alcohol intake and watch for warning signs like nausea or dizziness. Talk with your doctor about alcohol use while taking Berotralstat to get personalized advice.
Is it safe to exercise while taking Berotralstat?
You can exercise while taking Berotralstat, but be mindful of how your body feels. This medication can cause dizziness or fatigue, which might affect your exercise capacity. To exercise safely, stay hydrated and listen to your body. If you feel dizzy or unusually tired, slow down or stop exercising and rest. Consult your doctor if you have concerns about exercising while on Berotralstat.
Is it safe to stop Berotralstat?
Stopping Berotralstat suddenly can lead to a return of hereditary angioedema attacks, which are episodes of swelling. Always talk with your doctor before stopping Berotralstat. They might suggest a gradual reduction or an alternative treatment to manage your condition safely. Your doctor will help you make any medication changes to protect your health.
What are the most common side effects of Berotralstat?
Side effects are unwanted reactions to a medication. Common side effects of Berotralstat include abdominal pain, diarrhea, and headache. These occur in a small percentage of people and are usually mild. If you experience new symptoms after starting Berotralstat, they might be temporary or unrelated to the medication. Talk with your doctor before stopping any medication.
Who should avoid taking Berotralstat?
Do not take Berotralstat if you're allergic to it or its ingredients. Serious allergic reactions require immediate medical help. Berotralstat is not recommended for people with severe liver problems, as it may worsen liver function. Always consult your doctor about any concerns or conditions you have before starting Berotralstat.
