Avacopan

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Drug Status

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Government Approvals

US(FDA)

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WHO Essential Medicine

NO

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Known Teratogen

NO

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Pharmaceutical Class

Complement 5a Receptor Antagonist

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Controlled Drug Substance

NO

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Drug Ingredient

Avacopan

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Summary

  • Avacopan is used to treat severe active ANCA-associated vasculitis, including conditions like granulomatosis with polyangiitis and microscopic polyangiitis.

  • Avacopan works by blocking the activity of a component of the immune system called the complement system. This reduces inflammation and prevents damage to your blood vessels.

  • The usual dose for adults is 30 mg of Avacopan, taken as three 10 mg capsules twice daily with food. The capsules should be swallowed whole with water.

  • Common side effects of Avacopan include nausea, headache, high blood pressure, diarrhea, and vomiting. If you experience any severe symptoms, seek medical attention immediately.

  • Avacopan may cause serious side effects like liver problems, serious infections, and hypersensitivity reactions. It should not be used if you have severe allergies to Avacopan or its ingredients. Always consult with your doctor for personalized advice.

Indications and Purpose

What is Avacopan used for?

Avacopan is indicated for the treatment of severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, specifically granulomatosis with polyangiitis and microscopic polyangiitis, in combination with standard therapy including glucocorticoids.

How does Avacopan work?

Avacopan is a complement 5a receptor (C5aR) antagonist that inhibits the interaction between C5aR and the anaphylatoxin C5a. This action blocks C5a-mediated neutrophil activation and migration, reducing inflammation and preventing damage to blood vessels.

Is Avacopan effective?

Avacopan's efficacy was demonstrated in a phase 3 clinical trial involving 330 patients with ANCA-associated vasculitis. The trial showed that Avacopan, in combination with standard therapy, was effective in achieving sustained remission at 52 weeks in a higher percentage of patients compared to those receiving prednisone.

How does one know if Avacopan is working?

The benefit of Avacopan is evaluated through regular medical appointments and laboratory tests to monitor the patient's response to treatment. Doctors will assess the effectiveness of the medication in controlling symptoms and achieving disease remission.

Directions for Use

What is the usual dose of Avacopan?

The usual daily dose for adults is 30 mg, taken as three 10 mg capsules twice daily with food. Avacopan is not recommended for use in children under 18 years of age.

How do I take Avacopan?

Take Avacopan as three 10 mg capsules twice daily with food. Swallow the capsules whole with water, without crushing or chewing them. Consult your doctor about any specific food restrictions, such as grapefruit, which may interact with the medication.

For how long do I take Avacopan?

Avacopan is typically used for a duration of 52 weeks in clinical trials for ANCA-associated vasculitis, but the exact duration may vary based on individual treatment plans. Always follow your doctor's guidance.

How long does it take for Avacopan to start working?

From all available and reliable information, there is no confirmed data on this. Please consult a doctor for personalized advice.

How should I store Avacopan?

Store Avacopan capsules at room temperature between 68°F to 77°F (20°C to 25°C). Keep the medication in its original container, tightly closed, and out of reach of children. Avoid storing it in the bathroom to prevent exposure to moisture.

Warnings and Precautions

Who should avoid taking Avacopan?

Important warnings for Avacopan include the risk of liver problems, serious infections, and hypersensitivity reactions. It is contraindicated in patients with serious hypersensitivity to avacopan or its ingredients. Patients should be monitored for liver function and signs of infection.

Can I take Avacopan with other prescription drugs?

Avacopan interacts with CYP3A4 inhibitors and inducers. Strong CYP3A4 inhibitors can increase avacopan exposure, requiring a dosage adjustment. Strong CYP3A4 inducers can decrease avacopan exposure, potentially reducing its effectiveness. Consult your doctor about all medications you are taking.

Can I take Avacopan with vitamins or supplements?

From all available and reliable information, there is no confirmed data on this. Please consult a doctor for personalized advice.

Can Avacopan be taken safely while pregnant?

There are no adequate and well-controlled studies of Avacopan in pregnant women. Animal studies showed no evidence of fetal harm at certain exposure levels, but Avacopan caused an increase in abortions in rabbits at lower exposure levels. Consult your doctor if you are pregnant or planning to become pregnant.

Can Avacopan be taken safely while breastfeeding?

There is no available data on the effects of Avacopan on breastfed children or milk production. It is unknown if Avacopan is secreted in human milk. Consult your doctor to weigh the benefits and risks of breastfeeding while taking Avacopan.

Is Avacopan safe for the elderly?

In clinical trials, no overall differences in safety or effectiveness were observed between elderly patients and younger patients. However, elderly patients should be monitored closely for any adverse effects due to potential age-related health issues.

Is it safe to exercise while taking Avacopan?

From all available and reliable information, there is no confirmed data on this. Please consult a doctor for personalized advice.

Is it safe to drink alcohol while taking Avacopan?

From all available and reliable information, there is no confirmed data on this. Please consult a doctor for personalized advice.