Avacopan 10mg Hard Capsule

What is Avacopan used for?

Complement 5a receptor has a key role in stimulating inflammation. Avacopan attaches to Complement 5a receptors and prevents it from working, thereby reducing inflammation of blood vessels.

Avacopan is used to treat adults with gradually worsening disease caused by inflammation of the small blood vessels, called granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA):

• Granulomatosis with polyangiitis mainly affects small blood vessels and tissues in the kidneys, lungs, throat, nose and sinuses, but also other organs. Patients develop small lumps (granulomas) in and around blood vessels, which are formed by tissue damage caused by inflammation.
• Microscopic polyangiitis affects the smaller blood vessels. It often affects the
  • Kidneys but may also affect other organs.

Avacopan can be used together with other treatments prescribed by your doctor.

How to take Avacopan

Avacopan is a capsule that is taken with food and drink. It is important to avoid grapefruit and grapefruit juice during treatment with Avacopan, as these can influence the effect of the medicine.

If a dose is missed and more than nine hours late, the missed dose should not be taken and the next dose should be taken at the normal time.

Pregnancy and breast-feeding

• Pregnancy - This medicine is not recommended during pregnancy or in women of childbearing potential not using contraception.
• Breast Feeding - It is unknown whether Avacopan passes into breast milk.

Possible risks and side effects

Common side effects of Avacopan include nausea, vomiting, upper abdominal pain, diarrhoea, headache, and it may affect liver function.

Because of its effects on the immune system Avacopan can make it more likely to pick up infections. Please report any of the following side effects to your doctor or nurse as it will be necessary to withhold Avacopan:

• angioedema (swelling to the face, throat, tongue, mouth).
• a sore throat.
• a fever.
• any other symptoms of infection.
• unexplained bruising or bleeding.
• any other new symptoms or anything that concerns you.

Avacopan can also affect your blood count or liver function and blood tests will be undertaken every three months on treatment.

Avacopan can make you more susceptible to a type of lung infection known as Pneumocystis jirovecii pneumonia and therefore medication to prevent this will be given also.

It is recommended that any vaccinations are had preferably before starting treatment. Safety of immunisation with live viral vaccines is unknown and therefore to be avoided.

Drug Interactions

It is important to tell your doctor especially if you use any of the following medicines as they may reduce the efficacy of avacopan:

• carbamazepine, phenobarbital, phenytoin: medicines to treat epilepsy and other illnesses.
• enzalutamide, mitotane: medicines to treat cancer • rifampicin, a medicine to treat tuberculosis or certain other infections.
• St. John’s wort, an herbal medicine used for mild depression.

The use of strong CYP3A4 inhibitors (e.g. itraconazole, clarithromycin, ketoconazole, lopinavir/ritonavir, ritonavir, saquinavir, telaprevir, voriconazole) may increase the risk of side effects due to the increased exposure of avacopan; you may need more regular blood tests to monitor for the development of low blood counts and/or liver damage.

Avacopan can affect or be affected by other medications. Always check with your doctor before starting the medication.

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