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Avacopan oral


Oral formulations of avacopan.

Drugs List

  • avacopan 10mg capsules
  • TAVNEOS 10mg capsules
  • Therapeutic Indications


    Granulomatosis with polyangiitis
    Microscopic polyangiitis

    Treatment of severe, active granulomatosis with polyangiitis or microscopic polyangiitis in adult patients, in combination with a rituximab or cyclophosphamide regimen.


    30mg twice daily, morning and evening with food.

    Avacopan should be administered in combination with rituximab or cyclophosphamide regimen as below:
    Rituximab for 4 weekly intravenous doses and glucocorticoids as clinically necessary
    Oral or intravenous cyclophosphamide for 13 or 14 weeks, followed by oral azathioprine or mycophenolate mofetil and glucocorticoids as clinically necessary

    Additional Dosage Information

    Missed doses
    In the event of a missed dose, the missed dose is to be taken as soon as possible, unless within three hours of the next scheduled dose.


    Children under 18 years
    Lymphocyte count below 0.5 x 10 to the power 9/L at baseline
    Neutrophil count below 1.5 x 10 to the power of 9 / L at baseline
    White cell count below 3.5 x 10 to the power 9/L at baseline
    Serum bilirubin above 3 times upper limit of normal
    Severe hepatic impairment - Child-Pugh score greater than or equal to 10

    Precautions and Warnings

    History of hepatitis B
    History of hepatitis C
    History of tuberculosis
    Positive HIV status
    Renal impairment - eGFR below 15ml/minute/1.73m sq
    Small-vessel vasculitis with alveolar haemorrhage

    Administration of live vaccines is not recommended
    Before starting therapy ensure immunisations are up to date
    Pneumocystis jiroveci pneumonia (PCP) prophylaxis if treating GPA and MPA
    Treatment to be initiated and supervised by a specialist
    Contains macrogolglycerol hydroxystearate
    Contains polysorbate
    Blood counts should be performed before and periodically during treatment
    Monitor transaminases & total bilirubin before initiation and as indicated
    Perform white blood cell count before initiation and as indicated
    Monitor for Neisseria infections as per standard practice
    Monitor patient for signs of serious infection
    Advise patient to report immediately any symptoms of angioedema
    Advise patient to report immediately signs/symptoms bone marrow suppression
    Advise patient to report symptoms of infection immediately
    Immunosuppressive drugs may increase risk of malignancy
    Discontinue if ALT/AST > 3x ULN & signs of hepatotoxicity
    Discontinue if AST or ALT level > 3x ULN and bilirubin > 2x ULN
    Discontinue if AST or ALT level > 3x ULN and INR > 1.5
    Discontinue if AST or ALT level exceeds 5x ULN for more than 2 weeks
    Discontinue if AST or ALT level exceeds 8 x ULN
    Interrupt therapy if lymphocyte count less than 0.2 x10 to the power of 9/L
    Interrupt therapy if neutrophil count <1.0x10 to the power 9/L
    Interrupt treatment if angioedema due to hypersensitivity occurs
    Interrupt treatment if severe infection develops
    Suspend treatment if AST/ALT is 3-5 times upper limit of normal
    Advise patient not to take St John's wort concurrently
    Advise patient to avoid grapefruit products
    Female: Ensure adequate contraception during treatment

    Before and during treatment, patients must notify their physician if they have been diagnosed with tuberculosis, HIV infection, hepatitis B or hepatitis C.

    Patients treated for ANCA-associated vasculitis must be monitored according to standard practise for clinical signs and symptoms of Neisseria infections.

    It is recommended that patients receiving avacopan treatment also receive pneumocystis pneumonia prophylaxis.

    Administration of live viral vaccines is not recommended and should only be administered before treatment initiation, or during quiescent phase of the disease.

    Use with caution in patients taking low-bioavailability P-gp substrates as the excipient macrogolglycerol hydroxystearate may affect plasma levels of some P-gp substrates. See product literature.

    Pregnancy and Lactation


    Avacopan is contraindicated during pregnancy.

    The manufacturer does not recommend using avacopan during pregnancy. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.


    Avacopan is contraindicated during breastfeeding.

    The manufacturer advises that the patient either discontinues avacopan or discontinues breastfeeding. Animal data reports levels of avacopan in breast milk however the presence in human breast milk is unknown. Effects on exposed infants are unknown.

    Side Effects

    Abnormal liver function
    Alanine aminotransferase increased
    Candidiasis (mouth or throat)
    Cardiac disorders
    Creatine phosphokinase increased
    Gamma glutamyl transferase (GGT) increased
    Herpes zoster
    Increase of liver transaminases
    Lower respiratory tract infection
    Oral herpes
    Otitis media
    Serum bilirubin increased
    Upper abdominal pain
    Upper respiratory tract infection
    Urinary tract infections
    White blood cell count decreased


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: October 2022

    Reference Sources

    Summary of Product Characteristics: Tavneos (Avacopan). Vifor Fresenius Medical Care Renal Pharma UK Ltd. Revised May 2022.

    NICE Evidence Services Available at: Last accessed: 06 December 2022

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