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Adverse events should be reported to the Vifor Pharma group: safety@viforpharma.com

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E 10/2023 CH-AVA-2300103

Abbreviated professional information

Tavneos®. C: Avacopan. I: Tavneos, as an adjunct therapy to standard immunosuppressive treatment based on rituximab or cyclophosphamide with glucocorticoids, is indicated for the treatment of adult patients with severe active ANCA vasculitis (GPA/MPA). Po: Oral intake 30 mg (3 capsules of 10 mg each) twice daily in the morning and evening with food. CI: Hypersensitivity to the active substance or any of the excipients. W/P: Hepatotoxicity; angioedema; monitoring of blood count (white blood cells); severe infections; hepatitis B virus reactivation; cardiac disorders; malignant tumours; macroglycerin hydroxystearate. P/L: Use during pregnancy and in women of childbearing age who are not using a contraceptive method is not recommended. It is not known whether Avacopan is excreted into breast milk. The benefit of breastfeeding to the child should be weighed against the benefit of treatment to the patient. UE: Very common: upper respiratory tract infection, nasopharyngitis; headache; vomiting, diarrhoea, nausea; increased liver test; decreased white blood cell count. Frequent: pneumonia, lower respiratory tract infection, influenza, bronchitis, cellulitis, urinary tract infection, herpes zoster, sinusitis, oral candidiasis, oral herpes, otitis media, rhinitis, gastroenteritis; neutropenia; upper abdominal pain; increase in blood creatine phosphokinase. Occasional: angioedema. IA: Avacopan is a substrate of CYP3A4. Co-administration of inducers or inhibitors of this enzyme may affect the pharmacokinetics of Avacopan. See SmPC. P: Tavneos 10 mg: 30 and 180 hard capsules. List B. Detailed information: www.swissmedicinfo.ch. Date of information: January 2024. Marketing authorization holder: Vifor Fresenius Medical Care Renal Pharma Ltd, St. Gallen. Distribution: Vifor Pharma Switzerland AG, CH-1752 Villars-sur-Glâne | CH-AVA-2300143

This medicinal product is subject to additional monitoring. For further information, see professional information TAVNEOS® on www.swissmedicinfo.ch.

E 01/2024 CH-AVA-2300101 v2.0

Templates for the request of cost reimbursement

TAVNEOS® is indicated as an adjunctive treatment to standard immunosuppressive treatment that includes rituximab or cyclophosphamide with glucocorticoids for the treatment of adult patients with severe, active ANCA-associated vasculitis (GPA/MPA).1

TAVNEOS® is not included in the specialties list (SL/LS).

To simplify the process on your side, we offer templates for the request of cost reimbursement which can be sent to the respective health insurance company or the medical examiner.

Download the TAVNEOS® cost reimbursement request form here

In German:

Kostengutsprachegesuchs-Formular TAVNEOS® herunterladen

In French:

Télécharger le formulaire de demande de prise en charge des coûts de TAVNEOS®

In Italian:

Scarica il modulo di richiesta assunzione dei costi di TAVNEOS®

References

1. TAVNEOS® Fachinformation, www.swissmedicinfo.ch.

E 10/2023 CH-AVA-2300102

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    Vifor Fresenius Medical Care Renal Pharma (VFMCRP) Ltd. is a CSL Vifor joint company with Fresenius Medical Care.
    CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron de ciency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care).
    The parent company, CSL (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 30,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor visit, www.cslvifor.com

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