Tavneos
Pronunciation: tav' nee ose
Generic name: avacopan
Dosage form: capsules (10mg)
Drug class: Selective immunosuppressants
What is Tavneos?
Tavneos (avacopan) capsules are used to treat types of anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis), including granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). Tavneos capsules can reduce the risk of disease relapse and help patients go into remission by reducing inflammation of blood vessels.
Tavneos is used as an add-on treatment with other medications such as glucocorticoids. Tavneos is a C5a receptor antagonist (complement 5a receptor (C5aR) antagonist.))
Tavneos capsules are taken twice daily with food. They should be swallowed whole and not crushed, chewed, or opened.
Tavneos' active ingredient is avacopan, there is no generic Tavneos (avacopan) available.
Tavneos was developed by ChemoCentryx, a biopharmaceutical company specializing in oral medications for autoimmune diseases, inflammatory disorders, and cancers. ChemoCentryx was acquired by Amgen, a leading independent biotechnology company, on October 20, 2022.
Tavneos FDA approval
Tavneos' FDA approval is for the indication of severe active ANCA-associated vasculitis conditions, granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA] in adults. It is used in combination with standard therapy. Tavneos' FDA approval was granted on 7 October 2021, after positive results from the Phase III ADVOCATE trial (NCT02994927), published in The New England Journal of Medicine (NEJM).
What is ANCA-Associated Vasculitis?
ANCA-associated vasculitis is a rare autoimmune disease that causes inflammation and damage to small or medium-sized blood vessels, affecting organs like the kidneys, lungs, and respiratory tract. The two most common types of ANCA-associated vasculitis are:
- Granulomatosis with Polyangiitis (GPA): Mainly affects the respiratory tract and kidneys, leading to sinusitis, nosebleeds, and kidney disease. GPA was previously known as Wegener’s granulomatosis.
- Microscopic Polyangiitis (MPA): Primarily affects the kidneys and lungs, with less frequent upper respiratory tract involvement.
Anti-neutrophil cytoplasmic autoantibody-associated vasculitis is often shortened to ANCA-associated vasculitis.
How does Tavneos work?
Tavneos' mechanism of action is as a C5a receptor antagonist that blocks complement 5a (C5aR), a key part of the immune system responsible for inflammation. The complement cascade is a part of the immune system that, when overactive, may mistakenly attack and damage your cells. By inhibiting this receptor, Tavneos calms down the overactive immune system, helping to reduce inflammation of blood vessels, relieve symptoms, and prevent further damage to blood vessels.
Tavneos Side Effects
Common Tavneos Side Effects
Common Tavneos side effects include:
- Nausea 39%
- Headache 34%
- High blood pressure 30%
- Diarrhea 25%
- Vomiting 25%
- Rash 19%
- Tiredness 17%
- Stomach pain 11%
- Dizziness 11%
- Increase blood creatinine levels 10%
- pins and needles (tingling or numbness) 9%.
These are the common side effects that occurred in 5% or more of patients in the Phase 3 clinical trial (NCT02994927) who received Tavneos 30 mg avacopan twice daily for 52 weeks.
Serious Side Effects
Tavneos may cause serious side effects. Seek immediate medical attention if you have:
- Allergic reactions: Hives, difficulty breathing, swelling of face, lips, tongue, or throat.
- Liver problems: Loss of appetite, jaundice (yellowing of skin/eyes), pain or swelling in your stomach, swelling in your legs, easy bleeding, drowsiness, confusion.
- Severe infections: Fever, flu-like symptoms, painful urination, cold sores in the mouth or throat.
This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Warnings and precautions
Liver Toxicity Risk
Tavneos may cause serious side effects, including liver problems. Your doctor will perform liver function tests before and during treatment. Call your doctor immediately if you experience symptoms of liver problems.
Before taking this medicine
Do not use Tavneos if you are allergic to the active ingredient avacopan or any inactive ingredients. Inform your doctor if you have:
- Liver problems or abnormal liver function tests
- Hepatitis B or C
- Active infections.
Pregnancy and Breastfeeding
- Pregnancy: It is unknown if Tavneos may harm an unborn baby. Talk to your doctor if you are pregnant or planning pregnancy.
- Breastfeeding: It is not known if Tavneos passes into breast milk. Discuss the best feeding options with your doctor.
Tavneos dosing information
- Recommended dose: 30 mg (three 10 mg capsules) twice daily with food.
- Administration: Swallow capsules whole with water. Do not crush, chew, break, or open the capsules.
- Important: Continue taking Tavneos as prescribed by your healthcare provider. Do not stop treatment without consulting your doctor.
- Dose modification: Reduce the Tavneos dose to 30 mg once daily when used together with medications that are strong CYP3A4 inhibitors.
Missed Dose: Skip the missed dose and take your next dose at the regular time. Do not take two doses at once.
Overdose: Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Tavneos Drug Interactions
- Inform your doctor about all prescription and over-the-counter medicines, vitamins, and herbal supplements you take.
- Some medicines should not be taken with Tavneos (avacopan)
- Keep a list of all the medicines that you take, and show it to your healthcare provider and pharmacist.
- Your healthcare provider may prescribe other medicines to treat your disease.
Strong and moderate CYP3A4 enzyme inducers: Avoid use.
Strong CYP3A4 enzyme inhibitors: Reduce avacopan dose to 30 mg once daily.
CYP3A4 substrates: Consider dose reduction of CYP3A4 substrates when co-administering Tavneos with CYP3A4 substrates.
Not all possible drug interactions are listed here.
Tavneos Package Insert
The Tavneos Package Insert (PI) provides detailed prescribing information for healthcare professionals (HCPs) and patients. It includes comprehensive data on indications, dosage, administration guidelines, clinical pharmacology, drug interactions, and safety warnings.
The Tavneos PI, also referred to as the Tavneos Prescribing Information or FDA label, is an essential resource for understanding the full scope of this medication’s use. While it offers extensive details, it does not replace medical advice. Patients should consult their healthcare provider for personalized guidance on Tavneos treatment.
Tavneos Connect Program
The Tavneos Connect Program is designed to provide patient support, financial assistance, and access resources for individuals prescribed Tavneos. This program helps eligible patients with:
- Insurance coverage support – Assistance with navigating insurance benefits and coverage verification.
- Co-pay and financial assistance – Eligible patients may qualify for savings programs to help reduce out-of-pocket costs.
- Prescription fulfillment support – Guidance on obtaining Tavneos through specialty pharmacies.
- Educational resources – Access to materials and support to better understand ANCA-associated vasculitis and Tavneos treatment.
For more information about the Tavneos Connect Program, see the Tavneos Prices, Coupons, Copay Cards & Patient Assistance page, speak with your healthcare provider, or visit the official Tavneos website.
Tavneos Start Form
The Tavneos Start Form is used to enroll appropriate patients in the Quick Start Program. Your healthcare professional (HCP) will fill out this form as it is the easiest way to get you started with treatment. The downloadable Tavneos Start Form is available on the patient-support page and faxed to 1-866-312-4206.
This medicine is a limited-distribution specialty product available commercially to patients only through select Specialty Pharmacy providers.
Storage and Handling
- Store at room temperature (68°F to 77°F or 20°C to 25°C).
- Keep out of reach of children and pets.
Ingredients
Active ingredient: avacopan
Inactive ingredients: polyethylene glycol 4000 (PEG-4000), Polyoxyl-40 hydrogenated castor oil.
Tavneos manufacturer information
Tavneos ChemoCentryx, Inc.
Tavneos Amgen (acquired ChemoCentryx in October 2022)
One Amgen Center Drive, Thousand Oaks, CA 91320-1799
References
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.