Tavneos
Pronunciation: tav' nee ose
Generic name: avacopan
Dosage form: capsules (10mg)
Drug class: Selective immunosuppressants
What is Tavneos?
Tavneos (avacopan) is a prescription medication used to treat severe active ANCA-associated vasculitis, including granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). It works by blocking the complement 5a receptor (C5aR) to reduce inflammation in blood vessels. Tavneos is used as an adjunctive treatment with standard therapy, including glucocorticoids.
Tavneos FDA approval was granted for the treatment of adults with severe active ANCA-associated vasculitis when used in combination with standard therapy, on 7 October 2021. The manufacturer of Tavneos is Chemocentryx, who is owned by Amgen.
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.
- 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.
Tavneos (avacopan) is used in combination with standard therapy to manage both GPA and MPA. 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. By inhibiting this receptor, Tavneos helps reduce blood vessel inflammation, relieving symptoms and preventing further damage.
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%
- Increased 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.
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.
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.
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.
Manufacturer Information
- Manufacturer: Chemocentryx, Inc.
- Parent Company: Amgen (acquired Chemocentryx in October 2022)
- Address: One Amgen Center Drive, Thousand Oaks, CA 91320-1799
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.