Tavneos (avacopan)
Tavneos (avacopan) is a prescription medicine used as an add-on treatment to standard therapy including glucocorticoids for adults with anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis.
- Disease Indications : ANCA-Associated Vasculitis
- Manufacturer: ChemoCentryx
- Usage : Oral
Medicine approved by
- European Medical Agency (EMA)
- Food and Drug Administration (FDA)
- Pharmaceuticals and Medical Devices Agency (PMDA)
Details
What is Tavneos (avacopan) for?
Tavneos (avacopan) is a selective complement 5a receptor inhibitor indicated for use with other medicines (such as glucocorticoids) to treat adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) (granulomatosis with polyangiitis [GPA], formerly known as Wegener’s granulomatosis, and microscopic polyangiitis [MPA]).
It does not eliminate the need for use of glucocorticoids.
It is available in capsule form, each containing 10 mg of avacopan.
How does Tavneos (avacopan) work?
AAV is a rare autoimmune disorder in which the body’s immune system attacks small blood vessels. This causes organ damage and failure, especially the kidneys. Currently, AAV is treated with a combination of medications, including glucocorticoids, which can have toxic effects when used for prolonged periods of time.
AAV occurs when the complement pathway is activated, leading to production of the protein complement 5a (C5a). The active ingredient in Tavneos, avacopan, blocks the effects of C5a through the C5a receptor. This is expected to help reduce blood vessel inflammation and improve symptoms.
Where has Tavneos (avacopan) been approved?
Tavneos (avacopan) was approved for the treatment of AAV by:
- The Food and Drug Administration (FDA), USA on October 13, 2021.
- The European Medicines Agency (EMA) on January 11, 2022.
Tavneos (avacopan) received Orphan Drug Designation for the treatment of AAV and for C3 glomerulopathy (C3G).
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
How is Tavneos (avacopan) taken?
The standard dosage is:
- 30 mg (three 10 mg capsules) twice daily, with food.
If you miss a dose of Tavneos, do not take the missed dose. Just take the next dose at your regular time. Do not double the next dose.
Before starting with treatment, your liver function will be evaluated and you will be tested for Hepatitis B (HBV).
Do not use Tavenos together with strong and moderate CYP3A4 enzyme inducers. Reduce the to 30 mg once daily when using together with CYP3A4 inhibitors.
Complete information about Tavneos (avacopan) dosage (modifications) and administration can be found in the official prescribing information listed in our references section.
Note: Please consult with your treating doctor for personalised dosing.
Are there any known adverse reactions or side effects of Tavneos (avacopan)?
Common adverse reactions
The most common side effects (≥5% of patients) listed in the prescribing information include:
- Nausea
- Diarrhea
- Tiredness
- Increase in blood creatinine
- Headache
- Vomiting
- Stomach pain
- Burning or prickling sensation
- High blood pressure
- Rash
- Dizziness
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:
- Liver problems (hepatotoxicity)
- Serious hypersensitivity reactions
- Hepatitis B virus (HBV) reactivation
- Serious infections
Use in a specific population
It is not known if Tavneos (avacopan) will harm your unborn baby or if it passes into your breast milk Talk to your treating doctor if you are pregnant or planning to become pregnant, or about the best way to feed your baby while taking this medicine.
Tavneos is not recommended for patients with active, untreated and/or uncontrolled chronic liver disease (e.g., hepatitis B, hepatitis C, autoimmune hepatitis) and cirrhosis. Discuss the risk and benefit with your treating doctor before starting treatment.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.
References
- Full prescribing information [FDA]: Tavneos (avacopan) [PDF] ChemoCentryx, Oct 2021
- What is ANCA vasculitis? Ancavasculitisnews.com, cited Oct 2021
- Avacopan for the Treatment of ANCA-Associated Vasculitis Jayne DRW, et al., NEJM, Feb 2021
- FDA approves add-on drug for adults with rare form of blood vessel inflammation FDA press release, Oct 2021
- Tavneos EMA, Jan 2022
Clinical trials
The Food and Drug Administration (FDA) approval of Tavneos (avacopan) for the treatment of adults with severe active anti-neutrophil cytoplasmic autoantibody-associated (ANCA) vasculitis (AAV) was based on data of the ADVOCATE trial (NCT02994927).
ADVOCATE was a phase 3, randomized, controlled trial that involved 330 patients AAV. Patients received oral Tavneos 30 mg twice daily or oral glucocorticoids for 52 weeks. All the patients received either cyclophosphamide/azathioprine or rituximab.
Results
The main study endpoints were the proportion of patients achieving disease remission at 26 weeks and sustained remission at 52 weeks.
Tavneos showed to be superior to prednisone after 1 year of treatment:
- 72.3% of patients in the Tavneos group were in remission at 26 weeks, versus 70.1% of patients in the prednisone group (2.2% difference)
- 65.7% of patients in the Tavneos group were in remission at 52 weeks, versus 54.9% patients in the prednisone group (12.5% difference)
Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Tavneos (avacopan) for the approved indication.
References
- FDA approves add-on drug for adults with rare form of blood vessel inflammation FDA press release, Oct 2021
- A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis ADVOCATE trial, cited Oct 2021
- Avacopan for the Treatment of ANCA-Associated Vasculitis Jayne DRW, et al., NEJM, Feb 2021
- Full prescribing information [FDA]: Tavneos (avacopan) [PDF] ChemoCentryx, Oct 2021
Price & Costs
Kevzara (sarilumab) price in other currencies*
Package | Euro | Australian dollars | Canadian dollar | New Zealand dollar | Nigerian naira | Singapore dollar | Pound sterling | United States dollar |
---|---|---|---|---|---|---|---|---|
30 capsules of 10 mg | 1986 EUR | 3279 AUD | 2963 CAD | 3607 NZD | 3299796 NGN | 2805 SGD | 1637 GBP | 2092 USD |
180 capsules of 10 mg | 11543 EUR | 19056 AUD | 17224 CAD | 20965 NZD | 19175979 NGN | 16305 SGD | 9516 GBP | 12157 USD |
*The prices listed above are based on the cheapest package size and strength everyone.org has access to. Please make an enquiry for more specific pricing. The prices listed above are a guide only, we operate in Euros.
Tavneos (avacopan) treatment costs
The cost for a monthly or yearly treatment of Tavneos (avacopan) depends on your prescription requirements which includes the dosage in mg and medicine type (Capsules).
The price of the medicines you see on sale is the cost set by the manufacturer. In addition, shipping costs and a Named Patient support fee will apply.
Make an enquiry and we will help you calculate the total price to buy Tavneos (avacopan) online and have it delivered where you live. From your side, we’ll simply need a prescription from your treating doctor. In some countries we might also need an import license. Our Patient Support team will guide you throughout the process.
Tavneos (avacopan) price and additional costs
- The price of Tavneos (avacopan)
- Our Named Patient support fee
- Shipping costs
- Payment methods when you buy Tavneos (avacopan)
The base cost of each medicine is set by the manufacturer. Generally, our Named Patient support fee, shipping costs and any local tax (if applicable) are not included in the product price that is displayed on our website unless stated otherwise.
everyone.org provides access to Tavneos (avacopan) on the Named Patient import basis, which means that we work on behalf of the patient in cooperation with their treating doctor. Our Named Patient support fee covers sourcing, logistics and following up to make sure that the order is received safely and in perfect condition. The Named Patient support fee is tiered relative to the cost of the medicine.
The shipping prices are dependent on the type of shipping necessary for the particular medicine (regular or cold chain) and upon the destination country. The shipping fees may include the shipping from our supplier to our partner pharmacy as well as the shipping costs to deliver the medicine to the patient’s country of residence. The shipping fee might also include the cost of special packaging, such as coolboxes, cool packs and data loggers, as well as transport insurance to guarantee that you receive your medicine in good order.
When you buy Tavneos (avacopan), you can make the payment by bank transfer or by credit card. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
Tavneos (avacopan) reimbursement
It might be possible for you to claim the cost of Tavneos (avacopan) via your country's healthcare system. Some countries have a government fund providing financial assistance for citizens to access lifesaving medical treatment abroad. The best thing would be to check with your country's own health ministry. We also highly recommend checking out local patient blogs, communities and patient organisations to find out more about your options.
Medical insurance
Generally, we do not support medical insurance, but we do provide you with an invoice after you make the payment that you may send to your medical insurance company so they can reimburse you. In some limited circumstances, we do accept insurance. Contact us for more details. You can pay by bank transfer or credit card.
Crowdfunding
Crowdfunding might also be an option for you. It is a means of raising funds by using an online platform to group together many small donations from friends, family and others, in order to help you afford medical treatment. Here are some crowdfunding platforms where you can seek support: GoFundMe, GiveForward, FundRazr and Watsi.
Shipping
Room temperature shipping
For this medication, standard shipping applies. This means that a consistent room temperature of 15 to 25°C is maintained during transit.
Your order will be shipped to you by our partner couriers, such as DHL, UPS and specialised cold chain couriers. If you would like your order to be shipped by a specific courier, please inform us when you place the order.
Our standard delivery time varies from 5 to 10 working days.
The shipping cost depends on the medicine and the destination country. After making an enquiry, you will receive a detailed quote that includes the shipping costs.
You can also pick up your medicine from our partner pharmacy in Amsterdam or our partner pharmacy in Luxembourg after the order has been paid for.
Our Process
Four steps to access the medicines you need
How and where to access and buy Tavneos: You can access Tavneos from everyone.org if the drug has not been approved or is not available in your country.
- Step 1: You send a request for your medicine online
- Step 2: We verify your prescription and medical details
- Step 3: We source your medicine
- Step 4: We deliver your medicine
Submit a request for a specific medicine, or a general request, and your Patient Support Manager will contact you within 24 hours. They will be there to support and guide you in anyway possible to help you get the medicine you need.
Since we help patients access medicines not available in their home country, our first step is to check that the medicine you need is not currently available in your home country. Next we will also verify that you have a prescription from a doctor in your home country for the medicine you need.
Once we have verified your prescription and medical details, our expert sourcing team will work with our global network of suppliers to find you the best price. Once we have found you the lowest possible cost for your medicine, we will present you with a final offer for your approval.
After you have accepted our offer, our experienced logistics team will arrange all the shipping and transportation of your medicine. We will work hard to keep you informed at every step along the way and get your medicine to you quickly and safely. To date we have successfully delivered packages to over 75 countries around the world.
Contact Patient Support
If you have any questions or need any help, contact our Patient Support Team. We will get in touch with you within 24 hours from Monday to Friday between 9:00 and 10:00 CET.
Email Address
Sshealthcare1012@gmail.com
+91 7575883015
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