Rinvoq (upadacitinib)
Rinvoq (upadacitinib) is a medication used to treat adults with active rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis and ankylosing spondylitis.
- Disease Indications : Psoriatic Arthritis, Rheumatoid Arthritis
- Manufacturer: AbbVie Ltd
- Usage : Oral
Medicine approved by
- European Medical Agency (EMA)
- Food and Drug Administration (FDA)
- Pharmaceuticals and Medical Devices Agency (PMDA)
Details
What is Rinvoq (upadacitinib) for?
Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with:
- Moderate to severe active rheumatoid arthritis (RA)
- Psoriatic arthritis
- Atopic dermatitis
- Ulcerative colitis
- Ankylosing spondylitis (AS)
It is used for patients with RA for whom disease-modifying anti-rheumatic medicines (DMARDs) or methotrexate did not work well enough. It can be used on its own (monotherapy) or with methotrexate.
It is available in extended-release tablet form each containing 15 mg of upadacitinib.
How does Rinvoq (upadacitinib) work?
RA is a disease in which the body’s immune system attacks healthy tissue to cause inflammation and pain in joints.
The active substance in Rinvoq, upadacitinib, acts on enzymes known as Janus kinases (JAK). These enzymes play an important role in the process of inflammation that is seen in rheumatoid arthritis.
By blocking JAK1’s action, upadacitinib helps reduce the inflammation and other symptoms of RA. It helps in reducing pain, tiredness, stiffness and swelling in the joints. It can slow down damage to the bone and cartilage in the joints.
Where has Rinvoq (upadacitinib) been approved?
Rinvoq (upadacitinib) was approved for the treatment of adults with:
- Moderate to severe active RA by:
- The Food and Drug Administration (FDA), US on August 16, 2019.
- The European Medicines Agency (EMA), Europe on December 16, 2019.
- The Pharmaceuticals and Medical Devices Agency (PMDA), Japan on May 27, 2021
- The Food and Drug Administration (FDA), USA on January 20, 2022.
- Psoriatic arthritis
- Atopic dermatitis
- Ulcerative colitis
On December 11, 2020, the EMA recommended the approval of Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis and for adults with active ankylosing spondylitis.
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 Rinvoq (upadacitinib) taken?
The standard dosage is:
- One 15 mg tablet taken once daily with or without food.
Rinvoq (upadacitinib) may be used alone or in combination with methotrexate or other nonbiologic DMARDs.
Before starting with treatment, the treating doctor should test you for tuberculosis and other serious infections using a blood test.
The treatment may be interrupted in case of certain side effects, including a drop in blood cell counts.
Complete information about Rinvoq (upadacitinib) 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 Rinvoq (upadacitinib)?
Common adverse reactions
The most common side effects (≥1% of patients) listed in the prescribing information include:
- Upper respiratory tract infections (common cold, sinus infections)
- Nausea
- Cough
- Fever
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:
- Serious infections
- Lymphoma and other malignancies
- Thrombosis
Use in a specific population
Rinvoq (upadacitinib) can cause fetal harm when administered to a pregnant woman; it is advised to avoid pregnancies and breastfeeding.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.
References
- 1. Full prescribing information [FDA]: Rinvoq (upadacitinib) [PDF] AbbVie, Aug 16, 2019
- 2. Full prescribing information [EMA]: Rinvoq (upadacitinib) [PDF] AbbVie, Dec 18, 2019
- 3. A review of upadacitinib in rheumatoid arthritis Tanaka Y, Modern Rheumatology, Jul 13, 2020
- 4. AbbVie Receives FDA Approval of RINVOQ™ (upadacitinib), an Oral JAK Inhibitor For The Treatment of Moderate to Severe Rheumatoid Arthritis AbbVie Press release, Aug 16, 2019
- 5. AbbVie Receives European Commission Approval of RINVOQ™ (upadacitinib) for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis AbbVie press release, Dec 18, 2019
- 6. CHMP Recommends the Approvals of RINVOQ™ (Upadacitinib) for the Treatment of Adults with Active Psoriatic Arthritis and Ankylosing Spondylitis AbbVie press release, Dec 11, 2020
- 7. FDA approves Janus kinase inhibitors Rinvoq and Cibinqo despite safety concerns Press release, Jan 2022
Clinical trials
The Food and Drug Administration (FDA), US approval of Rinvoq (upadacitinib) for the treatment of moderate to severe active rheumatoid arthritis (RA) was based on the data of five studies in the SELECT program (NCT02706847, NCT03086343, NCT02629159, NCT02706873, NCT02706951, NCT02675426).
The SELECT program comprises five phase 3 studies that involved a total of approximately 4,400 patients. The trial included studies of efficacy, safety and tolerability across a variety of RA patients, including those who failed or were intolerant to biologic disease-modifying anti-rheumatic drugs and who were naïve or inadequate responders to methotrexate (MTX). Patients were treated with either placebo, or 15 mg upadacitinib, or 15 mg upadacitinib plus MTX or a disease-modifying anti-rheumatic medicine (DMARD) once daily.
Results
The main efficacy outcomes of the SELECT phase 3 studies were the ability to reach ACR20 or ACR50. ACR20 is a measure of improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in patient wellbeing.
Patients who received treatment with Rinvoq reached all the main endpoints:
- In SELECT-EARLY, 52% of MTX-naïve patients treated with Rinvoq reached ACR50 vs 28% treated with MTX at week 121
- In SELECT-MONOTHERAPY, 68% of MTX patients treated with Rinvoq achieved ACR20 vs 41% treated with continued MTX at week 141
- In SELECT-COMPARE, 71% of MTX patients treated with Rinvoq plus MTX achieved ACR20 vs 36% treated with placebo plus MTX at week 121
- In SELECT-NEXT, 64% of DMARD patients treated with Rinvoq plus DMARD achieved ACR20 vs 36% treated with placebo plus DMARDs at week 121
- In SELECT-BEYOND, 65% of patients treated with Rinvoq plus DMARD achieved ACR20 vs 28% treated with placebo plus DMARD at week 121
- Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Rinvoq (upadacitinib) for the approved indication.
References
- 1. AbbVie Receives FDA Approval of RINVOQ™ (upadacitinib), an Oral JAK Inhibitor For The Treatment of Moderate to Severe Rheumatoid Arthritis AbbVie Press release, Aug 16, 2019
- 2. AbbVie Presents Additional Outcomes Data from Three Upadacitinib Phase 3 Studies in Rheumatoid Arthritis at the Annual European Congress of Rheumatology (EULAR 2018) AbbVie press release, Jun 12, 2018
- 3. Full prescribing information [FDA]: Rinvoq (upadacitinib) [PDF] AbbVie, Aug 16, 2019
Price & Costs
Rinvoq (upadacitinib) price in other currencies*
| Package | Euro | Australian dollars | Canadian dollar | New Zealand dollar | Nigerian naira | Singapore dollar | Pound sterling | United States dollar |
|---|---|---|---|---|---|---|---|---|
| 30 extended-release tablets of 15 mg | 1559 EUR | 2574 AUD | 2326 CAD | 2832 NZD | 2590295 NGN | 2202 SGD | 1285 GBP | 1642 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.
Rinvoq (upadacitinib) treatment costs
The cost for a monthly or yearly treatment of Rinvoq (upadacitinib) depends on your prescription requirements which includes the dosage in mg and medicine type (30 tablets).
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 Rinvoq (upadacitinib) 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.
Rinvoq (upadacitinib) price and additional costs
- The price of Rinvoq (upadacitinib)
- Our Named Patient support fee
- Shipping costs
- Payment methods when you buy Rinvoq (upadacitinib)
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 Rinvoq (upadacitinib) 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 Rinvoq (upadacitinib), 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.
Rinvoq (upadacitinib) reimbursement
It might be possible for you to claim the cost of Rinvoq (upadacitinib) 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 Rinvoq: You can access Rinvoq 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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