Taltz (ixekizumab)
Taltz (ixekizumab) is a medication used for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis.
- Disease Indications : Psoriasis
- Manufacturer: Eli Lilly Nederland B.V.
- Usage : Subcutaneous
Medicine approved by
- European Medical Agency (EMA)
- Food and Drug Administration (FDA)
- Health Canada
- Therapeutic Goods Administration (TGA)
Details
What is Taltz (ixekizumab) for?
Taltz (ixekizumab) is a monoclonal antibody indicated for the treatment of people with:
- moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy
- Active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies.
How does Taltz (ixekizumab) work?
The active ingredient in Taltz, ixekizumab, is a humanised interleukin-17A antagonist; a protein designed to attach to interleukin 17A, a messenger molecule in the immune system.
Interleukin 17A is involved in immune system effects, including inflammation, that cause psoriasis and psoriatic arthritis. By attaching to interleukin 17A, ixekizumab blocks its action and reduces the activity of the immune system, thereby reducing the symptoms of psoriasis and psoriatic arthritis.
Where has Taltz (ixekizumab) been approved?
Taltz (ixekizumab) was approved by:
- Food and Drug Administration (FDA), USA:
- March 22, 2016, for plaque psoriasis
- December 1, 2017, for psoriatic arthritis
- European Medical Agency (EMA), European Union:
- May 2, 2016, for plaque psoriasis
- January 11, 2018, for psoriatic arthritis
- Therapeutic Goods Administration (TGA), Australia, September 6, 2016, for plaque psoriasis
- Health Canada, August 11, 2016, for plaque psoriasis
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 Taltz (ixekizumab) taken?
The standard dosage for plaque psoriasis is:
- first dose of 160 mg (two subcutaneous injections)
- for the first 12 weeks: a subcutaneous injection of 80 mg every 2 weeks
- thereafter a subcutaneous injection of 80 mg every 4 weeks.
The standard dosage for psoriatic arthritis is:
- first dose of 160 mg (two subcutaneous injections)
- thereafter a subcutaneous injection of 80 mg every 4 weeks.
Taltz (ixekizumab) is provided as a prefilled syringe or a prefilled pen. Instruction for the use of the prefilled syringe and the prefilled pen can be found in our resources section.
Complete information about Taltz (ixekizumab) dosage and administration can be found in the official prescribing information listed in our references section.
Please consult with your treating doctor for personalised dosing.
Are there any known side effects of Taltz (ixekizumab)?
Common side effects
The most common side effects listed in the prescribing information include.
- injection site reactions
- upper respiratory tract infections
- nausea (feeling sick)
- tinea infections (superficial fungal infection of the skin)
Serious side effects
The serious side effects listed in the prescribing information include.
- serious infections
- hypersensitivity (serious allergic reaction)
- inflammatory Bowel Disease
Use in a specific population
Taltz (ixekizumab) must not be given to patients with active tuberculosis (TB). Anti-TB therapy should be considered in patients with latent TB prior to initiation of treatment.
There is a limited knowledge about the use of ixekizumab in pregnant women. As a precautionary measure, it is preferable to avoid the use of Taltz during pregnancy and use of effective contraception during treatment and for at least 10 weeks after treatment is recommended.
Breast-feeding should be avoided during treatment.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.
References
- 1. EMA. Human Medicines: Taltz (ixekizumab) cited March 2017
- 2. Summary of Product Characteristics [FDA]: Taltz (ixekizumab) [PDF] Eli Lilly and Co., Dec. 2017.
- 3. Summary of Product Characteristics [TGA]: Taltz (ixekizumab) [PDF] Eli Lilly Australia Pty. Ltd., Apr. 2017.
- 4. Summary of Product Characteristics [EMA]: Taltz (ixekizumab), [PDF] Eli Lilly Nederland B.V., Feb. 2018.
- 5. Instructions for use: Taltz (ixekizumab) prefilled syringe [PDF]
- 6. Instructions for use: Taltz (ixekizumab) prefilled pen [PDF]
- 7. Chow C., et al. Comparison of three methods for measuring psoriasis severity in clinical studies(Part 1 of 2): change during therapy in Psoriasis Area and Severity Index, Static Physician's Global Assessment and Lattice System Physician's Global Assessment. J Eur Acad Dermatol Venereol. 2015 Jul.; 29 (7):1406–1414.
- 8. Drugs@FDA: FDA Approved Drug Products: Taltz (ixekizumab) cited on 16/02/2018
- 9. Pincus T. The American College of Rheumatology (ACR) Core Data Set and derivative “patient only” indices to assess rheumatoid arthritis Clin Exp Rheumatol 2005; 23(39):109–113.
- 10. Product monograph [Health Canada]: Taltz (ixekizumab), [PDF] Eli Lilly Canada, Feb. 2020.
Clinical trials
Plaque psoriasis
The Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, and Therapeutic Goods Administration (TGA), Australia, approvals of Taltz (ixekizumab) for plaque psoriasis were based on 3 double-blind trials that tested Taltz (ixekizumab) against placebo and an active comparator (UNCOVER-1,2,3). These studies involved a total of 3,866 patients with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy.
Results
The major efficacy outcome measures were the static Physician Global Assessment (sPGA) and the Psoriasis Area and Severity Index (PASI).
The sPGA is a measure of the status of the psoriatic lesions of a patient (i.e. plaque thickness/induration, erythema, scaling) on a severity scale from 0 (=clear) to 5 (=severe). The PASI additionally to the severity of the lesions takes into account the body surface area covered with psoriatic lesions.
The results presented here are the average across the 3 studies, the complete results can be found in our resources section2,4. After 12 weeks Taltz (ixekizumab) administered every 2 weeks resulted as superior in all the measured parameters to all other tested conditions.
The sPGA after 12 weeks was:
- sPGA =0 (=clear) or 1 (=almost clear) in 81.8% of patients treated with Taltz (ixekizumab) every 2 weeks
- sPGA =1 in 39.7% of the patients
- sPGA =0 or 1 in
- 74.9% of the patients treated with Taltz (ixekizumab) every 4 weeks
- 38.8% of those treated with etanercept
- 4.1 % in the placebo cohort.
The PASI after 12 weeks was:
- reduced by 100% in 37.8% of patients treated with Taltz (ixekizumab)every 2 weeks
- reduced by 75% in:
- almost 89% of those treated every 2 weeks with Taltz (ixekizumab)
- 82.5% of the patients on Taltz (ixekizumab) every 4 weeks
- 47.5% of patients on etanercept
- 4.5% of those given placebo.
To evaluate the maintenance and durability of the response, two studies continued for an additional 48 weeks in patients who at week 12 had responded to Taltz (ixekizumab) (both those on the biweekly plan and those on the monthly plan). These patients were randomly assigned to a maintenance dosage of Taltz (ixekizumab) every 4 weeks or to placebo. The best results were obtained in patients who took Taltz (ixekizumab) every 2 weeks for the first 12 weeks and every 4 weeks for the following 48 weeks. In this cohort, 78.3% of the patients maintained a sPGA of 0 or 1, and about 58% of these had maintained or achieved clear skin (sPGA = 0 in 58.8% and 100% reduction in PASI in 57.5%). On the other hand, only about 7% of the initial responders that switched to placebo had a sPGA of 0 or 14, meaning that most of them relapsed after interruption of the treatment with Taltz (ixekizumab).
Psoriatic arthritis
The Food and Drug Administration (FDA), USA, and European Medical Agency (EMA), European Union, approvals of Taltz (ixekizumab) for psoriatic arthritis were based on 2 placebo-controlled studies (SPIRIT-P1/PsA1 and SPIRIT -P2/PsA2). These studies involved a total of 780 patients with active psoriatic arthritis.
Results
The major efficacy outcomes were the ACR 20, 50 and 70. In both studies, patients treated with Taltz (ixekizumab) 80 mg demonstrated a greater clinical response compared to placebo at Week 24.
An important measure in patients with rheumatoid arthritis is the ACR 20, 50 or 70 which is a criteria to measure the improvement of patients of 20%, 50% or 70% based on measures as swollen joint count, tender joint count, patient assessment of global status, acute phase reactant (dramatic increase in hepatic synthesis of plasma proteins which accompanies acute phases of tissue injury and inflammation), health professional assessment of global status, physical function, and pain.
The ACR20 response at week 24 was:
- 58% with Taltz every 4 weeks vs. 30% with placebo in study SPIRIT-P1/PsA1
- Difference from placebo 28% [95% CI: 15, 41].
- 53% with Taltz every 4 weeks vs. 20% with placebo in study SPIRIT-P2/PsA2
- Difference from placebo 34% [95% CI: 22, 45].
The ACR50 response at week 24 was:
- 40% with Taltz every 4 weeks vs. 15% with placebo in study SPIRIT-P1/PsA1
- Difference from placebo 25% [95% CI: 14, 37].
- 35% with Taltz every 4 weeks vs. 5% with placebo in study SPIRIT-P2/PsA2
- Difference from placebo 30% [95% CI: 21, 40].
The ACR70 response at week 24 was:
- 23% with Taltz every 4 weeks vs. 6% with placebo in study SPIRIT-P1/PsA1
- Difference from placebo 18% [95% CI: 9, 27].
- 22% with Taltz every 4 weeks vs. 0% with placebo in study SPIRIT-P2/PsA2
- Difference from placebo 22% [95% CI: 15, 30].
References
- Summary of Product Characteristics [FDA]: Taltz (ixekizumab) [PDF] Eli Lilly and Co., Dec. 2017.
- Summary of Product Characteristics [TGA]: Taltz (ixekizumab) [PDF] Eli Lilly Australia Pty. Ltd., Apr. 2017.
- Summary of Product Characteristics [EMA]: Taltz (ixekizumab), [PDF] Eli Lilly Nederland B.V., Feb. 2018.
- Instructions for use: Taltz (ixekizumab) prefilled syringe [PDF]
- Chow C., et al. Comparison of three methods for measuring psoriasis severity in clinical studies(Part 1 of 2): change during therapy in Psoriasis Area and Severity Index, Static Physician's Global Assessment and Lattice System Physician's Global Assessment. J Eur Acad Dermatol Venereol. 2015 Jul.; 29 (7):1406–1414.
- Pincus T. The American College of Rheumatology (ACR) Core Data Set and derivative “patient only” indices to assess rheumatoid arthritis Clin Exp Rheumatol 2005; 23(39):109–113.
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 |
|---|---|---|---|---|---|---|---|---|
| 2 prefilled syringes or pens of 80 mg | 3185 EUR | 5258 AUD | 4752 CAD | 5785 NZD | 5291329 NGN | 4499 SGD | 2625 GBP | 3354 USD |
| 3 prefilled syringes or pens of 80 mg | 5033 EUR | 8310 AUD | 7511 CAD | 9142 NZD | 8362389 NGN | 7110 SGD | 4149 GBP | 5301 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.
Taltz (ixekizumab) treatment costs
The cost for a monthly or yearly treatment of Taltz (ixekizumab) depends on your prescription requirements which includes the dosage in mg and medicine type (Prefilled syringe or autoinjector).
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 Taltz (ixekizumab) 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.
Taltz (ixekizumab) price and additional costs
- The price of Taltz (ixekizumab)
- Our Named Patient support fee
- Shipping costs
- Payment methods when you buy Taltz (ixekizumab)
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 Taltz (ixekizumab) 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 Taltz (ixekizumab), 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.
Taltz (ixekizumab) reimbursement
It might be possible for you to claim the cost of Taltz (ixekizumab) 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
Cold chain shipping
Some medicinal ingredients are susceptible to damage from heat, light and handling. Using "cold chain" delivery, specialised medical couriers have temperature regulated boxes and vehicles to ensure that the medicine is uncompromised. For that reason, cold chain shipping can be more expensive than regular shipping. For more details, please see our article on cold chain delivery.
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 Taltz: You can access Taltz 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
Landline
079 48916267
Disclaimer
All Trademarks and Brands that appear on the website belong to their respective owners, and S S Healthcare does not lay any claim on them. We only provide information.
