Details

What is Saphnelo (anifrolumab) for?

Saphnelo (anifrolumab) is a first-in-class type I interferon receptor antibody with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.

It is available in vial form, each containing 300 mg/2 mL (150 mg/mL) anifrolumab.

How does Saphnelo (anifrolumab) work?

SLE is an autoimmune disease, the most common form of lupus. In SLE patients, the immune system produces antibodies that can attack any part of the body. SLE can affect multiple organs and damage them.

Anifrolumab can block type I interferons (IFN), which are proteins made by the immune system, which are one of the main triggers of tissue damage and progression of the disease. The majority of SLE patients have increased type I IFN signaling, which is associated with symptoms and severity of the disease.

Where has Saphnelo (anifrolumab) been approved?

Saphnelo (anifrolumab) was approved for the treatment of people with SLE by:

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 Saphnelo (anifrolumab) taken?

The standard dosage is:

Complete information about Saphnelo (anifrolumab) dosage 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 Saphnelo (anifrolumab)?

Common adverse reactions

The most common side effects (≥5% of patients) listed in the prescribing information include:

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:

Use in a specific population

It is not (yet) known if Saphnelo (anifrolumab) can cause major birth defects or miscarriage. Females who are able to become pregnant are advised to inform their treating doctor if they intend to become pregnant during therapy, suspect they are pregnant or become pregnant while receiving this medicine.

The safety and efficacy of Saphnelo (anifrolumab) in patients younger than 18 years of age has not been established.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.

References

Clinical trials

The Food and Drug Administration (FDA) approval of Saphnelo (anifrolumab) for treatment of adults with systemic lupus erythematosus (SLE) was based on the data of the Saphnelo clinical development programme, including two TULIP Phase 3 trials (NCT02446912 and NCT02446899) and the MUSE Phase 2 trial (NCT01438489).

The trials were three 52-week, multicenter, randomized, double-blind, placebo-controlled studies that involved a total of 1,459 patients with moderately to severely active SLE.

In MUSE, the efficacy and safety of two doses of Saphnelo versus placebo were studied. Patients received a fixed-dose intravenous infusion of 300 mg Saphnelo, 1,000 mg Saphnelo or placebo every four weeks, in addition to standard therapy, for 48 weeks.

In TULIP-1 and TULIP-2, patients were treated with either 300 mg Saphnelo or placebo every 4 weeks for a total of 13 doses, both with standard of care (SOC) treatment (either 1 or any combination of the following: oral corticosteroids, antimalarial, and/or immunosuppressants).

Results

MUSE showed that Saphnelo was more efficient than placebo across multiple efficacy endpoints.

The main efficacy outcome of TULIP-1 was the number of patients who achieved a SLE Responder Index ≥4 (SRI4).

The trial did not meet its primary endpoint based on the SRI4 composite measure.

The main efficacy outcome of TULIP-2 was the proportion of patients showing a reduction of disease activity at week 52, as measured by the BILAG-Based Composite Lupus Assessment (BICLA) scale.

TULIP-1 and TULIP-2 showed that Saphnelo reduced flares in people with moderate to severe lupus while allowing lowered steroid use.

Saphnelo significantly lowered disease activity compared with placebo in patients with SLE: BICLA responders were 47.8% of patients receiving Saphnelo versus 31.5% in patients receiving placebo.

Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Saphnelo (anifrolumab) for the approved indication.

References

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
One vial of 300 mg/2 mL	1491 EUR	2462 AUD	2225 CAD	2708 NZD	2477414 NGN	2106 SGD	1229 GBP	1570 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.

Saphnelo (anifrolumab) treatment costs

The cost for a monthly or yearly treatment of Saphnelo (anifrolumab) depends on your prescription requirements which includes the dosage in mg and medicine type (Single-dose vial).

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 Saphnelo (anifrolumab) 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.

Saphnelo (anifrolumab) price and additional costs

Saphnelo (anifrolumab) reimbursement

It might be possible for you to claim the cost of Saphnelo (anifrolumab) 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 Saphnelo: You can access Saphnelo from everyone.org if the drug has not been approved or is not available in your country.