Saphnelo (Anifrolumab-fnia) for Lupus

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Saphnelo (anifrolumab-fnia) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat adults with moderate to severe systemic lupus erythematosus (SLE).

What Members Say

These insights are based on 708 comments about Saphnelo from MyLupusTeam members. These are the experiences of a small number of people and are not meant to be medical advice.

Benefits:

Skin rashes, lesions, and itching often improve.
Pain, stiffness, and flare frequency decrease.
Some are able to lower steroid use over time.

Considerations:

Full benefit can take several months, and some feel no improvement.
Headache, nausea, fatigue, dizziness, and vomiting can happen after infusions.
Infection risk increases, especially respiratory infections and shingles.

How Saphnelo Works and How It’s Taken

Saphnelo is a monoclonal antibody. It blocks the type 1 interferon receptor (IFNAR). Type 1 interferon is a signal that can affect immune system activity.

Blocking this signal reduces inflammatory and immune system processes linked to SLE.

Doctors prescribe Saphnelo for adults with moderate to severe SLE who are receiving standard therapy.

Saphnelo may be given in two ways:

As an intravenous (IV) infusion every four weeks
As an injection under the skin once every week

The under-the-skin injection is available as a single-dose prefilled syringe or Saphnelo Pen. People with lupus or caregivers may give the injection after proper training and when a healthcare provider decides it is appropriate.

The injection may be given in the thigh or abdomen. A caregiver or healthcare professional may also give it in the upper arm.

Typical Dosing for SLE

The recommended Saphnelo dose is either:

300 milligrams given as an IV infusion over 30 minutes every four weeks
120 milligrams given as an injection under the skin once every week

This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Top Advice From Members on Saphnelo

These insights are based on 708 comments about Saphnelo from MyLupusTeam members.

Members who use Saphnelo often say that patience, symptom tracking, and close communication with their rheumatologist matter most. Many also mention practical issues like staying on schedule, preparing for infusion days, and speaking up quickly about infections or possible reactions.

1

Stay on schedule with your infusions when you can.
“The key is not to miss or delay an infusion. Stay on schedule and keep it up; it has truly been life changing.”
2

Be patient. Improvement can take a few months.
“My doctor said it will take probably four infusions to get the full effect.”
3

Talk to your doctor about infections before continuing treatment.
“I’ve had a few viral infections, and they make me feel worse, so I have to skip an infusion when I’m sick. My care team also waits until I’ve been off antibiotics for a week before restarting treatment.”

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Saphnelo Side Effects

In clinical studies of Saphnelo in adults with moderate to severe SLE who were receiving standard therapy, the most common side effects occurred in about 5 percent to 34 percent of people. These include:

Upper respiratory tract infection (such as a cold)
Nasopharyngitis (stuffy or runny nose and sore throat)
Bronchitis (infection or inflammation of the airways in the lungs)
Infusion-related reactions (reactions during or after an IV infusion)
Herpes zoster (shingles)
Cough

Serious Side Effects and Warnings

Saphnelo can cause serious side effects that may require immediate medical attention. These include:

Serious infections — These include COVID-19 and pneumonia and can sometimes be fatal.
Hypersensitivity reactions — These include anaphylaxis (a severe allergic reaction) and angioedema (swelling under the skin, often of the face, lips, or throat).
Malignancy — There is a possible risk of cancer.

Get medical help right away if you think you are having a serious reaction.

How To Save on Saphnelo

AstraZeneca, the manufacturer of Saphnelo, offers the Saphnelo Co-pay Savings Program. Eligible people with commercial insurance may pay as little as $0 per administration.

The Saphnelo Co-pay Savings Program is part of Saphnelo Supports. Through Access 360, the program also offers help understanding insurance coverage, out-of-pocket costs, and available affordability programs.

To learn more, visit the Saphnelo Supports page or call 866-727-4635.

What To Know Before Taking Saphnelo

Before starting Saphnelo, ask your doctor whether you need any vaccines. Do not receive live or live-attenuated vaccines while using Saphnelo.

Tell your doctor if you:

Have an active infection or infections that keep coming back
Are scheduled to receive a vaccine
Have or have had cancer
Are using other biologic medicines or monoclonal antibodies
Are allergic to Saphnelo or any of its ingredients

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

Do not use Saphnelo if you have had anaphylaxis (a serious allergic reaction) to anifrolumab-fnia.

If you miss an IV infusion, receive it as soon as possible. Keep at least 14 days between infusions.

If you miss a weekly injection, inject it as soon as you remember. You may then start a new weekly schedule from that day or return to your usual injection day. Keep at least three days between injections.

If you are pregnant, planning to become pregnant, or breastfeeding while taking Saphnelo, talk with your doctor about the risks and benefits.

There is a pregnancy registry for people exposed to Saphnelo during pregnancy. To learn more, visit the Saphnelo pregnancy and breastfeeding study website or call 877-693-9268.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Saphnelo for SLE?

In clinical studies of adults with moderate to severe SLE who were receiving standard therapy, more people had a BICLA response at week 52 with Saphnelo than with placebo (an inactive treatment).

A BICLA response means lupus activity improved without worsening in other important measures.

The results were:

47.8 percent with Saphnelo compared with 31.5 percent with placebo
47.1 percent with Saphnelo compared with 30.2 percent with placebo
54.6 percent with Saphnelo compared with 25.8 percent with placebo

In one trial, some people were taking at least 10 milligrams of oral corticosteroids each day when the study began. By week 40, 52 percent of people taking Saphnelo reduced their dose by at least 25 percent to 7.5 milligrams a day or less and kept that lower dose through week 52.

This happened in 30 percent of people taking placebo.

How long does Saphnelo take to work for SLE?

Clinical studies measured how well Saphnelo worked at week 52.

In blood tests, Saphnelo reduced a type 1 interferon gene signal from week 4 through week 52 in people who had high levels at the start. However, it is not clear what this blood test change means for symptoms.

The study does not say exactly when each person should begin to feel better.

Should I take Saphnelo for lupus if I have an infection?

Saphnelo can lower your body’s ability to fight infections. Serious infections, including fatal infections, have happened in people taking Saphnelo.

Do not start Saphnelo if you have a clinically significant active infection. Wait until the infection has gone away or has been properly treated.

If you develop an infection while taking Saphnelo, or if the infection is not getting better with standard treatment, your healthcare provider should monitor you closely. They may pause Saphnelo until the infection goes away.