Saphnelo (anifrolumab-fnia) is a prescription drug used to treat systemic lupus erythematosus. The drug is given as an intravenous (IV) infusion by a healthcare professional.

Saphnelo is used to treat moderate to severe systemic lupus erythematosus (SLE) in adults who are receiving other SLE treatments. Saphnelo is not approved to treat other kinds of lupus. To learn more, see the “Is Saphnelo used for lupus?” section below.

Saphnelo basics

Saphnelo contains the active ingredient anifrolumab-fnia.* (An active ingredient is what makes a drug work.)

Saphnelo is a brand-name biologic drug. A biologic is made from parts of living organisms. Saphnelo is not available in a biosimilar form. (Biosimilars are like generic drugs. But unlike generics, which are made for nonbiologic drugs, biosimilars are made for biologic drugs.)

* The reason “-fnia” appears at the end of the drug’s name is to show that the drug is distinct from similar medications that may be created in the future.

Like most drugs, Saphnelo may cause mild or serious side effects. The lists below describe some of the drug’s more common side effects. These lists don’t include all possible side effects.

Keep in mind that side effects of a drug can depend on:

  • your age
  • other health conditions you have
  • other medications you take

Your doctor or pharmacist can tell you more about the potential side effects of Saphnelo. They can also suggest ways to help reduce side effects.

Mild side effects

Here’s a short list of some of the mild side effects Saphnelo can cause. To learn about other possible mild side effects, talk with your doctor or pharmacist or read Saphnelo’s prescribing information.

Mild side effects of Saphnelo that have been reported include:

  • mild infections, such as the common cold
  • infusion reactions, such as headaches, nausea or vomiting, dizziness, and fatigue (low energy)
  • cough
  • mild allergic reaction*

* To learn more about this side effect, see the “Allergic reaction” section below.

Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Saphnelo can occur, but they aren’t common. If you have serious side effects from Saphnelo, call your doctor right away. But if you think you’re having a medical emergency, you should call 911 or your local emergency number.

Serious side effects of Saphnelo that have been reported include:

* To learn more about this side effect, see the “Allergic reaction” section below.

Allergic reaction

Some people may have an allergic reaction to Saphnelo.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include swelling under your skin, usually in your eyelids, lips, hands, or feet. They can also include swelling of your tongue, mouth, or throat, which can cause trouble breathing.

Call your doctor right away if you have an allergic reaction to Saphnelo. But if you think you’re having a medical emergency, call 911 or your local emergency number.

Costs of prescription drugs can vary depending on many factors, including what your insurance plan covers and which pharmacy you use.

Here are a few things to consider regarding cost:

  • Cost information and savings coupons: You can visit Optum Perks* to get price estimates of what you’d pay for Saphnelo when using coupons from the site.
  • Savings programs: If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. Programs called AstraZeneca Access 360 and Co-Pay Savings may also be available. For more information and to find out if you’re eligible for these programs, visit the Saphnelo website.

If you have questions about how to pay for Saphnelo, talk with your doctor or pharmacist. You can also check out this article to learn more about saving money on prescriptions.

* Optum Perks is a sister site of Healthline. Optum Perks coupons cannot be used with any insurance copays or benefits.

Find answers below to some commonly asked questions about Saphnelo.

What should I know about Saphnelo vs. Benlysta?

If you have systemic lupus erythematosus (SLE), your doctor may recommend Saphnelo or Benlysta to treat your condition. Benlysta can also be used to treat lupus nephritis (lupus that affects the kidneys). Saphnelo isn’t approved for this use. For treating SLE, you’ll need to take other medications with either Saphnelo or Benlysta.

Saphnelo is only for use in adults. Benlysta can be used in adults and children ages 5 years and older.

Both Saphnelo and Benlysta are biologic drugs. A biologic is made from parts of living organisms. The active ingredient in Saphnelo is anifrolumab-fnia,* while the active ingredient in Benlysta is belimumab. (An active ingredient is what makes a drug work.)

Saphnelo comes as a liquid solution that you receive as an intravenous (IV) infusion (an injection into a vein given over time). Benlysta comes as a powder that’s mixed into a solution for IV infusion. It also comes as a liquid solution for injection under your skin.

Some of the side effects of Saphnelo and Benlysta are similar. For example, both drugs can cause mild or serious infections.

For more information about these SLE treatment options, talk with your doctor. They can discuss which drug might be the better treatment for you.

* The reason “-fnia” appears at the end of the drug’s name is to show that the drug is distinct from similar medications that may be created in the future.

What is Saphnelo’s mechanism of action?

A drug’s mechanism of action is how it works. Saphnelo’s mechanism of action involves a protein called type 1 interferon (IFN-1).

IFN-1 usually works in the body to activate the immune system. But the protein tends to be overactive in a person with SLE. As a result, their immune system attacks their own body.

Saphnelo blocks IFN-1. This decreases immune system activity, which helps ease symptoms of SLE.

For more information about how Saphnelo works to treat SLE, talk with your doctor.

Is Saphnelo used for rheumatoid arthritis (RA)?

No, it isn’t. At this time, the Food and Drug Administration (FDA) has only approved Saphnelo to treat SLE. The FDA has not approved the drug to treat other conditions, including RA.

SLE and RA are both autoimmune diseases. That is, they both cause a person’s immune system to mistakenly attack their own body. But the symptoms of SLE and RA are different.

At this time, no studies have been done to check whether Saphnelo is a safe and effective treatment for people with RA.

If you have RA, talk with your doctor about the best treatment options for your condition.

Saphnelo is a prescription medication used to treat a certain kind of lupus called systemic lupus erythematosus (SLE). SLE is an autoimmune disease. With this kind of disease, your immune system mistakenly attacks your body.

Symptoms of SLE include:

Saphnelo works to treat SLE by blocking IFN-1, a protein that activates the immune system. This decreases immune system activity, which helps ease symptoms of SLE. For more information about how Saphnelo works, see the “What are some frequently asked questions about Saphnelo?” section above.

This medication has limitations of use. This means the drug isn’t used in certain cases. It’s not known if Saphnelo is effective for treating lupus nephritis (lupus that affects the kidneys) or central nervous system lupus (lupus that affects the brain or spinal cord). As a result, the drug is not recommended for treating these kinds of lupus.

Your doctor will recommend the dosage of Saphnelo that’s right for you. Below are commonly used dosages, but your doctor will determine the dosage you receive.

Form and strength

Saphnelo comes as a liquid solution for intravenous (IV) infusion (an injection into a vein given over time). It’s available in one strength of 300 milligrams (mg) in 2 milliliters (mL) of solution.

Recommended dosage

For treating systemic lupus erythematosus (SLE), the usual recommended dose of Saphnelo is 300 mg. A healthcare professional will give you this dose as an IV infusion over 30 minutes. You’ll receive an infusion of this drug once every 4 weeks. For more about this infusion, see the “How is Saphnelo given?” section below.

Questions about Saphnelo’s dosing

Below are some common questions about Saphnelo’s dosing.

  • What if I miss a dose of Saphnelo? If you miss an appointment to receive your dose of Saphnelo, reschedule it as soon as possible. Depending on when you get your missed dose, it may be safe to keep your next appointment. There needs to be at least 14 days between infusions.
  • Will I need to use Saphnelo long term? Yes, Saphnelo is usually recommended as a long-term treatment option for people with SLE. If this medication works for you, your doctor will likely recommend receiving it long term.
  • How long does Saphnelo take to work? Saphnelo begins working after your first dose. But it may take up to 3 months before the drug is fully effective. So it’s recommended that you continue receiving doses, even if you don’t experience a change in symptoms right away. Your doctor can discuss with you how long it may take for your symptoms to lessen.

For more details about Saphnelo’s dosage, see this article.

Your doctor will explain Saphnelo’s administration (how the drug is given) for systemic lupus erythematosus (SLE). They’ll also explain how much Saphnelo you’ll receive and how often.

Receiving Saphnelo

A healthcare professional will administer Saphnelo as an intravenous (IV) infusion. This is an injection into a vein given over time. With the Saphnelo infusion, you’ll receive your dose over a period of 30 minutes. You’ll have an infusion once every 4 weeks.

Since a healthcare professional administers Saphnelo, you’ll likely go to a doctor’s office, an infusion center, or a hospital for your infusions.

Using Saphnelo with other drugs

Saphnelo should be used with other medications to treat systemic lupus erythematosus (SLE). For example, Saphnelo may be prescribed with:

It’s usually not recommended to use Saphnelo with other biologic drugs to treat SLE. For more information, see the “What should be considered before receiving Saphnelo?” section below.

Certain factors can affect whether Saphnelo is a good treatment option for you. These may include having certain medical conditions or taking specific medications. Read on to find out more about these factors.

Interactions

Taking a medication with certain vaccines, foods, and other things can affect how the medication works. These effects are called interactions.

Before starting Saphnelo treatment, be sure to tell your doctor about all medications you take, including prescription and over-the-counter types. Also describe any vitamins, herbs, or supplements you use. Your doctor or pharmacist can tell you about any interactions these items may cause with Saphnelo.

Interactions with drugs or supplements

Saphnelo can interact with other biologic drugs, such as adalimumab (Humira) and etanercept (Enbrel). Biologic drugs such as Saphnelo are made from parts of living organisms.

If you take biologics, your doctor may recommend that you stop taking them before starting Saphnelo treatment.

Other drugs or supplements may interact with Saphnelo. Your doctor or pharmacist can tell you more about these interactions and any others that might occur when using Saphnelo.

Other interactions

Saphnelo can interact with certain vaccines, called live vaccines. Live vaccines contain weakened forms of the viruses or bacteria they protect against. In people with a healthy immune system, this usually is not an issue. But Saphnelo reduces your immune system activity, sometimes referred to as “weakening” your immune system. So getting a live vaccine during Saphnelo treatment may make you sick.

Examples of live vaccines that your doctor may recommend avoiding while receiving Saphnelo include:

Before starting treatment with Saphnelo, your doctor or pharmacist can check whether you’re up to date on your vaccinations. If you need to get any vaccines, they may recommend that you receive them before starting Saphnelo treatment.

Warnings

Saphnelo can sometimes cause harmful effects in people who have certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether Saphnelo is a good treatment option for you.

Talk with your doctor about your health history before you receive Saphnelo. Factors to consider include those described below.

Cancer. Taking drugs that reduce the activity of the immune system may increase the risk of cancer, but it’s not known whether this is the case with Saphnelo. Even so, if you have or have had cancer, tell your doctor before starting Saphnelo treatment. They may recommend monitoring you more often while you’re receiving Saphnelo. In some cases, they may recommend a different treatment option for you.

Allergic reaction. If you’ve had an allergic reaction to Saphnelo or any of its ingredients, your doctor will likely not prescribe Saphnelo. Ask them what other medications are better options for you.

Active infections. Saphnelo can reduce the activity of your immune system, which may increase your risk of infections. If you already have an infection, Saphnelo may worsen it. Before starting Saphnelo treatment, tell your doctor about any infections you may have. They’ll likely recommend treating the infection before you start receiving Saphnelo.

Saphnelo and alcohol

There aren’t any known interactions between Saphnelo and alcohol. But other medications you may take with Saphnelo to treat systemic lupus erythematosus (SLE), such as methotrexate (Trexall), could interact with alcohol.

If you’d like to drink alcohol during Saphnelo treatment, talk with your doctor. They’ll let you know how much alcohol, if any, is safe to consume with the medications you’re taking for your condition.

Pregnancy and breastfeeding

It’s not known if Saphnelo is safe to receive during pregnancy or while breastfeeding.

At this time, there isn’t enough information on whether Saphnelo may cause harm to a fetus if taken during pregnancy.

Note that not treating SLE during pregnancy may increase your risk of pregnancy loss or premature birth. Your doctor can recommend the best treatment plan for your SLE during pregnancy.

If you become pregnant while receiving Saphnelo, consider signing up for the drug’s pregnancy exposure registry. The registry collects information about the risks and benefits of receiving Saphnelo during pregnancy. This can help determine the effects of the drug on someone who is pregnant. To learn more about this registry, call 877-693-9268.

It’s not known if Saphnelo passes into breast milk or what effects the drug may have on a child who is breastfed. If you’re breastfeeding or planning to do so, talk with your doctor before starting Saphnelo treatment.

If you have questions about Saphnelo treatment, talk with your doctor or pharmacist. Questions you may want to ask include:

  • If I have side effects from Saphnelo, can my dosage be decreased?
  • How can I treat side effects that I develop from receiving Saphnelo?
  • How does Saphnelo compare with other drugs used for SLE?
  • If this medication isn’t working for me, what are the next steps?

For information about other lupus treatments, see this article.

To learn more about Saphnelo, see this article:

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Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.