Saphnelo is a brand-name prescription medication. It’s FDA-approved to treat a type of lupus called systemic lupus erythematosus (SLE).

Lupus is an autoimmune disease, which occurs when your immune system mistakenly attacks your own body. SLE can cause inflammation (swelling and damage) in multiple areas, including the joints, lungs, and kidneys.

Saphnelo is prescribed for adults with moderate to severe SLE. The drug should be used in combination with other SLE treatments.

Saphnelo has some limitations of use. For more information about when the drug may be recommended, see the “Saphnelo for lupus” section below.

Drug details

Saphnelo belongs to a drug class called type 1 interferon (IFN-1) receptor blockers. Saphnelo is a biologic drug.

Saphnelo comes as a solution, which a healthcare professional will give you as an IV infusion. Saphnelo comes in one strength: 300 milligrams/2 milliliters (mg/mL).

FDA approval

The Food and Drug Administration (FDA) approved Saphnelo in 2021 to treat moderate to severe SLE. This is the first medication used to treat SLE that works by blocking IFN-1 proteins.

Effectiveness

For information about the effectiveness of Saphnelo, see the “Saphnelo for lupus” section below.

Saphnelo is available only as a brand-name medication. It’s not currently available in a biosimilar form.

A biosimilar drug is a medication that’s similar to a brand-name biologic medication (the parent medication). Saphnelo is a biologic medication.

Biologic medications are made from living cells, so the medications can’t be copied exactly. A generic medication, on the other hand, refers to drugs made from chemicals. A generic is an exact copy of the active drug in a brand-name medication.

Biosimilar medications are considered to be just as safe and effective as their parent drug. Biosimilar medications (and generics) are also typically less expensive than brand-name forms.

Here are answers to some frequently asked questions about Saphnelo.

How does Saphnelo compare with Benlysta?

Both Saphnelo and belimumab (Benlysta) are approved to treat systemic lupus erythematosus (SLE). Benlysta is also approved to treat lupus nephritis, which is a kidney problem related to lupus. Saphnelo is for use only in adults. Benlysta is for use in adults as well as children ages 5 years and older.

Saphnelo and Benlysta are both biologic drugs. However, they work in different ways to treat SLE. This means that the drugs have different doses and different side effects.

Saphnelo is given as an IV infusion. This is an injection into a vein over a period of time. Benlysta can be given as an IV infusion or a subcutaneous injection. This type of injection is given just under the skin.

For more information about how Saphnelo and Benlysta are alike and different, talk with your doctor.

Is Saphnelo used to treat rheumatoid arthritis?

Saphnelo is not approved to treat rheumatoid arthritis (RA). Currently, the only approved use for Saphnelo is treating SLE.

RA and SLE are both autoimmune diseases, which means that both diseases cause your immune system to mistakenly attack your own body. RA typically affects your joints, and may also cause other symptoms, such as fever.

Although SLE and RA have some similarities, Saphnelo has not been studied in clinical trials of RA. Because of this, it’s not known if Saphnelo is a safe or effective treatment for RA.

Other medications that affect your immune system, such as adalimumab (Humira), are commonly prescribed to treat RA. If you’re interested in medication for RA, talk with your doctor.

Is cancer a side effect of Saphnelo?

Cancer has not been reported as a side effect of Saphnelo. However, medications that are known to affect your immune system may increase the risk of cancer. Saphnelo is a drug that affects your immune system. So it’s possible that Saphnelo may also increase the risk of developing cancer.

It’s not known if and how much Saphnelo may increase the risk of cancer, or what type of cancer the drug could cause.

If you’re concerned about cancer with Saphnelo treatment, talk with your doctor. They may be able to recommend certain cancer screenings to help detect any changes. Also, be sure to tell your doctor if you have or have had cancer in the past. A history of cancer could increase the risk of developing it with Saphnelo. (To learn more, see the “Saphnelo precautions” section below.)

As with all medications, the cost of Saphnelo can vary. To find current prices for Saphnelo in your area, check out WellRx.com.

The cost you find on WellRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Before approving coverage for Saphnelo, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure whether you’ll need to get prior authorization for Saphnelo, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Saphnelo, or if you need help understanding your insurance coverage, help is available.

AstraZeneca, the manufacturer of Saphnelo, offers two programs called AstraZeneca Access 360 and Co-Pay Savings. For more information and to find out if you’re eligible for support, visit the drug website. You can also call these numbers to learn more about each program:

  • AstraZeneca Access 360: 844-ASK-A360 (844-275-2360)
  • Co-Pay Savings: 866-SAPHNELO (866-727-4635)

To learn more about saving money on prescriptions, check out this article.

Biosimilar form

Saphnelo is available only as a brand-name medication. It’s not currently available in a biosimilar form.

A biosimilar drug is a medication that’s similar to a brand-name biologic medication (the parent medication). Saphnelo is a biologic medication.

Biologic medications are made from living cells, so the medications can’t be copied exactly. A generic medication, on the other hand, refers to drugs made from chemicals. A generic is an exact copy of the active drug in a brand-name medication.

Biosimilar medications are considered to be just as safe and effective as their parent drug. Biosimilar medications (and generics) are also typically less expensive than brand-name forms.

Saphnelo can cause mild or serious side effects. The following lists contain some of the key side effects that may occur with Saphnelo. These lists do not include all possible side effects.

For more information about the possible side effects of Saphnelo, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Saphnelo, you can do so through MedWatch.

Mild side effects

Mild side effects* of Saphnelo can include:

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Saphnelo. To learn about other mild side effects, talk with your doctor or pharmacist, or see Saphnelo’s prescribing information.
† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Saphnelo aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects* of Saphnelo can include:

* For more information about these side effects, see “Side effect details” below.

Side effect details

Here’s some detail on certain side effects this drug may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Saphnelo.

Infection

Saphnelo may increase the risk of infection. The drug works by weakening your immune system, which is your body’s defense against infection. If your immune system isn’t strong, you may develop an infection more easily than you usually would. Most infections that people receiving Saphnelo experienced in clinical trials were mild. Examples include the common cold and other upper respiratory infections.

However, Saphnelo may cause more serious infections, which may be life threatening. Serious respiratory infections that have occurred with the drug include bronchitis and pneumonia. Saphnelo can also increase the risk of shingles.

What you can do

You should be aware of possible symptoms of infections, such as:

If you develop symptoms of an infection with Saphnelo, talk with your doctor right away. They’ll monitor you. Your doctor may also recommend treatment such as antibiotics or steroid medications. An example of a steroid drug is prednisone (Rayos). The sooner the infection is treated, the better. This helps prevent the infection from worsening.

Before receiving Saphnelo, it’s important to talk with your doctor about infections you have or have had. To learn more, see the “Saphnelo precautions” section below.

For more information about infections that may occur during treatment with Saphnelo, talk with your doctor.

Infusion-related reaction

Some people may have a reaction to Saphnelo infusions, which is called an infusion-related reaction. The reactions may occur during the infusion or shortly after receiving an infusion.

For most people who experienced a reaction during Saphnelo treatment in clinical trials, the reaction was mild or moderate. Mild reactions may cause symptoms such as:

Mild reactions did not lead people to stop Saphnelo treatment.

In rare cases, Saphnelo may cause severe infusion-related reactions. Symptoms may include swelling of your lips, mouth, or throat. Other possible symptoms include difficulty breathing and changes in blood pressure.

You may have an increased risk of a reaction within your first 12 weeks of Saphnelo treatment.

What you can do

To help lower your risk of reactions with Saphnelo infusions, you may receive certain medications before treatment, such as:

  • methylprednisolone (Solu-Medrol)
  • diphenhydramine (Benadryl)
  • acetaminophen (Tylenol)

A healthcare professional will monitor you for symptoms of reactions during your Saphnelo infusions. If you have mild symptoms, they may slow or stop the infusion. They may also give you your next infusion over a longer period of time to help prevent symptoms.

If you develop a serious infusion-related reaction, the healthcare professional can treat it right away. Your doctor may then recommend switching from Saphnelo to a different drug.

Allergic reaction

As with most drugs, some people can have an allergic reaction after receiving 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, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Saphnelo, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

The Food and Drug Administration (FDA) approves prescription drugs such as Saphnelo to treat certain conditions.

Saphnelo is used to treat a type of lupus called systemic lupus erythematosus (SLE). To be specific, the drug is for moderate to severe SLE in adults. Saphnelo should be prescribed in combination with other treatments for SLE, which may include:

Saphnelo has some limitations of use. The drug is not recommended for severe lupus nephritis in people who currently have symptoms. This type of lupus affects the kidneys. Saphnelo is also not recommended for severe central nervous system lupus in people who currently have symptoms. This kind of lupus affects the brain or spinal cord. It’s not known if the drug is safe or effective for these forms of lupus.

Systemic lupus erythematous explained

Lupus is an autoimmune disease, which occurs when your immune system mistakenly attacks your own body. SLE can cause inflammation (swelling and damage) in multiple areas, including the joints, lungs, and kidneys.

Symptoms of SLE may vary based on what part of your body the disease affects. In general, symptoms of SLE can include:

It’s not known what causes SLE. It may have genetic or other factors. This means that having certain genes may increase the risk of the disease. In addition, factors such as stress, diet, and exposure to dangerous chemicals may increase the risk of SLE.

Effectiveness for lupus

Saphnelo is an effective treatment option for SLE. For information about how Saphnelo performed in clinical trials, see the drug’s prescribing information.

Saphnelo and children

Saphnelo is not approved for use in children. It’s not known if the drug is a safe or effective treatment option for SLE in children. If your child has this disease, talk with their doctor about other medications.

Saphnelo comes as a solution that a healthcare professional will administer as an IV infusion. This is an injection into a vein over time.

Each infusion takes about 30 minutes to complete. Your doctor may recommend that you bring a book, phone, or music to keep busy.

You’ll receive your doses at your doctor’s office, at a hospital, or at an infusion suite. (The suite is a specific center for infusions.)

Your doctor can help answer any questions you have about what to expect during Saphnelo infusions.

When it’s given

You’ll receive Saphnelo infusions once every 4 weeks.

To help make sure that you don’t miss an appointment for an infusion, try using a medication reminder. You could also download a reminder app on your phone.

The Saphnelo dosage your doctor prescribes will be the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. Your doctor will determine the best dosage to fit your needs.

Drug form and strength

Saphnelo comes as a solution, which a healthcare professional will give you as an IV infusion. Saphnelo comes in one strength: 300 milligrams/2 milliliters (mg/mL).

Dosage for lupus

The dosage of Saphnelo is a 300-mg infusion once every 4 weeks.

What if I miss an appointment to receive a dose?

If you miss an appointment for a Saphnelo infusion, call your doctor’s office to reschedule it for as soon as possible. Your doses of Saphnelo should be at least 14 days apart.

To help make sure that you don’t miss an appointment for an infusion, try using a medication reminder. You could also download a reminder app on your phone.

Will I need to receive this drug long term?

Saphnelo is meant to be used as a long-term treatment. If you and your doctor determine that Saphnelo is safe and effective for you, you’ll likely receive it long term.

Saphnelo is approved to treat a type of lupus called systemic lupus erythematosus (SLE). Lupus is an autoimmune disease, which occurs when your immune system mistakenly attacks your own body. SLE can cause inflammation (swelling and damage) in multiple areas, including the joints, lungs, and kidneys.

What is Saphnelo’s mechanism of action?

Saphnelo’s mechanism of action (the way the drug works) is to prevent a protein called type 1 interferon (IFN-1) from working. IFN-1 is overactive in most people with lupus.

The job of IFN-1 is to spark the activity of the immune system. However, in people with lupus, this makes the immune system overactive, causing it to attack your own body by mistake.

Saphnelo prevents IFN-1 from working, which decreases the activity of your immune system. Your immune system is then less likely to attack your body, so symptoms of lupus ease.

How long does it take to work?

Saphnelo begins working in your body to relieve symptoms of SLE as soon as you receive your first dose. However, it can take about 3 months for you to notice the full effects of the medication.

Talk with your doctor to find out how soon your symptoms might ease.

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Saphnelo, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when a drug that’s approved by the Food and Drug Administration (FDA) is prescribed for a purpose other than what it’s approved for.

Alternatives for lupus

Examples of other drugs that may be prescribed to treat systemic lupus erythematosus include:

There are no known interactions between Saphnelo and alcohol. Talk with your doctor about how much alcohol, if any, is safe for you to drink while you receive Saphnelo.

Saphnelo can interact with several other medications. The drug is not known to interact with supplements or foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Saphnelo and other medications

Below is a list of medications that can interact with Saphnelo. This list does not contain all drugs that may interact with Saphnelo.

Before you start Saphnelo treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Types of drugs that can interact with Saphnelo include:

Other biologic drugs. Saphnelo is a biologic drug. If you have cancer or an autoimmune disease besides systemic lupus erythematosus, you may be receiving other biologic drugs. Saphnelo has not been studied in people receiving the medication along with other biologic drugs. Because it’s not known what effects this combination could have, receiving Saphnelo with another biologic drug is not recommended. Examples of other biologic drugs include:

Saphnelo and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Saphnelo. However, you should still check with your doctor or pharmacist before using any of these products while receiving Saphnelo.

Saphnelo and foods

There aren’t any foods that have been specifically reported to interact with Saphnelo. If you have any questions about eating certain foods with Saphnelo, talk with your doctor.

Saphnelo and vaccines

You should not get any live vaccines during Saphnelo treatment.

Live vaccines have a small, weakened amount of the live virus they’re meant to protect against. If your immune system is strong, live vaccines do not typically cause infection. If your immune system is weak, your body may not be able to fight the live virus. Saphnelo works by weakening your immune system.

Examples of live vaccines include:

Before you start Saphnelo treatment, your doctor can check whether you’re up to date with your vaccines. If you need any vaccines, they may recommend that you get them before you begin receiving Saphnelo.

It’s not known if Saphnelo is safe to receive during pregnancy. Medications that are known to affect your immune system can also affect a developing fetus. Saphnelo is a drug that affects your immune system. So it’s possible that Saphnelo may affect pregnancy.

Animal studies did not show an increased risk of problems with fetal development in animals given the drug during pregnancy. However, animal studies do not always indicate what may happen in humans.

Due to the risk in humans, Saphnelo has a pregnancy registry. A pregnancy registry is a collection of data on people who have received Saphnelo while pregnant. The registry collects information about how a drug affects pregnancy and if the drug may increase the risk of problems with a fetus. To find out more information about the pregnancy registry, call 877-693-9268.

If you’re pregnant or planning to become pregnant, talk with your doctor before receiving Saphnelo. They can advise you on the pros and cons of the medication.

It’s not known if Saphnelo is safe to receive during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you receive Saphnelo.

For more information about Saphnelo treatment during pregnancy, see the “Saphnelo and pregnancy” section above.

It’s not known if Saphnelo passes into breast milk or what effects the drug may have on a child who is breastfed.

In animal studies, Saphnelo passed into the breast milk of animals given the drug. However, it is important to note that animal studies do not always indicate what may happen in humans.

If you’re breastfeeding or thinking about it, talk with your doctor before receiving Saphnelo. They can review the risks and benefits of the drug with you.

This drug comes with several precautions. Before receiving Saphnelo, talk with your doctor about your health history. Saphnelo may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Infection. If you currently have an infection or have infections that keep coming back, tell your doctor before you start Saphnelo treatment. This medication may increase your risk of new or worsened infections. Your doctor may treat any infections that you have before you begin receiving Saphnelo. They can help you determine if Saphnelo is a safe option for you.
  • Cancer. Saphnelo may increase the risk of cancer. If you have cancer or had it in the past, talk with your doctor. Receiving Saphnelo may worsen your cancer or increase the risk of your cancer coming back. Your doctor can advise you on whether it’s safe for you to receive the medication.
  • Allergic reaction. If you’ve had an allergic reaction to Saphnelo or any of its ingredients, your doctor will likely not prescribe Saphnelo. Ask your doctor what other medications are better options for you.
  • Pregnancy. It’s not known if Saphnelo is safe to receive during pregnancy, or what effects the drug may have on a developing fetus. For more information, see the “Saphnelo and pregnancy” section above.
  • Breastfeeding. It’s not known if Saphnelo is safe to receive while you’re breastfeeding. For more information, see the “Saphnelo and breastfeeding” section above.

Note: For more information about the potential negative effects of Saphnelo, see the “Saphnelo side effects” section above.

Disclaimer: Medical News Today 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.