Saphnelo (anifrolumab-fnia) is a brand-name injection that’s prescribed for systemic lupus erythematosus in adults. As with other drugs, Saphnelo can cause side effects, such as infection and infusion-related reactions.

Saphnelo is a biologic that belongs to a drug class called type 1 interferon (IFN-1) receptor blockers. The drug is not available in a biosimilar version.

Read on to learn about potential common, mild, and serious side effects of Saphnelo. For a general overview of the drug, including details about its uses, see this article.

Saphnelo can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Saphnelo in clinical trials:

* For more information about this side effect, see “Side effect specifics” below.

Mild side effects can occur with Saphnelo. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Saphnelo ’s prescribing information.

Mild side effects that have been reported with Saphnelo include:

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect during Saphnelo treatment and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics” below.

Saphnelo may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Saphnelo’s prescribing information.

If you develop serious side effects during Saphnelo treatment, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported include:

* For more information about this side effect, see “Side effect specifics” below.

Saphnelo may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

How do side effects of Saphnelo compare with those of Benlysta?

Saphnelo and Benlysta (belimumab) are both drugs prescribed to help treat certain types of lupus. Specifically, both drugs can be prescribed to help treat systemic lupus erythematosus.

These drugs may cause some of the same side effects. However, Benlysta may cause other side effects that aren’t known to occur with Saphnelo.

For example, both Saphnelo and Benlysta may cause infection and infusion-related reactions. Benlysta may also cause fever, insomnia, migraine, and depression.

For lists of possible side effects of Saphnelo, see the “Mild side effects of Saphnelo” and “Serious side effects of Saphnelo” sections above. To learn more about Benlysta and its side effects, see this article.

Does Saphnelo weaken your immune system?

Yes, Saphnelo may weaken your immune system. This is because of how the drug works in your body.

As a result, Saphnelo may cause certain side effects related to a weakened immune system. For example, the drug could lower your immune system’s ability to respond to an infection. Infections were a common side effect in clinical trials of Saphnelo. (To learn more, see “Side effect specifics” below.)

In addition, drugs that weaken your immune system may increase your risk of cancer. However, it isn’t known for certain whether Saphnelo increases this risk.

If you have questions about how Saphnelo works or its effects on your immune system, talk with your doctor.

Learn more about some of the side effects that Saphnelo may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Saphnelo.

Cough

Cough was one of the more common side effects in Saphnelo’s clinical trials.

Keep in mind that cough is a possible symptom of an infection, which is another common side effect of Saphnelo.

What you can do

If you have a bothersome cough during Saphnelo treatment, talk with your doctor. They can help determine whether the drug or another factor, such as infection, may be the cause.

If necessary, your doctor can recommend certain treatments to ease your symptoms. For example, they may suggest you take a cough suppressant, such as Delsym (dextromethorphan).

Infections

It’s possible to develop an infection from treatment with Saphnelo. In clinical trials of the drug, reported infections were commonly mild. Serious infections were less common.

Examples of mild infections that may occur with Saphnelo include the common cold or bronchitis. Possible serious infections include pneumonia or shingles.

Symptoms of infection will vary depending on the specific infection. These may include:

What you can do

If you have symptoms of infection during Saphnelo treatment, tell your doctor. They can run tests to check for infection.

If you do have an infection, your doctor may temporarily stop treatment with Saphnelo until the infection has cleared. Your doctor can recommend whether it’s safe to resume treatment with the drug.

Infusion-related reactions

Infusion-related reactions were one of the more common side effects in Saphnelo’s clinical trials.

With infusion-related reactions, you may have mild symptoms during your Saphnelo infusion or shortly after. Examples of these symptoms include:

In rare cases, an infusion-related reaction may cause severe symptoms that are similar to an allergic reaction. For details about these symptoms, see “Allergic reaction” below.

What you can do

Before your Saphnelo infusions, your doctor may recommend certain medications to help lower your risk of an infusion-related reaction. For example, they may prescribe an antinausea drug such as ondansetron.

Saphnelo infusions are given by a healthcare professional. They’ll watch for any infusion-related reactions while you receive the drug.

If you have an infusion-related reaction, they may slow down your infusion or stop it completely. Your healthcare professional may also slow down your next infusion to help prevent this side effect from happening again.

Allergic reaction

As with most drugs, Saphnelo can cause an allergic reaction in some people. This was a less common side effect in clinical trials.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep receiving Saphnelo. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Be sure to talk with your doctor about your health history before you receive Saphnelo. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:

Cancer. Medications that weaken your immune system may increase the risk of cancer. Saphnelo weakens your immune system, but it isn’t known for certain whether the drug increases this risk. If you have cancer or had it in the past, talk with your doctor before starting Saphnelo treatment. They can tell you whether Saphnelo is a safe treatment option for you.

Current infection. Saphnelo may cause a new or worsened infection. Before starting Saphnelo treatment, be sure to tell your doctor if you have an infection. They’ll likely treat it before you begin receiving Saphnelo.

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 may be better options for you.

Alcohol with Saphnelo

There are no known interactions between Saphnelo and alcohol.

If you have questions about drinking alcohol during Saphnelo treatment, talk with your doctor or pharmacist.

Pregnancy and breastfeeding while receiving Saphnelo

It’s not known whether Saphnelo is safe to receive during pregnancy or while breastfeeding. Clinical trials haven’t studied the Saphnelo in people who are pregnant or breastfeeding.

Animal studies haven’t shown harm to offspring of animals given the drug during pregnancy. However, these studies have shown the drug may pass into breast milk. Keep in mind that animal studies may not predict what happens with humans.

If you’re pregnant, breastfeeding, or planning for either, talk with your doctor before starting Saphnelo treatment. They’ll advise you on the risks and benefits of receiving Saphnelo during these times.

If you do receive Saphnelo during pregnancy, consider enrolling in the drug’s pregnancy registry. This registry helps collect important information about the safety of Saphnelo during pregnancy. To learn more, call 877-693-9268 or talk with your doctor.

Saphnelo may cause mild and serious side effects. If you have side effects that are bothersome or long lasting with Saphnelo, talk with your doctor or pharmacist.

If you’d like to learn more about Saphnelo, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from treatment with the drug.

Besides talking with your doctor, you can do some research on your own. These articles might help:

  • More information about Saphnelo. For details about other aspects of Saphnelo, refer to this article.
  • Dosage. For information about the dosage of Saphnelo, view this article.
  • Interactions. To find out about Saphnelo’s interactions, see this article.
  • A look at lupus. For details about lupus, see our list of lupus articles.

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.