Key takeaways

  • Saphnelo (anifrolumab-fnia) is a prescription drug used to treat lupus. The drug can cause mild side effects including cough, sore throat, and upper respiratory infection or bronchitis.
  • Serious side effects of Saphnelo include infection, cancer, and shingles (if you’ve ever had chickenpox).
  • Certain health factors may raise your risk of side effects from Saphnelo or make the drug harmful for you. Examples include frequent infections, previous allergic reactions to Saphnelo, and cancer, chickenpox, or shingles.

Saphnelo is used with other lupus medications to treat moderate to severe systemic lupus erythematosus (SLE) in adults.

Saphnelo comes as a liquid solution for intravenous (IV) infusion (an injection into a vein given over time).

Keep reading to learn about common, mild, and serious side effects Saphnelo can cause. To learn more about Saphnelo, including details about its uses and how it’s given, read this Saphnelo overview.

Some people may experience mild to serious side effects during Saphnelo treatment. Examples of the drug’s commonly reported side effects include:

Mild side effects have been reported with Saphnelo. These include:

  • sore throat
  • common cold symptoms
  • upper respiratory infection or bronchitis
  • cough
  • infusion reactions (see “Tips for managing side effects”)

In most cases, these side effects should be temporary. And some may be easily managed. But if you have symptoms that are ongoing or bothersome, talk with your doctor or pharmacist. And do not stop taking Saphnelo unless your doctor recommends it.

Saphnelo may cause mild side effects other than those listed here. See the drug’s prescribing information for details.

Saphnelo may cause serious side effects. The following list 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 treatment with Saphnelo, 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 some of these side effects, see the “Tips for managing side effects” section.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews the side effects of the medication. Sharing your experience helps make medication safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect during treatment with Saphnelo and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.

Allergic reaction

For some people, Saphnelo can cause a severe allergic reaction, including anaphylaxis and angioedema (giant hives). For this reason, Saphnelo is given in a doctor’s office, hospital, or infusion center by a healthcare professional equipped to handle severe allergic reactions.

In general, symptoms of an allergic reaction can be mild or serious.

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms and can determine whether you should keep taking Saphnelo.

If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Saphnelo, they’ll likely have you switch to a different treatment.

Here are answers to some commonly asked questions about Saphnelo’s side effects.

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

Saphnelo and Benlysta are used to treat SLE. These two drugs have some similar side effects, including:

  • common cold symptoms
  • upper respiratory infection
  • bronchitis
  • serious infection
  • increased risk of cancer
  • IV infusion reactions
  • severe allergic reaction

However, some side effects were reported in Benlysta studies that weren’t reported with Saphnelo. These include:

If you’re considering either medication, talk with your doctor about these side effects. They’ll need to take into account any other health conditions you have or drugs you take. They can then help you make an informed choice.

Does Saphnelo cause weight loss or weight gain?

Weight loss and gain weren’t side effects reported in studies of Saphnelo. Talk with your doctor if you notice significant weight changes while taking this medication. They can check for other conditions or adjust your treatment plan if needed.

Does Saphnelo cause hair loss?

Hair loss wasn’t a side effect reported in Saphnelo studies.

SLE can cause hair loss, and since Saphnelo decreases the symptoms of SLE, it may allow hair to regrow. But this will depend on whether the hair follicles are damaged or destroyed.

There may be things you can do to help make certain Saphnelo side effects more manageable. If you have ongoing, worsening, or bothersome side effects, talk with your doctor or pharmacist. They can suggest tips for managing them or recommend other available treatment options for your condition.

Infusion reactions

Infusion reactions were a common side effect reported in studies of Saphnelo. These can occur during or soon after infusion and may cause symptoms such as:

  • dizziness
  • fatigue
  • nausea
  • vomiting
  • headache

These reactions are usually mild and may go away after a few months of treatment as your body gets used to the drug. While rare, some people need to stop Saphnelo treatment because they’re unable to tolerate the infusion reactions.

What might help

Saphnelo is given in a doctor’s office, hospital, or infusion center by a healthcare professional. They’ll watch for symptoms of an infusion reaction while you receive the drug.

If you experience mild infusion reactions during Saphnelo treatment, the following may help relieve your symptoms:

  • Rest after the infusion.
  • Drink plenty of fluids.
  • Eat a well-balanced diet.

Your doctor may prescribe certain medications to help lower the risk of this side effect during your next infusion. For example, they may prescribe an antihistamine such as diphenhydramine (Benadryl).

If you experience a serious infusion reaction during Saphnelo treatment, your healthcare professional will likely stop the infusion. They’ll also give you treatments for your symptoms and may switch you to a drug other than Saphnelo.

If you have infusion symptoms that are ongoing or bothersome, talk with your doctor or pharmacist.

Serious infection

Serious infections were a common side effect reported in studies of Saphnelo. Symptoms may vary depending on the type of infection, but they may include symptoms such as:

Saphnelo can reduce your immune system’s ability to fight off infection and increase your risk of pneumonia or shingles. Infections may become severe, resulting in hospitalization or even death.

What might help

To help prevent infection, try the following:

  • Wash your hands often.
  • Disinfect commonly used surfaces.
  • Limit close physical contact with people who are sick.
  • Talk with your pharmacist or doctor about preventive vaccines before starting Saphnelo treatment.

If you develop symptoms of an infection, notify your doctor right away, even if you think the symptoms are mild. Early treatment can limit severe illness.

Cancer

Cancer was a rare side effect reported in studies of Saphnelo. Reported cancers include squamous cell skin cancer (nonmelanoma) and breast cancer.

Saphnelo may reduce your immune system’s ability to fight cancer, especially if you have an active case of cancer or have had it in the past.

What might help

To decrease your cancer risk, follow your doctor’s recommendations for age-appropriate cancer screenings. Some examples include:

For questions about recommended cancer screenings, talk with your doctor.

Before starting Saphnelo, talk with your doctor about your health history. Saphnelo can sometimes cause harmful effects in people with certain conditions. Other factors may also affect whether this treatment is right for you.

Be sure to tell them whether any of the following factors apply to you:

  • received a live vaccine in the past 2 weeks
  • active or frequent infections
  • history of chickenpox or shingles
  • history of cancer
  • previous allergic reaction to Saphnelo
  • taking other biologic drugs or monoclonal antibodies (the group of drugs Saphnelo belongs to)
  • taking other prescription or over-the-counter medications, vitamins, herbs, or dietary supplements
  • pregnancy
  • breastfeeding

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.