Saphnelo (anifrolumab-fnia) is a prescription drug used to treat systemic lupus erythematosus. Saphnelo can cause side effects that range from mild to serious. Examples include cold symptoms, infusion reactions, and cough.

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

The active ingredient in Saphnelo is anifrolumab-fnia. (The reason “-fnia” appears at the end of the drug’s name is to show that it’s distinct from similar medications that may be created in the future.) Saphnelo is a biologic drug, which means it’s made from living organisms such as human, animal, virus, or bacteria cells.

Saphnelo comes as a liquid solution for intravenous (IV) infusion (an injection into a vein given over time). It’s typically administered in a doctor’s office, infusion center, or hospital by a healthcare professional.

Keep reading to learn about common, mild, and serious side effects Saphnelo can cause. For a general overview of the drug, including details about its uses, see this article.

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

* To learn more about this side effect, see the “Side effects explained” section below.

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

  • sore throat
  • common cold symptoms
  • upper respiratory tract infection or bronchitis
  • cough
  • infusion reactions*

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 above. See the drug’s prescribing information for details.

* To learn more about this side effect, see the “Side effects explained” section below.

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

If you develop serious side effects while taking 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.

* To learn more about this side effect, see the “Side effects explained” section below.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews the side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Saphnelo, visit MedWatch.

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. You can learn more about possible symptoms in this article.

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.

Get answers to some frequently asked questions about Saphnelo’s side effects.

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

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

  • common cold symptoms
  • upper respiratory tract 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 weight gain were not 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 was not 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.

Learn more about some of the side effects Saphnelo may cause.

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. Serious infections may cause 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 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 of an infection can limit severe illness.

Cancer

Cancer was a rare side effect reported in studies of Saphnelo. Reported cancers include:

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.

Keeping track of side effects

During your Saphnelo treatment, consider taking notes on any side effects you’re having. You can then share this information with your doctor. This is especially helpful when you first start a new drug or combination of treatments.

Your side effect notes can include things such as:

  • what dose of the drug you were receiving when you had the side effect
  • how soon you had the side effect after starting that dose
  • what your symptoms were
  • how your symptoms affected your daily activities
  • what other medications you were taking
  • any other information you feel is important

Sharing notes with your doctor will help them learn more about how Saphnelo affects you. They can then use this information to adjust your treatment plan if needed.

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

Talk with your doctor about your health history before starting Saphnelo. Be sure to tell them if any of the following factors apply to you:

  • 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 medicines, vitamins, herbs, or dietary supplements
  • pregnancy
  • breastfeeding
  • alcohol consumption

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.