What Is Saphnelo? Saphnelo (anifrolumab-fnia) is a treatment option for moderate to severe systemic lupus erythematosus (SLE), the most common type of lupus.This medication is a monoclonal antibody, which is a human-made protein that can bind to
This medication is a monoclonal antibody, which is a human-made protein that can bind to another protein. Saphnelo, specifically, attaches to subunit 1 of a type 1 interferon (IFN) receptor (binding site). By attaching to the IFN receptor, Saphnelo prevents this binding site from working.
Saphnelo also blocks type 1 IFN—a protein that causes many signs and symptoms of SLE—from binding to its IFN receptor. Saphnelo can reduce inflammation (swelling) and suppress the immune system (the body's defense system).
As a type 1 IFN receptor antagonist, Saphnelo is typically used along with a standard therapy for SLE. SLE standard therapy usually includes one or a combination of antimalarials, such as Plaquenil (hydroxychloroquine), and immunosuppressants, such as Imuran (azathioprine). If you're experiencing worsening active SLE symptoms, then your standard therapy may also include oral (by mouth) corticosteroids, like prednisone. Note that steroids should be slowly stopped over time.
Saphnelo is available as a prescription intravenous (into the vein) infusion during an office visit with your healthcare provider. The Food and Drug Administration (FDA) has not assigned any black box warnings to this medication.
Generic Name: Anifrolumab-fnia
Brand Name(s): Saphnelo
Drug Availability: Prescription
Therapeutic Classification: Type 1 interferon (IFN) receptor antagonist
Available Generically: No, Saphnelo doesn't have an interchangeable biosimilar version
Controlled Substance: N/A
Administration Route: Intravenous (into the vein) infusion
Active Ingredient: Anifrolumab-fnia
Dosage Form(s): Injection solution
Saphnelo is used to treat systemic lupus erythematosus (SLE). SLE is an autoimmune medical condition. In SLE, your immune system (the body's defense system) attacks different parts of your body by mistake.
Symptoms for SLE can vary from person to person, but some common symptoms may include:
While Saphnelo is a treatment option for moderate to severe SLE, it hasn't been studied in people with severe active lupus nephritis or severe active central nervous system (CNS) lupus. Therefore, it isn't recommended for these conditions related to lupus.
Lupus nephritis is a medical condition of the kidneys that's caused by lupus. CNS lupus negatively affects the CNS, which includes the brain and spinal cord.
To receive Saphnelo, you'll need to see your healthcare provider every four weeks. During your office visits, your healthcare provider will inject Saphnelo as an intravenous (into the vein) infusion over 30 minutes.
You can only receive Saphnelo during office visits with your healthcare provider. As a result, you will not need to worry about how to store Saphnelo or how to travel with this medication.
Saphnelo will reach steady levels in your body within 85 days, which is close to three months. Within one year, people with SLE should notice an improvement in symptoms. How long Saphnelo takes to work will vary by person. If you have any questions or concerns, check with your healthcare provider.
Presently, Saphnelo has no off-label uses.
Side effects are possible with Saphnelo.
This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.
Common side effects with Saphnelo may include:
Severe side effects are possible with Saphnelo. Get medical help right away if you're experiencing the following serious side effects:
Long-term side effects with Saphnelo include risks of developing serious infections or cancer.
Saphnelo may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
Your healthcare provider will determine your dosage and administer Saphnelo in their office.
The following modifications (changes) should be kept in mind when using Saphnelo:
Pregnancy: There is limited safety and effectiveness data about Saphnelo in pregnant parents, but there might be a higher risk of fetal exposure to Saphnelo during your third trimester. In animal studies, however, high doses of Saphnelo in cynomolgus monkeys weren't linked to negative effects on the unborn fetus.
If you're receiving Saphnelo during your pregnancy, consider reporting your pregnancy to the pregnancy exposure registry by calling 877-693-9268. You can also have a discussion with your healthcare provider about the benefits and risks of receiving Saphnelo during your pregnancy.
Keep in mind, however, that uncontrolled SLE is linked to preeclampsia, which is a high blood pressure condition during pregnancy. Uncontrolled SLE also raises the risk of the following negative effects on the unborn fetus or newborn baby: premature birth, miscarriage, and neonatal lupus. Neonatal lupus is a condition that usually goes away within six months, but it can have a serious symptom or complication—congenital heart block (abnormal heartbeat or heart rhythm).
Breastfeeding: There is no safety and effectiveness data about Saphnelo in nursing babies. Low amounts of Saphnelo are expected to be present in breast milk and transferred to nursing infants. Therefore, negative effects in nursing babies are unlikely. Until more information is available, however, use caution while nursing.
Children: There is limited safety and effectiveness information about Saphnelo in children.
Older adults over the age of 65 years: Clinical studies did not include a sufficient number of people in this age group to determine whether they respond differently from younger people.
Serious infections: Your healthcare provider will not begin or restart Saphnelo until your infection goes away or you're receiving adequate treatment for your infection.
To receive Saphnelo every four weeks, you will need to see your healthcare provider during office visits. If you miss any of your appointments, reach out to your healthcare provider as soon as possible to reschedule.
If necessary, your healthcare provider can make up for your missed Saphnelo dose by giving you the infusion 14 days before your next scheduled appointment. There should be a minimum of 14 days between infusions.
Try to keep up with your appointments. If you miss too many Saphnelo infusions, the medication might be less effective.
There is limited information available about Saphnelo overdose.
If you think that you're experiencing an overdose or life-threatening symptoms, however, seek immediate medical attention.
If you think you or someone else may have overdosed on Saphnelo, call a healthcare provider or the Poison Control Center (800-222-1222).
If someone collapses or isn't breathing after taking Saphnelo, call 911 immediately.
It is very important that your doctor check your progress closely and at regular visits to make sure this medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.
Tell your doctor if you are pregnant or planning to become pregnant during treatment with this medicine.
Do not have any live vaccines (immunizations) while you are being treated with anifrolumab-fnia. Check with your doctor before having any vaccines.
This medicine may cause serious infections (eg, lung infection, herpes zoster). Check with your doctor right away if you have cough, fever, painful blisters on the trunk of the body, sneezing, or sore throat.
Anifrolumab-fnia may cause infusion reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting, after receiving this medicine.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.
Using this medicine may increase your risk of getting cancer. Talk to your doctor if you have concerns about this risk.
Tell your doctor if you are also receiving other biologic treatments.
Before receiving Saphnelo infusions, talk with your healthcare provider if any of the following applies to you:
Use caution when taking Saphnelo with the following medications:
For more detailed information about medication interactions with Saphnelo, talk with your pharmacist or healthcare provider.
There are a number of medications that treat systemic lupus erythematosus (SLE) by suppressing the immune system. Some of these medications are biologics and others are chemical-based (non-biologics). Since Saphnelo is a biologic that suppresses the immune system, the following medications are most similar to Saphnelo:.
Clinical studies suggest that Benlysta is modestly effective for lupus. Results from Rituxan clinical trials, on the other hand, conflict with several reports and observations of this medication's benefits in the "real world."
As for Saphnelo, clinical trials suggest some benefits for study participants that have a high interferon (IFN) signature. People with high IFN signatures have high amounts of certain proteins that may influence inflammation (swelling) and the immune system (the body's defense system). These high protein levels are present due to the influence of another protein called IFN.
Since Saphnelo hasn't been studied with other biologic medications, combining it with biologics isn't recommended.
Saphnelo isn't typically available at your local retail pharmacy. To receive Saphnelo, you'll need to see your healthcare provider for an office visit.
Saphnelo is a biologic medication. Additionally, Saphnelo doesn't have an "interchangeable biosimilar," which is a term meaning "generic product." As a result, Saphnelo might be expensive without insurance. If cost is a concern, the manufacturer does have the AstraZeneca Access 360 and Co-Pay Savings programs that might be helpful for some people. For eligibility questions, visit the AstraZeneca website or call 844-275-2360.
Clinical trials suggest that Saphnelo may benefit people with a high interferon (IFN) signature. When the FDA approved Saphnelo, however, they didn't specify Saphnelo for only this population with SLE.
Living with systemic lupus erythematosus does have its difficulties. Fortunately, many people with SLE can live long and normal lives. In addition to taking your medications—like Saphnelo, trying the following tips may help you stay healthy:
Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.