Saphnelo
Saphnelo (anifrolumab or anifrolumab-fnia) is a newly approved injectable medication used for moderate-to-severe systemic lupus erythematosus (SLE), which is a condition where your immune system attacks your own body. It's given as an infusion through the veins (intravenous, or IV) by a healthcare provider.
What is Saphnelo (anifrolumab)?
What is Saphnelo (anifrolumab) used for?
- Add-on therapy for moderate-to-severe systemic lupus erythematosus (SLE)
How Saphnelo (anifrolumab) works
Saphnelo (anifrolumab) is a biologic medication. It attaches to certain proteins in your immune system that play a role in SLE. By attaching to these proteins, Saphnelo (anifrolumab) stops them from turning on and blocks inflammatory pathways in your body.
Drug facts
Side effects of Saphnelo (anifrolumab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Upper respiratory infection (34%)
- Bronchitis (11%)
- Infusion-related reactions (headache, dizziness, nausea; 9%)
- Herpes zoster infection (shingles; 6%)
- Cough (5%)
Less Common Side Effects
- Other respiratory infections
- Allergic reactions
Saphnelo (anifrolumab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe infection: confusion, fever, difficulty breathing, weakness, cough, sweating, chills, stomach pain, diarrhea, burning sensation when you urinate
- Serious allergic reaction (anaphylaxis): difficulty breathing, tightness in the throat, hives, itching, fast heartbeat, nausea, dizziness, lightheadedness, swelling in the face or tongue
The following Saphnelo (anifrolumab) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Cough
- Dizziness
- Fatigue
- Headache
- Nausea
- Sore throat
Pros and cons of Saphnelo (anifrolumab)
Pros
- Works well to improve moderate-to-severe SLE
- Given only once per month
Cons
- Needs to be given by a healthcare provider
- Can't be used alone; only approved as an add-on to standard therapy
- Brand-name only, which can be expensive
Pharmacist tips for Saphnelo (anifrolumab)
- Mark your appointments to see your provider and receive Saphnelo (anifrolumab) on your calendar. This can help make sure you don't miss any doses. If you accidentally miss a dose, talk with your provider right away about rescheduling your appointment.
- Possible infusion-related reactions include headache, fatigue, dizziness, nausea, and vomiting. These reactions are typically mild to moderate in severity. Let your provider know if they become bothersome or untolerable.
- Before getting any vaccines, let your provider know you're receiving Saphnelo (anifrolumab), because it might interfere with your response to live vaccines (e.g., FluMist Quadrivalent (live attenuated influenza vaccine), MMR (measles, mumps, and rubella vaccine). Your provider can make sure any vaccines you receive during your Saphnelo (anifrolumab) treatment are safe for you.
Common questions about Saphnelo (anifrolumab)
No. You'll need to receive Saphnelo (anifrolumab) at a clinic, your provider's office, hospital, or infusion center. Your healthcare provider is trained to properly prepare the medication and administer it you as an IV infusion. They'll monitor you for side effects and any infusion-related reactions.
Saphnelo (anifrolumab) can be used in people aged 18 to 69 years. It's not known if the medication is safe or works well for children younger than 18 years old, since it hasn't been studied in this age group. Talk to your child's provider about available treatment options for children. Additionally, Saphnelo (anifrolumab) wasn't well studied in people of older ages, so it's not known if they can respond differently to the medication than younger people. Ask your provider if you have any concerns.
Both medications are biologics that work well to treat SLE, but Benlysta (belimumab) can also treat lupus nephritis (a kidney problem caused by SLE). Some initial studies suggest that Saphnelo (anifrolumab) might work better than Benlysta (belimumab) in treating moderate-to-severe SLE symptoms. Additionally, they are both available as IV infusions (injections through the veins), but Benlysta (belimumab) is also available as an injection under the skin (subcutaneous, or SC) that can be given at home. While Saphnelo (anifrolumab) isn't approved for use in children, Benlysta (belimumab) can be used in those older than 5 years with the IV infusion.
While taking Saphnelo (anifrolumab), you can still receive certain vaccines, including most forms of the flu shot. But, you shouldn't receive live vaccines, because it's not known how Saphnelo (anifrolumab) will affect your body's response to the vaccine. Examples of live vaccines include FluMist Quadrivalent (live attenuated influenza vaccine) that's given as a nasal spray and MMR (measles, mumps, and rubella vaccine) injection. Before starting Saphnelo (anifrolumab), discuss with your provider to make sure you're up-to-date with all vaccines. Once you've started treatment, be sure to let your providers know you're taking Saphnelo (anifrolumab) before you receive any vaccines.
There isn't enough information available to say if Saphnelo (anifrolumab) is safe to take during pregnancy. In animal studies, the medication didn't cause harm to pregnant mothers and their unborn babies. If you're pregnant and taking Saphnelo (anifrolumab), it's recommended that you enroll in the manufacturer's (AstraZeneca) pregnancy registry by calling 1-877-693-9268. This registry will monitor your and your baby's health. If your provider recommends that you avoid getting pregnant during treatment, make sure to use effective birth control while taking Saphnelo (anifrolumab).
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Risks and warnings for Saphnelo (anifrolumab)
Saphnelo (anifrolumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Serious infections
- Risk factors: Long-term or recurrent infection | Other conditions that raise your risk of infection | Taking medications that weaken your immune system
Saphnelo (anifrolumab) can affect your immune system and your body's ability to fight off infections. This can raise your risk of serious and sometimes life-threatening infections. During clinical studies, the most common serious infections reported with Saphnelo (anifrolumab) use were pneumonia, bronchitis, and infections affecting the skin. Your risk is higher if you have certain infections that keep coming back, have other conditions that make it harder for you to fight infections, or take other medications that weaken your immune system (e.g., oral corticosteroids).
If you develop any symptoms of an infection (e.g., fever, chills, weakness, cough, difficulty breathing, sweating) while taking Saphnelo (anifrolumab), contact your provider. You might have to stop taking Saphnelo (anifrolumab) so your body can fight the infection.
Serious allergic reactions
Serious allergic reactions to Saphnelo (anifrolumab) are possible, including life-threatening reactions like anaphylaxis (e.g., closing of the throat). If you notice a choking sensation, difficulty breathing, dizziness, sweating, nausea, or swelling around your eyes, lips, or tongue or at any point during your Saphnelo (anifrolumab) treatment, get medical attention right away.
Saphnelo (anifrolumab) dosage
Typical dosage for Saphnelo (anifrolumab)
The typical dose is 300 mg injected into the veins (IV) once every month. It's given as an infusion over 30 minutes.
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