Pronunciation:

an-i-FROL-ue-mab - fnia

Brand Names:

• Saphnelo

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Immunological Agent

Pharmacologic—

Anifrolumab

Uses of This Medicine:

Anifrolumab-fnia injection is used to treat moderate to severe systemic lupus erythematosus (SLE) in patients who are also receiving other lupus treatments. It is a monoclonal antibody that changes the immune system to help control lupus symptoms.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of anifrolumab-fnia injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of anifrolumab-fnia injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept
• Adalimumab
• Adenovirus Vaccine, Live
• Alefacept
• Anakinra
• Bacillus of Calmette and Guerin Vaccine, Live
• Brodalumab
• Certolizumab Pegol
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Ebola Zaire Vaccine, Live
• Etanercept
• Golimumab
• Guselkumab
• Infliximab
• Influenza Virus Vaccine, Live
• Ixekizumab
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Natalizumab
• Poliovirus Vaccine, Live
• Risankizumab
• Rituximab
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Sarilumab
• Secukinumab
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Tildrakizumab
• Tocilizumab
• Tofacitinib
• Typhoid Vaccine, Live
• Ustekinumab
• Varicella Virus Vaccine, Live
• Vedolizumab
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cancer, history of—Use with caution. May make this condition worse.

• Central nervous system lupus, severe active or
• Lupus nephritis, severe active—Use is not recommended in patients with these conditions.

• Infection or
• Weak immune system—May decrease your body's ability to fight infection.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. It must be given slowly, so the needle will have to remain in place for at least 30 minutes. It is usually given every 4 weeks.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Missed dose—

Call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

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 increase your risk of serious infections, including lung infections, herpes zoster, or COVID-19. 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Back pain

chest tightness

chills

cough or hoarseness

cough producing mucus

diarrhea

fever

flushing

headache

loss of taste or smell

lower back or side pain

muscle or body pain

nausea and vomiting

painful blisters on the trunk of the body

painful or difficult urination

stuffy or runny nose

trouble breathing

weakness

Less common

Difficulty swallowing

dizziness

fast heartbeat

hives, itching, skin rash

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Ear congestion

loss of voice

muscle aches

sneezing

sore throat

tender, swollen glands in the neck

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.