Saphnelo Prefilled Syringe

Saphnelo Prefilled Syringe is used to treat moderate to severe systemic lupus erythematosus (SLE or lupus) in adults who are already receiving standard treatment for lupus.

It is not known if Saphnelo Prefilled Syringe works in people with severe active lupus nephritis or central nervous system lupus.

Saphnelo Prefilled Syringe may also be used for reasons not mentioned in this medication guide.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

You should not be treated with Saphnelo Prefilled Syringe if you are allergic to it.

Tell your doctor if you have or have ever had:

• an active, chronic, or recent infection;
• cancer;
• treatment with a biologic medicine or monoclonal antibody; or
• if you are scheduled to receive a vaccine.

Make sure you are up to date on all vaccines before you start using Saphnelo Prefilled Syringe.

Tell your doctor if you are pregnant or plan to become pregnant, or if you are breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of anifrolumab on the baby.

Saphnelo Prefilled Syringe may affect your baby's immune system, but having systemic lupus erythematosus (SLE) during pregnancy may cause complications such as worsened lupus, eclampsia (dangerously high blood pressure), premature birth, miscarriage, or growth problems in the unborn baby. SLE in the mother may also cause lupus or heart problems to develop in the newborn. The benefit of treating SLE may outweigh any risks to the baby.

Not approved for use by anyone younger than 18 years old.

Using Saphnelo Prefilled Syringe may increase your risk of developing cancer. Ask your doctor about your individual risk.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, sweats, muscle aches;
• painful skin sores with warmth or redness;
• urinating more, pain or burning when you urinate;
• diarrhea, stomach pain; or
• cough, shortness of breath.

Saphnelo Prefilled Syringe may cause serious side effects. Call your doctor at once if you have:

• fever, chills, cough with mucus, chest pain, feeling short of breath; or
• symptoms of herpes zoster (shingles)--skin sores or blisters, itching, tingling, burning pain, rash on your face or torso.

Common side effects of Saphnelo Prefilled Syringe may include:

• bronchitis;
• shingles;
• cough;
• cold symptoms such as stuffy nose, sneezing, sore throat; or
• headache, tiredness, dizziness, nausea, or vomiting during or after an infusion.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Saphnelo Prefilled Syringe is given as an infusion into a vein, usually once every 4 weeks. A healthcare provider will give you this injection. The medicine must be given slowly over 30 minutes.

Saphnelo Prefilled Syringe may also be injected under the skin, usually once every week.

Read and carefully follow any Instructions for Use provided with your medicine. If you are prescribed the subcutaneous injection, a healthcare provider may teach you or your caregiver how to properly use Saphnelo Prefilled Syringe. Ask your doctor or pharmacist if you don't understand these instructions.

Prepare a prefilled syringe or autoinjector only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Inject Saphnelo Prefilled Syringe under the skin in the stomach or thigh. A caregiver may also inject the medicine into your upper arm. Do not try to inject yourself in the upper arm. Do not inject within 2 inches of your navel (belly button) or areas where the skin is red, warm, tender, bruised, scaly, hard, scarred, damaged, discolored, or tattooed. Use an injection site at least 1 inch away from your last injection site.

Each prefilled syringe or autoinjector is for one use only. Throw away after one use, even if there is still medicine left inside. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Store the prefilled syringe or autoinjector in the original container in the refrigerator. Protect from light. Do not freeze or shake the medicine.

Take the prefilled syringe or autoinjector out of the refrigerator and let it reach room temperature for 60 minutes before using. Do not warm the medicine with hot water, sunlight, or a microwave.

Saphnelo Prefilled Syringe may also be stored in the original container at room temperature, protected from light for 7 days. Do not return the medicine to the refrigerator. Throw the medicine away after 7 days if you have not used it.

Call your doctor for instructions if you miss an appointment for your Saphnelo Prefilled Syringe infusion. There should be at least 14 days between infusions.

If you are giving yourself the injection: Use the medicine as soon as you remember. Then start a new weekly schedule from that day, or return to your regular schedule if there are at least 3 days between injections. Do not use two doses at one time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Do not get a "live" vaccine. The vaccine may not be effective while you are using Saphnelo Prefilled Syringe. Live vaccines may include measles, mumps, rubella (MMR), varicella (chickenpox), live nasal flu vaccine, and others.

Other drugs may affect Saphnelo Prefilled Syringe, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.

Find detailed information on biosimilars for this medication.