SAPHNELO contains the active ingredient anifrolumab-fnia, which is a type I interferon receptor antagonist and monoclonal antibody of the IgG1 kappa type. It is formulated as a sterile, preservative-free solution for intravenous injection, with each single-dose vial containing 300 mg of anifrolumab-fnia. Key inactive ingredients include L-histidine, L-histidine hydrochloride monohydrate, L-lysine hydrochloride, polysorbate 80, trehalose dihydrate, and Water for Injection.
How should I use this medication?
This medication is injected into a vein. It is given by your care team in a hospital or clinic setting. Talk to your care team about the use of this medication in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.
Where should I keep my medication?
This medication is given in a hospital or clinic. It will not be stored at home.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
What side effects may I notice from receiving this medication?
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 to your care team if they continue or are bothersome): -Cough -Dizziness -Fatigue -Headache -Nausea -Sore throat
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What should I tell my care team before I take this medication?
They need to know if you have any of these conditions: -Cancer -Infection, especially a viral infection, such as chickenpox, cold sores, or herpes -Recent or upcoming vaccine -An unusual or allergic reaction to anifrolumab, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding
What may interact with this medication?
Do not take this medication with any of the following: -Live virus vaccines This medication may also interact with the following: -Biologic medications, such as adalimumab, certolizumab, etanercept, golimumab, infliximab -Cyclophosphamide -Monoclonal antibodies such as belimumab, ocrelizumab, ofatumumab, rituximab
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medication?
Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick. Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.
Source: This information is sourced from Elsevier Inc.
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Prescription medications affect individuals differently, and what works for one person may not work for another. Always consult your doctor, pharmacist, or other qualified healthcare provider to ensure the information displayed applies to your personal circumstances. Only a licensed healthcare provider can advise you on what is safe and effective for you.
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