Is Anifrolumab approved by the FDA?

Yes, Anifrolumab is FDA approved. The U.S. Food and Drug Administration (FDA) approved Anifrolumab for the treatment of moderate to severe systemic lupus erythematosus (SLE) in adults on July 30, 2021. This approval provides a new option for patients with SLE who are already receiving standard treatment.

Uses and Benefits

Anifrolumab is specifically used to treat adults with moderate to severe systemic lupus erythematosus (SLE). It is designed to be used in conjunction with standard SLE treatments to help manage the symptoms of this autoimmune disease.

Administration and Dosage

Anifrolumab is administered as follows:

• Dosage Form: Intravenous solution (300 mg/2 mL)
• Usual Adult Dose: 300 mg IV over 30 minutes every 4 weeks
• Administration: Given by a healthcare provider, the medication is infused slowly over 30 minutes.

Side Effects

While Anifrolumab is effective, it can cause side effects. Common side effects include:

• Shingles
• Cough or trouble breathing
• Cold symptoms (stuffy nose, sneezing, sore throat)
• Headache, tiredness, dizziness, or nausea

Serious side effects that require immediate medical attention include:

• Allergic reactions (hives, lightheadedness, difficulty breathing, swelling of face or throat)
• Increased susceptibility to infections (fever, chills, muscle aches, painful skin sores, painful urination, diarrhea, stomach pain, cough, shortness of breath)
• Symptoms of herpes zoster (shingles)

Precautions

Before starting treatment with Anifrolumab, consider the following precautions:

• Allergies: Do not use Anifrolumab if allergic to it.
• Infections and Medical Conditions: Inform your doctor about any active or chronic infections, cancer, or previous treatments with biologics or monoclonal antibodies.
• Vaccinations: Ensure all vaccines are up-to-date before starting Anifrolumab. Avoid live vaccines during treatment.
• Pregnancy and Breastfeeding: Discuss with your doctor if you are pregnant, planning to become pregnant, or breastfeeding. The benefits of treating SLE during pregnancy may outweigh potential risks.

Conclusion

Anifrolumab offers a new treatment option for adults with moderate to severe systemic lupus erythematosus (SLE). It is essential to follow the prescribed administration guidelines and take necessary precautions to minimize side effects and ensure effective treatment. Always consult with a healthcare provider for personalized medical advice and treatment plans.

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