Is Palforzia approved by the FDA?
Yes, Palforzia is FDA approved. The U.S. Food and Drug Administration (FDA) approved Palforzia on January 31, 2020. This approval marked a significant advancement in the management of peanut allergies, offering a new therapeutic option for those affected.
What is Palforzia?
Palforzia, a peanut allergen extract, is used to help reduce the severity of allergic reactions, including anaphylaxis, when someone accidentally consumes peanuts. However, it is not a treatment for allergic reactions that have already started.
Key Points:
- Target Group: Palforzia is intended for use in individuals aged 4 years and older who have been diagnosed with a peanut allergy.
- Special Program: The medication is available only under a special program that requires patients to be registered and understand the associated risks and benefits.
Usage Instructions
Palforzia should be taken exactly as prescribed by a doctor. The initial dose and any dose increases must be administered in a healthcare setting under medical supervision to monitor for any adverse reactions. The medication is taken orally, mixed with a small amount of food like applesauce, yogurt, or pudding, and should not be mixed with liquids.
Dosing Information
Initial Dose Escalation (Ages 4 to 17):
- Single doses of 0.5 mg, 1 mg, 1.5 mg, 3 mg, and 6 mg taken on a single day under healthcare supervision.
- Followed by a series of escalating doses administered under similar supervision, each for a duration of two weeks until the maintenance dose is reached.
Maintenance Dose:
- 300 mg taken orally daily to maintain the effect.
Side Effects
Common side effects of Palforzia include:
- Itching or burning in the mouth
- Coughing, wheezing, or trouble breathing
- Tightness or irritation in the throat
- Rash, itchy skin
- Stomach pain, nausea, vomiting
Severe side effects requiring immediate medical attention include:
- Chest discomfort, wheezing, trouble breathing
- Swelling of the face, lips, eyes, or tongue
- Severe stomach pain, vomiting, or diarrhea
Warnings and Precautions
Palforzia can cause severe or life-threatening allergic reactions. Patients must have injectable epinephrine on hand at all times while using Palforzia and should seek emergency medical help if they experience any signs of a severe allergic reaction.
Contraindications:
- Uncontrolled asthma
- Problems with the esophagus or digestive tract caused by high eosinophil levels
Conclusion
Palforzia represents an important development in the treatment of peanut allergies, offering a way to mitigate the severity of allergic reactions in case of accidental exposure. Approved by the FDA on January 31, 2020, it provides a structured, monitored approach to desensitization for individuals with peanut allergies, improving their safety and quality of life.
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