IMPORTANT WARNING:
Peanut (Arachis hypogaea) allergen powder-dnfp may cause severe or life-threatening allergic reactions, including anaphylaxis, at any time during your treatment. Your doctor or nurse will monitor you very closely for at least one hour after your first dose and each time your dose is increased. Tell your doctor if you have had a severe or life-threatening allergic reaction within the last 60 days. Also, tell your doctor if you have or have ever had asthma or other breathing problems; mastocytosis (a blood disorder in which there are too many mast cells [a certain kind of white blood cell]), or heart problems. Your doctor may tell you not to take peanut (Arachis hypogaea) allergen powder-dnfp. If you experience any of the following symptoms, tell your doctor immediately or seek emergency medical care: swelling of your face, lips, tongue, or throat; difficulty breathing or swallowing; rash; hives; itching; flushing; vomiting; diarrhea; stomach pain; dizziness; fainting; fast or irregular heartbeat; or chest pain.
You should know that you are still allergic to peanuts, even if you have not had an allergic reaction after eating a peanut by accident during your treatment with peanut (Arachis hypogaea) allergen powder-dnfp. Do not eat peanuts or peanut products.
The risk of having an allergic reaction may be greater in certain situations. You should not exercise or take a hot bath or shower within 3 hours after you take peanut (Arachis hypogaea) allergen powder-dnfp. You should not take peanut (Arachis hypogaea) allergen powder-dnfp if you have been exercising or if your heart is beating fast; you should wait until you have cooled down and your heart is beating normally. Tell your doctor if you are feeling sick, very tired or missing sleep, stressed, if you are having your menstrual period, or if you have skipped a meal.
Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking peanut (Arachis hypogaea) allergen powder-dnfp. The following nonprescription products may increase the risk of having an allergic reaction: ibuprofen (Advil, Motrin) or aspirin. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking peanut (Arachis hypogaea) allergen powder-dnfp. Do not start any of these medications while taking peanut (Arachis hypogaea) allergen powder-dnfp without discussing with your healthcare provider.
Your doctor will prescribe injectable epinephrine for you to have at home in case you have a severe allergic reaction after you take peanut (Arachis hypogaea) allergen powder-dnfp. Keep your automatic injection devices with you or available at all times so that you will be able to inject epinephrine quickly when a severe allergic reaction begins.
Because of the risk of anaphylaxis with this medication, peanut (Arachis hypogaea) allergen powder-dnfp is available only through a special restricted distribution program called the Palforzia Risk Evaluation and Mitigation Strategy (REMS) Program. You, your doctor, and your pharmacy must be enrolled in the Palforzia REMS program before you can receive this medication. Your doctor will give you more information about the program, will have you sign an enrollment form, and will answer any questions you have about the program and your treatment with peanut (Arachis hypogaea) allergen powder-dnfp.
Keep all appointments with your doctor.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with peanut (Arachis hypogaea) allergen powder-dnfp. and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) {or the manufacturer's website} to obtain the Medication Guide.
Talk to your doctor about the risks of taking peanut (Arachis hypogaea) allergen powder-dnfp.