Peanut (Arachis hypogaea) Allergen Powder-dnfp

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.

Peanut (Arachis hypogaea) allergen powder-dnfp is used to reduce the risk of severe or life-threatening allergic reactions to peanuts in people who are allergic to peanuts. Peanut (Arachis hypogaea) allergen powder-dnfp does not reduce the risk allergic reactions to any other food allergies. Peanut (Arachis hypogaea) allergen powder-dnfp is in a class of medications called oral immunotherapy. It works by gradually decreasing sensitivity to small amounts of peanuts over time.

Peanut (Arachis hypogaea) allergen powder-dnfp comes as a powder contained in capsules or in a foil packet to take by mouth. It is usually taken once a day with food, preferably in the evening. Take peanut (Arachis hypogaea) allergen powder-dnfp at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take peanut (Arachis hypogaea) allergen powder-dnfp exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Peanut (Arachis hypogaea) allergen powder-dnfp must be taken every day for it to be effective.

Initially, you will receive 5 increasing doses of peanut (Arachis hypogaea) allergen powder-dnfp in a single day in a doctor's office. After each of the first 4 doses, your doctor will monitor you for 20 to 30 minutes for any allergic reactions. After the fifth dose, your doctor will monitor you for 60 minutes. If you tolerate the first 5 doses, you will return to the doctor's office the next day to receive your sixth dose. If the sixth dose is tolerated, your doctor may tell you that you can take peanut (Arachis hypogaea) allergen powder-dnfp at that dose for 2 weeks at home.

Your doctor will probably gradually increase your dose, not more than once every 2 weeks. You will need to return to your doctor's office every time the dose of peanut (Arachis hypogaea) allergen powder-dnfp is increased.

Peanut (Arachis hypogaea) allergen powder-dnfp capsules and foil packets should be opened and sprinkled on 2 or 3 spoonfuls of refrigerated or room temperature soft foods such as applesauce, yogurt, or pudding and mixed well. Do not mix the powder with liquids. After mixing peanut (Arachis hypogaea) allergen powder-dnfp, take the medication right away. Do not store peanut (Arachis hypogaea) allergen powder-dnfp after mixing.

Do not swallow the capsules. Do not breathe in the powder.

Wash your hands after you have finished handling peanut (Arachis hypogaea) allergen powder-dnfp capsules and foil packets.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking peanut (Arachis hypogaea) allergen powder-dnfp,

• tell your doctor and pharmacist if you are allergic to any other medications or any of the ingredients in peanut (Arachis hypogaea) allergen powder-dnfp powder. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor if you have or have ever had eosinophilic esophagitis (EoE; a condition that involves high levels of blood cells in the esophagus [tube that connects the mouth to the stomach] that may damage the esophagus) or any other gastrointestinal disease (GI; affecting the stomach or intestines). Your doctor may tell you not to take peanut (Arachis hypogaea) allergen powder-dnfp.
• tell your doctor if you have or have ever had any other medical conditions.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking peanut (Arachis hypogaea) allergen powder-dnfp, call your doctor.
• ask your doctor about the safe use of alcoholic beverages while you are taking peanut (Arachis hypogaea) allergen powder-dnfp. Alcohol can increase the risk that you will have an allergic reaction to peanut (Arachis hypogaea) allergen powder-dnfp.

It is important that you do not eat peanuts or peanut products.

If you miss a dose contact your doctor right away. Do not take a double dose to make up for a missed one.

Peanut (Arachis hypogaea) allergen powder-dnfp may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• runny nose
• cough
• sneezing
• itchy ears
• itching, burning or tingling in the mouth
• nausea

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop taking peanut (Arachis hypogaea) allergen powder-dnfp and call your doctor immediately or get emergency medical treatment:

• trouble swallowing, food getting stuck in your throat, chest pain, heartburn, throat burning, or vomiting

Peanut (Arachis hypogaea) allergen powder-dnfp may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator. Do not freeze.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• hives; flushing; difficulty breathing or swallowing; wheezing; chest pain or tightness; hoarseness or throat tightness; trouble speaking; swelling of your face, lips, eyes, or tongue; or dizziness or fainting
• stomach pain, nausea, or vomiting

Do not let anyone else take your medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Palforzia ^®