Peanut Allergen-dnfp

Lessens the severity of an allergic reaction to peanuts. This medicine is derived from peanuts.

Brand Name(s):

Palforzia Initial Dose Escalation, Palforzia Level 1, Palforzia Level 10, Palforzia Level 2, Palforzia Level 3, Palforzia Level 4, Palforzia Level 5, Palforzia Level 6, Palforzia Level 7, Palforzia Level 8, Palforzia Level 9

When This Medicine Should Not Be Used:

How to Use This Medicine:

Powder

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Your doctor will give you the first dose of this medicine in a hospital or medical facility. You will need to stay for at least 60 minutes to check for unwanted effects. You will also need an epinephrine injection during treatment with this medicine for any allergic reaction that may occur.
• Take this medicine with food, especially in the evening.
• Do not swallow the capsule. Do not inhale the powder.
• To prepare the mixture:
  • Wash your hands before and after preparing the mixture.
  • Empty the contents of the capsule or sachet onto a few spoonfuls of refrigerated or room temperature semisolid food (including applesauce, yogurt, or pudding). Do not use liquid (including milk, water, or juice) to prepare.
  • Mix well.
• Take this medicine together with a no-peanut-diet.
• Do not exercise or have a hot bath or shower within 3 hours after taking this medicine.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store this medicine in the refrigerator. Do not freeze. Keep it in its original packaging until you are ready to use it. Throw away any unused medicine.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how peanut allergen-dnfp works. Tell your doctor if you are using NSAIDs or pain medicines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have asthma, a viral infection, little to no sleep, menstruation, a high metabolism (including redness of the skin, sweating, rapid breathing, fast heartbeat), or other food allergies. Tell your doctor if you are fasting.
• This medicine may cause the following problems:
  • Severe allergic reactions that may be life-threatening (including anaphylaxis)
  • Eosinophilic gastrointestinal disease (including swelling of the esophagus)
• You should not be given this medicine for the first time if you have had a severe allergic reaction (anaphylaxis) within the previous 60 days.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Trouble swallowing, food stuck in the throat, burning in the chest, mouth, or throat, vomiting, heartburn

If you notice these less serious side effects, talk with your doctor:

• Stomach pain, vomiting, nausea, numbness in the mouth

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088