Palforzia Level 11 (maintenance), Palforzia Level 11 (titration)

Peanut Allergen Powder

(pee nut AL er jen pow der)

Palforzia

Allergic reactions have happened with this drug. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor. The first dose and all dose increases will be given in a doctor's office or other healthcare setting. Your doctor will give you another drug (epinephrine) to use in case of an allergic reaction. Be sure you know how and when to use it. Certain drugs may make epinephrine not work as well or raise the chance of side effects. This includes some drugs used to treat depression, heart problems, or high blood pressure. There are many drugs that interact with epinephrine. Talk with your doctor or pharmacist to make sure it is safe to take epinephrine with all of your drugs. Do not take this drug if you have very bad asthma or asthma that is not controlled.

It is used to help with allergies caused by peanuts. This drug is not for use to treat an allergic reaction.

If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. If you ever had a very bad allergic reaction. If you have ever had eosinophilic esophagitis. This is not a list of all drugs or health problems that interact with this drug. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. Follow the diet plan that your doctor told you about. Talk with your doctor if you drink alcohol, have an illness like a viral infection, are fasting, are very tired or have missed sleep, have your menstrual period, or are taking a nonsteroidal anti-inflammatory drug (NSAID) like ibuprofen or naproxen. The risk of an allergic reaction may be raised. Do not take this drug within 3 hours before or 3 hours after you exercise or take a hot shower or bath. If you have exercised or have taken a hot shower or bath and you feel hot, are sweating, or have fast breathing or heartbeat, wait to take this drug until these signs go away. If you have asthma and you have trouble breathing or your asthma gets harder to control, call your doctor right away. Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Trouble swallowing or speaking. Pain with swallowing. Heartburn. Chest pain or pressure, a fast heartbeat, or passing out. Dizziness. Flushing. Shortness of breath. Severe diarrhea. Stomach cramps.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Stomach pain. Upset stomach or throwing up. Itching in the ear, mouth, or tongue. Numbness or tingling in the mouth. Throat irritation. Cough. Runny nose. Sneezing. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. Take with a meal. Take this drug at the same time of day. It is best if this drug is taken in the evening. Do not swallow the capsules or inhale the powder. Open capsule or sachet and empty the contents onto a few spoonfuls of soft food like applesauce, yogurt, or pudding. Mix well. Do not mix with liquids. After mixing, take your dose right away. Do not store for future use. Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well. Throw away any part left over after the dose is given. Wash your hands after use. If you are visiting your doctor for up-dosing, do not take your dose that day.

Call your doctor to find out what to do.

Store in a refrigerator. Do not freeze. Store in original container. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled. If you have any questions about this drug, please talk with the doctor, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.