Warnings:

This product may cause a serious (rarely fatal) allergic reaction. This may occur at any time during treatment. Get medical help right away if you notice any symptoms of a serious allergic reaction, including: flushing, rash, itching/swelling (especially of the face, tongue, throat), severe dizziness, fainting, fast heartbeat, shortness of breath, or trouble breathing. When you take this drug for the first time, and any time your dose is increased, you will need to stay in a health care setting (such as a doctor's office) for at least 60 minutes so your doctor can carefully monitor you and provide medical help if needed.

People with worsening asthma are especially at risk for a serious allergic reaction. If you get worsening asthma symptoms, talk to your doctor right away before taking your dose of this medication.

Your doctor will also prescribe another medication (epinephrine) to use in case you have a serious allergic reaction outside the health care setting. Read the Patient Information Leaflet for this medication provided by your pharmacist. Learn ahead of time when and how to use your brand of epinephrine. If you have to use it, get medical help as soon as you have used it. Also, some medications (including beta blockers such as atenolol) may make epinephrine or other rescue medications not work as well or increase your risk for side effects from these medications. Be sure to tell your doctor about all the drugs you use (including prescription/nonprescription drugs and herbal products).

For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Palforzia REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Warnings:

This product may cause a serious (rarely fatal) allergic reaction. This may occur at any time during treatment. Get medical help right away if you notice any symptoms of a serious allergic reaction, including: flushing, rash, itching/swelling (especially of the face, tongue, throat), severe dizziness, fainting, fast heartbeat, shortness of breath, or trouble breathing. When you take this drug for the first time, and any time your dose is increased, you will need to stay in a health care setting (such as a doctor's office) for at least 60 minutes so your doctor can carefully monitor you and provide medical help if needed.

People with worsening asthma are especially at risk for a serious allergic reaction. If you get worsening asthma symptoms, talk to your doctor right away before taking your dose of this medication.

Your doctor will also prescribe another medication (epinephrine) to use in case you have a serious allergic reaction outside the health care setting. Read the Patient Information Leaflet for this medication provided by your pharmacist. Learn ahead of time when and how to use your brand of epinephrine. If you have to use it, get medical help as soon as you have used it. Also, some medications (including beta blockers such as atenolol) may make epinephrine or other rescue medications not work as well or increase your risk for side effects from these medications. Be sure to tell your doctor about all the drugs you use (including prescription/nonprescription drugs and herbal products).

For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Palforzia REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

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Uses

This medication is used by people with peanut allergy to reduce the severity of an allergic reaction when accidentally exposed to peanuts. People using this medication should continue to avoid eating peanuts.This medication is made from peanuts. It works by making your body less sensitive to small amounts of peanuts. This medication must be used regularly to be effective. It does not work right away to treat an allergic reaction to peanuts.

How to use Palforzia (Level 11 Maintenance) 300 Mg Oral Powder Packet Allergenic Extract-Peanut

See also Warning section.

Read the Medication Guide provided by your pharmacist before you start using this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with a meal as directed by your doctor, usually once daily in the evening. This medication comes in a powder form inside a capsule or a packet. Do not swallow the capsules or inhale the powder. To use this medication, open the capsule(s) or packet and sprinkle the contents on a few spoonfuls of refrigerated or room temperature soft food (such as applesauce, yogurt, pudding). Mix the drug and food together well and then swallow the mixture right away. Do not prepare the mixture with liquid or prepare the mixture ahead of time for later use. Wash your hands after handling the product.

The dosage is based on your medical condition and response to treatment. Be watchful for any side effects after taking the medication, especially during the first 60 minutes after taking it. Your first day of treatment will be in a health care setting (such as a doctor's office) where your doctor will slowly increase your dose of this medication and monitor you in case of a serious reaction. For your second day of treatment, and whenever you start a new dose of this medication (usually every 2 weeks), you will take the medication in a health care setting where you will be monitored for at least 60 minutes in case of a serious reaction. To reduce your risk of side effects, your doctor will raise your dose slowly, and will adjust your dose based on any reactions to the medication. If you are taking one of your doses in the doctor's office, make sure not to take another dose in the evening that day.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition does not get better or if it gets worse, or if you get a serious reaction after taking the medication.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.