Palforzia (Level 2) 6 mg (1 mg x 6) sprinkle capsule

Generic name:
Peanut allergen powder - oral

Pronunciation
(PEE-nut)

Brand name(s)
Palforzia

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).

To receive peanut allergen powder in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

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.

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.

Nausea, vomiting, abdominal pain, sore throat, or numbness/itching in the mouth may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Get medical help right away if you have any very serious side effects, including:

• trouble swallowing/speaking
• chest pain
• severe stomach pain/vomiting/diarrhea

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction (see also Warning section).

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• breathing disorders (such as asthma)
• stomach/intestinal disorders (such as eosinophilic esophagitis)
• heart problems (such as chest pain, previous heart attack)
• previous allergic reaction
• other immune system problems

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Exercising or taking a hot shower or bath may increase your risk for an allergic reaction to the medication. If you have just exercised or taken a hot shower or bath, you should wait until your body is cool and your heart is beating normally before using this medication. Do not exercise or take a hot shower or bath for at least 3 hours after taking this medication.

Certain conditions may also increase your risk for an allergic reaction to the medication. Medical conditions may include having an illness/infection, having worsening asthma, not getting enough sleep, fasting, or getting your period. Taking nonsteroidal anti-inflammatory drugs-NSAIDs (such as ibuprofen, naproxen) or drinking alcohol may also increase your risk. Ask your doctor beforehand what to do if these conditions occur.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: trouble swallowing/breathing, throat tightness/swelling.

Do not share this medication with others.

If you miss a dose, take it as soon as you remember. If you don't remember until the next day, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up or take more than one dose in a day. If you miss more than 2 doses, call your doctor for advice.

Store in the original packaging in the refrigerator or at room temperature. Do not freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.