Palforzia Level 7 Capsules

Palforzia is an oral immunotherapy (OIT) indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. It works by gradually introducing increasing amounts of peanut protein to the immune system, aiming to induce desensitization. This process involves modulating the immune response, shifting from a predominantly IgE-mediated allergic response to a more tolerant state, potentially involving IgG4 antibodies and regulatory T cells, thereby reducing the severity of allergic reactions upon subsequent peanut exposure.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you or your child experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Trouble swallowing or speaking
Pain with swallowing
Heartburn
Chest pain or pressure
Fast heartbeat
Passing out
Dizziness
Flushing
Shortness of breath
Severe diarrhea
Stomach cramps

In children, watch for:
Unusual crying
Feeling sluggish or extremely sleepy
Pulling legs up to the stomach

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you or your child experience any of the following side effects, contact your doctor if they bother you or do not go away:

Diarrhea
Stomach pain
Upset stomach
Vomiting
Itching in the ear, mouth, or tongue
Numbness or tingling in the mouth
Throat irritation
Cough
Runny or stuffy nose
* Sneezing

This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
A history of life-threatening reactions to peanuts.
Previous severe allergic reactions.
Eosinophilic esophagitis or other eosinophilic stomach or bowel diseases.
* Heart problems, lung problems, or mast cell disorders.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to the diet plan recommended by your doctor and continue to avoid peanuts as previously advised. Certain factors may increase your risk of an allergic reaction, so be sure to discuss the following with your doctor: alcohol consumption, illness such as a viral infection, fasting, fatigue or lack of sleep, menstrual period, or use of nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.

To minimize potential risks, avoid taking this medication within 3 hours before or after exercising, or taking a hot shower or bath. If you have exercised or taken a hot shower or bath and experience symptoms such as feeling hot, sweating, or rapid breathing or heartbeat, wait until these symptoms resolve before taking your medication.

If you have asthma and experience difficulty breathing or a worsening of your asthma symptoms, contact your doctor immediately. Additionally, if you are pregnant, plan to become pregnant, or are breast-feeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.

• Uncontrolled asthma
• Eosinophilic esophagitis
• Other eosinophilic gastrointestinal disease

• Beta-blockers (may exacerbate anaphylaxis and interfere with epinephrine's effects)
• Angiotensin-converting enzyme (ACE) inhibitors (may increase risk of anaphylaxis)

• Antihistamines (may mask early symptoms of allergic reaction)
• Systemic corticosteroids (may reduce efficacy of immunotherapy)

• Not available

• Hives
• Swelling (face, lips, tongue, throat)
• Difficulty breathing or wheezing
• Dizziness or fainting
• Rapid heart rate
• Pale or bluish skin
• Severe abdominal pain, vomiting, diarrhea
• Feeling of impending doom

No adequate and well-controlled studies of Palforzia in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies have not been conducted.

No data on the presence of peanut allergen powder in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Palforzia and any potential adverse effects on the breastfed infant from Palforzia or from the underlying maternal condition.

Palforzia is approved for patients 4 through 17 years of age. Safety and effectiveness have not been established in patients younger than 4 years of age. Close monitoring for adverse reactions is crucial in this population.

Safety and effectiveness have not been established in geriatric patients (65 years of age and older). Not typically indicated for this age group.

• Palforzia is NOT a cure for peanut allergy; patients must continue strict peanut avoidance and carry epinephrine.
• All initial dose escalations and the first dose of each up-dosing level MUST be administered in a healthcare setting with anaphylaxis management capabilities.
• Patients should avoid taking Palforzia if they are experiencing illness (e.g., fever, vomiting, diarrhea) or have uncontrolled asthma, as this increases the risk of adverse reactions.
• Administer Palforzia with food to help mitigate gastrointestinal side effects.
• Missed doses or extended breaks in treatment may require re-evaluation by a healthcare provider and potentially restarting at a lower dose.
• The goal of Palforzia is to reduce the severity of reactions to accidental peanut exposure, not to enable unrestricted peanut consumption.

• Strict peanut avoidance (current standard of care)
• Epinephrine auto-injectors (for emergency treatment of anaphylaxis)
• Investigational therapies (e.g., epicutaneous immunotherapy patches, other oral immunotherapies in clinical trials)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information about its safe and effective use. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred.