Palforzia Level 10 Capsules

Palforzia is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. It works by inducing desensitization to peanut allergens through repeated, controlled exposure to increasing amounts of peanut protein. This process is thought to modulate the immune response, shifting it from a Th2-mediated allergic response (characterized by IgE production and mast cell/basophil activation) towards a more Th1-mediated response, increasing IgG4 antibodies, and potentially inducing T-regulatory cells, thereby reducing the severity of allergic reactions upon subsequent accidental peanut exposure.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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 when 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 for advice:

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 you experienced, including any symptoms that occurred.
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 change the dosage 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 conditions or activities may increase your risk of an allergic reaction. Therefore, discuss the following with your doctor: alcohol consumption, illness such as viral infections, fasting, fatigue or lack of sleep, menstrual periods, or the use of nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.

To minimize potential risks, do not take this medication within 3 hours before or after exercising or taking a hot shower or bath. If you have recently exercised or taken a hot shower or bath and are experiencing 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.

It is crucial to discuss your pregnancy status or plans with your doctor, as well as any breast-feeding intentions. This will enable a thorough discussion about the benefits and risks of this medication to both you and your baby.

• Uncontrolled asthma
• Eosinophilic esophagitis or other eosinophilic gastrointestinal disease
• Known hypersensitivity to any Palforzia excipients

• Beta-blockers (may exacerbate anaphylaxis and interfere with epinephrine treatment)
• Angiotensin-converting enzyme (ACE) inhibitors (may increase risk of anaphylaxis)
• Antihistamines (may mask symptoms of allergic reaction, but may be used for symptom management)
• Omalizumab (Xolair) - concurrent use has not been studied, potential for altered immune response

• Systemic corticosteroids (may suppress immune response, potentially affecting efficacy)
• Immunosuppressants (may suppress immune response, potentially affecting efficacy)

• Anaphylaxis (difficulty breathing, wheezing, hives, swelling, dizziness, rapid heart rate, severe abdominal pain, vomiting, diarrhea, feeling of impending doom)
• Gastrointestinal symptoms (abdominal pain, nausea, vomiting, diarrhea)
• Respiratory symptoms (cough, shortness of breath, wheezing, chest tightness)
• Skin reactions (hives, itching, flushing, angioedema)
• Oral symptoms (oral itching, tingling, swelling of lips/tongue/throat)

There are no adequate and well-controlled studies of Palforzia in pregnant women. Animal reproduction studies have not been conducted. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. The clinical significance of IgE-mediated allergic reactions in pregnant women is unknown.

There are no data on the presence of peanut allergen 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.

Approved for patients aged 4 through 17 years. Safety and effectiveness have not been established in patients younger than 4 years of age. The dosing regimen is the same as for adults.

Clinical studies of Palforzia did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Palforzia is not typically used in this population.

• Palforzia is NOT a cure for peanut allergy; patients must continue strict peanut avoidance and carry epinephrine.
• The first dose of Initial Dose Escalation and the first dose of each Up-Dosing level MUST be administered in a healthcare setting with anaphylaxis management capabilities.
• Patients must be observed for at least 60 minutes after administration of doses in the healthcare setting.
• Missed doses or prolonged interruptions in treatment may require re-initiation at a lower dose under medical supervision.
• Patients should take Palforzia with food to help mitigate gastrointestinal symptoms.
• Uncontrolled asthma and eosinophilic esophagitis are absolute contraindications.

• Strict peanut avoidance (standard of care prior to OIT)
• Epinephrine auto-injectors (for emergency treatment of allergic reactions)
• Antihistamines (for symptomatic relief of mild allergic reactions)
• Corticosteroids (for severe allergic reactions)
• Omalizumab (Xolair) - an anti-IgE antibody, not approved for peanut allergy but used off-label in some cases or in clinical trials for food allergy.

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.

In the event of a suspected overdose, it's crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the type and amount of medication taken, as well as the time it was taken.