Palforzia Level 11 (maintenance)pow

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 inducing desensitization to peanut allergens through repeated, controlled exposure to increasing doses of peanut protein. This process is thought to modulate the immune response, shifting from a Th2-mediated allergic response to a more tolerant Th1-mediated response, and potentially inducing regulatory T cells, thereby reducing the severity of allergic reactions upon subsequent peanut exposure.

Serious Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

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, seek medical help right away if you notice:

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 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 conditions affecting the stomach or bowel.
* Heart problems, lung conditions, 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 drugs and health conditions. Never start, stop, or adjust 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 situations may increase your risk of an allergic reaction. 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, 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 inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. Your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.

• Uncontrolled asthma
• Eosinophilic esophagitis (EoE) or other eosinophilic gastrointestinal disease
• History of severe allergic reaction to any inactive ingredient of Palforzia

• Beta-adrenergic blockers (e.g., propranolol): May blunt the response to epinephrine, which is the primary treatment for anaphylaxis. May also worsen bronchospasm in patients with asthma.
• Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the pressor effects of epinephrine.

• Antihistamines (e.g., diphenhydramine, cetirizine): May mask mild allergic reactions, potentially delaying recognition of more severe reactions. Use with caution.
• H2-receptor antagonists (e.g., famotidine): Similar to antihistamines, may mask mild allergic reactions.

• Hives
• Swelling (face, lips, tongue, throat)
• Difficulty breathing, wheezing, shortness of breath
• Dizziness, lightheadedness, fainting
• Rapid heart rate
• Abdominal pain, cramping, nausea, vomiting, diarrhea
• Flushing
• Itching (especially in mouth or throat)
• Runny nose, sneezing, nasal congestion
• Oral allergy syndrome symptoms (itching/tingling in mouth/throat)

There are no adequate and well-controlled studies of Palforzia in pregnant women. Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Peanut proteins are naturally present in the diet.

It is not known whether Palforzia is excreted in human milk. Peanut proteins are naturally present in breast milk from maternal dietary intake. 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 use in children aged 4 through 17 years. Safety and efficacy have not been established in children younger than 4 years of age. The maintenance dose (Level 11, 300 mg) is the same for pediatric patients in the approved age range 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 indicated for this age group.

• Palforzia is NOT a cure for peanut allergy; patients must continue strict peanut avoidance and carry epinephrine.
• The initial dose escalation and 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 the initial dose escalation and first dose of each up-dosing level.
• Adherence to daily dosing is crucial for maintaining desensitization. Missed doses may require re-evaluation by a healthcare provider.
• Patients should avoid taking Palforzia if they are sick (e.g., fever, vomiting, diarrhea) or have uncontrolled asthma, as this increases the risk of adverse reactions.
• Exercise and hot showers/baths should be avoided for at least 3 hours after taking Palforzia due to increased risk of systemic reactions.

• Strict peanut avoidance (standard of care prior to OIT)
• Investigational oral immunotherapies for peanut allergy (e.g., other peanut protein formulations)
• Investigational epicutaneous immunotherapies (e.g., Viaskin Peanut patch)

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 each time you refill your prescription. 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 name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.