Palforzia Level 8 Capsules

Palforzia is an oral immunotherapy that works by desensitizing patients to peanut allergens. It is believed to induce a systemic immunomodulatory effect, shifting the immune response from a Th2-mediated allergic reaction towards a more tolerant Th1-mediated response, and potentially inducing regulatory T cells (Tregs). This leads to an increased threshold for eliciting an allergic reaction to peanut.

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 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 have mild 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 existing health conditions and other drugs. 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 instructed. Certain factors may increase your risk of an allergic reaction, so discuss the following with your doctor: alcohol consumption, illness such as a viral infection, fasting, fatigue or sleep deprivation, 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 the 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.

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

• Antihistamines (may mask early symptoms of an allergic reaction)
• Tricyclic antidepressants (TCAs) (may potentiate cardiovascular effects of epinephrine)

• Hives, itching, flushing
• Swelling of lips, face, tongue, throat
• Wheezing, shortness of breath, difficulty breathing
• Dizziness, lightheadedness, fainting
• Abdominal pain, vomiting, diarrhea
• Feeling of impending doom

There are no adequate and well-controlled studies of Palforzia in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. It is unknown if Palforzia can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

It is not known whether Palforzia is excreted in human milk. 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 indicated for patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy. Safety and effectiveness have not been established in patients younger than 4 years of age. Patients who complete up-dosing may continue maintenance dosing into adulthood.

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, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

• Palforzia is NOT a cure for peanut allergy; patients must continue strict peanut avoidance and carry epinephrine.
• The first dose of each up-dosing level and all doses during the Initial Dose Escalation must be given in a healthcare setting with resuscitation capabilities.
• Patients must be observed for at least 60 minutes after each dose administered in a healthcare setting.
• Poorly controlled asthma is a contraindication to initiating or continuing treatment; ensure asthma is well-controlled.
• Temporary discontinuation or dose reduction may be necessary during illness (e.g., fever, vomiting, uncontrolled asthma) or during periods of increased allergic sensitivity.
• Adherence to the daily dosing schedule is critical for maintaining desensitization. Missed doses may require re-evaluation and potentially restarting at a lower dose.
• Educate patients and caregivers thoroughly on recognizing and managing allergic reactions, including proper use of epinephrine.

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

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, 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 details about the medication taken, the amount consumed, and the time it occurred.