Palforzia Level 5 Capsules
WARNING: Allergic reactions have happened with this drug. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.The first dose and all dose increases will be given in a doctor's office or other healthcare setting.Your doctor will give you another drug (epinephrine) to use in case of an allergic reaction. Someone else may have to give you the shot. Be sure you and other people who may need to give the shot know how and when to use it. Certain drugs may make epinephrine not work as well or raise the chance of side effects. This includes some drugs used to treat depression, heart problems, or high blood pressure. There are many drugs that interact with epinephrine. Talk with your doctor or pharmacist to make sure it is safe to take epinephrine with all of your drugs.Do not take this drug if you have very bad asthma or asthma that is not controlled. @ COMMON USES: It is used to help with allergies caused by peanuts. This drug is not for use to treat an allergic reaction.
Drug Class
Allergen immunotherapy
Pharmacologic Class
Allergen extract
Pregnancy Category
Not available
FDA Approved
Jan 2020
DEA Schedule
Not Controlled
Overview
What is this medicine?
Palforzia is a medicine made from peanut protein. It's used for children and teenagers (ages 4-17) who have a confirmed peanut allergy. The goal of Palforzia is to help your body become less sensitive to peanuts over time, so that if you accidentally eat a small amount of peanut, you might have a less severe allergic reaction. It is NOT a cure for peanut allergy, and you must continue to avoid peanuts in your diet.
How to Use This Medicine
To take this medication correctly, follow your doctor's instructions and read all accompanying information carefully. Take your dose with a meal, at the same time every day, preferably in the evening.
When preparing your dose, do not swallow the capsules or inhale the powder. Instead, open the capsule or sachet and sprinkle the contents onto a small amount of soft food, such as applesauce, yogurt, or pudding. Mix the medication with the food thoroughly, but do not mix it with any liquids. Take your dose immediately after mixing, and do not store any leftover mixture for future use.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start to feel better. After administering your dose, discard any remaining medication and wash your hands.
If you have a scheduled appointment with your doctor to adjust your dosage, do not take your dose on that day.
To store this medication, keep it in the refrigerator or at room temperature. If you miss a dose, contact your doctor for guidance on what to do next.
When preparing your dose, do not swallow the capsules or inhale the powder. Instead, open the capsule or sachet and sprinkle the contents onto a small amount of soft food, such as applesauce, yogurt, or pudding. Mix the medication with the food thoroughly, but do not mix it with any liquids. Take your dose immediately after mixing, and do not store any leftover mixture for future use.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start to feel better. After administering your dose, discard any remaining medication and wash your hands.
If you have a scheduled appointment with your doctor to adjust your dosage, do not take your dose on that day.
To store this medication, keep it in the refrigerator or at room temperature. If you miss a dose, contact your doctor for guidance on what to do next.
Lifestyle & Tips
- Maintain a strict peanut-avoidant diet.
- Always carry at least two epinephrine auto-injectors and know how to use them.
- Do not take Palforzia if you are sick (e.g., with a fever, viral infection, or uncontrolled asthma exacerbation).
- Avoid strenuous exercise, hot showers, or alcohol consumption immediately before or after taking Palforzia, as these can increase the risk of allergic reactions.
- Take Palforzia at approximately the same time each day, preferably with a meal or snack.
- Do not open, chew, or crush the capsules. Swallow them whole or sprinkle the powder on a small amount of soft food (e.g., applesauce, yogurt, pudding, water) and consume immediately.
- Report any allergic reactions or side effects to your healthcare provider immediately.
Available Forms & Alternatives
Available Strengths:
- Palforzia Level 4 Capsules
- Palforzia Level 3 Capsules
- Palforzia Level 5 Capsules
- Palforzia Level 6 Capsules
- Palforzia 4-17yr Escalation Dose Pk
- Palforzia Level 1 Capsules
- Palforzia Level 8 Capsules
- Palforzia Level 9 Capsules
- Palforzia Level 2 Capsules
- Palforzia Level 11 (titration) Pow
- Palforzia Level 11 (maintenance)pow
- Palforzia Level 10 Capsules
- Palforzia Level 7 Capsules
Dosing & Administration
Adult Dosing
Standard Dose:
Not approved for this age group.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Approved for patients aged 4 through 17 years. Treatment consists of three phases: Initial Dose Escalation (IDE), Up-Dosing, and Maintenance. All doses must be administered in a healthcare setting with immediate access to epinephrine and personnel trained to manage anaphylaxis.
**Initial Dose Escalation (IDE):** Administered on Day 1, typically 5 doses over several hours, starting at 0.5 mg and increasing to 6 mg.
**Up-Dosing:** Consists of 11 increasing dose levels (3 mg, 6 mg, 12 mg, 20 mg, 32 mg, 50 mg, 80 mg, 120 mg, 160 mg, 200 mg, 240 mg, 300 mg). Each level is taken daily for 2 weeks before advancing to the next. The first dose of each up-dosing level must be administered in a healthcare setting.
**Maintenance:** 300 mg daily. This dose is taken daily for long-term management.
Adolescent:
Approved for patients aged 4 through 17 years. Dosing regimen is the same as for children (see 'child' section).
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended; not studied.
Moderate:
No specific dose adjustment recommended; not studied.
Severe:
No specific dose adjustment recommended; not studied.
Dialysis:
Not applicable; not studied.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended; not studied.
Moderate:
No specific dose adjustment recommended; not studied.
Severe:
No specific dose adjustment recommended; not studied.
Pharmacology
Mechanism of Action
Palforzia is an oral immunotherapy (OIT) product containing peanut allergen powder. Its mechanism of action involves exposing the immune system to increasing amounts of peanut protein, which is thought to induce desensitization. This process leads to a reduction in the severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. The exact immunological changes involve modulation of T-cell and B-cell responses, and alterations in IgE and IgG4 antibody levels, leading to a blunted allergic response.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable in the traditional pharmacokinetic sense for an allergen product.
Tmax:
Not applicable.
FoodEffect:
Administer with food (e.g., applesauce, yogurt, pudding, water) to facilitate ingestion and reduce local reactions. Do not mix with hot food or beverages.
Distribution:
Vd:
Not applicable.
ProteinBinding:
Not applicable.
CnssPenetration:
Not applicable.
Elimination:
HalfLife:
Not applicable.
Clearance:
Not applicable.
ExcretionRoute:
Not applicable.
Unchanged:
Not applicable.
Pharmacodynamics
OnsetOfAction:
Gradual, over several months of treatment (initial dose escalation, up-dosing, and reaching maintenance phase).
PeakEffect:
Achieved after reaching and consistently maintaining the 300 mg daily dose.
DurationOfAction:
Ongoing as long as maintenance therapy is continued. Efficacy may wane if treatment is discontinued.
Safety & Warnings
BLACK BOX WARNING
RISK OF ANAPHYLAXIS. Palforzia can cause life-threatening allergic reactions, including anaphylaxis. Palforzia is available only through a restricted program called the Palforzia REMS Program. Palforzia must be administered in a healthcare setting equipped to manage anaphylaxis and under the supervision of a healthcare provider experienced in the diagnosis and treatment of allergic diseases.
Side Effects
Urgent 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 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
Additional Side Effects in Children:
Unusual crying
Feeling extremely sluggish or 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 or any other unusual symptoms, 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
Reporting Side Effects
This list is not exhaustive, and you may experience other 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.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you 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
Additional Side Effects in Children:
Unusual crying
Feeling extremely sluggish or 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 or any other unusual symptoms, 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
Reporting Side Effects
This list is not exhaustive, and you may experience other 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.
Seek Immediate Medical Attention If You Experience:
- Signs of anaphylaxis (difficulty breathing, wheezing, hives, swelling, dizziness, vomiting, diarrhea)
- Severe or persistent stomach pain, nausea, or vomiting
- Persistent itching or swelling in the mouth or throat
- Worsening asthma symptoms
Before Using This Medicine
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 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 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 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.
Precautions & Cautions
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 conditions 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, 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. 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.
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. 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.
Overdose Information
Overdose Symptoms:
- Severe allergic reaction, including anaphylaxis
- Exacerbation of existing allergic symptoms
What to Do:
Seek immediate medical attention. Administer epinephrine if signs of anaphylaxis are present. Call 911 or your local emergency number. Contact Poison Control at 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Confirmed diagnosis of peanut allergy
Rationale: Palforzia is indicated only for patients with confirmed peanut allergy.
Timing: Prior to initiation of treatment.
Asthma control assessment
Rationale: Uncontrolled asthma is a contraindication to Palforzia. Asthma must be well-controlled prior to and during treatment.
Timing: Prior to initiation and regularly throughout treatment.
Eosinophilic esophagitis (EoE) screening
Rationale: Active EoE is a contraindication to Palforzia.
Timing: Prior to initiation.
Routine Monitoring
Observation for allergic reactions
Frequency: For at least 60 minutes after initial dose escalation and the first dose of each up-dosing level.
Target: Absence of significant allergic symptoms.
Action Threshold: Any signs of allergic reaction (e.g., urticaria, angioedema, respiratory distress, gastrointestinal symptoms) require immediate assessment and management, including epinephrine administration if indicated.
Asthma symptoms and control
Frequency: Regularly, especially before and after dosing.
Target: Well-controlled asthma.
Action Threshold: Worsening asthma symptoms or uncontrolled asthma may require temporary discontinuation or dose adjustment of Palforzia.
Gastrointestinal symptoms (e.g., abdominal pain, vomiting, diarrhea)
Frequency: Daily, especially after dosing.
Target: Absence of severe or persistent GI symptoms.
Action Threshold: Persistent or severe GI symptoms may indicate an adverse reaction or potential EoE, requiring evaluation and possible treatment modification.
Symptom Monitoring
- Anaphylaxis (difficulty breathing, wheezing, hives, swelling of face/lips/tongue/throat, dizziness, lightheadedness, rapid weak pulse, nausea, vomiting, diarrhea, abdominal pain)
- Oral pruritus (itching in mouth/throat)
- Urticaria (hives)
- Angioedema (swelling under the skin)
- Rhinitis (runny nose, sneezing)
- Conjunctivitis (red, itchy eyes)
- Abdominal pain
- Nausea
- Vomiting
- Diarrhea
- Cough
- Dyspnea (shortness of breath)
- Wheezing
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Palforzia in pregnant women. 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.
Trimester-Specific Risks:
First Trimester:
Not established.
Second Trimester:
Not established.
Third Trimester:
Not established.
Lactation
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.
Infant Risk:
Not established.
Pediatric Use
Approved for patients aged 4 through 17 years. Safety and efficacy have not been established in children younger than 4 years of age or in adults 18 years of age and older.
Geriatric Use
Safety and efficacy have not been established in geriatric patients (65 years and older). Not indicated for this population.
Clinical Information
Clinical Pearls
- Palforzia is NOT a cure for peanut allergy; patients must continue to maintain a strict peanut-avoidant diet.
- Epinephrine auto-injectors must always be readily available to the patient and caregivers.
- All initial dose escalation and the first dose of each up-dosing level must be administered in a healthcare setting with immediate access to epinephrine and personnel trained to manage anaphylaxis.
- Patients should not take Palforzia if they have uncontrolled asthma, active eosinophilic esophagitis, or other conditions that increase the risk of adverse reactions.
- Temporary discontinuation or dose reduction may be necessary during illness (e.g., asthma exacerbation, viral infection, fever) or if significant adverse reactions occur.
- Adherence to the daily dosing regimen is crucial for maintaining desensitization. Missed doses or prolonged interruptions may require re-evaluation and potentially restarting at a lower dose.
Alternative Therapies
- Strict peanut avoidance
- Epinephrine auto-injectors (for emergency treatment of allergic reactions)
- Other investigational oral, sublingual, or epicutaneous immunotherapies for food allergy (not yet FDA approved for peanut allergy)
Cost & Coverage
Insurance Coverage:
Specialty tier, often requires prior authorization and may have specific criteria for coverage.
General Drug Facts
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, seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred, as this information is crucial for receiving appropriate care.
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, seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred, as this information is crucial for receiving appropriate care.