Palforzia Level 4 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 used to help reduce severe allergic reactions, including anaphylaxis, that can happen if someone with a peanut allergy accidentally eats peanuts. It works by giving you very small, increasing amounts of peanut protein over time to help your body get used to it.
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 save 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 save 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
- Continue to strictly avoid peanuts in your diet.
- Always carry at least two epinephrine auto-injectors and know how to use them.
- Adhere strictly to the prescribed dosing schedule; do not miss doses or take extra doses.
- Administer doses with food as instructed.
- Report any allergic reactions or symptoms to your healthcare provider immediately.
- Avoid taking Palforzia if you have uncontrolled asthma or are feeling unwell (e.g., fever, vomiting, diarrhea, severe asthma exacerbation).
- Inform all healthcare providers (including dentists) that you are taking Palforzia.
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 indicated for adults.
Pediatric Dosing
Neonatal:
Not established. Indicated for patients aged 4 through 17 years.
Infant:
Not established. Indicated for patients aged 4 through 17 years.
Child:
Indicated for patients aged 4 through 17 years. Dosing involves three phases: Initial Dose Escalation, Up-Dosing, and Maintenance. All doses are administered orally. Initial Dose Escalation and the first dose of each Up-Dosing level must be administered in a healthcare setting with the ability to manage severe allergic reactions, including anaphylaxis. Patients must be observed for at least 60 minutes after administration.
Adolescent:
Indicated for patients aged 4 through 17 years. Dosing involves three phases: Initial Dose Escalation, Up-Dosing, and Maintenance. All doses are administered orally. Initial Dose Escalation and the first dose of each Up-Dosing level must be administered in a healthcare setting with the ability to manage severe allergic reactions, including anaphylaxis. Patients must be observed for at least 60 minutes after administration.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended. Pharmacokinetics of peanut allergen powder have not been studied in patients with renal impairment.
Moderate:
No specific dose adjustment recommended. Pharmacokinetics of peanut allergen powder have not been studied in patients with renal impairment.
Severe:
No specific dose adjustment recommended. Pharmacokinetics of peanut allergen powder have not been studied in patients with renal impairment.
Dialysis:
No specific considerations. Pharmacokinetics of peanut allergen powder have not been studied in patients undergoing dialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended. Pharmacokinetics of peanut allergen powder have not been studied in patients with hepatic impairment.
Moderate:
No specific dose adjustment recommended. Pharmacokinetics of peanut allergen powder have not been studied in patients with hepatic impairment.
Severe:
No specific dose adjustment recommended. Pharmacokinetics of peanut allergen powder have not been studied in patients with hepatic impairment.
Pharmacology
Mechanism of Action
Palforzia is an oral immunotherapy that works by exposing the patient to increasing amounts of peanut protein, leading to desensitization. This process is thought to involve immunomodulation, including a shift in the immune response from a Th2-mediated (IgE-driven) allergic response towards a Th1-mediated response, an increase in allergen-specific IgG4 antibodies, and a decrease in allergen-specific IgE antibodies. This desensitization aims to raise the threshold of peanut protein that can trigger an allergic reaction, thereby mitigating the severity of reactions to accidental peanut exposure.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable; not a typical small molecule drug. The clinical effect is mediated by an immune response, not systemic drug levels.
Tmax:
Not applicable; not a typical small molecule drug.
FoodEffect:
Administered with food to reduce gastrointestinal symptoms and potentially slow absorption, but not to alter overall efficacy.
Distribution:
Vd:
Not applicable; not a typical small molecule drug.
ProteinBinding:
Not applicable; not a typical small molecule drug.
CnssPenetration:
Not applicable; not a typical small molecule drug.
Elimination:
HalfLife:
Not applicable; not a typical small molecule drug.
Clearance:
Not applicable; not a typical small molecule drug.
ExcretionRoute:
Not applicable; digested proteins are absorbed as amino acids or peptides.
Unchanged:
Not applicable.
Pharmacodynamics
OnsetOfAction:
Gradual, over weeks to months, as desensitization occurs through the Initial Dose Escalation and Up-Dosing phases.
PeakEffect:
Achieved after reaching and maintaining the maintenance dose, typically after approximately 6 months of treatment.
DurationOfAction:
Ongoing as long as the maintenance dose is continued. The long-term duration of protection after discontinuation is not fully established.
Safety & Warnings
BLACK BOX WARNING
Risk of Anaphylaxis: Palforzia can cause anaphylaxis, which may be life-threatening. Reactions may include anaphylaxis, which can be severe and require immediate medical intervention, including epinephrine. 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. Patients must be observed for at least 60 minutes following administration. Patients must have an epinephrine auto-injector available for immediate use at all times.
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
Most people taking this medication do not experience severe side effects, and some may not have any side effects at all. However, 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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor for medical advice. 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
Most people taking this medication do not experience severe side effects, and some may not have any side effects at all. However, 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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor for medical advice. 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:
- Hives, itching, skin redness or swelling
- Swelling of the lips, face, or throat
- Difficulty breathing, wheezing, shortness of breath
- Dizziness, lightheadedness, fainting
- Rapid heart rate
- Severe stomach pain, vomiting, diarrhea
- Feeling of impending doom
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 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 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.
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 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 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 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, planning 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, 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, planning 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, due to excessive exposure to peanut protein.
What to Do:
Seek immediate emergency medical attention. Administer epinephrine if available. Call 911 or your local emergency number. Follow up with your healthcare provider. Call 1-800-222-1222 for poison control.
Drug Interactions
Contraindicated Interactions
- Uncontrolled asthma
- Eosinophilic esophagitis (EoE) or other eosinophilic gastrointestinal disease
- History of severe allergic reaction to any inactive ingredient in Palforzia
Major Interactions
- Beta-blockers (may exacerbate anaphylaxis and interfere with the effectiveness of epinephrine)
- Antacids, H2-receptor antagonists, proton pump inhibitors (PPIs) (may alter gastric pH, potentially affecting protein digestion and increasing allergen absorption, leading to increased risk of allergic reactions)
Moderate Interactions
- Systemic corticosteroids (may reduce the effectiveness of immunotherapy, but not a direct interaction with Palforzia itself)
- Immunosuppressants (may reduce the effectiveness of immunotherapy)
Monitoring
Baseline Monitoring
Confirmed diagnosis of peanut allergy
Rationale: To ensure appropriate patient selection for oral immunotherapy.
Timing: Prior to initiation of Palforzia treatment.
Asthma control assessment
Rationale: Uncontrolled asthma is a contraindication and a risk factor for severe reactions.
Timing: Prior to initiation and periodically throughout treatment.
Eosinophilic esophagitis (EoE) screening
Rationale: EoE is a contraindication.
Timing: Prior to initiation.
Routine Monitoring
Observation for allergic reactions
Frequency: For at least 60 minutes after administration of Initial Dose Escalation and the first dose of each Up-Dosing level.
Target: Absence of allergic symptoms.
Action Threshold: Any signs or symptoms of allergic reaction (e.g., urticaria, angioedema, wheezing, abdominal pain, anaphylaxis) require immediate intervention.
Availability and proper use of epinephrine auto-injector
Frequency: At every dose administration and for patient/caregiver to carry at all times.
Target: N/A
Action Threshold: Any signs of severe allergic reaction or anaphylaxis.
Asthma control
Frequency: Regularly, especially before and during up-dosing.
Target: Well-controlled asthma.
Action Threshold: Poorly controlled asthma requires temporary cessation or dose adjustment of Palforzia.
Patient adherence to dosing schedule and avoidance of peanut exposure
Frequency: Ongoing.
Target: Consistent adherence.
Action Threshold: Missed doses or significant accidental exposure may require re-evaluation of treatment plan.
Symptom Monitoring
- Oral pruritus (itching in mouth/throat)
- Abdominal pain, cramping, nausea, vomiting, diarrhea
- Urticaria (hives), angioedema (swelling)
- Dyspnea (shortness of breath), wheezing, cough, chest tightness
- Hypotension (low blood pressure), dizziness, syncope (fainting)
- Rhinorrhea (runny nose), nasal congestion, sneezing
- Conjunctivitis (red, itchy eyes)
- Anaphylaxis (severe, life-threatening allergic reaction)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Palforzia in pregnant women. The decision to use Palforzia during pregnancy should be made after careful consideration of the potential benefits and risks. Animal reproduction studies have not been conducted.
Trimester-Specific Risks:
First Trimester:
Risk not established.
Second Trimester:
Risk not established.
Third Trimester:
Risk not established.
Lactation
It is not known whether peanut allergen powder 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:
Risk not established. Caution should be exercised when Palforzia is administered to a nursing woman.
Pediatric Use
Palforzia is indicated for patients aged 4 through 17 years. Safety and effectiveness have not been established in patients younger than 4 years of age.
Geriatric Use
Safety and effectiveness have not been established in patients 18 years of age and older. Palforzia is not indicated for geriatric patients.
Clinical Information
Clinical Pearls
- Palforzia is not a cure for peanut allergy; patients must continue strict peanut avoidance.
- The treatment is designed to mitigate reactions to accidental exposure, not to allow free consumption of peanuts.
- All initial dose escalation and first doses of up-dosing levels must be administered in a healthcare setting due to the high risk of anaphylaxis.
- Patients must always carry at least two epinephrine auto-injectors.
- Uncontrolled asthma is a contraindication and a significant risk factor for severe reactions; asthma must be well-controlled before and during treatment.
- Patients should not take Palforzia if they are experiencing an acute illness (e.g., fever, vomiting, diarrhea) or an asthma exacerbation.
- Compliance with the dosing schedule is critical for efficacy and safety. 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 the proper use of epinephrine.
Alternative Therapies
- Strict peanut avoidance (current standard of care for peanut allergy management)
- Epinephrine auto-injector (for emergency treatment of allergic reactions)
- Other investigational oral immunotherapies or epicutaneous immunotherapies (e.g., Viaskin Peanut patch, currently not FDA approved for this indication in the US)
Cost & Coverage
Average Cost:
High, typically several thousand dollars per month for treatment kits. per treatment kit (e.g., initial dose escalation kit, up-dosing kit, maintenance kit)
Insurance Coverage:
Specialty tier, often requires prior authorization and may have high co-pays or co-insurance.
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.