Palforzia Level 6 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
Oral immunotherapy; 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 that helps reduce the severity of allergic reactions, including life-threatening anaphylaxis, if you accidentally eat peanuts. It works by gradually training your body's immune system to become less sensitive to peanuts. It's not a cure for peanut allergy, and you still need to avoid peanuts.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
1. Follow Your Doctor's Orders: Take this medication exactly as directed by your doctor. Read all the information provided with your medication and follow the instructions carefully.
2. Take with Food: Take your medication with a meal to help your body absorb it properly.
3. Consistent Timing: Take your medication at the same time every day. It is recommended to take it in the evening.
4. Preparing Your Dose: Do not swallow the capsules or inhale the powder. Instead, open the capsule or sachet and mix the contents with a few spoonfuls of soft food, such as applesauce, yogurt, or pudding. Mix well to ensure the medication is evenly distributed.
5. Important Mixing Instructions: Do not mix the medication with liquids. After mixing with food, take your dose immediately. Do not store the mixture for future use.
6. Continuing Your Medication: Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.
7. Disposing of Leftovers: Throw away any remaining medication after you have taken your dose.
8. Hand Hygiene: Wash your hands after handling the medication.
9. Special Instructions for Doctor's Visits: If you are visiting your doctor for a dose increase, do not take your medication on that day.
Storing and Disposing of Your Medication
Store your medication in a refrigerator or at room temperature.
If you miss a dose, call your doctor to find out what to do.
To ensure you get the most benefit from your medication, follow these steps:
1. Follow Your Doctor's Orders: Take this medication exactly as directed by your doctor. Read all the information provided with your medication and follow the instructions carefully.
2. Take with Food: Take your medication with a meal to help your body absorb it properly.
3. Consistent Timing: Take your medication at the same time every day. It is recommended to take it in the evening.
4. Preparing Your Dose: Do not swallow the capsules or inhale the powder. Instead, open the capsule or sachet and mix the contents with a few spoonfuls of soft food, such as applesauce, yogurt, or pudding. Mix well to ensure the medication is evenly distributed.
5. Important Mixing Instructions: Do not mix the medication with liquids. After mixing with food, take your dose immediately. Do not store the mixture for future use.
6. Continuing Your Medication: Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.
7. Disposing of Leftovers: Throw away any remaining medication after you have taken your dose.
8. Hand Hygiene: Wash your hands after handling the medication.
9. Special Instructions for Doctor's Visits: If you are visiting your doctor for a dose increase, do not take your medication on that day.
Storing and Disposing of Your Medication
Store your medication in a refrigerator or at room temperature.
If you miss a dose, call your doctor to find out what to do.
Lifestyle & Tips
- Always carry at least two epinephrine auto-injectors and know how to use them.
- Continue to strictly avoid peanuts in your diet.
- Do not take Palforzia if you are sick with a fever, vomiting, diarrhea, or have uncontrolled asthma.
- Take Palforzia at approximately the same time each day, with food.
- Do not mix Palforzia with hot foods or beverages, as this can affect the protein structure.
- Avoid strenuous exercise for at least 3 hours after taking Palforzia.
- Avoid hot showers or baths immediately after taking Palforzia.
- Report any allergic reactions or side effects to your doctor 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 applicable (approved for ages 4-17)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Initial Dose Escalation: Day 1, in a healthcare setting, administer 0.5 mg, 1 mg, 2 mg, 3 mg, and 6 mg doses sequentially over several hours. Up-Dosing: 11 increasing dose levels (3 mg to 200 mg). Each level is taken daily for 2 weeks. The first dose of each up-dosing level is administered in a healthcare setting. Maintenance: 300 mg daily. Approved for ages 4-17 years.
Adolescent:
Initial Dose Escalation: Day 1, in a healthcare setting, administer 0.5 mg, 1 mg, 2 mg, 3 mg, and 6 mg doses sequentially over several hours. Up-Dosing: 11 increasing dose levels (3 mg to 200 mg). Each level is taken daily for 2 weeks. The first dose of each up-dosing level is administered in a healthcare setting. Maintenance: 300 mg daily. Approved for ages 4-17 years.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended as systemic absorption is not expected to be significant.
Moderate:
No specific adjustment recommended as systemic absorption is not expected to be significant.
Severe:
No specific adjustment recommended as systemic absorption is not expected to be significant.
Dialysis:
No specific adjustment recommended as systemic absorption is not expected to be significant.
Hepatic Impairment:
Mild:
No specific adjustment recommended as systemic absorption is not expected to be significant.
Moderate:
No specific adjustment recommended as systemic absorption is not expected to be significant.
Severe:
No specific adjustment recommended as systemic absorption is not expected to be significant.
Pharmacology
Mechanism of Action
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 desensitizing the immune system to peanut allergens through repeated, controlled exposure. The exact immunological mechanisms are not fully understood but are thought to involve a shift in the immune response from a Th2-mediated allergic response towards a more tolerogenic Th1-mediated response, including changes in T-cell populations (e.g., increased regulatory T cells) and antibody profiles (e.g., increased peanut-specific IgG4, decreased IgE). This process aims to reduce the likelihood and severity of allergic reactions upon accidental peanut exposure.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (allergen, not systemically absorbed as intact drug)
Tmax:
Not applicable
FoodEffect:
Must be taken with food. Do not mix with hot foods or beverages.
Distribution:
Vd:
Not applicable
ProteinBinding:
Not applicable
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable
Clearance:
Not applicable
ExcretionRoute:
Not applicable
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Desensitization develops gradually over weeks to months with consistent dosing.
PeakEffect:
Achieved after completing the up-dosing phase and continuing maintenance therapy.
DurationOfAction:
Maintained with continued daily maintenance therapy.
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
ANAPHYLAXIS: Palforzia can cause anaphylaxis, which may be life-threatening. 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 patients must be observed for at least 60 minutes following administration. Patients must have epinephrine auto-injector(s) available for immediate use at all times. Do not administer Palforzia to patients with uncontrolled asthma. See full prescribing information for complete boxed warning.
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 right away:
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 immediately 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 or any other symptoms that bother you or do not go away, contact your doctor:
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 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 right away:
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 immediately 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 or any other symptoms that bother you or do not go away, contact your doctor:
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 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:
- Hives or rash
- Swelling of the face, lips, tongue, or throat
- Difficulty breathing, wheezing, or shortness of breath
- Dizziness or fainting
- Rapid heart rate
- Severe stomach pain, vomiting, or diarrhea
- Feeling of warmth or flushing
- 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 conditions to ensure safe treatment:
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 diseases 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 treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
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 diseases 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 treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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.
If you consume alcohol, have an illness such as a viral infection, are fasting, are extremely tired or have missed sleep, are experiencing your menstrual period, or are taking a nonsteroidal anti-inflammatory drug (NSAID) like ibuprofen or naproxen, discuss these factors with your doctor, as they may increase the risk of an allergic reaction.
Avoid taking 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 subside before taking the medication.
If you have asthma and experience difficulty breathing or notice that your asthma is becoming more challenging to control, contact your doctor immediately.
It is crucial to inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
If you consume alcohol, have an illness such as a viral infection, are fasting, are extremely tired or have missed sleep, are experiencing your menstrual period, or are taking a nonsteroidal anti-inflammatory drug (NSAID) like ibuprofen or naproxen, discuss these factors with your doctor, as they may increase the risk of an allergic reaction.
Avoid taking 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 subside before taking the medication.
If you have asthma and experience difficulty breathing or notice that your asthma is becoming more challenging to control, contact your doctor immediately.
It is crucial to inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You and your doctor will need 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
What to Do:
Seek immediate emergency medical attention. Administer epinephrine if signs of anaphylaxis are present. Call 911 or your local emergency number. For general overdose information, call Poison Control at 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Uncontrolled asthma
- Eosinophilic esophagitis or other eosinophilic gastrointestinal disease
Major Interactions
- Beta-blockers (may exacerbate anaphylaxis and interfere with epinephrine treatment)
- ACE inhibitors (may increase risk of angioedema)
Moderate Interactions
- Antihistamines (may mask early symptoms of allergic reaction)
- Oral corticosteroids (may affect immune response, use with caution)
Monitoring
Baseline Monitoring
Comprehensive allergy history and physical examination
Rationale: To confirm diagnosis of peanut allergy and assess suitability for treatment.
Timing: Prior to initiation of therapy
Spirometry (for patients with asthma)
Rationale: To ensure asthma is well-controlled, as uncontrolled asthma is a contraindication.
Timing: Prior to initiation and periodically during treatment
Peanut-specific IgE and/or skin prick test
Rationale: To confirm peanut allergy diagnosis.
Timing: Prior to initiation
Routine Monitoring
Observation for allergic reactions (especially during initial dose escalation and up-dosing)
Frequency: During and after each dose administered in a healthcare setting (initial dose escalation, first dose of each up-dosing level)
Target: Absence of severe allergic reactions
Action Threshold: Any signs of allergic reaction require immediate assessment and management, including epinephrine administration if indicated.
Asthma control assessment
Frequency: Regularly, especially before each up-dosing visit
Target: Well-controlled asthma
Action Threshold: Poorly controlled asthma requires temporary discontinuation or delay of dosing.
Adherence to daily dosing regimen
Frequency: At follow-up visits
Target: Consistent daily dosing
Action Threshold: Missed doses may require re-evaluation and potential re-initiation at a lower dose.
Symptom Monitoring
- Hives
- Swelling (angioedema)
- Difficulty breathing (wheezing, shortness of breath)
- Throat tightness
- Dizziness or lightheadedness
- Vomiting
- Diarrhea
- Abdominal pain
- Oral itching or tingling
- Flushing
- Feeling of impending doom
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Palforzia in pregnant women. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies have not been conducted.
Trimester-Specific Risks:
First Trimester:
Limited data, potential risk unknown.
Second Trimester:
Limited data, potential risk unknown.
Third Trimester:
Limited data, potential risk unknown.
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:
Unknown. Monitor breastfed infants for signs of allergic reactions.
Pediatric Use
Approved for use in patients aged 4 through 17 years. Safety and effectiveness have not been established in patients younger than 4 years of age.
Geriatric Use
Clinical studies of Palforzia did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Safety and effectiveness have not been established in geriatric patients.
Clinical Information
Clinical Pearls
- Palforzia is NOT a cure for peanut allergy; strict peanut avoidance must continue.
- 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 trained personnel to manage anaphylaxis.
- Patients must always carry at least two epinephrine auto-injectors.
- Dosing must be interrupted if the patient experiences a significant allergic reaction, has uncontrolled asthma, or is ill (e.g., fever, vomiting, diarrhea). Re-initiation may require starting at a lower dose.
- Do not mix Palforzia with hot foods or beverages, as heat can denature the peanut protein and alter its effect.
- Patients should avoid strenuous exercise or hot showers/baths for at least 3 hours after taking Palforzia, as these activities can increase the risk of allergic reactions.
Alternative Therapies
- Strict peanut avoidance (standard of care for peanut allergy)
- Epinephrine auto-injectors (for emergency treatment of anaphylaxis)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand dollars per month per month
Insurance Coverage:
Specialty Tier (requires prior authorization, may have high co-pays/coinsurance)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, 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 when you first receive your medication and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
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 detailed information, 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 and 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 when you first receive your medication and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
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 detailed information, 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 and care.