Palforzia Level 1 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 desensitization agent
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 to help children and teenagers (ages 4-17) who have a peanut allergy become less sensitive to peanuts. It works by giving you tiny, increasing amounts of peanut protein over time, which helps your body get used to it. This can make your allergic reactions less severe if you accidentally eat peanuts. It's not a cure for peanut allergy, and you still need to avoid peanuts and carry an epinephrine auto-injector.
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. Establish a Routine: Take your medication at the same time every day. It is recommended to take it in the evening.
4. Prepare 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. Continue Taking as Directed: Keep taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel well.
7. Dispose of Leftovers: Throw away any remaining medication after taking your dose.
8. Practice Good 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. Establish a Routine: Take your medication at the same time every day. It is recommended to take it in the evening.
4. Prepare 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. Continue Taking as Directed: Keep taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel well.
7. Dispose of Leftovers: Throw away any remaining medication after taking your dose.
8. Practice Good 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 two epinephrine auto-injectors (e.g., EpiPen, Auvi-Q) at all times and know how to use them.
- Continue to strictly avoid peanuts in your diet, even while on Palforzia. This medication is for accidental exposure, not for eating peanuts freely.
- Administer Palforzia daily at approximately the same time each day, preferably with a meal or snack.
- Do not take Palforzia if you are sick with a fever, vomiting, diarrhea, or have an asthma flare-up. Consult your doctor.
- Avoid strenuous exercise for at least 3 hours after taking Palforzia, as exercise can increase the risk of allergic reactions.
- Avoid hot showers or baths immediately after taking Palforzia.
- Inform all healthcare providers, including dentists, that you are taking Palforzia.
- Wear medical alert identification indicating your peanut allergy and Palforzia treatment.
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. Approved for patients aged 4 through 17 years.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Initial Dose Escalation: Administered on a single day under medical supervision in a healthcare setting. Consists of 5 doses (0.5 mg, 1 mg, 2 mg, 4 mg, 6 mg) given over several hours. Up-Dosing: 11 increasing dose levels (3 mg to 300 mg) administered daily. Each level is taken for approximately 2 weeks before advancing to the next, if tolerated. The first dose of each up-dosing level is administered under medical supervision. Maintenance: 300 mg daily. Administered daily for long-term maintenance.
Adolescent:
Initial Dose Escalation: Administered on a single day under medical supervision in a healthcare setting. Consists of 5 doses (0.5 mg, 1 mg, 2 mg, 4 mg, 6 mg) given over several hours. Up-Dosing: 11 increasing dose levels (3 mg to 300 mg) administered daily. Each level is taken for approximately 2 weeks before advancing to the next, if tolerated. The first dose of each up-dosing level is administered under medical supervision. Maintenance: 300 mg daily. Administered daily for long-term maintenance.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended. Not systemically absorbed.
Moderate:
No specific adjustment recommended. Not systemically absorbed.
Severe:
No specific adjustment recommended. Not systemically absorbed.
Dialysis:
No specific adjustment recommended. Not systemically absorbed.
Hepatic Impairment:
Mild:
No specific adjustment recommended. Not systemically absorbed.
Moderate:
No specific adjustment recommended. Not systemically absorbed.
Severe:
No specific adjustment recommended. Not systemically absorbed.
Pharmacology
Mechanism of Action
Palforzia is an oral immunotherapy 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 amounts of peanut protein. This process is thought to modulate the immune response, shifting it from a Th2-mediated allergic response (IgE-driven) towards a more tolerant Th1-mediated response, involving regulatory T cells and IgG4 antibodies, thereby reducing the severity of allergic reactions upon subsequent accidental peanut exposure.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (not absorbed systemically as an intact protein)
Tmax:
Not applicable
FoodEffect:
Administered with a small amount of semi-solid food (e.g., applesauce, yogurt, pudding) to facilitate ingestion and reduce local irritation. Avoid mixing with hot foods, carbonated beverages, or foods requiring chewing.
Distribution:
Vd:
Not applicable
ProteinBinding:
Not applicable
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable
Clearance:
Not applicable
ExcretionRoute:
Not applicable (digested)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Gradual, over weeks to months of treatment, as desensitization develops.
PeakEffect:
Achieved after completing the up-dosing phase and continuing maintenance therapy.
DurationOfAction:
Maintained with continued daily administration of the maintenance dose.
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
RISK OF ANAPHYLAXIS: PALFORZIA can cause anaphylaxis, which may be life-threatening. Administer the Initial Dose Escalation and the first dose of each Up-Dosing level in a healthcare setting equipped to manage anaphylaxis, and under the observation of a healthcare provider experienced in the diagnosis and treatment of allergic reactions. Observe patients for at least 60 minutes following administration of the Initial Dose Escalation and for at least 30 minutes following the first dose of each Up-Dosing level. PALFORZIA is available only through a restricted program called the PALFORZIA Risk Evaluation and Mitigation Strategy (REMS) Program.
Side Effects
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 with 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.
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 with 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.
Seek Immediate Medical Attention If You Experience:
- Sudden onset of hives or rash
- Swelling of the face, lips, tongue, or throat
- Difficulty breathing, wheezing, shortness of breath
- Dizziness, lightheadedness, fainting
- 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 you experienced, including any symptoms that occurred.
A history of life-threatening reactions to peanuts.
Previous severe allergic reactions.
Diagnosis of eosinophilic esophagitis or other eosinophilic stomach or bowel diseases.
* Presence of 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 in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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 you experienced, including any symptoms that occurred.
A history of life-threatening reactions to peanuts.
Previous severe allergic reactions.
Diagnosis of eosinophilic esophagitis or other eosinophilic stomach or bowel diseases.
* Presence of 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 in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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 situations 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 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 your medication.
If you have asthma and notice difficulty breathing or a worsening of your asthma symptoms, contact your doctor immediately. Additionally, if you are pregnant, plan to become pregnant, or are breastfeeding, 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 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 your medication.
If you have asthma and notice difficulty breathing or a worsening of your asthma symptoms, contact your doctor immediately. Additionally, if you are pregnant, plan to become pregnant, or are breastfeeding, 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 (anaphylaxis)
- Widespread hives or rash
- Significant swelling (angioedema)
- Severe respiratory distress (wheezing, stridor, cyanosis)
- Hypotension, shock
- Gastrointestinal symptoms (severe vomiting, diarrhea)
What to Do:
Seek immediate emergency medical attention. Administer epinephrine auto-injector if available and indicated. Call 911 or your local emergency number. Do not attempt to manage severe reactions at home without medical supervision. Call 1-800-222-1222 for Poison Control if needed for advice on accidental ingestion of a very large amount.
Drug Interactions
Contraindicated Interactions
- Uncontrolled asthma
- Eosinophilic esophagitis
- Other eosinophilic gastrointestinal diseases
Major Interactions
- Beta-blockers (may exacerbate anaphylaxis and interfere with epinephrine treatment)
- Angiotensin-converting enzyme (ACE) inhibitors (may increase risk of anaphylaxis)
Moderate Interactions
- Antihistamines (may mask early symptoms of allergic reaction, but may be used for symptom management)
- Oral corticosteroids (may affect immune response, use with caution)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Comprehensive medical history and physical examination
Rationale: To assess suitability for treatment, identify contraindications (e.g., uncontrolled asthma, eosinophilic esophagitis), and establish baseline health.
Timing: Prior to initiation of treatment
Spirometry (for patients with asthma)
Rationale: To ensure asthma is well-controlled before starting and throughout treatment.
Timing: Prior to initiation and periodically during treatment
Serum IgE levels (peanut-specific and total)
Rationale: To confirm peanut allergy diagnosis and provide baseline immunological markers (though not directly used for dosing adjustments).
Timing: Prior to initiation
Routine Monitoring
Observation for allergic reactions (e.g., anaphylaxis, oral pruritus, abdominal pain, vomiting)
Frequency: During initial dose escalation and first dose of each up-dosing level (in healthcare setting); daily at home.
Target: Absence of severe reactions
Action Threshold: Any signs of systemic allergic reaction or severe local reaction require immediate medical attention and potential epinephrine administration.
Asthma control assessment
Frequency: Regularly throughout treatment, especially before advancing to next dose level.
Target: Well-controlled asthma (e.g., FEV1 > 80% predicted, minimal symptoms)
Action Threshold: Poorly controlled asthma requires temporary cessation or delay of Palforzia until control is re-established.
Adherence to daily dosing regimen
Frequency: At each follow-up visit.
Target: Consistent daily dosing
Action Threshold: Missed doses or non-adherence may require re-evaluation of treatment plan or re-initiation at a lower dose.
Patient/caregiver education on epinephrine auto-injector use
Frequency: Ongoing, at each visit.
Target: Proficient use
Action Threshold: Lack of proficiency requires re-education.
Symptom Monitoring
- Oral pruritus (itching in mouth/throat)
- Dysphagia (difficulty swallowing)
- Abdominal pain, cramping
- Nausea, vomiting, diarrhea
- Urticaria (hives), angioedema (swelling)
- Dyspnea (shortness of breath), wheezing, cough
- Hypotension (low blood pressure), dizziness, syncope (fainting)
- Rhinitis (runny nose), nasal congestion
- Conjunctivitis (red, itchy eyes)
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 not known.
Trimester-Specific Risks:
First Trimester:
Not available
Second Trimester:
Not available
Third Trimester:
Not available
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. Caution should be exercised when Palforzia is administered to a nursing woman.
Infant Risk:
Risk unknown. Peanut protein is known to be excreted in human milk, but the clinical significance of this for a breastfed infant is not known.
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. The dosing regimen is specifically designed for this age group, with careful supervision required due to the risk of anaphylaxis.
Geriatric Use
Safety and effectiveness have not been established in geriatric patients (65 years of age and older). Palforzia is not indicated for this population.
Clinical Information
Clinical Pearls
- Palforzia is NOT a cure for peanut allergy; patients must continue strict peanut avoidance and carry epinephrine.
- The initial dose escalation and the 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 initial dose escalation and 30 minutes after the first dose of each up-dosing level.
- Adherence to the daily dosing schedule is critical. Missed doses may require re-initiation at a lower dose level.
- Patients with uncontrolled asthma should not initiate or continue Palforzia. Asthma must be well-controlled.
- Educate patients and caregivers thoroughly on recognizing and managing allergic reactions, including proper epinephrine auto-injector use.
- Avoid administering Palforzia during illness (fever, vomiting, diarrhea) or during an asthma exacerbation.
- Exercise and hot showers/baths should be avoided for at least 3 hours after dosing due to increased risk of reaction.
Alternative Therapies
- Strict peanut avoidance (standard of care)
- Epinephrine auto-injectors (for emergency treatment of anaphylaxis)
- Omalizumab (Xolair) - an anti-IgE antibody, approved as an add-on therapy for food allergy, including peanut, in certain patients aged 1 year and older.
- Investigational therapies (e.g., other oral immunotherapies, epicutaneous immunotherapy patches, sublingual immunotherapy)
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 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, a patient fact sheet that provides important information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them 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 details about the overdose, including the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides important information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them 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 details about the overdose, including the medication taken, the amount, and the time it occurred.