Palforzia Level 3 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 extract, oral immunotherapy
Pharmacologic Class
Allergen, desensitizing 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 reduce the severity of allergic reactions if you accidentally eat peanuts.
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 mix the contents with a small amount of soft food, such as applesauce, yogurt, or pudding. Mix well to ensure the medication is evenly distributed, but do not mix with 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 thoroughly.
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 mix the contents with a small amount of soft food, such as applesauce, yogurt, or pudding. Mix well to ensure the medication is evenly distributed, but do not mix with 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 thoroughly.
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
- Always take Palforzia with a small amount of semi-solid food (e.g., applesauce, yogurt, pudding). Do NOT mix with hot food.
- Take Palforzia at approximately the same time each day.
- Avoid taking Palforzia during or immediately after strenuous exercise, hot showers, or hot baths, as these can increase the risk of a reaction.
- Avoid taking Palforzia if you are sick with a fever, vomiting, or diarrhea, or if you have uncontrolled asthma. Consult your doctor.
- Always carry two epinephrine auto-injectors and know how to use them. Your doctor will train you.
- Continue to avoid peanuts in your diet, as Palforzia does not cure peanut allergy but helps reduce reaction severity.
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:
Maintenance dose: 300 mg daily. Follows initial dose escalation and up-dosing phases.
Condition-Specific Dosing:
Initial Dose Escalation:
Administered on a single day in a healthcare setting. Consists of 5 doses (0.5 mg, 1 mg, 2 mg, 3 mg, 6 mg) given over several hours.
Up-Dosing:
11 increasing doses (3 mg, 6 mg, 12 mg, 20 mg, 30 mg, 40 mg, 80 mg, 120 mg, 160 mg, 200 mg, 240 mg). Each dose taken daily for 2 weeks before increasing. Administered in a healthcare setting for the first dose of each new up-dosing level.
Maintenance:
300 mg daily. Administered at home after successful completion of up-dosing.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Approved for ages 4-17 years. Dosing regimen is identical to adult dosing (initial dose escalation, up-dosing, maintenance).
Adolescent:
Approved for ages 4-17 years. Dosing regimen is identical to adult dosing (initial dose escalation, up-dosing, maintenance).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Dialysis:
No specific adjustment recommended.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Pharmacology
Mechanism of Action
Palforzia is an oral immunotherapy that works by exposing the immune system to increasing amounts of peanut protein. This controlled exposure is thought to induce desensitization, a state where the body's immune response to peanut allergens is attenuated, reducing the severity of allergic reactions upon accidental exposure. The exact mechanisms are not fully elucidated but are believed to involve a shift in T-cell responses (e.g., from Th2 to Th1), induction of regulatory T cells, reduction in peanut-specific IgE, and an increase in peanut-specific IgG4 antibodies.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (immunological effect, not systemic absorption for drug action)
Tmax:
Not applicable
FoodEffect:
Must be mixed with a small amount of semi-solid food (e.g., applesauce, yogurt, pudding) and consumed immediately. Do not mix with hot food.
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 weeks to months of treatment as desensitization develops.
PeakEffect:
Achieved after completing the up-dosing phase and continuing maintenance therapy.
DurationOfAction:
Requires continued daily maintenance dosing to sustain desensitization. If treatment is interrupted, desensitization may wane.
Safety & Warnings
BLACK BOX WARNING
RISK OF ANAPHYLAXIS: PALFORZIA can cause anaphylaxis, which may be life-threatening. Administer PALFORZIA only 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 each dose during initial dose escalation and the first dose of each up-dosing level. PALFORZIA is available only through a restricted program called the PALFORZIA 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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Trouble swallowing or speaking
Pain when swallowing
Heartburn
Chest pain or pressure
Fast heartbeat
Passing out
Dizziness
Flushing
Shortness of breath
Severe diarrhea
Stomach cramps
In children, watch for:
Unusual crying
Feeling sluggish or extremely sleepy
Pulling legs up to the stomach
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor 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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Trouble swallowing or speaking
Pain when swallowing
Heartburn
Chest pain or pressure
Fast heartbeat
Passing out
Dizziness
Flushing
Shortness of breath
Severe diarrhea
Stomach cramps
In children, watch for:
Unusual crying
Feeling sluggish or extremely sleepy
Pulling legs up to the stomach
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor 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:
- Hives, itching, flushing, swelling (especially of the face, lips, tongue, or throat)
- Difficulty breathing, wheezing, shortness of breath, chest tightness
- Dizziness, lightheadedness, fainting
- Nausea, vomiting, abdominal pain, diarrhea
- Rapid or weak pulse
- 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.
Diagnosis of eosinophilic esophagitis or other eosinophilic diseases affecting the stomach or bowel.
* Existing 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 alongside your other treatments 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.
Diagnosis of eosinophilic esophagitis or other eosinophilic diseases affecting the stomach or bowel.
* Existing 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 alongside your other treatments 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 viral infections, fasting, fatigue or lack of sleep, menstrual periods, or taking 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 the medication.
If you have asthma and experience difficulty breathing or a worsening of your asthma symptoms, contact your doctor immediately. Additionally, if you are pregnant, plan to become pregnant, or are breast-feeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
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 the medication.
If you have asthma and experience difficulty breathing or a worsening of your asthma symptoms, contact your doctor immediately. Additionally, if you are pregnant, plan to become pregnant, or are breast-feeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe allergic reaction, potentially anaphylaxis
What to Do:
Seek immediate emergency medical attention. Administer epinephrine if available. Call 911 or your local emergency number. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Major Interactions
- Beta-blockers: May exacerbate anaphylaxis and interfere with the effectiveness of epinephrine used to treat anaphylaxis. Use with caution.
- Angiotensin-converting enzyme (ACE) inhibitors: May increase the risk of severe allergic reactions.
Moderate Interactions
- Antihistamines: May mask symptoms of an allergic reaction, making it difficult to assess the severity of a reaction to Palforzia.
- Corticosteroids (systemic): May mask symptoms of an allergic reaction.
Monitoring
Baseline Monitoring
Diagnosis of peanut allergy
Rationale: Confirm eligibility for treatment.
Timing: Prior to initiation
Baseline peanut-specific IgE and/or skin prick test
Rationale: To establish baseline immunological status, though not used for dosing decisions.
Timing: Prior to initiation
Patient and caregiver education on anaphylaxis recognition and epinephrine auto-injector use
Rationale: Crucial for managing potential severe allergic reactions.
Timing: Prior to initiation and ongoing
Routine Monitoring
Observation for allergic reactions (oral pruritus, GI symptoms, respiratory symptoms, skin reactions, anaphylaxis)
Frequency: During initial dose escalation and first dose of each up-dosing level (in clinic); daily at home after each dose.
Target: Absence of severe reactions.
Action Threshold: Any signs of allergic reaction require immediate assessment; severe reactions require epinephrine and emergency medical attention.
Patient adherence to dosing schedule
Frequency: Regularly at follow-up visits.
Target: Consistent daily dosing.
Action Threshold: Missed doses may require re-evaluation and potential dose reduction.
Review of concomitant medications
Frequency: At each follow-up visit.
Target: Avoidance of medications that may exacerbate reactions or mask symptoms.
Action Threshold: Adjust or avoid interacting medications.
Symptom Monitoring
- Oral pruritus (itching in mouth/throat)
- Nausea, vomiting, abdominal pain, diarrhea
- Urticaria (hives), angioedema (swelling)
- Dyspnea (shortness of breath), wheezing, cough, chest tightness
- Dizziness, lightheadedness, syncope (fainting)
- Hypotension (low blood pressure)
- 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 be considered only if the potential benefit justifies the potential risk to the mother and fetus. The decision should be made in consultation with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Risk unknown. Potential for allergic reactions in the mother, which could indirectly affect the fetus.
Second Trimester:
Risk unknown. Potential for allergic reactions in the mother, which could indirectly affect the fetus.
Third Trimester:
Risk unknown. Potential for allergic reactions in the mother, which could indirectly affect the fetus.
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. Caution should be exercised.
Infant Risk:
Risk unknown. Potential for allergic reactions in the infant if peanut protein is transferred through breast milk, though unlikely to be significant given the small amounts.
Pediatric Use
Approved for children and adolescents aged 4 through 17 years. Safety and effectiveness have not been established in children 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. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Palforzia is NOT a cure for peanut allergy; patients must continue to avoid peanuts in their diet.
- Strict adherence to the dosing schedule is critical. Missed doses may require re-evaluation and potential dose reduction by a healthcare provider.
- The first dose of each new up-dosing level and all doses during the initial dose escalation must be administered in a healthcare setting with immediate access to epinephrine and the ability to manage anaphylaxis.
- Patients should avoid activities that increase the risk of systemic reactions (e.g., strenuous exercise, hot showers/baths, alcohol consumption) for at least 3 hours after dosing.
- Patients should not take Palforzia if they are experiencing an asthma exacerbation, uncontrolled asthma, or any acute illness (e.g., fever, vomiting, diarrhea).
- Educate patients and caregivers thoroughly on recognizing symptoms of anaphylaxis and the proper use of epinephrine auto-injectors.
Alternative Therapies
- Strict peanut avoidance (standard of care prior to OIT)
- Omalizumab (Xolair) - approved as an add-on therapy for food allergy, not as a standalone treatment for desensitization.
- Other investigational oral immunotherapies or sublingual immunotherapies (not FDA-approved for peanut allergy).
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)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, immediately call the poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.