Palforzia Level 2 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 that helps reduce the severity of allergic reactions, including life-threatening ones, if you accidentally eat peanuts. It works by gradually training your body's immune system to tolerate small amounts of peanut protein. It's not a cure for peanut allergy, and you must still avoid peanuts in your diet.
How to Use This Medicine
To take this medication correctly, follow your doctor's instructions and read all accompanying information carefully. Take your dose with a meal, at the same time every day, preferably in the evening.
When preparing your dose, do not swallow the capsules or inhale the powder. Instead, open the capsule or sachet and 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 carry two epinephrine auto-injectors and be prepared to use them.
- Continue to strictly avoid peanuts in your diet.
- Administer Palforzia daily, at approximately the same time each day, with food.
- Do not administer Palforzia if you are experiencing an asthma exacerbation, a viral illness, or other acute illness.
- 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 new symptoms to your healthcare provider immediately.
- Enroll in the PALFORZIA REMS program and understand its requirements.
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:
Initial Dose Escalation (IDE) on Day 1 (single day, 5 doses), followed by Up-Dosing (11 levels, 2-week intervals), then Maintenance (300 mg daily). All initial doses and up-dosing must be administered in a healthcare setting.
Condition-Specific Dosing:
Initial Dose Escalation (IDE):
Day 1: 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg (total 7.5 mg). Administered in a healthcare setting with observation.
Up-Dosing:
11 levels, starting at 3 mg and increasing up to 300 mg. Each level administered daily for 2 weeks. The first dose of each new up-dosing level must be administered in a healthcare setting.
Maintenance:
300 mg daily. Administered at home after completing all up-dosing levels.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Approved for ages 4 to 17 years. Dosing regimen is identical to adult dosing (IDE, Up-Dosing, Maintenance).
Adolescent:
Approved for ages 4 to 17 years. Dosing regimen is identical to adult dosing (IDE, 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 indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. It works by gradually desensitizing the immune system to peanut allergens through controlled, increasing exposure. This process is thought to induce a state of desensitization, where the immune system's response to peanut protein is attenuated, reducing the severity of allergic reactions upon accidental exposure.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (oral immunotherapy, not systemically absorbed in a typical pharmacokinetic sense for drug action)
Tmax:
Not applicable
FoodEffect:
Administer with food (e.g., applesauce, yogurt, pudding, water). Do not mix with hot food, carbonated beverages, or foods containing peanut.
Distribution:
Vd:
Not applicable
ProteinBinding:
Not applicable
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable
Clearance:
Not applicable
ExcretionRoute:
Not applicable
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Gradual, over several months of treatment (desensitization is achieved over time with increasing doses).
PeakEffect:
Achieved after completing the up-dosing phase and continuing maintenance therapy.
DurationOfAction:
Maintained with continued daily administration of the maintenance dose.
Confidence:
High
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 professional. Observe patients for at least 60 minutes following administration. 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, 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
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 experience any of the following side effects or any other unusual 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 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
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 experience any of the following side effects or any other unusual 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:
- Difficulty breathing, wheezing, shortness of breath
- Throat tightness, hoarseness
- Hives, itching, flushing, swelling of face/lips/tongue
- Dizziness, lightheadedness, fainting
- Severe abdominal pain, vomiting, diarrhea
- Any signs of a severe allergic reaction
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 advised.
If you consume alcohol, are experiencing an illness such as a viral infection, are fasting, are extremely tired or have missed sleep, are having your menstrual period, or are taking a nonsteroidal anti-inflammatory drug (NSAID) like ibuprofen or naproxen, discuss this with your doctor, as these factors 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 notice 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.
If you consume alcohol, are experiencing an illness such as a viral infection, are fasting, are extremely tired or have missed sleep, are having your menstrual period, or are taking a nonsteroidal anti-inflammatory drug (NSAID) like ibuprofen or naproxen, discuss this with your doctor, as these factors 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 notice 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 (anaphylaxis)
- Worsening of existing allergic symptoms
What to Do:
Seek immediate medical attention. Administer epinephrine if signs of anaphylaxis are present. Call 911 or your local emergency number. Call 1-800-222-1222 (Poison Control).
Drug Interactions
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 confirm diagnosis and establish baseline sensitivity.
Timing: Prior to initiation
Asthma control assessment
Rationale: Uncontrolled asthma is a contraindication. Ensure asthma is well-controlled.
Timing: Prior to initiation and periodically
Eosinophilic esophagitis (EoE) screening
Rationale: EoE is a contraindication. Screen for symptoms.
Timing: Prior to initiation
Routine Monitoring
Observation for allergic reactions (e.g., anaphylaxis)
Frequency: During and after each dose of Initial Dose Escalation and the first dose of each Up-Dosing level.
Target: Absence of severe reactions.
Action Threshold: Any signs of allergic reaction, especially severe symptoms, require immediate intervention (e.g., epinephrine).
Asthma control
Frequency: Regularly throughout treatment.
Target: Well-controlled asthma.
Action Threshold: Worsening asthma symptoms may require temporary interruption or discontinuation of Palforzia.
Symptoms of eosinophilic esophagitis
Frequency: Regularly throughout treatment.
Target: Absence of symptoms (e.g., dysphagia, vomiting, abdominal pain).
Action Threshold: New or worsening symptoms of EoE require evaluation and potential discontinuation.
Symptom Monitoring
- Hives
- Swelling (face, lips, tongue, throat)
- Difficulty breathing (wheezing, shortness of breath)
- Cough
- Throat tightness
- Dizziness
- Lightheadedness
- Fainting
- Abdominal pain
- Vomiting
- Diarrhea
- Flushing
- Itching
- Runny nose
- Sneezing
- Watery eyes
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Palforzia in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Consider the risk of anaphylaxis in the mother and fetus.
Trimester-Specific Risks:
First Trimester:
Potential risk of anaphylaxis to mother, which could impact fetal well-being.
Second Trimester:
Potential risk of anaphylaxis to mother, which could impact fetal well-being.
Third Trimester:
Potential risk of anaphylaxis to mother, which could impact fetal well-being.
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. Consider the risk of anaphylaxis in the mother.
Infant Risk:
L3 - Moderate risk. No human data, but peanut protein is a known allergen. Potential for allergic reaction in the infant if excreted in milk, though unlikely to be significant given the oral route of administration for the mother's treatment.
Pediatric Use
Approved for ages 4 to 17 years. Safety and effectiveness in children younger than 4 years have not been established. Dosing is the same as for adults.
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, 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 strict peanut avoidance.
- Epinephrine auto-injectors must be readily available and patients/caregivers trained on their use.
- Initial Dose Escalation and the first dose of each Up-Dosing level MUST be administered in a healthcare setting with anaphylaxis management capabilities.
- Patients should not take Palforzia if they are sick (e.g., viral illness, asthma exacerbation) as this increases the risk of adverse reactions.
- Contraindicated in patients with uncontrolled asthma or eosinophilic esophagitis.
- Adherence to the daily dosing regimen is critical for maintaining desensitization.
- Counsel patients on the importance of avoiding factors that can increase the risk of allergic reactions (e.g., exercise, hot showers, alcohol consumption) around the time of dosing.
Alternative Therapies
- Strict peanut avoidance (standard of care prior to Palforzia)
- Omalizumab (Xolair) - may be used as an adjunct to oral immunotherapy to reduce reactions, but not approved as monotherapy for desensitization.
- Other investigational oral immunotherapies or epicutaneous patch therapies (not yet FDA approved for general use).
Cost & Coverage
Average Cost:
Highly variable, often several thousand dollars per month for the initial phases. per month
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to step therapy and quantity limits)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which 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, we encourage you 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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.