Palforzia Level 11 (titration) Pow
WARNING: Allergic reactions have happened with this drug. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.The first dose and all dose increases will be given in a doctor's office or other healthcare setting.Your doctor will give you another drug (epinephrine) to use in case of an allergic reaction. Someone else may have to give you the shot. Be sure you and other people who may need to give the shot know how and when to use it. Certain drugs may make epinephrine not work as well or raise the chance of side effects. This includes some drugs used to treat depression, heart problems, or high blood pressure. There are many drugs that interact with epinephrine. Talk with your doctor or pharmacist to make sure it is safe to take epinephrine with all of your drugs.Do not take this drug if you have very bad asthma or asthma that is not controlled. @ COMMON USES: It is used to help with allergies caused by peanuts. This drug is not for use to treat an allergic reaction.
Drug Class
Allergen immunotherapy
Pharmacologic Class
Allergen extract
Pregnancy Category
Not available
FDA Approved
Jan 2020
DEA Schedule
Not Controlled
Overview
What is this medicine?
Palforzia is a medicine 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's not a cure, but it helps reduce the severity of allergic reactions if they accidentally eat a small amount of peanut. You take it by mixing the powder with food. It's a long-term treatment that starts with very small doses and gradually increases.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most out of 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 to you and follow the instructions carefully.
2. Take with Food: Take this medication with a meal to help your body absorb it properly.
3. Establish a Routine: Take this 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 empty the contents onto a small amount of soft food, such as applesauce, yogurt, or pudding. Mix well to ensure the medication is evenly distributed. Note: Do not mix the medication with liquids.
5. Take Your Dose Immediately: After mixing the medication with food, take your dose right away. Do not store the mixture for future use.
6. Continue Taking as Directed: Keep taking this medication as instructed by your doctor or healthcare provider, even if you start feeling 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 scheduled to see your doctor for a dose increase, do not take your medication on that day.
Storing and Disposing of Your Medication
Store this 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 out of 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 to you and follow the instructions carefully.
2. Take with Food: Take this medication with a meal to help your body absorb it properly.
3. Establish a Routine: Take this 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 empty the contents onto a small amount of soft food, such as applesauce, yogurt, or pudding. Mix well to ensure the medication is evenly distributed. Note: Do not mix the medication with liquids.
5. Take Your Dose Immediately: After mixing the medication with food, take your dose right away. Do not store the mixture for future use.
6. Continue Taking as Directed: Keep taking this medication as instructed by your doctor or healthcare provider, even if you start feeling 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 scheduled to see your doctor for a dose increase, do not take your medication on that day.
Storing and Disposing of Your Medication
Store this medication in a refrigerator or at room temperature.
If you miss a dose, call your doctor to find out what to do.
Lifestyle & Tips
- Continue strict peanut avoidance in the diet.
- Always carry at least two epinephrine auto-injectors and know how to use them.
- Avoid exercise for at least 3 hours after taking a dose.
- Avoid hot showers or baths for at least 3 hours after taking a dose.
- Avoid alcohol consumption for at least 3 hours after taking a dose.
- Do not take Palforzia if you are sick with a fever, vomiting, or diarrhea, or if your asthma is not well-controlled. Consult your doctor.
- Report any allergic reactions or side effects to your healthcare provider 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 approved for adults (age > 17 years).
Pediatric Dosing
Neonatal:
Not established (approved for ages 4-17 years)
Infant:
Not established (approved for ages 4-17 years)
Child:
Palforzia Level 11 (Up-Dosing Phase): 300 mg (peanut protein) once daily. This dose is administered in a healthcare setting with immediate access to epinephrine and personnel trained to manage anaphylaxis. This is the final dose of the Up-Dosing phase before transitioning to the Maintenance phase.
Adolescent:
Palforzia Level 11 (Up-Dosing Phase): 300 mg (peanut protein) once daily. This dose is administered in a healthcare setting with immediate access to epinephrine and personnel trained to manage anaphylaxis. This is the final dose of the Up-Dosing phase before transitioning to the Maintenance phase.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended as systemic absorption is not expected.
Moderate:
No specific dose adjustment recommended as systemic absorption is not expected.
Severe:
No specific dose adjustment recommended as systemic absorption is not expected.
Dialysis:
No specific considerations as systemic absorption is not expected.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended as systemic absorption is not expected.
Moderate:
No specific dose adjustment recommended as systemic absorption is not expected.
Severe:
No specific dose adjustment recommended as systemic absorption is not expected.
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 gradually introducing increasing amounts of peanut protein to the patient's immune system, aiming to induce desensitization. This process involves immunomodulatory changes, such as a shift from a Th2 to a Th1 immune response, an increase in regulatory T cells, a decrease in allergen-specific IgE, and an increase in allergen-specific IgG4, which collectively reduce the severity of allergic reactions upon subsequent peanut exposure.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (not systemically absorbed as a traditional drug)
Tmax:
Not applicable
FoodEffect:
Must be mixed with a small amount of semi-solid food (e.g., applesauce, yogurt, pudding) and consumed immediately.
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 (desensitization occurs over weeks to months of treatment)
PeakEffect:
Achieved after completion of up-dosing and continued maintenance therapy
DurationOfAction:
Ongoing with continued daily maintenance therapy; effect may wane if treatment is discontinued.
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 Up-Dosing. PALFORZIA is contraindicated in patients with uncontrolled asthma, or with a history of eosinophilic esophagitis or other eosinophilic gastrointestinal disease. Patients must have auto-injectable epinephrine available for immediate use at all times.
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 Up-Dosing. PALFORZIA is contraindicated in patients with uncontrolled asthma, or with a history of eosinophilic esophagitis or other eosinophilic gastrointestinal disease. Patients must have auto-injectable epinephrine available for immediate use at all times.
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 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 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 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, 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 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 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 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
- Tightness in the throat or chest
- Dizziness or feeling faint
- Severe stomach pain, vomiting, or diarrhea
- Rapid heart rate
- Feeling of impending doom
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
A history of life-threatening reactions to peanuts.
Previous severe allergic reactions.
Eosinophilic esophagitis or other eosinophilic stomach or bowel diseases.
* 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 with your other drugs and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
A history of life-threatening reactions to peanuts.
Previous severe allergic reactions.
Eosinophilic esophagitis or other eosinophilic stomach or bowel diseases.
* 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 with your other drugs and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to the diet plan recommended by your doctor and continue to avoid peanuts as previously instructed. Certain factors may increase your risk of an allergic reaction, so be sure to discuss the following with your doctor: alcohol consumption, illness such as a viral infection, fasting, fatigue or sleep deprivation, 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 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 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 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 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)
- Exacerbation of existing allergic symptoms
What to Do:
Seek immediate emergency medical attention. Administer epinephrine if signs of anaphylaxis are present. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Uncontrolled asthma
- Eosinophilic esophagitis or other eosinophilic gastrointestinal disease
- History of severe allergic reaction to any inactive ingredient (e.g., gelatin)
Major Interactions
- Beta-blockers (may exacerbate anaphylaxis or interfere with the effectiveness of epinephrine)
- Angiotensin-converting enzyme (ACE) inhibitors (may increase risk of anaphylaxis)
Moderate Interactions
- Antihistamines (may mask symptoms of allergic reaction, but may be used for symptom management)
- Oral corticosteroids (may reduce efficacy of immunotherapy, but may be used for acute asthma exacerbations)
Monitoring
Baseline Monitoring
Diagnosis of peanut allergy
Rationale: Confirm appropriate patient selection for oral immunotherapy.
Timing: Prior to initiation of Palforzia treatment.
Asthma control assessment
Rationale: Uncontrolled asthma is a contraindication. Asthma must be well-controlled before and during treatment.
Timing: Prior to initiation and regularly throughout treatment.
Eosinophilic esophagitis (EoE) screening
Rationale: EoE is a contraindication. Patients with a history or symptoms suggestive of EoE should be evaluated.
Timing: Prior to initiation.
Patient and caregiver education
Rationale: Ensure understanding of risks, administration, symptom recognition, and proper use of epinephrine.
Timing: Prior to initiation and ongoing.
Routine Monitoring
Observation for allergic reactions
Frequency: For at least 60 minutes after each dose during Initial Dose Escalation and Up-Dosing (including Level 11).
Target: Absence of allergic symptoms or mild, manageable symptoms.
Action Threshold: Any signs of allergic reaction (e.g., urticaria, angioedema, respiratory distress, gastrointestinal symptoms, hypotension) require immediate assessment and management, including epinephrine administration if indicated.
Patient symptom monitoring
Frequency: Daily at home, especially after each dose.
Target: Absence of symptoms or mild, transient symptoms.
Action Threshold: Persistent or worsening symptoms, or any signs of severe reaction, require medical attention.
Epinephrine auto-injector availability
Frequency: Always (patient must carry at least two auto-injectors at all times).
Target: Immediate access.
Action Threshold: Any signs of anaphylaxis.
Asthma symptom review
Frequency: Regularly, especially before each dose.
Target: Well-controlled asthma.
Action Threshold: Worsening asthma symptoms may require temporary discontinuation or dose adjustment.
Symptom Monitoring
- Urticaria (hives)
- Angioedema (swelling of face, lips, tongue, throat)
- Pruritus (itching)
- Flushing
- Nasal congestion
- Rhinorrhea (runny nose)
- Sneezing
- Cough
- Wheezing
- Dyspnea (shortness of breath)
- Chest tightness
- Throat tightness
- Dysphagia (difficulty swallowing)
- Abdominal pain
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Lightheadedness
- Syncope (fainting)
- Hypotension (low blood pressure)
Special Patient Groups
Pregnancy
There are no available data on Palforzia use in pregnant women to inform a drug-associated risk. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
No specific data available.
Second Trimester:
No specific data available.
Third Trimester:
No specific data available.
Lactation
There are no data on the presence of Palforzia in human milk, the effects on the breastfed infant, or the effects on milk production. 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.
Pediatric Use
Approved for use in pediatric patients aged 4 to 17 years. Safety and effectiveness have not been established in pediatric patients younger than 4 years of age. Dosing is weight-independent within the approved age range.
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.
- Each dose of Palforzia during the Initial Dose Escalation and Up-Dosing phases (including Level 11) must be administered in a healthcare setting with immediate access to epinephrine and personnel trained to manage anaphylaxis.
- Patients must be observed for at least 60 minutes after each dose during Initial Dose Escalation and Up-Dosing.
- Patients must always carry at least two epinephrine auto-injectors.
- Doses should be taken at approximately the same time each day, preferably with a meal.
- Do not take Palforzia if you are experiencing an asthma exacerbation, have a fever, or are experiencing vomiting or diarrhea.
- Ensure patients understand the importance of avoiding factors that can increase the risk of allergic reactions (e.g., exercise, hot showers, alcohol) for a period after dosing.
- Uncontrolled asthma and eosinophilic esophagitis are absolute contraindications to Palforzia treatment.
Alternative Therapies
- Strict peanut avoidance (standard of care)
- Epinephrine auto-injectors (for emergency treatment of anaphylaxis)
- Omalizumab (Xolair) - approved as an add-on therapy for food allergy, including peanut, in certain patients (ages 1 year and older) to reduce allergic reactions, including anaphylaxis, that may occur with accidental exposure.
- Investigational therapies (e.g., epicutaneous immunotherapy, sublingual immunotherapy)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand dollars per month per month
Insurance Coverage:
Specialty drug, typically Tier 4 or 5, requiring prior authorization and potentially step therapy.
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 provides crucial information about its safe use. It is vital to read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. 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 appropriate care and treatment.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is vital to read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. 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 appropriate care and treatment.