Palforzia Level 9 Capsules
WARNING: Allergic reactions have happened with this drug. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.The first dose and all dose increases will be given in a doctor's office or other healthcare setting.Your doctor will give you another drug (epinephrine) to use in case of an allergic reaction. Someone else may have to give you the shot. Be sure you and other people who may need to give the shot know how and when to use it. Certain drugs may make epinephrine not work as well or raise the chance of side effects. This includes some drugs used to treat depression, heart problems, or high blood pressure. There are many drugs that interact with epinephrine. Talk with your doctor or pharmacist to make sure it is safe to take epinephrine with all of your drugs.Do not take this drug if you have very bad asthma or asthma that is not controlled. @ COMMON USES: It is used to help with allergies caused by peanuts. This drug is not for use to treat an allergic reaction.
Drug Class
Allergen immunotherapy
Pharmacologic Class
Oral immunotherapy; Allergen extract
Pregnancy Category
Not assigned; detailed risk summary available
FDA Approved
Jan 2020
DEA Schedule
Not Controlled
Overview
What is this medicine?
Palforzia is a medicine used to help reduce the severity of allergic reactions, including life-threatening reactions like anaphylaxis, that can happen if you accidentally eat peanuts. It works by gradually exposing your body to tiny, increasing amounts of peanut protein. This helps your immune system become less sensitive to peanuts over time, so your body reacts less severely if you accidentally come into contact with them. It's not a cure for peanut allergy, and you still need to avoid peanuts.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
1. Follow Your Doctor's Orders: Take this medication exactly as directed by your doctor. Read all the information provided with your medication and follow the instructions carefully.
2. Take with Food: Take your medication with a meal to help your body absorb it properly.
3. Establish a Routine: Take your medication at the same time every day. It is recommended to take it in the evening.
4. Preparing Your Dose: Do not swallow the capsules or inhale the powder. Instead, open the capsule or sachet and mix the contents with a few spoonfuls of soft food, such as applesauce, yogurt, or pudding. Mix well to ensure the medication is evenly distributed.
5. Important Mixing Instructions: Do not mix the medication with liquids. After mixing with food, take your dose immediately. Do not store the mixture for future use.
6. Continuing Your Medication: Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.
7. Disposing of Leftover Medication: Throw away any leftover medication after each dose.
8. 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 the day of your visit.
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. Preparing Your Dose: Do not swallow the capsules or inhale the powder. Instead, open the capsule or sachet and mix the contents with a few spoonfuls of soft food, such as applesauce, yogurt, or pudding. Mix well to ensure the medication is evenly distributed.
5. Important Mixing Instructions: Do not mix the medication with liquids. After mixing with food, take your dose immediately. Do not store the mixture for future use.
6. Continuing Your Medication: Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.
7. Disposing of Leftover Medication: Throw away any leftover medication after each dose.
8. 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 the day of your visit.
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
- Strictly adhere to the prescribed dosing schedule; do not skip doses or take extra doses.
- Always carry two epinephrine auto-injectors and know how to use them.
- Continue to strictly avoid peanuts in your diet, except for the prescribed Palforzia dose.
- Administer each dose with food (e.g., applesauce, yogurt, pudding) and consume the entire dose within 10 minutes.
- Avoid exercise, hot showers, or alcohol for at least 3 hours after taking a dose.
- Do not take Palforzia if you are experiencing an acute illness (e.g., asthma exacerbation, viral infection, vomiting, diarrhea).
- 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 over 17 years of age.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Approved for ages 4-11 years. Dosing involves three phases: Initial Dose Escalation (single day in healthcare setting), Up-Dosing (11 increasing dose levels, first dose of each level in healthcare setting, then daily at home), and Maintenance (daily at home). The 'Level 9' capsule contains 120 mg of peanut protein, taken daily during the up-dosing phase after successfully completing previous levels.
Adolescent:
Approved for ages 12-17 years. Dosing involves three phases: Initial Dose Escalation (single day in healthcare setting), Up-Dosing (11 increasing dose levels, first dose of each level in healthcare setting, then daily at home), and Maintenance (daily at home). The 'Level 9' capsule contains 120 mg of peanut protein, taken daily during the up-dosing phase after successfully completing previous levels.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended; systemic exposure to intact peanut protein is minimal.
Moderate:
No specific adjustment recommended; systemic exposure to intact peanut protein is minimal.
Severe:
No specific adjustment recommended; systemic exposure to intact peanut protein is minimal.
Dialysis:
No specific considerations; systemic exposure to intact peanut protein is minimal.
Hepatic Impairment:
Mild:
No specific adjustment recommended; systemic exposure to intact peanut protein is minimal.
Moderate:
No specific adjustment recommended; systemic exposure to intact peanut protein is minimal.
Severe:
No specific adjustment recommended; systemic exposure to intact peanut protein is minimal.
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 exposing the patient's immune system to increasing amounts of peanut protein. This controlled exposure leads to a desensitization process, which involves a modulation of the immune response. This includes a shift from a Th2-mediated allergic response towards a Th1-mediated response, induction of regulatory T cells (Tregs), and a decrease in allergen-specific IgE, while increasing allergen-specific IgG4. This process aims to raise the threshold of peanut protein that can trigger an allergic reaction, thereby reducing the severity of reactions to accidental exposures.
Pharmacokinetics
Absorption:
Bioavailability:
Not quantifiable in traditional pharmacokinetic terms; the goal is immune system exposure, not systemic absorption of intact protein.
Tmax:
Not applicable
FoodEffect:
Must be administered with food to reduce gastrointestinal symptoms and potential for systemic reactions.
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:
Desensitization is gradual, occurring over several months of the up-dosing phase.
PeakEffect:
Achieved after completing the up-dosing phase and continuing daily maintenance therapy.
DurationOfAction:
Requires continued daily maintenance therapy to sustain desensitization and protection.
Safety & Warnings
BLACK BOX WARNING
ANAPHYLAXIS: PALFORZIA can cause anaphylaxis, which may be life-threatening. PALFORZIA is available only through a restricted program called the PALFORZIA Risk Evaluation and Mitigation Strategy (REMS) Program. As part of the PALFORZIA REMS Program, PALFORZIA must be administered in a healthcare setting equipped to manage anaphylaxis, and patients must be observed for at least 60 minutes following administration. Patients must be prescribed auto-injectable epinephrine and instructed on its appropriate use. Do not administer PALFORZIA to patients with uncontrolled asthma.
Side Effects
Serious 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 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 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 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 or rash
- Swelling of the face, lips, tongue, or throat
- Difficulty breathing, wheezing, or shortness of breath
- Dizziness or fainting
- Rapid heart rate
- Severe stomach pain, nausea, vomiting, or 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.
Eosinophilic esophagitis or other eosinophilic conditions 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 in conjunction with 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 you experienced, including any symptoms that occurred.
A history of life-threatening reactions to peanuts.
Previous severe allergic reactions.
Eosinophilic esophagitis or other eosinophilic conditions 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 in conjunction with 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 instructed.
Certain situations may increase your risk of an allergic reaction. Be sure to discuss the following with your doctor: alcohol consumption, illnesses like viral infections, fasting, fatigue or lack of sleep, menstrual periods, or the use of nonsteroidal anti-inflammatory drugs (NSAIDs) such as 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 like 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, planning 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.
Certain situations may increase your risk of an allergic reaction. Be sure to discuss the following with your doctor: alcohol consumption, illnesses like viral infections, fasting, fatigue or lack of sleep, menstrual periods, or the use of nonsteroidal anti-inflammatory drugs (NSAIDs) such as 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 like 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, planning 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, including anaphylaxis (as listed above)
What to Do:
If a dose larger than prescribed is taken, or if a dose is taken incorrectly, immediately administer epinephrine if symptoms of an allergic reaction occur. Seek emergency medical attention. Call 911 or your local emergency number. For general overdose information, call a poison control center at 1-800-222-1222.
Drug Interactions
Major Interactions
- Beta-blockers (may blunt response to epinephrine, which is used to treat anaphylaxis)
- Angiotensin-converting enzyme (ACE) inhibitors (may increase risk of angioedema/anaphylaxis)
Moderate Interactions
- Antihistamines (may mask mild allergic symptoms, but not contraindicated for use if needed for other conditions)
Monitoring
Baseline Monitoring
Diagnosis of peanut allergy
Rationale: Confirm eligibility for treatment.
Timing: Prior to initiation of therapy
Baseline peanut-specific IgE and/or skin prick test
Rationale: To confirm allergy and aid in monitoring response.
Timing: Prior to initiation of therapy
Asthma control assessment
Rationale: Poorly controlled asthma is a risk factor for severe reactions.
Timing: Prior to initiation and periodically during therapy
Routine Monitoring
Observation for allergic reactions
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 allergic reaction, especially severe symptoms, require immediate medical attention and epinephrine administration.
Adherence to dosing schedule
Frequency: Ongoing
Target: Consistent daily dosing
Action Threshold: Missed doses or non-adherence may require re-evaluation of treatment plan.
Asthma control
Frequency: Periodically
Target: Well-controlled asthma
Action Threshold: Worsening asthma may necessitate temporary discontinuation or dose adjustment.
Symptom Monitoring
- Oral pruritus
- Abdominal pain
- Nausea
- Vomiting
- Diarrhea
- Urticaria (hives)
- Angioedema (swelling)
- Dyspnea (shortness of breath)
- Wheezing
- Hypotension (low blood pressure)
- Dizziness
- Syncope (fainting)
- Throat tightness
- Difficulty swallowing
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Palforzia in pregnant women. Animal reproduction studies have not been conducted. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
No human data available to assess risk.
Second Trimester:
No human data available to assess risk.
Third Trimester:
No human data available to assess risk.
Lactation
There is no information on the presence of peanut allergen powder 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; potential for allergic reaction in a highly sensitive infant cannot be ruled out, but systemic exposure to intact protein is minimal.
Pediatric Use
Palforzia is approved for use in pediatric patients aged 4 through 17 years. Safety and effectiveness have not been established in children younger than 4 years of age. Close monitoring for allergic reactions is crucial in this population.
Geriatric Use
The safety and effectiveness of Palforzia have not been established in patients 18 years of age and older. It is not indicated for use in geriatric patients.
Clinical Information
Clinical Pearls
- Palforzia is part of a restricted program (REMS) due to the risk of anaphylaxis. It must be administered in a healthcare setting equipped to manage anaphylaxis for initial dose escalation and the first dose of each up-dosing level.
- Patients must always carry two epinephrine auto-injectors and be trained on their use.
- Strict adherence to the dosing schedule is critical for efficacy and safety. Missed doses or interruptions may require re-initiation or dose adjustment.
- Patients should not take Palforzia if they are experiencing an acute illness (e.g., asthma exacerbation, viral infection, vomiting, diarrhea) or have uncontrolled asthma.
- Each dose must be mixed with a small amount of semi-solid food (e.g., applesauce, yogurt) and consumed immediately and completely.
- Avoid activities that may increase systemic absorption or risk of reaction (e.g., exercise, hot showers, alcohol) for at least 3 hours after dosing.
- Palforzia is not a cure for peanut allergy; patients must continue to avoid peanuts in their diet and carry epinephrine.
Alternative Therapies
- Strict avoidance of peanuts (current standard of care)
- Symptomatic treatment of allergic reactions (e.g., antihistamines, corticosteroids, epinephrine auto-injectors)
- Investigational therapies (e.g., other oral immunotherapies, sublingual immunotherapies, epicutaneous patches, biologics like omalizumab in combination with OIT)
Cost & Coverage
Average Cost:
Highly variable; typically several thousand dollars per month for treatment kits. per treatment kit
Insurance Coverage:
Specialty Tier (requires prior authorization, may have high co-pays or co-insurance)
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 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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred.