Palforzia 4-17yr Escalation Dose Pk
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
Oral Immunotherapy
Pharmacologic Class
Allergen Extract
Pregnancy Category
Not assigned (Risk Summary available)
FDA Approved
Jan 2020
DEA Schedule
Not Controlled
Overview
What is this medicine?
Palforzia is a medicine used to help reduce allergic reactions, including severe ones, that can happen if you accidentally eat peanuts. It's not a cure for peanut allergy, and you still need to avoid peanuts and carry emergency epinephrine.
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 to you and follow the instructions carefully.
2. Take with Food: Take your medication with a meal to help your body absorb it properly.
3. Consistent Schedule: 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. Do not mix with liquids.
5. Take Immediately: After mixing, take your dose right away. Do not store the mixture for future use.
6. Continue as Directed: Keep taking your medication as instructed by your doctor or healthcare provider, even if you start to feel well.
7. Dispose of Leftovers: Throw away any remaining medication after you have taken your dose.
8. Hand Hygiene: Wash your hands after handling the medication.
9. Special Instructions for Doctor's Visits: If you are visiting your doctor for a dose increase, do not take your medication on that day.
Storing and Disposing of Your Medication
Store your medication in a refrigerator or at room temperature.
If you miss a dose, call your doctor to find out what to do.
To ensure you get the most benefit from your medication, follow these steps:
1. Follow Your Doctor's Orders: Take this medication exactly as directed by your doctor. Read all the information provided to you and follow the instructions carefully.
2. Take with Food: Take your medication with a meal to help your body absorb it properly.
3. Consistent Schedule: 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. Do not mix with liquids.
5. Take Immediately: After mixing, take your dose right away. Do not store the mixture for future use.
6. Continue as Directed: Keep taking your medication as instructed by your doctor or healthcare provider, even if you start to feel well.
7. Dispose of Leftovers: Throw away any remaining medication after you have taken your dose.
8. Hand Hygiene: Wash your hands after handling the medication.
9. Special Instructions for Doctor's Visits: If you are visiting your doctor for a dose increase, do not take your medication on that day.
Storing and Disposing of Your Medication
Store your medication in a refrigerator or at room temperature.
If you miss a dose, call your doctor to find out what to do.
Lifestyle & Tips
- Always carry two epinephrine auto-injectors and know how to use them.
- Continue strict avoidance of peanuts in your diet.
- Do not take Palforzia if you are sick with a fever, vomiting, diarrhea, or uncontrolled asthma. Consult your doctor.
- Avoid strenuous exercise, hot showers, or baths immediately before or after taking Palforzia, as these can increase the risk of allergic reactions.
- Take Palforzia at the same time each day, preferably with food (e.g., applesauce, yogurt).
- Never open the capsule or mix the powder with hot food or liquids.
- Report any allergic symptoms immediately to your healthcare provider.
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 (18 years and older)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Initial Dose Escalation (IDE): Administered on Day 1 in a healthcare setting. Doses are 0.5 mg, 1 mg, 1.5 mg, 2 mg, 3 mg (total 5 doses, 20-30 min apart). Up-Dosing (UD): 11 dose levels, each taken daily for 2 weeks. Doses are 6 mg, 12 mg, 20 mg, 32 mg, 48 mg, 80 mg, 120 mg, 160 mg, 200 mg, 240 mg, 300 mg. Each new dose level of Up-Dosing must be initiated in a healthcare setting. Maintenance: 300 mg daily.
Adolescent:
Initial Dose Escalation (IDE): Administered on Day 1 in a healthcare setting. Doses are 0.5 mg, 1 mg, 1.5 mg, 2 mg, 3 mg (total 5 doses, 20-30 min apart). Up-Dosing (UD): 11 dose levels, each taken daily for 2 weeks. Doses are 6 mg, 12 mg, 20 mg, 32 mg, 48 mg, 80 mg, 120 mg, 160 mg, 200 mg, 240 mg, 300 mg. Each new dose level of Up-Dosing must be initiated in a healthcare setting. Maintenance: 300 mg daily.
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 inducing desensitization to peanut allergens. It involves the controlled, gradual exposure to increasing amounts of peanut protein, which is thought to modulate the immune response, leading to a reduction in allergic reactions upon accidental exposure to peanuts. The exact immunological mechanisms are not fully elucidated but involve changes in T-cell responses, IgE and IgG4 antibody levels, and mast cell/basophil reactivity.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (not absorbed systemically in a traditional pharmacokinetic sense)
Tmax:
Not applicable
FoodEffect:
Administer with food (e.g., applesauce, yogurt, pudding, water) to ensure consistent delivery and reduce gastrointestinal symptoms. Do not mix with hot food.
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 (after completing Up-Dosing and reaching maintenance)
PeakEffect:
Achieved after completing the Up-Dosing phase and continuing daily maintenance therapy
DurationOfAction:
Sustained with continued daily maintenance therapy; desensitization may wane if treatment is discontinued
Safety & Warnings
BLACK BOX WARNING
Risk of Anaphylaxis: Palforzia can cause life-threatening allergic reactions (anaphylaxis). Reactions may be severe and require epinephrine. Palforzia is available only through a restricted program called the Palforzia REMS Program. Patients must be prescribed auto-injectable epinephrine and be instructed on its appropriate use. Initial Dose Escalation and the first dose of each Up-Dosing level must be administered in a healthcare setting equipped to manage anaphylaxis, and patients must be observed for at least 60 minutes.
Side Effects
Serious 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 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
Additional Serious Side Effects in Children:
Unusual crying
Feeling extremely sluggish or sleepy
Pulling legs up to the stomach
Other Possible Side Effects
Most people taking this medication do not experience serious side effects, and some may have only minor side effects. However, if you experience any of the following side effects and they 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
Reporting Side Effects
This is not a complete list of possible side effects. If you have questions or concerns about side effects, 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 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
Additional Serious Side Effects in Children:
Unusual crying
Feeling extremely sluggish or sleepy
Pulling legs up to the stomach
Other Possible Side Effects
Most people taking this medication do not experience serious side effects, and some may have only minor side effects. However, if you experience any of the following side effects and they 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
Reporting Side Effects
This is not a complete list of possible side effects. If you have questions or concerns about side effects, 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 feeling faint
- Nausea, vomiting, or stomach cramps
- Sudden feeling of warmth or flushing
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 health conditions and medications with your doctor. Provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking.
Natural products and vitamins you are using.
Any health problems you have.
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
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 health conditions and medications with your doctor. Provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking.
Natural products and vitamins you are using.
Any health problems you have.
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
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.
Certain factors may increase your risk of an allergic reaction. Therefore, 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.
It is crucial to discuss your pregnancy status or plans with your doctor, as well as whether you are breast-feeding. This will enable you to have a thorough discussion about the benefits and risks of this medication to both you and your baby.
Certain factors may increase your risk of an allergic reaction. Therefore, 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.
It is crucial to discuss your pregnancy status or plans with your doctor, as well as whether you are breast-feeding. This will enable you to have a thorough discussion about the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe allergic reaction (anaphylaxis) including widespread hives, angioedema, respiratory distress, hypotension, gastrointestinal symptoms.
What to Do:
Seek immediate emergency medical attention. Administer epinephrine if available. Call 911 or your local emergency number. Management is supportive, focusing on treating anaphylaxis symptoms. Call 1-800-222-1222 for Poison Control.
Drug Interactions
Major Interactions
- Beta-blockers (may exacerbate anaphylaxis and interfere with epinephrine's effect)
- ACE inhibitors (may increase risk of angioedema during allergic reactions)
Moderate Interactions
- Antihistamines (may mask early symptoms of an allergic reaction, but may be used for symptom management)
- Omalizumab (Xolair) - concurrent use has been studied and may be considered, but requires careful monitoring.
Monitoring
Baseline Monitoring
Comprehensive medical history and physical examination
Rationale: To assess overall health, identify contraindications (e.g., uncontrolled asthma, eosinophilic esophagitis), and establish baseline allergic status.
Timing: Prior to initiation of treatment
Spirometry (for patients with asthma)
Rationale: To ensure asthma is well-controlled before starting treatment, as uncontrolled asthma is a contraindication.
Timing: Prior to initiation of treatment
Baseline peanut-specific IgE and/or skin prick test
Rationale: To confirm peanut allergy diagnosis (though not used for dosing decisions).
Timing: Prior to initiation of treatment
Routine Monitoring
Observation for allergic reactions
Frequency: During Initial Dose Escalation (IDE) and initiation of each Up-Dosing level (minimum 60 minutes post-dose)
Target: Absence of severe allergic symptoms
Action Threshold: Any signs of allergic reaction (e.g., hives, angioedema, respiratory distress, gastrointestinal symptoms, hypotension) require immediate assessment and management (e.g., epinephrine administration).
Asthma control assessment
Frequency: Regularly throughout treatment, especially before dose increases
Target: Well-controlled asthma
Action Threshold: Poorly controlled asthma (e.g., increased rescue inhaler use, nocturnal symptoms, decreased peak flow) requires temporary cessation of Palforzia and re-evaluation.
Adherence to dosing regimen
Frequency: At each follow-up visit
Target: Consistent daily dosing
Action Threshold: Missed doses or non-adherence may require re-initiation at a lower dose level under medical supervision.
Symptom Monitoring
- Hives (urticaria)
- Swelling (angioedema) of face, lips, tongue, throat
- Difficulty breathing, wheezing, shortness of breath, cough
- Dizziness, lightheadedness, fainting
- Rapid or weak pulse
- Nausea, vomiting, abdominal pain, diarrhea
- Flushing, itching
- Feeling of impending doom
Special Patient Groups
Pregnancy
Limited human data on Palforzia use in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, potential risk unknown.
Second Trimester:
Limited data, potential risk unknown.
Third Trimester:
Limited data, potential risk unknown.
Lactation
There are no data 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:
Risk unknown due to lack of data.
Pediatric Use
Approved for use in pediatric patients aged 4 through 17 years. Safety and effectiveness in patients younger than 4 years of age have not been established. Dosing is weight-independent within the approved age range.
Geriatric Use
Safety and effectiveness in geriatric patients (65 years and older) have not been established. Palforzia is not approved for use in this population.
Clinical Information
Clinical Pearls
- Palforzia is NOT a cure for peanut allergy; patients must continue strict peanut avoidance and carry epinephrine.
- All initial doses (Initial Dose Escalation and first dose of each Up-Dosing level) MUST be administered in a healthcare setting with anaphylaxis management capabilities.
- Patients should be observed for at least 60 minutes after each dose administered in a healthcare setting.
- Do not administer Palforzia if the patient is experiencing uncontrolled asthma, a febrile illness, or significant allergic symptoms.
- Instruct patients to avoid factors that can increase the risk of systemic reactions (e.g., strenuous exercise, hot showers, acute illness) for at least 3 hours after dosing.
- Ensure patients understand how to properly mix and administer the powder with food and the importance of daily adherence.
- Missed doses may require re-initiation at a lower dose level under medical supervision to minimize the risk of severe reactions.
Alternative Therapies
- Strict peanut avoidance (current standard of care for many)
- Investigational therapies (e.g., epicutaneous immunotherapy, other oral immunotherapies in clinical trials)
Cost & Coverage
Average Cost:
Varies significantly, typically several thousand dollars per month per month of treatment
Insurance Coverage:
Specialty Tier (requires prior authorization, may have high co-pays/co-insurance)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult 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 quantity, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult 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 quantity, and the time it occurred.