Palforzia
- Generic Name: [peanut (arachis hypogaea) allergen powder-dnfp] powder for oral administration
- Brand Name: Palforzia
Palforzia ([Peanut (arachis hypogaea) Allergen Powder-dnfp] Powder for Oral Administration) side effects drug center
Palforzia Side Effects Center
What Is Palforzia?
Palforzia [peanut (Arachis hypogaea) allergen powder-dnfp] is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut for people who with a confirmed diagnosis of peanut allergy. Palforzia can help reduce the severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. Palforzia is to be used in conjunction with a peanut-avoidant diet. Palforzia does NOT treat allergic reactions and should not be given during an allergic reaction.
What Are Side Effects of Palforzia?
Side effects of Palforzia include:
- abdominal pain,
- vomiting,
- nausea,
- oral itching,
- oral numbness and tingling,
- throat irritation,
- cough,
- runny nose,
- sneezing,
- throat tightness,
- wheezing,
- shortness of breath,
- itching,
- hives,
- severe allergic reaction (anaphylaxis), and
- ear itching
Dosage for Palforzia
The initial dose escalation of Palforzia is administered on a single day under the supervision of a health care professional in a health care setting with the ability to manage potentially severe allergic reactions, including anaphylaxis. The maintenance dose of Palforzia is 300 mg daily.
Palforzia In Children
Palforzia may be started in patients aged 4 through 17 years old. If you turn 18 years of age while on Palforzia treatment you should continue taking Palforzia unless otherwise instructed by your doctor. Safety and effectiveness of Palforzia have not been established in persons younger than 4 years of age.
What Drugs, Substances, or Supplements Interact with Palforzia?
Palforzia may interact with other medicines.
Tell your doctor all medications and supplements you use.
Palforzia During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Palforzia; there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Palforzia during pregnancy. It is unknown if Palforzia passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Palforzia [peanut (Arachis hypogaea) allergen powder-dnfp] Powder for Oral Administration Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Palforzia Consumer Information
Peanut allergen extract can cause a severe or life-threatening allergic reaction. Stop using this medicine and get emergency medical help if you have signs of an allergic reaction:
- chest discomfort, wheezing, trouble breathing;
- tightness in your throat;
- trouble speaking or swallowing;
- swelling of your face, lips, eyes, or tongue;
- itchy, raised bumps on your skin;
- flushing (sudden warmth, redness, or tingly feeling);
- severe stomach pain, vomiting, or diarrhea; or
- a light-headed feeling, like you might pass out.
Your doctor may prescribe epinephrine injection to keep on hand in case you have an allergic reaction. Get emergency medical help if you have an allergic reaction, even if you have used epinephrine to treat it.
Also call your doctor at once if you have symptoms of inflammation in your stomach or esophagus:
- vomiting undigested food;
- trouble swallowing (food getting stuck in throat);
- feeling sick; or
- burning in your mouth, throat, or chest.
Common side effects may include:
- itching or burning in your mouth;
- cough, wheezing, trouble breathing;
- tightness or irritation in your throat;
- rash, itchy skin;
- itching in or around your ear;
- runny nose, sneezing; or
- stomach pain, nausea, vomiting.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Palforzia ([Peanut (arachis hypogaea) Allergen Powder-dnfp] Powder for Oral Administration)
Palforzia Professional Information
SIDE EFFECTS
Clinical Trial Experience
Use of PALFORZIA has been associated with:
- Anaphylaxis [see WARNINGS AND PRECAUTIONS]
- Eosinophilic esophagitis [see WARNINGS AND PRECAUTIONS]
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared with the adverse reaction rates in clinical trials of another drug and may not reflect the rates observed in practice.
The clinical data for PALFORZIA reflect exposure in 709 peanut-allergic subjects enrolled in two phase 3, double-blind, placebo-controlled trials (Study 1 and Study 2), and in long-term, open-label, follow-on studies. In Study 1, subjects were Up-Dosed for 20-40 weeks followed by Maintenance dosing for 24-28 weeks. In Study 2 subjects were Up-Dosed for 20-40 weeks up to a 300 mg daily dose with no extended Maintenance dosing. In these studies, subjects recorded adverse reactions daily in an electronic diary card throughout the study duration.
Study 1 (NCT02635776) was a randomized, double-blind, placebo-controlled efficacy and safety study conducted in the United States, Canada, and Europe evaluating PALFORZIA versus placebo in 555 subjects aged 4 through 55 years with peanut allergy. Subjects were required to have serum IgE to peanut ≥ 0.35 kUA/L within 12 months before study entry and/or a mean wheal diameter on skin prick test to peanut ≥3 mm greater than the negative control. The primary analysis population was aged 4 through 17 years, 78% white and 57% male. At study entry, subjects reacted at 100 mg or less of peanut protein in a double-blind, placebo-controlled food challenge (DBPCFC). The primary analysis was conducted in 496 subjects aged 4 through 17 years (PALFORZIA, N = 372; placebo, N = 124). Of the subjects aged 4 through 17 years treated with PALFORZIA, 72% had a medical history of anaphylactic reactions to peanut, 66% reported multiple food allergies, 63% had a medical history of atopic dermatitis, and 53% had a present or previous diagnosis of asthma. Subjects with severe persistent or uncontrolled asthma were excluded.
Study 2 (NCT03126227) was a randomized, double-blind, placebo-controlled safety study conducted in the United States and Canada evaluating PALFORZIA versus placebo in 506 subjects aged 4 through 17 years with peanut allergy. Subjects were required to have a clinical history of peanut allergy including onset of characteristic allergic signs and symptoms within 2 hours of known oral exposure to peanut, serum IgE to peanut of ≥ 14 kUA/L and a mean wheal diameter on skin prick test ≥ 8 mm greater than the negative control at screening. Subjects were not required to complete a DBPCFC for study entry. The study duration was approximately 6 months and compared the safety and tolerability of PALFORZIA (N = 337) with placebo (N = 168). Most subjects were male (63%) and white (79%). Of the subjects treated with PALFORZIA, 60.5% had a medical history of anaphylactic reactions, 65.0% reported multiple food allergies, 57.9% had a medical history of atopic dermatitis, and 52.2% had a present or previous diagnosis of asthma. Subjects with severe persistent or uncontrolled asthma were excluded.
Across these two phase 3, double-blind, placebo-controlled, randomized clinical studies the most common adverse reactions in subjects treated with PALFORZIA (incidence ≥ 5% and at least 5 percentage points greater than in subjects treated with placebo) were gastrointestinal, respiratory, and skin symptoms commonly associated with allergic reactions, as shown in Table 4.
Table 4: Treatment-Emergent Adverse Reactions in ≥ 5% of PALFORZIA-Treated Subjects and ≥ 5% Percentage Points Greater Than Placebo-Treated Subjects in any Dosing Phase (Aged 4 through 17 Years)
| System Organ Class / Preferred Term [2] | Study 1 & Study 2 IDE PALFORZIA (N = 709) | Study 1 & Study 2 IDE Placebo (N = 292) | Study 1 & Study 2 Up-Dosing PALFORZIA (N = 693) | Study 1 & Study 2 Up-Dosing Placebo (N = 289) | Study 1 [1] 300 mg PALFORZIA (N = 310) | Study 1 [1] 300 mg Placebo (N = 118) |
| Gastrointestinal disorders | ||||||
| Abdominal pain [3] | 185 (26.1%) | 24 (8.2%) | 465 (67.1%) | 100 (34.6%) | 90 (29.0%) | 20 (16.9%) |
| Vomiting | 22 (3.1%) | 2 (0.7%) | 253 (36.5%) | 47 (16.3%) | 50 (16.1%) | 14 (11.9%) |
| Nausea | 60 (8.5%) | 2 (0.7%) | 224 (32.3%) | 41 (14.2%) | 45 (14.5%) | 8 (6.8%) |
| Oral pruritus [4] | 62 (8.7%) | 9 (3.1%) | 216 (31.2%) | 30 (10.4%) | 51 (16.5%) | 7 (5.9%) |
| Oral paresthesia | 13 (1.8%) | 7 (2.4%) | 94 (13.6%) | 11 (3.8%) | 23 (7.4%) | 2 (1.7%) |
| Respiratory, thoracic, and mediastinal disorders | ||||||
| Throat irritation | 66 (9.3%) | 15 (5.1%) | 279 (40.3%) | 49 (17.0%) | 43 (13.9%) | 11 (9.3%) |
| Cough | 18 (2.5%) | 1 (0.3%) | 221 (31.9%) | 68 (23.5%) | 61 (19.7%) | 22 (18.6%) |
| Rhinorrhea | 9 (1.3%) | 4 (1.4%) | 145 (20.9%) | 50 (17.3%) | 46 (14.8%) | 9 (7.6%) |
| Sneezing | 24 (3.4%) | 8 (2.7%) | 140 (20.2%) | 31 (10.7%) | 33 (10.6%) | 5 (4.2%) |
| Throat tightness | 18 (2.5%) | 3 (1.0%) | 98 (14.1%) | 8 (2.8%) | 20 (6.5%) | 0 (0.0%) |
| Wheezing | 4 (0.6%) | 0 (0.0%) | 85 (12.3%) | 21 (7.3%) | 19 (6.1%) | 10 (8.5%) |
| Dyspnea | 2 (0.3%) | 1 (0.3%) | 53 (7.6%) | 5 (1.7%) | 17 (5.5%) | 1 (0.8%) |
| Skin and subcutaneous tissue disorders | ||||||
| Pruritus | 56 (7.9%) | 16 (5.5%) | 225 (32.5%) | 59 (20.4%) | 45 (14.5%) | 14 (11.9%) |
| Urticaria | 28 (3.9%) | 10 (3.4%) | 197 (28.4%) | 54 (18.7%) | 63 (20.3%) | 17 (14.4%) |
| Immune system disorders | ||||||
| Anaphylactic reaction [5] | 5 (0.7%) | 1 (0.3%) | 63 (9.1%) | 10 (3.5%) | 27 (8.7%) | 2 (1.7%) |
| Ear and labyrinth disorders | ||||||
| Ear pruritus | 5 (0.7%) | 1 (0.3%) | 41 (5.9%) | 2 (0.7%) | 7 (2.3%) | 0 (0.0%) |
| At each level of summarization (any event, system organ class, or preferred term) subjects with more than 1 adverse reaction were counted only once within each study period. [1] In Study 2, no adverse reactions s 5% were reported in subjects following treatment with 300 mg PALFORZIA (N = 265). [2] Adverse events were coded to system organ class and preferred term using the MedDRA, version 19.1. [3] Includes preferred terms of abdominal pain, abdominal pain upper, and abdominal discomfort. [4] Includes preferred terms of oral pruritus, tongue pruritis, and lip pruritus. [5] The anaphylactic reaction preferred term includes systemic allergic reactions of any severity, of which severe anaphylaxis was reported in 4 PALFORZIA-treated subjects (0.6%) during Up-Dosing and 1 PALFORZIA-treated subject (0.3%) during Maintenance. IDE, Initial Dose Escalation; MedDRA, Medical Dictionary for Regulatory Activities. | ||||||
A total of 155 (21.9%) PALFORZIA-treated subjects and 19 (6.5%) placebo-treated subjects discontinued for any reason in Studies 1 and 2. Adverse reactions led to study discontinuation in 9.2% PALFORZIA-treated subjects and 1.7% placebo-treated subjects during Initial Dose Escalation and Up-Dosing combined in Studies 1 and 2, and 1.0% PALFORZIA-treated subjects and no placebo-treated subjects during Maintenance dosing in Study 1. Gastrointestinal reactions were the most common reason leading to discontinuation of study product during Initial Dose Escalation and Up-Dosing combined (6.5% PALFORZIA, 1.0% placebo), followed by respiratory disorders (2.3% PALFORZIA, 1.0% placebo) in Studies 1 and 2.
The timing of symptoms relative to exposure to PALFORZIA was evaluated for dosing that occurred within a clinical setting during Initial Dose Escalation and on the day of initiation of each new dose level during the Up-Dosing phase (every 2 weeks) and during monthly Maintenance visits. Symptoms occurring in the clinic following any dose of PALFORZIA had a median time to onset of 4 minutes for 502 subjects (70.8%). The median time to resolution of the last symptom was 37 minutes.
Read the entire FDA prescribing information for Palforzia ([Peanut (arachis hypogaea) Allergen Powder-dnfp] Powder for Oral Administration)
&Copy; Palforzia Patient Information is supplied by Cerner Multum, Inc. and Palforzia Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.