Dosage & Administration
For oral administration only ( 2)
| Total Dose | Dose Configuration |
|---|---|
| 0.5 mg | One 0.5 mg capsule |
| 1 mg | One 1 mg capsule |
| 1.5 mg | One 0.5 mg capsule; One 1 mg capsule |
| 3 mg | Three 1 mg capsules |
| 6 mg | Six 1 mg capsules |
| Total Daily Dose | Daily Dose Configuration |
|---|---|
| 3 mg | Three 1 mg capsules |
| 6 mg | Six 1 mg capsules |
| 12 mg | Two 1 mg capsules; One 10 mg capsule |
| 20 mg | One 20 mg capsule |
| 40 mg | Two 20 mg capsules |
| 80 mg | Four 20 mg capsules |
| 120 mg | One 20 mg capsule; One 100 mg capsule |
| 160 mg | Three 20 mg capsules; One 100 mg capsule |
| 200 mg | Two 100 mg capsules |
| 240 mg | Two 20 mg capsules; Two 100 mg capsules |
| 300 mg | One 300 mg sachet |
| Total Daily Dose | Daily Dose Configuration |
|---|---|
| 300 mg | One 300 mg sachet |
By using PrescriberAI, you agree to the AI Terms of Use.
Palforzia Prescribing Information
- PALFORZIA can cause anaphylaxis, which may be life-threatening and can occur at any time during PALFORZIA therapy [see Warnings and Precautions (5.1)] .
- Prescribe injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use [see Warnings and Precautions (5.1)] .
- Do not administer PALFORZIA to patients with uncontrolled asthma [see Contraindications (4)] .
- Dose modifications may be necessary following an anaphylactic reaction [see Dosage and Administration (2.5)] .
- Observe patients during and after administration of the Initial Dose Escalation and the first dose of each Up-Dosing level, for at least 60 minutes [see Dosage and Administration (2.4)] .
- Because of the risk of anaphylaxis, PALFORZIA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the PALFORZIA REMS [see Warnings and Precautions (5.2)] .
PALFORZIA is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial Dose Escalation may be administered to patients aged 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 years of age and older [see Dosage and Administration (2.4)] .
PALFORZIA is to be used in conjunction with a peanut-avoidant diet.
Limitation of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
Important Considerations Prior to Initiation and During Therapy
Verify that the patient has injectable epinephrine and instruct patient on its appropriate use [see Warnings and Precautions (5.2)] .
Dosage
Treatment with PALFORZIA is administered in 3 sequential phases: Initial Dose Escalation, Up-Dosing, and Maintenance.
The dose configurations for each phase of dosing are provided in Table 1 through Table 3.
| Dose Level | Total Dose | Dose Configuration |
|---|---|---|
| Initial Dose Escalation supplied as a single card consisting of 5 blisters containing a total of 13 capsules. | ||
| A | 0.5 mg | One 0.5 mg capsule |
| B | 1 mg | One 1 mg capsule |
| C | 1.5 mg | One 0.5 mg capsule; One 1 mg capsule |
| D | 3 mg | Three 1 mg capsules |
| E | 6 mg | Six 1 mg capsules |
| Dose Level | Total Daily Dose | Daily Dose Configuration | Dose Duration (weeks) |
|---|---|---|---|
| 1 | 3 mg | Three 1 mg capsules | 2 |
| 2 | 6 mg | Six 1 mg capsules | 2 |
| 3 | 12 mg | Two 1 mg capsules; One 10 mg capsule | 2 |
| 4 | 20 mg | One 20 mg capsule | 2 |
| 5 | 40 mg | Two 20 mg capsules | 2 |
| 6 | 80 mg | Four 20 mg capsules | 2 |
| 7 | 120 mg | One 20 mg capsule; One 100 mg capsule | 2 |
| 8 | 160 mg | Three 20 mg capsules; One 100 mg capsule | 2 |
| 9 | 200 mg | Two 100 mg capsules | 2 |
| 10 | 240 mg | Two 20 mg capsules; Two 100 mg capsules | 2 |
| 11 | 300 mg | One 300 mg sachet | 2 |
| Dose Level | Total Daily Dose | Daily Dose Configuration |
|---|---|---|
| 11 | 300 mg | One 300 mg sachet |
Preparation and Handling
PALFORZIA is to be administered orally.
- Open capsule(s) or sachet and empty the entire dose of PALFORZIA powder onto a few spoonfuls of refrigerated or room temperature semisolid food (e.g., applesauce, yogurt, pudding). Do not use liquid (e.g., milk, water, juice) to prepare.
- Mix well.
- Consume the entire volume of the prepared mixture promptly.
- Dispose of the opened capsule(s) or sachet.
- Wash hands immediately after handling PALFORZIA capsule(s) or sachets.
- Dispose of all unused PALFORZIA.
Administration
- For oral administration only.
- Do not swallow capsule(s).
- Do not inhale powder.
Initial Dose Escalation
Initial Dose Escalation 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.
Initial Dose Escalation is administered in sequential order on a single day beginning at Level A (5 Levels A-E, 0.5-6 mg; Table 1).
Each dose should be separated by an observation period of 20 to 30 minutes.
No dose level should be omitted.
Observe patients after the last dose for at least 60 minutes until suitable for discharge.
Discontinue PALFORZIA if symptoms requiring medical intervention (e.g., use of epinephrine) occur with any dose during Initial Dose Escalation [see Dosage and Administration (2.5)] .
Patients who tolerate at least the 3 mg single dose (Level D) of PALFORZIA during Initial Dose Escalation must return to the health care setting for initiation of Up-Dosing.
If possible, begin Up-Dosing the day after Initial Dose Escalation.
Repeat Initial Dose Escalation in a health care setting if the patient is unable to begin Up-Dosing within 4 days.
Up-Dosing
Complete Initial Dose Escalation before starting Up-Dosing.
Up-Dosing consists of 11 dose levels and is initiated at a 3 mg dose (Level 1).
The first dose of each new Up-Dosing level is administered under the supervision of a health care professional in a health care setting with the ability to manage potentially severe allergic reactions, including anaphylaxis.
Observe patients after administering the first dose of a new Up-Dosing level for at least 60 minutes until suitable for discharge.
If the patient tolerates the first dose of the increased dose level, the patient may continue that dose level at home. Each dose should be consumed daily with a meal at approximately the same time each day, preferably in the evening.
Administer all the dose levels in Table 2 in sequential order at 2-week intervals if tolerated.
No dose level should be omitted.
Do not progress through Up-Dosing more rapidly than shown in Table 2.
No more than 1 dose should be consumed per day. Instruct patients not to consume a dose at home on the same day as a dose consumed in the clinic.
Consider dose modification or discontinuation for patients who do not tolerate Up-Dosing as described in Table 2 [see Dosage and Administration (2.5)] .
Maintenance
Complete all dose levels of Up-Dosing before starting Maintenance.
The Maintenance dose of PALFORZIA is 300 mg daily.
Daily Maintenance is required to maintain the effect of PALFORZIA.
During Maintenance, contact patient at regular intervals to assess for adverse reactions to PALFORZIA.
Schedule Modification and Product Discontinuation
Dose Modification
Dose modifications are not appropriate during Initial Dose Escalation.
Temporary dose modification of PALFORZIA may be required for patients who experience allergic reactions during Up-Dosing or Maintenance, for patients who miss doses, or for practical reasons of patient management. Allergic reactions, including gastrointestinal reactions, that are severe, recurrent, bothersome, or last longer than 90 minutes during Up-Dosing or Maintenance should be actively managed with dose modifications. Use clinical judgment to determine the best course of action, which can include maintaining the dose level for longer than 2 weeks, reducing, withholding, or discontinuing PALFORZIA doses.
Management of Consecutive Missed Doses
Following 1 to 2 consecutive days of missed doses, patients may resume PALFORZIA at the same dose level. Data are insufficient to inform resumption of PALFORZIA following 3 or more consecutive days of missed doses. Patients who miss 3 or more consecutive days of PALFORZIA should consult their healthcare providers; resumption of PALFORZIA should be done under medical supervision.
Discontinuation of PALFORZIA
Discontinue treatment with PALFORZIA for:
- Patients who are unable to tolerate doses up to and including the 3 mg dose during Initial Dose Escalation
- Patients with suspected eosinophilic esophagitis [see Warnings and Precautions (5.4 and 5.5)]
- Patients unable to comply with the daily dosing requirements
- Patients with recurrent asthma exacerbations or persistent loss of asthma control
PALFORZIA powder description and dosage strengths are as follows:
- 0.5 mg: white to off-white fine granular oral powder (may contain clumps) in white opaque capsules with Aimmune printed on the body and 0.5 mg printed on the cap in grey ink
- 1 mg: white to off-white fine granular oral powder (may contain clumps) in red opaque capsules with Aimmune printed on the body and 1 mg printed on the cap in white ink
- 10 mg: white to off-white fine granular oral powder (may contain clumps) in blue opaque capsules with Aimmune printed on the body and 10 mg printed on the cap in white ink
- 20 mg: off-white to light beige fine granular oral powder (may contain clumps) in white opaque capsules with Aimmune printed on the body and 20 mg printed on the cap in grey ink
- 100 mg: beige fine oral powder (may contain clumps) in red opaque capsules with Aimmune printed on the body and 100 mg printed on the cap in white ink
- 300 mg: beige fine oral powder (may contain clumps) in white foil-laminate sachets with printed information
Combinations of capsules for doses are described in Dosage and Administration (2.2).
Pregnancy
Pregnancy Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to PALFORZIA during pregnancy. Women exposed to PALFORZIA during pregnancy or their health care professionals are encouraged to contact Aimmune by calling 1-833-246-2566.
Risk Summary
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. No human or animal data are available to establish the presence or absence of the risks due to PALFORZIA in pregnant women.
Clinical Considerations
Disease-associated maternal and/or embryo/fetal risk
Anaphylaxis may occur following accidental exposure to peanut in peanut-allergic pregnant women. Anaphylaxis can cause a dangerous decrease in blood pressure, which could result in compromised placental perfusion and significant risk to a fetus.
Maternal adverse reactions
PALFORZIA may cause anaphylaxis [see Warnings and Precautions (5.1) and Fetal/Neonatal adverse reactions] .
Fetal/Neonatal adverse reactions
PALFORZIA may cause anaphylaxis [see Warnings and Precautions (5.1)] . Anaphylaxis can cause a dangerous decrease in blood pressure, which could result in compromised placental perfusion and significant risk to a fetus.
Lactation
Risk Summary
There are no data available 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 other potential adverse effects on the breastfed child from PALFORZIA or from the underlying maternal condition.
Pediatric Use
Safety and effectiveness of PALFORZIA have not been established in persons younger than 4 years of age.
PALFORZIA is contraindicated in patients with the following:
- Uncontrolled asthma [see Warnings and Precautions (5.3)]
- A history of eosinophilic esophagitis and other eosinophilic gastrointestinal disease [see Warnings and Precautions (5.4 and 5.5)]