Drug Detail:Palforzia (Peanut allergen extract [ pee-nut-al-er-jen-ex-tract ])
Generic Name: PEANUT 0.5mg; PEANUT 1mg
Dosage Form: oral kit
Drug Class: Allergenics
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)] .
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
