PALFORZIA Initial Dose Escalation

PALFORZIA INITIAL DOSE ESCALATION- peanut
PALFORZIA (LEVEL 1)- peanut powder
PALFORZIA (LEVEL 2)- peanut powder
PALFORZIA (LEVEL 3)- peanut
PALFORZIA (LEVEL 4)- peanut powder
PALFORZIA (LEVEL 5)- peanut powder
PALFORZIA (LEVEL 6)- peanut powder
PALFORZIA (LEVEL 7)- peanut
PALFORZIA (LEVEL 8)- peanut
PALFORZIA (LEVEL 9)- peanut powder
PALFORZIA (LEVEL 10)- peanut
PALFORZIA (LEVEL 11)- peanut powder
Aimmune Therapeutics

WARNING: ANAPHYLAXIS

  • 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)] .

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 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)] .

2.2 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.

Table 1: Dosing Configuration for Initial Dose Escalation (Single Day Dose Escalation)
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
Table 2: Daily Dosing Configuration for Up-Dosing
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
Table 3: Daily Dosing Configuration for Maintenance
Dose Level Total Daily Dose Daily Dose Configuration
11 300 mg One 300 mg sachet

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.