Brand Names:

• Palforzia

Dosage Forms:

• Capsule
• Powder

Warnings:

Peanut (Arachis hypogaea) Allergen Powder-dnfp can cause anaphylaxis (also called anaphylactic reaction), which may be life-threatening and can occur at any time during. Prescribe injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use. Do not administer Peanut (Arachis hypogaea) Allergen Powder-dnfp to patients with uncontrolled asthma. Dose modifications may be necessary following an anaphylactic reaction. 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. Because of the risk of anaphylaxis, Peanut (Arachis hypogaea) Allergen Powder-dnfp is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Palforzia REMS .

Classifications:

Therapeutic—

Immunological Agent

Uses of This Medicine:

Peanut allergen-dnfp is used together with a no-peanut diet to help lessen the severity of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to peanuts. This medicine is derived from peanuts. It is not effective against other food allergies. Peanut allergen-dnfp should not be used during an emergency allergic reaction.

This medicine is available only under a restricted distribution program called Palforzia™ REMS (Risk Evaluation and Mitigation Strategy) Program.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of peanut allergen-dnfp in children younger than 4 years of age. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of peanut allergen-dnfp in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma, severe, persistent, or uncontrolled or
• Emergency allergic reaction (anaphylaxis) or
• Eosinophilic gastrointestinal disease (eg, eosinophilic esophagitis) or
• Patients on long-term steroid treatment—Should not be used in patients with these conditions.

• Fasting or
• High metabolism (eg, flushing of the skin, sweating, rapid breathing, fast heartbeat) or
• Infection (eg, viral) or
• Menstruation or
• Sleep deprivation (little to no sleep)—Use with caution. May increase risk for an allergic reaction to occur.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Your doctor will give you the first dose of this medicine in a hospital or medical facility. You will need to stay for at least 60 minutes to check for unwanted effects. You will also need an epinephrine injection during treatment with this medicine for any allergic reaction that may occur.

Take this medicine with food, especially in the evening.

Do not swallow the capsule. Do not inhale the powder.

To prepare the mixture:

• Wash your hands before and after preparing the mixture.
• Empty the contents of the capsule or sachet onto a few spoonfuls of refrigerated or room temperature semisolid food (including applesauce, yogurt, or pudding). Do not use liquid (including milk, water, or juice) to prepare.
• Mix well.

Take this medicine together with a no-peanut-diet.

Do not exercise or have a hot bath or shower within 3 hours after taking this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsule, powder):
  • For decreasing severity of peanut allergy reaction:
    • Children 4 to 17 years of age—There are three different phases of dosing with this medicine, including Initial Dose Escalation, Up-Dosing, and Maintenance Dosing. The first 5 doses, 0.5 to 6 milligrams (mg) (Initial Dose Escalation) will be given by your doctor on a single day. The first dose of each Up-Dosing level is also given by your doctor. For the Up-Dosing Phase, you will start with 3 mg and finish with 300 mg. You will need to visit your doctor every 2 weeks. 300 mg or one-300 mg sachet is to be taken every day for the Maintenance Dosing Phase.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your child's progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

You should not be given this medicine for the first time if you have had a severe allergic reaction (anaphylaxis) within the previous 60 days.

This medicine may cause a serious allergic reaction, called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if your child has a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

This medicine may cause eosinophilic gastrointestinal disease, including eosinophilic esophagitis (allergic swelling of the esophagus). Check with your doctor right away if you have trouble swallowing, vomiting, nausea, heartburn, chest pain, or stomach pain.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Chest tightness

cough

difficulty swallowing

dizziness

fast heartbeat

hives, itching, skin rash

nausea

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

stomach pain

throat irritation and tightness

trouble breathing

unusual tiredness or weakness

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Ear itching

numbness or itching of the mouth

runny nose

sneezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.