PALFORZIA : Peanut (Arachis hypogaea) Allergen Powder-dnfp
Aimmune Therapeutics, Inc., a Nestlé Health Science company developing pharmaceutical therapies to prevent, manage, and treat food, gastrointestinal, and metabolic-related diseases, and Allergy Partners, the nation’s largest single specialty allergy practise group, have announced a strategic partnership to provide Allergy Partners’ patients aged 4 through 17 with these pharmaceutical therapies.
The U.S. Food and Drug Administration (FDA) authorised PALFORZIA in January 2020 as an oral immunotherapy (OIT) for the prevention of allergic responses, including anaphylaxis, that could arise from unintentional peanut exposure in patients aged 4 to 17 with a verified diagnosis of peanut allergy. It is not recommended for the treatment of severe allergic reactions, such as anaphylaxis. Use of PALFORZIA should be combined with a diet free of nuts, especially peanuts.
The nationwide care network of Allergy Partners offers patients with asthma and allergic disorders high-quality medical care while advancing knowledge, investigation, and advancement in the field. Through this partnership, Allergy Partners will start distributing PALFORZIA directly to patients through its specialised pharmacy, Allergy Partners Therapeutics (APT), over its complete national network of 64 clinics and 126 community locations in 19 states.
“Supported by the recent strategic investment from B-Flexion, our commitment will continue to be to provide the best possible care to our patients and improve health outcomes across an expanding allergy network, and this unique collaboration with Aimmune will enable us to improve patient access to this important treatment through APT and our network of dedicated providers”, “We are pleased to be working with Aimmune, which is at the forefront of developing allergy therapies like PALFORZIA that have the potential to help transform the lives of patients that often have few or no treatment options available to them.”
Dr. Bill McCann, Chief Medical Officer of Allergy Partners.
“PALFORZIA is an important treatment option for patients living with peanut allergy, helping to reduce the risk of severe allergic reactions due to accidental exposure, and enabling them to live with fewer restrictions”, “Aimmune is committed to help ensure that all eligible patients who wish to access PALFORZIA are able to do so, and the announcement today of our collaboration with Allergy Partners marks another step toward that goal.”
Andrew Oxtoby, President and CEO, Aimmune Therapeutics.
Please read the critical safety information below, or go to www.PALFORZIA.com for the complete prescribing details, which include the boxed warning and medication guide.
What Is PALFORZIA?
For those who are allergic to peanuts, there is a medication called PALFORZIA. If you accidentally eat a peanut, PALFORZIA can help lessen the severity of allergic responses, including anaphylaxis. Patients 4 to 17 years old can start taking PALFORZIA. If you turn 18 while taking Palforza, you should keep taking Palforza unless your doctor instructs you differently.
Given during an allergic response, PALFORZIA DOES NOT treat allergic reactions. While taking PALFORZIA, you must strictly adhere to a peanut-free diet.
Information Important To Safety
- Anaphylaxis brought on by PALFORZIA may be potentially fatal. Your initial dose will be administered to you at a medical facility under the supervision of competent medical personnel.
- The initial dose of every dose increase will be given to you in a medical setting.
- You will be monitored in a medical environment for at least one hour for indications of a severe allergic reaction.
- You must administer an epinephrine injection right away and seek emergency medical attention if you experience a severe response while undergoing treatment.
- If you have any trouble tolerating your home doses, you will go back to the medical facility.
If you experience any of the following symptoms after using PALFORZIA, stop using the medication and seek immediate emergency medical attention:
- Trouble breathing or wheezing
- Chest discomfort or tightness
- Throat tightness
- Trouble swallowing or speaking
- Swelling of your face, lips, eyes, or tongue
- Dizziness or fainting
- Severe stomach cramps or pain, vomiting, or diarrhea
- Hives (itchy, raised bumps on skin)
- Severe flushing of the skin
Only through a limited programme known as the PALFORZIA Risk Evaluation and Mitigation Strategy (REMS) Program is PALFORZIA available due to the possibility of life-threatening allergic reactions. For additional information on the PALFORZIA REMS programme and how to sign up, consult your healthcare provider.
If you have uncontrolled asthma, eosinophilic esophagitis (EoE), or another eosinophilic gastrointestinal illness, you SHOULD NOT TAKE PALFORZIA.
If you don’t feel well before beginning PALFORZIA therapy, tell your doctor. Until you feel better, your doctor may opt to put off starting your treatment. Tell your doctor about any of your health issues as well as any medications you are now taking or have recently taken, including over-the-counter medications and herbal supplements.
If PALFORZIA is not the best course of treatment for you, your doctor may decide:
- You are unwilling or unable to receive (or self-administer) injectable epinephrine.
- You have a condition or are taking a medication that reduces the ability to survive a severe allergic reaction.
Possible side effects of PALFORZIA?
Itching or burning in the mouth, throat irritation, coughing, runny nose, sneezing, throat tightness, wheezing, shortness of breath, itchy skin, hives, and/or itchy ears were the most frequently reported side effects of PALFORZIA.
Anaphylaxis brought on by PALFORZIA may be potentially fatal. Esophageal inflammation is one of the symptoms of PALFORZIA that can affect the stomach or gut (called eosinophilic esophagitis). Eosinophilic esophagitis symptoms can include:
- Trouble swallowing
- Food stuck in throat
- Burning in chest, mouth, or throat
- Regurgitation of undigested food
- Feeling sick
Speak with your doctor or pharmacist for further details on PALFORZIA’s potential adverse effects.
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