Training Example: Pulmozyme (Genentech) – Review the Data, Give Your Score & Compare to the Real AI Evaluation

[H5] Over 30+ years of results and counting

[H3] Over 30+ years of results and counting

[H1] Pulmozyme is an important part of a multitherapy approach to treating CF

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[H3] Over 30+ years of results and counting

[H1] Pulmozyme is an important part of a multitherapy approach to treating CF

Learn More

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[H2] There are financial assistance options for Pulmozyme

Financial support

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[H2] Discover how to fit Pulmozyme into everyday life

Preparing for treatment

[IMG: Nebulizer]

[H2] Learn how to take Pulmozyme

Pulmozyme administration

[H2] Equipment needed for taking Pulmozyme

Administer Pulmozyme via a jet nebulizer connected to an air compressor with an adequate air flow and equipped with a mouthpiece or suitable face mask, or via a vibrating mesh nebulizer.
Follow the Manufacturer’s Instructions for Use on the use, maintenance, and replacement of the equipment, including cleaning and disinfection procedures.
For additional information, refer to the selected nebulizer Manufacturer’s Instructions for Use.

Learn about equipment

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Pulmozyme is a prescription medicine indicated along with standard therapies, for the management of pediatric and adult patients with cystic fibrosis (CF) to improve lung function. It works by breaking down DNA in airway mucus, reducing its thickness and helping clear the airways. Pulmozyme is administered as an inhalation via a nebulizer, typically once daily. Some patients may benefit from twice-daily use. Your healthcare provider will determine your dosing schedule based on your needs.
Common side effects of Pulmozyme include voice changes, sore throat, rash, chest pain, and eye irritation. You should call your doctor if you experience any of these side effects or if any of these side effects are severe, get worse, or do not go away.

[H1]
Important Safety Information

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[H2] Indication and Usage
Pulmozyme (dornase alfa) is indicated, along with standard therapies, for the management of pediatric and adult patients with cystic fibrosis (CF) to improve pulmonary function.
In CF patients with an FVC ≥ 40% of predicted, daily administration of Pulmozyme has also been shown to reduce the risk of respiratory tract infections requiring injectable antibiotics.

Pulmozyme should not be used in patients who are allergic to any of its ingredients.
Patients may experience the following when using Pulmozyme: change in or loss of their voice, discomfort in the throat, rash, chest pain, red watery eyes, runny nose, lowering of lung function, fever, indigestion, and shortness of breath. There have been no reports of severe allergic reactions caused by the administration of Pulmozyme. Mild to moderate hives and mild skin rash have been observed and have been short-lived.

[H3] Pediatric Use
The safety and effectiveness of Pulmozyme along with standard therapies for cystic fibrosis have been established in pediatric patients. The use of Pulmozyme in pediatric patients at 5 to 17 years of age is supported by evidence from a randomized, controlled trial. The use of Pulmozyme in patients less than 5 years of age is supported by the efficacy data from the same randomized, controlled trial and additional safety data in pediatric patients aged 3 months to less than 5 years who received Pulmozyme.

You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

For further information, please see the Pulmozyme full Prescribing Information. If you have questions, please discuss them with your CF Care Team.

[H1] What are my equipment options for taking Pulmozyme?

[H3] Quick Links

What are my options for taking Pulmozyme?

Take Pulmozyme on the go

You have options for taking Pulmozyme. The first option uses a jet nebulizer and a compressor. The second option uses a vibrating mesh nebulizer. Talk to your doctor about which option is right for you.
Here’s why you need a nebulizer and compressor for Pulmozyme:
A nebulizer changes the Pulmozyme liquid medicine into a fine mist you inhale by breathing through a mouthpiece
A compressor gives the nebulizer power and makes the nebulizer work

Administer Pulmozyme via a vibrating mesh nebulizer, or via a jet nebulizer connected to an air compressor with an adequate air flow and equipped with a mouthpiece or suitable face mask.
Follow the Manufacturer’s Instructions for Use on the use, maintenance, and replacement of the equipment, including cleaning and disinfection procedures.
For additional information, refer to the selected nebulizer Manufacturer’s Instructions for Use.

[H2] What are my options for taking Pulmozyme?

Several nebulizer and compressor combinations are FDA-approved for use with Pulmozyme:

Jet Nebulizers
Compressors
Hudson T Up-draft II®
Compressor with pressure and flow rate maximum 30 psi, 12 LPM
Marquest Acorn II®

PARI LC® Plus
Compressor with pressure and flow rate maximum 24 psi, 9 LPM
PARI BABY™**

Durable Sidestream®
Compressor with pressure and flow rate maximum 25 psi, 7 LPM

Five vibrating mesh nebulizers are approved by FDA for use with Pulmozyme:

Vibrating Mesh Nebulizers
eRapid® Nebulizer System†
Innospire Go
Pulmogine Vibrating Mesh Nebulizer
AireHealth Nebulizer™
Intelligent Mesh Nebulizer

**Patients who are unable to inhale or exhale orally through the entire nebulization period may use the PARI BABY™ nebulizer.
†Consisting of the eRapid® Nebulizer Handset with eBase™ Controller. Avoid use in patients who need a mask to inhale PULMOZYME.

Read and understand the Instructions for Use and the nebulizer Manufacturer’s Instructions for Use before you start taking Pulmozyme and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

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[H2] Looking for financial support?
Check out the financial assistance programs available to help patients, with or without insurance

Learn more

Next Page: Administering with Jet Nebulizer

[H1]
Important Safety Information

Back to Top

[H2] Indication and Usage
Pulmozyme (dornase alfa) is indicated, along with standard therapies, for the management of pediatric and adult patients with cystic fibrosis (CF) to improve pulmonary function.
In CF patients with an FVC ≥ 40% of predicted, daily administration of Pulmozyme has also been shown to reduce the risk of respiratory tract infections requiring injectable antibiotics.

Pulmozyme should not be used in patients who are allergic to any of its ingredients.
Patients may experience the following when using Pulmozyme: change in or loss of their voice, discomfort in the throat, rash, chest pain, red watery eyes, runny nose, lowering of lung function, fever, indigestion, and shortness of breath. There have been no reports of severe allergic reactions caused by the administration of Pulmozyme. Mild to moderate hives and mild skin rash have been observed and have been short-lived.

[H3] Pediatric Use
The safety and effectiveness of Pulmozyme along with standard therapies for cystic fibrosis have been established in pediatric patients. The use of Pulmozyme in pediatric patients at 5 to 17 years of age is supported by evidence from a randomized, controlled trial. The use of Pulmozyme in patients less than 5 years of age is supported by the efficacy data from the same randomized, controlled trial and additional safety data in pediatric patients aged 3 months to less than 5 years who received Pulmozyme.

You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

For further information, please see the Pulmozyme full Prescribing Information. If you have questions, please discuss them with your CF Care Team.

[H1] Treating Cystic Fibrosis

[H3] Quick Links

CF Treatment types

Get the most out of your cystic fibrosis treatment

Every prescribed therapy plays a unique role in the fight against CF.

[H3] Pulmozyme and your other treatments: Together they help manage CF in different ways

[IMG: Pulmozyme® (dornase alfa) cuts apart extracellular DNA]

Pulmozyme: Cuts apart extracellular DNA to help thin and loosen thick, sticky mucus that may be in the lungs. Extracellular DNA are the remains of white blood cells that came forward to fight an infection. Thinner and looser mucus is easier to clear from your lungs and less likely to trap bacteria, which can lead to infections.

[IMG: CFTR modulators]

CFTR Modulators: CFTR stands for cystic fibrosis transmembrane conductance regulator. CFTRs help keep a balance of salt and water in the lungs and other organs, and can reduce the amount of mucus that builds up. When salt and water in the lungs are not balanced, it can lead to a buildup of thick and sticky mucus. These treatments help keep that balance.

[H4] CFTRs were studied in patients taking Pulmozyme
CFTR modulators were studied in patients taking Pulmozyme. CFTRs modulators are gene-specific treatments. They were studied for use in patients with specific genetic mutations (changes in specific genes). The CF patients in these studies took the CFTR modulator in addition to their prescribed CF therapies (eg, Pulmozyme, bronchodilators, and inhaled antibiotics).

[IMG: Bronchodilators]

Bronchodilators: Help open airways. They relax the muscles in the airways to make breathing easier.

[IMG: Hydrators]

Hydrators: Help increase moisture in thick mucus to improve mucus clearance.

[IMG: Airway clearance techniques]

Airway Clearance Techniques: Help physically loosen and move mucus out of the airway. Moving mucus out of airways is important in preventing bacteria from getting trapped.

[IMG: Antibiotics]

Antibiotics: Help prevent and treat infections. Infections could lead to hospitalizations and more health problems if not treated.

[H2] Get the most out of your treatment

Eat a healthy diet: CF can block important enzymes needed to break down and absorb nutrients. It is important to eat a lot of high-calorie and healthy foods to manage your CF
Exercise: Being active may also help manage your CF. It is important to discuss your exercise plans with your doctor and CF Care Team. The effect of Pulmozyme on exercise tolerance has not been established in adults or children.

Get tips and resources for living with CF

[H3] Here are a few things to discuss with your CF Care Team and your doctor before getting started exercising:

Set goals for your exercise plan. Discuss exercises that may be fun, but are also safe
Create a routine that gradually allows you to do more
Work with your CF Care Team to discuss signs that may mean it’s time to take a break from the action

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[H2] Need help paying for Pulmozyme?

Learn more

Next Page: How Pulmozyme Works

[H1]
Important Safety Information

Back to Top

[H2] Indication and Usage
Pulmozyme (dornase alfa) is indicated, along with standard therapies, for the management of pediatric and adult patients with cystic fibrosis (CF) to improve pulmonary function.
In CF patients with an FVC ≥ 40% of predicted, daily administration of Pulmozyme has also been shown to reduce the risk of respiratory tract infections requiring injectable antibiotics.

Pulmozyme should not be used in patients who are allergic to any of its ingredients.
Patients may experience the following when using Pulmozyme: change in or loss of their voice, discomfort in the throat, rash, chest pain, red watery eyes, runny nose, lowering of lung function, fever, indigestion, and shortness of breath. There have been no reports of severe allergic reactions caused by the administration of Pulmozyme. Mild to moderate hives and mild skin rash have been observed and have been short-lived.

[H3] Pediatric Use
The safety and effectiveness of Pulmozyme along with standard therapies for cystic fibrosis have been established in pediatric patients. The use of Pulmozyme in pediatric patients at 5 to 17 years of age is supported by evidence from a randomized, controlled trial. The use of Pulmozyme in patients less than 5 years of age is supported by the efficacy data from the same randomized, controlled trial and additional safety data in pediatric patients aged 3 months to less than 5 years who received Pulmozyme.

You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

For further information, please see the Pulmozyme full Prescribing Information. If you have questions, please discuss them with your CF Care Team.

[H5] Más de 30+ años de resultados hasta ahora

[H3] Más de 30+ años de resultados hasta ahora

[H1] Pulmozyme es una parte importante de un enfoque multiterapéutico para tratar la fibrosis quística (FQ)

[H3] Más de 30+ años de resultados hasta ahora

[H1] Pulmozyme es una parte importante de un enfoque multiterapéutico para tratar la fibrosis quística (FQ)

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[H2] Descubre cómo integrar Pulmozyme en la vida diaria

Preparación para el tratamiento

[IMG: Nebulizador]

[H2] Aprende a usar Pulmozyme

Administración de Pulmozyme

[H2] Equipo necesario para usar Pulmozyme

Administre Pulmozyme a través de un nebulizador de malla vibratoria o a través de un nebulizador a chorro conectado a un compresor de aire con un flujo de aire adecuado y equipado con una boquilla o mascarilla facial adecuada.
Siga las instrucciones de uso del fabricante para el uso, mantenimiento y reemplazo del equipo, incluidos los procedimientos de limpieza y desinfección.
Para obtener información adicional, consulte las instrucciones de uso del fabricante del nebulizador recomendadas.

Infórmate sobre el equipo

[IMG: Equipo]

[H1]
Información de seguridad importante

volver arriba

[H2] Indicaciones y uso
Pulmozyme (dornasa alfa) está indicado junto con tratamientos estándar para el tratamiento de pacientes pediátricos y adultos con fibrosis quística (FQ) para mejorar la función pulmonar.
También se ha demostrado que la administración diaria de Pulmozyme disminuye el riesgo de infecciones en las vías respiratorias que requieren la administración de antibióticos inyectables en pacientes con FQ que tienen una FVC ≥ 40 % del valor esperado.

Pulmozyme no debe ser utilizado en pacientes alérgicos a cualquiera de sus ingredientes.
Es posible que los pacientes experimenten lo siguiente al utilizar Pulmozyme: cambios en la voz o pérdida de esta, molestias en la garganta, erupciones cutáneas, dolor de pecho, ojos rojos y llorosos, goteo nasal, disminución de la función pulmonar, fiebre, indigestión y disnea. No se han informado reacciones alérgicas graves causadas por la administración de Pulmozyme. Se han observado urticarias de leves a moderadas y erupciones cutáneas leves y temporales.

[H3] Uso pediátrico
Se ha establecido la seguridad y eficacia de Pulmozyme junto con los tratamientos estándar para la fibrosis quística en pacientes pediátricos. El uso de Pulmozyme en pacientes pediátricos de 5 a 17 años de edad está respaldado por evidencias de un estudio controlado aleatorizado. El uso de Pulmozyme en pacientes menores de 5 años está respaldado por los datos de eficacia del mismo estudio controlado aleatorizado y datos de seguridad adicionales en pacientes pediátricos de 3 meses a menos de 5 años que recibieron Pulmozyme.

Lo alentamos a que informe sobre los efectos secundarios a Genentech y a la Administración de alimentos y fármacos (Food and Drug Administration, FDA). Puede reportar los efectos secundarios a la FDA al 1-800-FDA-1088 o www.fda.gov/medwatch. También puede reportar los efectos secundarios a Genentech al 1-888-835-2555.

Para obtener más información, consulte toda la Información sobre prescripción de Pulmozyme.