Dornase alfa is a medication used in the treatment of cystic fibrosis (CF), a genetic disorder that affects the lungs and digestive system. CF is characterized by the production of thick, sticky mucus that can clog the airways and lead to respiratory infections. Dornase alfa is a recombinant human deoxyribonuclease I (DNase I), an enzyme that helps break down the DNA present in the thick mucus, making it easier to clear from the airways.

By reducing the viscosity of the mucus, dornase alfa can improve lung function and decrease the frequency of respiratory infections in individuals with CF. It is typically administered via inhalation using a nebulizer device.

Pulmozyme (Dornase alfa) is a recombinant human deoxyribonuclease I (rhDNase) an enzyme that selectively cleaves DNA. It is used in patients with cystic fibrosis to reduce the sputum viscosity and in loculated parapneumonic effusions.

Dornase alfa (Pulmozyme) Uses:

• Cystic fibrosis:
  • Management of cystic fibrosis patients, in conjunction with standard therapies, to improve pulmonary function;
  • reduce the risk of respiratory tract infections requiring parenteral antibiotics in patients with a forced vital capacity (FVC) ≥40% of predicted.
• Off Label Use of Dornase alfa in Adults:
  • Parapneumonic pleural effusions and empyemas

Pulmozyme (Dornase alfa) use in COVID-19 associated severe ARDS:

Dornase alfa (Pulmozyme) has also been postulated to promote recovery from severe COVID-19 (Coronavirus) related ARDS primarily via inhibiting dornase alfa-sensitive neutrophil extracellular traps (NETs) from neutrophils [Ref]. Dornase alfa is well tolerated and can be easily administered to mechanically ventilated patients.

Dornase alfa (Pulmozyme) Dose in Adults

Dornase alfa (Pulmozyme) Dose in the treatment of Cystic fibrosis:

Dornase alfa is a medicine used to help people with cystic fibrosis (CF), a condition that makes mucus in the lungs thick and sticky. This makes breathing difficult and can lead to infections.

• To use dornase alfa, you inhale it through a nebulizer device, which turns the medicine into a mist that you can breathe in.
• The typical dose is 2.5 milligrams once a day.
• You can use certain nebulizers like Pulmo-Aide, Pari-Proneb, Mobilaire, or Porta-Neb with a compressor machine to help deliver the medicine.
• If you can't breathe through your mouth, you can use a Pari-Baby nebulizer.
• Some people might need to use dornase alfa twice a day to get the best results.

Dornase alfa (Pulmozyme) Dose in the treatment of Parapneumonic pleural effusions and empyemas (off-label):

Dornase alfa is sometimes used "off-label" to treat parapneumonic pleural effusions and empyemas, which are serious lung conditions. In this case, it's given directly into the space around the lungs (intrapleural).

• The typical dose for this purpose is 5 milligrams twice a day.
• It's usually given after a dose of another medicine called alteplase, with a gap of more than 2 hours between the two doses.
• This treatment is done for a total of 3 days.
• There's some evidence from studies that giving dornase alfa and alteplase together (with a 2-hour gap) is safe and effective for this condition.
• However, it's important to note that using dornase alfa in this way is not officially approved by regulatory authorities, hence why it's called "off-label." Always follow your doctor's advice when using medications in this manner.

Dornase alfa (Pulmozyme) Dose in Childrens

Pulmozyme (Dornase alfa) Dose in the treatment of Cystic fibrosis:

• For infants and children under 2 years old with cystic fibrosis who have symptoms, the recommended dose of dornase alfa is 2.5 milligrams per day. This is given through a nebulizer, which turns the medicine into a mist that can be inhaled. You can use certain nebulizers like Pulmo-Aide, Pari-Proneb, Mobilaire, PortaNeb, or Pari Baby compressor system, or the eRapid Nebulizer System with a compressor machine to help deliver the medicine.
• For children aged 2 to under 5 years, whether it's for treating acute exacerbations or for chronic use in certain cases, the same dose of 2.5 milligrams per day is recommended using the same nebulizers mentioned above.
• For children aged 5 years and older, as well as adolescents who need chronic therapy, the same dose of 2.5 milligrams per day is used. This is also given through selected nebulizers mentioned earlier, with the addition of the eRapid Nebulizer System. Some patients may need to use the medicine twice daily for better results.

Pulmozyme (Dornase Alfa) Dose in the treatment of chronic Rhinosinusitis Secondary to cystic fibrosis:

• For children aged 5 years and older, as well as adolescents with chronic rhinosinusitis secondary to cystic fibrosis, the recommended dose of dornase alfa is 2.5 milligrams per day. This dose is administered through intranasal nebulization using the Pari Sinus device.
• This recommendation is based on limited data from a study involving 23 subjects ranging from 5 to 67 years old. The study showed that dornase alfa helped improve primary nasal symptoms compared to a placebo (isotonic saline). The treatments were generally well tolerated, although nasal bleeding was reported in two patients.

Pregnancy Risk Category: B

• In studies with animals to see how dornase alfa might affect reproduction, no negative effects have been seen.
• This means that there haven't been any harmful events observed in the animals or their offspring when they were given this medicine.

Dornase alfa use during breastfeeding:

• After inhaling dornase alfa, it's unlikely that significant amounts of the medication would be found in breast milk.
• However, it's uncertain whether dornase alfa is actually present in breast milk.
• The decision about breastfeeding while undergoing treatment should consider both the potential risk of exposing the infant to the medication and the benefits of the treatment for the mother's health.

Pulmozyme Dose in Kidney disease:

• The manufacturer's instructions do not include any specific adjustments to the dosage of dornase alfa for individuals with kidney problems.
• This means that there are no recommended changes to the standard dosage based solely on kidney impairment.

Pulmozyme Dose in Liver disease:

• The manufacturer's instructions for dornase alfa do not mention any specific adjustments to the dosage for individuals with liver (hepatic) impairment.
• This means that there are no recommended changes to the standard dosage based solely on liver function.

• Adverse events were similar in children using the PARI BABY nebulizer (facemask as opposed to mouthpiece) with the addition of cough.

Common Side Effects of Pulmozyme (Dornase alfa):

• Cardiovascular:
  • Chest Pain
• Central Nervous System:
  • Voice Disorder
• Dermatologic:
  • Skin Rash
• Respiratory:
  • Cough
  • Pharyngitis
  • Rhinitis
  • Decrease In Forced Vital Capacity
  • Dyspnea
• Miscellaneous:
  • Fever

Less Common Side Effects Of Pulmozyme (Dornase alfa):

• Gastrointestinal:
  • Dyspepsia
• Immunologic:
  • Antibody Development
• Ophthalmic:
  • Conjunctivitis
• Respiratory:
  • Laryngitis

Contraindications to Pulmozyme (Dornase alfa):

• If someone has a known hypersensitivity (allergic reaction) to dornase alfa, Chinese hamster ovary cell products, or any component of the formulation, they should not use this medication.
• This includes any allergic reaction to any specific ingredient or component present in dornase alfa.
• If there's uncertainty about allergies or concerns about potential reactions.

Warnings and precautions

Reduced pulmonary function

• For patients with pulmonary function measuring less than 40% of normal, it's important to note that dornase alfa may not significantly decrease the risk of respiratory infections that require antibiotics administered through injections (parenteral antibiotics).
• This means that despite using dornase alfa, there might not be a considerable reduction in the likelihood of respiratory infections needing such antibiotic treatments.

Monitoring Parameters

Monitor Pulmonary function tests and oxygen saturation.

How to administer Pulmozyme (Dornase alfa)?

Nebulization:

• Check for Leaks: Before using dornase alfa, squeeze each ampule to make sure there are no leaks.
• Do Not Dilute: Don't mix dornase alfa with any other drugs in the nebulizer because it might make the drug less effective.
• eRapid Nebulizer System: If using the eRapid Nebulizer System, replace the handset after 90 uses to ensure you get the right dose. This system is only for patients who can use a mouthpiece. Follow the manufacturer’s instructions carefully for using and maintaining the equipment.

Parapneumonic Pleural Effusions and Empyemas (Off-Label Use):

• Sequential Administration: If giving dornase alfa after alteplase, dilute each dose in 30 mL sterile water. Use the mixture right away after preparing it. Put the dose into the chest tube and close it with a clamp. After an hour, release the clamp and connect the tube to continuous suction.
• Concurrent Administration: If giving dornase alfa at the same time as alteplase, dilute each dose in 50 mL normal saline. Put each dose into the chest tube, one after the other, followed by a flush of 60 mL normal saline. Close the tube with a clamp. After two hours, release the clamp.

Mechanism of action of Pulmozyme (Dornase alfa):

• Cystic fibrosis lung disease is characterized by thick, sticky mucus filled with a lot of DNA, mainly from dying white blood cells called neutrophils.
• This DNA makes the mucus thick and hard to clear from the lungs, leading to breathing difficulties and frequent infections.
• Dornase alfa is a special enzyme made using advanced genetic technology.
• It works by breaking down this excess DNA in the mucus, making it thinner and easier to move out of the lungs.
• This helps improve airflow and may reduce the risk of infections in people with cystic fibrosis.

Onset of Action:

• Nebulization: After inhaling dornase alfa, the levels of the enzyme in the sputum (mucus from the lungs) are typically measured within about 15 minutes. However, these levels decrease quickly after that.

Duration:

• After inhalation, the concentrations of dornase alfa in the sputum start to decrease within about 2 hours.

International Brands of Dornase alfa:

• Pulmozyme

Dornase alfa Brand Names in Pakistan:

No Brands Available in Pakistan.