INSTRUCTIONS FOR USE PULMOZYME® (PULL-muh-zyme

INSTRUCTIONS FOR USE

PULMOZYME

(PULL-muh-zyme)

(dornase alfa)

Inhalation Solution

This Instructions for Use contains information on how to use PULMOZYME with Jet Nebulizers and Compressors

See the other side of this Instructions for Use for information on use of Pulmozyme with the recommended

vibrating mesh nebulizers

Read and understand this Instructions for Use and the nebulizer manufacturer’s instruction manual 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.

A nebulizer and a compressor are used together to give a dose of 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.

Pulmozyme should only be used with the approved nebulizers and appropriate compressors as recommended below, or

with the recommended vibrating mesh nebulizers (see other side of this Instructions for Use). Read and follow

the manufacturer’s instruction manual.

Do not use any other inhaled medicines in the nebulizer at the same time. Keep all other inhaled medicine

systems completely separate from Pulmozyme.

Use the mouthpiece or face mask provided with the nebulizer kit.

If your child cannot breathe in or breathe out by mouth, you may use the PARI BABY reusable nebulizer, but you should

discuss it with your doctor first. The PARI BABY nebulizer is the same as the PARI LC Plus Jet system, except the

mouthpiece is replaced by a tight-fitting face mask connected to an elbow piece.

Reference ID: 5326389

Follow the steps on this side of the Instructions for Use to give Pulmozyme using the following jet nebulizer

systems

Jet Nebulizer Compressor

Hudson T Up-draft II

A compressor with the following specifications

is recommended:

 Approximate air flow of 3.5 L/min to 12

L/min at approximately 20 psi to 45 psi

pressure

Marquest Acorn II

PARI LC Plus

PARI BABY

Durable Sidestream

For additional information on an appropriate compressor to use with Pulmozyme, read the manufacturer’s instruction

manual for the recommended nebulizer.

Important Information You Need to Know Before Using PULMOZYME

Read and follow the nebulizer manufacturer’s instruction manual for correct use and maintenance:

 to clean the nebulizer before first use and after each use as recommended.

 to disinfect the nebulizer parts by using the disinfecting method recommended.

 to replace nebulizer parts as recommended.

Supplies you will need to give a dose of Pulmozyme (See Figure A):

 1 Pulmozyme ampule

 Compressor

 Nebulizer cup and cap (screw-on or snap-on)

 Plastic T (not needed for Sidestream nebulizer or PARI BABY)

 Flexible aerosol tube (not needed for Sidestream nebulizer or PARI BABY)

 Mouthpiece (clean) or PARI BABY facemask

 Long connecting tube

 Nose clip (optional, not needed for PARI BABY)

Reference ID: 5326389

Preparing the jet nebulizer and compressor:

Step 1. Clean a flat table surface and wash your hands.

 Clean a flat table surface.

 Wash your hands well with soap and water before using

the Pulmozyme ampule and nebulizer. This helps

prevent infection (See Figure B).

Step 2. Gather the nebulizer and test the compressor.

 Place the nebulizer parts on a clean, flat table surface

within reach.

 Test the compressor by turning it on and putting your

finger in front of the "air out" or "air" port to feel air

flowing. Turn off the compressor (See Figure C).

Step 3. Gather the Pulmozyme ampule and check the

expiration date.

 Remove 1 foil pouch of Pulmozyme from the refrigerator.

Open the foil pouch and remove 1 ampule of

Pulmozyme. Put the remaining ampules back in the foil

pouch and return them to the refrigerator.

 Check the expiration (exp.) date printed on the ampule

(See Figure D).

 Do not use the Pulmozyme ampule if the expiration date

has passed.

Step 4. Check the Pulmozyme ampule.

 Check the ampule for leaks by turning it upside down and

gently squeezing (See Figure E).

Do not use the ampule if it is leaking. Throw it away and

get a new one.

 Check the Pulmozyme liquid in the ampule and make

sure it is clear and free of particles.

 Do not use Pulmozyme if the liquid is cloudy or

discolored. Take the Pulmozyme back to the pharmacy,

hospital, or clinic that gave you the medicine.

Reference ID: 5326389

Step 5. Attach the long connecting tube to the

compressor.

 Attach the long connecting tube to the "air out" or "air"

port on the compressor (See Figure F).

Step 6. Attach the mouthpiece.

 Skip to Step 7 if you use the Sidestream nebulizer or

the PARI BABY nebulizer.

 Push the mouthpiece into the wider end of the plastic T.

Attach the flexible aerosol tube to the other end of the T

(See Figure G).

Step 7. Remove the cap from the cup.

 Unscrew or unsnap the cap from the nebulizer cup (See

Figure H).

 Put the nebulizer cup on the table

face up and place the cap upside down on a clean

surface (See Figure I).

Step 8. Open the Pulmozyme ampule.

 Hold the tab at the bottom of the Pulmozyme ampule

firmly. Twist off the top. Do not squeeze the body of the

ampule (See Figure J).

Step 9. Pour the full Pulmozyme dose into the nebulizer

cup.

 Turn the ampule upside down and squeeze gently to

empty the medicine into the nebulizer cup.

Keep squeezing until the ampule is empty. It is very

important you squeeze all of the medicine out of the

ampule (See Figure K).

 Screw or snap the cap onto the nebulizer cup (See

Figure L).

Reference ID: 5326389

Step 10. Connect the plastic T.

 Connect the plastic T to the nebulizer cap (See Figure

M).

 If you are using the Sidestream nebulizer, attach the

mouthpiece to the top of the nebulizer (See Figure

N).

 If you are using the PARI BABY nebulizer, connect

the elbow piece and mask to the nebulizer outlet (See

Figure O).

Step 11. Attach the long connecting tube to the cup.

 Connect the open end of the long connecting tube to the

port on the bottom of the nebulizer cup by pushing up

firmly (See Figure P).

Step 12. Turn on the compressor.

 Turn on the compressor and check to see that mist is

coming out of the nebulizer (See Figure Q).

Taking your dose of Pulmozyme with a nebulizer:

Step 13. Breathe through the mouthpiece.

 Skip to Step 14 if you are using the PARI BABY to give

Pulmozyme to your child.

 Place the mouthpiece between your teeth and on top of your

tongue (See Figure R).

 Breathe slowly in and out through your mouth. Do not block

the airflow with your tongue.

 Do not breathe through your nose. If you have problems

breathing only through your mouth, use a nose clip (See

Figure S).

Reference ID: 5326389

 Do not be concerned if liquid droplets form in the long

connecting tube during treatment. When the nebulizer begins

spitting, gently tap the nebulizer cup and continue breathing

until the nebulizer cup is empty or stops making mist (See

Figure T).

 If you need to stop treatment before you are finished, or you

begin coughing, turn off the compressor and do not spill any

of the medicine.

 To start treatment again, turn on the compressor and

continue breathing slowly in and out through your mouth.

 The complete treatment usually takes from 10 to 15 minutes

for most nebulizers.

 If you are using the Sidestream nebulizer, treatment usually

takes from 2 to 6 minutes.

 It is important to inhale the full dose of Pulmozyme. If you find

a leak or feel any moisture coming from the nebulizer during

treatment, turn off the compressor and check to make sure

the nebulizer cap is sealed correctly before continuing (See

Figure U).

If you are using the PARI BABY nebulizer to give Pulmozyme to your child, follow the

instructions below in Step 14. If not, go to Step 15

Step 14. Breathing through the facemask.

 During the treatment your child may sit, lie down or stand.

 Place the facemask gently but firmly over your child’s nose

and mouth (See Figure V).

 Make sure there are no air gaps between the mask and

your child's face. This will help make sure that your

child will get the full dose of Pulmozyme.

 It is important that you try to keep the body of the nebulizer

upright during the entire treatment (See Figure V). The

elbow piece will allow you to move the mask for a good fit

while keeping the nebulizer body upright.

 When the nebulizer begins "spitting," gently tap the

nebulizer cup and continue treatment until the nebulizer is

empty or stops making a mist (See Figure W).

Reference ID: 5326389

 If you need to stop the treatment or your child begins

to cough d

uring treatment, turn the compressor of

f. Do

not spill any Pulm

ozyme.

 If you have not removed the mask and you wa

nt to begin

the treatment

again, turn on the compressor.

 If you have removed the mask, repeat the steps abo

ve to

repla

ce the mask on your child’s face and restar

t the

comp

ressor.

 The complete treatment usually takes from 10 to 15

minutes.

It is important that your child inhale the full dose of

Pulmozyme. If you find a leak or feel moisture coming from the

nebulizer during the treatment, turn off the compressor and

make sure the nebulizer cap is sealed correctly before starting

the compressor again (See Figure X).

After your treatment with Pulmozyme:

Step 15. Prepare the nebulizer for cleaning and storage.

 Turn off the compressor and take apart the nebulizer system. Set aside the flexible aeros

tube and the l

ong connecti

ng tube.

Not

e: The Sidestream nebulizer does not use a flexible aerosol tube.

 Throw away the Pulmozyme ampule in your household trash.

 Follow the manufacturer's recommendations for care of your nebulizer and compressor.

How should I store Pulmozyme?

• Store Pulmozyme ampules at a refrigerated temperature between 36°F to 46°F (2°C

to 8°C) in their protective foil pouch to protect from light and heat until you are ready

to use them. When the protective foil pouch is opened, the unused ampules must be kept

refrigerated in the protective foil pouch to protect from light and heat.

• When traveling, Pulmozyme ampules should be kept refrigerated in their protective foil

pouch to protect from light and heat.

• Protect Pulmozyme from excessive heat and light.

• Do not use Pulmozyme if the ampules have been exposed to room temperature 72°F to

82°F (22°C to 28°C) for more than a total of 60 hours or if the solution has turned cloudy or

discolored.

• Do not use Pulmozyme past the expiration date printed on the ampule.

Reference ID: 5326389

Genentech, Inc.

A Member of the Roche Group

1 DNA Way

South San Francisco, CA 94080-4990

US License No. 1048

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 02/2024

Reference ID: 5326389



INSTRUCTIONS FOR USE

PULMOZYME

(PULL-muh-zyme)

(dornase alfa)

Inhalation Solution

This Instructions for Use contains information on how to use PULMOZYME with the following recommended

vibrating mesh nebulizers:

Recommended Vibrating Mesh Nebulizers

eRapid

Nebulizer System

Innospire Go

Pulmogine Vibrating Mesh Nebulizer

AireHealth Nebulizer™

Intelligent Mesh Nebulizer

See the other side of this Instructions for Use for information on use with Jet Nebulizers and Compressors

Read and understand this Instructions for Use and the nebulizer manufacturer’s instruction manual 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 healthcare provider about your medical condition or your treatment.

This information does not take the place of the manufacturer’s instruction manual for the vibrating mesh nebulizer.

The vibrating mesh nebulizer changes the Pulmozyme liquid medicine into a fine mist you inhale by breathing

through a mouthpiece.

Do not use any other inhaled medicines in the nebulizer at the same time. Keep all other inhaled medication

systems completely separate from Pulmozyme.

The eRapid Nebulizer System should only be used by adults and children who can use a mouthpiece, and not by

younger children who need a mask to take Pulmozyme.

Follow the instructions on this side of the Instructions for Use to give Pulmozyme using a vibrating mesh

nebulizer.

Important Information You Need to Know Before Using PULMOZYME

Read and follow the nebulizer manufacturer’s instruction manual for correct use and maintenance:

 to clean the nebulizer before first use and after each use as recommended

 to disinfect the nebulizer parts by using the disinfecting method recommended

 to replace nebulizer parts as recommended

Supplies you will need to give a dose of PULMOZYME:

 1 Pulmozyme ampule (See Figure A)

 Vibrating mesh nebulizer and its parts

 Manufacturer’s instruction manual for the vibrating mesh nebulizer

 Nose clip (optional) (See Figure B)

Reference ID: 5326389



Pulmozyme ampule

Figure A

Figure B

Prepare the vibratin

mesh nebulizer:

Step 1. Clean a flat table surface and wash your hands.

 Clean a flat table surface.

 Wash your hands well with soap and water before using

the Pulmozyme ampule and nebulizer. This helps

prevent infection (See Figure C).

Figure C

Step 2. Gather the nebulizer. Make sure you have all parts and make sure they are clean

and not damaged. Prepare and test it as recommended in the manufacturer’s instruction

manual.

 Place the vibrating mesh nebulizer on a clean, flat table surface within reach. Make sure

you have followed the manufacturer’s instruction manual to make sure that the nebulizer

is charged and ready for use.

Reference ID: 5326389



Step 3. Gather the Pulmozyme ampule and check the

expiration date.

 Remove 1 foil pouch of Pulmozyme from the refrigerator.

Open the foil pouch and remove 1 ampule of

Pulmozyme. Put the remaining ampules back in the foil

pouch and return them to the refrigerator.

 Check the expiration (exp.) date printed on the ampule

(See Figure D).

Do not use the Pulmozyme ampule if the expiration date

has passed.

Figure D

Step 4. Check the Pulmozyme ampule.

 Check the ampule for leaks by turning it upside down

and gently squeezing (See Figure E).

Do not use the ampule if it is leaking. Throw it away and

get a new one.

 Check the Pulmozyme liquid in the ampule and make

sure it is clear and free of particles.

Do not use Pulmozyme if the liquid is cloudy or

discolored. Take the Pulmozyme back to the pharmacy,

hospital, or clinic that gave you the medicine.

Figure E

Step 5. Put the vibrating mesh nebulizer together.

 Put the nebulizer together according to the step-by-step manufacturer’s instruction

manual.

Reference ID: 5326389



Step 6. Prepare to take the Pulmozyme treatment.

 Follow the manufacturer’s instruction manual on how to

add the Pulmozyme medicine to the nebulizer.

 Open the Pulmozyme ampule.

 Hold the tab at the bottom of the Pulmozyme ampule

firmly. Twist off the top. Do not squeeze the body of the

ampule (See Figure F).

 Turn the ampule upside down and squeeze gently to

empty the medicine into the medicine cup. Keep

squeezing until the ampule is empty. It is very important

that you squeeze out all the medicine in the ampule.

Taking your dose of Pulmozyme with a nebulizer:

 Read the manufacturer’s instruction manual on how to

turn the nebulizer on and off and follow the steps for how

to:

o take your nebulized treatment,

o breathe through the mouthpiece or facemask,

o restart treatment if you need to stop before you are

finished, and

o confirm that your treatment is complete.

Step 7. Breathing through the mouthpiece.

 Skip to Step 8 if you are using a facemask to take

your dose of Pulmozyme.

 Place the mouthpiece between your teeth and on top of

your tongue.

o Breathe slowly in and out through your mouth when

using a mouthpiece. Do not block medicine flow with

your tongue.

o Do not breathe through your nose when using a

mouthpiece. If you have problems breathing only

through your mouth, use a nose clip (See Figure B).

Step 8. Breathing through the facemask.

 Place the facemask gently but firmly over the nose and

mouth.

 Make sure there are no air gaps between the mask and

the face. This will help make sure that you will get the full

dose of Pulmozyme.

Figure F

Reference ID: 5326389



After Your Treatment with Pulmozyme:

Step 9. Clean the nebulizer

 Throw away the empty Pulmozyme ampule in your household trash.

 Clean the nebulizer thoroughly after each use. Follow the manufacturer’s instruction

manual for cleaning the nebulizer.

 All nebulizer parts must be cleaned after each use and disinfected after each day of use

as recommended in the manufacturer’s instruction manual.

 Replace the handset as recommended in the manufacturer’s instruction manual.

How should I store Pulmozyme?

 Store Pulmozyme ampules at a refrigerated temperature between 36°F to 46°F (2°C

to 8°C) in their protective foil pouch to protect from light and heat until you are ready

to use them. When the protective foil pouch is opened, the unused ampules must be kept

refrigerated in the protective foil pouch to protect from light and heat.

 When traveling, Pulmozyme ampules should be kept refrigerated in their protective foil

pouch to protect from light and heat.

 Protect Pulmozyme from excessive heat and light.

 Do not use Pulmozyme if the ampules have been exposed to room temperature at 72°F

to 82°F (22°C to 28°C) for more than a total of 60 hours or if the solution has turned

cloudy or discolored.

 Do not use Pulmozyme past the expiration date printed on the ampule.

Genentech, Inc.

A Member of the Roche Group

1 DNA Way

South San Francisco, CA 94080-4990

US License No. 1048

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 02/2024

Reference ID: 5326389