PULMOZYME- dornase alfa solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

DORNASE ALFA (UNII: 953A26OA1Y) (DORNASE ALFA - UNII:953A26OA1Y)

Предлага се от:

Genentech, Inc.

INN (Международно Name):

DORNASE ALFA

Композиция:

DORNASE ALFA 1 mg in 1 mL

Начин на приложение:

RESPIRATORY (INHALATION)

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

PULMOZYME® is indicated, in conjunction 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 parenteral antibiotics. PULMOZYME is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product. Risk Summary There are no adequate and well-controlled studies with PULMOZYME in pregnant women. However, animal reproduction studies have been conducted with dornase alfa. In these studies, no evidence of fetal harm was observed in rats and rabbits at doses of dornase alfa up to approximately 600 times the maximum recommended human dose (MRHD). The background risk of major birth defects and miscarriage for the cystic fibrosis population is unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. Data Animal Data Reproductive studies have been performed in rats and rabbits at intravenous doses of dornase alfa up to 10 mg/kg/day (approximately 600 times the MRHD in adults). In a combined embryo-fetal development and pre- and post-natal development study, no evidence of maternal toxicity, embryotoxicity, or teratogenicity was observed when dornase alfa was administered to dams throughout organogenesis (Gestation days 6 to 17). Dornase alfa did not elicit adverse effects on fetal or neonatal growth when administered to dams throughout most of gestation and delivery (Gestation days 6 to 25) and nursing (Post-partum days 6 to 21). A pharmacokinetic study in Cynomolgus monkeys found no detectable levels of dornase alfa in fetal blood or amniotic fluid on gestation day 150 (end of gestation) from mothers that were administered an intravenous bolus dose (0.1 mg/kg) followed by an intravenous infusion dose (0.080 mg/kg) over a 6-hour period during pregnancy. Risk Summary It is not known whether PULMOZYME is present in human milk. In a pharmacokinetic study in Cynomolgus monkeys, levels of dornase alfa detected in milk were less than 0.1% of the maternal serum concentration at 24 hours after dosing [intravenous bolus dose (0.1 mg/kg) of dornase alfa followed by an intravenous infusion (0.080 mg/kg/hr) over a 6-hour period] on post-partum day 14. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PULMOZYME and any potential adverse effects on the breastfed child from PULMOZYME or from the underlying maternal condition. The safety and effectiveness of PULMOZYME in conjunction with standard therapies for cystic fibrosis have been established in pediatric patients. Use of PULMOZYME in pediatric patients is supported by evidence in the following age groups: - Patients 5 to 17 years of age: Use of PULMOZYME in patients 5 to 17 years of age is supported by evidence from a randomized, placebo-controlled trial of 303 of clinically stable cystic fibrosis patients 5 to 17 years of age who received PULMOZYME [see Clinical Studies (14)]. - Patients less than 5 years : Use of PULMOZYME in patients less than 5 years of age is supported by extrapolation of efficacy data in patients 5 years of age and older with additional safety data in 65 pediatric patients aged 3 months to less than 5 years who received PULMOZYME 2.5 mg daily by inhalation for 2 weeks [see Adverse Reactions (6.1) and Clinical Studies (14)] . Cystic fibrosis is primarily a disease of children and young adults. Clinical studies of PULMOZYME did not include sufficient numbers of subjects aged 65 or older to determine whether they respond differently from younger subjects. 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. Follow the steps on this side of the Instructions for Use to give Pulmozyme using the following jet nebulizer systems - Approximate air flow of 3.5 L/min to 12 L/min at approximately 20 psi to 45 psi pressure 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) - 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) . - 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) . - 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. - 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. - Attach the long connecting tube to the "air out" or "air" port on the compressor (See Figure F) . - 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) . - 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) . - 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) . - 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) . - 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). - 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) . - Turn on the compressor and check to see that mist is coming out of the nebulizer (See Figure Q) . - 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) . - 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) . - 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) . - If you need to stop the treatment or your child begins to cough during treatment, turn the compressor off. Do not spill any Pulmozyme. - If you have not removed the mask and you want to begin the treatment again, turn on the compressor. - If you have removed the mask, repeat the steps above to replace the mask on your child's face and restart the compressor. - The complete treatment usually takes from 10 to 15 minutes. - Turn off the compressor and take apart the nebulizer system. Set aside the flexible aerosol tube and the long connecting tube. Note: 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. - 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. 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 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: 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) - 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) . - 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. - 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. - 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. - Put the nebulizer together according to the step-by-step manufacturer's instruction manual. - 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. - Read the manufacturer's instruction manual on how to turn the nebulizer on and off and follow the steps for how to: take your nebulized treatment, breathe through the mouthpiece or facemask, restart treatment if you need to stop before you are finished, and confirm that your treatment is complete. - take your nebulized treatment, - breathe through the mouthpiece or facemask, - restart treatment if you need to stop before you are finished, and - confirm that your treatment is complete. - 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. Breathe slowly in and out through your mouth when using a mouthpiece. Do not block medicine flow with your tongue. 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) . - Breathe slowly in and out through your mouth when using a mouthpiece. Do not block medicine flow with your tongue. - 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) . - 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. - 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 Representative sample of labeling (see the HOW SUPPLIED section for complete listing):

Каталог на резюме:

PULMOZYME (dornase alfa) inhalation solution is a sterile, clear, colorless solution supplied in: Storage and Handling Store PULMOZYME ampules at a refrigerated temperature between 2°C to 8°C (36°F to 46°F) in their protective foil to protect from light and heat. Once the protective foil pouch is opened, the unused ampules must be kept refrigerated in the protective foil pouch to protect from light and heat. Do not use beyond the expiration date stamped on the ampule. During transport, keep the ampules refrigerated in their protective foil pouch to protect from light and heat. Do not use if the ampules are exposed to room temperature (22°C to 28°C [72°F to 82°F]) for more than a total of 60 hours. Avoid excessive heat and light.

Статус Оторизация:

Biologic Licensing Application

Данни за продукта

PULMOZYME- DORNASE ALFA SOLUTION
GENENTECH, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PULMOZYME SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PULMOZYME.
PULMOZYME (DORNASE ALFA) INHALATION SOLUTION, FOR INHALATION USE
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
Dosage and Administration. (2.1, 2.2)
02/2024
INDICATIONS AND USAGE
PULMOZYME is a recombinant DNase enzyme indicated in conjunction with
standard therapies for the
management of cystic fibrosis (CF) patients to improve pulmonary
function. (1)
DOSAGE AND ADMINISTRATION
The recommended dosage is 2.5 mg (one single-dose ampule) inhaled once
daily using a
recommended nebulizer. (2.1)
Some patients may benefit from twice daily administration. (2.1)
See full prescribing information for the recommended nebulizers for
use with PULMOZYME. (2.2)
DOSAGE FORMS AND STRENGTHS
Inhalation solution: 2.5 mg/2.5 mL (1 mg/mL) clear, colorless solution
in single-dose ampules (3)
CONTRAINDICATIONS
PULMOZYME is contraindicated in patients with known hypersensitivity
to dornase alfa, Chinese Hamster
Ovary cell products, or any component of the product. (4)
WARNINGS AND PRECAUTIONS
None. (5)
ADVERSE REACTIONS
The most common adverse reactions (occurring in ≥3% of patients
treated with PULMOZYME over
placebo) seen in clinical trials in CF patients were: voice
alteration, pharyngitis, rash, laryngitis, chest pain,
conjunctivitis, rhinitis, decrease in FVC of ≥10%, fever, and
dyspnea. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GENENTECH AT
1-888-835-2555 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 2/2024
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Administration Instructions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
®
7 DRUG