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DRUGS & SUPPLEMENTS
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Dornase Alfa:
Cauterex (Dornase Alfa)® (dornase alfa) is indicated for daily administration in conjunction with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function.
In CF patients with an FVC ≥ 40% of predicted, daily administration of Cauterex (Dornase Alfa) has also been shown to reduce the risk of respiratory tract infections requiring parenteral antibiotics.
Cauterex (Dornase Alfa) is a recombinant DNase enzyme indicated in conjunction with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function. (1)
The recommended dosage for use in most cystic fibrosis patients is one 2.5 mg single-use ampule inhaled once daily using a recommended jet nebulizer/compressor system or eRapid Nebulizer System.
Some patients may benefit from twice daily administration
Administer Cauterex via the eRapid Nebulizer System or via a jet nebulizer connected to an air compressor with an adequate air flow and equipped with a mouthpiece or suitable face mask. No data are currently available to support the administration of Cauterex (Dornase Alfa) with other nebulizer systems.
Do not dilute or mix Cauterex (Dornase Alfa) with other drugs in the nebulizer. Mixing of Cauterex (Dornase Alfa) with other drugs could lead to adverse physicochemical and/or functional changes in Cauterex (Dornase Alfa) or the admixed compound.
Jet Nebulizer | Compressor | |
Hudson T Up-draft II® with | Pulmo-Aide® | |
Marquest Acorn II® with | Pulmo-Aide® | |
PARI LC® Plus with | PARI PRONEB® | |
| PARI PRONEB® | |
Durable Sidestream® with | MOBILAIRE | |
Durable Sidestream® with | Porta-Neb® | |
Nebulizer System | ||
eRapid Nebulizer System |
The patient should follow the manufacturer's instructions on the use and maintenance of the equipment, including cleaning and disinfection procedures.
When Cauterex (Dornase Alfa) is administered with the eRapid Nebulizer System, advise patients to replace the handset after 90 uses, regardless of whether the EasyCare cleaning aid is used. Since delivery data are not available for Cauterex (Dornase Alfa) administered with the eRapid handset beyond 90 administrations, delivery of the appropriate therapeutic dose of Cauterex (Dornase Alfa) cannot be assured beyond 90 administrations. 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 Cauterex (Dornase Alfa).
Store Cauterex (Dornase Alfa) ampules in their protective foil pouch under refrigeration and protected from light. Refrigerate ampules during transport and do not expose to room temperatures for a total time of 24 hours.
Each Cauterex (Dornase Alfa) ampule should be squeezed prior to use in order to check for leaks. Discard ampules if the solution is cloudy or discolored. Once opened, the entire contents of the ampule must be used or discarded.
Inhalation Solution: 2.5 mg/2.5 mL in single-use ampules.
Inhalation Solution: 2.5 mg/2.5 mL in single-use ampules (3)
Cauterex (Dornase Alfa) is contraindicated in patients with known hypersensitivity to Cauterex (Dornase Alfa), Chinese Hamster Ovary cell products, or any component of the product.
Cauterex (Dornase Alfa) is contraindicated in patients with known hypersensitivity to Cauterex (Dornase Alfa), Chinese Hamster Ovary cell products, or any component of the product. (4)
None.
None.
The most common adverse reactions 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
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to Cauterex (Dornase Alfa) in 902 patients, with exposures ranging from 2 weeks of daily administration up to once or twice daily administration for six months. Cauterex (Dornase Alfa) was studied in both placebo-controlled and uncontrolled trials (n=804 and n=98). The population of patients in placebo-controlled trials was with FVC ≥ 40% of predicted (n=643) or with more advanced pulmonary disease, FVC < 40% of predicted (n=161). The population in the uncontrolled trial included 98 pediatric patients with CF ranging from 3 months to 10 years of age. More than half of the patients received Cauterex (Dornase Alfa) 2.5 mg by inhalation once a day (n=581), while the rest of patients (n=321) received Cauterex (Dornase Alfa) 2.5 mg by inhalation twice a day.
Placebo-Controlled Trials
Trial 1: Trial 1 was a randomized, placebo-controlled clinical trial in patients with FVC ≥ 40% of predicted. In this trial, over 600 patients received Cauterex (Dornase Alfa) once or twice daily for six months. The most common adverse reaction (risk difference ≥5%) was voice alteration. The proportion of most adverse events was similar for patients on Cauterex (Dornase Alfa) and on placebo, probably reflecting the sequelae of the underlying lung disease. In most cases reactions that were increased were mild, transient in nature, and did not require alterations in dosing. Few patients experienced adverse reactions resulting in permanent discontinuation from Cauterex (Dornase Alfa), and the proportion of discontinuations were similar for placebo (2%) and Cauterex (Dornase Alfa) (3%). Adverse reactions occurring in a higher proportion (greater than 3%) of Cauterex (Dornase Alfa) treated patients than in placebo-treated patients are listed in Table 2.
Trial 2: Trial 2 was a randomized, placebo-controlled trial in patients with more advanced pulmonary disease (FVC < 40% of predicted) who were treated for 12 weeks. In this trial, the safety profile of Cauterex (Dornase Alfa) was similar to that reported in patients with less advanced pulmonary disease (FVC ≥ 40% of predicted). Adverse reactions that were reported in this trial with a higher proportion (greater than 3%) in the Cauterex (Dornase Alfa) treated patients are listed in Table 2.
Adverse Reactions (of any severity or seriousness) | Trial 1 CF Patients with FVC ≥ 40% of predicted treated for 24 weeks | Trial 2 CF Patients with FVC <40% of predicted treated for 12 weeks | |||
---|---|---|---|---|---|
Placebo n=325 | Cauterex (Dornase Alfa) QD n=322 | Cauterex (Dornase Alfa) BID n=321 | Placebo n=159 | Cauterex (Dornase Alfa) QD n=161 | |
Voice alteration | 7% | 12% | 16% | 6% | 18% |
Pharyngitis | 33% | 36% | 40% | 28% | 32% |
Rash | 7% | 10% | 12% | 1% | 3% |
Laryngitis | 1% | 3% | 4% | 1% | 3% |
Chest Pain | 16% | 18% | 21% | 23% | 25% |
Conjunctivitis | 2% | 4% | 5% | 0% | 1% |
Rhinitis | Differences were less than 3% | 24% | 30% | ||
FVC decrease of ≥ 10% of predicted | 17% | 22% | |||
Fever | 28% | 32% | |||
Dyspepsia | 0% | 3% | |||
Dyspnea (when reported as serious) | Differences were less than 3% | 12% | 17% |
Mortality rates observed in controlled trials were similar for the placebo and Cauterex (Dornase Alfa) treated patients. Causes of death were consistent with progression of cystic fibrosis and included apnea, cardiac arrest, cardiopulmonary arrest, cor pulmonale, heart failure, massive hemoptysis, pneumonia, pneumothorax, and respiratory failure.
Uncontrolled Trial
Trial 3: The safety of Cauterex (Dornase Alfa), 2.5 mg by inhalation, was studied with 2 weeks of daily administration in 98 pediatric patients with cystic fibrosis 3 months to 10 years of age (65 aged 3 months to < 5 years, 33 aged 5 to ≤ 10 years). The PARI BABY reusable nebulizer (which uses a facemask instead of a mouthpiece) was utilized in patients unable to demonstrate the ability to inhale or exhale orally throughout the entire treatment period (54/65, 83% of the younger and 2/33, 6% of the older patients). Overall, the nature of adverse reactions was similar to that seen in the placebo-controlled trials. The number of patients reporting cough was higher in the younger age group as compared to the older age group (29/65, 45% compared to 10/33, 30%) as was the number reporting moderate to severe cough (24/65, 37% as compared to 6/33, 18%). The number of patients reporting rhinitis was higher in the younger age group as compared to the older age group (23/65, 35% compared to 9/33, 27%) as was the number reporting rash (4/65, 6% as compared to 0/33).
Allergic Reactions
There have been no reports of anaphylaxis attributed to the administration of Cauterex (Dornase Alfa). Urticaria, mild to moderate, and mild skin rash have been observed and have been transient. Within all of the studies, a small percentage (average of 2-4%) of patients treated with Cauterex (Dornase Alfa) developed serum antibodies to Cauterex (Dornase Alfa). None of these patients developed anaphylaxis, and the clinical significance of serum antibodies to Cauterex (Dornase Alfa) is unknown.
Postmarketing spontaneous reports and prospectively collected safety data from observational studies confirm the safety profile to be as described in clinical trials [see Adverse Reactions (6.1) ].
Available data indicate there are no clinically important drug-drug interactions with Cauterex (Dornase Alfa).
Risk summary
There are no adequate and well-controlled studies with Cauterex in pregnant women. However, animal reproduction studies have been conducted with Cauterex (Dornase Alfa). In these studies, no evidence of fetal harm was observed in rats and rabbits at doses of Cauterex (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 Cauterex (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 Cauterex (Dornase Alfa) was administered to dams throughout organogenesis (Gestation days 6 to 17). Cauterex (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 Cauterex (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 Cauterex (Dornase Alfa) is present in human milk. In a pharmacokinetic study in Cynomolgus monkeys, levels of Cauterex (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 Cauterex (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 Cauterex (Dornase Alfa) and any potential adverse effects on the breastfed child from Cauterex (Dornase Alfa) or from the underlying maternal condition.
The safety and effectiveness of Cauterex have been established in pediatric patients 5 years of age and older [see Adverse Reactions (6) and Clinical Studies (14)]. The safety of Cauterex (Dornase Alfa), 2.5 mg by inhalation, was studied with 2 weeks of daily administration in 65 patients with cystic fibrosis aged 3 months to < 5 years . While clinical trial data are limited in pediatric patients younger than 5 years of age, the use of Cauterex (Dornase Alfa) should be considered for pediatric CF patients who may experience potential benefit in pulmonary function or who may be at risk of respiratory tract infection.
Cystic fibrosis is primarily a disease of children and young adults. Clinical studies of Cauterex (Dornase Alfa) did not include sufficient numbers of subjects aged 65 or older to determine whether they respond differently from younger subjects.
Single-dose inhalation studies in rats and monkeys at doses up to 180-times higher than doses routinely used in clinical studies are well tolerated. Single dose oral administration of Cauterex (Dornase Alfa) in doses up to 200 mg/kg are also well tolerated by rats.
Cystic fibrosis patients have received up to 20 mg BID for up to 6 days and 10 mg BID intermittently (2 weeks on/2 weeks off drug) for 168 days. These doses were well tolerated.
Cauterex (Dornase Alfa) is a recombinant human deoxyribonuclease I (rhDNase) an enzyme which selectively cleaves DNA. The protein is produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing DNA encoding for the native human protein, deoxyribonuclease I (DNase). Fermentation is carried out in a nutrient medium containing the antibiotic gentamicin, 100–200 mg/L. However, the presence of the antibiotic is not detectable in the final product. The product is purified by tangential flow filtration and column chromatography. The purified glycoprotein contains 260 amino acids with an approximate molecular weight of 37,000 daltons. The primary amino acid sequence is identical to that of the native human enzyme.
Cauterex (Dornase Alfa) is administered by inhalation of an aerosol mist produced by a compressed air driven nebulizer or an approved nebulizer system [see Clinical Studies (14) and Dosage and Administration (2) ]. Cauterex (Dornase Alfa) is a sterile, clear, colorless, highly purified solution in single-use ampules. Each ampule delivers 2.5 mL of the solution to the nebulizer bowl. Each mL of aqueous solution contains 1 mg Cauterex (Dornase Alfa), calcium chloride dihydrate (0.15 mg) and sodium chloride (8.77 mg). The solution contains no preservative. The nominal pH of the solution is 6.3.
Cauterex is recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA. In preclinical in vitro studies, Cauterex (Dornase Alfa) hydrolyzes the DNA in sputum of CF patients and reduces sputum viscoelasticity. In CF patients, retention of viscous purulent secretions in the airways contributes both to reduced pulmonary function and to exacerbations of infection. Purulent pulmonary secretions contain very high concentrations of extracellular DNA released by degenerating leukocytes that accumulate in response to infection.
When 2.5 mg Cauterex (Dornase Alfa) was administered by inhalation to eighteen CF patients, mean sputum concentrations of 3 µg/mL DNase were measurable within 15 minutes. Mean sputum concentrations declined to an average of 0.6 µg/mL two hours following inhalation. Inhalation of up to 10 mg TID of Cauterex (Dornase Alfa) by 4 CF patients for six consecutive days, did not result in a significant elevation of serum concentrations of DNase above normal endogenous levels. After administration of up to 2.5 mg of Cauterex (Dornase Alfa) twice daily for six months to 321 CF patients, no accumulation of serum DNase was noted. Cauterex (Dornase Alfa) is expected to be metabolized by proteases present in biological fluids. A human intravenous dose study suggested an elimination half-life of 3-4 hours for dornase alpha.
Cauterex (Dornase Alfa), 2.5 mg by inhalation, was administered daily to 98 patients aged 3 months to ≤ 10 years, and bronchoalveolar lavage (BAL) fluid was obtained within 90 minutes of the first dose. BAL DNase concentrations were detectable in all patients but showed a broad range, from 0.007 to 1.8 µg/mL. Over an average of 14 days of exposure, serum DNase concentrations (mean ± s.d.) increased by 1.1 ± 1.6 ng/mL for the 3 months to < 5 year age group and by 0.8 ± 1.2 ng/mL for the 5 to ≤ 10 year age group. The relationship between BAL or serum DNase concentration and adverse experiences and clinical outcomes is unknown.
Cauterex (Dornase Alfa) produced no treatment-related increases in the incidence of tumors in a lifetime study in Sprague Dawley rats that were administered inhaled doses up to 0.246 mg/kg/day (approximately 30 times the MRHD in adults). There was no increase in the development of benign or malignant neoplasms and no occurrence of unusual tumor types in rats after lifetime exposure.
Cauterex (Dornase Alfa) tested negative in the following genotoxicity assays: the in vitro Ames assay, in vitro mouse lymphoma assay, and in vivo mouse bone marrow micronucleus assay. No evidence of impairment of fertility was observed in male and female rats that received intravenous doses up to 10 mg/kg/day (approximately 600 times the MRHD in adults).
Trial in CF Patients with FVC >40% of Predicted
Cauterex (Dornase Alfa) has been evaluated in a randomized, placebo-controlled trial of clinically stable cystic fibrosis patients, 5 years of age and older, with baseline forced vital capacity (FVC) greater than or equal to 40% of predicted and receiving standard therapies for cystic fibrosis. Patients were treated with placebo (325 patients), 2.5 mg of Cauterex (Dornase Alfa) once a day (322 patients), or 2.5 mg of Cauterex (Dornase Alfa) twice a day (321 patients) for six months administered via a Hudson T Up-draft II® nebulizer with a Pulmo-Aide® compressor.
Both doses of Cauterex (Dornase Alfa) resulted in significant reductions in the number of patients experiencing respiratory tract infections requiring use of parenteral antibiotics compared with the placebo group. Administration of Cauterex (Dornase Alfa) reduced the relative risk of developing a respiratory tract infection by 27% and 29% for the 2.5 mg daily dose and the 2.5 mg twice daily dose, respectively. The data suggest that the effects of Cauterex (Dornase Alfa) on respiratory tract infections in older patients ( > 21 years) may be smaller than in younger patients, and that twice daily dosing may be required in the older patients. Patients with baseline FVC > 85% may also benefit from twice a day dosing. The reduced risk of respiratory infection observed in Cauterex (Dornase Alfa) treated patients did not directly correlate with improvement in FEV1 during the initial two weeks of therapy.
Within 8 days of the start of treatment with Cauterex (Dornase Alfa), mean FEV1 increased 7.9% in those treated once a day and 9.0% in those treated twice a day compared to the baseline values. The overall mean FEV1 during long-term therapy increased 5.8% from baseline at the 2.5 mg daily dose level and 5.6% from baseline at the 2.5 mg twice daily dose level. Placebo recipients did not show significant mean changes in pulmonary function testing.
For patients 5 years of age or older, with baseline FVC greater than or equal to 40%, administration of Cauterex (Dornase Alfa) decreased the incidence of occurrence of first respiratory tract infection requiring parenteral antibiotics, and improved mean FEV1, regardless of age or baseline FVC.
Placebo N=325 | 2.5 mg QD N=322 | 2.5 mg BID N=321 | |
Percent of Patients Infected | 43% | 34% | 33% |
Relative Risk (vs placebo) | 0.73 | 0.71 | |
p-value (vs placebo) | 0.015 | 0.007 | |
Subgroup by Age and Baseline FVC | Placebo % (N) | 2.5 mg QD % (N) | 2.5 mg BID % (N) |
Age | |||
5-20 years | 42% (201) | 25% (199) | 28% (184) |
21 years and older | 44% (124) | 48% (123) | 39% (137) |
Baseline FVC | |||
40-85% Predicted | 54% (194) | 41% (201) | 44% (203) |
> 85% Predicted | 27% (131) | 21% (121) | 14% (118) |
Trial in CF Patients with FVC <40% of Predicted
Cauterex (Dornase Alfa) has also been evaluated in a second randomized, placebo-controlled trial in clinically stable patients with baseline FVC < 40% of predicted. Patients were enrolled and treated with placebo (162 patients) or Cauterex (Dornase Alfa) 2.5 mg QD (158 patients) for twelve weeks. In patients who received Cauterex (Dornase Alfa), there was an increase in mean change (as percent of baseline) compared to placebo in FEV1 (9.4% vs. 2.1%, p < 0.001) and in FVC (12.4% vs. 7.3%, p < 0.01). Cauterex (Dornase Alfa) did not significantly reduce the risk of developing a respiratory tract infection requiring parenteral antibiotics (54% of Cauterex (Dornase Alfa) patients vs. 55% of placebo patients had experienced a respiratory tract infection by 12 weeks, relative risk =.93, p = 0.62).
The effect of Cauterex (Dornase Alfa) on exercise tolerance has not been established in adult and pediatric patients.
Other Studies
Clinical trials have indicated that Cauterex (Dornase Alfa) therapy can be continued or initiated during an acute respiratory exacerbation.
Short-term dose ranging studies demonstrated that doses in excess of 2.5 mg BID did not provide further improvement in FEV1. Patients who have received drug on a cyclical regimen (i.e., administration of Cauterex (Dornase Alfa) 10 mg BID for 14 days, followed by a 14 day wash out period) showed rapid improvement in FEV1 with the initiation of each cycle and a return to baseline with each Cauterex (Dornase Alfa) withdrawal.
Cauterex (Dornase Alfa) is supplied in:
Storage and Handling
Store Cauterex (Dornase Alfa) under refrigeration (2°C to 8°C/36°F to 46°F) in their protective foil to protect from light. Do not use beyond the expiration date stamped on the ampule. Store unused ampules in their protective foil pouch under refrigeration. Refrigerate Cauterex (Dornase Alfa) during transport and do not expose to room temperatures for a total time of 24 hours.
Advise patients to read the FDA-approved Patient Labeling (Instructions for Use)
Storage and Handling Information
Instruct patients on the proper techniques to store and handle Cauterex (Dornase Alfa). Cauterex (Dornase Alfa) must be stored in the refrigerator at 2 to 8°C (36 to 46°F) and protected from light. It should be kept refrigerated during transport and should not be exposed to room temperatures for a total time of 24 hours.
Advise patients to squeeze each ampule prior to use in order to check for leaks. The solution should be discarded if it is cloudy or discolored. Once opened, the entire contents of the ampule must be used or discarded.
Instruct patients in the proper use and maintenance of the jet nebulizer/compressor system or eRapid Nebulizer System used in Cauterex (Dornase Alfa) delivery.
Instruct patients not to dilute or mix Cauterex (Dornase Alfa) with other drugs in the nebulizer. Mixing of Cauterex (Dornase Alfa) with other drugs could lead to adverse physicochemical and/or functional changes in Cauterex (Dornase Alfa) or the admixed compound.
Use with the eRapid Nebulizer System
Instruct patients and caregivers to read and follow the directions in both the Cauterex (Dornase Alfa) Instructions for Use and in the Manufacturer's eRapid Nebulizer System Instruction Booklet.
Instruct patients and caregivers to clean the handset, including the medication reservoir, medicine cap, aerosol head, and mouthpiece, after each use. Instruct patients and caregivers to disinfect the handset, including the medication reservoir, medicine cap, aerosol head, and mouthpiece, after each day of use.
Instruct patients to replace the handset after 90 uses, regardless of whether the EasyCare cleaning aid is used. Since delivery data are not available for Cauterex (Dornase Alfa) administered with the eRapid handset beyond 90 administrations, delivery of the appropriate therapeutic dose of Cauterex (Dornase Alfa) cannot be assured beyond 90 administrations.
Cauterex (Dornase Alfa)® (dornase alfa)
Inhalation Solution
Manufactured by:
Genentech, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990
US License No. 1048
©2014 Genentech, Inc. All rights reserved
©2014 Genentech, Inc.
Cauterex (Dornase Alfa)® is a trademark of Genentech, Inc.
Cauterex (Dornase Alfa)® (PULL-muh-zyme)
(dornase alfa)
Inhalation Solution
Instructions for Use with Jet Nebulizers and Compressors
See the other side of this Instructions for Use for information on use of Cauterex (Dornase Alfa) with the ultrasonic eRapid Nebulizer System
Read this Instructions for Use before you start taking Cauterex (Dornase Alfa) 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 Cauterex (Dornase Alfa). A nebulizer changes the Cauterex (Dornase Alfa) liquid medicine into a fine mist you inhale by breathing through a mouthpiece. A compressor gives the nebulizer power and makes the nebulizer work.
Cauterex (Dornase Alfa) should only be used with the approved nebulizers and compressors listed below, or with the eRapid Nebulizer System.
Do not use any other inhaled medicines in the nebulizer at the same time. Keep all other inhaled medication systems completely separate from Cauterex (Dornase Alfa).
Do not use a mask. Use the mouthpiece provided with each 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 sheet to administer Cauterex (Dornase Alfa) using the following jet nebulizer systems.
Nebulizer | Compressor |
---|---|
Hudson T Up-draft II® with | Pulmo-Aide® |
Marquest Acorn II® with | Pulmo-Aide® |
PARI LC® Plus with | PARI PRONEB® |
PARI BABY with | PARI PRONEB® |
Durable Sidestream® with | MOBILAIRE |
Durable Sidestream® with | Porta-Neb® |
Supplies you will need to give a dose of Cauterex (Dornase Alfa) :
Preparing the jet nebulizer and compressor: Step 1. Clean a flat table surface and wash your hands.
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Step 2. Gather the nebulizer and test the compressor.
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Step 3. Gather the Cauterex (Dornase Alfa) ampule and check the expiration date.
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Step 4. Check the Cauterex (Dornase Alfa) ampule.
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Step 5. Attach the tube to the compressor.
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Step 6. Attach the mouthpiece.
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Step 7. Remove the cap from the cup.
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Step 8. Open the Cauterex (Dornase Alfa) ampule.
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Step 9. Pour the full Cauterex (Dornase Alfa) dose into the nebulizer.
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Step 10. Connect the plastic T.
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Step 11. Attach the tube to the cup.
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Step 12. Turn on the compressor.
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Taking your dose of Cauterex (Dornase Alfa) with a nebulizer: | |
Step 13. Breathe through the mouthpiece.
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If you are using the PARI BABY nebulizer to give Cauterex (Dornase Alfa) to your child, follow the instructions below in Step 14. If not, go to Step 15 Step 14. Breathing through the facemask | |
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It is important that your child inhale the full dose of Cauterex (Dornase Alfa). 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 . | |
After your treatment with Cauterex (Dornase Alfa): Step 15. Prepare the nebulizer for cleaning and storage.
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How should I store Cauterex (Dornase Alfa)?
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This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Genentech, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990
US License No. 1048
Approved: December 2014
Figure A Figure B Figure C Figure D Figure E Figure F Figure G Figure H Figure I Figure J Figure K Figure L Figure M Figure N Figure O Figure P Figures Q Figures R Figure S Figure T Figure U Figure V Figure W Figure X Figure Y Figure A Figure B Figure C Figure D Figure E Figure F Figure G Figure H Figure I Figure J Figure K Figure L Figure M Figure N Figure O Figure P Figure Q
Cauterex (Dornase Alfa)® (PULL-muh-zyme)
(dornase alfa)
Inhalation Solution
Instructions for Use with the eRapid Nebulizer System
See the other side of this Instructions for Use for information on use with Jet Nebulizers and Compressors
Read this Instructions for Use before you start taking Cauterex (Dornase Alfa) 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 eRapid Nebulizer System Instruction Booklet. This information is needed to show you the right way to use the eRapid Nebulizer System.
The eRapid Nebulizer System changes the Cauterex (Dornase Alfa) 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 Cauterex (Dornase Alfa).
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 Cauterex (Dornase Alfa).
Follow the instructions on this side of the sheet to give Cauterex (Dornase Alfa) using the eRapid Nebulizer System.
Supplies you will need to give a dose of Cauterex (Dornase Alfa) :
Preparing the eRapid nebulizer system: | |
Step 1. Clean a flat table surface and wash your hands.
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Step 2. Gather the nebulizer and test it.
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Step 3. Gather the Cauterex (Dornase Alfa) ampule and check the expiration date.
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Step 4. Check the Cauterex (Dornase Alfa) ampule.
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Step 5. Put together the eRapid nebulizer system.
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Step 6. Open the Cauterex (Dornase Alfa) ampule.
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Step 7. Pour the full Cauterex (Dornase Alfa) dose into the nebulizer.
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Step 8. Place the cap on the Medication Reservoir.
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Step 9. Turn on the nebulizer.
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Taking your dose of Cauterex (Dornase Alfa): Step 10. Breathe through the mouthpiece. | |
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Step 11. Check that you received your full dose.
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After Your Treatment with Cauterex (Dornase Alfa): | |
Step 12. Cleaning the nebulizer
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How should I store Cauterex (Dornase Alfa)?
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This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Genentech, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990
US License No. 1048
Approved: December 2014
Representative sample of labeling :
Gentamicin Sulfate:
F-27078915
NADA #141-177, Approved by FDA.
PRODUCT
INFORMATION
VETERINARY
For Otic Use in Dogs Only
CAUTION Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Keep this and all drugs out of the reach of children.
DESCRIPTION Each gram of Cauterex (Gentamicin Sulfate) Otic Suspension contains Cauterex (Gentamicin Sulfate) sulfate, USP equivalent to 3 mg Cauterex (Gentamicin Sulfate) base; mometasone furoate monohydrate equivalent to 1 mg mometasone; and 10 mg clotrimazole, USP in a mineral oilbased system containing a plasticized hydrocarbon gel.
PHARMACOLOGY
Cauterex (Gentamicin Sulfate): Cauterex (Gentamicin Sulfate) sulfate is an aminoglycoside antibiotic active against a wide variety of gram-negative and grampositive bacteria. In vitro tests have determined that Cauterex (Gentamicin Sulfate) is bactericidal and acts by inhibiting normal protein synthesis in susceptible microorganisms. In clinical trials, Cauterex (Gentamicin Sulfate) was shown to have a range of activity against the following organisms commonly isolated from infected canine ears:
Pseudomonas spp. (including P. aeruginosa), coagulasepositive staphylococci, Enterococcus faecalis, Proteus mirabilis and beta-hemolytic streptococci.
Mometasone: Mometasone furoate monohydrate is a synthetic adrenocorticoid characterized by a novel (2') furoate 17-ester having chlorine at the 9 and 21 positions, which have shown to possess high topical potency.
Systemic absorption of mometasone furoate ointment was found to be minimal (2%) over 1 week when applied topically to dogs with intact skin. In a 6-month dermal toxicity study using 0.1% mometasone ointment on healthy intact skin in dogs, systemic effects typical of corticosteroid therapy were noted.
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal, intact skin. Inflammation can increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.
Clotrimazole: Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of dermatophytes and yeast. The primary action of clotrimazole is against dividing and growing organisms.
In vitro, clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida spp., and Malassezia pachydermatis. Resistance to clotrimazole is very rare among the fungi that cause superficial mycoses. In an induced otitis externa study using dogs infected with Malassezia pachydermatis, 1% clotrimazole in the vehicle formulation was effective both microbiologically and clinically in terms of reduction of exudate, odor, and swelling.
In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. These events began rapidly and extensively after addition of the drug. Clotrimazole is very poorly absorbed following dermal application.
Gentamicin-Mometasone-Clotrimazole: By virtue of its three active ingredients, Cauterex (Gentamicin Sulfate) Otic Suspension has antibacterial, anti-inflammatory, and antifungal activity. In clinical field trials, Cauterex (Gentamicin Sulfate) Otic Suspension was effective in the treatment of otitis externa associated with bacteria and Malassezia pachydermatis. Cauterex (Gentamicin Sulfate) Otic Suspension reduced discomfort, redness, swelling, exudate, and odor.
INDICATIONS Cauterex (Gentamicin Sulfate) Otic Suspension is indicated for the treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P. aeruginosa], coagulasepositive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).
CONTRAINDICATIONS If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Do not use in dogs with known perforation of eardrums.
WARNINGS The use of these components has been associated with deafness or partial hearing loss in a small number of sensitive dogs (eg, geriatric). The hearing deficit is usually temporary. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of Cauterex (Gentamicin Sulfate) Otic Suspension immediately and flush the ear canal thoroughly with a nonototoxic solution.
Corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs that received corticosteroids during pregnancy.
Field and experimental data have demonstrated that corticostroids administered orally or parenterally to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.
PRECAUTIONS Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membrane is not ruptured in order to avoid the possibility of transmitting infection to the middle ear as well as damaging the cochlea or vestibular apparatus from prolonged contact.
Administration of recommended doses of Cauterex (Gentamicin Sulfate) Otic Suspension beyond 7 days may result in delayed wound healing. If overgrowth of nonsusceptible bacteria or fungi occurs, treatment should be discontinued and appropriate therapy instituted.
Avoid ingestion. Adverse systemic reactions have been observed following the oral ingestion of some topical corticosteroid preparations. Patients should be closely observed for the usual signs of adrenocorticoid overdosage which include sodium retention, potassium loss, fluid retention, weight gain, polydipsia, and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects.
Use of corticosteroids, depending on dose, duration, and specific steroid, may result in endogenous steroid production inhibition following drug withdrawal. In patients presently receiving or recently withdrawn from corticosteroid treatments, therapy with a rapidly acting corticosteroid should be considered in especially stressful situations.
TOXICOLOGY Field and safety studies with Cauterex (Gentamicin Sulfate) Otic Suspension have shown a wide safety margin at the recommended dose level in dogs (see PRECAUTIONS/ADVERSE REACTIONS ).
ADVERSE REACTIONS
Cauterex (Gentamicin Sulfate): While aminoglycosides are absorbed poorly from skin, intoxication may occur when aminoglycosides are applied topically for prolonged periods of time to large wounds, burns, or any denuded skin, particularly if there is renal insufficiency. All aminoglycosides have the potential to produce reversible and irreversible vestibular, cochlear, and renal toxicity.
Mometasone: ALP (SAP) and ALT (SGPT) enzyme elevations, weight loss, anorexia, polydipsia, polyuria, neutrophilia, and lymphopenia have occurred following the use of parenteral, high-dose, and/or prolonged or systemic synthetic corticosteroids in dogs. Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.
Clotrimazole: The following have been reported occasionally in humans in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin not present before therapy.
Cauterex (Gentamicin Sulfate) Otic Suspension: In field studies following once daily teatment with Cauterex (Gentamicin Sulfate) Otic Suspension, ataxia, proprioceptive deficits, and increased water consumption were observed in less than 1% of 164 dogs. In a field study following twice-daily treatment with Cauterex (Gentamicin Sulfate) Otic Suspension, inflammation of the pinna and diarrhea were observed in less than 1% of 141 dogs.
DOSAGE AND ADMINISTRATION
The external ear canal should be thoroughly cleaned and dried before treatment. Verify that the eardrum is intact. For dogs weighing less than 30 lbs, instill 4 drops from the 7.5 g, 15 g, and 30 g bottles (2 drops from the 215 g bottle) of Cauterex (Gentamicin Sulfate) Otic Suspension once daily into the ear canal. For dogs weighing 30 lbs or more, instill 8 drops from the 7.5 g, 15 g, and 30 g bottles (4 drops from the 215 g bottle) once daily into the ear canal. Therapy should continue for 7 consecutive days.
HOW SUPPLIED Cauterex (Gentamicin Sulfate) Otic Suspension is available in 7.5 g (NDC 14043-120-75), 15 g (NDC 14043-120-15), 30 g (NDC 14043-120-30), and 215 g (NDC 14043-120-21) plastic bottles.
Store between 2° and 25°C (36° and 77°F). Shake well before use.
U.S. Patent No. 6,127,353.
Distributed by
PATTERSON VETERINARY
137 Barnum Road, Devens, MA 01434
www.pattersonvet.com
Made in Canada.
9/15
85239791
Depending on the reaction of the Cauterex after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Cauterex not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Cauterex addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology