Curosurf

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Curosurf uses


1 INDICATIONS AND USAGE

Curosurf® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants. Curosurf reduces mortality and pneumothoraces associated with RDS.

Curosurf is a surfactant indicated for the rescue treatment, including the reduction of mortality and pneumothoraces, of Respiratory Distress Syndrome (RDS) in premature infants. (1)


2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

For intracheal administration only.

Curosurf should be administered by, or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants. Before administering Curosurf, assure proper placement and patency of the endotracheal tube. At the discretion of the clinician, the endotracheal tube may be suctioned before administering Curosurf. Allow the infant to stabilize before proceeding with dosing.

Administer Curosurf either:

2.2 Recommended Dosage

The initial recommended dose is 2.5 mL/kg birth weight, administered as one or two aliquots depending upon the instillation procedure .

Up to two repeat doses of 1.25 mL/kg birth weight each may be administered at approximately 12-hour intervals in infants who remain intubated and in whom RDS is considered responsible for their persisting or deteriorating respiratory status. The maximum recommended total dosage (sum of the initial and up to two repeat doses) is 5 mL/kg.

Table 1: Curosurf Weight-Based Dosing Chart for Rescue Treatment of RDS


Weight

(grams)


Initial Dose

2.5 mL/kg


Repeat Dose

1.25 mL/kg


Weight

(grams)


Initial Dose

2.5 mL/kg


Repeat Dose

1.25 mL/kg


Each Dose (mL)


Each Dose (mL)


600-650


1.60


0.80


1301-1350


3.30


1.65


651-700


1.70


0.85


1351-1400


3.50


1.75


701-750


1.80


0.90


1401-1450


3.60


1.80


751-800


2.00


1.00


1451-1500


3.70


1.85


801-850


2.10


1.05


1501-1550


3.80


1.90


851-900


2.20


1.10


1551-1600


4.00


2.00


901-950


2.30


1.15


1601-1650


4.10


2.05


951-1000


2.50


1.25


1651-1700


4.20


2.10


1001-1050


2.60


1.30


1701-1750


4.30


2.15


1051-1100


2.70


1.35


1751-1800


4.50


2.25


1101-1150


2.80


1.40


1801-1850


4.60


2.30


1151-1200


3.00


1.50


1851-1900


4.70


2.35


1201-1250


3.10


1.55


1901-1950


4.80


2.40


1251-1300


3.20


1.60


1951-2000


5.00


2.50


2.3 Preparation of the Curosurf Suspension

2.4 Administration

For endotracheal tube instillation using a 5 French end-hole catheter


For endotracheal instillation using the secondary lumen of a dual lumen endotracheal tube

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3 DOSAGE FORMS AND STRENGTHS

Curosurf (poractant alfa) is an intratracheal suspension available in vials:


Curosurf is a white to creamy white suspension. Each mL of suspension contains 80 mg Curosurf (surfactant extract) that includes 76 mg of phospholipids and 1 mg of protein of which 0.45 mg is SP-B and 0.59 mg is SP-C.

Intratracheal Suspension: 80 mg Curosurf (surfactant extract) in 1 mL of suspension includes 76 mg of phospholipids and 1 mg of protein of which 0.45 mg is SP-B and 0.59 mg is SP-C

4 CONTRAINDICATIONS

None.

None.

5 WARNINGS AND PRECAUTIONS

5.1 Acute Changes in Oxygenation and Lung Compliance

The administration of exogenous surfactants, including Curosurf, can rapidly affect oxygenation and lung compliance. Therefore, infants receiving Curosurf should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified to respond to respiratory changes. Curosurf should only be administered by those trained and experienced in the care, resuscitation, and stabilization of pre-term infants.

5.2 Administration-Related Adverse Reactions

Transient adverse reactions associated with administration of Curosurf include bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation. These events require stopping Curosurf administration and taking appropriate measures to alleviate the condition. After the patient is stable, dosing may proceed with appropriate monitoring.

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6 ADVERSE REACTIONS


To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA, Inc. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1 Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Adverse Reactions in Studies in Premature Infants with Respiratory Distress Syndrome

The safety data described below reflect exposure to Curosurf at a single dose of 2.5 mL/kg (200 mg/kg), in 78 infants of 700-2000 grams birth weight with RDS requiring mechanical ventilation and a FiO2 ≥ 0.60 (Study 1) [see clinical studies (14.1)]. A total of 144 infants were studied after RDS developed and before 15 hours of age; 78 infants received Curosurf 2.5 mL/kg single dose (200 mg/kg), and 66 infants received control treatment (disconnection from the ventilator and manual ventilation for 2 minutes).

Transient adverse effects seen with the administration of Curosurf included bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation. The rates of the most common serious complications associated with prematurity and RDS observed in Study 1 are shown in Table 2.

Table 2: Most Common Serious Complications Associated with Prematurity and RDS in Study 1


Curosurf 2.5 mL/kg

n=78


CONTROL*

n=66


Acquired Pneumonia


17%


21%


Acquired Septicemia


14%


18%


Bronchopulmonary Dysplasia


18%


22%


Intracranial Hemorrhage


51%


64%


Patent Ductus Arteriosus


60%


48%


Pneumothorax


21%


36%


Pulmonary Interstitial Emphysema


21%


38%


*Control patients were disconnected from the ventilator and manually ventilated for 2 minutes. No surfactant was instilled.

Seventy-six infants (45 treated with Curosurf) from study 1 were evaluated at 1 year of age and 73 infants (44 treated with Curosurf) were evaluated at 2 years of age to assess for potential long-term adverse reactions. Data from follow-up evaluations for weight and length, persistent respiratory symptoms, incidence of cerebral palsy, visual impairment, or auditory impairment was similar between treatment groups. In 16 patients (10 treated with Curosurf and 6 controls) evaluated at 5.5 years of age, the developmental quotient, derived using the Griffiths Mental Developmental Scales, was similar between groups.

6.2 Immunogenicity

Immunological studies have not demonstrated differences in levels of surfactant-anti-surfactant immune complexes and anti-CUROSURF antibodies between patients treated with Curosurf and patients who received control treatment.

6.3 Postmarketing Experience

Pulmonary hemorrhage, a known complication of premature birth and very low birth-weight, has been reported both in clinical trials with Curosurf and in postmarketing adverse event reports in infants who had received Curosurf.

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8 USE IN SPECIFIC POPULATIONS

8.4 Pediatric Use

Curosurf is indicated for the rescue treatment, including the reduction of mortality and pneumothoraces, of Respiratory Distress Syndrome (RDS) in premature infants [see Indications and Usage (1) and Dosage Administration (2)].

The safety and efficacy of Curosurf in the treatment of full term infants or older pediatric patients with respiratory failure has not been established.

10 OVERDOSAGE

There have been no reports of overdosage following the administration of Curosurf.

In the event of accidental overdosage, and if there are clear clinical effects on the infant's respiration, ventilation, or oxygenation, aspirate as much of the suspension as possible and provide the infant with supportive treatment, with particular attention to fluid and electrolyte balance.

11 DESCRIPTION

Curosurf (poractant alfa) is a sterile, non-pyrogenic pulmonary surfactant intended for intratracheal use only. Curosurf is an extract of natural porcine lung surfactant consisting of 99% polar lipids (mainly phospholipids) and 1% hydrophobic low molecular weight proteins (surfactant associated proteins SP-B and SP-C).

Curosurf is a white to creamy white suspension of Curosurf. Each milliliter of suspension contains 80 mg of Curosurf (surfactant extract) that includes 76 mg of phospholipids and 1 mg of protein of which 0.45 mg is SP-B and 0.59 mg is SP-C. The amount of phospholipids is calculated from the content of phosphorus and contains 55 mg of phosphatidylcholine of which 30 mg is dipalmitoylphosphatidylcholine. It is suspended in 0.9% sodium chloride solution. The pH is adjusted with sodium bicarbonate to a pH of 6.2 (5.5 to 6.5).

Curosurf contains no preservatives.

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Endogenous pulmonary surfactant reduces surface tension at the air-liquid interface of the alveoli during ventilation and stabilizes the alveoli against collapse at resting transpulmonary pressures. A deficiency of pulmonary surfactant in preterm infants results in Respiratory Distress Syndrome characterized by poor lung expansion, inadequate gas exchange, and a gradual collapse of the lungs (atelectasis).

Curosurf compensates for the deficiency of surfactant and restores surface activity to the lungs of these infants.

12.2 Pharmacodynamics

In vitro - Curosurf lowers minimum surface tension to ≤ 4mN/m as measured by the Wilhelmy Balance System.

12.3 Pharmacokinetics

Curosurf is administered directly to the lung, where biophysical effects occur at the alveolar surface. No human pharmacokinetic studies have been performed to characterize the absorption, biotransformation, or elimination of Curosurf.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies to assess potential carcinogenic effects of Curosurf have not been conducted.

Curosurf was negative for genotoxicity in the following assays: bacterial reverse mutation assay (Ames test), gene mutation assay in Chinese hamster V79 cells, chromosomal aberration assay in Chinese hamster ovary cells, unscheduled DNA synthesis in HELA S3 cells, and in vivo mouse micronucleus assay.

No studies to assess reproductive effects of Curosurf have been performed.

14 CLINICAL STUDIES

14.1 Rescue Treatment of Respiratory Distress Syndrome

The clinical efficacy of Curosurf in the treatment of established Respiratory Distress Syndrome (RDS) in premature infants was demonstrated in one single-dose study (Study 1) and one multiple-dose study (Study 2) involving approximately 500 infants. Each study was randomized, multicenter, and controlled.

In study 1, premature infants 700 to 2000 grams birth weight with RDS requiring mechanical ventilation and a FiO2 ≥ 0.60 were enrolled. Curosurf 2.5 mL/kg single dose (200 mg/kg) or control (disconnection from the ventilator and manual ventilation for 2 minutes) was administered after RDS developed and before 15 hours of age. The results from Study 1 are shown below in Table 3.

Table 3: Study 1 Results in Premature Infants with Respiratory Distress Syndrome


Efficacy Parameter


Single Dose

Curosurf

n=78


Control

n=67


p-Value


Mortality at 28 Days (All Causes)


31%


48%


≤0.05


Bronchopulmonary Dysplasia*


18%


22%


N.S.


Pneumothorax


21%


36%


≤0.05


Pulmonary Interstitial Emphysema


21%


38%


≤0.05


*Bronchopulmonary dysplasia (BPD) diagnosed by positive x-ray and supplemental oxygen dependence at 28 days of life.

N.S.: not statistically significant

In Study 2, premature infants 700 to 2000 g birth weight with RDS requiring mechanical ventilation and a FiO2 ≥ 0.60 were enrolled. In this two-arm trial, Curosurf was administered after RDS developed and before 15 hours of age, as a single-dose or as multiple doses. In the single-dose arm, infants received Curosurf 2.5 mL/kg (200 mg/kg). In the multiple-dose arm, the initial dose of Curosurf was 2.5 mL/kg followed by up to two 1.25 mL/kg (100 mg/kg) doses of Curosurf. The results from Study 2 are shown below in Table 4.

Table 4: Study 2 Results in Premature Infants with Respiratory Distress Syndrome


Efficacy Parameter


Single Dose

Curosurf

n=184

Rate (%)


Multiple Dose

Curosurf

n=173

Rate (%)


p-Value


Mortality at 28 Days (All Causes)


21


13


0.048


Bronchopulmonary Dysplasia*


18


18


N.S.


Pneumothorax


17


9


0.03


Pulmonary Interstitial Emphysema


27


22


N.S.


*Bronchopulmonary dysplasia (BPD) diagnosed by positive x-ray and supplemental oxygen dependence at 28 days of life.

N.S.: not statistically significant

There is no controlled experience on the effects of administering initial doses of Curosurf other than 2.5 mL/kg (200 mg/kg), subsequent doses other than 1.25 mL/kg (100 mg/kg), administration of more than three total doses, dosing more frequently than every 12 hours, or initiating therapy with Curosurf more than 15 hours after diagnosing RDS. Adequate data are not available on the use of Curosurf in conjunction with experimental therapies of RDS, e.g., high-frequency ventilation or extracorporeal membrane oxygenation.

16 HOW SUPPLIED/STORAGE AND HANDLING

Curosurf (poractant alfa) intratracheal suspension is available in sterile, rubber-stoppered clear glass vials containing (one vial per carton):


Store Curosurf intratracheal suspension in a refrigerator at +2 to +8°C (36 to 46°F). PROTECT FROM LIGHT. Do not shake. Vials are for single use only. After opening the vial discard the unused portion [see Dosage and Administration (2.3)].

Manufactured for:

Chiesi USA, Inc.

Cary, NC 27518

Manufactured by and licensed from:

Chiesi Farmaceutici, S.p. A.

Parma, Italy 43100

CTC-007-1214-01-SPL-2



Curosurf 1.5mL Box

Curosurf pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Curosurf available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Curosurf destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Curosurf Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Curosurf pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."CUROSURF (PORACTANT ALFA) SUSPENSION [CHIESI USA, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "Poractant alfa". https://pubchem.ncbi.nlm.nih.gov/su... (accessed August 28, 2018).
  3. "Poractant alfa - DrugBank". http://www.drugbank.ca/drugs/DB0911... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Curosurf?

Depending on the reaction of the Curosurf after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Curosurf 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 Curosurf 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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Review

sdrugs.com conducted a study on Curosurf, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Curosurf consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

One visitor reported price estimates

What is your opinion about drug cost? Did you feel the cost is apt, or did you feel it is expensive?
The report given by the sdrugs.com website users shows the following figures about several people who felt the medicine Curosurf is expensive, and the medicine is not expensive. The results are mixed. The perception of the cost of the medicine to be expensive or not depends on the brand name of the medicine, country, and place where it is sold, and the affordability of the patient. You can choose a generic drug in the place of the branded drug to save the cost. The efficiency of the medicine will not vary if it is generic or a branded one.
Visitors%
Expensive1
100.0%

Visitor reported frequency of use

No survey data has been collected yet

Visitor reported doses

No survey data has been collected yet

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

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Visitor reported age

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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