Poractant Alfa

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# Overview
Poractant Alfa is a lung surfactant that is FDA approved for the treatment of Respiratory Distress Syndrome (RDS) in premature infants.   Common adverse reactions include bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Indication and Dosage of Poractant Alfa in adult patients.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Poractant Alfa in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Poractant Alfa in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)

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

## Dosage
The initial recommended dose is 2.5 mL/kg birth weight (see Table 1), 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.

### Preparation of the Poractant alfa Suspension
- Remove the vial of poractant alfa suspension from a refrigerator at +2 to +8C (36 to 46F) and slowly warm the vial to room temperature before use.
- Visually inspect the poractant alfa suspension for discoloration prior to administration.                                        *The color of the poractant alfa suspension should be white to creamy white. Discard the poractant alfa vial if the suspension is discolored.
- Gently turn the vial upside-down, in order to obtain a uniform suspension.
- DO NOT SHAKE.
- Locate the notch (FLIP UP) on the colored plastic cap and lift the notch and pull upwards.
- Pull the plastic cap with the aluminum portion downwards.
- Remove the whole ring by pulling off the aluminum wrapper.
- Remove the rubber cap to extract content.
- Unopened, unused vials of poractant alfa suspension that have warmed to room temperature can be returned to refrigerated storage within 24 hours for future use.
- Do not warm to room temperature and return to refrigerated storage more than once.
- Protect from light.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Poractant Alfa in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Poractant Alfa in pediatric patients.

# Contraindications
None.

# Warnings

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

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

# Adverse Reactions

## 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 poractant alfa 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). A total of 144 infants were studied after RDS developed and before 15 hours of age; 78 infants received poractant alfa 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 poractant alfa 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.
Seventy-six infants (45 treated with poractant alfa) from study 1 were evaluated at 1 year of age and 73 infants (44 treated with poractant alfa) 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 poractant alfa and 6 controls) evaluated at 5.5 years of age, the developmental quotient, derived using the Griffiths Mental Developmental Scales, was similar between groups.

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

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

# Drug Interactions
There is limited information regarding Drug Interactions of Poractant Alfa.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): 
There is no FDA guidance on usage of Poractant Alfa in women who are pregnant.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Poractant Alfa in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Poractant Alfa during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Poractant Alfa in women who are nursing.

### Pediatric Use
poractant alfa is indicated for the rescue treatment, including the reduction of mortality and pneumothoraces, of Respiratory Distress Syndrome (RDS) in premature infants.
The safety and efficacy of poractant alfa in the treatment of full term infants or older pediatric patients with respiratory failure has not been established.

### Geriatic Use
There is no FDA guidance on the use of Poractant Alfa in geriatric settings.

### Gender
There is no FDA guidance on the use of Poractant Alfa with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Poractant Alfa with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Poractant Alfa in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Poractant Alfa in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Poractant Alfa in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Poractant Alfa in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Intratracheal  administration only.
poractant alfa should be administered by, or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants. Before administering poractant alfa, assure proper placement and patency of the endotracheal tube. At the discretion of the clinician, the endotracheal tube may be suctioned before administering poractant alfa. Allow the infant to stabilize before proceeding with dosing.
Administer Poractant alfa either:
- Intratracheally by instillation in two divided aliquots through a 5 French end-hole catheter after briefly disconnecting the endotracheal tube from the ventilator.
- Intratracheally in a single aliquot through the secondary lumen of a dual lumen endotracheal tube without interrupting mechanical ventilation.

### For endotracheal tube instillation using a 5 French end-hole catheter
Slowly withdraw the entire contents of the vial of poractant alfa suspension into a 3 or 5 mL plastic syringe through a large-gauge needle (e.g., at least 20 gauge). Enter each single-use vial only once.
Attach the pre-cut 8-cm 5 end-hole French catheter to the syringe. Fill the catheter with poractant alfa suspension. Discard excess poractant alfa through the catheter so that only the dose to be given remains in the syringe.
When administering poractant alfa using a 5 French end-hole catheter, administer in two divided aliquots:
- For the first dose: 1.25 mL/kg (birth weight) per aliquot.
- For each repeated dose: 0.635 mL/kg (birth weight) per aliquot.
First aliquot of Poractant alfa suspension:
- Position the infant in a neutral position (head and body in alignment without inclination), with either the right or left side dependent.
- Immediately before poractant alfa administration, change the infants ventilator settings to a rate of 40-60 breaths/minute, inspiratory time 0.5 second, and supplemental oxygen sufficient to maintain SaO2 > 92%.
- Briefly disconnect the endotracheal tube from the ventilator.
- Insert the pre-cut 5 French catheter into the endotracheal tube and instill the first aliquot of poractant alfa suspension.
- After the first aliquot is instilled, remove the catheter from the endotracheal tube and manually ventilate the infant with 100% oxygen at a rate of 40-60 breaths/minute for one minute.
Second aliquot of Poractant alfa suspension:
- When the infant is stable, reposition the infant such that the other side is dependent.
- Administer the remaining aliquot using the same procedures as the first aliquot.
- After completion of the dosing procedure, resume usual ventilator management and clinical care.
- Do not suction airways for 1 hour after surfactant instillation unless signs of significant airway obstruction occur.
- Post dosing, consider maintenance of PaO2 of about 55 mmHg, PaCO2 of 35-45, and pH > 7.3.

### For endotracheal instillation using the secondary lumen of a dual lumen endotracheal tube
- Slowly withdraw the entire contents of the vial of poractant alfa suspension into a 3 or 5 mL plastic syringe through a large-gauge needle (e.g., at least 20 gauge). Do not attach 5 French end-hole catheter. Remove the needle and discard excess poractant alfa so that only the dose to be given remains in the syringe.
- Keep the infant in a neutral position (head and body in alignment without inclination).
- Administer poractant alfa suspension through the proximal end of the secondary lumen of the endotracheal tube as a single dose, given over 1 minute, and without interrupting mechanical ventilation.
- After completion of this dosing procedure, ventilator management may require transient increases in FiO2 , ventilator rate, or PIP.
- Do not suction airways for 1 hour after surfactant instillation unless signs of significant airway obstruction occur.

### Monitoring
There is limited information regarding Drug Donitoring of Poractant Alfa.

# IV Compatibility
There is limited information regarding the compatibility of Poractant Alfa and IV administrations.

# Overdosage
There have been no reports of overdosage following the administration of poractant alfa.
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.

# Pharmacology

## 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 (RDS) characterized by poor lung expansion, inadequate gas exchange, and a gradual collapse of the lungs (atelectasis).
Poractant alfa compensates for the deficiency of surfactant and restores surface activity to the lungs of these infants.

## Structure
Poractant alfa is a sterile, non-pyrogenic pulmonary surfactant intended for intratracheal use only. Poractant alfa 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).
Poractant alfa is a white to creamy white suspension of poractant alfa.  Each milliliter of suspension contains 80 mg of poractant alfa (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).
Poractant alfa contains no preservatives.

## Pharmacodynamics
In vitro - poractant alfa lowers minimum surface tension to  4mN/m as measured by the Wilhelmy Balance System.

## Pharmacokinetics
poractant alfa 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 poractant alfa.

## Nonclinical Toxicology

## Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies to assess potential carcinogenic effects of poractant alfa have not been conducted.
Poractant alfa 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 poractant alfa have been performed.

# Clinical Studies

## Rescue Treatment of Respiratory Distress Syndrome
The clinical efficacy of poractant alfa 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. Poractant alfa 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.
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, poractant alfa 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 poractant alfa 2.5 mL/kg (200 mg/kg). In the multiple-dose arm, the initial dose of poractant alfa was 2.5 mL/kg  followed by up to two 1.25 mL/kg (100 mg/kg) doses of poractant alfa. The results from Study 2 are shown below in Table 4.
There is no controlled experience on the effects of administering initial doses of poractant alfa 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 poractant alfa more than 15 hours after diagnosing RDS. Adequate data are not available on the use of poractant alfa in conjunction with experimental therapies of RDS, e.g., high-frequency ventilation or extracorporeal membrane oxygenation.

# How Supplied
Poractant alfa intratracheal suspension is available in sterile, rubber-stoppered clear glass vials containing (one vial per carton):
- 1.5 mL  of suspension: NDC Number: 10122-510-01.
- 3 mL  of suspension. NDC Number: 10122-510-03.

## Storage
Store poractant alfa intratracheal suspension in a refrigerator at +2 to +8C (36 to 46F). PROTECT FROM LIGHT. Do not shake. Vials are for single use only. After opening the vial discard the unused portion.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Poractant Alfa Patient Counseling Information in the drug label.

# Precautions with Alcohol
Alcohol-Poractant Alfa interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- CUROSURF

# Look-Alike Drug Names
There is limited information regarding Look-Alike Drug Names.

# Drug Shortage Status

# Price