Poractant Alfa

R07A - Other respiratory system products ATC R07AA02 Unknown approved 1999 Parenteral

JFDA label: Curosurf

Mechanism of Action

— Surfactant agent

Indications

Approved

Respiratory distress syndrome (RDS)

Contraindications

Source: Lexicomp

Additional contraindications (not in US labeling): Hypersensitivity to poractant alfa or any component of the formulation Absolute
There are no contraindications listed in the manufacturer’s labeling Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Cardiac disorders (3)

Not Known bradycardia · hypotension · Patent ductus arteriosus

Blood and lymphatic system disorders (1)

Not Known Oxygen desaturation

General disorders and administration site conditions (1)

Not Known Obstruction of endotracheal tube

Dosing

Source: Lexicomp

(For additional information see "Poractant alfa: Pediatric drug information") Note: For intratracheal use only Respiratory distress syndrome (RDS): Neonates: Intratracheal: Initial: 2.5 mL/kg of birth weight. May administer up to 2 additional doses of 1.25 mL/kg birth weight at 12-hour intervals if needed for infants who continue to require mechanical ventilation and supplemental oxygen. Maximum total dose: 5 mL/kg birth weight

There are no dosage adjustments provided in the manufacturer’s labeling.

Warnings & Precautions

Source: Lexicomp

Pulmonary hemorrhage

Pulmonary hemorrhage is a known complication of premature birth and very low birth-weight. It has been reported in both clinical trials and postmarketing reports in infants who have received poractant alfa.

Transient adverse effects

Transient episodes of bradycardia, decreased oxygen saturation, hypotension, or endotracheal tube blockage may occur. Discontinue dosing procedure and initiate measures to alleviate the condition; may reinstitute after the patient is stable. Other warnings/precautions:

Administration

For intratracheal administration only.

Monitoring

Produces rapid improvements in lung oxygenation and compliance; may require frequent adjustments to oxygen delivery and ventilator settings.

Trained personnel

Rapidly affects oxygenation and lung compliance; restrict use to a highly-supervised clinical setting with immediate availability of clinicians experienced in intubation and ventilatory management of premature infants.

Pregnancy & Lactation

Pregnancy

This drug is not indicated for use in adults.

Lactation

This drug is not indicated for use in adults.

Monitoring

Clinical pearl	Arterial blood gases, ventilator measurement assessment

Registered Products (1)

Brand	Form / strength	Pack	Agent	Citizen (JOD)
Curosurf	Injection 80 mg/ml	1.5 ml	Kurdi Drug Store	—