Poractant Alfa
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Turky Alkathery, M.D. [2]
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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.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Poractant Alfa in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Indication
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.
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 CUROSURF Suspension
- Remove the vial of CUROSURF suspension from a refrigerator at +2 to +8°C (36 to 46°F) and slowly warm the vial to room temperature before use.
- Visually inspect the CUROSURF suspension for discoloration prior to administration. *The color of the CUROSURF suspension should be white to creamy white. Discard the CUROSURF 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 CUROSURF 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.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Poractant Alfa in pediatric patients.
Contraindications
There is limited information regarding Poractant Alfa Contraindications in the drug label.
Warnings
There is limited information regarding Poractant Alfa Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Poractant Alfa Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Poractant Alfa Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Poractant Alfa Drug Interactions in the drug label.
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
There is no FDA guidance on the use of Poractant Alfa in pediatric settings.
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
There is limited information regarding Poractant Alfa Administration in the drug label.
Monitoring
There is limited information regarding Poractant Alfa Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Poractant Alfa and IV administrations.
Overdosage
There is limited information regarding Poractant Alfa overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Poractant Alfa Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Poractant Alfa Mechanism of Action in the drug label.
Structure
There is limited information regarding Poractant Alfa Structure in the drug label.
Pharmacodynamics
There is limited information regarding Poractant Alfa Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Poractant Alfa Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Poractant Alfa Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Poractant Alfa Clinical Studies in the drug label.
How Supplied
There is limited information regarding Poractant Alfa How Supplied in the drug label.
Storage
There is limited information regarding Poractant Alfa Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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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
There is limited information regarding Poractant Alfa Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Poractant Alfa Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.