Curosurf (poractant alfa) dosing, indications, interactions, adverse effects, and more

Sections

Sections poractant alfa
Dosing & Uses
Adverse Effects
Warnings
Pregnancy
Pharmacology
Administration
Images
Patient Handout
Formulary

Dosing & Uses

AdultPediatric

Not indicated

Dosage Forms & Strengths

intratracheal suspension

80mg/mL (1.5mL or 3mL vial)

Respiratory Distress Syndrome

Indicated for rescue treatment of respiratory distress syndrome (RDS) in premature infants

It reduces mortality and pneumothoraces associated with RDS

2.5 mL/kg birth weight intratracheal, THEN may repeat up to 2 more time at 1.25 mL/kg ~q12hr in infants whom RDS is considered responsible for their persisting or deteriorating respiratory status

Maximum total dosage (sum of the initial and up to 2 repeat doses): 5 mL/kg

>10%

Patent ductus arteriosus (60%)

Intracranial hemorrhage (51%)

Pneumothorax (21%)

Pulmonary interstitial emphysema (21%)

Bronchopulmonary dysplasia (18%)

Acquired pneumonia (17%)

Acquired septicemia (14%)

Postmarketing Reports

Pulmonary hemorrhage, a known complication of premature birth and very low birth-weight, has been reported

Contraindications

None

Cautions

Administration of exogenous surfactants can rapidly affect oxygenation and lung compliance; infants should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified to respond to respiratory changes

Transient adverse reactions associated with administration include bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation

Pregnancy & Lactation

Pregnancy Category: Not applicable

Lactation: Not applicable

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Replaces deficient endogenous lung surfactant in neonates with respiratory distress syndrome

Surfactant prevents the alveoli from collapsing during expiration by lowering surface tension between alveolar surfaces and air

Preparation of suspension

Remove vial from a refrigerator and slowly warm the vial to room temperature before use

Visually inspect suspension for discoloration before use; suspension should appear white to creamy white

Discard if 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 plastic cap with the aluminum portion downwards

Remove the whole ring by pulling off aluminum wrapper

Remove the rubber cap to extract content

Intratracheal Administration

For intratracheal administration only

Administered by, or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants

Before administering, assure proper placement and patency of the endotracheal tub

Allow the infant to stabilize before proceeding with dosing

Administer intratracheally by instillation in two divided aliquots through a 5 French end-hole catheter OR in a single bolus through the secondary lumen of a dual lumen endotracheal tube without interrupting mechanical ventilation

Storage

Unopened vials: Refrigerate at 2-8ºC (36-46ºF)

Protect from light

Do not shake

Vials are for single use only; discard unused portion after opening the vial

BRAND	FORM.	UNIT PRICE	PILL IMAGE
Curosurf intratracheal -	120 mg/1.5 mL vial
Curosurf intratracheal -	240 mg/3 mL vial

Patient Handout

NO MONOGRAPH AVAILABLE AT THIS TIME

USES: Consult your pharmacist.

HOW TO USE: Consult your pharmacist.

SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Consult your pharmacist.

DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: No monograph available at this time.

MISSED DOSE: Consult your pharmacist.

STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Create Your List of Plans

Adding plans allows you to:

View the formulary and any restrictions for each plan.
Manage and view all your plans together – even plans in different states.
Compare formulary status to other drugs in the same class.
Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

View explanations for tiers and restrictions

Tier	Description
1	This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2	This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC	NOT COVERED – Drugs that are not covered by the plan.

Code	Definition
PA	Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL	Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST	Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR	Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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