"LONDON, UK â€” The European Commission (EC) has followed the recommendation last year from its Committee for Medicinal Products for Human Use (CHMP) for an additional indication for the oral platelet inhibitor ticagrelor (Brilique, AstraZe"...
DOSAGE AND ADMINISTRATION
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:
- Intratracheally by instillation in two divided aliquots through a 5 French end-hole catheter after briefly disconnecting the endotracheal tube from the ventilator; or
- Intratracheally in a single aliquot through the secondary lumen of a dual lumen endotracheal tube without interrupting mechanical ventilation.
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 [see Preparation of the CUROSURF Suspension].
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)|
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.
For Endotracheal Tube Instillation Using a 5 French End-Hole Catheter
- Slowly withdraw the entire contents of the vial of CUROSURF 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 CUROSURF suspension. Discard excess CUROSURF through the catheter so that only the dose to be given remains in the syringe.
- When administering CUROSURF 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 CUROSURF 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 CUROSURF administration, change the infant's 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 CUROSURF 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 CUROSURF 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 [see Clinical Studies].
For endotracheal instillation using the secondary lumen of a dual lumen endotracheal tube
- Slowly withdraw the entire contents of the vial of CUROSURF 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 CUROSURF 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 CUROSURF 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.
Dosage Forms And Strengths
CUROSURF (poractant alfa) is an intratracheal suspension available in vials:
- 1.5 mL [120 mg poractant alfa (surfactant extract)], or
- 3 mL [(240 mg poractant alfa (surfactant extract)].
CUROSURF is a white to creamy white suspension. Each mL of suspension contains 80 mg 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.
Storage And Handling
CUROSURF (poractant alfa) intratracheal suspension is available in sterile, rubber-stoppered clear glass vials containing (one vial per carton):
- 1.5 mL [120 mg poractant alfa (surfactant extract)] of suspension: NDC Number: 10122-510-01
- 3 mL [(240 mg poractant alfa (surfactant extract)] of suspension. NDC Number: 10122-510-03
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 Preparation of the CUROSURF Suspension].
Manufactured for: Chiesi USA, Inc., Cary, NC 27518. Manufactured by and licensed from: Chiesi Farmaceutici, S.p.A., Parma, Italy 43100. Revised: Dec 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/7/2016
Additional Curosurf Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.