Curosurf: Uses, Side Effects and Dosage

What is Curosurf used for?

• Curosurf is used to treat Respiratory Distress Syndrome (RDS) in newborn premature babies.
• Your baby may have other problems as well as RDS which may need other treatments.

How does Curosurf work?

Most babies are born with a substance in their lungs known as ‘surfactant’. This substance lines the lungs and stops them from sticking together and so makes normal breathing possible. Some babies, however, particularly premature babies, do not have enough of this surfactant when they are born, which causes RDS. Curosurf is a natural surfactant, which works in the same way as your baby's own surfactant would have done and, therefore, will help your baby to breathe normally until your baby produces his or her own surfactant.

What are the ingredients in Curosurf?

Medicinal ingredients: The active substance is a mixture of fats and proteins which come from a pig lung called poractant alfa.

Non-medicinal ingredients: The other ingredients are sodium bicarbonate, sodium chloride and water for injection. This product contains less than 1 mmol sodium (23 mg) per vial.

Curosurf comes in the following dosage forms:

It is a sterile suspension and is supplied in a single use 5 mL glass vial containing either 1.5 mL (120 mg) or 3 mL (240 mg) of phospholipid fraction from pig lung. Each mL of sterile suspension contains 80mg of phospholipid fractions from pig lungs.

Serious Warnings and Precautions

• Curosurf should only be given to your baby by trained healthcare professional(s) with experience in treating premature babies.
• Giving surfactants such as Curosurf to babies with Respiratory Distress Syndrome can have a very quick effect on their lungs. Your baby will need to stay in the hospital. The healthcare professional(s) will need to carefully observe your baby and make adjustments to medications and equipment as needed to help your baby until your baby’s breathing becomes normal.

Do not use Curosurf if:

• Your baby has any allergies to Curosurf or any other ingredients in this product or components of the container.

To help avoid side effects and ensure proper use, talk to your healthcare professional about Curosurf. Before using Curosurf, the healthcare professional(s) will check that the baby’s general conditions are stabilized, by adjusting, for example, acid blood pH (acidosis), low blood pressure (hypotension), red blood cell decrease (anaemia), blood sugar levels (hypoglycaemia), low body temperature (hypothermia).

Other warnings you should know about:

• If your baby gets an infection, antibiotics may be given to treat the infection.
• After administration of Curosurf a momentary lowering (transient depression) of the electrical activity of the brain (cerebro-electrical activity), lasting from 2 to 10 minutes has been recorded.

The following may interact with Curosurf:

There are no known drug interactions with this medication.

How to take Curosurf:

The healthcare professional(s) will give Curosurf to your baby. They will warm the Curosurf liquid to room temperature, and then using a syringe they will give it to your baby through tubes or catheter into the baby’s windpipe. They may disconnect your baby from the ventilator for a few minutes to do this.

Your healthcare professional(s) will decide the right dose for your baby, depending on your baby’s weight. If your baby is being given Curosurf to prevent Respiratory Distress Syndrome (RDS) it is important that Curosurf is given as soon as possible after RDS has been diagnosed.

Usual dose:

The initial dose is 2.5 mL/kg of birth weight. If your baby needs another dose of Curosurf, up to two repeat doses of 1.25 mL/kg of birth weight each may be given every 12 hours.

Overdose:

There have been no reported overdoses of Curosurf; however, if your baby is overdosed your healthcare professional(s) will decide on the best course of treatment.

Missed Dose:

Not applicable.

What are possible side effects from using Curosurf?

These are not all the possible side effects your baby may feel when taking Curosurf. If your baby experiences any side effects not listed here, contact your healthcare professional.

During the administration of Curosurf with a thin catheter, some temporary side effects have been seen: slow heart rate, stopping of breathing, decreased amount of oxygen in the body, froth at the mouth, coughing, choking, and sneezing. Furthermore, necrotizing enterocolitis (severe infection and inflammation of the GI tract) and focal intestinal perforation (localized rupture of the intestinal wall) are signals possibly linked to the LISA method used by your healthcare professional to give the drug to your baby.

Reporting Side Effects

Reporting Suspected Side Effects

Storage:

Keep out of reach and sight of children.

Store in a refrigerator at 2°C to 8°C, protected from light. Do not shake. However, before it is given to your baby it will be warmed to room temperature.

Unopened unused vials of Curosurf that have warmed to room temperature can be returned to the refrigerator within 24 hours for future use. Do not warm to room temperature and return to refrigerated storage more than once.

Do not use Curosurf after the expiry date that is on the label. The expiry date refers to the last day of that month.

Use each vial once, and then throw away what is left over. The hospital will make sure that any unused Curosurf is disposed of safely.

If you want more information about Curosurf:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the Canadian distributor’s website www.methapharm.com or by calling Methapharm at 1-866-701-4636

Last Revised July 22, 2021