Infasurf

What is Infasurf used for?

Infasurf is a prescription medicine that is used to treat or prevent lung distress in premature babies.

Description

Infasurf® (calfactant) Intratracheal Suspension is a sterile, non-pyrogenic lung surfactant intended for intratracheal instillation only. It is an extract of natural surfactant from calf lungs which includes phospholipids, neutral lipids, and hydrophobic surfactant-associated proteins B and C (SP-B and SP-C). It contains no preservatives.

Infasurf is an off-white suspension of calfactant in 0.9% aqueous sodium chloride solution. It has a pH of 5.0 – 6.2 (target pH 5.7). Each milliliter of Infasurf contains 35 mg total phospholipids (including 26 mg phosphatidylcholine of which 16 mg is disaturated phosphatidylcholine) and 0.7 mg proteins including 0.26 mg of SP-B.

Before taking Infasurf, tell your doctor:

• If your child is allergic to Infasurf; any part of this medicine; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.

This medicine may interact with other drugs or health problems.

Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take Infasurf with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while I take Infasurf?

• Tell all of your child’s health care providers that your child is taking Infasurf. This includes your child’s doctors, nurses, pharmacists, and dentists.
• This medicine may raise the chance of a certain type of bad infection (sepsis). Talk with the doctor.

How is Infasurf best taken?

Give Infasurf as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.

• This medicine is given into the lungs with a tube.

What do I do if I miss a dose?

• Call your child’s doctor to find out what to do.

What are the side effects of Infasurf that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Trouble breathing that is new or worse.
• Blue or gray skin color.
• Slow heartbeat.

What are some other side effects of Infasurf?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if your child has any side effects that bother your child or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Infasurf?

• If you need to store Infasurf at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL