Pronunciation:

paf-oh-la-SYE-a-neen

Brand Names:

• Cytalux

Uses of This Medicine:

Pafolacianine injection is used to help identify and remove ovarian cancer lesions during surgery.

This medicine is to be given only by or under the direct supervision of a doctor with specialized training in near infrared imaging (NIR) systems.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of pafolacianine injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pafolacianine injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Folic Acid

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins. It must be given slowly, so the needle will have to remain in place for at least 60 minutes. You will receive this medicine 1 to 9 hours before surgery.

You may also receive other medicines (eg, allergy medicine, medicine to prevent nausea) before you receive this medicine.

Precautions While Using This Medicine:

It is very important that your doctor check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. If you are pregnant or think you may be pregnant, tell your doctor right away.

Do not take folate, folic acid, or folate-containing supplements 48 hours before receiving this medicine.

This medicine may cause infusion-related reactions. Tell your doctor right away if you have back pain, chest tightness, chills, fever, flushing, headache, nausea and vomiting, weakness, or trouble breathing after receiving this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Nausea

vomiting

Less common

Acid or sour stomach

back pain

chest discomfort or tightness

chills

fast heartbeat

feeling of warmth

fever

headache

heartburn

hives, itching, rash

hoarseness

indigestion

joint pain, stiffness, or swelling

redness of the face, neck, arms and occasionally, upper chest

stomach pain, discomfort, or upset

swelling of the eyelids, face, lips, hands, or feet

trouble breathing

weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.