Pafolacianine (Intravenous)

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

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

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.

In deciding to use a medicine, you and your doctor need to think about the risks of taking the medicine versus the benefits it might provide. Here are some important points to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how pafolacianine injection affects children. Safety and effectiveness have not been established for this age group.

Geriatric

Current studies have not shown any specific issues in older adults that would limit the use of pafolacianine injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication if you are breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others can be used together with caution. If you are receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and may not include all possibilities.

Using this medicine with the following medicine is generally not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

• Folic Acid

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at the same time as eating food or certain types of food due to possible interactions. Drinking alcohol or using tobacco with certain medicines can also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

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

In the U.S.

• Cytalux

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.