Cytalux (Intravenous)

Pafolacianine injection is used to help find 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 monitor you closely while you are receiving this medicine. This will help your doctor determine if the medicine is working properly and 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 ensure you are not pregnant. If you are pregnant or think you may be pregnant, tell your doctor immediately.

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 experience 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 must consider the risks of taking the medicine against the benefits it may provide. For this medicine, keep the following in mind:

Allergies

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

Pediatric

There have not been appropriate studies on how age affects the use of pafolacianine injection in children. Its safety and effectiveness for this age group have not been established.

Geriatric

Studies conducted so far have not found geriatric-specific issues that would limit the effectiveness of pafolacianine injection in older adults.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In such cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while receiving this medicine. The following interactions are based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended but may be necessary in certain situations. If both medicines are prescribed together, your doctor may alter the dose or frequency for one or both medicines.

• Folic Acid

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may 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 right away 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.