Pafolacianine

What is Pafolacianine?

• Pafolacianine (Cytalux) is an optical imaging agent used in adult patients with ovarian cancer to help identify ovarian cancer lesions.

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Pafolacianine skeletal

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Pafolacianine structural components

What are the uses of this medicine?

• Pafolacianine (Cytalux) is an optical imaging agent used in adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions.

How does this medicine work?

• Cytalux is a fluorescent drug that targets folate receptor (FR) which may be overexpressed in ovarian cancer.
• Pafolacianine binds to FR-expressing cancer cells internalizes via receptor mediated endocytosis, and concentrates in FR-positive cancer tissues.
• Pafolacianine absorbs light in the near-infrared (NIR) region within a range of 760 nm to 785 nm with peak absorption of 776 nm and emits fluorescence within a range of 790 nm to 815 nm with a peak emission of 796 nm.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Use of folate, folic acid, or folate-containing supplements may reduce binding of pafolacianine to folate receptors overexpressed on ovarian cancer cells and could reduce the detection of malignant lesions with Cytalux.
• Avoid administration of folate, folic acid, or folate-containing supplements within 48 hours before administration of Cytalux.

Is this medicine FDA approved?

• It was approved for medical use in the United States in November 2021.

How should this medicine be used?

• Obtain a pregnancy test in females of reproductive potential and verify the absence of pregnancy prior to administration of Cytalux.
• Discontinue folate, folic acid, or folate containing supplements 48 hours before administration of Cytalux.
• Consider administering antihistamines and/or anti-nausea medication for prophylaxis against infusion related reactions.

Recommended dosage and administration:

• The recommended dose of Cytalux is a single intravenous infusion of 0.025 mg/kg diluted in 250 mL of 5% Dextrose Injection, administered over 60 minutes using a dedicated infusion line, 1 hour to 9 hours prior to surgery.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 3.2 mg/1.6 mL (2 mg/mL) of pafolacianine in a single-dose vial.

This medicine is available in fallowing brand namesː

• Cytalux

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• vomiting
• abdominal pain
• flushing
• dyspepsia
• chest discomfort
• pruritus
• hypersensitivity

What special precautions should I follow?

• Adverse reactions consisting of nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, and pruritus were reported in patients receiving Cytalux. Interrupt the infusion and treat as necessary with antihistamines and/or nausea medications.
• Errors may occur with the use of Cytalux during intraoperative fluorescence imaging to detect ovarian cancer, including false negatives and false positives. Non-fluorescing tissue in the surgical field does not rule out the presence of tumor. Fluorescence may be seen in non-cancerous tissues.
• Cytalux may cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus.
• Use of the incorrect diluent to prepare the Cytalux infusion solution can cause the aggregation of pafolacianine; aggregation may induce infusion reactions, such as nausea, vomiting, abdominal pain or rash. Use only 5% Dextrose Injection for dilution. Do not use other diluents.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on its mechanism of action, pafolacianine may cause fetal harm when administered to a pregnant woman.
• There are no available human data to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Can this medicine be used in children?

• Safety and effectiveness of Cytalux in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• PAFOLACIANINE SODIUM

Inactive ingredients:

• WATER
• SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
• SODIUM CHLORIDE
• HYDROCHLORIC ACID
• POTASSIUM PHOSPHATE, MONOBASIC
• SODIUM HYDROXIDE

Who manufactures and distributes this medicine?

Manufactured for:

• On Target Laboratories
• West Lafayette, IN

What should I know about storage and disposal of this medication?

• Store frozen between -25° to -15°C (-13° to 5°F).
• Store in original carton to protect from light.

• Dailymed label info on Pafolacianine
• FDA Pafolacianine

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