Pafolacianine

What is Pafolacianine?

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

Pafolacianine skeletal

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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