Pafolacianine
What is Pafolacianine?[edit | edit source]
- Pafolacianine (Cytalux) is an optical imaging agent used in adult patients with ovarian cancer to help identify ovarian cancer lesions.
What are the uses of this medicine?[edit | edit source]
- 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?[edit | edit source]
- 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 ?[edit | edit source]
- This medicine have no usage limitations.
What drug interactions can this medicine cause?[edit | edit source]
- 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?[edit | edit source]
- It was approved for medical use in the United States in November 2021.
How should this medicine be used?[edit | edit source]
- 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?[edit | edit source]
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?[edit | edit source]
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?[edit | edit source]
- 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?[edit | edit source]
- 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?[edit | edit source]
- 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?[edit | edit source]
- Safety and effectiveness of Cytalux in pediatric patients have not been established.
What are the active and inactive ingredients in this medicine?[edit | edit source]
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?[edit | edit source]
Manufactured for:
- On Target Laboratories
- West Lafayette, IN
What should I know about storage and disposal of this medication?[edit | edit source]
- Store frozen between -25° to -15°C (-13° to 5°F).
- Store in original carton to protect from light.
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