Name of the generic: pafolacianine (Intravenous route)
Drug class: Malignancy photosensitizers
Brand name: Cytalux
Uses for Pafolacianine
Pafolacianine injections are used to aid in the identification and removal of ovarian cancerous lesions that occur during surgery.
This medication is administered only under the supervision of a physician who has special training in near-infrared imaging (NIR) systems.
Pafolacianine contains pafolacianine sodium, a tetrasodium salt of pafolacianine, an optical imaging agent. Pafolacianine sodium has the chemical formula (S)-2-(4-((2-amino-4-oxo-3,4- dihydropteridin-6-yl)methyl)amino)benzamido). -3-(4-(((E)-2-((E)-2-(3,3-dimethyl-5-sulfonato-1-(4-\ssulfonatobutyl) -3H-indol-1-ium-2-yl)vinyl) hydrate of -6-((E)-2-(3,3-dimethyl-5-sulfonato-1-(4-sulfonatobutyl)indolin-2-ylidene)ethylidene)cyclohex-1-en-1-yl)oxy)phenyl)propanoate
Tetrasodium. Pafolacianine sodium has the following structure: C 61H 63N 9Na 4O 17S 4, a molecular mass of 1414.42 g/mol, and a molecular formula of C 61H 63N 9Na 4O 17S 4.
The intravenous solution of Pafolacianine injection is a sterile, non-pyrogenic, dark blue green, clear water solution. In a 1.6 mL volume, each vial contains 3.2 mg (2 mg/mL) pafolacianine (equal to 3.4 mg pafolacianine sodium), 14.4 mg sodium chloride, 0.23 mg potassium phosphate monobasic, 1.27 mg sodium phosphate dibasic heptahydrate, and 0.23 mg potassium phosphate monobasic. The pH is between 7.1 and 7.8 and is modified with sodium hydroxide and/or hydrochloric acid.
Before making use of Pafolacianine
When deciding whether to take a medication, the potential risks of using the drug should be evaluated against the benefits it can bring. It is a choice both you and your physician will take. To determine the appropriate medicine it is important to take the following into assessed:
Discuss with your physician whether you’ve had any allergic or unusual reaction to this medication or any other medications. Inform your health care doctor if you are suffering from other allergies, like dyes, foods, or preservatives. You may also be allergic to animals. For products without a prescription, review the label or the ingredient list carefully.
The right studies haven’t been conducted on the relation of age to the effect of the pafolacianine injectable in the children’s population. The safety and efficacy of this treatment have not been proven.
Studies that are appropriate up to now haven’t revealed the existence of geriatric-specific issues that hinder the effectiveness of the injection of pafolacianine to the older.
There aren’t enough studies on women to determine the risk to infants when taking this medication while breastfeeding. Be sure to weigh the potential benefits against the risks that could be associated with using this medication during nursing.
Interactions with medications
Certain medicines shouldn’t be taken together however, there are instances where two different medications can be combined even though there is a chance of interaction. In these situations, the doctor might decide to adjust the dose or take other precautions needed. If you’re taking this medication, it is particularly important to let your healthcare provider know they are prescribing any of the drugs that are listed below. The following interactions were chosen based on their potential importance and are not meant to be comprehensive.
Utilizing this medicine in conjunction together with any of the following medications is generally not recommended, but it could be necessary for certain instances.
Interactions with alcohol, tobacco, or food
Certain medications shouldn’t be used during or in conjunction with having food items or eating particular kinds of food, as interactions can happen. Smoking or drinking alcohol in conjunction together with certain medications can result in interactions. Talk with your healthcare provider about the interaction of your medication in conjunction with alcohol, food, or tobacco.¶
Proper use of Pafolacianine
A doctor or another trained medical professional will provide you with this medication. The medication is administered through an injection into the vein in your arm. It is administered slowly, which means the needle should remain there for 60 minutes at a minimum. This medicine is given up to 9 hours prior to surgery.
It is possible to get other medicines (eg allergy medicine, medicines to treat nausea) prior to receiving this medication.
Precautions and warnings when using Pafolacianine
It is crucial to have your doctor examine your health closely when you are receiving this medication. This will allow your physician to determine if the medication is working as it should and determine if it is appropriate to continue receiving the medication.
Taking this medication while you are pregnant could cause harm to your baby. If you’re pregnant or could become pregnant, your physician might conduct an ultrasound test prior to when you begin taking this medication to confirm that you’re not expecting. If you’re pregnant or suspect you are pregnant, consult your doctor immediately.
Do not consume folate, folic acid, or folate-containing products for at least 48 hours prior to the start of this medicine.
This medication may trigger reactions to infusions. Contact your physician immediately when you experience chest tightness, back pain chills, fever nausea, flushing, headache and vomiting, weakness or trouble breathing following the administration of this medication.
- Infusion-Related Reactions: Stop the infusion and use antihistamines and/or nausea drugs as needed.
- The presence of non-fluorescing tissue in the surgical field does not rule out the presence of a tumor, but it does raise the risk of misinterpretation. Non-cancerous tissues may show fluorescence.
- Toxicity to the fetus: Pafolacianine may harm the fetus. Inform females with reproductive potential of the risk to a fetus.
- Use just 5% Dextrose Injection to reduce the risk of Pafolacianine Aggregation and Infusion Reactions.
Dosage and administration
Recommended Testing, Prior to Administration of Pafolacianine
- Take a pregnancy test on females with reproductive potential to determine if there is no pregnancy.
prior to the administration of Pafolacianine
Do not stop taking folate, folic acid, or folate supplements at least 48 hours prior to taking the medication.
It is recommended to administer antihistamines and/or anti-nausea medications to prevent the effects of infusions.
Recommended Dosage and Administration
- The recommended dosage of Pafolacianine is an injection intravenously of 0.025 mg/kg, diluted to 250
5mL of Dextrose Injection, given over a period of 60 minutes with an infusion line that is specifically designed for this purpose 1 hour prior to
9 hours before surgery.
Preparation and Storage Instructions
Drug products for the parenteral system should be examined visually for particles of substance and discoloration prior
Administration whenever solution and container permits.
- Utilize an aseptic method for the making in the making of Pafolacianine Infusion Solution.
- Use only the 5% Dextrose Injection to dilute. Do not mix other diluents because of incompatibility.
- Thaw to freeze Pafolacianine vials in the original carton, at a set room temperature, ranging from 20deg to up to 25degC (68deg up to 77degF) for a minimum of 90 minutes.
- Handshake or swirl the frozen Pafolacianine vial for up to 60 seconds.
- Take the amount of Pafolacianine at a dose that is 0.025 mg/kg. Discard any A portion of the vial that is unopened.
- Put it in a 250mL of 5 percent Dextrose Injection Bag from USP.
- Swirl the bag gently by hand for one minute to combine the ingredients.
- Check the infusion bag’s visual appearance. The solution should range from lighter blue/green or clear in the color and shouldn’t contain visible particles.
- Guard the infusion bag against illumination by covering it with a dark-blocking material for storage and infusion.
Management of Infusion-Related Reactions
If the patient experiences an infusion reaction while administering discontinue the infusion, and treat the patient with Antihistamines and/or anti-nausea drugs in the event that is necessary, based on a clinical judgment. Complete the Infusion is administered within 3 hours of the beginning of the administration
Clinical studies show the effectiveness of near infrared (NIR) imagers stimulate at 760 nm
785 Nm and detect emission from 794 nm to 796nm are compatible in conjunction with Pafolacianine.
- Pafolacianine is intended to be used in conjunction with an NIR imaging device that has been cleared by the FDA specifically for use with
- Pafolacianine should be only used by surgeons who’ve completed a course of training for the use of the
Utilization of NIR imaging systems to perform fluorescence imaging during surgical procedures. The training is provided by
the manufacturer of the device.
Pafolacianine side effects
Alongside its necessary effects, some medicines may result in unwanted negative effects. While not all of these adverse effects can occur, if they occur, they might require medical attention.
Talk to your doctor or nurse right away in the event that any of these adverse effects happen:
- Acid or a sour stomach
- Back discomfort
- Tightness in the chest, chest pain
- fast heartbeat
- the feeling of warmth
- Itching, hives, rash
- stiffness, joint pain or swelling
- facial redness neck, arms, and sometimes, upper chest
- abdominal pains, excessive discomfort or stomach upset
- eyes the lips, face, feet, or hands
- Trouble breathing
Other adverse side effects that are not mentioned may occur in certain patients. If you observe any other symptoms, consult with your doctor.
Contact your doctor to seek medical advice on adverse effects. You can report any adverse reactions to the FDA at 1-800-FDA-1088.
- Rx only
- Pafolacianine injection
- 3.2 mg / 1.6 mL(2 mg/mL)
- Store at -25° to -15°C ( -13° to 5°F)
Always consult your doctor to make sure the information presented on this page is applicable to your specific situation.