Pronunciation:

in-fig-RA-ti-nib

Brand Names:

• Truseltiq

Classifications:

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Infigratinib is used to treat cholangiocarcinoma (bile duct cancer) that has spread or cannot be removed by surgery. It is used in patients who have already tried cancer treatment before and have a certain type of abnormal FGFR2 gene in their cancer. Your doctor will test for the presence of this gene.

Infigratinib is an antineoplastic (cancer) agent. It interferes with the growth of cancer cells, which are eventually destroyed by the body.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of infigratinib in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of infigratinib in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Apalutamide
• Aprepitant
• Atazanavir
• Boceprevir
• Bosentan
• Calcium Carbonate
• Calcium Silicate
• Carbamazepine
• Cenobamate
• Cimetidine
• Ciprofloxacin
• Clarithromycin
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclosporine
• Dabrafenib
• Dexlansoprazole
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Diltiazem
• Dronedarone
• Ebrotidine
• Efavirenz
• Enzalutamide
• Erythromycin
• Esomeprazole
• Etravirine
• Famotidine
• Fluconazole
• Fluvoxamine
• Fosnetupitant
• Fosphenytoin
• Idelalisib
• Imatinib
• Indinavir
• Itraconazole
• Ketoconazole
• Lansoprazole
• Letermovir
• Lopinavir
• Lorlatinib
• Lumacaftor
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Peroxide
• Magnesium Trisilicate
• Mitotane
• Modafinil
• Nafcillin
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Nizatidine
• Omeprazole
• Pantoprazole
• Phenobarbital
• Phenytoin
• Posaconazole
• Primidone
• Rabeprazole
• Ranitidine
• Ranitidine Bismuth Citrate
• Rifabutin
• Rifampin
• Ritonavir
• Roxatidine
• Saquinavir
• Sodium Bicarbonate
• St John's Wort
• Telaprevir
• Telithromycin
• Verapamil
• Voriconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Eye or vision problem (eg, retinal pigment epithelial detachment)—Use with caution. May make this condition worse.

• Kidney disease, severe or
• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine usually comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor or pharmacist if you have any questions.

Take this medicine at least 1 hour before or 2 hours after food at about the same time each day. Infigratinib is taken in cycles of 28 days.

Swallow the capsule whole with water. Do not crush, break, chew, or dissolve it.

If you need to take an acid reducer (eg, H2 blocker) or antacid, take Truseltiq™ 2 hours before or 10 hours after taking an acid reducer or 2 hours before or 2 hours after taking an antacid.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For cholangiocarcinoma (bile duct cancer):
    • Adults—At first, 125 milligrams (mg) (one 100 mg and one 25 mg capsule) once a day for 21 days, followed by 7 days off treatment, to complete a 28-day treatment cycle. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If it is less than 4 hours on the same day, take it as soon as you remember. If more than 4 hours have passed, skip the missed dose and go back to your regular dosing schedule. If you vomit after taking your medicine, do not take an extra dose.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests will be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 1 month after your last dose. Males who are taking this medicine, with female partners who can become pregnant must use effective birth control during treatment and for at least 1 month after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor right away if eye pain, dryness, swelling, or a change in vision occurs during treatment. This could be a sign of a serious eye problem. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor). You may use artificial tear substitutes, or hydrating or lubricating eye gels to help prevent to treat dry eyes.

This medicine may cause hyperphosphatemia (high potassium levels in the blood). Check with your doctor right away it you have stomach cramps, confusion, seizures, difficulty in breathing, irregular heartbeat, mood or mental changes, muscle cramps in the hands, arms, feet, legs, or face, numbness and tingling around the mouth, fingertips, or feet, or tremor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blindness

blurred vision

confusion

constipation

decreased vision

depression

difficulty in breathing

dry eye

dry mouth

eyelash changes

headache

incoherent speech

increased urination

irregular heartbeats

loss of appetite

metallic taste

mood or mental changes

muscle cramps in the hands, arms, feet, legs, or face

muscle weakness

nausea

numbness and tingling around the mouth, fingertips, or feet

redness, swelling, or itching of the eyelid

redness, swelling, pain, or ulceration of the skin

scaling of the skin on the hands and feet

seizures

stomach cramps

thirst

tingling of the hands and feet

tremor

unusual tiredness

vomiting

weight loss

Less common

Chills

cough or hoarseness

dizziness, lightheadedness, or fainting

dry mouth

fast heartbeat

fever or chills

lower back or side pain

painful or difficult urination

rapid, shallow breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

bloody nose

change in taste

decreased weight

diarrhea

difficulty in moving

dry skin

hair loss, thinning of hair

heartburn

indigestion

lack or loss strength

loss of taste

muscle pain or stiffness

pain in the arms or legs

pain in the joints

redness or soreness around the fingernails or loosening of the fingernails

stomach discomfort, upset, or pain

swelling of the hands, ankles, feet, or lower legs

swelling or inflammation of the mouth

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.