Infigratinib

Infigratinib is a prescription medication indicated for the treatment of adults with previously treated, unresectable locally advanced, or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

• Infigratinib is available under the following different brand names: Truseltiq.

Common side effects of Infigratinib include:

• diarrhea
• nausea
• vomiting
• constipation
• loss of appetite
• changes in taste
• heartburn or indigestion
• stomach pain
• sores on the lips, mouth, or throat
• dry mouth and/or skin
• nail disorders
• hair loss
• headache
• fatigue
• swelling of hands, feet, legs, or ankles
• pain in joints, arms, or legs
• nose bleeds

Serious side effects of Infigratinib include:

• blurred vision, floaters in the eye, seeing flashes of light, or other changes in vision
• muscle cramps, numbness, or tingling around the mouth
• fever, chills, or other signs of infection
• blistering and peeling skin

Rare side effects of Infigratinib include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule

• 25 mg
• 100 mg

Cholangiocarcinoma

Adult dosage

• Each cycle is 28 days
  • 125 mg orally once a day for 21 consecutive days followed by 7 days off therapy
  • Continue until disease progression or unacceptable toxicity

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Infigratinib has severe interactions with the following drugs:
  • idelalisib
  • isoniazid
• Infigratinib has serious interactions with at least 119 other drugs
• Infigratinib has moderate interactions with no other drugs
• Infigratinib has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Infigratinib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Infigratinib?”

Cautions

• Fetal harm may occur
• Retinal pigment epithelial detachment (RPED)
  • May cause RPED, which may cause symptoms such as blurred vision
  • Perform a comprehensive ophthalmic examination including optical coherence tomography before initiation, at 1 month, at 3 months, and then every 3 months thereafter during treatment
  • Refer patients for ophthalmic evaluation urgently for onset of visual symptoms, and follow up every 3 weeks until resolution or discontinuation
• Hyperphosphatemia
  • Hyperphosphatemia was reported, leading to soft-tissue mineralization, cutaneous calcinosis, nonuremic calciphylaxis, vascular calcification, and myocardial calcification
  • Median onset time for hyperphosphatemia was 8 days
  • Monitor for hyperphosphatemia throughout treatment
• Drug interaction overview
  • Strong or moderate CYP3A inhibitors
    • Avoid coadministration
  • Strong or moderate CYP3A4 inhibitors may increase Infigratinib plasma concentrations and risk of adverse reactions
  • Strong or moderate CYP3A inducers
    • Avoid coadministration
  • Strong or moderate CYP3A4 inducers may decrease Infigratinib plasma concentrations and its efficacy
  • Gastric acid–reducing agents
    • Avoid coadministration
    • Gastric acid–reducing agents may decrease Infigratinib plasma concentrations and its efficacy
    • If use is unavoidable, stagger administration of Infigratinib from H2-antagonists or locally acting antacids

Pregnancy and Lactation

• Based on findings in animal studies and its mechanism of action, fetal harm or loss of pregnancy may occur
• There are no available data on use during pregnancy
• Verify the pregnancy status of women of reproductive potential before initiation
• Contraception
  • Females of reproductive potential: Use effective contraception during treatment and for 1 month after the final dose
  • Male with female partners of reproductive potential: Use effective contraception during treatment and for 1 month after the final dose
• Lactation 
  • There are no data on the presence of infigratinib or its metabolites in human milk, or its effects on breastfed children, or milk production
• Advise women not to breastfeed during treatment and for 1 month after the final dose