Futibatinib

What is Futibatinib?

• Futibatinib (Lytgobi) is a kinase inhibitor.

Futibatinib

What are the uses of this medicine?

Futibatinib (Lytgobi) is a prescription medicine that is used to treat adults with bile duct cancer (intrahepatic cholangiocarcinoma) that has spread or cannot be removed by surgery:

• who have already received a previous treatment, and
• whose tumor has a certain type of abnormal "FGFR2” gene.

How does this medicine work?

• Futibatinib (Lytgobi) is an orally bioavailable inhibitor of the fibroblast growth factor receptor (FGFR) with potential antineoplastic activity.
• Futibatinib selectively and irreversibly binds to and inhibits FGFR, which may result in the inhibition of both the FGFR-mediated signal transduction pathway and tumor cell proliferation, and increased cell death in FGFR-overexpressing tumor cells.
• FGFR is a receptor tyrosine kinase essential to tumor cell proliferation, differentiation and survival and its expression is upregulated in many tumor cell types.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Lytgobi and other medicines may affect each other causing side effects. Lytgobi may affect the way other medicines work, and other medicines may affect how Lytgobi works.

Be sure to mention any if you:

• dual P-gp and strong CYP3A inhibitors.
• substrates of P-gp or BCRP.

• Advise patients to avoid grapefruit products during treatment with Lytgobi.

Is this medicine FDA approved?

• Futibatinib was approved for medical use in the United States in September 2022.

How should this medicine be used?

• Your healthcare provider will test your cancer for a certain type of abnormal FGFR2 gene and make sure that Lytgobi is right for you.

Recommended dosage:

• Recommended dose is 20 mg orally (five 4 mg tablets) once daily until disease progression or unacceptable toxicity occurs.

Administration:

• Take Lytgobi exactly as your healthcare provider tells you.
• Take Lytgobi 1 time each day with or without food at about the same time each day.
• Swallow Lytgobi tablets whole. Do not crush, chew, split, or dissolve Lytgobi tablets.

Tell your healthcare provider if you have problems swallowing Lytgobi tablets whole.

• You should not eat or drink grapefruit products during treatment with Lytgobi.
• Your healthcare provider may change your dose of Lytgobi, or may temporarily or completely stop treatment if you get certain side effects.
• If you miss a dose of Lytgobi, you can take the missed dose within 12 hours on the same day. If more than 12 hours have passed, do not make up the dose. Take your regular dose of Lytgobi the next day at the usual time. Do not take more Lytgobi than prescribed to make up for the missed dose.
• If you vomit after taking Lytgobi, do not take another Lytgobi tablet. Take your regular dose of Lytgobi the next day at the usual time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 4 mg

This medicine is available in fallowing brand namesː

• Lytgobi

What side effects can this medication cause?

The most common side effects of this medicine include:

• changes in kidney function blood tests
• increased blood glucose level
• decreased red blood cell, white blood cell, and platelet counts
• increased calcium level in the blood
• decreased sodium and phosphate levels in the blood
• changes in liver function blood tests
• nails separate from the bed or poor formation of the nail; change in the color of nails
• muscle pain
• constipation
• diarrhea
• feeling tired or weak
• changes in tests used to measure your blood clotting time
• dry mouth
• hair loss
• decreased protein level (albumin) in the blood
• mouth sores
• stomach area (abdominal) pain
• dry skin
• decreased glucose and potassium level in the blood
• joint pain
• changes in sense of taste
• dry eye
• nausea
• decrease in appetite
• urinary tract infection
• redness, swelling, peeling or tenderness, mainly on the hands or feet (hand-foot syndrome)
• vomiting

Less common, but serious side effects may include:

• Eye problems
• hyperphosphatemia

What special precautions should I follow?

• Lytgobi can cause retinal pigment epithelial detachment (RPED). Perform a comprehensive ophthalmological examination including optical coherence tomography (OCT) prior to initiation of therapy, every 2 months for the first 6 months, and every 3 months thereafter and urgently at any time for visual symptoms.
• Inform patients that Lytgobi may cause hyperphosphatemia and soft tissue mineralization and to immediately inform their healthcare provider of any symptoms related to acute change in phosphate levels such as muscle cramps, numbness, or tingling around the mouth.
• Advise patients that Lytgobi may cause nail disorders.
• Advise females to inform their healthcare provider if they are pregnant or become pregnant. Inform female patients of the risk to a fetus and potential loss of pregnancy.
• Advise females of reproductive potential to use effective contraception while on Lytgobi and for 1 week after the last dose.
• Advise males with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 1 week after receiving the last dose of Lytgobi.
• Advise patients not to breastfeed during treatment with Lytgobi and for 1 week after the last dose .

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 findings in an animal study and its mechanism of action, Lytgobi can cause fetal harm or loss of pregnancy when administered to a pregnant woman.
• There are no available data on the use of Lytgobi in pregnant women.

Can this medicine be used in children?

• It is not known if Lytgobi is safe and effective in children.

What are the active and inactive ingredients in this medicine?

• Active ingredient: futibatinib
• Inactive ingredients: corn starch, crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulfate.
• The film coating material contains: hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide.

Who manufactures and distributes this medicine?

Manufactured for:

• Taiho Pharmaceutical Co., Ltd. Japan

What should I know about storage and disposal of this medication?

• Store Lytgobi at room temperature between 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Futibatinib
• FDA Futibatinib

Futibatinib Resources
Latest articles Most recent articles Ongoing trials	Wikipedia