LYTGOBI

Generic Name/API: futibatinib

Manufacturer: Taiho Oncology, Inc.

Dosage Forms & Strength & Pack Size:
Tablets: 4 mg

Storage:
Store LYTGOBI tablets at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C
and 30°C (59°F to 86°F).

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATIONS
WHAT IS LYTGOBI?
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.

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

It is not known if LYTGOBI is safe and effective in children.

LYTGOBI is approved based on tumor response and duration of response. There are ongoing studies to show if LYTGOBI improves survival or symptoms.

IMPORTANT SAFETY INFORMATION
LYTGOBI may cause serious side effects, including:

Eye problems: Certain eye problems are common with LYTGOBI but can also be serious. Eye problems include dry or inflamed eyes, inflamed cornea (front part of the eye), increased tears, and a disorder of the retina (an internal part of the eye). You will need to see an eye specialist for a complete eye exam before you begin treatment with LYTGOBI, every 2 months for the first 6 months, and every 3 months thereafter during treatment with LYTGOBI.
Tell your healthcare provider right away if you develop any changes in your vision during treatment with LYTGOBI, including blurred vision, flashes of light, or seeing black spots. You may need to see an eye specialist right away.
You should use artificial tears or substitutes, or hydrating or lubricating eye gels during treatment with LYTGOBI to help prevent or treat dry eyes.
High phosphate levels in your blood (hyperphosphatemia) and buildup of minerals in different tissues in your body: Hyperphosphatemia is common with LYTGOBI but can also be serious. High levels of phosphate in your blood may lead to buildup of minerals such as calcium in different tissues in your body. Your healthcare provider will check your blood phosphate levels during treatment with LYTGOBI.
Your healthcare provider may prescribe changes in your diet or phosphate-lowering therapy, or change, interrupt, or stop LYTGOBI if needed.
Tell your healthcare provider right away if you develop any muscle cramps, or numbness or tingling around your mouth.
The most common side effects of LYTGOBI 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
Before you take LYTGOBI, tell your healthcare provider about all of your medical conditions, including if you:

have vision or eye problems.
are pregnant or plan to become pregnant. LYTGOBI can harm your unborn baby or cause loss of your pregnancy (miscarriage). You should not become pregnant during treatment with LYTGOBI.
Females who can become pregnant:
Your healthcare provider should do a pregnancy test before you start treatment with LYTGOBI.
You should use an effective method of birth control during treatment and for 1 week after your final dose of LYTGOBI. Talk to your healthcare provider about birth control methods that may be right for you.
Tell your healthcare provider right away if you become pregnant or think that you may be pregnant.
Males with female partners who can become pregnant:
You should use effective birth control when sexually active during treatment with LYTGOBI and for 1 week after your last dose of LYTGOBI.
are breastfeeding or plan to breastfeed. It is not known if LYTGOBI passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose of LYTGOBI.

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