Medication info

Pemazire 4.5 mg (Famitinib)

Prescription medicationTablet경구
Ingredient · strength
Pemigatinib›4.5mg / 1 tablet
Manufacturer / importer
(주)한독
Appearance
Round tablets, white to pale yellow, imprinted with "I" on one side and "4.5" on the other side.
Packaging
PTP - 14 tablets/box [14 PTP x 1]
Approval status
Active

MFDS item code 202301339 · Approved 2023.04.25 · Insurance code 652105880

Summary

Main use
Treatment of locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement.
Who takes it
Adults
Adult dose
Take 13.5 mg of this medication orally once daily for 14 days, followed by a 7-day break. Ideally take it at the same time every day and swallow it whole. It can be taken regardless of meals. If you miss a dose for more than 4 hours or vomit after taking the medication, do not take an extra dose, but continue with the next scheduled dose. Continue until the disease progresses or unacceptable toxicity appears.

Ingredients

Importer
(주)한독

Efficacy & effects

Treatment of locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement.

  • Locally advanced cholangiocarcinoma
  • metastatic cholangiocarcinoma
View approved original text

This medication is used for the treatment of locally advanced or metastatic cholangiocarcinoma confirmed to have FGFR2 gene fusion or rearrangement in adult patients who have received systemic treatment at least once. It is designed to assist cholangiocarcinoma patients when previous treatments have proven ineffective. Patients can expect better outcomes in their cholangiocarcinoma treatment with this medication.

How to take

Adult dose

Take 13.5 mg of this medication orally once daily for 14 days, followed by a 7-day break. Ideally take it at the same time every day and swallow it whole. It can be taken regardless of meals. If you miss a dose for more than 4 hours or vomit after taking the medication, do not take an extra dose, but continue with the next scheduled dose. Continue until the disease progresses or unacceptable toxicity appears.

Precautions

This medication can be harmful to fetuses during pregnancy, so it should not be administered to pregnant women. Women of childbearing age and men with a potential for fathering a child must use effective contraception during and for one week after taking this medication. Patients with allergies to this medication or its components, as well as those taking St. John's Wort, should not use this medication. Patients with hyperphosphatemia should be monitored closely because phosphorous levels may increase when taking this medication, and dietary restrictions on phosphorous and drug therapy should be followed. Conversely, patients with hypophosphatemia may experience excessively low phosphorous levels while taking this medication, warranting dietary adjustment and consideration of stopping treatment. This medication may affect eye health; if symptoms such as blurred vision, floaters, or light sensitivity arise, an eye examination should be conducted immediately, and regular eye examinations are required before and during treatment. Dry eye symptoms may occur frequently; lubricants such as artificial tears can be used as necessary to alleviate these symptoms. This medication may interact with other drugs that inhibit or induce specific enzymes (CYP3A4); therefore, dose adjustments are necessary when taking strong CYP3A4 inhibitors or inducers together, and consumption of grapefruit or grapefruit juice should be avoided. Blood tests may show elevated creatinine levels, but this may not indicate impaired kidney function; therefore, other indicators should also be considered when assessing kidney function. This medication may moderately affect the ability to drive or operate machinery, thus care should be taken when engaging in such activities. The safety and effectiveness in children under 18 years have not been established, and elderly patients use the same dosage as general adults. This medication should be stored in its original packaging, protected from direct sunlight, out of reach of children, and expired medications should not be used.

Side effects and when to seek care immediately

Serious side effects

  • Abdominal pain
  • fever
  • cholangitis
  • pleural effusion
  • acute kidney failure
  • infectious cholangitis
  • growth retardation
  • hypercalcemia
  • hyponatremia
  • intestinal obstruction
Show 17 more
  • pneumonia
  • sepsis
  • urinary tract infection
  • bowel obstruction
  • QT interval prolongation
  • syncope
  • acute kidney failure
  • pneumonia
  • biliary obstruction
  • sepsis
  • pleural effusion
  • severe edema or urination abnormalities
  • severe allergic reactions
  • severe skin adverse reactions
  • respiratory problems
  • liver abnormalities (jaundice)
  • severe neurological symptoms.

Mild side effects

  • Decreased appetite
  • hair loss
  • nail toxicity
  • dry skin
  • palmoplantar erythrodysesthesia syndrome
  • diarrhea
  • nausea
  • constipation
  • stomatitis
  • dry mouth
Show 19 more
  • vomiting
  • abdominal pain
  • fatigue
  • taste alteration
  • headache
  • dry eyes
  • arthralgia
  • back pain
  • limb pain
  • weight loss
  • fractures
  • pathologic fractures
  • decreased hemoglobin
  • lymphopenia
  • thrombocytopenia
  • leukocytosis
  • leukopenia
  • increased alanine aminotransferase
  • aspartate aminotransferase increase.

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is recommended to maintain the storage temperature between 1 and 30 degrees Celsius to ensure the drug's effectiveness.

Appearance and packaging

Appearance

Round tablets, white to pale yellow, imprinted with "I" on one side and "4.5" on the other side.

Package unit

PTP - 14 tablets/box [14 PTP x 1]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.