Medication info
Geotrip Tablet 20 mg (Apatinib Maleate)

Geotrip Tablet 20 mg (Apatinib Maleate)

Prescription medicationTabletOral
Ingredient · strength
Afatinib Dimaleate›29.56mg / 1 tablet
Manufacturer / importer
Boehringer Ingelheim Korea
Appearance
White to off-white, round, biconvex film-coated tablet
Packaging
28 tablets (7 tablets/PTP * 4 packs)
Approval status
Active

MFDS item code 201400441 · Approved 2014.01.29 · Insurance code 653501430

Summary

Main use
First-line treatment of EGFR-mutated non-small cell lung cancer; treatment of squamous non-small cell lung cancer
Who takes it
Adults · Children
Adult dose
Take 40mg orally once daily at least 1 hour before a meal or at least 3 hours after a meal. This medicine should be administered without food; swallow the tablet whole with water. Treatment may be continued until disease progression or unacceptable toxicity occurs. Temporarily interrupt treatment with this medicine if an adverse drug reaction occurs, including NCI CTCAE1 grade 3 or higher, grade 2 or higher diarrhea lasting 2 days or more despite antidiarrheal treatment, grade 2 skin reactions lasting 7 days or more or that are intolerable, or grade 2 or higher renal impairment. Once the adverse drug reaction has recovered to grade 1 or lower, restart treatment at a dose reduced by 10mg from the previous dose. Permanently discontinue this medicine in the event of severe bullous, blistering, or exfoliative skin symptoms; interstitial lung disease; severe hepatic impairment; persistent ulcerative keratitis; symptoms of left ventricular dysfunction; or a severe or intolerable adverse reaction at a daily dose of 20mg. No dose adjustment is required in patients with mild (glomerular filtration rate (eGFR) 60-89mL/min) or moderate (glomerular filtration rate (eGFR) 30-59mL/min) renal impairment. A dose of 30mg once daily is recommended in patients with severe renal impairment (glomerular filtration rate (eGFR) 15-29mL/min). Use of this medicine is not recommended in patients with a glomerular filtration rate (eGFR) below 15mL/min or in patients on dialysis. No initial dose adjustment is required in patients with mild hepatic impairment (Child Pugh A) or moderate hepatic impairment (Child Pugh B). Studies of this medicine have not been conducted in patients with severe hepatic impairment (Child Pugh C); therefore, its use is not recommended. Patients who need to receive a P-glycoprotein (P-gp) inhibitor should take it with this medicine or after taking this medicine. If the tablet cannot be swallowed whole, it may be dispersed in approximately 100ml of noncarbonated drinking water; do not use any other liquid. Do not crush this medicine. Place it in water and stir occasionally for 15 minutes until the tablet breaks into very small particles, then take the dispersion immediately. Rinse the cup used with approximately 100ml of water and drink it. The dispersion may also be administered through a gastric tube.
Child dose
The safety and efficacy of this medicine in children have not been studied; therefore, its use is not recommended in pediatric patients.

Ingredients

Importer
Boehringer Ingelheim Korea

Efficacy & effects

First-line treatment of EGFR-mutated non-small cell lung cancer; treatment of squamous non-small cell lung cancer

  • Locally advanced non-small cell lung cancer
  • metastatic non-small cell lung cancer
  • locally advanced squamous cell non-small cell lung cancer
  • metastatic squamous cell non-small cell lung cancer
View approved original text

This medicine is used as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer with EGFR active mutations. Additionally, it is effective for the treatment of locally advanced or metastatic squamous cell non-small cell lung cancer that has progressed during or after platinum-based chemotherapy. This drug helps improve patients' conditions by providing customized treatment based on various types of lung cancer.

How to take

Adult dose

Take 40mg orally once daily at least 1 hour before a meal or at least 3 hours after a meal. This medicine should be administered without food; swallow the tablet whole with water. Treatment may be continued until disease progression or unacceptable toxicity occurs. Temporarily interrupt treatment with this medicine if an adverse drug reaction occurs, including NCI CTCAE1 grade 3 or higher, grade 2 or higher diarrhea lasting 2 days or more despite antidiarrheal treatment, grade 2 skin reactions lasting 7 days or more or that are intolerable, or grade 2 or higher renal impairment. Once the adverse drug reaction has recovered to grade 1 or lower, restart treatment at a dose reduced by 10mg from the previous dose. Permanently discontinue this medicine in the event of severe bullous, blistering, or exfoliative skin symptoms; interstitial lung disease; severe hepatic impairment; persistent ulcerative keratitis; symptoms of left ventricular dysfunction; or a severe or intolerable adverse reaction at a daily dose of 20mg. No dose adjustment is required in patients with mild (glomerular filtration rate (eGFR) 60-89mL/min) or moderate (glomerular filtration rate (eGFR) 30-59mL/min) renal impairment. A dose of 30mg once daily is recommended in patients with severe renal impairment (glomerular filtration rate (eGFR) 15-29mL/min). Use of this medicine is not recommended in patients with a glomerular filtration rate (eGFR) below 15mL/min or in patients on dialysis. No initial dose adjustment is required in patients with mild hepatic impairment (Child Pugh A) or moderate hepatic impairment (Child Pugh B). Studies of this medicine have not been conducted in patients with severe hepatic impairment (Child Pugh C); therefore, its use is not recommended. Patients who need to receive a P-glycoprotein (P-gp) inhibitor should take it with this medicine or after taking this medicine. If the tablet cannot be swallowed whole, it may be dispersed in approximately 100ml of noncarbonated drinking water; do not use any other liquid. Do not crush this medicine. Place it in water and stir occasionally for 15 minutes until the tablet breaks into very small particles, then take the dispersion immediately. Rinse the cup used with approximately 100ml of water and drink it. The dispersion may also be administered through a gastric tube.

Child dose

The safety and efficacy of this medicine in children have not been studied; therefore, its use is not recommended in pediatric patients.

Precautions

This drug may harm the fetus if taken during pregnancy, so women who are pregnant or may become pregnant must use effective contraception, and if pregnancy is suspected, they should immediately inform their doctor. This drug can rarely cause serious skin conditions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, so treatment should be stopped immediately if blisters or exfoliative skin symptoms appear. Patients with allergies to the main ingredient or any components of this drug or certain lactose intolerance should not take this medicine. Patients with a history of interstitial lung disease or severely impaired liver function must exercise caution when taking this drug; if pulmonary symptoms or signs of impaired liver function appear, consult a doctor immediately. This drug can interact with other medications, so especially if taking P-glycoprotein inhibitors or inducers, inform your doctor and use with caution. Diarrhea may occur frequently during treatment, and severe diarrhea can cause dehydration or kidney problems, so if diarrhea begins, take anti-diarrheal medication immediately and ensure adequate fluid intake. Skin rashes or acne-like skin reactions may occur, and symptoms can worsen with sun exposure, so care should be taken to protect against sunlight. If there is inflammation, pain, or redness in the eyes, seek ophthalmologist care immediately; in severe cases, this drug should be discontinued. This drug may affect heart function, so patients with heart disease or weakened heart function may require regular heart examinations. Pregnant or breastfeeding women should not take this drug, and especially during breastfeeding, the risk of the drug being transmitted to the baby through breast milk necessitates ceasing breastfeeding. In case of overdose, there is no specific antidote, so stop taking it immediately and receive treatment for symptoms; if necessary, vomiting or gastric lavage can be performed to remove the drug. The effect on driving or operating machines is unclear, so caution is advised.

Side effects

Stevens-Johnson syndrome, toxic epidermal necrolysis, blistering skin symptoms accompanying desquamation, interstitial lung disease, diarrhea, dermatological adverse events, stomatitis, paronychia, cystitis, decreased appetite, dehydration, hypokalemia, dysgeusia, conjunctivitis, dry eye, keratitis, epistaxis, rhinorrhea, nausea, vomiting, dyspepsia, cheilitis, pancreatitis, gastrointestinal perforation, elevated alanine aminotransferase, elevated aspartate aminotransferase, rash, acneiform dermatitis, pruritus, dry skin, erythema neuropathy syndrome, nail disorders, muscle cramps, renal impairment, renal failure, fever, weight loss, pneumonia, dyspnea, pleural effusion, acute kidney injury, nausea, abdominal pain, oral ulcer formation, colitis, upper respiratory infection, gastroenteritis, atypical pneumonia, bacterial pneumonia, acute pyelonephritis, septic shock, cough, productive cough, hemoptysis, lung inflammation, pulmonary embolism, asthma, pneumothorax, pulmonary fibrosis, hyponatremia, hyperglycemia, hypoalbuminemia, hypoglycemia, malnutrition, lactic acidosis, weakness, headache, dizziness, hemiparesis, cerebral infarction, hydrocephalus, seizures, back pain, limb pain, spondylolisthesis, delirium, anemia, deep vein thrombosis, pericardial effusion, gastroesophageal reflux disease, dysphagia, gastric ulcer, hemorrhoids, hematochezia, melena, pruritus, drug rash, seborrheic dermatitis, papular-patchy rash, skin pain, nail pain, photosensitivity reactions, psoriasis, rosacea, bacteremia, impetigo, herpes zoster, athlete's foot, oral candidiasis, skin infections, limb abscess, allergic rhinitis, hiccups, cachexia, hypercalcemia, hypophosphatemia, hypoproteinemia, hypovolemia, zinc deficiency, fatigue, insomnia, anxiety, depression, hematuria, toxic nephropathy, ureteral stones, neurogenic bladder, cataracts, decreased vision, visual impairment, conjunctival hemorrhage, allergic conjunctivitis, punctate keratitis, thrombocytopenia, compression fractures, hypotension, hypertension, ventricular tachycardia, atrial fibrillation, sinus tachycardia, tinnitus, otorrhea, orthostatic dizziness, cholelithiasis, hepatotoxicity, cholecystitis, genital pruritus, atrophic vaginitis, genital erosion, irregular menstruation, vaginal bleeding, adrenal insufficiency, antidiuretic hormone secretion abnormality

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

Storage

This drug should be stored at room temperature between 1°C and 30°C, and it is important to store it in a sealed container to prevent air from entering. Storing it this way will help maintain the drug's efficacy and prevent degradation.

Appearance and packaging

Appearance

White to off-white, round, biconvex film-coated tablet

Package unit

28 tablets (7 tablets/PTP * 4 packs)

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

No questions yet.

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

Related searches

Search tags

Suggested searches

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.