Vigim Pro Tablet 30 mg (Dacomitinib Hydrate)

Adult dose

Administer this medicine orally at the recommended dose of 45 mg once daily until disease progression or unacceptable toxicity occurs. Advise patients to take this medicine at the same time each day. If a patient vomits or misses a dose, do not administer an additional dose; the prescribed dose should be taken at the scheduled time the following day. Recommended starting dose: 45 mg, once daily First dose reduction: 30 mg, once daily Second dose reduction: 15 mg, once daily Temporarily withhold this medicine during diagnostic evaluation for interstitial lung disease/interstitial pneumonia. Permanently discontinue this medicine if interstitial lung disease/interstitial pneumonia is confirmed. For Grade 1 diarrhea, no dose adjustment is required. Start antidiarrheal treatment (e.g., loperamide) at the first occurrence of diarrhea. Maintain adequate oral fluid intake during diarrhea. For Grade 2 diarrhea, if it does not improve to Grade 1 or lower within 24 hours despite administration of an antidiarrheal (e.g., loperamide) and adequate oral fluid intake, temporarily withhold this medicine. Once it resolves to Grade 1 or lower, resume this medicine at the same dose or consider reducing the dose by one level. For Grade 3 or higher diarrhea, temporarily withhold this medicine. Administer an antidiarrheal (e.g., loperamide) and ensure adequate oral fluid intake, or administer intravenous fluids or electrolytes as needed. Once it resolves to Grade 1 or lower, resume this medicine with the dose reduced by one level. For Grade 1 rash or erythematous skin, no dose adjustment is required. Initiate treatment (e.g., antibiotics, topical corticosteroids, and emollients). For Grade 1 exfoliative skin reactions, no dose adjustment is required. Initiate treatment (e.g., oral antibiotics and topical corticosteroids). For Grade 2 rash or erythematous or exfoliative skin reactions, no dose adjustment is required. Initiate or add treatment (e.g., oral antibiotics and topical corticosteroids). If Grade 2 rash or erythematous or exfoliative skin reactions persist for 72 hours despite treatment, temporarily withhold this medicine. Once they resolve to Grade 1 or lower, resume this medicine at the same dose or consider reducing the dose by one level. For Grade 3 or higher rash or erythematous or exfoliative skin reactions, temporarily withhold this medicine. Initiate or continue treatment and/or provide additional treatment (e.g., broad-spectrum oral or intravenous antibiotics and topical corticosteroids). Once they resolve to Grade 1 or lower, resume this medicine with the dose reduced by one level. For Grade 1 or 2 toxicity, no dose adjustment is required. For Grade 3 or higher toxicity, temporarily withhold this medicine until symptoms resolve to Grade 2 or lower. Once recovered, resume this medicine with the dose reduced by one level. This medicine is for oral use. Swallow the tablet with water; it may be taken with or without food. No adjustment of the starting dose is required when administering this medicine to patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment. For patients with severe (Child-Pugh class C) hepatic impairment, adjust the starting dose to 30mg once daily. After at least 4 weeks of treatment, the dose may be increased to 45mg once daily based on the individual's safety and tolerability. No adjustment of the starting dose is required when administering this medicine to patients with mild or moderate renal impairment (creatinine clearance [CrCl] ≥30 mL/min). Data are limited for patients with severe renal impairment (CrCl <30 mL/min), and no data are available for patients requiring hemodialysis. Therefore, recommended doses for these two patient groups are unknown.

This medication may cause interstitial lung disease or interstitial pneumonia, so if symptoms related to the lungs, such as shortness of breath, cough, or fever, suddenly appear or worsen, consult a doctor immediately. Persons who are allergic to the active ingredient or excipients of this medication should not take it, and patients with lactose intolerance or genetic lactose metabolism issues should also avoid this medication. While taking this medication, common side effects may include diarrhea, rash, stomatitis, nail issues, dry skin, decreased appetite, conjunctivitis, weight loss, hair loss, itching, abnormal taste, keratitis, vomiting, hand/foot erythematous sensory syndrome, skin cracking, weakness, fatigue, elevated aminotransferases, hirsutism, or mucosal pain in the mouth/eyes. If these symptoms are severe or persistent, patients should consult healthcare professionals. In particular, diarrhea is very common and can lead to dehydration, so when diarrhea begins, patients should take anti-diarrheal medications and maintain adequate hydration, adjusting the medication dosage according to healthcare professionals’ instructions if necessary. If skin-related adverse effects such as rashes or erythema and skin peeling occur, moisturizing treatments should be used, and if symptoms are severe, topical steroids or antibiotic treatments should be given. When exposed to sunlight, sunscreen should be applied. Since liver function abnormalities may occur, it is important to undergo regular liver function tests while taking this medication, and if liver function tests significantly increase, the medication may need to be discontinued. As this medication is metabolized by a specific enzyme (CYP2D6) in the liver, drug interactions may occur when taken with other drugs that affect this enzyme, so patients must inform their doctor or pharmacist if they are taking other medications. Using proton pump inhibitors (PPIs) concurrently may reduce the effectiveness of this medication, so it is advisable to avoid PPI use or adjust the dosing intervals if necessary. This medication may require caution when driving or operating machinery, so if fatigue or visual disruptions occur during treatment, patients should avoid driving or performing hazardous activities. Women who are pregnant or planning to become pregnant should not take this medication, and during treatment, appropriate contraceptive methods must be used. Breastfeeding women should also avoid breastfeeding during treatment. Safety for pediatric use has not been established, so children under 18 should not take this medication, and no special dosage adjustment is needed for older adults. In case of overdose, there is no specific antidote; symptomatic treatment and general supportive care should be administered, and the medication should be stored out of reach of children and kept in its original container.

Diarrhea, rash, stomatitis, nail disorders, dry skin, loss of appetite, conjunctivitis, weight loss, hair loss, itching, increased aminotransferases, nausea, hypokalemia, dehydration, taste disturbance, keratitis, vomiting, hand/foot erythematous sensory disturbance syndrome, skin fissures, skin peeling, hirsutism, fatigue, asthenia, interstitial lung disease, interstitial pneumonia

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to keep the storage temperature between 1 and 30 degrees Celsius.

Appearance

Blue, double-convex, round film-coated tablet

Package unit

Domestic use - 30 tablets/blister