Vigim Pro Tablet 45 mg (Dacomitinib Hydrate)

Adult dose

1. Dosage This medication is administered orally at the recommended dose of 45 mg once daily until disease progression or unacceptable toxicity occurs. Patients should be advised to take this medication at the same time each day. If a patient vomits or misses a dose, an additional dose should not be taken; the prescribed dose should be taken at the scheduled time the following day. 1) Dose modifications Dose modifications may be necessary based on each patient’s individual tolerability and safety. If a dose reduction is required, reduce the dose of this medication as shown in Table 1. Dose modification and management guidelines for specific adverse reactions are described in Table 2. [Table 1] Recommended dose modifications for this medication for adverse reactions Regimen Dose (once daily) Recommended starting dose 45 mg First dose reduction 30 mg Second dose reduction 15 mg [Table 2] Dose modifications and management of adverse reactions for this medication Adverse reaction Dose modification Interstitial lung disease (ILD)/interstitial pneumonitis Temporarily interrupt treatment with this medication while evaluating for a diagnosis of interstitial lung disease/interstitial pneumonitis. If interstitial lung disease/interstitial pneumonitis is confirmed, permanently discontinue treatment with this medication. Diarrhea For Grade 1 diarrhea, no dose modification is required. At the first occurrence of diarrhea, initiate treatment with an antidiarrheal agent (e.g., loperamide). Maintain adequate oral fluid intake during diarrhea. For Grade 2 diarrhea, administer an antidiarrheal agent (e.g., loperamide) and maintain adequate oral fluid intake. If diarrhea does not improve to Grade 1 or lower within 24 hours, temporarily interrupt treatment with this medication. Once it resolves to Grade 1 or lower, resume treatment with this medication at the same dose or consider reducing the dose by one level. For Grade 3 or higher diarrhea, temporarily interrupt treatment with this medication. Administer an antidiarrheal agent (e.g., loperamide) and provide adequate oral fluid intake or, as needed, intravenous fluids or electrolytes. Once it resolves to Grade 1 or lower, resume treatment with this medication at a dose reduced by one level. Skin-related adverse reactions For Grade 1 rash or erythematous skin, no dose modification is required. Initiate treatment (e.g., antibiotics, topical corticosteroids, and emollients). For Grade 1 exfoliative skin, no dose modification is required. Initiate treatment (e.g., oral antibiotics and topical corticosteroids). For Grade 2 rash, erythematous skin, or exfoliative skin, no dose modification is required. Initiate or intensify treatment (e.g., oral antibiotics and topical corticosteroids). If Grade 2 rash, erythematous skin, or exfoliative skin persists for 72 hours despite treatment, temporarily interrupt treatment with this medication. Once it resolves to Grade 1 or lower, resume treatment with this medication at the same dose or consider reducing the dose by one level. For Grade 3 or higher rash, erythematous skin, or exfoliative skin, temporarily interrupt treatment with this medication. Initiate or continue treatment and/or provide additional treatment (e.g., broad-spectrum oral or intravenous antibiotics and topical corticosteroids). Once it resolves to Grade 1 or lower, resume treatment with this medication at a dose reduced by one level. Other For Grade 1 or 2 toxicity, no dose modification is required. For Grade 3 or higher toxicity, temporarily interrupt treatment with this medication until symptoms resolve to Grade 2 or lower. Once recovered, resume treatment with this medication at a dose reduced by one level. 2) Method of administration This medication is for oral use. Tablets should be swallowed with water and may be taken with or without food. 3) Patients with hepatic impairment No adjustment of the starting dose is required when administering this medication 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, the starting dose should be adjusted to 30 mg once daily. After at least 4 weeks of treatment, the dose may be increased to 45 mg once daily based on the individual’s safety and tolerability. 4) Patients with renal impairment No adjustment of the starting dose is required when administering this medication to patients with mild or moderate renal impairment (creatinine clearance [CrCl] ≥30 mL/min). Data in patients with severe renal impairment (CrCl <30 mL/min) are limited, and no data are available for patients requiring hemodialysis. Therefore, the recommended dose for these two patient groups is unknown.

This drug may cause serious lung diseases such as interstitial lung disease or pneumonitis. Patients must seek immediate medical evaluation if respiratory symptoms such as shortness of breath, cough, or fever suddenly appear or worsen. Patients with allergies to any component or excipients contained in this medication, those with lactose intolerance, galactose intolerance, or genetic glucose-galactose malabsorption should not take this medication. While taking this medication, common side effects may include diarrhea, rash, stomatitis, nail abnormalities, dry skin, decreased appetite, conjunctivitis, weight loss, hair loss, itching, nausea, increased transaminases, and vomiting. If the symptoms are severe or persistent, consult with medical staff. Diarrhea is particularly common and can cause dehydration, so initial symptoms should be managed with anti-diarrheal medication and adequate hydration, and dosage adjustment or drug discontinuation may be necessary. Rashes or erythema and exfoliative skin disorders may occur, and patients should use moisturizers. If symptoms are severe, local antibiotics or steroid treatments should be employed, and sun exposure should be avoided while using sunscreen. Liver function tests are required, and if transaminase levels are elevated, drug administration may need to be discontinued. This medication may interact with drugs that are metabolized by specific enzymes (CYP2D6) in the liver; therefore, it is advisable to avoid co-administration of such drugs. Using this medication with proton pump inhibitors or other acid-reducing drugs may reduce its effectiveness, so caution is required to avoid taking these medications together. Patients may experience fatigue or visual disturbances while taking this medication, making it necessary to exercise caution when driving or operating machinery. Women of childbearing potential should avoid pregnancy during and for some time after taking this medication, and it should not be taken during pregnancy. Breastfeeding women should avoid nursing as this medication may be passed through breast milk. Use in children is not recommended as safety and efficacy have not been established, while elderly patients can use it without special dose adjustment. In cases of overdose, gastrointestinal, skin, and systemic symptoms may occur, and treatment will be symptom-dependent, as there is no specific antidote. Keep this medication out of reach of children and store it in its original container in a tightly sealed manner.

• Diarrhea
• rash
• stomatitis
• nail disorders
• dry skin
• decreased appetite
• conjunctivitis
• weight loss
• hair loss
• itching

Store this medication in a tightly sealed container to protect it from air and moisture. Additionally, keep the medication at room temperature, not too hot or cold, ideally between 1 to 30 degrees Celsius.

Appearance

Blue, round film-coated tablets with a biconvex shape

Package unit

For domestic use - 30 tablets/blister