Robicua Tablet 100mg (Lorlatinib)

Adult dose

The recommended dose of this medicine is 100 mg orally once daily. Treatment with this medicine is recommended as long as the patient does not experience intolerable toxicity and clinical benefit continues. If a dose of this medicine is missed, take it as soon as remembered if 4 hours or more remain until the next dose; if less than 4 hours remain, skip the missed dose. Do not take 2 doses at once to make up for a missed dose. First dose reduction: 75 mg orally once daily Second dose reduction: 50 mg orally once daily If the patient cannot tolerate 50 mg orally once daily, permanently discontinue this medicine. Mild hypercholesterolemia (cholesterol between the upper limit of normal (ULN) and 300 mg/dL or between the ULN and 7.75 mmol/L) or moderate hypercholesterolemia (cholesterol between 301 mg/dL and 400 mg/dL or between 7.76 mmol/L and 10.34 mmol/L) or mild hypertriglyceridemia (triglycerides between 150 mg/dL and 300 mg/dL or between 1.71 mmol/L and 3.42 mmol/L) or moderate hypertriglyceridemia (triglycerides between 301 mg/dL and 500 mg/dL or between 3.43 mmol/L and 5.7 mmol/L): Initiate or adjust lipid-lowering therapyb according to the respective prescribing information. Continue this medicine at the same dose. Severe hypercholesterolemia (cholesterol between 401 mg/dL and 500 mg/dL or between 10.35 mmol/L and 12.92 mmol/L) or severe hypertriglyceridemia (triglycerides between 501 mg/dL and 1,000 mg/dL or between 5.71 mmol/L and 11.4 mmol/L): Initiate lipid-lowering therapyb. If the patient is currently receiving lipid-lowering therapy, increase the doseb according to the respective prescribing information. Alternatively, switch to a new lipid-lowering therapyb. Continue this medicine at the same dose without interruption. Life-threatening hypercholesterolemia (cholesterol greater than 500 mg/dL or 12.92 mmol/L) or life-threatening hypertriglyceridemia (triglycerides greater than 1,000 mg/dL or 11.4 mmol/L): Initiate lipid-lowering therapyb or increase the doseb according to the respective prescribing information. Alternatively, switch to a new lipid-lowering therapyb. Interrupt this medicine until hypercholesterolemia and/or hypertriglyceridemia resolves to moderate or mild grade. Try to resume this medicine at the same dose while maximizing lipid-lowering therapyb according to the respective prescribing information. If severe hypercholesterolemia and/or hypertriglyceridemia recurs despite maximizing lipid-lowering therapyb according to the respective prescribing information, reduce the dose of this medicine by 1 dose level. Central nervous system (CNS) effects: Grade 2: moderate or Grade 3: severe: Interrupt treatment until the toxicity is Grade 1 or lower. Then resume this medicine at a dose reduced by 1 dose level. Central nervous system (CNS) effects: Grade 4: life-threatening/emergency intervention required: Permanently discontinue this medicine. Increased lipase (lipid-digesting enzyme)/amylase: Grade 3: severe or Grade 4: life-threatening/emergency intervention required: Interrupt this medicine until lipase or amylase returns to baseline. Then resume this medicine at a dose reduced by 1 dose level. Interstitial lung disease (ILD)/pneumonitis: Grade 1: mild or Grade 2: moderate: Interrupt this medicine until symptoms return to baseline, and consider initiating corticosteroid treatment. Resume this medicine at a dose reduced by 1 dose level. Permanently discontinue this medicine if ILD/pneumonitis recurs or does not resolve within 6 weeks after treatment interruption and steroid administration. Interstitial lung disease (ILD)/pneumonitis: Grade 3: severe or Grade 4: life-threatening/urgent intervention required: Permanently discontinue this medicine. PR interval prolongation/atrioventricular (AV) block: 1st-degree AV block: asymptomatic: Continue this medicine at the same dose without interruption. Consider the effects of concomitant medications and assess and correct electrolyte imbalances that may prolong the PR interval. Closely monitor the ECG/symptoms that may be associated with AV block. PR interval prolongation/atrioventricular (AV) block: 1st-degree AV block: symptomatic: Temporarily interrupt this medicine. Consider the effects of concomitant medications and assess and correct electrolyte imbalances that may prolong the PR interval. Closely monitor the ECG/symptoms that may be associated with AV block. If symptoms resolve, resume this medicine at a dose reduced by 1 dose level. PR interval prolongation/atrioventricular (AV) block: 2nd-degree AV block: asymptomatic: Temporarily interrupt this medicine. Consider the effects of concomitant medications and assess and correct electrolyte imbalances that may prolong the PR interval. Closely monitor the ECG/symptoms that may be associated with AV block. If no 2nd-degree AV block is observed on subsequent ECGs, resume this medicine at a dose reduced by 1 dose level. PR interval prolongation/atrioventricular (AV) block: 2nd-degree AV block: symptomatic: Temporarily interrupt this medicine. Consider the effects of concomitant medications and assess and correct electrolyte imbalances that may prolong the PR interval. Refer the patient for cardiac observation and monitoring. Consider pacemaker placement if symptomatic AV block persists. If symptoms and 2nd-degree AV block resolve or reverse to asymptomatic 1st-degree AV block, resume this medicine at a dose reduced by 1 dose level. PR interval prolongation/atrioventricular (AV) block: complete AV block: Temporarily interrupt this medicine. Consider the effects of concomitant medications and assess and correct electrolyte imbalances that may prolong the PR interval. Refer the patient for cardiac observation and monitoring. A pacemaker may be used for severe symptoms associated with AV block. If AV block does not resolve, permanent pacemaker placement may be considered. If a pacemaker is placed, resume this medicine at the full dose. If no pacemaker is placed, resume this medicine at a dose reduced by 1 dose level when symptoms resolve and the PR interval decreases to less than 200 msec. Hypertension: Grade 3 (systolic blood pressure (SBP) 160 mmHg or higher or diastolic blood pressure (DBP) 100 mmHg or higher; medical intervention required; two or more antihypertensive drugs or a more intensive regimen than previously used): Temporarily interrupt this medicine until hypertension resolves to Grade 1 or lower (SBP less than 140 mmHg, DBP less than 90 mmHg), then resume this medicine at the same dose. If Grade 3 hypertension recurs, temporarily interrupt this medicine until it resolves to Grade 1 or lower, then resume treatment at a reduced dose. Permanently discontinue this medicine if hypertension cannot be adequately controlled with optimal medical management. Hypertension: Grade 4 (life-threatening consequences, urgent intervention required): Temporarily interrupt this medicine until it resolves to Grade 1 or lower, then resume treatment at a reduced dose or permanently discontinue this medicine. If Grade 4 hypertension recurs, permanently discontinue this medicine. Hyperglycemia: Grade 3 or Grade 4 (persistent hyperglycemia greater than 250 mg/dL despite optimal antihyperglycemic therapy): Temporarily interrupt this medicine until hyperglycemia is adequately controlled, then resume this medicine at the next lower dose level. Permanently discontinue this medicine if hyperglycemia cannot be adequately controlled with optimal medical management. Other adverse reactions: Grade 1: mild or Grade 2: moderate: No dose adjustment or reduce the dose by 1 dose level, depending on the clinical situation. Other adverse reactions: Grade 3 or higher: severe: Interrupt this medicine until symptoms resolve to Grade 2 or lower or return to baseline. Then resume this medicine at a dose reduced by 1 dose level. If concomitant administration of a strong CYP3A4/5 inhibitor is unavoidable, reduce the starting dose of this medicine (100 mg once daily) to 75 mg once daily. When concomitant use of the strong CYP3A4/5 inhibitor is discontinued, resume this medicine at the dose used before administration of the strong CYP3A4/5 inhibitor, after a washout period equivalent to 3-5 half-lives of the strong CYP3A4/5 inhibitor. Avoid concomitant use of this medicine and fluconazole. If concomitant administration is unavoidable, reduce the starting dose from 100 mg orally once daily to 75 mg orally once daily. No dose adjustment is required in patients with mild or moderate renal impairment [absolute estimated glomerular filtration rate (eGFR): ≥30 mL/min]. Dose reduction is recommended in patients with severe renal impairment (eGFR: <30 mL/min) (starting dose 75 mg orally once daily). Dose adjustment is not recommended in patients with mild hepatic impairment. There are no data on this medicine in patients with moderate or severe hepatic impairment. Therefore, this medicine is not recommended for patients with moderate to severe hepatic impairment. Encourage patients to take this medicine at the same time every day, with or without food. Tablets must be swallowed whole (do not chew, crush, or split before swallowing). Do not take tablets that are broken, cracked, or otherwise not intact.

This medication may cause serious pulmonary-related side effects such as interstitial lung disease or pneumonia that can lead to inflammation of the liver. If you experience worsening symptoms such as difficulty breathing, coughing, or fever, you should immediately undergo tests at a hospital and discontinue the medication if necessary. Do not take this medication if you have an allergy to it or its ingredients. Additionally, it is prohibited to take this medication in conjunction with certain strong liver enzyme inducers. Since it contains lactose, patients with lactose intolerance or specific genetic metabolic disorders should not take it. While taking this medication, blood cholesterol and triglyceride levels may rise, so regular blood tests are required. It may also affect the central nervous system and lead to symptoms such as memory loss, mood changes, or language disorders, and you should consult a doctor if these symptoms occur. There may be cardiac side effects such as cardiac conduction abnormalities or decreased left ventricular function, so cardiac tests are recommended. This medication can also increase pancreatic enzyme levels, posing a risk of pancreatitis, thus blood tests should be performed when necessary. Blood pressure may rise, so it is essential to monitor blood pressure frequently before and during treatment, and blood sugar management may be necessary as hyperglycemia can occur. This medication may interact with several drugs, especially those that strongly induce or inhibit liver enzymes, so caution is advised when used in combination. It should not be used during pregnancy as it may harm the fetus, and breastfeeding should also be avoided. Women of childbearing age should use effective non-hormonal contraception during and for a certain period after treatment. Men are also advised to use contraception during and for a certain period after treatment. The safety and efficacy for children under 18 years have not been established, and data on its use in elderly patients over 65 years is limited. In case of overdose, general treatment should be provided and cardiac conditions should be monitored, as there is no specific antidote for this medication. Keep this medication out of reach of children, and store it in its original container.

• Interstitial lung disease
• pneumonia
• hypercholesterolemia
• hypertriglyceridemia
• edema
• peripheral neuropathy
• weight gain
• cognitive effects
• fatigue
• arthralgia

This medication can be sensitive to air and humidity, so it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 degrees and 30 degrees at room temperature. Proper storage will help maintain the medication's effectiveness.

Appearance

Dark pink oval film-coated tablet

Package unit

30 tablets/box [10 tablets/blister X 3]