Octairo Capsule 160 mg (Repotrectinib)

Adult dose

The recommended dose of this drug in adults is 160mg orally once daily for the first 14 days, and thereafter 160mg twice daily, with or without food. Continue treatment until disease progression or unacceptable toxicity. The capsules should be swallowed whole at the same time each day; do not open, crush, chew, or dissolve the capsules. If a dose is missed or the patient vomits after taking the drug, the next dose should be taken at the next scheduled time; do not take two doses at the same time. The recommended dose reductions for this drug to manage adverse reactions are shown in Table 1. Table 1: Recommended Dose Reductions for Adverse Reactions Dose Dose reduction 1st 2nd 160 mg once daily 120 mg once daily 80 mg once daily 160 mg twice daily 120 mg twice daily 80 mg twice daily The recommended dose modifications for this drug to manage adverse reactions are shown in Table 2. Table 2: Recommended Dose Modifications for Adverse Reactions Adverse reaction Severity* Dose modification Central nervous system effects (See 3. Precautions) Intolerable Grade 2 Temporarily withhold this drug until recovery to Grade 1 or lower or baseline. Resume treatment at the same dose or a reduced dose, as clinically indicated. Grade 3 Temporarily withhold this drug until recovery to Grade 1 or lower or baseline. Resume treatment at a reduced dose. Grade 4 Permanently discontinue this drug. Interstitial lung disease (ILD)/pneumonitis (See 3. Precautions) All grades Temporarily withhold this drug if ILD/pneumonitis is suspected. Permanently discontinue this drug if ILD/pneumonitis is confirmed. Hepatotoxicity (See 3. Precautions) Grade 3 Temporarily withhold this drug until recovery to Grade 1 or lower or baseline. If recovery occurs within 4 weeks, resume treatment at the same dose. For recurrent Grade 3 events that recover within 4 weeks, resume treatment at a reduced dose. Grade 4 Temporarily withhold this drug until recovery to Grade 1 or lower or baseline. Permanently discontinue if the adverse reaction does not recover within 4 weeks. Permanently discontinue for recurrent Grade 4 events. If ALT or AST is greater than 3 times the upper limit of normal (ULN) and total bilirubin is greater than 1.5 times the upper limit of normal (ULN) (in the absence of cholestasis or hemolysis) Permanently discontinue this drug. Creatine phosphokinase (CPK) elevation (See 3. Precautions) CPK elevation greater than 5 times the ULN Temporarily withhold this drug until recovery to Grade 1 or lower or baseline. Resume treatment at the same dose. CPK elevation greater than 10 times the ULN or a second occurrence of CPK elevation greater than 5 times the ULN Temporarily withhold this drug until recovery to Grade 1 or lower or baseline. Resume treatment at a reduced dose. Hyperuricemia (See 3. Precautions) Grade 3 or Grade 4 Temporarily withhold this drug until symptoms or signs improve. Resume treatment at the same dose or a reduced dose. Other clinically significant adverse reactions (See 2. Adverse Reactions) Intolerable Grade 2 or Grade 3 or Grade 4 Temporarily withhold this drug until recovery to Grade 1 or lower or baseline. If recovery occurs within 4 weeks, resume treatment at the same dose or a reduced dose. Permanently discontinue if the adverse reaction does not recover within 4 weeks. Permanently discontinue for recurrent Grade 4 events. * Severity as defined by the Common Terminology Criteria for Adverse Events v4.03

Child dose

The recommended dose of this drug in pediatric patients aged 12 years and older is 160mg orally once daily for the first 14 days, followed by 160mg orally twice daily, regardless of meals. Continue treatment until disease progression or unacceptable toxicity.

This drug should not be used in patients with allergies to the active ingredient or excipients. Various side effects may occur when taking this medication, so caution is necessary. Commonly reported symptoms include dizziness, taste disturbances, peripheral neuropathy, constipation, dyspnea, fatigue, ataxia, cognitive impairment, muscle weakness, and nausea. Serious side effects include pneumonia, dyspnea, pleural effusion, hypoxia, and some patients may experience heart-related problems or life-threatening adverse reactions. This medication may affect the central nervous system, so caution is needed when driving or operating machinery, and if symptoms are severe, the medication should be temporarily discontinued or stopped. If respiratory symptoms or pulmonary issues occur, consult a physician immediately, and since liver function abnormalities are also frequently encountered, regular liver function tests should be conducted. Muscle pain or weakness may occur, so patients should inform healthcare providers if these symptoms arise, and serum creatine phosphokinase levels should also be checked periodically. Blood uric acid levels may increase, and if necessary, treatment to lower uric acid should be implemented. There is also a risk of fractures, so if pain or deformity symptoms appear, it should be confirmed immediately. Women who are pregnant or may become pregnant should verify their pregnancy status before administration as this medication may pose serious risks to the fetus, and effective non-hormonal contraceptives should be used during treatment. It is safe for breastfeeding women to discontinue breastfeeding while taking this medication. Additionally, this medication may inhibit or induce certain liver enzymes, leading to drug interactions, so if there are other medications being taken, be sure to inform healthcare providers. Elderly patients or those with impaired kidney or liver function also require special caution, as dosage adjustments may be necessary. This drug carries a high risk of fractures when used in pediatric patients, thus careful monitoring is necessary.

pneumonia, dyspnea, pleural effusion, hypoxemia, aspiration pneumonia, cardiac arrest, acute cardiac death, heart failure, respiratory failure, tremor, disseminated intravascular coagulation, dizziness, muscle weakness, ataxia, peripheral neuropathy, anemia, vomiting, taste disturbance, constipation, fatigue, cognitive impairment, nausea, headache, cough, edema, decreased appetite, myalgia, weight gain, visual disturbances, fever, falls, decreased hemoglobin, decreased lymphocyte count, decreased neutrophil count, increased activated partial thromboplastin time, increased international normalized ratio, increased creatine phosphokinase, increased gamma-glutamyl transferase, increased aspartate aminotransferase, increased alanine aminotransferase, increased sodium, increased alkaline phosphatase, increased glucose, increased uric acid, decreased phosphate, increased potassium, decreased glucose, sleep disturbances, mood disorders, insomnia, hypersomnia, interstitial lung disease, lung inflammation, hepatotoxicity, hyperuricemia, fractures, memory impairment, attention deficit, confusional state, anxiety, drowsiness, aphasia, confusion state, decreased consciousness level, hallucinations, changes in mental status, neurological deficit, mood disorders, mania, drowsiness, insomnia, hypersomnia, aspiration pneumonia, lower respiratory tract infection, viral pneumonia, bacterial pneumonia, Klebsiella pneumonia, generalized edema, periorbital edema, localized edema, facial edema, peripheral edema, ocular edema, scrotal edema, myositis, musculoskeletal discomfort, musculoskeletal pain, decreased vision, dry eyes, visual impairment, visual field defect, cataract, conjunctivitis, eye pain, photophobia, photosensitivity, reduced vision, vitreous floaters, eyelid spasm, color blindness, diplopia, eye hematoma, eye swelling, eyelid disorders, eyelid injuries, eyelid itching, glaucoma, night blindness, ophthalmic herpes zoster, fever, increased appetite, hyperkalemia, hyperuricemia, dysesthesia, drowsiness, insomnia, obstructive sleep apnea syndrome, blurred vision, eye pain, homonymous hemianopsia, photophobia, visual damage, pleural effusion, abdominal pain, oral dysesthesia, skeletal fractures, ankle fractures, foot fractures, fatigue fractures, calf fractures, tibial fractures, arthralgia, fever, decreased white blood cell count

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness and safety.

Appearance

A blue hard capsule filled with a powder that may appear as a lump that is white to almost white.

Package unit

60 capsules/bottle, 14 capsules/bottle