Ujedi 2M Injection 150 mg (Risperidone)

Adult dose

1. Adults: For patients who have never received risperidone, establish tolerability with oral risperidone before administering this medicine. This medicine must be administered by a healthcare professional as a subcutaneous injection into the abdomen or upper arm and must not be administered by any other route. (See Precautions for Use, “9. Precautions for Administration.”) When switching patients receiving a stabilized dose of oral risperidone to this medicine, start treatment by administering this medicine once every 2 months on the day after the last oral dose. • Switching patients receiving oral risperidone See Table 1 below for how to switch from oral risperidone to this medicine. A loading dose or additional oral risperidone is not recommended when switching. Switching to this medicine has not been studied in patients previously treated with an oral risperidone daily dose exceeding 5mg. Table 1. Recommended doses when switching from daily oral risperidone to this medicine Previous treatment (daily oral risperidone dose) Dose of this medicine (administered once every 2 months) 3mg 150mg 4mg 200mg 5mg 250mg • Switching patients receiving a long-acting risperidone injection Patients may be switched between this medicine and a risperidone injection administered once every month (see Table 2). In this case, administer the first dose of the new regimen on the next scheduled administration date of the original regimen. Adjust the dosing schedule to reflect the change. Table 2. Doses for switching between this medicine and a risperidone injection administered once every month Dose of Yujedi 1M Injection (administered once every month) Dose of this medicine (administered once every 2 months) 75mg 150mg 100mg 200mg 125mg 250mg If a dose is missed, administer the next dose as soon as possible. Do not administer more frequently than the recommended schedule. It may be administered within 1 week before or after the last administration date; however, the safety and efficacy of administration more than 1 week outside this period have not been established. 2. Dose adjustment in patients with renal or hepatic impairment This medicine has not been studied in patients with renal or hepatic impairment. 3. Dose adjustment with concomitant use of strong CYP2D6 inhibitors and strong CYP3A4 inducers [See Precautions for Use 6. Drug Interactions] 1) Concomitant use with strong CYP2D6 inhibitors If a strong CYP2D6 inhibitor (e.g., fluoxetine or paroxetine) is initiated in a patient receiving this medicine, risperidone plasma concentrations may increase; therefore, administration of a lower dose of this medicine is recommended before concomitant use of a CYP2D6 inhibitor. The effect of discontinuing a strong CYP2D6 inhibitor on the pharmacokinetics of risperidone and 9-hydroxyrisperidone has not been studied. 2) Concomitant use with strong CYP3A4 inducers When treatment with a strong CYP3A4 inducer (e.g., carbamazepine) is initiated, closely monitor the patient, as dose adjustment of this medicine may be necessary during the first 4~8 weeks. For patients receiving a particular dose of this medicine, consider increasing the dose by one dose level. For patients receiving 250 mg of this medicine once every 2 months, additional oral risperidone may be considered. If treatment with a strong CYP3A4 inducer is discontinued, risperidone plasma concentrations may increase; therefore, reassess the dose of this medicine and any additional oral risperidone dose, and reduce the dose of this medicine if necessary.

Caution is required when using this medication in elderly dementia patients, as it may increase the risk of death. It should not be used, especially for the treatment of dementia-related psychosis, as it is not approved for this purpose. Before administering this medication, risk factors for venous thromboembolism should be assessed, and preventive measures taken as necessary. Patients with an allergy to risperidone or any component of this medication should not receive it. Patients with heart disease, cerebrovascular disease, hypotension, renal or hepatic impairment, or a history of seizures should be given this medication with caution. Patients with Parkinson's disease or dementia with Lewy bodies may be sensitive to this medication, thus symptoms should be closely monitored. Women who are pregnant or breastfeeding should also exercise caution with this medication. This medication may cause various neurological and gastrointestinal adverse reactions; drowsiness, dizziness, nausea, and weight gain are common. Particularly, symptoms related to extrapyramidal disorders may occur, so monitoring is essential. QT interval prolongation may be observed on ECG, so the cardiac condition should be checked periodically. Local reactions at the injection site may occur, thus careful observation is necessary. Serious side effects can include neuroleptic malignant syndrome, tardive dyskinesia, metabolic abnormalities (hyperglycemia, dyslipidemia, weight gain). Elevated prolactin levels may affect reproductive function, hence related symptoms should be monitored. There is a risk of orthostatic hypotension and syncope, so blood pressure and vital signs should be closely monitored. There is a risk of falls, especially in elderly patients, so utmost caution is needed. Leukopenia and neutropenia may occur, thus regular blood tests are required. This medication may cause drowsiness and decreased cognitive and motor function, necessitating caution while driving or operating dangerous machinery. Patients with a history of seizures or at risk of seizures should be administered this medication with caution. In case of overdose, drowsiness, hypotension, and extrapyramidal symptoms may appear, thus immediate medical attention is necessary. This medication must be administered subcutaneously only by a healthcare professional, and should be stored at room temperature before administration. Interactions with other medications may occur, thus consultation with a doctor or pharmacist is recommended. Pregnant or breastfeeding women should carefully consider the risks and benefits of administering this medication, and elderly patients should have their dosage adjusted and renal function monitored periodically.

Increased mortality, heart failure, sudden death, pneumonia, anaphylactic reactions, angioedema, Parkinsonism, akathisia, muscle tone abnormalities, tremors, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, abdominal pain, gastric discomfort, dyspepsia, diarrhea, excessive salivation, constipation, dry mouth, increased appetite, weight gain, fatigue, rash, nasal congestion, upper respiratory infection, nasopharyngitis, oropharyngeal pain, tachycardia, chest pain, weakness, nasal bleeding, dry skin, orthostatic hypotension, back pain, arthralgia, limb pain, nasopharyngitis, upper respiratory infection, sinusitis, urinary tract infection, increased blood creatine phosphokinase activity, increased heart rate, homogenous bradycardia, homogenous tachycardia, first-degree atrioventricular block, left bundle branch block, right bundle branch block, heart block, ear pain, tinnitus, hyperprolactinemia, conjunctival hyperemia, eye discharge, conjunctivitis, eye rotation, eyelid edema, eye swelling, eyelid crusting, dry eyes, increased tear production, photophobia, glaucoma, vision impairment, dysphagia, fecal impaction, fecal incontinence, gastritis, lip swelling, cheilitis, xerostomia, peripheral edema, thirst, gait disturbances, chest discomfort, influenza-like illness, urticaria, edema, chills, lethargy, malaise, facial edema, discomfort, generalized edema, drug withdrawal syndrome, peripheral coldness, strange sensations, drug hypersensitivity, pneumonia, influenza, ear infections, viral infections, pharyngitis, tonsillitis, bronchitis, eye infections, localized infections, cystitis, soft tissue infection, otitis media, onychomycosis, distal dermatitis, bronchopneumonia, respiratory infections, bronchial bronchitis, chronic otitis media, increased body temperature, elevated serum prolactin, increased alanine aminotransferase, ECG abnormalities, increased eosinophils, decreased white blood cells, elevated blood glucose levels, decreased hemoglobin, decreased hematocrit, decreased body temperature, decreased blood pressure, increased aminotransferase, decreased appetite, somnolence, anorexia, joint swelling, joint stiffness, musculoskeletal chest pain, postural abnormalities, myalgia, neck pain, muscle weakness, muscle rigidity, rhabdomyolysis, balance disorders, attention disorders, speech disorders, unresponsiveness to stimuli, decreased consciousness level, movement disorders, transient ischemic attack, coordination abnormalities, cerebrovascular accidents, language impairments, syncope, loss of consciousness, sensory deficits, delayed movement disorders, cerebral ischemia, cerebrovascular disorders, neuroleptic malignant syndrome, diabetic coma, tremors of the head, anxiety, blunted affect, confusional state, sleep interruption, neurological irritability, sleep disorders, apathy, decreased libido, hypersexuality, nocturia, dysuria, frequency of urination, urinary incontinence, irregular menstruation, amenorrhea, gynecomastia in males, enuresis, vaginal discharge, menstrual disorders, erectile dysfunction, retrograde ejaculation, ejaculation disorders, sexual dysfunction, breast enlargement, wheezing, aspiration pneumonia, sinus congestion, voice disturbances, moist cough, pulmonary congestion, respiratory congestion, wheezing, respiratory difficulties, breathing, nasal edema, erythema, skin discoloration, skin lesions, pruritus, skin disorders, erythematous rash, papular rash, acne, excessive keratinization, seborrheic dermatitis, generalized rash, maculopapular rash, hypotension, flushing, drowsiness, syncope, seizures, priapism, hyperthermia, hypothermia, priapism, alopecia, atrial fibrillation, cardiopulmonary arrest, tension, glucose metabolism disorders, diabetic ketoacidosis, taste disorders, hypoglycemia, intestinal obstruction, inappropriate secretion of antidiuretic hormone, bowel obstruction, jaundice, mania, pancreatitis, pituitary adenomas, precocious puberty, pulmonary embolism, QT prolongation, sleep apnea syndrome, somnambulism, Stevens-Johnson syndrome, toxic epidermal necrolysis, sudden death, thrombocytopenia, thrombotic thrombocytopenic purpura, urinary stasis, water intoxication, stroke, transient ischemic attacks, neuroleptic malignant syndrome, delayed movement disorder, hyperglycemia, dyslipidemia, weight gain, hyperprolactinemia, orthostatic hypotension, falls, leukopenia, neutropenia, agranulocytosis, drowsiness, seizures, aspiration pneumonia, extrapyramidal symptoms and withdrawal symptoms, sedation, tachycardia, hypotension, QT interval prolongation, convulsions, torsades de pointes.

This medication should be stored in a sealed container to avoid exposure to air and light, and kept in a refrigerator at temperatures between 2 and 8 degrees to maintain its efficacy.

Appearance

A translucent solid that is white to light gray under refrigerated conditions, and a white to light gray opaque suspension contained in a colorless transparent pre-filled syringe at room temperature, in a sustained-release injectable form.

Package unit

1 pre-filled syringe/box [pre-filled syringe (150 mg/0.42 mL)] - 150 mg/per pre-filled syringe [pre-filled syringe (150 mg/0.42 mL)]