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    更新日: 2024.10.03
    Medical information: AKNETRENT® (Isotretinoin)

    Important safety information including dosage, side effects, and precautions of AKNETRENT.


    WARNING


    RISK OF SEVERE HARM TO AN UNBORN BABY


    Women must use effective contraception.


    Do not use if you are pregnant or think you may be pregnant.


    ▼This medicine is subject to additional monitoring. This allows for quick identification of new safety information. You can help by reporting any side effects you may experience. Refer to the end of section 4 to learn how to report side effects.


    - Active ingredient: Isotretinoin


    • Inactive ingredients: Refined soybean oil, yellow beeswax, hydrogenated soybean oil, partially hydrogenated soybean oil, gelatin (bovine gelatin), glycerol, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172)


    Before you start using this medication, carefully read this INSTRUCTIONS FOR USE because it contains important details for you.


    - Keep this information for future reference; you may need to recall it later.


    - If you have any additional questions, please consult your doctor or pharmacist.


    - This medication has been prescribed specifically for you; do not share it with others.


    - Inform your doctor that you are taking this medication when you visit them or go to the hospital.


    - Follow the instructions exactly as written in this leaflet; **do not use higher or lower doses** than recommended for you.

    1. What is AKNETRENT® and what is it used for?

    AKNETRENT contains isotretinoin, which belongs to a group of compounds associated with vitamin A known as retinoids.


    Each package of AKNETRENT contains 30 soft gelatin capsules in duplex (PVC/PE/PVDC/Alu) blister packs of 10 capsules each. The capsules are oval and reddish-orange.


    AKNETRENT is used to treat severe forms of acne (such as cystic acne) that are at risk of leaving permanent scars. Use AKNETRENT if your acne has not improved with other acne treatments, including antibiotics and topical therapies.


    AKNETRENT treatment should be supervised by a dermatologist (a doctor specializing in skin problems).


    2. What you need to know before using AKNETRENT®.

    DO NOT USE AKNETRENT® in the following cases:


    If you are pregnant or breastfeeding.


    If you think you might be pregnant.


    If you are planning to become pregnant. If there is a possibility of pregnancy, you must follow the measures under the "Pregnancy Prevention Program" section; see the "Warnings and precautions" section.


    If you are allergic (hypersensitive) to soy or any of the excipients contained in AKNETRENT®. This medicine contains soybean oil in addition to isotretinoin and should not be used in individuals with soy allergy.


    If you have liver disease.


    If you have very high blood lipid levels (e.g., high cholesterol or triglycerides).


    If you have very high levels of vitamin A in your body (vitamin A hypervitaminosis).


    Do not use in children under 12 years of age. AKNETRENT® should only be used in children aged 12 years and older who have reached puberty.


    If you are receiving treatment with tetracyclines (a type of antibiotic). (Refer to the "Other medicines and AKNETRENT" section.)



    Pregnancy Prevention Program


    Pregnant women should not use AKNETRENT


    This medication can cause serious harm to an unborn baby (known to be 'teratogenic') – it can lead to serious abnormalities in the unborn baby's brain, face, ears, eyes, heart, and certain glands (thymus gland and parathyroid gland). It also increases the risk of miscarriage. This risk can occur even if AKNETRENT is taken for a short period during pregnancy.


    Do not use AKNETRENT if you are pregnant or think you may be pregnant.


    Do not use AKNETRENT if you are breastfeeding. This medication may pass into your breast milk and harm your baby.


    Do not use AKNETRENT if you have a possibility of becoming pregnant during treatment.


    You must not become pregnant for one month after stopping this treatment because there may still be some medication left in your body.



    **AKNETRENT is prescribed under strict rules for women who could become pregnant. This is because of the risk of serious harm to the unborn baby.**

    These rules are as follows:


    Your doctor should have explained the risk of harming the unborn baby – you should understand why you should not become pregnant and what you need to do to prevent pregnancy.


    You should have discussed contraception (birth control) with your doctor. Your doctor will provide you with information about preventing pregnancy. They may refer you to a specialist who can advise you on birth control.


    Before starting treatment, your doctor will ask you to undergo a pregnancy test. This test should show that you are not pregnant when starting treatment with AKNETRENT.


    Women should use effective birth control before starting AKNETRENT, during use, and for one month after stopping.


    You must agree to use at least one highly effective method of birth control (such as an intrauterine device or contraceptive implant) or two different effective methods (such as a hormonal contraceptive pill and a condom). Discuss with your doctor which methods will be suitable for you.


    One month before starting AKNETRENT treatment, during treatment, and for one month after treatment, you must use a birth control method.


    Even if you do not have periods or are not sexually active, you should use contraception (unless your doctor decides it is not necessary).


    Women should agree to undergo pregnancy testing before starting AKNETRENT, during use, and after stopping.


    Ideally, you should regularly visit your doctor for treatment monitoring every month.


    You should agree to have regular pregnancy tests one month after stopping



    AKNETRENT because some medication may still be in your body (unless your doctor decides it is not necessary).


    If your doctor asks, you should agree to additional pregnancy tests.


    You should not become pregnant during treatment or one month after treatment because there may still be some medication in your body.


    Your doctor will discuss all these conditions with you using a checklist and ask you (or a parent/guardian) to sign. This form confirms that you have been informed of the risks and will comply with the above rules.


    If you become pregnant while using AKNETRENT, stop using the medication immediately and consult your doctor. Your doctor may refer you to a specialist for advice.


    Additionally, if you become pregnant within one month after stopping AKNETRENT, you should consult your doctor. Your doctor may refer you to a specialist for advice.


    Your doctor should provide written information about preventing pregnancy for AKNETRENT users.



    Advice for Men


    Levels of oral retinoids in the semen of men using AKNETRENT are low enough not to harm their partner's unborn baby. However, you should never share your medication with anyone.



    Additional Precautions


    You should never give this medication to anyone else. Please return all unused capsules to your pharmacist at the end of treatment.


    During treatment with AKNETRENT and for 1 month after stopping treatment, you should not donate blood. This is because if a pregnant patient receives your blood, it could harm the unborn baby.


    Pregnancy, breastfeeding, and fertility


    For more information on pregnancy and contraception, see Section 2 'Pregnancy Prevention Program.'



    If any of these conditions apply to you, consult your doctor before using AKNETRENT.


    Discuss with your doctor before using AKNETRENT:


    Depression, aggressive tendencies, or mood changes; also, if you have had any mental health problems including thoughts of harming yourself or suicide.


    Other mental health issues


    You may not notice some changes in your mood and behavior, so it's important to tell your friends and family that this medication can affect your mood and behavior. They may notice these changes and help you identify issues you need to discuss with your doctor.



    Advice for all patients


    If you have ever experienced a mental health condition (such as depression, suicidal behavior, or psychosis) or are taking medication for these conditions, inform your doctor.


    Severe skin reactions associated with AKNETRENT use have been reported (e.g., erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis).


    Rashes can progress to blistering or peeling of the skin. Also, check for ulcers in the mouth, nose, and genital area or signs of eye infection (redness and swelling of the eyes).


    AKNETRENT can rarely cause severe allergic reactions affecting the skin, such as eczema, hives, bruises, or red patches on the arms and legs. If an allergic reaction occurs, stop using AKNETRENT, consult a doctor immediately, and inform them that you are taking this medication.


    Cease vigorous exercise and physical activity. AKNETRENT can cause muscle and joint pain, especially in children and adolescents engaging in intense physical activities.


    AKNETRENT has been associated with inflammatory bowel disease. If you experience severe bloody diarrhea despite not having a history of gastrointestinal disease, your doctor will discontinue your AKNETRENT treatment.


    AKNETRENT may cause vision difficulties such as dry eyes, intolerance to contact lenses, and decreased night vision. Inform your doctor if you experience any of these symptoms. Your doctor may recommend using lubricating eye ointment or artificial tears. If you wear contact lenses and develop lens intolerance during treatment, your doctor may suggest wearing glasses during the treatment period. If you experience vision difficulties, your doctor may refer you to a specialist and may consider discontinuing AKNETRENT.


    Intracranial hypertension, benign increased pressure inside the head, has been reported with AKNETRENT use and in some cases when used with tetracyclines (a type of antibiotic). If you notice symptoms such as headache, nausea, vomiting, or vision changes, stop using AKNETRENT and seek urgent advice from your doctor. Your doctor may refer you to a specialist to check for swelling of the optic disc (papilledema) in your eye.


    AKNETRENT can increase liver enzyme levels. Your doctor will perform blood tests to monitor these values before, during, and after AKNETRENT treatment. If your levels increase, your doctor may reduce your dose or discontinue your AKNETRENT treatment.


    AKNETRENT commonly raises blood fats such as cholesterol or triglycerides. Your doctor will monitor these values before, during, and after AKNETRENT treatment. It is recommended to avoid alcohol consumption during treatment or at least reduce your usual intake. Inform your doctor if you already have increased blood fats, diabetes (elevated blood sugar), weight gain, or alcohol-related problems. You may need more frequent blood tests. If your blood fats remain high, your doctor may reduce your dose or discontinue your AKNETRENT treatment.


    Inform your doctor if you have any kidney problems. Your doctor may start your AKNETRENT treatment at a lower dose and gradually increase it to the maximum dose you can tolerate.


    AKNETRENT can elevate blood sugar levels. Patients may rarely develop diabetes.


    Your doctor may monitor your blood sugar levels, especially if you already have diabetes, are overweight, or have alcoholism during treatment.


    Your skin may become dry. Use moisturizing creams or lotions for your skin and lip balm during treatment. Avoid using exfoliants or acne products to prevent irritation to the skin.


    Avoid excessive sun exposure and tanning beds. Your skin may be more sensitive to sunlight. Before going out in the sun, use a high-protection sunscreen (SPF 15 or higher).


    Avoid cosmetic skin treatments. AKNETRENT can make your skin more sensitive.


    Avoid waxing, dermabrasion, or laser treatments for at least 6 months after treatment completion. These procedures can cause scarring, skin irritation, or rarely, changes in skin color.


    *Please consult your doctor if any of these warnings apply to you, even if they occurred in the past.*



    Using AKNETRENT® with food and drink


    You can normally eat and drink while taking AKNETRENT. The capsules are taken by mouth, preferably with a meal.



    Pregnancy


    Consult your doctor or pharmacist before using this medication. Do not use AKNETRENT if you are pregnant or planning to become pregnant. Your doctor can provide you with more information. For more information about pregnancy and birth control, refer to Section 2 "Pregnancy Prevention Program". If you discover you are pregnant during your treatment, consult your doctor immediately.



    Breastfeeding


    Do not use AKNETRENT if you are breastfeeding. Your doctor can provide you with more information. Consult your doctor or pharmacist before using this medication.



    Driving and Operating Machinery


    You may experience difficulty seeing at night during your treatment. This can occur suddenly. In rare cases, fatigue and dizziness have been reported to persist after discontinuation of treatment. If you experience these symptoms, refrain from driving or operating machinery.



    Important Information about the Ingredients of AKNETRENT


    AKNETRENT contains soybean oil. Do not use this medicinal product if you are allergic to peanuts or soy.


    Interaction with Other Medications


    While using AKNETRENT, do not take vitamin A supplements or tetracycline (an antibiotic) or undergo any skin treatments for acne. You can use moisturizers and emollients (skin creams and preparations that prevent water loss and soften the skin).


    Avoid using topical keratolytics or exfoliating acne products while using AKNETRENT.


    *If you are currently taking any prescription or over-the-counter medications or have recently used them, please inform your doctor or pharmacist about them.*



    Use in Children and Adolescents


    Do not use AKNETRENT in children under 12 years of age due to its safety and efficacy in this age group being unknown. In children aged 12 and older, it should only be used in those who have reached adolescence.


    3. How to use AKNETRENT®?

    Always take AKNETRENT as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.


    Instructions for Proper Use and Dosage/Administration Frequency


    The usual starting dose is 0.5 mg per kilogram of body weight per day (0.5 mg/kg/day).


    For example, if you weigh 70 kg, you will start treatment with a dose of 35 mg per day.


    Take the capsules once or twice daily on a full stomach.


    After a few weeks, your doctor may adjust your dose depending on how well you respond to the medication. For most patients, the dose will be between 0.5 and 1.0 mg/kg/day.


    Treatment generally lasts between 16 to 24 weeks. Most patients require only one treatment period. Your acne may continue to improve for up to 8 weeks after treatment. Do not start a new treatment during this period.


    Some patients may notice their acne worsening during the first weeks of treatment. This usually improves as treatment continues.



    How to take AKNETRENT


    Take the capsules by mouth on a full stomach. Swallow them whole with a drink or food.



    Different Age Groups


    For Use in Children


    AKNETRENT should not be administered to children under 12 years of age. For children aged 12 and older, it should only be used in those who have reached adolescence. There is no specific dosage adjustment for this group.


    For Use in the Elderly:


    No dosage adjustment is required for elderly patients.



    Special Usage Conditions


    Renal Insufficiency (Acute Kidney Failure)


    If you have severe kidney problems, you will generally start with a low dose (e.g., 10 mg perday) and this dose will be increased to the highest dose your body can tolerate.

    If your body cannot tolerate the recommended dose, your doctor may prescribe a lower dose, which may mean longer-term treatment and the possibility of acne recurrence.


    Hepatic Insufficiency (Acute Liver Failure)


    AKNETRENT should not be used if you have liver insufficiency.


    Follow these instructions unless your doctor advises otherwise.


    Do not forget to take your medication on time.


    Your doctor will inform you of the duration of your treatment with AKNETRENT. Do not


    discontinue treatment early as you may not achieve the desired results.



    If you believe that the effect of AKNETRENT is too strong or too weak, consult your doctor or pharmacist.


    If you have used more AKNETRENT than you should.


    If you have used more AKNETRENT than you should, speak to a doctor or pharmacist.


    If you forget to use AKNETRENT.


    If you forget to take AKNETRENT, take the missed dose as soon as possible. However, if you notice this close to your next dose, skip the missed dose and continue as usual. *Do not take a double dose to make up for forgotten doses.*



    Effects of Stopping AKNETRENT®


    There are no known effects when discontinuing AKNETRENT.

    4. What are the possible side effects?

    Like all medications, AKNETRENT can cause side effects in individuals who are sensitive to its ingredients. Some of these side effects can be serious and may require hospitalization.


    If you experience any of the following, stop using AKNETRENT immediately and NOTIFY your doctor or seek the nearest emergency department:


    Severe (anaphylactic) reactions: Sudden swelling of the throat, face, lips, or mouth with difficulty breathing or swallowing. Also, sudden swelling of the hands, feet, or ankles.


    All of these are serious side effects. If you experience any of these, you may have a serious allergy to AKNETRENT and may require urgent medical intervention or hospitalization. The side effects are classified into the following categories based on occurrence frequency:


    Very common: May affect up to 1 in 10 people.


    Common: May affect up to 1 in 100 people.


    Uncommon: May affect up to 1 in 1,000 people.


    Rare: May affect up to 1 in 10,000 people.


    Very rare: May affect fewer than 1 in 10,000 people.


    Unknown: Frequency cannot be estimated from available data.



    Skin Problems


    Potentially life-threatening serious skin rashes requiring urgent medical examination (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis). These typically appear as circular patches with blisters in the center, often on the arms and legs or feet, and more severe rashes may involve blisters on the chest and back. Additional symptoms may include eye infections (conjunctivitis) or ulcers in the mouth, throat, or nose. Severe forms of these rashes can progress to widespread peeling of the skin, which can be life-threatening.


    Often, before these severe skin rashes occur, headache, fever, and body aches (flu-like symptoms) may be experienced.


    If you develop severe skin rashes or these skin symptoms, STOP using AKNETRENT and consult your doctor immediately.



    Mental Health Problems


    Rare


    Depression or depression-related disorders, including feeling sad or having altered mood, anxiety, or emotional discomfort.


    Worsening of existing depression


    Tendency towards violence or aggression


    Very rare


    Some individuals may have thoughts or feelings of harming themselves or ending their lives (suicidal thoughts), attempted suicide, or completed suicide. These individuals may not appear depressed.


    Unusual behavior


    Symptoms of psychosis: Disturbances in evaluating reality, such as hearing unusual voices or seeing things.


    If you experience any of these mental health problems, consult your doctor immediately.


    Your doctor may advise you to discontinue AKNETRENT use, although this may not be sufficient to address your issues; you may require further assistance, which your doctor can determine.



    Allergic Reactions


    Rare


    Severe (anaphylactic) reactions: Sudden swelling of the throat, face, lips, or mouth with difficulty breathing or swallowing. Also, sudden swelling of the hands, feet, or ankles.


    Very rare


    Rapid tightening of the chest, difficulty breathing, and wheezing, especially if you have asthma.


    If you experience a severe reaction, seek emergency medical assistance immediately. If you have an allergic reaction, discontinue AKNETRENT use and consult your doctor.



    Bone and Muscle

    Potentially life-threatening muscle weakness, with difficulty moving arms and legs, body swelling and bruising, dark-colored urine, decreased urine output, or inability to urinate, confusion, or dehydration may occur. These are symptoms of muscle breakdown called rhabdomyolysis, which can result in kidney failure. This condition may occur with heavy physical activity during AKNETRENT use.



    Liver and Kidney Problems


    Very rare

    Jaundice (yellowing of the skin or eyes) and feeling tired. These symptoms may indicate hepatitis. Stop using AKNETRENT immediately and consult your doctor.


    Difficulty urinating, swollen and puffy eyelids, extreme fatigue. These symptoms may indicate kidney inflammation. Stop using AKNETRENT immediately and consult your doctor.



    Nervous System Problems


    Very rare


    Constant headaches and blurred vision accompanied by nausea and vomiting. These may be symptoms of benign intracranial hypertension (increased pressure inside the skull), especially when AKNETRENT is taken with antibiotics called tetracyclines.


    **Stop using AKNETRENT immediately and consult your doctor.**


    **Digestive System Problems**


    **Very rare**


    Bloody or non-bloody diarrhea, bleeding in the stool or around the anus, severe abdominal pain, nausea, and vomiting. These may be symptoms of serious intestinal disorders. Stop using AKNETRENT immediately and consult your doctor.



    Eye Disorders


    Very rare


    Blurred vision



    If you experience blurred vision, stop using AKNETRENT and consult your doctor.


    Report any other vision-related effects to your doctor as soon as possible.


    Other Side Effects:


    Very common


    Dryness of the skin, especially on the lips and face; skin inflammation, cracked and inflamed lips, rash, mild itching, and peeling. Use a moisturizing cream from the beginning of treatment.


    Skin may appear redder and more sensitive than normal, especially on the face.


    Back pain; muscle pain; joint pain, especially in children and adolescents.


    Eye inflammation (conjunctivitis) and inflammation around the eyelids; dryness and irritation of the eyes. Consult your doctor for appropriate eye drops. If your eyes become dry and you wear contact lenses, you may need to switch to glasses.



    Common


    Headache


    Elevated cholesterol levels in the blood


    Protein or blood in the urine


    Decrease in white blood cell count (neutropenia) leading to increased susceptibility to


    infections



    Rare


    Hair loss (baldness), which is usually temporary and resolves after treatment cessation.



    Very rare


    Impaired night vision; worsening color vision or color blindness


    Increased sensitivity to light; may require wearing sunglasses to protect your eyes from bright sunlight.


    Other vision problems, such as blurred vision, distorted vision, cloudy surface on the eye (corneal opacity, cataract).


    Excessive thirst; frequent urination; increased blood sugar levels on blood tests. These can be signs of diabetes.



    Unknown


    Dark-colored urine


    Problems achieving or maintaining an erection


    Decreased libido (sexual desire)


    *If you experience any side effects not mentioned in this instruction, inform your doctor or pharmacist.

    5. How to store AKNETRENT®.

    Store AKNETRENT where children cannot see or reach it, in its original packaging, protected from light and moisture, at temperatures below 25°C.


    Return any unused capsules to your pharmacist.


    Use AKNETRENT before the expiration date shown on the packaging.


    Do not use AKNETRENT after the expiration date on the packaging.


    Do not dispose of expired or unused medications in the trash! Follow the waste collection system determined by the Ministry of Environment and Urbanization.


    Approval status in Japan

    AKNETRENT is not approved in Japan for skincare treatment.


    *Medicines prescribed by this department are not covered by the Adverse Reactions Relief System.

    Availability of approved medicines that have the same active ingredients in Japan

    There are no approved medicines containing the same active ingredients in Japan.

    Means of acquisition

    Our affiliated clinic physicians purchase through a domestic pharmaceutical distributor.

    Information on safety and approval in other countries

    Isotretinoin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of refractory acne.


    Because of the risk of fetal teratogenicity when taken by pregnant women, the U.S. Food and Drug Administration (FDA) advises against obtaining isotretinoin over the Internet or through private importation.