Consumer Information for: ACCUTANE ROCHE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

ACCUTANE™ ROCHE® (isotretinoin) is indicated for the treatment of:

  • Severe Nodular and/or Inflammatory Acne
  • Acne Conglobata
  • Recalcitrant Acne

    • Because of significant side effects associated with its use, ACCUTANE should be reserved for patients where the conditions listed above are unresponsive to conventional first line therapies.

    What it does

    ACCUTANE is used to treat severe acne (nodular and or inflammatory acne). It is used when the acne cannot be cleared up by other treatments, including antibiotics.

    ACCUTANE can cause serious side effects. Before starting ACCUTANE, discuss with your doctor how bad your acne is, the possible benefits of ACCUTANE, and its possible side effects, to decide if ACCUTANE is right for you. Your doctor will ask you to read and sign a form indicating you understand some of the serious risks of ACCUTANE.

    When it should not be used
    • Do not get pregnant while taking ACCUTANE and stop taking immediately if you do get pregnant (see Serious Warnings and Precautions Box).
    • Do not breastfeed while taking ACCUTANE and for 1 month after stopping ACCUTANE. ACCUTANE may pass through your milk and harm the baby.
    • Do not take Vitamin A supplements. Vitamin A in high doses has many of the same side effects as ACCUTANE. Taking both together may increase your chance of getting side effects.
    • Do not take ACCUTANE if you have liver or kidney disease.
    • Do not take ACCUTANE if you have high blood fat (lipid) levels.
    • Do not take ACCUTANE if you are sensitive to retinoids, or hydrogenated soybean oil, parabens, partially hydrogenated soybean oil, soybean oil, or any other non-medicinal ingredient listed under:

    What the medicinal ingredient is

    isotretinoin

    What the non-medicinal ingredients are

    Capsule, 10 mg Brown-red opaque, ovalshaped soft gelatin capsules containing 10 mg isotretinoin, imprinted ‘ROA 10’:

    Beeswax, Black Iron Oxide, Gelatin, Glycerol, Hydrogenated Hydrolysed Starch, Hydrogenated Soybean Oil, Mannitol, Partially Hydrogenated Soybean Oil (see CONTRAINDICATIONS [2]), Propylene Glycol, Red Iron Oxide, Shellac, Sorbitol, Soybean Oil, Titanium Dioxide

    Capsule, 40 mg Yellow opaque, oval-shaped soft gelatin capsules containing 40 mg isotretinoin, imprinted ‘ROA 40’:

    Beeswax, Black Iron Oxide, Gelatin, Glycerol, Hydrogenated Soybean Oil (see CONTRAINDICATIONS [2]), Methylparaben (see CONTRAINDICATIONS [2]), Partially Hydrogenated Soybean Oil (see CONTRAINDICATIONS [2]), Propylene Glycol, Propylparaben (see CONTRAINDICATIONS [2]), Quinoline Yellow WS, Shellac, Soybean Oil, Sunset Yellow FCF, Titanium Dioxide

    What dosage form it comes in

    Initial Therapy

    The initial dose of ACCUTANE should be individualized according to the patient’s weight and severity of the disease.

    In general, patients initially should receive ACCUTANE 0.5 mg/kg body weight daily for a period of two to four weeks, when their responsiveness to the drug will usually be apparent. It should be noted that transient exacerbation of acne is occasionally seen during this initial period.

    The daily dosage should be taken with food in the nearest number of whole capsules, either as a single dose or in two divided doses during the day, whichever is more convenient.

    Maintenance Therapy

    Maintenance dose should be adjusted between 0.1 and 1 mg/kg body weight daily and, in exceptional instances, up to 2 mg/kg body weight daily, depending upon individual patient response and tolerance to the drug.

    A complete course of therapy consists of 12 – 16 weeks of ACCUTANE administration. Patients may show additional improvement for up to several months after a course of ACCUTANE has been completed. With effective treatment, appearance of new lesions will not normally be evident for a period of at least three to six months.

    Warnings and precautions

    Serious Warnings and Precautions

    ACCUTANE should only be prescribed by physicians knowledgeable in the use of retinoids systemically, who understand the risk of teratogenicity in females of child bearing age and who are experienced in counselling young adults for whom ACCUTANE is generally indicated (see CONTRAINDICATIONS [2] and SERIOUS WARNINGS AND PRECAUTIONS BOX [3] and WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women [7.1.1]). A careful assessment of the patient’s mental state should be made, including whether or not they have a history of previous psychiatric illness (see SERIOUS WARNINGS AND PRECAUTIONS BOX, Psychiatric [3]). It is strongly recommended that each ACCUTANE prescription be limited to a one-month supply in order to encourage patients to return for follow-up to monitor side-effects. The pharmacist must ensure that:

    • Prescriptions of ACCUTANE for women of child-bearing potential should be limited to 30 days of treatment and continuation of treatment requires a new prescription. Ideally, pregnancy testing, issuing a prescription and dispensing of ACCUTANE should occur on the same day.
    • Dispensing of ACCUTANE should occur within a maximum of 7 days of the prescription”

    What you should avoid while taking ACCUTANE:

    • Do not give blood while you take ACCUTANE and for 1 month after stopping ACCUTANE. If someone who is pregnant gets your donated blood, the baby may be exposed to
      • ACCUTANE and may be born with birth defects.
    • Do not have cosmetic procedures to smooth your skin, such as waxing, dermabrasion, or laser procedures, while you are using ACCUTANE and for at least 6 months after you stop. ACCUTANE can increase your chance of scarring or inflammation of the skin from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.
    • Avoid the use of artificial ultraviolet lights such as the ones used in tanning machines and protect yourself from excessive sunlight. ACCUTANE may make your skin more sensitive to ultraviolet (UV) light. When necessary, sunscreen with a high protection factor of at least SPF 15 should be used
    • Avoid the use of exfoliative anti-acne agents

    Interactions with this medication

    Interactions

    Tetracyclines: Rare cases of benign intracranial hypertension ‘pseudotumor cerebri’ have been reported after use of ACCUTANE (isotretinoin) and/or tetracyclines. Therefore, concomitant treatment with tetracyclines must be avoided (see SERIOUS WARNINGS AND PRECAUTIONS BOX, Neurologic [3]).

    Vitamin A: Because of the relationship of ACCUTANE to vitamin A, patients should be advised against taking vitamin supplements containing vitamin A, to avoid additive toxic effects.

    Phenytoin: ACCUTANE has not been shown to alter the pharmacokinetics of phenytoin in a study in seven healthy volunteers. These results are consistent with the in vitro finding that neither isotretinoin nor its metabolites induce or inhibit the activity of the CYP 2C9 human hepatic P450 enzyme. Phenytoin is known to cause osteomalacia. No formal clinical studies have been conducted to assess if there is an interactive effect on bone loss between phenytoin and ACCUTANE. Therefore, caution should be exercised when using these drugs together.

    Norethindrone/ethinyl estradiol: In a study of 31 premenopausal women with severe recalcitrant nodular acne receiving 1OrthoNovum® 7/7/7 Tablets as an oral contraceptive agent, ACCUTANE at the recommended dose of 1 mg/kg/day, did not induce clinically relevant changes in the pharmacokinetics of ethinyl estradiol and norethindrone and in the serum levels of progesterone, follicle-stimulating hormone (FSH) and luteinizing hormone (LH). A drug interaction that decreases effectiveness of hormonal contraceptives has not been entirely ruled out for ACCUTANE.

    Microdosed progesterone preparations (minipills) are not a suitable method of contraception during ACCUTANE therapy.

    Systemic Corticosteroids: Systemic corticosteroids are known to cause osteoporosis. No formal clinical studies have been conducted to assess if there is an interactive effect on bone loss between systemic corticosteroids and ACCUTANE. Therefore, caution should be exercised when using these drugs together.

    The following may interact with ACCUTANE:

    • Low-dose contraceptives (birth control pills). Low dose birth control pills may not work while you are taking ACCUTANE.
    • Antibiotics (such as tetracyclines),
    • Corticosteroids,
    • Phenytoin
    • Vitamin Supplements including Vitamin A
    • St. John’s Wort.

    Proper use of this medication

    Usual Dose

    In general, patients initially should receive ACCUTANE 0.5 mg/kg body weight daily for a period of two to four weeks, when their responsiveness to the drug will usually be apparent. It should be noted that transient exacerbation of acne is occasionally seen during this initial

    Read your prescription label carefully and be sure to take the exact amount of medicine prescribed by your doctor. Your doctor may change your prescribed dose from time to time, therefore, it is important that you check the label each time you fill your ACCUTANE prescription. If you have any questions, call your doctor.

    Be sure to return to your doctor as scheduled. It is important for your doctor to see you regularly, every month, when you are taking ACCUTANE. Blood tests and other tests allow your doctor to check your response to ACCUTANE. Discuss your progress and any concerns with your doctor.

    Overdose

    If you think you have taken too much ACCUTANE, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

    In the event of acute ACCUTANE overdose evacuation of the stomach should be considered during the first few hours after this overdose. Signs and symptoms of acute overdose have been associated with headache, vomiting, facial flushing, cheilitis, abdominal pain, dizziness and ataxia. To date, all symptoms have quickly resolved without apparent residual effects and usually without treatment. Elevated intracranial pressure has been reported with patients receiving therapeutic doses of ACCUTANE. Patients with an ACCUTANE overdose should be monitored closely for signs of increased intracranial pressure. Signs of hypervitaminosis A could appear in cases of overdose.

    Limited data exists on the pharmacokinetic characteristics of isotretinoin in an overdose situation. Following the oral administration of single 80, 160, 240 and 340 mg doses to 12 healthy male subjects Cmax was 366, 820, 1,056 and 981 ng/mL, and t1/2 was 13.6, 14.1, 14.4 and 16.5 hours for isotretinoin, respectively. Twenty-three compromised cancer patients received weekly oral doses of 200 (3 patients); 400 (7 patients); 660 (2 patients); 1,000 (3 patients); 1,400 (6 patients) and 1,800 (1 patient) mg/m2. Normal body surface area for healthy subjects is 1.73 m2. After the first dose, Cmax was 1.5, 3.8, 3.5, 2.5, 2.7 and 4.6 µg/mL, and t1/2 was 45, 9.1, 14.5, 57, 13.1 and 6.1 hours for isotretinoin, respectively. The absorption of isotretinoin appears to be a saturable process.

    Since it is difficult to extrapolate from the results of these studies to the overdose situation, the following precautions should be taken with all female patients of childbearing potential who have taken an overdose of ACCUTANE.

    1. At the time of the overdose, a pregnancy test must be performed and a blood sample collected for the determination of isotretinoin and metabolite concentrations.

    2. One complete menstrual cycle after the overdose, a second pregnancy test must be performed and a second blood sample collected for the determination of isotretinoin and metabolite concentrations.

    3. Effective contraception must be used for at least one complete menstrual cycle after the overdose and continued longer, if necessary until physiological plasma concentrations of isotretinoin and its major metabolites are reached.

    Patients who present with a positive pregnancy test at the time of the overdose, one complete menstrual cycle after the overdose, or while isotretinoin or metabolite blood concentrations are measurable, should be fully counselled on the serious risk to the fetus from this exposure to ACCUTANE and the physician and patient should discuss the desirability of continuing the pregnancy. (See CONTRAINDICATIONS [2], WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women [7.1.1] and NON-CLINICAL TOXICOLOGY, Reproduction and Teratology Studies [16]). Canadian Regional Poison Information Centres have been advised on the proper collection and handling of ACCUTANE blood samples and also on the laboratory(s) equipped to assay these samples.

    Missed Dose

    If a patient misses a dose of ACCUTANE, it may be taken later the same day, but, the patient should be instructed to not take more ACCUTANE in one day than what has been prescribed. The patient should then administer the next dose on the usual scheduled dosing day. The patient should not take a double dose to make up for a missed dose.

    Side effects and what to do about them

    Serious side effects and what to do about them
    Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
    Mental health problems such as depression or psychosis (a severe mental disturbance)
    • changes in your mood such as becoming depressed, feeling sad, or having crying spells
    • losing interest in your usual activities
    • changes in your normal sleep patterns
    • becoming more irritable or aggressive than usual (for example, temper outbursts, thoughts of violence)
    • losing your appetite, becoming unusually tired
    • having trouble concentrating
    • withdrawing from family and friends
    • having thoughts about taking your own life (suicidal thoughts)

    Your doctor may recommend a consultation with a specialist if you become depressed or experience these changes in mood.

    		    ✔
    Inflammation of the liver, pancreas or intestine (bowel)
    • severe stomach pain, diarrhea, rectal bleeding; yellowing of the skin or eyes and/or dark urine.
    		     ✔
    Bone and Muscle Changes
    • aches or pains in bones or joints, back pain, or difficulty in moving, muscle pain, especially after vigorous exercise
    • muscle weakness with or without pain can be a sign of serious muscle damage
      • Tell a healthcare provider you are taking ACCUTANE if you break a bone.
    		    ✔
    Hyper-sensitivity (allergic) reactions
    • hives, swollen face or mouth, trouble breathing, fever, rash, red patches, bruises
    		     ✔
    Increased pressure in the brain bad headaches, blurred vision, dizziness, nausea, vomiting, seizures (convulsions) and stroke.     ✔
    Hearing and vision differences
    • changes in your hearing or ringing in your ears
    • changes in your vision especially at night, decreased night vision may occur suddenly in some patients (take caution when driving at night), persistent feelings of dry eyes
    		     ✔
    Heart problems
    • chest pain, palpitations, vascular thrombotic disease, stroke, leg swelling, seizures (convulsions), slurred speech, problems moving or any other serious unusual problems.
    		     ✔
    Pregnancy issues during or after treatment
    • Birth defects, miscarriage, premature birth or death of baby.
    Do not take Accutane if you are pregnant.    		     ✔
    Problems with blood sugar levels
    • fainting, become very thirsty, urinating a lot, feeling weak.
    		     ✔
    Serious Skin Reactions such as erythema multiforme (EM), Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN)
    • blisters, peeling skin, severe red/purple rash, fever, conjunctivitis (red or inflamed eyes)
    • multiple lesions and sores, particularly in your mouth,nose, eyes and genitals
    		    ✔

    How to store

    Reporting side effects

    You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

    • Report online at MedEffect
    • Call toll-free at 1-866-234-2345
    • Complete a Canada Vigilance Reporting Form and:
      • Fax toll-free to 1-866-678-6789, or
      • Mail to:
        Canada Vigilance Program
        Health Canada
        Postal Locator 0701D
        Ottawa, Ontario
        K1A 0K9

    Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at MedEffect.

    NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

    More information
    • Talk to your doctor or pharmacist.
    • Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website ***

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