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Details for: TOCTINO

Company: GLAXOSMITHKLINE INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02337630TOCTINOALITRETINOIN10 MGCAPSULEORAL
02337649TOCTINOALITRETINOIN30 MGCAPSULEORAL
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Summary Reports

Summary Basis of Decision
Summary Safety Review - Oral Retinoid Products - Assessing the Potential Risk of Impotence (erectile dysfunction)

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

TOCTINO is used for adults with severe chronic hand eczema that has not improved after topical treatments, including steroids.

TOCTINO capsules are not to be given to children or adolescents less than 18 years old.

TOCTINO should be used under the care of a doctor who is knowledgeable in the use of systemic retinoids

What it does

The active substance in TOCTINOis alitretinoin. It belongs to a group of medicines known as retinoids which are related to vitamin A. Alitretinoin is believed to modify the immune system and have an anti-inflammatory effect on the eczematous lesions by reducing the production of some substances responsible for inflammation, thereby reducing and helping to clear eczema.

When it should not be used

Do not use TOCTINO if you:

  • are pregnantor if you can become pregnant and are not using two effective birth control measures
  • are breast feeding
  • have liver disease
  • have severe kidney disease
  • have high blood cholesterol or raised triglycerides
  • have uncontrolled thyroid disease
  • have very high levels of vitamin A in your body (hypervitaminosis A)
  • are allergic (hypersensitive) to alitretinoin or to other retinoids (such as isotretinoin), soya, peanuts, or any of the other ingredients of TOCTINO(other nonmedicinalingredients are listed below).
  • are taking tetracycline (a type of antibiotic)
  • have a hereditary problem of fructose intolerance, as this product contains sorbitol

If any of these apply to you, go back to your doctor without taking TOCTINO.

What the medicinal ingredient is

What the medicinal ingredient is: alitretinoin

What the non-medicinal ingredients are

DL-α-tocopherol, Gelatin, Glycerol, Medium chain triglycerides, Partially hydrogenated soybean oil, Sorbitol,Soybean oil, Water, Yellow wax, iron oxide red, iron oxide black (10 mg capsules only), iron oxide yellow (30 mg capsules only).

What dosage form it comes in

Soft capsule, 10 mg (brown) and 30 mg (red-brown).

Warnings and precautions

Serious Warnings and Precautions

All Women: Birth defects:

TOCTINO can cause birth defects (deformed babies). It can also cause miscarriage, premature birth, or death of the baby. Therefore, adequate birth controlmeasures are essential when taking TOCTINO. See “What are the important warnings for women taking TOCTINO?”

Treatment with systemic retinoids, including alitretinoin, may cause increased pressure in the brain, with symptoms such as headache, nausea, vomiting and visual disturbances.

For other serious side effects of TOCTINO, see “SERIOUS SIDE EFFECTSAND WHAT TO DO ABOUT THEM” Table below.

What are the important warnings for women taking TOCTINO?

  • Do not take TOCTINO if you are pregnant
  • If you become pregnant, stop taking TOCTINO and contact your doctor immediately
  • TOCTINO can cause deformed babies. There is an extremely high risk that your baby will be deformed if you are pregnant while taking TOCTINO. This risk exists even if TOCTINO is taken for a short time. If you are a woman of childbearing potential, your physician should have discussed this risk with you, and explained how to avoid becoming pregnant while taking TOCTINO.
  • You must avoid becoming pregnant while you are taking TOCTINO and for at least one month after you stop taking TOCTINO.
  • You must discuss effective birth control with your doctor before beginning TOCTINO treatment, and you must use effective birth control:
    • For at least one month before you start TOCTINO;
    • While you are taking TOCTINO; and
    • For at least one month after you stop taking TOCTINO;
    Bearing in mind that any method of birth control can fail.
  • You must use two effective and complementary methods of birth control at the same time, even if you have a history of infertility or are not sexually active.
  • Microdosed progesterone preparations (minipills) are not a suitable method of contraception during TOCTINO therapy.
  • Do not take TOCTINO until you are sure that you are not pregnant.
  • You must have two negative pregnancy tests at least 3 weeks apart before you start TOCTINO. Take pregnancy tests at doctor’s visits on a monthly basis while on the drug and take a pregnancy test at a doctor’s visit one month after stopping treatment with TOCTINO. If your menstrual period is abnormal in length and intensity,tell your doctor.You must wait until the second or third day of your next normal menstrual period before you start TOCTINO.
  • Your doctor can write a prescription for no more than 30 days of treatment. A new prescription is needed for more treatment. Each new prescription must be started within 11 days from the last negative pregnancy test.
  • Stop taking TOCTINO and contact your doctor immediately if you do become pregnant while taking TOCTINO or during the first month after treatment has stopped, if you miss your period, or if you have sexual intercourse without using effective birth control. You should discuss with your doctor the serious risk of your baby having severe birth deformities because you are taking or have taken TOCTINO. You should also discuss the desirability of continuing with your pregnancy.
  • Do not breastfeed while taking TOCTINO.
  • Do not take the supplement St John's Wort (Hypericum perforatum) if you are taking an oral contraceptive. St. John's Wort(Hypericum perforatum) can interact with oral contraceptives and may decrease their effectiveness in preventing pregnancy.

You should have been counseled using the manufacturer’s Patient Information and Pregnancy Prevention Programwhich includes:

  • Comprehensive information about the risks of this drug
  • A checklist of criteria you had to meet before receiving this drug
  • Detailed information on birth control options
  • An acknowledgement form for you to review and sign

Advice for men taking TOCTINO

Very low amounts of alitretinoin are present in the semen of men taking TOCTINO, but too little to harm the unborn baby of your partner.

All patients should read the rest of this Consumer Information.

Do not take TOCTINO unless you completelyunderstand its possible risks and are willing to follow all of the instructions in this Consumer Information.

BEFORE you use TOCTINO tell your doctor or pharmacist if

  • you have ever had any mental health problems, including depression, suicidal behaviour or psychosis, or if you take medicines for any of these conditions.
  • you have high blood cholesterol or triglycerides or have a blood lipid (fats) disorder, risk of heart problems or are obese, you may need blood tests more often.If your blood cholesterol or triglycerides stayhigh, your doctor may lower your dose, or take you off TOCTINO.
  • you have been suffering from thyroid disease. TOCTINO may lower your thyroid hormone levels. If your thyroid hormone level is low, your doctor may prescribe supplements.
  • you plan vigorous physicalactivity during treatment with TOCTINO.
  • you have any food or drugallergies.
  • you are taking any vitamin preparations or health food supplements that containVitamin A.
  • what brand of contraceptives you are taking. There are certain types of contraceptives thatshould not be taken while on TOCTINO.
  • you are taking an antibiotic (particularly tetracyclines).
  • you have liver disease, kidney disease or high lipid levels in your blood
  • you have diabetes. TOCTINO may increase blood sugar levels. Your doctor may request periodic tests for blood sugar levels during treatment, particularly if you already have diabetes or are overweight.

While taking TOCTINO

  • Do not donate blood while you take TOCTINOand for one month after stopping TOCTINO. If someone who is pregnant gets your donated blood, her baby may be exposed to TOCTINOand may be born with birth defects.
  • Do not share TOCTINO with other people. It can cause birth defects and other serious health problems.
  • Minimise your exposure to sunlight and avoid exposure to sun lamps. Your skin may become more sensitive to sunlight. Before you go out in the sun, use a sun protection product with a high protection factor (SPF 15 or higher).
  • Cut down on intensive physical activity: TOCTINO can cause muscle and joint pain.
  • If you develop dry eyes, contact your doctor as soon as possible This can be helped by the application of a lubricating eye ointment or tear replacement drops. If you wear contact lenses and experience dry eyes you may need to wear glasses for the duration of TOCTINO treatment. Dry eyes and sight problems normally return to normal once treatment is stopped
  • If you experience any problems with your sight, tell your doctor immediately. You should not drive or operate machinery. TOCTINOmay need to be stopped and your sight monitored.
  • If you get a persistent headache, nausea or vomiting (feeling or being sick) and blurred vision, these may be signs of a condition called benign intracranial hypertension. Stop taking TOCTINO immediately and contact your doctor as soon as possible.
  • If you have bloody diarrhea, severe diarrhea, abdominal pain or rectal bleeding,stop taking TOCTINO immediately and contact your doctor as soon as possible.
  • TOCTINO may change your liver enzyme levels, cholesterol or triglyceride levels, blood sugar levels or thyroid function. Your doctor will test these during treatment.
  • If you have a rash, swelling of your face or mouth, difficulty breathing, or feel unwell, you may be allergic to the ingredients in TOCTINO. Contact your doctor immediately.
  • If your mood changes, you feel sad, angry, or notice other emotional problems, contact your doctor immediately.
Interactions with this medication

Tell your doctor or pharmacist about all the medicines you take or have taken recently, including non-prescription or herbal medicines.

Tell your doctor or pharmacist if:

Proper use of this medication

Usual Adult Dose

  • Read your prescription labelcarefully and be sure to take the exact amount of medicine prescribed by your doctor, usually either 10mg or 30mg once a day. 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 TOCTINOprescription. If you have any questions, call your doctor.
  • Swallow each capsule whole and don’t chew them.
  • It is important to take TOCTINOwith a main meal, preferably at the same time each day. Be sure to return to your doctor as scheduled. It is important for your doctor to see you regularly, (every monthfor women of child bearing potential), when you are taking TOCTINO. Discuss your progress and any concerns with your doctor.
  • A course of treatment usually lasts for 12 to 24 weeks depending on your disease. If your first treatment was successful, your doctor may prescribe another course of treatment if symptoms return.

Overdose

In cases of overdose or suspected overdose, contact a healthcare practitioner (or doctor), hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

If you are a woman and have taken an overdose of TOCTINO, ask your doctor to test if you are pregnant. If you find out you are pregnant, stop taking TOCTINO and contact your doctor immediately.

Missed Dose

If you forget to take a dose of TOCTINOit may be taken later the same day, but do not take more TOCTINOin one day than your doctor has prescribed. Do not double dose.

Side effects and what to do about them

Like all medicines, TOCTINOcan cause side effects, although not everybody gets them.

  • Headache
  • Raised blood fats: higher levels of fats (triglycerides) and cholesterol in the blood
  • Blood cell disorders: increase in the number of blood platelets (cells that help blood to clot), decrease in the number of red and white blood cells seen in blood tests
  • Thyroid problems: decreased levels of thyroid hormones
  • Eye problems: inflammation of the eye and eyelid area (conjunctivitis); eyes feel dry and irritated.Ask a pharmacist for suitable eye drops. If you wear contact lenses and get dry eyes, you may need to wear glasses instead.
  • Blood and circulation:flushing, high blood pressure, inflammation of blood vessels, swelling of the hands, lower legs and feet
  • Muscle and joint pain: back pain, muscle pain, joint pain. High levels of muscle breakdown products in your blood if you exercise vigorously.
  • Skin, nail and hair problems: dryness of the skin, especially of the lips and face, inflamed skin, redness of the skin, itchy skin, skin peeling, rash, dry skin eczema, itchy skin rash, hair loss, increased sensitivity of the skin to sunlight, nail disorders, abnormal hair texture (e.g. curling of the hair)
  • Liver problems: raised liver enzymes seen in blood tests
  • Sensory problems: dizziness, persistent noise in the ears
  • General: nausea, vomiting, dry mouth, lack of energy (fatigue)
  • Ear, nose and throat problems: nose bleeding
  • Bone disorders: extra growth of bone, including the spine disorder ankylosing spondylitis
  • Stomach problems: indigestion
  • Vision: blurred, distorted vision, difficulty seeing at night. If you suffer these problems, do not drive or operate machinery until these symptoms have passed. If vision problems persist, contact your doctor and your doctor may stop TOCTINO treatment and may refer you to an eye specialist.

Side effects of other medicines in the same family of medications as TOCTINO.

The following effects haven’tyet been seen in TOCTINObut have occurred in this product class and may occur.

  • Diabetes
    Excessive thirst; frequent need to urinate; blood tests show an increase in your blood sugar.
  • Bone disorders
    Arthritis; bone disorders (delayed growth, changes to bone density); growing bones may stop growing.
  • Visual disorders
    Colour blindness and colour vision gets worse.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect Talk with your doctor or pharmacist right away Stop taking drug and call your doctor or pharmacist right away
Common
Depression and other mental problems including sad or empty mood, mood changes, tearfulness, and emotional disorder.
Some people have had thoughts about harming themselves or ending their lives, have attempted suicide or committed suicide. These people may not appear to be depressed. Your doctor can arrange help.
You should tell a family member or close friend that you can become depressed, or have significant changes in mood or behaviour, and ask them to read this leaflet. You might ask them to look after you.		 ✔  
Uncommon
Sight problems including blurred vision, distorted vision, cloudy surface on the eye (corneal opacity, cataracts).   ✔
Rare
Severe allergic reaction including swelling of the face or mouth causing difficulty in breathing (angioedema), raised and itchy rash (hives).   ✔
Immune reaction including vasculitis (swelling of the blood vessel) with symptom such as bruises and red patches.   ✔
Benign Intracranial Hypertension Lasting headache along with feeling sick (nausea), being sick (vomiting), and changes in your eyesight including blurred vision.   ✔
Very Rare
Stomach disorders Severe abdominal (tummy) pain, with or without bloody diarrhea, feeling sick (nausea) and being sick (vomiting). These can be signs of serious abdominal conditions.   ✔
Unknown
Keratitis(inflamed cornea). Severe abdominal (tummy) pain, with or without bloody diarrhea, feeling sick (nausea) and being sick (vomiting). These can be signs of serious abdominal conditions.   ✔
Pancreatitis (inflammation of the pancreas) which can be fatal, with symptoms such as abdominal pain, nausea, vomiting, diarrhea and fatty stool.   ✔

This is not a complete list of side effects. For any unexpected effectswhile takingTOCTINO, contact your doctor or pharmacist.

How to store
  • Keep out of the sight andreach of children
  • TOCTINO blister strips should be stored in its cardboard package at 15-30°C and protected from sunlight and heat
  • Return any unused capsules to your pharmacist at the end of treatment
Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professionalif you need information about how to manage your side effects.The Canada Vigilance Program does not provide medical advice.

More information

This document, along with the full product monograph, (prepared for health professionals) and the TOCTINO Patient Information and Pregnancy Prevention Programmaterials can be found at: www. toctino.caor can be obtained by contacting the sponsor, GlaxoSmithKline Inc.7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374

This leaflet was prepared by GlaxoSmithKline Inc.

Last revised: June 25, 2019

©2019 GSK group of companies or its licensor

Trademarks are owned by or licensed to the GSK group of companies.

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