Taro-Acitretin: Uses, Side Effects and Dosage

Serious Warnings and Precautions

You must sign the informed consent form before you start taking Taro-Acitretin.

Female patients:

Birth defects (deformed babies)

• Do NOT take Taro-Acitretin if you are pregnant or want to become pregnant. Taro- Acitretin can cause severely deformed babies.

• You must discuss effective birth control with your doctor before beginning treatment and you must use effective birth control without interruption as follows:

  • for at least one month before you start Taro-Acitretin;
  • while you are taking Taro-Acitretin; and
  • for at least 3 years after you stop taking Taro-Acitretin (discuss this with your doctor); and
• Bear in mind that any method of birth control can fail. It is recommended that you either abstain from sexual intercourse or use two effective methods of birth control at the same time (discuss this with your doctor).
• Low dose progesterone-only may not be an effective method to prevent pregnancy during treatment with Taro-Acitretin and is not recommended for use.

• Do NOT take Taro-Acitretin until you are sure that you are not pregnant:

  • You must have 2 negative pregnancy tests before you start Taro-Acitretin. The first test will be done at screening when Taro-Acitretin treatment is under consideration. A second (confirmatory) test must be done within 3 days before the first dose is taken. Both tests must show you are not pregnant.
  • You must wait until the second or third day of your next menstrual period before you start Taro-Acitretin.
• During treatment, you must have a pregnancy test at 28-day intervals in a licensed laboratory. The test must be no older than 3 days and show you are not pregnant before you can receive another prescription for Taro-Acitretin.
• After stopping treatment, you must have pregnancy tests every 1-3 months for at least 3 years after your last dose.

• Every time you start a new course of treatment with Taro-Acitretin, however long the intervening period may have been, you must use effective and uninterrupted birth

  control, during treatment and for at least 3 years after you stop taking Taro-Acitretin.

• Contact your doctor immediately if you do become pregnant while taking Taro- Acitretin or after treatment has stopped. You should discuss the serious risk of having a baby with severe birth deformities because you are taking or have taken Taro-Acitretin, as well as available options, with your doctor.
• Do NOT breastfeed while taking Taro-Acitretin and until at least 3 years after the treatment has stopped.

All patients:

• Do NOT consume alcohol while taking Taro-Acitretin and for at least 2 months after the treatment has stopped.
• Do NOT donate blood while taking Taro-Acitretin and until at least 3 years after the treatment has stopped. If someone who is pregnant gets your donated blood, the baby may be exposed to Taro-Acitretin and be born with birth defects.

Taro-Acitretin can cause serious side effects, including:

• Liver problems

  • Cases of jaundice, toxic hepatitis (inflammation of the liver) and liver injury havebeen reported in patients taking Taro-Acitretin.
  • Before starting treatment and during treatment with Taro-Acitretin, your healthcare professional will do blood tests to check how your liver is working.
• Pseudotumor cerebri (benign intracranial hypertension). This is a condition where there is an increased pressure in the brain.

• Mood changes (including irritability, aggression, depression, suicide and thoughts of suicide and self-harm)

  • Before you take Taro-Acitretin, your healthcare professional will assess you for mood changes, including depression.
  • Tell your healthcare professional right away if you have any symptoms of new depression or worsening depression.
• Psychotic disorder (hallucinations or delusions): This may cause you to experience hallucinations (seeing or hearing things) or delusions (have false beliefs).

What is Taro-Acitretin used for?

Taro-Acitretin (acitretin) is used in the treatment of:

• Severe psoriasis
• Other disorders of keratinization in adult patients who have not responded to standard treatments.

How does Taro-Acitretin work?

Taro-Acitretin (acitretin) is a retinoid. It works by leading to a more normal pattern of growth for skin cells.

What are the ingredients in Taro-Acitretin?

Medicinal ingredients: Acitretin

Non-medicinal ingredients: Ammonium hydroxide, Gelatin, Iron oxide black, Iron oxide red, Iron oxide yellow, Maltodextrin, Microcrystalline cellulose, Potassium hydroxide, Propylene glycol, Shellac, Sodium lauryl sulfate, Sorbic acid, and Titanium dioxide.

Taro-Acitretin comes in the following dosage forms:

Capsules: 10 mg and 25 mg

Do not use Taro-Acitretin if you:

• are pregnant, or plan to become pregnant
• become pregnant while taking Taro-Acitretin. You must stop taking Taro-Acitretin immediately. See

“Serious warnings and precautions” box.

• are breastfeeding.
• are allergic to acitretin, or any of the other ingredients in Taro-Acitretin,
• are allergic to other retinoids, or Vitamin A, or its metabolites,
• consume alcohol (in drinks, food or medicines),
• have severe liver problems.
• have severe kidney problems.
• have consistent high blood lipid levels
• take tetracyclines, medicines used to treat bacterial infections.
• take methotrexate, medicine used to treat cancer and other conditions caused byoveractive immune system.
• have high vitamin A levels (hypervitaminosis A).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Taro-Acitretin. Talk about any health conditions or problems you may have, including if you:

• have high cholesterol or triglycerides.
• have high blood sugar, or have a family history of diabetes. You may need to check your blood sugar levels more frequently at the beginning of treatment.
• have liver problems
• have kidney problems
• have or have had depression, or have a family history of depression.
• have eye problems or wear contact lenses. Taro-Acitretin may cause dry eyes, light sensitivity, or other eyes problems.

Other warnings you should know about:

• Taro-Acitretin Pregnancy Prevention Program

  You should have been counselled using the manufacturer’s Taro-Acitretin Pregnancy Prevention Program which includes:

  • Comprehensive information about the risks of this drug
  • A line drawing of a deformed baby
  • A checklist of the criteria you had to meet before receiving this drug
  • Detailed information on birth control options
  • A chart outlining the Taro-Acitretin Pregnancy Prevention Program
  • An informed consent form for you to review and sign (for males and females)

If you were not counselled using the Taro-Acitretin Pregnancy Prevention Program, please visit www.taro-acitretin.ca to access pregnancy prevention materials or contact Sun Pharma Canada Customer Service at (toll-free) 1-800-268-1975 to request them.

Skin

• Avoid prolonged exposure to sunlight or sun lamps while taking Taro-Acitretin. Use protective clothing or hat or sunscreen with SPF 30 or more. Taro-Acitretin may make your skin more sensitive to UV light.
• Avoid cosmetic procedures that smooth your skin (such as waxing, dermabrasion or laser procedures), while taking Taro-Acitretin and for a period of time after stopping. Taro- Acitretin may cause scarring or inflammation of the skin from these procedures. Check with your healthcare professional for advice about when you can have cosmetic procedures.
• Avoid the use of anti-acne agents that exfoliate your skin since it can irritate your skin.
• You should use a skin moisturizing ointment or cream and a lip balm while taking Taro-Acitretin. This is because Taro-Acitretin can make your skin and lips dry.
• Check-ups and testing

• You will have regular visits with your healthcare professional during your treatment with Taro-Acitretin. They will:

  • Do blood tests to check blood lipid levels (cholesterol, triglycerides), sugar levels and liver health.
  • Assess you for mood changes.
  • Examine you for signs of bone abnormalities and vision problems.
• In female patients, your healthcare professional will ask you to have pregnancy tests before treatment with Taro-Acitretin and regularly during and after treatment. During treatment, a pregnancy test is needed every 28 days. After stopping treatment, pregnancy tests must be done every 1-3 months for 3 years after your last dose.

• Driving and using machinery

• Taro-Acitretin may change your vision and ability to drive at night. Be cautious when driving any vehicles or doing tasks that require special attention, especially at night.

• Children (younger than 18 years of age)

• You should not take Taro-Acitretin if you are younger than 18 years of age.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Serious Drug Interactions:

The following may also interact with Taro-Acitretin:

• Phenytoin, medicine used to treat seizures
• Glyburide, or a sulfonylurea, medicines used to treat diabetes
• St John’s Wort
• Low dose birth control pills. Low dose birth control pills that contain progesterone only (mini pills) may not work while you are taking Taro-Acitretin.

How to take Taro-Acitretin:

• Always take Taro-Acitretin exactly as your healthcare professional tells you.

• Take by mouth once daily with food or after a meal

Usual dose:

Your dose will depend on your medical condition and the recommendations of your healthcare professional. Your healthcare professional may change or stop your dose depending on how well Taro-Acitretin is working for you.

For Severe psoriasis: starting dose of 25 mg once daily; maintenance daily dose from 25 mg to 50 mg; maximum daily dose of 75 mg.

For Other disorders of keratinization: 10 mg once daily; maximum daily dose of 50 mg

Overdose:

Missed Dose:

• If you miss a dose of Taro-Acitretin, take it as soon as you remember on the same day. However, if it is almost time for your next dose, skip the missed dose and take the next dose at your regular time.
• Do NOT take a double dose to make up for a missed dose.

What are possible side effects from using Taro-Acitretin?

These are not all the possible side effects you may have when taking Taro-Acitretin. If you experience any side effects not listed here, tell your healthcare professional.

Serious drug interactions with Taro-Acitretin include:

• Vitamin A or retinoids.
• Methotrexate. Taking Taro-Acitretin with methotrexate may increase your risk of hepatitis.
• Tetracyclines. Taking Taro-Acitretin with tetracyclines may increase your risk of increased pressure in the skull (intracranial pressure).
• Alcohol. It converts Acitretin to etretinate, a chemical that also causes birth defects and stays in the body longer.

If you think you, or a person you are caring for, have taken too much Taro-Acitretin, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll- free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

• Back pain, bone pain or muscle pain
• Brittle nails
• Bleeding or inflammation of the gums, or inflammation of the mucous lining of the mouth
• Chills, increased sensitivity to touch.
• Dry eyes, particularly if you wear contact lenses
• Dry mouth, chapped lips, runny or dry nose
• Decreased or increased appetite
• Ear problems such as pain, wax build-up, or buzzing in the ear
• Eye problems such as light sensitivity, pain, impaired vision
• Hair loss or abnormal hair texture. Whether all your hair will return to normal after treatment cannot be predicted.
• Infections, including skin around the fingernail
• Inflammation along the edge of the eyelid (blepharitis), inflammation or infection of the membrane lining the eyelids (conjunctivitis)
• Nose bleeds
• Skin problems such as cold sweat, excessive sweating, sensitivity to sunlight, inflamed, ulcerated, and oily or cracked skin.
• Tiredness, pain, thirst
• Trouble sleeping

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Storage:

Store at 15-25°C. Protect Taro-Acitretin capsules from heat, light and moisture. Store in original package. Taro-Acitretin does not need to be refrigerated. Taro-Acitretin should not be used after the expiry date (EXP) shown on the package.

• Keep out of reach and sight of children

Reporting Side Effects

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

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

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

If you want more information about Taro-Acitretin:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this

  Patient Medication Information by visiting the Health Canada website:

  (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html); the manufacturer’s website www.taro.ca, or by calling 1-800-268-1975.

• Important safety information about Taro-Acitretin and Taro-Acitretin Pregnancy Prevention

  Program is also available from: www.taro-acitretin.ca