Dovonex - Crm 50mcg/gm: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• Dovonex® cream and ointment is used for the topical treatment of psoriasis on your body.
• Dovonex® scalp solution is used for the topical treatment of scalp psoriasis.
• Dovonex® may be used together with a moderate to very potent topical corticosteroid, cyclosporin A (oral) or acitretin (oral).
• Dovonex® is not for use on the face.

What it does:

Dovonex® contains the active ingredient calcipotriol, a vitamin D-like agent.

Psoriasis results from skin cells growing and dividing too quickly, causing plaques (scaly, red patches) to form on the skin. Calcipotriol comes from naturally occurring vitamin D and acts to return the growth of skin cells to normal.

When it should not be used:

• Do not use this product if you are allergic to any of the ingredients in Dovonex® (calcipotriol) cream, ointment or scalp solution, or to components of the container.
• Dovonex® is not for use in your eyes.

What the medicinal ingredient is:

Calcipotriol

What the important nonmedicinal ingredients are: Ointment: white soft paraffin, propylene glycol, liquid paraffin, polyoxyethylene-(2)-stearyl ether, purified water, disodium phosphate dehydrate, disodium edentate, DL-α-tocopherol.

Cream: white soft paraffin, cetostearyl alcohol, liquid paraffin, glycerol 85%, macrogol cetostearyl ether, disodium phosphate dehydrate, disodium edentate, chloroallylhexaminium (dowicil 200), purified water.

Scalp solution: hydroxypropyl cellulose, isopropanol, levomenthol, sodium citrate, propylene glycol, purified water.

What dosage forms it comes in:

Dovonex® is available in three topical formulations.

• Ointment, 50 mcg/g
• Cream, 50 mcg/g
• Scalp solution, 50 mcg/mL

WARNINGS AND PRECAUTIONS

Calcipotriol when used with ultraviolet radiation (UVR) may increase the risk of developing skin cancer caused by UVR. Calcipotriol alone does not cause cancer.

If Dovonex® is used together with other psoriasis treatments, you should read the warning section of the consumer information for those treatments.

Dovonex® is not recommended for your face as it may cause skin irritation. Use the cream or ointment carefully on body areas with skin folds. If air can not reach the skin under the fold, this area may become irritated if treated with Dovonex®.

Children from 2 to 14 years of age should apply Dovonex® cream or ointment only when supervised by adults. The scalp solution is not recommended for use in children under 18 years old. Do not use Dovonex® in children under 2 years of age.

Dovonex® should only be used during pregnancy or while nursing if the benefit clearly outweighs the potential risk to your baby. Tell your doctor if you are pregnant, nursing, or become pregnant during your treatment.

If more than the maximum recommended weekly amount of Dovonex® is used (i.e., 100g), there is the risk of developing high blood calcium levels.

BEFORE you use Dovonex® talk to your doctor or pharmacist if:

• you have severe extensive psoriasis (the use of Dovonex® may not be recommended).
• you are using any other psoriasis treatments.
• you are using sun tanning beds or sun lamps.
• you are currently using phototherapy for your psoriasis.
• you have allergies to any of the ingredients in Dovonex® cream, ointment or scalp solution or to components of the container.

INTERACTIONS WITH THIS MEDICATION

Dovonex® has been used safely in combination with topical steroids. Except for steroids, there is no clinical trial experience on the interaction of Dovonex® with other topical drugs for psoriasis.

PROPER USE OF THIS MEDICATION

Usual dose:

At the start of your treatment Dovonex® should be rubbed onto affected skin areas twice a day (morning and evening). You should begin to see an improvement within 2 weeks. Best results are seen within 6-8 weeks.

Once your psoriasis improves your doctor may reduce the dose to once a day. Using Dovonex® once a day will help keep your psoriasis under control.

Your doctor may prescribe using Dovonex® together with a steroid. Use each medicine once a day and at different times of the day (i.e., one in the morning, the other in the evening).

Dovonex® may also be used twice daily in combination with cyclosporin A or acitretin. There are no clinical studies in children of combination therapy with Dovonex®.

How to use the cream or ointment:

• Remove the cap. Check that the aluminium seal has not been broken before you use it for the first time. To break the seal, use the other end of the cap to pierce the seal.

• Gently rub Dovonex® on the areas of your skin affected by

  psoriasis. Wash your hands after using to prevent getting any on your face. You can wear your usual clothes and no special dressing or cover is needed.

• If you accidentally spread Dovonex® onto the surrounding healthy skin, wash it off right away.
• Dovonex® may irritate your skin for a short while after you apply it, especially in skin folds. Try not to scratch the area.
• Dovonex® is not recommended for use on your face because it may irritate this more sensitive area of skin. If you accidentally get some on your face, wash it off right away.
• Do not use more than the maximum amount of Dovonex® in one week for your age group (see table below).

• If Dovonex® cream and ointment are used together then the total amount of Dovonex® should not be more than the maximum amount allowed for each age group in one week (see table above).

How to use the scalp solution:

The instructions below are for adults only, the scalp solution is not recommended for use in children under 18 years old.

• After washing your hair, dry it thoroughly before using

  Dovonex® scalp solution. Do not wash your hair immediately after using the scalp solution or you will wash out the medicine.

• Remove cap, place the nozzle through your hair next to the scalp. Squeeze the bottle gently and apply a few drops on to the affected area.
• Rub in gently with your fingertips. One or two drops should cover the area of a postage stamp.
• Wash your hands after using Dovonex® to avoid getting any on your face.
• Dovonex® may irritate your scalp for a short time after you apply it. Try not to scratch the area.
• Dovonex® scalp solution should not be used on your face because it could irritate your skin. If you accidentally get some on your face, wash it off right away. If you get the scalp solution in your eyes, flush your eyes with water.
• Do not use more than 60 mL of Dovonex® scalp solution in one week.

• If you use the scalp solution with Dovonex® cream or ointment then the total amount of Dovonex® should not be more than the maximum amount allowed;100g or mL.

  For example, if you use 60 g of cream or ointment, then you should not use more than 40 mL of scalp solution.

Overdose:

The calcipotriol in Dovonex® can lead to increased blood calcium levels if more than the maximum 100g weekly amount is used. This effect is reversible when treatment is stopped. If you have overdosed, contact your Doctor or go to the nearest Hospital Emergency.

Missed Dose:

If you forget to use Dovonex® at the right time, use it as soon as you remember. Then go on as before.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The most common side effect is local irritation which is usually mild and temporary.

Face and scalp irritation is usually related to the accidental transfer of Dovonex® from other parts of your body. Rare cases of allergic reaction have been reported.

Use of calcipotriol can lead to high blood calcium levels but this is usually related to using more than the weekly maximum.

This is not a complete list of side effects. For any unexpected effects while taking Dovonex®, contact your doctor or pharmacist.

HOW TO STORE IT

Cream and ointment: Store at room temperature (15-25^°C). Scalp Solution: Store below 25^°C.

• For easy spreading and to prevent pulling of delicate skin do not refrigerate the cream or ointment.
• Keep Dovonex® in a safe place where children cannot reach it.
• Keep Dovonex® away from your pets. Dogs like the taste of Dovonex® but the medicine can be fatal to dogs if eaten. If your dog eats Dovonex® contact a veterinarian immediately.
• Do not use Dovonex® past the expiry date marked on the bottom of the tube.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345 toll-free fax: 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

www.leo-pharma.com/canada or by contacting the sponsor, LEO Pharma Inc. at: 1-800-668-7234.

® LEO Pharma A/S used under license by LEO Pharma Inc.