Dovonex

Calcipotriene is a man-made form of vitamin D. It is involved in the growth and development of skin cells.

Calcipotriene topical (for the skin) is used to treat plaque psoriasis (psoriasis with scaly patches).

Calcipotriene topical may also be used for purposes not listed in this medication guide.

You should not use calcipotriene topical if you have high levels of calcium or vitamin D in your body. Do not apply this medicine to your face.

You should not use calcipotriene topical if you are allergic to it, or if you have:

• high levels of calcium in your blood (hypercalcemia); or
• high levels of vitamin D in your body (usually caused by taking too much vitamin D supplements).

To make sure calcipotriene topical is safe for you, tell your doctor if you are receiving phototherapy (light treatments) for your psoriasis.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether calcipotriene topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Calcipotriene topical is not approved for use by anyone younger than 18 years old.

If you use too much Dovonex, call your local Poison Control Center or seek emergency medical attention right away.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.

Antipsoriatic agent; a synthetic vitamin D3 derivative.2 3 5 6

Administration

Topical Administration

Apply topically to the skin as a 0.005% cream or as a fixed-combination ointment containing calcipotriene 0.005% and betamethasone dipropionate 0.064% (equivalent to 0.05% of betamethasone);2 5 apply to the scalp as a 0.005% solution or as a fixed-combination suspension containing calcipotriene 0.005% and betamethasone dipropionate 0.064% (equivalent to 0.05% of betamethasone).3 6

For dermatologic use only; not intended for oral, ophthalmic, or intravaginal use.2 3 5 6 Avoid contact with face, eyes, axillae, groin, and other mucous membranes.2 3 5 6

Apply cream in a thin film and rub gently and completely into affected area.2

Apply calcipotriene and betamethasone dipropionate fixed-combination ointment and rub gently and completely into affected area.5

For scalp psoriasis, comb hair to remove scaly debris; part the hair and apply calcipotriene solution to affected area; rub gently and completely into scalp.3 4 Avoid contact with forehead or uninvolved scalp margins.3

For scalp psoriasis, apply calcipotriene and betamethasone dipropionate fixed-combination suspension to affected areas; part the hair before applying the suspension.6 Shake bottle prior to each use.6

Wash hands thoroughly after application process.2 3 5 6

Dosage

Adults

Apply 0.005% cream sparingly to affected area twice daily.2

Apply ointment containing calcipotriene 0.005% and betamethasone 0.05% to the affected area(s) once daily.5

Apply 0.005% scalp solution to affected area twice daily.3

Apply suspension containing calcipotriene 0.005% and betamethasone 0.05% to affected area(s) of the scalp once daily for 2 weeks or until cleared.6

Prescribing Limits

Adults

Use of 0.005% cream >8 weeks not evaluated.2

Maximum 100 g weekly of the fixed-combination calcipotriene 0.005% and betamethasone 0.05% ointment.5 Do not apply to >30% of body surface area.5 Do not exceed 4 consecutive weeks of therapy.5

Use of 0.005% scalp solution >8 weeks not evaluated.3

Maximum 100 g weekly of the fixed-combination calcipotriene 0.005% and betamethasone 0.05% suspension.6 Do not exceed 8 consecutive weeks of therapy.6

Special Populations

No special population dosage recommendations at this time.2 3 5 6

You should not use Dovonex if you are allergic to calcipotriene, or if you have:

• high levels of calcium in your blood (hypercalcemia); or

• high levels of vitamin D in your body (usually caused by taking too much vitamin D supplements).

To make sure Dovonex is safe for you, tell your doctor if you are receiving phototherapy (light treatments) for your psoriasis.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether calcipotriene topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Dovonex is not approved for use by anyone younger than 18 years old.

Use Dovonex exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Dovonex is for use only on the skin. Do not use this medicine on open wounds or on sunburned, windburned, dry, chapped, or irritated skin.

Do not apply this medicine to your face.

Do not use Dovonex to treat any condition that has not been checked by your doctor.

Do not share this medicine with another person, even if they have the same symptoms you have.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after applying Dovonex, unless you are using it to treat a hand condition.

Clean and dry the area of skin where you will apply Dovonex. Apply the medicine only to the affected area, not to the surrounding skin.

It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 8 weeks of treatment.

Store at room temperature away from moisture and heat. Do not keep in a refrigerator or freezer.

Dovonex scalp solution is flammable. Avoid using near open flame, and do not smoke until the medicine has completely dried on your skin.

Usual Adult Dose for Psoriasis:

Cream: Apply a thin layer to affected areas twice a day and rub in gently and completely.

Comments:
-The safety and efficacy of cream has been demonstrated in patients treated for eight weeks.

Use: Treatment of plaque psoriasis in adults

Solution: After combing the hair to remove scaly debris and then suitably parting, apply to lesions twice a day, and rub in gently and completely, taking care to prevent the solution spreading onto the forehead.

Comments:
-The safety and efficacy of solution has been demonstrated in patients treated for eight weeks.
-Keep solution away from the eyes
-Avoid application of the solution to uninvolved scalp margins

Use: Topical treatment of chronic, moderately severe psoriasis of the scalp

Rinse with water if this medicine gets in your eyes.

Do not use vitamin or mineral supplements while you are using Dovonex, unless your doctor has told you to.

Avoid exposing treated skin areas to sunlight or tanning beds. Dovonex can make you sunburn more easily. Wear protective clothing when you are outdoors.

Avoid using other skin medications on the areas you treat with Dovonex, unless your doctor tells you to.

Get emergency medical help if you have signs of an allergic reaction to Dovonex: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Dovonex and call your doctor at once if you have:

• severe burning, stinging, skin rash, or other irritation after applying the medicine;

• worsening of your skin condition; or

• high calcium - nausea, vomiting, constipation, increased thirst or urination, muscle pain or weakness, bone pain, confusion, and feeling tired or restless.

Common Dovonex side effects may include:

• mild skin irritation;

• skin rash; or

• itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.