Dovonex Topical

In the U.S.

• Calcitrene
• Dovonex
• Sorilux

Available Dosage Forms:

• Cream
• Foam
• Ointment
• Solution

Therapeutic Class: Antipsoriatic

Pharmacologic Class: Vitamin D3, Synthetic

Calcipotriene is used on the skin and scalp to treat plaque psoriasis. It is a form of vitamin D that works by changing how the skin cells are made in the areas affected by psoriasis.

This medicine is available only with your doctor's prescription.

This section provides information on the proper use of a number of products that contain calcipotriene. It may not be specific to Dovonex. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine should only be used on the skin. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

To help clear up your skin problem completely, it is very important that you keep using calcipotriene for the full time of treatment. Do not miss any doses.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other skin conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use the cream or ointment:

• Wash your hands with soap and water before and after using this medicine. If the skin on your hands is being treated with the medicine, only wash the skin that is not affected.
• Apply a thin layer to the affected area of the skin. Rub it in gently until it disappears into the skin.
• Do not get any medicine on your face or in your eyes.

To use the scalp solution:

• Wash your hands with soap and water before and after using this medicine.
• Before using the medicine, comb your dry hair to remove any skin flakes. Part your hair so you can see the scalp lesions.
• Apply the solution only to the scalp lesions. Rub it in gently until it disappears into the scalp.
• Do not get any medicine on your forehead or in your eyes.
• Do not use this medicine near heat, an open flame, or while smoking.

To use the foam:

• This medicine comes with a patient information insert. Read and follow the instructions carefully.
• Wash your hands with soap and water before and after using this medicine. If the skin on your hands is being treated with the medicine, only wash the skin that is not affected.
• Break the tiny plastic piece on the nozzle of the foam can.
• Shake the can before each use.
• Turn the can upside down and place a small amount into the palm of your hand.
• Apply a thin layer to the affected areas of the skin and scalp. Rub it in gently until it disappears into the skin. If using on the scalp, apply it when your hair is dry.
• Do not use the medicine in or near your eyes, mouth, or vagina. If the foam does get in your eyes, wash them right away with water.
• Do not use this medicine near heat, an open flame, or while smoking.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage forms (cream, foam, ointment, and scalp solution):
  • For plaque psoriasis:
    • Adults—Apply to the affected area of the skin or scalp once per day or two times per day as directed by your doctor.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

The scalp solution and foam are flammable. Keep them away from an open flame or heat. Do not smoke when you are applying the medicine. Do not poke holes in the foam canister or throw it into a fire, even if the canister is empty. Do not keep the foam inside a car where it could be exposed to extreme heat.

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Stop using this medicine and check with your doctor right away if you have a skin rash, burning, stinging, redness, swelling, or irritation on the skin.

If your psoriasis does not improve within a few weeks or becomes worse, check with your doctor.

Calcipotriene may make your skin more sensitive to sunlight. Use a sunscreen and wear protective clothing, including a hat, when you are outdoors. Avoid sunlamps and tanning beds.

Do not use cosmetics or other skin care products on the treated areas unless directed to do so by your doctor.

This medication is used to treat psoriasis. Calcipotriene is a form of vitamin D. It works by slowing down the growth of skin cells.

How to use Dovonex Cream

Use this medication on the skin only. Apply a thin layer of the medication as directed by your doctor to the affected area and gently rub in, usually once or twice daily for the ointment or twice daily for the cream or the foam. Wash your hands after using, unless you are using this medication to treat the hands. Do not apply the medication on the face, in the eyes, nose, or mouth, or inside the vagina. If you do get the medication in those areas, flush with plenty of water.

Do not apply more often or use longer than prescribed. This may increase the risk of side effects.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day.

Inform your doctor if your condition does not improve or if it worsens. You should usually begin to see an improvement in your skin condition after 2 weeks of treatment.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: high calcium/vitamin D levels (hypercalcemia/hypervitaminosis D).

Before using this medication, tell your doctor or pharmacist your medical history.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Your doctor may direct you to limit or avoid phototherapy while you use this product. Ask your doctor for details.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.