Pronunciation:

kal-si-poe-TRYE-een

Brand Names:

• Calcitrene
• Dovonex
• Sorilux

Dosage Forms:

• Cream
• Solution
• Ointment
• Foam

Classifications:

Therapeutic—

Antipsoriatic

Pharmacologic—

Vitamin D Analog

Uses of This Medicine:

Calcipotriene is used to treat plaque psoriasis of the skin and scalp. 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.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Sorilux® in children 4 years of age and older. However, safety and efficacy have not been established in children younger than 4 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of Dovonex® in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of calcipotriene in the elderly.

Breast-feeding—

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.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Erythrodermic, exfoliative, or pustular psoriasis—Use has not been studied in patients with these conditions.

• Hypercalcemia (high calcium in the blood)—Should not be used in patients with this condition.

• Skin irritation in areas with psoriasis—Use with caution. May make this condition worse.

Proper Use of This Medicine:

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 into 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 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 onto your face or into 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 into 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 and patient instructions. 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 into 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.

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.

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 plaque psoriasis:
  • For topical dosage forms (cream, ointment, and scalp solution):
    • 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.
  • For topical dosage form (foam):
    • Adults and children 4 years of age and older—Apply to the affected area of the skin or scalp 2 times a day.
    • Children younger than 4 years of age—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 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.

Precautions While Using This Medicine:

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

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.

This medicine may temporarily increase the calcium levels in your blood (hypercalcemia). Check with your doctor right away if you have stomach pain, confusion, depression, dry mouth, headache, incoherent speech, increased urination, loss of appetite, metallic taste, muscle weakness, unusual tiredness, nausea, vomiting, or weight loss.

Calcipotriene may make your skin more sensitive to sunlight. Use 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Skin redness, swelling, or itching

skin rash

worsening of psoriasis

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Confusion

constipation

discouragement

dry mouth

feeling sad or empty

headache

incoherent speech

increased urination

irritability

lack of appetite

loss of interest or pleasure

metallic taste

muscle weakness

nausea

stomach pain

thirst

tiredness

trouble concentrating

trouble sleeping

unusual tiredness

vomiting

weight loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Burning, dryness, irritation, peeling, or redness of the skin

Less common

Pain at the application site

Rare

Darker color in the treated areas of the skin

pus in the hair follicles

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.