Pronunciation:

kal-si-TRYE-ol

Brand Names:

• Vectical

Dosage Forms:

• Ointment

Classifications:

Therapeutic—

Antipsoriatic

Pharmacologic—

Vitamin D Analog

Uses of This Medicine:

Calcitriol topical ointment is used to treat mild to moderate plaque psoriasis, which is a skin disease with red patches and white scales that do not go away. Calcitriol is a form of vitamin D.

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 calcitriol topical in children 2 years of age and older. However, safety and efficacy have not been established in children younger than 2 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of calcitriol topical 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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Burosumab-twza

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:

• Hypercalcemia (high calcium in the blood)—Use with caution. May make this condition worse.

Proper Use of This Medicine:

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 into your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. Do not apply this medicine to your nipple or areola, if you are breastfeeding. If it does get on these areas, rinse it off right away with water.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

To use the 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 into your eyes, lips, or face.
• Do not cover the treated skin area unless your doctor told you to.

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

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 form (ointment):
  • For plaque psoriasis:
    • Adults and children 7 years of age and older—Apply to the affected area of the skin 2 times a day in the morning and evening. Do not use more than 200 grams (g) per week.
    • Children 2 to 6 years of age—Apply to the affected area of the skin 2 times a day in the morning and evening. Do not use more than 100 g per week.
    • Children younger than 2 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.

Do not freeze or refrigerate the ointment.

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 and to check for any unwanted effects.

If your condition does not improve 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.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

Incidence not known

Blistering, crusting, irritation, itching, or reddening, or burning feeling of the skin

confusion

cracked, dry, scaly skin

depression

dry mouth

headache

incoherent speech

increased urination

loss of appetite

metallic taste

muscle weakness

nausea

stomach pain

swelling

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:

Less common

Skin itching or discomfort

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.