Vectical

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

Stop using calcitriol topical and call your doctor at once if you have any of these serious side effects:

• blistering, or severe redness, itching, or other irritation of treated areas; or
• worsened symptoms or no improvement in psoriasis.

Using calcitriol topical can affect your body's ability to metabolize calcium. This can result in high levels of calcium in your blood (hypercalcemia). Symptoms of this condition include nausea, constipation, loss of appetite, increased thirst and urination, muscle weakness, confusion, and feeling tired or restless. Call your doctor if you have any of these symptoms.

Less serious side effects may include mild itching or skin discomfort.

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.

Dosage Forms & Strengths

ointment

• 0.0003%

Plaque Psoriasis

Apply to affected areas BID

200 mg/week maximum

Safety & efficacy not established

Calcitriol is a prescription medication used for various conditions. It can be used to treat and prevent low levels of calcium in the blood of patients whose kidneys or parathyroid glands are not functioning well. Calcitriol can also be used to treat plaque psoriasis.

Calcitriol belongs to a group of drugs called vitamin D analogs. In treating hypocalcemia, it works by restoring levels of calcium in the blood. It is not well understood how calcitriol works to treat plaque psoriasis.

This medication comes in capsule and oral solution forms and is taken once daily or every other day.

This medication is also available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

This medication addictionally comes in ointment form and is applied to the affected skin twice a day. It is not to be used in the mouth, on the eyes, or intravaginally.

Common side effects of calcitriol capsule, oral solution, and injectable forms include weakness, fatigue, nausea, and headache.

Common side effects of calcitriol ointment include psoriasis, elevated levels of calcium in the urine, and itching.

Serious side effects have been reported with this medication, and certain precautions should be followed:

Oral/Injectable:

• Overdosage of any form of vitamin D is dangerous. Calcitriol is a form of vitamin D. Tell your doctor if you experience signs/symptoms of vitamin D toxicity including dehydration, vomiting, decreased appetite, irritability, constipation, fatigue, muscle weakness). 
• It is recommended to avoid all non-prescription medications to avoid elevated phosphate levels in the body.

Do not take this medication if you

• are allergic to calcitriol or to any of its ingredients
• have hypercalcemia or evidence of vitamin D toxicity

Topical

• Avoid excessive exposure of calcitriol ointment treated areas to either natural or artificial sunlight.
• Taking this medication may alter the way your body processes calcium. Your doctor will want to monitor if these changes occur.

Do not take this medication if you are allergic to calcitriol or to any of its ingredients

Before taking calcitriol,

• tell your doctor and pharmacist if you are allergic to calcitriol, other forms of vitamin D such as calcifediol (Calderol), dihydrotachysterol (Hytakerol, DHT), doxercalciferol (Hectorol), ergocalciferol (Drisdol, Calciferol), paricalcitol (Zemplar) or any other medications or vitamins.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking.
• tell your doctor or pharmacist if you are taking ergocalciferol (Drisdol, Calciferol) or have stopped taking it in the past few months.Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• you should know that many nonprescription medications are not safe to take with calcitriol. Ask your doctor before you take any nonprescription medications while you are taking calcitriol.
• tell your doctor if you have recently had surgery or are unable to move around for any reason and if you have or have ever had kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking calcitriol, call your doctor. You should not breastfeed while you are taking calcitriol.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking calcitriol.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Indication

Vectical Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in adults 18 years and older.

Limitations of Use

Vectical Ointment should not be applied to the eyes, lips, or facial skin.

How Supplied

Vectical Ointment 3 mcg/g is available in collapsible aluminum tubes of the following package sizes:

• 100 g tube (NDC 0299-2012-10)

Storage

Store at Controlled Room temperature 68° - 77°F (20° - 25°C) with excursions permitted between 59° - 86°F (15° - 30°C). [See USP Controlled Room Temperature.] Do not freeze or refrigerate.

This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

Patients using Vectical Ointment should receive the following information:

Instructions for Use

This medication is to be used as directed by the physician. It is for external use only. This medication is to be applied only to areas of the skin affected by psoriasis, as directed. It should be gently rubbed into the skin so that no medication remains visible.

Adverse Reactions

Patients should report any signs of adverse reactions to their physician.

To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

U.S. Patent No. 7,749,986

Marketed by:
Galderma Laboratories, L.P.
Fort Worth, Texas 76177 USA

Manufactured by:
G Production Inc.
Baie d’Urfé, QC, H9X 3S4 Canada

Made in Canada.
GALDERMA is a registered trademark.
P51460-4