Dovonex, Calcitrene Ointment (calcipotriene) dosing, indications, interactions, adverse effects, and more (original) (raw)

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

topical solution

0.005% (generic)

topical ointment

0.005% (generic)

topical cream

0.005% (Dovonex, generic)

topical foam

0.005% (Sorilux)

Plaque Psoriasis

Ointment/Cream

Indicated for plaque psoriasis
Apply a thin layer of cream BID to affected area
Safety and efficacy have been established in patients treated for 8 weeks

Solution

Indicated for chronic, moderately severe psoriasis of the scalp
Apply solution BID to affected area
Safety and efficacy have been established in patients treated for 8 weeks

Foam

Indicated for plaque psoriasis of the scalp and body for patients ≥12 years
Apply a thin layer of foam BID to affected area

Dosing Considerations

Limitation of use

Safety and efficacy in dermatoses other than psoriasis have not been established

Dosage Forms & Strengths

topical foam

0.005% (Sorilux)

Plaque Psoriasis

Indicated for plaque psoriasis of the scalp and body

<4 years: Safety and efficacy not established

≥4 years: Apply a thin layer of foam BID to affected area

Interactions

Interaction Checker

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Contraindicated

Serious

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Minor

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Serious (0)

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Minor (0)

Adverse Effects

>10%

Burning

Itching

Skin irritation

1-10%

Dermatitis

Dry skin

Erythema

Peeling

Worsening of psoriasis including facial/scalp

Rash

<1%

Folliculitis

Hypercalcemia

Hyperpigmentation

Skin atrophy

Postmarketing Reports

Contact dermatitis, including allergic contact dermatitis

Warnings

Contraindications

Hypersensitivity

Hypercalcemia

Evidence of vitamin D toxicity

Topical use on the face

Cautions

Hypercalcemia and hypercalciuria reported with topical suspension; if hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized; incidence of hypercalcemia and hypercalciuria following topical suspension treatment of more than 8 weeks has not been evaluated

For cream only: Allergic contact dermatitis has been observed with use of topical calcipotriene; such an observation should be corroborated with appropriate diagnostic patch testing

Flammability

Foam contains a flammable propellant; advise patients to avoid fire, flames, and smoking during and immediately following application

Pregnancy & Lactation

Pregnancy

No data available on drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes in pregnant women exposed to calcipotriene

Foam: Systemic exposure to calcipotriene is likely to be low

Animal data

In animal reproduction studies, oral administration of calcipotriene to pregnant rats and rabbits during organogenesis resulted in an increased minor skeletal abnormalities, including enlarged fontanelles and extra ribs in rats and an increased incidence of minor skeletal abnormalities, including incomplete ossification of pubic bones and forelimb phalanges in rabbits

Lactation

There are no data on the presence of topically administered calcipotriene in human or animal milk, the effects on the breastfed infant, or the effects on milk production

After topical administration, plasma concentrations of calcipotriene are low, and therefore, concentrations in human milk are likely to be low

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Pharmacology

Mechanism of Action

In vitro evidence suggests drug is roughly equipotent to natural vitamin D in its effects on proliferation & differentiation of various cell types

Absorption

Absorption: 5-6% systemically

Metabolism

Metabolism: converted to inactive metabolites within 24 hr

Excretion

Excretion: bile

Administration

Topical Administration

For topical use only

Not for ophthalmic, oral or intravaginal use

Avoid contact with face and eyes

Wash hands after applying foam, cream, or solution

Cream or ointment: Apply a thin layer of cream to affected area and gently rub in completely

Foam

Apply a thin layer of foam to affected area and gently rub in completely
Apply to the scalp when hair is dry
Avoid fire, flame, and smoking during and immediately following application

Solution

Comb hair to remove scaly debris and after suitably parting, apply solution only to the lesions, and gently rub in completely, taking care to prevent the solution spreading onto the forehead

Storage

Cream/ointment: Store at room temperature 15- 25°C (59-77°F); do not freeze

Solution: Store at 20-25°C (68-77°F)

Foam

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F); flammable
Contents under pressure
Do not puncture or incinerate
Do not refrigerate or freeze
Do not expose to heat or store at temperatures >120°F (49°C)

Images

BRAND	FORM.	UNIT PRICE	PILL IMAGE
calcipotriene for the scalp-	0.005 % solution
calcipotriene for the scalp-	0.005 % solution
Sorilux topical-	0.005 % foam
Sorilux topical-	0.005 % foam
calcipotriene topical-	0.005 % cream
calcipotriene topical-	0.005 % cream
calcipotriene topical-	0.005 % ointment
calcipotriene topical-	0.005 % ointment
calcipotriene topical-	0.005 % cream
calcipotriene topical-	0.005 % cream
calcipotriene topical-	0.005 % ointment
calcipotriene topical-	0.005 % ointment
calcipotriene topical-	0.005 % ointment
calcipotriene topical-	0.005 % cream
calcipotriene topical-	0.005 % cream
calcipotriene topical-	0.005 % ointment
calcipotriene topical-	0.005 % cream
calcipotriene topical-	0.005 % cream

Patient Handout

CALCIPOTRIENE SCALP SOLUTION - TOPICAL

(KAL-si-poe-TRYE-een)

COMMON BRAND NAME(S): Dovonex

USES: This medication is used to treat long-term psoriasis of the scalp. Calcipotriene is a form of vitamin D. It works by slowing down the growth of skin cells.

HOW TO USE: Use this medication on the skin only. Comb the hair first to remove any scaly flakes. Apply the medication only to the affected areas of the scalp and gently rub in as directed by your doctor, usually twice daily. Take care not to let any of the solution spread onto the forehead or any unaffected area. Wash your hands after using. 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 times 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.

SIDE EFFECTS: Burning, stinging, tingling, rash, dry skin, or irritation at the application site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: skin thinning/discoloration, stretch marks, small red bumps on the skin (folliculitis), unusual tiredness, mental/mood changes, unexplained constipation.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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.Before using this medication, tell your doctor or pharmacist your medical history, especially of: high calcium/vitamin D levels (hypercalcemia/hypervitaminosis D).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.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: other products containing vitamin D.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

NOTES: Do not share this medication with others.Lab and/or medical tests (such as calcium levels) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.This medication has been prescribed for your current condition only. Do not use it later for another skin condition unless told to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from sunlight or open flames. Do not freeze. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

View explanations for tiers and restrictions

Tier	Description
1	This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2	This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC	NOT COVERED – Drugs that are not covered by the plan.

Code	Definition
PA	Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL	Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST	Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR	Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.