Kefunova

Drug overview for KEFUNOVA (fluorouracil/calcipotriene):

Generic name: FLUOROURACIL/CALCIPOTRIENE
Drug class: Actinic Keratoses Agents
Therapeutic class: Dermatological

Calcipotriene, a synthetic vitamin D3 derivative, is an antipsoriatic Fluorouracil, a fluorinated pyrimidine antagonist, acts as an agent. antimetabolite interfering with DNA synthesis.

Calcipotriene cream is used topically in the management of plaque psoriasis Fluorouracil is used topically for the treatment of multiple actinic (psoriasis vulgaris) and calcipotriene solution is used topically for the (solar) keratoses; curettage or cryotherapy is preferred for the treatment management of chronic, moderately severe psoriasis of the scalp. of isolated lesions. Calcipotriene in fixed combination with betamethasone dipropionate is used Fluorouracil is also used topically for the treatment of superficial basal topically as an ointment for the management of plaque psoriasis and as a cell carcinoma when conventional methods are impractical (e.g., in patients suspension for the management of moderate to severe plaque psoriasis of the scalp. Safety and efficacy of calcipotriene preparations in the management with multiple lesions or difficult treatment sites).

Since topical fluorouracil has not been shown to be more effective than other therapies of dermatoses other than psoriasis have not been established. in the treatment of other basal cell carcinomas, the diagnosis should be established before treatment is begun. When lesions are isolated and easily accessible, conventional techniques (e.g., surgery, curettage and dessication, cryotherapy) are preferred because they have a higher response rate (almost 100% vs approximately 93% with topical fluorouracil). For systemic uses of fluorouracil, see 10:00.

DRUG IMAGES

No Image Available

The following indications for KEFUNOVA (fluorouracil/calcipotriene) have been approved by the FDA:

Indications:
None.

Professional Synonyms:
None.

The following dosing information is available for KEFUNOVA (fluorouracil/calcipotriene):

Dosing
Administration
Dosing Information
Generic

At equivalent concentrations, the solutions are considered more effective Safety and efficacy of calcipotriene alone or in fixed combination with betamethasone dipropionate in pediatric patients have not been established. than the creams.

For the management of plaque psoriasis, calcipotriene 0.005% cream is applied as a thin film and rubbed gently and completely into the affected area twice daily. Safety and efficacy of calcipotriene cream have been demonstrated in patients receiving the drug for 8 weeks.

For the topical treatment of plaque psoriasis, the fixed-combination ointment containing calcipotriene 0.005% and betamethasone 0.05% should be applied and rubbed gently into the affected area(s), until absorbed, once daily.

The fixed-combination ointment should not be applied to greater than 30% of body surface area. The manufacturer states that dosage of the fixed-combination ointment should not exceed 100 g of ointment per week, and duration of therapy should not exceed 4 consecutive weeks. Occlusive dressings should not be used with the fixed-combination preparation, unless directed by a clinician.

The fixed-combination ointment should not be used in patients with erythrodermic, exfoliative, and pustular psoriasis or in patients with preexisting skin atrophy at the treatment site.

For chronic, moderately severe psoriasis of the scalp, the hair should be combed to remove scaly debris and, after the hair has been parted to reveal the affected area, the 0.005% solution should be applied only to the affected area and rubbed gently and completely into the scalp twice daily. Care should be taken to avoid contact of the drug with the forehead or uninvolved scalp margins.

The solution should not be used in patients with acute psoriatic eruptions of the scalp.

For the topical treatment of moderate to severe plaque psoriasis of the scalp, the fixed-combination suspension containing calcipotriene 0.005% and betamethasone 0.05% should be applied to the affected area(s) on the scalp once daily for 2 weeks or until clearing of psoriatic lesions occurs.

The bottle should be shaken prior to each use. The manufacturer states that dosage of the combination suspension should not exceed 100 g of suspension per week, and duration of therapy should not exceed 8 weeks. Occlusive dressings should not be used with the combination preparation, unless directed by a clinician.

In addition, the combination suspension should not be used in patients with preexisting skin atrophy at the treatment site.

Most patients with psoriasis received topical calcipotriene 0.005% cream or solution in adequate well-controlled clinical trials of 8 weeks' duration. Results of controlled clinical studies indicate that twice-daily topical application of calcipotriene 0.005%

cream or solution usually results in apparent improvement within 2 weeks; after 8 weeks of therapy, continued improvement was observed in 50 or 31% of patients receiving the cream or solution, respectively, while only 4 or 14% of patients showed complete clearing of lesions receiving calcipotriene cream or solution, respectively.

In a multicenter, double-blind, controlled study in patients with mild to very severe plaque psoriasis, absent or very mild disease after 4 weeks of treatment was reported in 48, 16.5, 26.3, and 7.6%,

respectively, of patients receiving fixed-combination ointment containing calcipotriene and betamethasone dipropionate, calcipotriene alone, betamethasone dipropionate alone, and vehicle alone. In multicenter, randomized, double-blind studies in patients with moderate to very severe scalp psoriasis, clear or almost clear disease after 8 weeks of once-daily treatment was observed in 67.2-70, 59.6-63.1,

and 36.7-41%, of patients receiving fixed-combination suspension containing calcipotriene and betamethasone dipropionate, betamethasone dipropionate monotherapy, and calcipotriene monotherapy, respectively.

Topically applied calcipotriene may be absorbed in sufficient amounts to produce systemic effects; elevated serum calcium concentrations have been observed with use of topical calcipotriene. If elevations in serum calcium concentration occur, use of calcipotriene preparations should be discontinued until normal serum calcium concentrations have been restored. Preparations containing calcipotriene should not be used in patients with demonstrated hypercalcemia or evidence of vitamin D toxicity (hypervitaminosis D) or in patients with known or suspected disorders of calcium metabolism.

Calcipotriene may increase the effect of ultraviolet radiation to induce skin tumors; patients who apply calcipotriene to exposed areas of the body should minimize exposure to sunlight or artificial ultraviolet light (e.g., sunlamps, tanning booths). In addition, the manufacturer states that clinicians may want to limit or avoid use of phototherapy in patients using calcipotriene alone or in fixed combination with betamethasone dipropionate.

Calcipotriene alone or in fixed combination with betamethasone dipropionate Fluorouracil cream or solution is applied topically with a nonmetallic applicator, clean fingertips, or gloved fingers in an amount sufficient to is applied topically to the skin as a cream or ointment, respectively; calcipotriene also is applied as a solution or as a fixed-combination cover the lesions. If the fingers are used to apply the drug, the hands should be washed immediately afterward. suspension containing calcipotriene and betamethasone dipropionate to the scalp.

The topical cream and solution are for external use only and should not be applied to the face, eyes, or mucous membranes. The topical fixed-combination ointment and suspension also are for external use onlyand should not be applied to the face, eyes, axillae, or groin area. The hands should be washed thoroughly after application of topical calcipotriene preparations.

No dosing information available.

No generic dosing information available.

The following contraindication information is available for KEFUNOVA (fluorouracil/calcipotriene):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

No enhanced Contraindications information available for this drug.

There are 4 contraindications. Absolute contraindication.

Contraindication List
Dihydropyrimidine dehydrogenase deficiency
Hypervitaminosis D
Lactation
Pregnancy

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Hypercalcemia
Hypercalcinuria

There are 0 moderate contraindications.

The following adverse reaction information is available for KEFUNOVA (fluorouracil/calcipotriene):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 10 severe adverse reactions.

More Frequent	Less Frequent
Dermatitis due to topical drug Pruritus of skin Skin rash	None.

Rare/Very Rare
Eosinophilia Folliculitis Hypercalcemia Hypercalcinuria Leukocytosis Skin atrophy Thrombocytopenic disorder

There are 32 less severe adverse reactions.

More Frequent	Less Frequent
Abnormal desquamation Dry skin Erythema Paresthesia Pruritus of skin Skin irritation Skin photosensitivity Stinging of skin	Acute pain at drug application site Drug-exacerbated psoriasis Headache disorder Ocular irritation Pain Skin irritation Skin swelling

Rare/Very Rare
Acquired ichthyosis Alopecia Basal cell carcinoma of skin Blistering skin Conjunctivitis Dyschromia Dysgeusia Eye tearing Miliaria Skin hypopigmentation Skin photosensitivity Skin scaling Skin thickening Skin ulcer Squamous cell carcinoma of skin Telangiectasia Urticaria

The following precautions are available for KEFUNOVA (fluorouracil/calcipotriene):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Safe use of fluorouracil topical solution or cream during pregnancy has not been established.

No enhanced Lactation information available for this drug.

No enhanced Geriatric Use information available for this drug.