Dovonex (Page 2 of 2)

ADVERSE REACTIONS

Clinical Trials Experience

In controlled clinical trials, the most frequent adverse experiences reported for Dovonex® (calcipotriene) Cream, 0.005% were cases of skin irritation, which occurred in approximately 10-15% of patients. Rash, pruritus, dermatitis and worsening of psoriasis were reported in 1 to 10% of patients.

Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions associated with the use of Dovonex® Cream have been identified post-approval: contact dermatitis including allergic contact dermatitis, erythema, skin exfoliation, skin burning sensation, application site pain, application site pigmentation disorder, urticaria, photosensitivity, rash 1, dry skin, hypercalcaemia and hypersensitivity.


1
rash erythematous, rash maculo-papular, rash morbilliform, rash popular, and rash pustular

OVERDOSAGE

Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of topical calcipotriene. If elevation in serum calcium should occur, discontinue treatment until normal calcium levels are restored. [See PRECAUTIONS]

DOSAGE AND ADMINISTRATION

Apply a thin layer of Dovonex® Cream to the affected skin twice daily and rub in gently and completely. The safety and efficacy of Dovonex® Cream have been demonstrated in patients treated for eight weeks.

HOW SUPPLIED

Dovonex® (calcipotriene) Cream, 0.005% is available in:

60 gram aluminum tubes ​NDC 50222-260-06

120 gram aluminum tubes ​NDC 50222-260-12

STORAGE

Store at controlled room temperature 15°C — 25°C (59°F — 77°F). Do not freeze.

LEO Laboratories Ltd. logo

LEO Laboratories Ltd. logo

Manufactured by:

LEO Laboratories Ltd.
Dublin 12, Ireland

Distributed by:

LEO Pharma Inc.
Seven Giralda Farms
Madison, NJ 07940, USA

To report SUSPECTED ADVERSE REACTIONS, contact
LEO Pharma Inc at 1-877-494-4536 or FDA at 1-800-FDA-1088
or www.fda.gov/medwatch

Revises 06/2021

PRINCIPAL DISPLAY PANEL — 60 g Tube Carton

LEO®

NDC 50222-260-06

Rx only

Dovonex®
(calcipotriene)
Cream, 0.005%

Net Wt. 60 g

PRINCIPAL DISPLAY PANEL -- 60 g Tube Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 120 g Tube Carton

NDC 50222-260-12

Rx only

Dovonex® (calcipotriene) Cream, 0.005%

Net Wt. 120 g

PRINCIPAL DISPLAY PANEL -- 120 g Tube Carton
(click image for full-size original)
DOVONEX
calcipotriene cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50222-260
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIPOTRIENE (CALCIPOTRIENE) CALCIPOTRIENE 50 ug in 1 g
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL
CETETH-20
DICHLOROBENZYL ALCOHOL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
EDETATE DISODIUM
GLYCERIN
MINERAL OIL
PETROLATUM
WATER
.ALPHA.-TOCOPHEROL, DL-
DIAZOLIDINYL UREA
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50222-260-12 1 TUBE in 1 CARTON contains a TUBE
1 120 g in 1 TUBE This package is contained within the CARTON (50222-260-12)
2 NDC:50222-260-06 1 TUBE in 1 CARTON contains a TUBE
2 60 g in 1 TUBE This package is contained within the CARTON (50222-260-06)
3 NDC:50222-260-99 10 TUBE in 1 CARTON contains a TUBE
3 3 g in 1 TUBE This package is contained within the CARTON (50222-260-99)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020554 10/01/1996 08/31/2023
Labeler — LEO Pharma Inc. (832692615)
Registrant — LEO Pharma A/S (306218108)
Establishment
Name Address ID/FEI Operations
LEO Laboratories Ltd. 306218108 MANUFACTURE (50222-260)

Revised: 01/2020 LEO Pharma Inc.

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