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Published by Parse, 2021-11-10 00:07:52

001 Product e-Brochure_Daivobet

Calcipotriol hydrate
Betamethasone dipropionate


Daivobet ®












Bring long-term







control to Psoriasis

Calcipotriol hydrate
Betamethasone dipropionate


Daivobet ®












Bring long-term







control to Psoriasis

Calcipotriol hydrate
Betamethasone dipropionate

Daivobet ®






®
Daivobet treatment
delivers effective


rapid clearance


of psoriatic plaques






* PASI = Psoriasis Area and Severity Index
** The mean percentage change in PASI from
baseline to the end of treatment was 57.2 in the
betamethasone group, 46.1 in the calcipotriol Reduction in PASI score Reduction in PASI score
*
*
group and 22.7 in the vehicle group. Speed of
response assessed by the mean percentage after week 1 1 after week 4 1
change in PASI after 1 week’s treatment was
33.3 in the betamethasone group, 23.4 in the
calcipotriol group and 18.1 in the vehicle group.










References: 1. Kaufmann R et al. Dermatology 2002;205:389-93.

Calcipotriol hydrate
Betamethasone dipropionate

Daivobet ®






®
Daivobet treatment
delivers effective


rapid clearance


of psoriatic plaques






* PASI = Psoriasis Area and Severity Index
** The mean percentage change in PASI from
baseline to the end of treatment was 57.2 in the
betamethasone group, 46.1 in the calcipotriol Reduction in PASI score Reduction in PASI score
*
*
group and 22.7 in the vehicle group. Speed of
response assessed by the mean percentage after week 1 1 after week 4 1
change in PASI after 1 week’s treatment was
33.3 in the betamethasone group, 23.4 in the
calcipotriol group and 18.1 in the vehicle group.










References: 1. Kaufmann R et al. Dermatology 2002;205:389-93.

of patients treated with Daivobet ®

Ointment as needed for 1 year

experienced skin atrophy* 1,2



®
No patients using Daivobet for 52 weeks as
needed or alternating 4 times weekly with
Daivonex developed HPA axis suppression** 1 * Adverse events of concern possibly related to long-term corticosteroid
®
use (e.g. skin atrophy, folliculitis, depigmentation, furuncle and purpura)
®
were reported by 4.8% of the patients in the Daivobet Ointment group. 2
**HPA: hypothalamic pituitary adrenal.







References: 1. Kragballe K et al. BrJ Dermatol2006;154:1155-60. 2. Daivobet Prescribing Information
®
(Philippines).

of patients treated with Daivobet ®

Ointment as needed for 1 year

experienced skin atrophy* 1,2



®
No patients using Daivobet for 52 weeks as
needed or alternating 4 times weekly with
Daivonex developed HPA axis suppression** 1 * Adverse events of concern possibly related to long-term corticosteroid
®
use (e.g. skin atrophy, folliculitis, depigmentation, furuncle and purpura)
®
were reported by 4.8% of the patients in the Daivobet Ointment group. 2
**HPA: hypothalamic pituitary adrenal.







References: 1. Kragballe K et al. BrJ Dermatol2006;154:1155-60. 2. Daivobet Prescribing Information
®
(Philippines).

Calcipotriol hydrate
Betamethasone dipropionate
High patient satisfaction High patient adherence
Daivobet ®





Patients on Daivobet ®

Ointment reported

high patient



satisfaction,


treatment



adherence and

improved quality


73.6% of patients reported they were 90.2% of patients fully adhered to
of life. satisfied or very satisfied with Daivobet - treatment with Daivobet Week 52
®
®
citing efficacy, tolerability and ease of use 1 (91.6% mean level of adherence) 2











References: 1. Clareus BW et al. Eur J Dermatol 2009;19:581 5. 2. Imafuku S et al. Jpn J Dermatol 2018;128:589 600.

Calcipotriol hydrate
Betamethasone dipropionate
High patient satisfaction High patient adherence
Daivobet ®





Patients on Daivobet ®

Ointment reported

high patient



satisfaction,


treatment



adherence and

improved quality


73.6% of patients reported they were 90.2% of patients fully adhered to
of life. satisfied or very satisfied with Daivobet - treatment with Daivobet Week 52
®
®
citing efficacy, tolerability and ease of use 1 (91.6% mean level of adherence) 2











References: 1. Clareus BW et al. Eur J Dermatol 2009;19:581 5. 2. Imafuku S et al. Jpn J Dermatol 2018;128:589 600.

Calcipotriol
Applying Daivonex ®* on seemingly healed psoriatic plaque
Daivonex ®
lesions suppresses recurrence better than applying it only on

remaining plaques. 1





®
BODY During a 6-month study, 45.3% of patients on Daivobet did not experience any recurrence of psoriasis 2**




















No recurrence One recurrence Two or more
recurrences
16.5% of patients had missing or incomplete data


* Daivonex is a topical formulation of the vitamin D derivative, calcipotriol, which induces differentiation and suppresses proliferation of skin cells (keratinocytes). Daivonex thus normalizes
abnormal cell proliferation and differentiation in psoriatic skin 3
** International, multi-centre, single-group, non-interventional study enrolling patients with a calcipotriol/betamethasone dipropionate prescription prior to study start who were followed for 6
months (N=1224). Patients were treated with a 4 week course initially and repeated courses for the following 6 months.





References: 1. Ito K et al. J Dermatol 2016;43:402-5. 2. Clareus BW et al. Eur J Dermatol 2009;19:581-5. 3. Daivonex Ointment Prescribing Information (Philippines).
®

Calcipotriol
Applying Daivonex ®* on seemingly healed psoriatic plaque
Daivonex ®
lesions suppresses recurrence better than applying it only on

remaining plaques. 1





®
BODY During a 6-month study, 45.3% of patients on Daivobet did not experience any recurrence of psoriasis 2**




















No recurrence One recurrence Two or more
recurrences
16.5% of patients had missing or incomplete data


* Daivonex is a topical formulation of the vitamin D derivative, calcipotriol, which induces differentiation and suppresses proliferation of skin cells (keratinocytes). Daivonex thus normalizes
abnormal cell proliferation and differentiation in psoriatic skin 3
** International, multi-centre, single-group, non-interventional study enrolling patients with a calcipotriol/betamethasone dipropionate prescription prior to study start who were followed for 6
months (N=1224). Patients were treated with a 4 week course initially and repeated courses for the following 6 months.





References: 1. Ito K et al. J Dermatol 2016;43:402-5. 2. Clareus BW et al. Eur J Dermatol 2009;19:581-5. 3. Daivonex Ointment Prescribing Information (Philippines).
®

Calcipotriol hydrate
Betamethasone dipropionate
Bring long-term control Daivobet ®



to Psoriasis








• Fast onset of action* and rapid


clearance of psoriatic plaques 1,2


• Effective long-term



management 3,5



• Well tolerated safety profile 4-6




*compared to betamethasone dipropionate, calcipotriol and vehicle 1









References: 1. Kaufmann R et al. Dermatology 2002;205:389-93. 2. Jemec GBE. J Am Acad Dermatol
2008;59:455-63. 3. Kragballe K et al. Dermatology 2006;213:319-326. 4. Kragballe Ket al. Br J Dermatol
2006;154:1155-60. 5. Luger TA et al. Dermatology 2008;217:321-8. 6. Fleming C et al. J Drugs Dermatol
2010;9(8):969-74.

Calcipotriol hydrate
Betamethasone dipropionate
Bring long-term control Daivobet ®



to Psoriasis








• Fast onset of action* and rapid


clearance of psoriatic plaques 1,2


• Effective long-term



management 3,5



• Well tolerated safety profile 4-6




*compared to betamethasone dipropionate, calcipotriol and vehicle 1









References: 1. Kaufmann R et al. Dermatology 2002;205:389-93. 2. Jemec GBE. J Am Acad Dermatol
2008;59:455-63. 3. Kragballe K et al. Dermatology 2006;213:319-326. 4. Kragballe Ket al. Br J Dermatol
2006;154:1155-60. 5. Luger TA et al. Dermatology 2008;217:321-8. 6. Fleming C et al. J Drugs Dermatol
2010;9(8):969-74.

Daivobet® Ointment Daivonex® Ointment
Abbreviated Product Information Abbreviated Product Information
FORMULATION: 1 g of Daivobet® ointment contains: Active ingredients: Calcipotriol 50 COMPOSITION: Daivonex® ointment contains 50 μg/g (0.005%w/w) calcipotriol. It is a
micrograms (as hydrate), Betamethasone 500 micrograms (as dipropionate). smooth, white, preservative free ointment. INDICATIONS: Psoriasis vulgaris. DOSAGE
INDICATION: For the management of psoriasis vulgaris. POSOLOGY AND METHOD OF AND ADMINISTRATION: Daivonex® ointment should be applied sparingly to the
ADMINISTRATION: Calcipotriol hydrate and betamethasone dipropionate (Daivobet®) affected skin lesions twice daily. For some patients the maintenance therapy may be
should be applied to the affected area once daily. There is experience with repeated achieved with less frequent application. The weekly dose should not exceed 100 g.
courses of Calcipotriol hydrate and betamethasone dipropionate (Daivobet®) up to 52 CONTRAINDICATIONS: Hypersensitivity to any of the constituents of Daivonex®
weeks. If it is necessary to continue or restart treatment after 4 weeks, treatment should ointment. Known disorder of calcium metabolism. SIDE EFFECTS: Minor adverse effects
be continued after medical review and under regular medical supervision. When using such as transient local irritation and, very rarely, facial dermatitis may occur. STORAGE
calcipotriol containing medicinal products, the maximum dose should not exceed 15 g CONDITION: Do not store above 30°C.
daily and 100 g weekly while the body surface area treated should not exceed 30%. It is Daivonex® Ointment API version JAN2019
not recommended to take a shower or bath immediately after application of
Calcipotriol hydrate and betamethasone dipropionate (Daivobet®).
CONTRAINDICATIONS: Hypersensitivity to the active substances or to any of the
excipients. Due to the content of calcipotriol, calcipotriol hydrate and betamethasone
dipropionate (Daivobet®) is contraindicated in patients with known disorders of Calcipotriol hydrate
calcium metabolism. Due to the content of corticosteroid, Calcipotriol hydrate and Betamethasone dipropionate
betamethasone dipropionate (Daivobet®) is contraindicated in the following
conditions: Viral (eg. herpes or varicella) lesions of the skin, fungal or bacterial skin Daivobet ®
infections, parasitic infections, skin manifestations in relation to tuberculosis, rosacea,
perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins,
ichthyosis, acne rosacea, ulcers andwounds. Calcipotriol hydrate and betamethasone
dipropionate (Daivobet®) is contraindicated in, erythrodermic, exfoliative and pustular Calcipotriol
psoriasis. UNDESIRABLE EFFECTS: Skin exfoliation and pruritus are common adverse
events of topically applied Daivobet® Ointment. Hypersensitivity is a rare adverse
event of topically applied Daivobet® Ointment. The most frequently reported adverse Daivonex ®
reactions during treatment are various skin reactions, like pruritus, and skin exfoliation.
STORAGE CONDITIONS: Store at temperatures not exceeding 30°C. Can be used for 12
months after opening.
Daivobet® Ointment API version JAN2019









LEO Pharma Philippines
For Healthcare Professionals Only
A Division of Getz Bros. Philippines, Inc. Full prescribing information available upon request.
th
th
Unit 9E, 9 Floor, Inoza Tower, 40 St., You may unsubscribe to this service by sending an email to [email protected]
© LEO PHARMA 2020. ALL TRADEMARKS MENTIONED BELONG TO THE LEO PHARMA GROUP.
Bonifacio Global City, Taguig MAT-37395 Valid until 08/12/2022

Daivobet® Ointment Daivonex® Ointment
Abbreviated Product Information Abbreviated Product Information
FORMULATION: 1 g of Daivobet® ointment contains: Active ingredients: Calcipotriol 50 COMPOSITION: Daivonex® ointment contains 50 μg/g (0.005%w/w) calcipotriol. It is a
micrograms (as hydrate), Betamethasone 500 micrograms (as dipropionate). smooth, white, preservative free ointment. INDICATIONS: Psoriasis vulgaris. DOSAGE
INDICATION: For the management of psoriasis vulgaris. POSOLOGY AND METHOD OF AND ADMINISTRATION: Daivonex® ointment should be applied sparingly to the
ADMINISTRATION: Calcipotriol hydrate and betamethasone dipropionate (Daivobet®) affected skin lesions twice daily. For some patients the maintenance therapy may be
should be applied to the affected area once daily. There is experience with repeated achieved with less frequent application. The weekly dose should not exceed 100 g.
courses of Calcipotriol hydrate and betamethasone dipropionate (Daivobet®) up to 52 CONTRAINDICATIONS: Hypersensitivity to any of the constituents of Daivonex®
weeks. If it is necessary to continue or restart treatment after 4 weeks, treatment should ointment. Known disorder of calcium metabolism. SIDE EFFECTS: Minor adverse effects
be continued after medical review and under regular medical supervision. When using such as transient local irritation and, very rarely, facial dermatitis may occur. STORAGE
calcipotriol containing medicinal products, the maximum dose should not exceed 15 g CONDITION: Do not store above 30°C.
daily and 100 g weekly while the body surface area treated should not exceed 30%. It is Daivonex® Ointment API version JAN2019
not recommended to take a shower or bath immediately after application of
Calcipotriol hydrate and betamethasone dipropionate (Daivobet®).
CONTRAINDICATIONS: Hypersensitivity to the active substances or to any of the
excipients. Due to the content of calcipotriol, calcipotriol hydrate and betamethasone
dipropionate (Daivobet®) is contraindicated in patients with known disorders of Calcipotriol hydrate
calcium metabolism. Due to the content of corticosteroid, Calcipotriol hydrate and Betamethasone dipropionate
betamethasone dipropionate (Daivobet®) is contraindicated in the following
conditions: Viral (eg. herpes or varicella) lesions of the skin, fungal or bacterial skin Daivobet ®
infections, parasitic infections, skin manifestations in relation to tuberculosis, rosacea,
perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins,
ichthyosis, acne rosacea, ulcers andwounds. Calcipotriol hydrate and betamethasone
dipropionate (Daivobet®) is contraindicated in, erythrodermic, exfoliative and pustular Calcipotriol
psoriasis. UNDESIRABLE EFFECTS: Skin exfoliation and pruritus are common adverse
events of topically applied Daivobet® Ointment. Hypersensitivity is a rare adverse
event of topically applied Daivobet® Ointment. The most frequently reported adverse Daivonex ®
reactions during treatment are various skin reactions, like pruritus, and skin exfoliation.
STORAGE CONDITIONS: Store at temperatures not exceeding 30°C. Can be used for 12
months after opening.
Daivobet® Ointment API version JAN2019









LEO Pharma Philippines
For Healthcare Professionals Only
A Division of Getz Bros. Philippines, Inc. Full prescribing information available upon request.
th
th
Unit 9E, 9 Floor, Inoza Tower, 40 St., You may unsubscribe to this service by sending an email to [email protected]
© LEO PHARMA 2020. ALL TRADEMARKS MENTIONED BELONG TO THE LEO PHARMA GROUP.
Bonifacio Global City, Taguig MAT-37395 Valid until 08/12/2022

Approval Signatures




Name: PH Psoriasis e-Brochure

Id: MAT-37395

Version: 0

Status: In Approval


Product: Daivobet®, Daivonex®

Form:

Strength:

Region/Country: Philippines

Target Audience: Healthcare Professionals (HCPs)


Description: PH Psoriasis e-Brochure for HCPs





Document Approvals

Regulatory and Trademark - 14-Aug-2020 09:33:05
Ee Me Khoo (KEMSG)
GMT+0000


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