Daivobet is used as a topical treatment for scalp psoriasis in adults and mild to moderate psoriasis (psoriasis vulgaris) patches in the rest of the body in adults. Psoriasis is caused by your skin cells being produced too quickly. This causes redness, peeling and thickening of the skin.

Daivobet contains calcipotriol and betamethasone. Calcipotriol helps restore the rate of growth of skin cells to normal, and betamethasone works by reducing inflammation.

PRESENTATION (S) AVAILABLE FOR DAIVOBET 50 ΜG / 0.5 MG / G

5 presentations are available for this drug:

1 bottle (s) high density polyethylene (HDPE) of 15 g
1 bottle (s) high density polyethylene (HDPE) of 30 g
1 bottle (s) high density polyethylene (HDPE) of 60 g
2 high density polyethylene (HDPE) bottle (s) of 60 g
3 high density polyethylene (HDPE) bottle (s) of 60 g

FEATURE	DESCRIPTION
Pharmaceutical class	psoriasis treatment
Active substance (s)	betamethasone dipropionate, calcipotriol monohydrate
General medicine	no
Pharmaceutical form	gel
Route (s) of administration	cutaneous
Social security reimbursement rate	65%
Laboratory (s)	LEO
Conditions of issue	available by simple prescription

daivobet gel Dosage

Always take the dose recommended by your doctor. If in doubt, consult your doctor or pharmacist.

How to apply Daivobet

Cutaneous use.

Instruction for correct use

Apply the product only to psoriasis and not to skin that does not have psoriasis.
Shake the bottle before use and remove the cap
Put gel on a clean finger or directly on the areas affected by psoriasis.
Apply Daivobet to the area affected by psoriasis with your fingertip and work it in by rubbing gently until this area is covered by a thin layer of gel.
Do not cover the treated area with neither a bandage nor a tight bandage
Wash hands thoroughly after using Daivobet. This will prevent accidental transfer of gel to other parts of the body (especially on the face, mouth and eyes)
Don’t worry if you accidentally apply the gel to healthy skin around the psoriasis lesions, but wipe it off if it spreads too widely
For optimal effect, it is recommended not to shower or bathe immediately after application of Daivobet gel.
After applying the gel, avoid contact with fabrics that are easily stained with grease (such as silk).

If you have scalp psoriasis

Before applying Daivobet to the scalp, first style your hair to eliminate dandruff. Tilt your head to make sure Daivobetdoes not run on your face. Making a line can facilitate the application of Daivobet. Apply Daivobet to the affected area with your fingertip and rub it in gently.
For the treatment of the scalp, usually an amount between 1 and 4 g is sufficient to treat the scalp (4 g corresponds to a teaspoon)
Washing your hair before applying Daivobet is not necessary
For optimum effect, it is recommended not to wash your hair immediately after applying Daivobet. Leave Daivobet in contact with the scalp overnight or during the day.

Duration of the treatment

Use the gel once a day. It may be more convenient to apply the gel in the evening
The normal initial treatment period is 4 weeks for the scalp and 8 weeks outside the scalp.
Your doctor may prescribe a different duration of treatment.
Your doctor may decide to repeat the treatment.
Do not use more than 15 grams per day.

If you are using other products containing calcipotriol, the total calcipotriol should not exceed 15 grams per day and the treated area should not exceed 30% of the total body surface.

What should I expect from my treatment with Daivobet

Most patients see a clear result after 2 weeks even if the psoriasis has not completely gone away.

daivobet gel Contraindications

Never use Daivobet:

If you are allergic (hypersensitive) to calcipotriol, betamethasone or any of the other ingredients of Daivobet.
If you have problems with calcium levels in the body (ask your doctor).
If you have psoriasis of a certain type: such as gouty, erythrodermic, exfoliating, or pustular psoriasis (ask your doctor).
If you have severe liver or kidney disease.

As Daivobet contains a strong corticosteroid, do NOT use it on skin with

infection caused by a virus (such as a cold sore or chickenpox)
infection caused by a fungus (athlete’s foot or ringworm),
infection caused by bacteria,
infection caused by a parasite (such as gall),
tuberculosis or syphilis,
perioral dermatitis (redness around the mouth),
thinning of the skin, easily damaged veins, stretch marks,
ichthyosis (dry skin with kinds of scales),
acne (pimples),
rosacea (sudden severe redness or redness of the skin of the face),
ulcers or rupture of the skin barrier,
itching of the anus (rectum) or genitals (sexual organs).

how does daivobet gel work?

Pharmacotherapeutic group: Antipsoriatics; other antipsoriatics for topical use – calcipotriol in combination (ATC code: D05AX52).

Calcipotriol is an analogue of vitamin D. In vitro data suggest that calcipotriol induces differentiation and inhibits the proliferation of keratinocytes. This is the mechanism proposed to explain its effects in psoriasis.

Like other topical corticosteroids, betamethasone dipropionate has anti-inflammatory, antipruritic, vasoconstrictive, and immunosuppressive properties, however, with no demonstrated curative action. Treatment under occlusion may increase the effect due to greater penetration into the stratum corneum. The incidence of side effects will therefore be increased. In general, the mechanism of action of the anti-inflammatory activity of topical corticosteroids is not fully understood.

The adrenal response to ACTH was determined by measuring cortisol in patients with both extensive scalp and body psoriasis using up to 106 g per week of Daivobet gel in combination with Daivobet ointment. A borderline decrease in cortisol levels 30 minutes after ACTH administration was observed in 5 of 32 patients (15.6%) after 4 weeks of treatment and in 2 of 11 patients (18.2%) who had prolonged treatment up to 8 weeks. In all cases, cortisol levels were at a normal level 60 minutes after the administration of ACTH. No changes in calcium metabolism were observed in these patients. Regarding hypothalamic-pituitary braking, this study demonstrates that

The efficacy of once-daily use of Daivobet gel has been evaluated in two randomized, double-blind, 8-week clinical studies including a total of over 2900 patients with scalp psoriasis of at least severity mild according to the Investigator’s Global Assessment of Disease Severity (IGA). The comparators were betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle, and (in one of the studies) the gel vehicle alone, all used once daily. Results for the primary endpoint (absence of disease or very slight presence of disease according to IGA at week 8) showed that Daivobet gel was significantly more effective than the comparators. The results on the speed of

% of patients with absence of disease or very slight presence of disease	week 2	week 8
Daivobet gel (n = 1108)	53.2%	69.8%
Betamethasone dipropionate (n = 1118)	42.8% ⁽¹⁾	62.5% ⁽¹⁾
Calcipotriol (n = 558)	17.2% ⁽¹⁾	40.1% ⁽¹⁾
Freeze vehicle (n = 136)	11.8% ⁽¹⁾	22.8% ⁽¹⁾

⁽¹⁾ Statistically less effective than Daivobet gel (p <0.001).

The effectiveness of Daivobet gel used once daily on the body (excluding the scalp) was evaluated in a randomized, double-blind, 8-week clinical study which included 296 patients with psoriasis vulgaris of mild or severe severity. moderate according to the IGA. The comparators were betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle, and the gel vehicle alone, all used once daily. The primary response criteria were IGA controlled disease at week 4 and week 8. Controlled disease was defined as “bleached” or “minimally impaired” for patients with moderate disease at T0 or “bleached” for patients with mild disease at T0.

The secondary response endpoints were percentage change in Psoriasis Severity and Area index (PASI) between T0 and week 4 and between T0 and week 8.

% of patients with controlled disease	week 4	week 8
Daivobet gel (n = 126)	20.6%	31.7%
Betamethasone dipropionate (n = 68)	10.3% ⁽¹⁾	19.1% ⁽¹⁾
Calcipotriol (n = 67)	4.5% ⁽¹⁾	13.4% ⁽¹⁾
Freeze vehicle (n = 35)	2.9% ⁽¹⁾	0.0% ⁽¹⁾

⁽¹⁾ Statistically less effective than Daivobet gel (p <0.05).

Average percentage reduction in PASI (DS)	week 4	week 8
Daivobet gel (n = 126)	50.2 (32.7)	58.8 (32.4)
Betamethasone dipropionate (n = 68)	40.8 (33.3) ⁽¹⁾	51.8 (35.0)
Calcipotriol (n = 67)	32.1 (23.6) ⁽¹⁾	40.8 (31.9) ⁽¹⁾
Freeze vehicle (n = 35)	17.0 (31.8) ⁽¹⁾	11.1 (29.5) ⁽¹⁾

⁽¹⁾ Statistically less effective than Daivobet gel (p <0.05).

Another randomized, single-blind, clinical study including 312 patients with scalp psoriasis of at least moderate severity according to the IGA investigated the use of Daivobet gel once daily compared with that of Daivonex scalp solution two. times a day for 8 weeks. Results for the primary endpoint (absence of disease or very mild disease presence according to IGA at week 8) showed that Daivobet gel was statistically more effective than Daivonex scalp solution.

% of patients with absence of disease or very slight presence of disease	week 8
Daivobet gel (n = 207)	68.6%
Daivonex scalp solution (n = 105)	31.4% ⁽¹⁾

⁽¹⁾ Statistically less effective than Daivobet gel (p <0.001).

A long-term, randomized, double-blind clinical study including 873 patients with scalp psoriasis of at least moderate severity at baseline (according to IGA) investigated the use of Daivobet gel in comparison with that of calcipotriol in the vehicle of the gel. Both treatments were applied once daily, intermittently as needed, for up to 52 weeks. Adverse effects, possibly related to the long-term use of corticosteroids on the scalp, have been identified blindly by an independent panel of dermatologists. There was no difference in the percentage of patients with such adverse effects between the treated groups (2.6% in the Daivobet gel group and 3.0% in the calcipotriol group; p = 0.73). No case of skin atrophy

Pediatric population:

Scalp :

The effects on calcium metabolism were investigated in 2 open-label, uncontrolled 8-week clinical trials including a total of 109 adolescents aged 12 to 17 years with scalp psoriasis, using up to 69 g per week of Daivobet gel. No cases of hypercalcaemia and no clinically relevant changes in calciuria have been reported. The adrenal response to the administration of ACTH was measured in 30 patients; one patient showed a slight decrease in his cortisol levels on administration of ACTH after 4 weeks of treatment, without clinical manifestation and reversible.

Scalp and body:

The effects on calcium metabolism were studied in an 8-week, open-label, uncontrolled clinical trial in 107 adolescents aged 12 to 17 years with psoriasis of the scalp and body, using up to 114.2 g per Daivobet gel week. No cases of hypercalcaemia and no clinically relevant changes in calciuria have been reported. The adrenal response to the ATCH test was measured in 31 patients; the response to cortisol was decreased after the ACTH test in 5 patients of which 2 patients showed only a limited decrease. This decrease was observed after 4 weeks of treatment in 4 patients, and after 8 weeks of treatment in 2 patients including 1 patient who showed a decrease in his cortisolemia after 4 and 8 weeks of treatment.

How To Store daivobet gel ?

Keep this medication out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and the cartridge after EXP. The expiration date refers to the last day of that month.
Do not put in the refigerator.
Store in the outer packaging in order to protect from light.
The bottle should be discarded 6 months after first opening with the gel it contains.
The applicator is disposable. The applicator should be discarded 6 months after first opening with the gel it contains.
Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.

daivobet gel Side Effects

Like all medicines, Daivobet can cause side effects, although not everybody gets them.

About 1 in 12 people may experience side effects, but most are reactions at the site of application of the gel.

Serious side effects:

Contact your doctor / nurse immediately or as soon as possible if any of these reactions occur. You may need to stop your treatment:

The following serious side effects have been reported for Daivobet

Rare (affect less than 1 in 100 people)

Worsening of your psoriasis. If your psoriasis gets worse, talk to your doctor as soon as possible.

Serious side effects are known to be caused by betamethasone (a strong corticosteroid), one of the ingredients of Daivobet gel. Tell your doctor as soon as possible if a serious side effect occurs. These side effects most often occur after prolonged use, or under occlusion. These effects include the following:

Your adrenal glands may stop working properly. The signs are fatigue, depression, and anxiety.
Cataract (signs are blurry and blurred vision, difficulty seeing at night, and sensitivity to light) or increased pressure in the eye (signs are eye pain, red eye, decreased vision or blurred vision ).
Infections (because your infection-fighting immune system may be weakened or weakened).
Pustular psoriasis (a red area with yellowish pustules usually on the hands or feet). If you notice it, stop taking Daivobet gel and talk to your doctor as soon as possible.
Impact on the control of the metabolism of diabetes mellitus (if you are diabetic you may have fluctuations in your blood sugar).

Serious side effects are known to be caused by calcipotriol:

Allergic reactions with severe swelling of the face or other parts of the body such as the hands or feet. Swelling of the lips and difficulty in breathing can happen. If you have an allergic reaction, stop using Daivobet gel, tell your doctor straight away, or go to the nearest hospital emergency room.
Treatment with this gel may increase your calcium levels in the blood or urine (usually when too much gel has been used). Signs of increased calcium in the blood are bone pain, constipation, loss of appetite, nausea, and vomiting. This can be serious and you should contact your doctor immediately. However, when treatment is stopped, the levels return to normal.

Less serious side effects:

The following less serious side effects have been reported with Daivobet:

Common side effects (affect less than 1 in 10 people)

Itching.

Uncommon side effects (affect less than 1 in 100 people):

Eye irritation.
Burning sensation of the skin.
Skin pain or irritation.
Inflammation or swelling of the hair roots (folliculitis).
Redness with inflammation of the skin (dermatitis).
Redness of the skin due to the dilation of small blood vessels (erythema).
Acne (pimples).
Dry skin.
Eruptions.
Rash of pustules.

Less serious side effects caused by betamethasone when used for a long time include the following side effects, and you should tell your doctor or nurse as soon as possible if you notice them:

Thinning of the skin.
Appearance of surface veins or stretch marks.
Change in hair growth.
Redness around the mouth (perioral dermatitis).
Red rash with inflammation and swelling (allergic contact dermatitis).
Small white buttons (colloid milium).
Depigmentation (lightening of the skin).

Other less serious side effects that have been reported include:

Sensitivity of the skin to light causing a rash.
Eczema.

If you notice the effects described above or other changes during treatment, tell your doctor.

If you experience any of the side effects listed as serious, or if you experience any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Keep out of the reach and sight of children.

daivobet gel Interactions

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

Effects on ability to Drive and use machines

Daivobet has no or negligible influence on the ability to drive and use machines.

Warnings and Precautions

Take special care with Daivobet

Before using this medicine, tell your doctor / nurse / pharmacist if:

you are taking other medicines which contain corticosteroids as you may have side effects
you have been taking this medicine for a long time and plan to stop the treatment (there is a risk that your psoriasis will get worse or ‘flare up’ when the corticosteroids are suddenly stopped),
you have diabetes (diabetes mellitus) because blood sugar / glucose levels may be affected by corticosteroids
your skin becomes infected because you may need to stop treatment.

Special precautions

Avoid using on more than 30% of your body or using more than 15 grams per day.
Avoid use under a shower cap, bandages or dressings as this increases the absorption of corticosteroids.
Avoid use on large areas of damaged skin or on skin folds (groin, under the arms, under the breasts) as this increases the absorption of corticosteroids.
Avoid use on the face or the genitals (sexual organs) as these are very sensitive to corticosteroids.
Avoid excessive exposure to the sun, excessive use of solar cabins, or other form of light therapy.

Children

Daivobet is not recommended for children and adolescents under the age of 18.

PREGNANCY & BREAST-FEEDING & FERTILITY

Pregnancy

There are no sufficiently good data from the use of Daivobet in pregnant women. Animal studies with glucocorticoids have shown reproductive toxicity ( see Preclinical Safety ), but a number of epidemiological studies (less than 300 pregnancies) have not shown congenital anomalies in patients. children born to mothers treated with corticosteroids during pregnancy. The potential risk for humans is not known for sure. Therefore, Daivobet should only be used during pregnancy when the potential benefit justifies the potential risk.

Feeding with milk

Betamethasone is excreted in human milk, but the risk of an adverse effect in the infant seems unlikely at therapeutic doses. There are no data on the excretion of calcipotriol in human milk. Caution should be exercised when prescribing Daivobet in nursing mothers. The patient should be instructed not to use Daivobet on the breasts while breastfeeding.

Fertility

Studies in rats after oral administration of calcipotriol or betamethasone dipropionate have shown no impairment of fertility in males and females ( see Preclinical Safety ).

What happens if I overdose from daivobet gel ?

The use of doses higher than the recommended dose may lead to an increase in serum calcium, this effect is reversible on discontinuation of treatment. Symptoms of hypercalcemia include polyuria, constipation, muscle weakness, confusion, and coma.
Excessive and prolonged use of topical corticosteroids can lead to hypothalamic-pituitary axis slowing, resulting in secondary adrenal insufficiency which is usually reversible. In this case, symptomatic treatment is indicated.
In the event of chronic toxicity, treatment with corticosteroids should be withdrawn gradually.
A case of misuse has been reported in a patient treated for extensive erythrodermic psoriasis with 240 g of Daivobet ointment per week (corresponding to a daily dose of approximately 34 g) for 5 months (maximum recommended dose 15 g per day); during treatment, the patient developed Cushing’s syndrome followed by pustular psoriasis after abrupt cessation of treatment.

What should I do if I miss a dose?

Do not apply a double dose to make up for the dose you forgot to apply.

What happens if you stop taking daivobet gel ?

Treatment with DAIVOBET should be stopped as instructed by your doctor. It may be necessary to stop treatment gradually, especially if you have been taking it for a long time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist for more information.

What is Forms and Composition ?

SHAPES and PRESENTATIONS

50 µg / 0.5 mg / g gel (almost transparent, colorless to very slightly off-white):

60 g vial, unit box.
60 g cartridge, with applicator, unit box.

Ointment at 50 µg / 0.5 mg / g (whitish to yellow):

Tube of 60 g.

COMPOSITION

	*p 1 g of gel*
Calcipotriol (INN) monohydrate expressed as calcipotriol	50 µg
Betamethasone (INN) dipropionate expressed as betamethasone	0.5 mg

Excipients: liquid paraffin, polyoxypropylene stearyl ether, hydrogenated castor oil, butylhydroxytoluene (E321), all-rac-alpha-tocopherol.
Excipients with known effect: 1 g of gel contains 160 µg of butylhydroxytoluene and 20 mg of castor oil.

NOT’s

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general information:

Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

It treats possible side effects and drug interactions that require attention and its effect on continuous use.
The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

Betamethasone Calcipotriol