ZEYZELF® TWICE WEEKLY TRANSDERMAL PATCH 9.5MG/24H [SIN17416P]

Product Info

ZEYZELF® TWICE WEEKLY TRANSDERMAL PATCH 9.5MG/24H

[SIN17416P]

Indication

4.1 Therapeutic indications

Symptomatic treatment of mild to moderately severe Alzheimer’s dementia.

Dosing

4.2 Posology and method of administration

Zeyzelf® twice weekly transdermal patches should be applied twice weekly on fixed days (after four and three days, respectively) (please see also Method of administration). Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia. Diagnosis should be made according to current guidelines. Similar to any treatment initiated in patients with dementia, therapy with rivastigmine should only be started if a caregiver is available to regularly administer and monitor the treatment.

Posology

Initial dose
Treatment is started with 4.6 mg/24 h.

Maintenance dose
After a minimum of four weeks of treatment and if well tolerated according to the treating physician, the dose of 4.6 mg/24 h should be increased to 9.5 mg/24 h, the daily recommended effective dose, which should be continued for as long as the patient continues to demonstrate therapeutic benefit.

Dose escalation
9.5 mg/24 h is the recommended daily effective dose which should be continued for as long as the patient continues to demonstrate therapeutic benefit. If well tolerated and only after a minimum of six months of treatment at 9.5 mg/24 h, the treating physician may consider increasing the dose to 13.3 mg/24 h in patients who have demonstrated a meaningful cognitive deterioration (e.g. decrease in the MMSE) and/or functional decline (based on physician judgement) while on the recommended daily effective dose of 9.5 mg/24 h (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The 13.3 mg/24 h dose strength cannot be achieved with Zeyzelf® twice weekly. For conditions where this strength should be used, other rivastigmine containing transdermal patches of the 13.3 mg/24 h strength are available.

The clinical benefit of rivastigmine should be reassessed on a regular basis. Discontinuation should also be considered when evidence of a therapeutic effect at the optimal dose is no longer present.

Treatment should be temporarily interrupted if gastrointestinal adverse reactions are observed until these adverse reactions resolve. Transdermal patch treatment can be resumed at the same dose if treatment is not interrupted for more than three days. Otherwise treatment should be re-initiated with 4.6 mg/24 h.

Switching from capsules or oral solution to transdermal patches
Based on comparable exposure between oral and transdermal rivastigmine (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), patients treated with rivastigmine capsules or oral solution can be switched to Zeyzelf® twice weekly transdermal patches as follows:

• A patient on a dose of 3 mg/day oral rivastigmine can be switched to 4.6 mg/24 h transdermal patches.

• A patient on a dose of 6 mg/day oral rivastigmine can be switched to 4.6 mg/24 h transdermal patches.

• A patient on a stable and well tolerated dose of 9 mg/day oral rivastigmine can be switched to 9.5 mg/24 h transdermal patches. If the oral dose of 9 mg/day has not been stable and well tolerated, a switch to 4.6 mg/24 h transdermal patches is recommended.

• A patient on a dose of 12 mg/day oral rivastigmine can be switched to 9.5 mg/24 h transdermal patches.

After switching to 4.6 mg/24 h transdermal patches, provided these are well tolerated after a minimum of four weeks of treatment, the dose of 4.6 mg/24 h should be increased to 9.5 mg/24 h, which is the recommended effective dose.

It is recommended to apply the first transdermal patch on the day following the last oral dose.

Special populations

• Paediatric population: There is no relevant use of rivastigmine in the paediatric population in the treatment of Alzheimer’s disease.

• Patients with body weight below 50 kg: Particular caution should be exercised in titrating patients with body weight below 50 kg above the recommended effective dose of 9.5 mg/24 h (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). They may experience more adverse reactions and may be more likely to discontinue due to adverse reactions. Carefully titrate and monitor these patients for adverse reactions (e.g., excessive nausea or vomiting) and consider reducing the dose if such adverse reactions develop.

• Hepatic impairment: Due to increased exposure in mild to moderate hepatic impairment as observed with the oral formulation, dosing recommendations to titrate according to individual tolerability should be closely followed. Patients with clinically significant hepatic impairment may experience more dose-dependent adverse reactions. Patients with severe hepatic impairment have not been studied. Particular caution should be exercised in titrating these patients (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Renal impairment: No dose adjustment is necessary for patients with renal impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration
Zeyzelf® twice weekly is for transdermal use.

Transdermal patches should be applied twice weekly on fixed days (after four and three days, respectively) to clean, dry, hairless, intact healthy skin on the upper or lower back, upper arm or chest, in a place which will not be rubbed by tight clothing. It is not recommended to apply the transdermal patch to the thigh or to the abdomen due to decreased bioavailability of rivastigmine observed when the transdermal patch is applied to these areas of the body.

The transdermal patch should not be applied to skin that is red, irritated or cut. Reapplication to the exact same skin location within 14 days should be avoided to minimise the potential risk of skin irritation.

To prevent interference with the adhesive properties of the transdermal patch, no cream, lotion or powder should be applied to the skin area where the medicinal product is to be applied.

Patients and caregivers should be instructed on important administration instructions:

• The pack contains for each application a rectangular, translucent transdermal patch and an oval, beige adhesive cover.
  Both patches are individually sealed in sachets. The adhesive cover is

• The previous patch must be removed before applying a new one (see section 4.9 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• The patch should be replaced by a new one latest after 4 days. Only one patch should be worn at a time (see section 4.9 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• The patch should be pressed down firmly for approx. 15 seconds using the palm of the hand until the edges stick well. Then it is covered with the adhesive cover and pressed down firmly for at least 30 seconds using the palm of the hand until it sticks well.

• If the patch falls off, a new one should be applied and be replaced at the same time as usual.

• The patch can be used in everyday situations, including bathing and during hot weather.

• The patch should not be exposed to any external heat sources (e.g. excessive sunlight, saunas, solarium) for long periods of time.

• The transdermal patch as well as the adhesive cover should not be cut into pieces.

Contraindications

4.3 Contraindications

Hypersensitivity to the active substance rivastigmine, to other carbamate derivatives or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Previous history of application site reactions suggestive of allergic contact dermatitis with rivastigmine patch (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).