- Approval Id
- 6281f075d671cb9e
- Drug Approval Emc Name
- Rotigotine Luye 4 mg/24 hours Transdermal patch
- Drug Name
- Rotigotine Luye 4 mg/24 hours Transdermal patch
- Company Address
- Surrey Technology Centre, 40 Occam Road, Surrey Research Park, Guildford, GU2 7YG
- Company Medical Info Email
- [email protected]
- Atc Code
- N04BC09
- Legal Category
- Prescription only medicine
- Authorisation Holder
- 7. Marketing authorisation holder Luye Pharma Ltd. 40 Occam Road Guildford, GU2 7YG UK
- Authorisation Number
- 8. Marketing authorisation number(s) PLGB 50827/0034
- Authorisation Date
- 9. Date of first authorisation/renewal of the authorisation 25/11/2024
- Instruction Authorisation Holder
- 7. Marketing authorisation holder Luye Pharma Ltd. 40 Occam Road Guildford, GU2 7YG UK
- Instruction Authorisation Number
- 8. Marketing authorisation number(s) PLGB 50827/0034
- Instruction Authorisation Date
- 9. Date of first authorisation/renewal of the authorisation 25/11/2024
- Instruction Composition
- 2. Qualitative and quantitative composition Each patch releases 4 mg of rotigotine per 24 hours. Each patch of 18.4cm2 contains 7.36 mg of rotigotine. For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- 3. Pharmaceutical form Transdermal patch. Thin, matrix-type, rectangular patch with rounded edges. The outside of the backing film is tan-coloured and imprinted with 'Rotigotine 4 mg/24 h'.
- Instruction Clinical Particulars
- 4. Clinical particulars 4.1 Therapeutic indications Rotigotine Luye is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or 'on-off' fluctuations). 4.2 Posology and method of administration Posology The dose recommendations made are in nominal dose. Dosing in patients with early-stage Parkinson's disease: A single daily dose should be initiated at 2 mg/24 h and then increased in weekly increments of 2 mg/24 h to an effective dose up to a maximum dose of 8 mg/24 h. 4 mg/24 h may be an effective dose in some patients. For most patients an effective dose is reached within 3 or 4 weeks at doses of 6 mg/24 h or 8 mg/24 h, respectively. The maximum dose is 8 mg/24 h. Dosing in patients with advanced stage Parkinson's disease with fluctuations: A single daily dose should be initiated at 4 mg/24 h and then increased in weekly increments of 2 mg/24 h to an effective dose up to a maximum dose of 16 mg/24 h. 4 mg/24 h or 6 mg/24 h may be effective doses in some patients. For most patients an effective dose is reached within 3 to 7 weeks at doses of 8 mg/24 h up to a maximum dose of 16 mg/24 h. For doses higher than 8 mg/24 h multiple patches may be used to achieve the final dose e.g. 10 mg/24 h may be reached by combination of a 6 mg/24 h and a 4 mg/24 h patch. Rotigotine Luye is applied once a day. The patch should be applied at approximately the same time every day. The patch remains on the skin for 24 hours and will then be replaced by a new one at a different site of application. If the patient forgets to apply the patch at the usual time of the day or if the patch becomes detached, another patch should be applied for the remainder of the day. Treatment discontinuation Rotigotine Luye should be discontinued gradually. The daily dose should be reduced in steps of 2 mg/24 h with a dose reduction preferably every other day, until complete withdrawal of Rotigotine Luye (see section 4.4). Special populations Hepatic impairment Adjustment of the dose is not necessary in patients with mild to moderate hepatic impairment. Caution is advised when treating patients with severe hepatic impairment, which may result in lower rotigotine clearance. Rotigotine has not been investigated in this patient group. A dose reduction might be needed in case of worsening of the hepatic impairment. Renal impairment Adjustment of the dose is not necessary in patients with mild to severe renal impairment, including those requiring dialysis. Unexpected accumulation of rotigotine levels may also occur at acute worsening of renal function (see section
- Instruction Pharmacology
- 5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Anti-parkinson drugs, dopamine agonists; ATC code: N04BC09 Rotigotine is a non-ergolinic dopamine agonist for the treatment of signs and symptoms of Parkinson's disease and Restless Legs Syndrome. Mechanism of action Rotigotine is believed to elicit its beneficial effect on Parkinson's disease by activation of the D3, D2 and D1 receptors of the caudate-putamen in the brain. The precise mechanism of action of rotigotine as a treatment of RLS is unknown. It is thought that rotigotine may exert its activity mainly via dopamine receptors. Pharmacodynamic effects Regarding the functional activity at the various receptor subtypes and their distribution in the brain, rotigotine is a D2 and D3 receptor agonist acting also on D1, D4 and D5 receptors. With non-dopaminergic receptors, rotigotine showed antagonism at alpha2B and agonism at 5HT1A receptors, but no activity on the 5HT2B receptor. Clinical efficacy and safety The effectiveness of rotigotine in the treatment of the signs and symptoms of idiopathic Parkinson's disease was evaluated in a multinational drug development program consisting of four pivotal, parallel, randomized, double-blind placebo controlled studies and three studies investigating specific aspects of Parkinson's disease. Two pivotal trials (SP512 Part I and SP513 Part I) investigating the effectiveness of rotigotine in the treatment of the signs and symptoms of idiopathic Parkinson's disease were conducted in patients who were not receiving concomitant dopamine agonist therapy and were either L-dopa naïve or previous L-dopa treatment was ≤ 6 months. The primary outcome assessment was the score for the Activities of Daily Living (ADL) component (Part II) plus the Motor Examination component (Part III) of the Unified Parkinson's Disease Rating Scale (UPDRS). Efficacy was determined by the subject's response to therapy in terms of responder and absolute points improvement in the scores of ADL and Motor Examination combined (UPDRS part II+III). In the double blind study SP512 Part I, 177 patients received rotigotine and 96 patients received placebo. The patients were titrated to their optimal dose of rotigotine or placebo in weekly increments of 2 mg/24 h starting at 2 mg/24 h to a maximum dose of 6 mg/24 h. Patients in each treatment group were maintained at their optimal dose for 6 months. At the end of the maintenance treatment in 91% of the subjects in the rotigotine arm, the optimal dose was the maximal dose allowed i.e. 6 mg/24 h. An improvement of 20% was seen in 48% of the subjects receiving rotigotine and in 19% of the subjects receiving placebo (Difference 29%, CI95% 18%; 39%, p<0.0001). With rotigotine, the mean improvement in the UPDRS score (Parts II + III) was -3.98 points (baseline 29.9 points) whereas in the placebo-treated arm a worsening of 1.31 points was observed (baseline 30.0 points). The difference was 5.28 points and statistically significant (p<0.0001). In the double-blind study SP513 Part I, 213 patients received rotigotine, 227 received ropinirole and 117 patients received placebo. The patients were titrated to their optimal dose of rotigotine in weekly increments of 2 mg/24 h starting at 2 mg/24 h to a maximum dose of 8 mg/24 h over 4 weeks. In the ropinirole group, patients were titrated to their optimal dose up to a maximum of 24 mg/day over 13 weeks. Patients in each treatment group were maintained for 6 months. At the end of the maintenance treatment in 92% of the subjects in the rotigotine arm, the optimal dose was the maximal dose allowed i.e. 8 mg/24 h. An improvement of 20% was seen in 52% of the subjects receiving rotigotine, 68% of the subjects receiving ropinirole and 30% of the subjects receiving placebo (Difference rotigotine versus placebo 21.7%, CI95% 11.1%; 32.4%, difference ropinirole versus placebo 38.4%, CI95% 28.1%; 48.6%, difference ropinirole versus rotigotine 1
- Instruction Pharmaceutical Particulars
- 6. Pharmaceutical particulars 6.1 List of excipients Backing film: Pigmented polyethylene aluminium vapor coated polyester, orange printing ink Matrix layer, containing the active substance: tocopherol paraffin povidone K90 silicone adhesive Release liner: polyester film, fluorosilicone coated Cover sheet: polyester film, fluorosilicone coated 6.2 Incompatibilities Not applicable. 6.3 Shelf life 2 years 6.4 Special precautions for storage This medicinal product does not require any special storage conditions. 6.5 Nature and contents of container Peel off sachet: one side is composed of an ethylene copolymer (innermost layer), an aluminium foil, low density polyethylene film and paper; the other side is composed of polyethylene (innermost layer), aluminium, ethylene copolymer and paper. The box contains 7, 14, 28, 30 or 84 (multipack containing 3 packs of 28) transdermal patches, individually sealed in sachets. Not all pack sizes may be marketed. 6.6 Special precautions for disposal and other handling After use the patch still contains active substance. After removal, the used patch should be folded in half, adhesive side inwards so that the matrix layer is not exposed, placed in the original sachet and then discarded. Any used or unused patches should be disposed of in accordance with local requirements or returned to the pharmacy.
- Instruction Content
- ## Composition
2. Qualitative and quantitative composition Each patch releases 4 mg of rotigotine per 24 hours. Each patch of 18.4cm2 contains 7.36 mg of rotigotine. For the full list of excipients, see section 6.1.
## Pharmaceutical Form
3. Pharmaceutical form Transdermal patch. Thin, matrix-type, rectangular patch with rounded edges. The outside of the backing film is tan-coloured and imprinted with 'Rotigotine 4 mg/24 h'.
## Clinical Particulars
4. Clinical particulars 4.1 Therapeutic indications Rotigotine Luye is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or 'on-off' fluctuations). 4.2 Posology and method of administration Posology The dose recommendations made are in nominal dose. Dosing in patients with early-stage Parkinson's disease: A single daily dose should be initiated at 2 mg/24 h and then increased in weekly increments of 2 mg/24 h to an effective dose up to a maximum dose of 8 mg/24 h. 4 mg/24 h may be an effective dose in some patients. For most patients an effective dose is reached within 3 or 4 weeks at doses of 6 mg/24 h or 8 mg/24 h, respectively. The maximum dose is 8 mg/24 h. Dosing in patients with advanced stage Parkinson's disease with fluctuations: A single daily dose should be initiated at 4 mg/24 h and then increased in weekly increments of 2 mg/24 h to an effective dose up to a maximum dose of 16 mg/24 h. 4 mg/24 h or 6 mg/24 h may be effective doses in some patients. For most patients an effective dose is reached within 3 to 7 weeks at doses of 8 mg/24 h up to a maximum dose of 16 mg/24 h. For doses higher than 8 mg/24 h multiple patches may be used to achieve the final dose e.g. 10 mg/24 h may be reached by combination of a 6 mg/24 h and a 4 mg/24 h patch. Rotigotine Luye is applied once a day. The patch should be applied at approximately the same time every day. The patch remains on the skin for 24 hours and will then be replaced by a new one at a different site of application. If the patient forgets to apply the patch at the usual time of the day or if the patch becomes detached, another patch should be applied for the remainder of the day. Treatment discontinuation Rotigotine Luye should be discontinued gradually. The daily dose should be reduced in steps of 2 mg/24 h with a dose reduction preferably every other day, until complete withdrawal of Rotigotine Luye (see section 4.4). Special populations Hepatic impairment Adjustment of the dose is not necessary in patients with mild to moderate hepatic impairment. Caution is advised when treating patients with severe hepatic impairment, which may result in lower rotigotine clearance. Rotigotine has not been investigated in this patient group. A dose reduction might be needed in case of worsening of the hepatic impairment. Renal impairment Adjustment of the dose is not necessary in patients with mild to severe renal impairment, including those requiring dialysis. Unexpected accumulation of rotigotine levels may also occur at acute worsening of renal function (see section
## Pharmacological Properties
5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Anti-parkinson drugs, dopamine agonists; ATC code: N04BC09 Rotigotine is a non-ergolinic dopamine agonist for the treatment of signs and symptoms of Parkinson's disease and Restless Legs Syndrome. Mechanism of action Rotigotine is believed to elicit its beneficial effect on Parkinson's disease by activation of the D3, D2 and D1 receptors of the caudate-putamen in the brain. The precise mechanism of action of rotigotine as a treatment of RLS is unknown. It is thought that rotigotine may exert its activity mainly via dopamine receptors. Pharmacodynamic effects Regarding the functional activity at the various receptor subtypes and their distribution in the brain, rotigotine is a D2 and D3 receptor agonist acting also on D1, D4 and D5 receptors. With non-dopaminergic receptors, rotigotine showed antagonism at alpha2B and agonism at 5HT1A receptors, but no activity on the 5HT2B receptor. Clinical efficacy and safety The effectiveness of rotigotine in the treatment of the signs and symptoms of idiopathic Parkinson's disease was evaluated in a multinational drug development program consisting of four pivotal, parallel, randomized, double-blind placebo controlled studies and three studies investigating specific aspects of Parkinson's disease. Two pivotal trials (SP512 Part I and SP513 Part I) investigating the effectiveness of rotigotine in the treatment of the signs and symptoms of idiopathic Parkinson's disease were conducted in patients who were not receiving concomitant dopamine agonist therapy and were either L-dopa naïve or previous L-dopa treatment was ≤ 6 months. The primary outcome assessment was the score for the Activities of Daily Living (ADL) component (Part II) plus the Motor Examination component (Part III) of the Unified Parkinson's Disease Rating Scale (UPDRS). Efficacy was determined by the subject's response to therapy in terms of responder and absolute points improvement in the scores of ADL and Motor Examination combined (UPDRS part II+III). In the double blind study SP512 Part I, 177 patients received rotigotine and 96 patients received placebo. The patients were titrated to their optimal dose of rotigotine or placebo in weekly increments of 2 mg/24 h starting at 2 mg/24 h to a maximum dose of 6 mg/24 h. Patients in each treatment group were maintained at their optimal dose for 6 months. At the end of the maintenance treatment in 91% of the subjects in the rotigotine arm, the optimal dose was the maximal dose allowed i.e. 6 mg/24 h. An improvement of 20% was seen in 48% of the subjects receiving rotigotine and in 19% of the subjects receiving placebo (Difference 29%, CI95% 18%; 39%, p<0.0001). With rotigotine, the mean improvement in the UPDRS score (Parts II + III) was -3.98 points (baseline 29.9 points) whereas in the placebo-treated arm a worsening of 1.31 points was observed (baseline 30.0 points). The difference was 5.28 points and statistically significant (p<0.0001). In the double-blind study SP513 Part I, 213 patients received rotigotine, 227 received ropinirole and 117 patients received placebo. The patients were titrated to their optimal dose of rotigotine in weekly increments of 2 mg/24 h starting at 2 mg/24 h to a maximum dose of 8 mg/24 h over 4 weeks. In the ropinirole group, patients were titrated to their optimal dose up to a maximum of 24 mg/day over 13 weeks. Patients in each treatment group were maintained for 6 months. At the end of the maintenance treatment in 92% of the subjects in the rotigotine arm, the optimal dose was the maximal dose allowed i.e. 8 mg/24 h. An improvement of 20% was seen in 52% of the subjects receiving rotigotine, 68% of the subjects receiving ropinirole and 30% of the subjects receiving placebo (Difference rotigotine versus placebo 21.7%, CI95% 11.1%; 32.4%, difference ropinirole versus placebo 38.4%, CI95% 28.1%; 48.6%, difference ropinirole versus rotigotine 1
## Pharmaceutical Particulars
6. Pharmaceutical particulars 6.1 List of excipients Backing film: Pigmented polyethylene aluminium vapor coated polyester, orange printing ink Matrix layer, containing the active substance: tocopherol paraffin povidone K90 silicone adhesive Release liner: polyester film, fluorosilicone coated Cover sheet: polyester film, fluorosilicone coated 6.2 Incompatibilities Not applicable. 6.3 Shelf life 2 years 6.4 Special precautions for storage This medicinal product does not require any special storage conditions. 6.5 Nature and contents of container Peel off sachet: one side is composed of an ethylene copolymer (innermost layer), an aluminium foil, low density polyethylene film and paper; the other side is composed of polyethylene (innermost layer), aluminium, ethylene copolymer and paper. The box contains 7, 14, 28, 30 or 84 (multipack containing 3 packs of 28) transdermal patches, individually sealed in sachets. Not all pack sizes may be marketed. 6.6 Special precautions for disposal and other handling After use the patch still contains active substance. After removal, the used patch should be folded in half, adhesive side inwards so that the matrix layer is not exposed, placed in the original sachet and then discarded. Any used or unused patches should be disposed of in accordance with local requirements or returned to the pharmacy.
- Company Detail Path
- /organization/luye-pharma
