VYALEV (foslevodopa/foscarbidopa solution) is indicated for the treatment of motor fluctuations in patients with advanced levodopa-responsive Parkinson’s disease who do not have satisfactory control of severe, debilitating motor fluctuations and hyper- /dyskinesia despite optimized treatment with available combinations of Parkinson’s medicinal products.
VYALEV should only be prescribed by neurologists who are experienced in the treatment of patients with Parkinson’s disease.
The recommended starting infusion rate of VYALEV is determined by calculating the LE from all levodopa-containing medications and COMT-inhibitors taken during daytime hours and then increasing it to account for a 24-hour administration. The dose may be adjusted to reach a clinical response that maximizes the functional “On” time and minimizes the number and duration of “Off” episodes and “On” episodes with troublesome dyskinesia. The lowest efficacious dose should be used to minimize the risk of adverse events. The maximum recommended daily dose of foslevodopa is 6000 mg (or 25mL of VYALEV per day equivalent to approximately 4260 mg levodopa per day). Note that a limited number of patients were exposed to daily doses higher than 4000 mg of foslevodopa.
VYALEV replaces levodopa-containing medications and COMT-inhibitors. If required, other classes of medicinal products for Parkinson’s disease can be taken concurrently.
VYALEV (foslevodopa/foscarbidopa solution) is indicated for the treatment of motor fluctuations in patients with advanced levodopa-responsive Parkinson’s disease who do not have satisfactory control of severe, debilitating motor fluctuations and hyper- /dyskinesia despite optimized treatment with available combinations of Parkinson’s medicinal products.
VYALEV should only be prescribed by neurologists who are experienced in the treatment of patients with Parkinson’s disease.
The recommended starting infusion rate of VYALEV is determined by calculating the LE from all levodopa-containing medications and COMT-inhibitors taken during daytime hours and then increasing it to account for a 24-hour administration. The dose may be adjusted to reach a clinical response that maximizes the functional “On” time and minimizes the number and duration of “Off” episodes and “On” episodes with troublesome dyskinesia. The lowest efficacious dose should be used to minimize the risk of adverse events. The maximum recommended daily dose of foslevodopa is 6000 mg (or 25mL of VYALEV per day equivalent to approximately 4260 mg levodopa per day). Note that a limited number of patients were exposed to daily doses higher than 4000 mg of foslevodopa.
VYALEV replaces levodopa-containing medications and COMT-inhibitors. If required, other classes of medicinal products for Parkinson’s disease can be taken concurrently.
Reference:
1. VYALEV Product Monograph. AbbVie Corporation.
CA-VYAL-230052 / MA24
Indication and clinical use:
VYALEV is indicated for the treatment of motor fluctuations in patients with advanced levodopa-responsive Parkinson’s disease who do not have satisfactory control of severe, debilitating motor fluctuations and hyper- /dyskinesia despite optimized treatment with available combinations of Parkinson’s medicinal products.
VYALEV should only be prescribed by neurologists who are experienced in the treatment of patients with Parkinson’s disease.
The safety and efficacy of VYALEV in patients under 18 years of age have not been evaluated; therefore, Health Canada has not authorized an indication for pediatric use.
Contraindications:
•Hypersensitivity to levodopa or carbidopa.
•Narrow-angle glaucoma.
•Clinical or laboratory evidence of uncompensated cardiovascular, cerebrovascular, endocrine, renal, hepatic, hematologic or pulmonary disease (including bronchial asthma).
•Concomitant use of non-selective monoamine oxidase (MAO) inhibitors and selective MAO type A inhibitors. These inhibitors must be discontinued at least two weeks prior to initiating therapy with VYALEV. VYALEV may be administered concomitantly with the manufacturer’s recommended dose of a MAO inhibitor with selectivity for MAO type B (e.g., selegiline hydrochloride).
•Undiagnosed skin lesions or a history of melanoma because levodopa may activate a malignant melanoma.
•Concomitant administration of a sympathomimetic amine (e.g., epinephrine, norepinephrine, isoproterenol).
•Conditions in which medication with adrenergic activity are contraindicated (e.g., pheochromocytoma, hyperthyroidism and Cushing’s syndrome).
Most serious warnings and precautions:
Sudden Onset of Sleep: patients receiving treatment with levodopa and other dopaminergic agents have reported suddenly falling asleep while engaged in activities of daily living, including driving a car, which has sometimes resulted in accidents. Some patients report somnolence while on levodopa, while others perceived no warning signs, such as excessive drowsiness. Alert patients to the sudden onset of sleep, which is not limited to initiation of therapy and can occur without warning signs. Ask patients about factors that may increase the risk with VYALEV, such as concomitant medications or the presence of sleep disorders. Caution patients about the risk of operating hazardous machinery, including driving motor vehicles. If drowsiness or sudden onset of sleep should occur, patients should immediately contact their physician.
Episodes of falling asleep while engaged in activities of daily living have also been reported in patients taking other dopaminergic agents; therefore, symptoms may not be alleviated by substituting these products.
Dose reduction reduces the degree of somnolence; however, there is insufficient information to establish that dose reduction will eliminate sudden onset of sleep while engaged in activities of daily living.
Infusion Site Reactions and Infections: a high proportion of patients have developed infusion site reactions and infections during clinical development and on multiple occasions for some of them. In a few patients, infusion site cellulitis or abscess led to sepsis which required hospitalization. Sepsis can potentially be life-threatening and must be recognized and treated in a timely manner. Refer to the Patient educational material (Patient Guide) for proper use of VYALEV.
Other relevant warnings and precautions:
•Carcinogenesis and mutagenesis
•History of myocardial infarction or atrial nodal or ventricular arrythmias
•Orthostatic hypotension
•Operation of motor vehicles or machinery
•History of peptic ulcer disease
•Monitoring and laboratory tests to periodically evaluate hepatic, hematopoietic, cardiovascular, and renal function, and blood pressure in patients receiving antihypertensive medication
•Plasma concentrations of vitamin B12, vitamin B6, homocysteine, methylmalonic acid and folic acid should be obtained at baseline and at regular intervals
•History of seizures, conditions associated with seizure or lowered seizure threshold
•Polyneuropathy
•Neuroleptic malignant syndrome
•Chronic wide-angle glaucoma
•Past or current psychosis
•Depression
•Hallucinations
•Impulse control, compulsive behaviours and dopamine dysregulation syndrome
•Infusion site reactions and infections
•Melanoma
•Pregnant women
•Should not be used during breastfeeding
For more information:
Please consult the Product Monograph at http://abbv.ie/VyalevCanadaPM_EN for important information relating to adverse reactions, drug interactions and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-888-704-8271.
Indication and clinical use:
VYALEV is indicated for the treatment of motor fluctuations in patients with advanced levodopa-responsive Parkinson’s disease who do not have satisfactory control of severe, debilitating motor fluctuations and hyper- /dyskinesia despite optimized treatment with available combinations of Parkinson’s medicinal products.
VYALEV should only be prescribed by neurologists who are experienced in the treatment of patients with Parkinson’s disease.
The safety and efficacy of VYALEV in patients under 18 years of age have not been evaluated; therefore, Health Canada has not authorized an indication for pediatric use.
Contraindications:
•Hypersensitivity to levodopa or carbidopa.
•Narrow-angle glaucoma.
•Clinical or laboratory evidence of uncompensated cardiovascular, cerebrovascular, endocrine, renal, hepatic, hematologic or pulmonary disease (including bronchial asthma).
•Concomitant use of non-selective monoamine oxidase (MAO) inhibitors and selective MAO type A inhibitors. These inhibitors must be discontinued at least two weeks prior to initiating therapy with VYALEV. VYALEV may be administered concomitantly with the manufacturer’s recommended dose of a MAO inhibitor with selectivity for MAO type B (e.g., selegiline hydrochloride).
•Undiagnosed skin lesions or a history of melanoma because levodopa may activate a malignant melanoma.
•Concomitant administration of a sympathomimetic amine (e.g., epinephrine, norepinephrine, isoproterenol).
•Conditions in which medication with adrenergic activity are contraindicated (e.g., pheochromocytoma, hyperthyroidism and Cushing’s syndrome).
Most serious warnings and precautions:
Sudden Onset of Sleep: patients receiving treatment with levodopa and other dopaminergic agents have reported suddenly falling asleep while engaged in activities of daily living, including driving a car, which has sometimes resulted in accidents. Some patients report somnolence while on levodopa, while others perceived no warning signs, such as excessive drowsiness. Alert patients to the sudden onset of sleep, which is not limited to initiation of therapy and can occur without warning signs. Ask patients about factors that may increase the risk with VYALEV, such as concomitant medications or the presence of sleep disorders. Caution patients about the risk of operating hazardous machinery, including driving motor vehicles. If drowsiness or sudden onset of sleep should occur, patients should immediately contact their physician.
Episodes of falling asleep while engaged in activities of daily living have also been reported in patients taking other dopaminergic agents; therefore, symptoms may not be alleviated by substituting these products.
Dose reduction reduces the degree of somnolence; however, there is insufficient information to establish that dose reduction will eliminate sudden onset of sleep while engaged in activities of daily living.
Infusion Site Reactions and Infections: a high proportion of patients have developed infusion site reactions and infections during clinical development and on multiple occasions for some of them. In a few patients, infusion site cellulitis or abscess led to sepsis which required hospitalization. Sepsis can potentially be life-threatening and must be recognized and treated in a timely manner. Refer to the Patient educational material (Patient Guide) for proper use of VYALEV.
Other relevant warnings and precautions:
•Carcinogenesis and mutagenesis
•History of myocardial infarction or atrial nodal or ventricular arrythmias
•Orthostatic hypotension
•Operation of motor vehicles or machinery
•History of peptic ulcer disease
•Monitoring and laboratory tests to periodically evaluate hepatic, hematopoietic, cardiovascular, and renal function, and blood pressure in patients receiving antihypertensive medication
•Plasma concentrations of vitamin B12, vitamin B6, homocysteine, methylmalonic acid and folic acid should be obtained at baseline and at regular intervals
•History of seizures, conditions associated with seizure or lowered seizure threshold
•Polyneuropathy
•Neuroleptic malignant syndrome
•Chronic wide-angle glaucoma
•Past or current psychosis
•Depression
•Hallucinations
•Impulse control, compulsive behaviours and dopamine dysregulation syndrome
•Infusion site reactions and infections
•Melanoma
•Pregnant women
•Should not be used during breastfeeding
For more information:
Please consult the Product Monograph at http://abbv.ie/VyalevCanadaPM_EN for important information relating to adverse reactions, drug interactions and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-888-704-8271.
Indication and clinical use:
VYALEV is indicated for the treatment of motor fluctuations in patients with advanced levodopa-responsive Parkinson’s disease who do not have satisfactory control of severe, debilitating motor fluctuations and hyper- /dyskinesia despite optimized treatment with available combinations of Parkinson’s medicinal products.
VYALEV should only be prescribed by neurologists who are experienced in the treatment of patients with Parkinson’s disease.
The safety and efficacy of VYALEV in patients under 18 years of age have not been evaluated; therefore, Health Canada has not authorized an indication for pediatric use.
Contraindications:
•Hypersensitivity to levodopa or carbidopa.
•Narrow-angle glaucoma.
•Clinical or laboratory evidence of uncompensated cardiovascular, cerebrovascular, endocrine, renal, hepatic, hematologic or pulmonary disease (including bronchial asthma).
•Concomitant use of non-selective monoamine oxidase (MAO) inhibitors and selective MAO type A inhibitors. These inhibitors must be discontinued at least two weeks prior to initiating therapy with VYALEV. VYALEV may be administered concomitantly with the manufacturer’s recommended dose of a MAO inhibitor with selectivity for MAO type B (e.g., selegiline hydrochloride).
•Undiagnosed skin lesions or a history of melanoma because levodopa may activate a malignant melanoma.
•Concomitant administration of a sympathomimetic amine (e.g., epinephrine, norepinephrine, isoproterenol).
•Conditions in which medication with adrenergic activity are contraindicated (e.g., pheochromocytoma, hyperthyroidism and Cushing’s syndrome).
Most serious warnings and precautions:
Sudden Onset of Sleep: patients receiving treatment with levodopa and other dopaminergic agents have reported suddenly falling asleep while engaged in activities of daily living, including driving a car, which has sometimes resulted in accidents. Some patients report somnolence while on levodopa, while others perceived no warning signs, such as excessive drowsiness. Alert patients to the sudden onset of sleep, which is not limited to initiation of therapy and can occur without warning signs. Ask patients about factors that may increase the risk with VYALEV, such as concomitant medications or the presence of sleep disorders. Caution patients about the risk of operating hazardous machinery, including driving motor vehicles. If drowsiness or sudden onset of sleep should occur, patients should immediately contact their physician.
Episodes of falling asleep while engaged in activities of daily living have also been reported in patients taking other dopaminergic agents; therefore, symptoms may not be alleviated by substituting these products.
Dose reduction reduces the degree of somnolence; however, there is insufficient information to establish that dose reduction will eliminate sudden onset of sleep while engaged in activities of daily living.
Infusion Site Reactions and Infections: a high proportion of patients have developed infusion site reactions and infections during clinical development and on multiple occasions for some of them. In a few patients, infusion site cellulitis or abscess led to sepsis which required hospitalization. Sepsis can potentially be life-threatening and must be recognized and treated in a timely manner. Refer to the Patient educational material (Patient Guide) for proper use of VYALEV.
Other relevant warnings and precautions:
•Carcinogenesis and mutagenesis
•History of myocardial infarction or atrial nodal or ventricular arrythmias
•Orthostatic hypotension
•Operation of motor vehicles or machinery
•History of peptic ulcer disease
•Monitoring and laboratory tests to periodically evaluate hepatic, hematopoietic, cardiovascular, and renal function, and blood pressure in patients receiving antihypertensive medication
•Plasma concentrations of vitamin B12, vitamin B6, homocysteine, methylmalonic acid and folic acid should be obtained at baseline and at regular intervals
•History of seizures, conditions associated with seizure or lowered seizure threshold
•Polyneuropathy
•Neuroleptic malignant syndrome
•Chronic wide-angle glaucoma
•Past or current psychosis
•Depression
•Hallucinations
•Impulse control, compulsive behaviours and dopamine dysregulation syndrome
•Infusion site reactions and infections
•Melanoma
•Pregnant women
•Should not be used during breastfeeding
For more information:
Please consult the Product Monograph at http://abbv.ie/VyalevCanadaPM_EN for important information relating to adverse reactions, drug interactions and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-888-704-8271.
Indication and clinical use:
VYALEV is indicated for the treatment of motor fluctuations in patients with advanced levodopa-responsive Parkinson’s disease who do not have satisfactory control of severe, debilitating motor fluctuations and hyper- /dyskinesia despite optimized treatment with available combinations of Parkinson’s medicinal products.
VYALEV should only be prescribed by neurologists who are experienced in the treatment of patients with Parkinson’s disease.
The safety and efficacy of VYALEV in patients under 18 years of age have not been evaluated; therefore, Health Canada has not authorized an indication for pediatric use.
Contraindications:
•Hypersensitivity to levodopa or carbidopa.
•Narrow-angle glaucoma.
•Clinical or laboratory evidence of uncompensated cardiovascular, cerebrovascular, endocrine, renal, hepatic, hematologic or pulmonary disease (including bronchial asthma).
•Concomitant use of non-selective monoamine oxidase (MAO) inhibitors and selective MAO type A inhibitors. These inhibitors must be discontinued at least two weeks prior to initiating therapy with VYALEV. VYALEV may be administered concomitantly with the manufacturer’s recommended dose of a MAO inhibitor with selectivity for MAO type B (e.g., selegiline hydrochloride).
•Undiagnosed skin lesions or a history of melanoma because levodopa may activate a malignant melanoma.
•Concomitant administration of a sympathomimetic amine (e.g., epinephrine, norepinephrine, isoproterenol).
•Conditions in which medication with adrenergic activity are contraindicated (e.g., pheochromocytoma, hyperthyroidism and Cushing’s syndrome).
Most serious warnings and precautions:
Sudden Onset of Sleep: patients receiving treatment with levodopa and other dopaminergic agents have reported suddenly falling asleep while engaged in activities of daily living, including driving a car, which has sometimes resulted in accidents. Some patients report somnolence while on levodopa, while others perceived no warning signs, such as excessive drowsiness. Alert patients to the sudden onset of sleep, which is not limited to initiation of therapy and can occur without warning signs. Ask patients about factors that may increase the risk with VYALEV, such as concomitant medications or the presence of sleep disorders. Caution patients about the risk of operating hazardous machinery, including driving motor vehicles. If drowsiness or sudden onset of sleep should occur, patients should immediately contact their physician.
Episodes of falling asleep while engaged in activities of daily living have also been reported in patients taking other dopaminergic agents; therefore, symptoms may not be alleviated by substituting these products.
Dose reduction reduces the degree of somnolence; however, there is insufficient information to establish that dose reduction will eliminate sudden onset of sleep while engaged in activities of daily living.
Infusion Site Reactions and Infections: a high proportion of patients have developed infusion site reactions and infections during clinical development and on multiple occasions for some of them. In a few patients, infusion site cellulitis or abscess led to sepsis which required hospitalization. Sepsis can potentially be life-threatening and must be recognized and treated in a timely manner. Refer to the Patient educational material (Patient Guide) for proper use of VYALEV.
Other relevant warnings and precautions:
•Carcinogenesis and mutagenesis
•History of myocardial infarction or atrial nodal or ventricular arrythmias
•Orthostatic hypotension
•Operation of motor vehicles or machinery
•History of peptic ulcer disease
•Monitoring and laboratory tests to periodically evaluate hepatic, hematopoietic, cardiovascular, and renal function, and blood pressure in patients receiving antihypertensive medication
•Plasma concentrations of vitamin B12, vitamin B6, homocysteine, methylmalonic acid and folic acid should be obtained at baseline and at regular intervals
•History of seizures, conditions associated with seizure or lowered seizure threshold
•Polyneuropathy
•Neuroleptic malignant syndrome
•Chronic wide-angle glaucoma
•Past or current psychosis
•Depression
•Hallucinations
•Impulse control, compulsive behaviours and dopamine dysregulation syndrome
•Infusion site reactions and infections
•Melanoma
•Pregnant women
•Should not be used during breastfeeding
For more information:
Please consult the Product Monograph at http://abbv.ie/VyalevCanadaPM_EN for important information relating to adverse reactions, drug interactions and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-888-704-8271.