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Dhivy

CARBIDOPA LEVODOPA

Standard Dose

2 DOSAGE AND ADMINISTRATION Evaluate vitamin B6 levels prior to starting treatment with carbidopa/levodopa therapies. ( 2.1 ) The recommended starting dosage of DHIVY is one 25 mg /100 mg tablet taken orally three times a day. ( 2.2 ) Dosage may be increased by up to one whole tablet every day or every other day, as needed, until a maximum dosage of eight whole tablets of DHIVY a day is reached. ( 2.2 ) Swallow DHIVY with or without food. ( 2.4 ) 2.1 Management of Vitamin B6 Levels Evaluate vitamin B6 levels prior to initiating treatment with carbidopa-levodopa therapies including DHIVY, periodically during treatment, and as clinically indicated [see Warnings and Precautions ( 5.7 )] . If vitamin B6 levels are low, supplement to sufficient levels per standard of care. Patients may initiate and continue treatment with DHIVY while supplementing vitamin B6. 2.2 Initial Dosage and Maintenance of Therapy The recommended starting dosage of DHIVY is one 25 mg / 100 mg tablet taken orally three times a day. This dosage schedule provides 75 mg of carbidopa per day. Dosage may be increased by up to one whole tablet every day or every other day, as needed to a maximum daily dosage of eight whole tablets. Dosing with DHIVY should be individualized and adjusted according to clinical response and tolerability. The tablet is functionally scored to facilitate dose adjustment. At least 70 mg to 100 mg of carbidopa per day should be provided. Experience with total daily dosages of carbidopa greater than 200 mg is limited. Monitor patients closely during the dose adjustment period. Specifically, involuntary movements may occur with DHIVY, which may require dosage reduction. Blepharospasm may be a useful early sign of excess dosage in some patients. Maintain patients on the lowest dosage required to achieve symptomatic control and to minimize adverse reactions, such as dyskinesia and nausea. 2.3 Discontinuation of DHIVY Avoid sudden discontinuation or rapid dose reduction of DHIVY. The daily dosage of DHIVY should be tapered at the time of treatment discontinuation [see Warnings and Precautions ( 5.2 ) ] . If general anesthesia is required, DHIVY may be continued as long as the patient is permitted to take fluids and medication by mouth. If therapy is interrupted temporarily, the patient should be observed for symptoms resembling neuroleptic malignant syndrome, and the usual daily dosage may be administered as soon as the patient is able to take oral medication. 2.4 Administration Information Swallow DHIVY with or without food. The patient should be advised that a change in diet to foods that are high in protein may delay the absorption of levodopa and may reduce the amount taken up in the circulation. Excessive acidity also delays stomach emptying, thus delaying the absorption of levodopa. If the patient has difficulty swallowing the tablet due to its size, the tablet can be broken at the score lines.

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE DHIVY is indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.

Summary

DHIVY is a combination of carbidopa (an aromatic amino acid decarboxylation inhibitor) and levodopa (an aromatic amino acid) indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Evaluate vitamin B6 levels prior to starting treatment with carbidopa/levodopa therapies. ( 2.1 ) The recommended starting dosage of DHIVY is one 25 mg /100 mg tablet taken orally three times a day. ( 2.2 ) Dosage may be increased by up to one whole tablet every day or every other day, as needed, until a maximum dosage of eight whole tablets of DHIVY a day is reached. ( 2.2 ) Swallow DHIVY with or without food. ( 2.4 ) 2.1 Management of Vitamin B6 Levels Evaluate vitamin B6 levels prior to initiating treatment with carbidopa-levodopa therapies including DHIVY, periodically during treatment, and as clinically indicated [see Warnings and Precautions ( 5.7 )] .

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE DHIVY is indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. DHIVY is a combination of carbidopa (an aromatic amino acid decarboxylation inhibitor) and levodopa (an aromatic amino acid) indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Evaluate vitamin B6 levels prior to starting treatment with carbidopa/levodopa therapies. ( 2.1 ) The recommended starting dosage of DHIVY is one 25 mg /100 mg tablet taken orally three times a day. ( 2.2 ) Dosage may be increased by up to one whole tablet every day or every other day, as needed, until a maximum dosage of eight whole tablets of DHIVY a day is reached. ( 2.2 ) Swallow DHIVY with or without food. ( 2.4 ) 2.1 Management of Vitamin B6 Levels Evaluate vitamin B6 levels prior to initiating treatment with carbidopa-levodopa therapies including DHIVY, periodically during treatment, and as clinically indicated [see Warnings and Precautions ( 5.7 )] . If vitamin B6 levels are low, supplement to sufficient levels per standard of care. Patients may initiate and continue treatment with DHIVY while supplementing vitamin B6. 2.2 Initial Dosage and Maintenance of Therapy The recommended starting dosage of DHIVY is one 25 mg / 100 mg tablet taken orally three times a day. This dosage schedule provides 75 mg of carbidopa per day. Dosage may be increased by up to one whole tablet every day or every other day, as needed to a maximum daily dosage of eight whole tablets. Dosing with DHIVY should be individualized and adjusted according to clinical response and tolerability. The tablet is functionally scored to facilitate dose adjustment. At least 70 mg to 100 mg of carbidopa per day should be provided. Experience with total daily dosages of carbidopa greater than 200 mg is limited. Monitor patients closely during the dose adjustment period. Specifically, involuntary movements may occur with DHIVY, which may require dosage reduction. Blepharospasm may be a useful early sign of excess dosage in some patients. Maintain patients on the lowest dosage required to achieve symptomatic control and to minimize adverse reactions, such as dyskinesia and nausea. 2.3 Discontinuation of DHIVY Avoid sudden discontinuation or rapid dose reduction of DHIVY. The daily dosage of DHIVY should be tapered at the time of treatment discontinuation [see Warnings and Precautions ( 5.2 ) ] . If general anesthesia is required, DHIVY may be continued as long as the patient is permitted to take fluids and medication by mouth. If therapy is interrupted temporarily, the patient should be observed for symptoms resembling neuroleptic malignant syndrome, and the usual daily dosage may be administered as soon as the patient is able to take oral medication. 2.4 Administration Information Swallow DHIVY with or without food. The patient should be advised that a change in diet to foods that are high in protein may delay the absorption of levodopa and may reduce the amount taken up in the circulation. Excessive acidity also delays stomach emptying, thus delaying the absorption of levodopa. If the patient has difficulty swallowing the tablet due to its size, the tablet can be broken at the score lines. Warnings and cautions 5 WARNINGS AND PRECAUTIONS May cause falling asleep during activities of daily living ( 5.1 ) Avoid sudden discontinuation or rapid dose reduction to reduce the risk of withdrawal-emergent hyperpyrexia and confusion ( 5.2 ) Cardiovascular Ischemic Events: Monitor patients with a history of cardiovascular disease ( 5.3 ) Hallucinations/Psychosis may occur ( 5.4 ) Impulse Control/Compulsive Behaviors: Consider dose reduction or stopping DHIVY if impulse control disorders occur ( 5.5 ) May cause or exacerbate dyskinesia: Consider dose reduction ( 5.6 ) 5.1 Falling Asleep During Activities of Daily Living and Somnolence Patients taking carbidopa/levodopa alone or with other dopaminergic drugs have reported suddenly falling asleep without prior warning of sleepiness while engaged in activities of daily living, including the operation of motor vehicles which have resulted in accidents. Although many patients reported somnolence while on dopaminergic medications, some perceived that they had no warning signs (sleep attack), such as excessive drowsiness, and believed that they were alert immediately prior to the event. Sudden onset of sleep has been reported to occur more than one year after the initiation of treatment. It has been reported that falling asleep while engaged in activities of daily living usually occurs in a setting of pre-existing somnolence, although some patients may not give such a history. For this reason, prescribers shoul

Monitoring

• 5 WARNINGS AND PRECAUTIONS May cause falling asleep during activities of daily living ( 5.1 ) Avoid sudden discontinuation or rapid dose reduction to reduce the risk of withdrawal-emergent hyperpyrexia and confusion ( 5.2 ) Cardiovascular Ischemic Events: Monitor patients with a history of cardiovascular disease ( 5.3 ) Hallucinations/Psychosis may occur ( 5.4 ) Impulse Control/Compulsive Behaviors: Consider dose reduction or stopping DHIVY if impulse control disorders occur ( 5.5 ) May cause or exacerbate dyskinesia: Consider dose reduction ( 5.6 ) 5.1 Falling Asleep During Activities of Daily Living and Somnolence Patients taking carbidopa/levodopa alone or with other dopaminergic drugs have reported suddenly falling asleep without prior warning of sleepiness while engaged in activities of daily living, including the operation of motor vehicles which have resulted in accidents.
• Although many patients reported somnolence while on dopaminergic medications, some perceived that they had no warning signs (sleep attack), such as excessive drowsiness, and believed that they were alert immediately prior to the event.
• Sudden onset of sleep has been reported to occur more than one year after the initiation of treatment.
• It has been reported that falling asleep while engaged in activities of daily living usually occurs in a setting of pre-existing somnolence, although some patients may not give such a history.

Interaction Notes

• 7 DRUG INTERACTIONS Iron salts and dopamine D2 antagonists including metoclopramide: May reduce the effectiveness of DHIVY ( 7.2 , 7.3 ) 7.1 Monoamine Oxidase (MAO) Inhibitors The use of nonselective MAO inhibitors with DHIVY is contraindicated [see Contraindications ( 4 ) ] .
• Discontinue use of any nonselective MAO inhibitors at least two weeks prior to initiating DHIVY.
• DHIVY may be administered concomitantly with the manufacturer's recommended dose of selective MAO-B inhibitors (e.g., rasagiline or selegiline HCl).
• Concomitant therapy with selegiline and carbidopa/levodopa may be associated with severe orthostatic hypotension not attributable to carbidopa/levodopa alone.