MIRAPEX®
Dosing and administration
It should be used by physician prescription.1
It may be used as monotherapy or in combination with levodopa.1
Dosing
Parkinson Disease (PD)
Immediate-release (IR)1
The tablets should be taken orally, swallowed with water, and can be taken either with or without food.1
The daily dosage is administered in equally divided doses 3x per day.1
As shown below dosages should be increased gradually from a starting dose of 0.375 mg per day and then increased every 5-7 days. Providing patients do not experience intolerable side effects, the dosage should be titrated to achieve a maximal therapeutic effect.1
| Ascending-Dose Schedule of MIRAPEX® 1 | |||
|---|---|---|---|
| week | dosage (mg) | total daily dose (mg) | |
| 1 | 3 x 0.125 | 0.375 | |
| 2 | 3 x 0.25 | 0.75 | |
| 3 | 3 x 0.5 | 1.50 | |
If a further dose increase is necessary, the daily dose should be increased by 0.75 mg at weekly intervals up to a maximum dose of 4.5 mg per day.1
Prolonged-release (PR)2
MIRAPEX® PR tablets are taken only once daily, with or without food.2
MIRAPEX® PR tablets must be swallowed whole and must not be chewed, crushed, or divided.2
The starting dose is 0.375 mg given once per day. Based on efficacy and tolerability, dosages may be increased gradually, not more frequently than every 5-7 days, first to 0.75 mg per day and then by 0.75 mg increments up to a maximum recommended dose of 4.5 mg per day.2
Restless Legs Syndrome
The IR tablets should be taken orally, swallowed with water, and can be taken either with or without food. The recommended starting dose of MIRAPEX is 0.125 mg taken once daily 2 - 3 hours before bedtime. For patients requiring additional symptomatic relief, the dose may be increased every 4 – 7 days to a maximum of 0.75 mg per day (as shown in the table below).1
| Ascending-Dose Schedule of MIRAPEX® | |||
|---|---|---|---|
| Titration Step | Once Daily Evening Dose (mg) | ||
| 1 | 0.125 | ||
| 2* | 0.25 | ||
| 3* | 0.50 | ||
| 4* | 0.75 | ||
Treatment discontinuation
MIRAPEX® tablets should be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter the dose should be reduced by 0.375 mg per day.1
MIRAPEX® can be discontinued without tapered dose reduction when treatment for restless legs syndrome.1
When discontinuing therapy with MIRAPEX® PR, taper the dose gradually over a period of one week.2
Dosage Modifications
Hepatic impairment
Dose reduction is not considered necessary in patients with hepatic impairment, as approximately 90% of absorbed drug is excreted through the kidneys1 in the urine as unchanged drug, hepatic impairment would not be expected to have a significant effect on MIRAPEX® elimination.2
Renal Impairment
PD
- IR
- creatinine clearance (CrCl) >50 mL/min: Dosage adjustment not necessary1
- CrCl 20-50 mL/min:0.125 mg twice daily initially (0.25 mg daily). A maximum daily dose of 2.25 mg should not be exceeded.1
- CrCl <20 mL/min: single dose of 0.125 mg daily. A maximum daily dose of 1.5 mg MIRAPEX® should not be exceeded1
- ESRD requiring hemodialysis: Dosage adjustment not provided in manufacturer's labeling; not studied.
- PR
- CrCl >50 mL/min: Dosage adjustment not necessary.2
- CrCl 30-50 mL/min: 0.375 every other day; may increase to 0.375 mg per day no sooner than 1 week after initiating therapy; may increase by 0.375 mg/dose not more frequently than every 7 days; not to exceed 2.25 mg per day.2
- CrCl <30 mL/min: Not recommended.2
- Patients on hemodialysis: Not recommended.2
Restless legs syndrome
- IR
- CrCl > 20 mL/min: Dosage adjustment not necessary
- CrCl < 20 mL/min: Dosage adjustment is not provided by manufacturer's labeling. The use of MIRAPEX in RLS patients with renal impairment has not been studied.1
Switching from IR MIRAPEX® Tablets to MIRAPEX® PR
Patients may be switched overnight from IR MIRAPEX® tablets to MIRAPEX® PR tablets at the same daily dose.2 When switching between immediate-release MIRAPEX® tablets and MIRAPEX® PR tablets, patients should be monitored to determine if dosage adjustment is necessary.2
Footnotes:
-
* if needed
-
CrCl, creatinine clearance; IR, immediate-release; PD, Parkinson's disease; PR, prolonged- release.
References:
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Mirapex® Tablets 0.25mg & 1.0mg. approved package insert. Approved in 08 Oct 2019.
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MIRAPEX® Prolonged-Release Tablets 0.375 mg & 0.75 mg & 1.5 mg. approved package insert. Approved in 08 Oct 2019.
