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Label Changes for:

Mirapex ER (pramipexole) extended-release

July 2016

Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

July 2016

ADVERSE REACTIONS

Postmarketing Experience

Addition of the following paragraph:

  • There are postmarketing reports of patients noticing tablet residue in their stool that resembles a swollen MIRAPEX ER whole tablet or swollen pieces of the tablet. Some patients have reported worsening of their Parkinson’s disease symptoms when tablet residue was observed. If a patient reports tablet residue with worsening of their Parkinson’s symptoms, prescribers may need to re-evaluate their medications.

USE IN SPECIFIC POPULATIONS

PLLR Conversion:

Pregnancy
Risk Summary
  • There are no adequate data on the developmental risk associated with the use of MIRAPEX ER in pregnant women. No adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. Effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures.
  • In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.
Data
Animal Data
  • Oral administration of pramipexole (0.1, 0.5, or 1.5 mg/kg/day) to pregnant rats during the period of organogenesis resulted in a high incidence of total resorption of embryos at the highest dose tested. This increase in embryolethality is thought to result from the prolactin-lowering effect of pramipexole; prolactin is necessary for implantation and maintenance of early pregnancy in rats but not in rabbits or humans. Because of pregnancy disruption and early embryonic loss in this study, the teratogenic potential of pramipexole could not be adequately assessed in rats. The highest no-effect dose for embryolethality in rats was associated with maternal plasma drug exposures (AUC) approximately equal to those in humans receiving the maximum recommended human dose (MRHD) of 4.5 mg/day. There were no adverse effects on embryo-fetal development following oral administration of pramipexole (0.1, 1, or 10 mg/kg/day) to pregnant rabbits during organogenesis (plasma AUC up to approximately 70 times that in humans at the MRHD). Postnatal growth was inhibited in the offspring of rats treated with pramipexole (0.1, 0.5, or 1.5 mg/kg/day) during the latter part of pregnancy and throughout lactation. The no-effect dose for adverse effects on offspring growth (0.1 mg/kg/day) was associated with maternal plasma drug esposure lower than that in humans at the MRHD.
Lactation
Risk Summary
  • There are no data on the presence of pramipexole in human milk, the effects of pramipexole on the breastfed infant, or the effects of pramipexole on milk production. However, inhibition of lactation is expected because pramipexole inhibits secretion of prolactin in humans. Pramipexole or metabolites, or both, are present in rat milk.
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for MIRAPEX ER and any potential adverse effects on the breastfed infant from MIRAPEX ER or from the underlying maternal condition.
Data
  • In a study of radiolabeled pramipexole, pramipexole or metabolites, or both, were present in rat milk at concentrations three to six times higher than those in maternal plasma.

PATIENT COUNSELING INFORMATION

Dosing Instructions
  • Addition of the following: Inform patients that residue in stool which may resemble a swollen original MIRAPEX ER tablet or swollen pieces of the original tablet have been reported. Instruct patients to contact their physician if this occurs.

PATIENT INFORMATION

How should I take MIRAPEX ER? (addition of the following)

  • You may see something that looks like a swollen original tablet or swollen pieces of the original tablet in your stool. If this happens, tell your doctor.
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