Motegrity

Motegrity is a prescription medicine used in adults to treat a type of constipation called chronic idiopathic constipation (CIC). Idiopathic means the cause of the constipation is unknown. It is not known if Motegrity is safe and effective in children.

Motegrity may cause serious side effects, including:

• unusual changes in mood or behavior, thoughts of hurting yourself, trying to hurt yourself, or suicide. Stop taking Motegrity right away and tell your healthcare provider immediately if your depression gets worse, you feel sad, hopeless or begin to have thoughts of suicide, thoughts of hurting yourself or have tried to hurt yourself.

The most common side effects of Motegrity include:

• headache
• stomach area (abdominal) pain or bloating
• nausea
• diarrhea
• dizziness
• vomiting
• gas
• fatigue

These are not all the possible side effects of Motegrity.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Motegrity can be taken with or without food. The recommended dosage by patient population is shown in Table 1.

Table 1: Recommended Dosage Regimen and Dosage Adjustments by Population

There is no information available on Motegrity drug interactions.

• Available data from case reports with prucalopride use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, major birth defects, or adverse maternal or fetal outcomes.
• In animal reproduction studies, no adverse developmental effects were observed with prucalopride administration during the period of organogenesis to pregnant rats and rabbits at doses up to approximately 390 times and 780 times, respectively, the recommended human dose of 2 mg/day.
• Prucalopride is present in breast milk. There are no data on the effects of prucalopride on the breastfed child or the effects on milk production.
• The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Motegrity and any potential adverse effects on the breastfed child from Motegrity or from the underlying maternal condition.