’s Wort
topiramate
7.2 Increase in Plasma Concentrations of ella Associated with Co-Administered Drugs
CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma concentrations of ella.
7.3 Effects of ella on Co-Administered Drugs
In vitro studies demonstrated that ella does not induce or inhibit the activity of cytochrome P450 enzymes.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category X. [See Contraindications (4).]
Use of ella is contraindicated during an existing or suspected pregnancy.
There are no adequate and well controlled studies in pregnant women.
Ulipristal acetate was administered repeatedly to pregnant rats and rabbits during the period of organogenesis. Embryofetal loss was noted in all pregnant rats and in half of the pregnant rabbits following 12 and 13 days of dosing, at daily drug exposures 1/3 and 1/2 the human exposure, respectively, based on body surface area (mg/m2). There were no malformations of the surviving fetuses in these studies. Adverse effects were not observed in the offspring of pregnant rats administered ulipristal acetate during the period of organogenesis through lactation at drug exposures 1/24 the human exposure based on AUC. Administration of ulipristal acetate to pregnant monkeys for 4 days during the first trimester caused pregnancy termination in 2/5 animals at daily drug exposures 3 times the human exposure based on body surface area.
8.3 Nursing Mothers
It is not known if ulipristal acetate is excreted in human milk. However, ulipristal acetate is detected in milk of lactating rats. Because many drugs are excreted in human milk, risk to the breast-fed child cannot be excluded. Use of ella by breastfeeding women is not recommended.
8.4 Pediatric Use
Safety and efficacy of ella have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents less than 18 years and for users 18 years and older. Use of ella before menarche is not indicated.
8.5 Geriatric Use
This product is not intended for use in postmenopausal women.
8.6 Race
While no formal studies have eva luated the effect of race, a cross-study comparison of two pharmacokinetic studies indicated that exposure in South Asians may exceed that in Caucasians and African Americans. However, no difference in efficacy and safety was observed for women of different races in clinical studies.
8.7 Hepatic Impairment
No studies have been conducted to eva luate the effect of hepatic disease on the disposition of ella.
8.8 Renal Impairment
No studies have been conducted to eva luate the effect of renal disease on the disposition of ella.
10 OVERDOSAGE
Experience with ulipristal acetate overdose is limited. In a clinical study, single doses equivalent to up to 4 times ella were administered to a limited number of subjects without any adverse reactions.
11 DESCRIPTION
The ella (ulipristal acetate) tablet for oral use contains 30 mg of a single active steroid ingredient, ulipristal acetate [17α-acetoxy-11β-(4-N,N-dimethylaminophenyl)-19-norpregna-4,9-diene-3,20-dione], a synthetic progesterone agonist/antagonist. The inactive ingredients are lactose monohydrate, povidone K-30, croscarmellose sodium and magnesium stearate.
Ulipristal acetate is a white to yellow crystalline powder which has a C30H37NO4
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
When taken imme |
