Ulipristal (Generic ella®)

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Introduction

Ella® is an emergency contraceptive than may be taken up to five days after unprotected sex, however, the sooner you take it, the more effective it will be.

This medication is intended for patients assigned female at birth. It may be less effective in individuals weighing over 195 pounds. If you fall into this category, closely monitor your pregnancy tests, and if any test is positive, you should consult your healthcare provider about alternative treatment options. For 5 days after taking Ella, do not use any hormonal medications, including birth control, as they may reduce the effectiveness of both Ella and your contraception. Use a backup method of contraception until you have your next menstrual cycle. If you do not get your period within 2 weeks, or if you experience increased lower abdominal pain 3–5 days after taking Ella or persistent irregular bleeding, contact your healthcare provider. You should not take Ella more than once in one cycle due to limited studies on safety and efficacy.

This plan reviews the risks and benefits of the treatment we are recommending. Please make sure to read it and the manufacturer's pamphlet that comes with the medicine. The manufacturer's pamphlet contains the full information on interactions, side effects, and other important information you should know about the medicine before you start.

Instructions

You have stated that you wish to take emergency contraception pills to prevent pregnancy. ella® is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. Ella® is not intended for routine use as a contraceptive.

When to Start

Take one tablet orally as soon as possible within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure. The tablet can be taken with or without food. If vomiting occurs within 3 hours of ella® intake, consideration should be given to repeating the dose. ella® can be taken at any time during the menstrual cycle.

Refills

You may request another dose of ella® by logging into your Account (Subscriptions > Next Refill) or placing a new one-time order. If you decide to stop treatment prior to using your complete subscription please contact us for further guidance.

Active Ingredients

The ella® (ulipristal acetate) tablet for oral use contains 30 mg of a single active steroid ingredient, a synthetic progesterone agonist/antagonist.

• Ulipristal acetate
  
  

Contraindications

ella® is contraindicated for use in the case of known or suspected pregnancy. The risks to a fetus when ella is administered to a pregnant woman are unknown. If this drug is inadvertently used during pregnancy, the woman should be apprised of the potential hazard to the fetus.

We have evaluated your health history and the specific health information you provided us, however if anything changes and you develop or discover that one of these conditions applies to you please stop taking this medicine and call or message us immediately.

Pregnancy and Breastfeeding

It is not known if ulipristal acetate is excreted in human milk. 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.

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.

Emergency Side Effects

This medicine can cause dangerous and potentially life threatening side effects. If any of the emergency side effects listed in the manufacturer's pamphlet or those below happen to you please call 911 or seek immediate medical help in-person.

The most common side effects of ella® include:

• headache
• nausea
• stomach (abdominal) pain
• menstrual pain (dysmenorrhea)
• tiredness
• dizziness

Some women taking ella® may have their next period earlier or later than expected. If your period is more than a week late, you should get a pregnancy test. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ella®. For more information, ask your healthcare provider or pharmacist.

Medications, Supplements and Foods

Changes in Emergency Contraceptive Effectiveness Associated with Co-administration of Other Products. Using ella® and hormonal birth control together can decrease the effectiveness of each, so they should not be taken at the same time. If a person wishes to start or resume hormonal contraception after the intake of ella®, they should do so no sooner than 5 days after taking ella®. Additionally, a rapid return of fertility is likely, following treatment with ella®, so a reliable barrier method should be used until the next menstrual period.

Drugs or herbal products that induce enzymes, including CYP3A4, may decrease the plasma concentrations of ella®, and may decrease its effectiveness. Some drugs or herbal products that may decrease the effectiveness of ella® include:

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John’s Wort
• topiramate

We have evaluated the specific health information you provided and are making our recommendations based on it. If you forgot to provide or incorrectly provided that information we may misdiagnose or fail to diagnose conditions that you may have which could affect our recommendation for treatment. If you need to clarify or update any information about your health you can message or call us anytime.

Treatment Failure

Do not use ella® more than one time in the same menstrual cycle for different acts of unprotected sex or birth control failure.

Accepting or Declining Our Recommendation

We are recommending this treatment for you because the potential benefits of treatment outweigh the risks. You should evaluate this information as well as the manufacturer's pamphlet, and any input from your in-person healthcare team, or other relevant information to decide if this treatment plan is appropriate for you. You are free to decline our treatment recommendations.

Share with Your In-Person Healthcare Team

You can access your records anytime. We strongly recommend that you update your in-person primary care provider, pharmacist, and the rest of your healthcare team to let them know about any new medicines you are taking or other changes in your health.

You can also ask us questions anytime and we are happy to help you share any information about your health with your in-person healthcare team.

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