Information for
Healthcare Providers

Picture of pregnant woman

What is a registry and why is it important?

A pregnancy registry is a study that collects health information from women who take prescription medications while they are pregnant. Information is also collected on the woman’s baby over time.

Who is eligible to participate?

Patients may be eligible if they are:

  • A resident of the United States
  • Fifteen to 50 years old
  • Currently or recently pregnant and have:
    • been diagnosed with uncomplicated urinary tract infection (uUTI)
      OR
    • Taken BLUJEPA (gepotidacin) during pregnancy or just prior to pregnancy (within 1 week prior to conception)
      OR
    • Taken specific medications to treat uUTI

How do I enroll a patient?

If you have patients who you think may be eligible, you can help them enroll by having them:

Complete the Potential Participant Contact Request Form and a Registry Team member will contact them

Contact Request Form

Call the registry team toll-free at 1-877-371-0315 (hours of operation 8:30am – 5:00pm EST Monday-Friday)

Why is this study needed?

Urinary Tract conditions and their symptoms occur frequently during pregnancy.

Since pregnant women are excluded from clinical trials participation, there is limited data on the potential impact of the safety of newer medications for the treatment of uUTI during pregnancy, on pregnancy and infant outcomes.

What does participation involve?

Eligible patients and their healthcare providers will provide information to the registry about their pregnancies and the health of their infants up to 1 year of age. This information can be provided by completing paper forms, or via a short phone interview with one of the registry staff members. Only information normally documented in patients’ medical records will be collected.

There will be:

  • No extra doctors’ visits or additional testing
  • No changes to patients’ medications or care

Eligible patients and their healthcare providers will receive compensation for providing data to the registry.

What information is collected?

The pregnant woman’s healthcare provider(s) will be asked to provide data at enrollment, approximately the end of the second trimester, and pregnancy outcome. For live-born infants, healthcare provider(s) will also be asked to provide data at approximately 4 and 12 months after delivery.

The following data will be collected:

  • Maternal obstetrical history
  • Family history of congenital malformations
  • Urinary Tract infection history and severity
  • Baseline and ongoing pregnancy information, including pregnancy dating and prenatal test information
  • Maternal exposures during pregnancy
  • Maternal medical conditions during pregnancy and pregnancy complications
  • Pregnancy outcome information, including fetus/infant characteristics and presence of congenital malformations
  • Infant growth and development information

Healthcare providers are compensated for time spent providing requested registry data at fair market value. Compensation is not intended, and should not be interpreted, as an inducement to prescribe, recommend, or influence treatment decisions for any medication or product. Payments to healthcare providers for participation in this registry may be subject to U.S. federal or state transparency reporting requirements, including reporting under the Physician Payments Sunshine Act.

Eligible patients will be asked to provide information to the registry at enrollment, including basic demographic information (e.g., race, ethnicity, education), height and weight, and information about their uUTI.

Thank you for your support in recruiting potential participants.

Register

Important Safety Information: BLUJEPA/gepotidacin

What is the most important information I should know about BLUJEPA?

BLUJEPA, an antibiotic, can cause serious side effects, including:

changes in electrical activity of your heart called QTc prolongation. BLUJEPA can cause QTc prolongation (also called prolonged QTc interval) that can lead to serious heart rhythm problems, including Torsades de Pointes. There may be changes in your heartbeat (a fast or irregular heartbeat).

Before starting BLUJEPA, tell your healthcare provider if you:

  • or anyone in your family has ever had a heart rhythm problem (problem with heart rate or heartbeat) or QTc prolongation.
  • are taking any medicines to treat heart rhythm problems. Using these medicines with BLUJEPA may cause serious side effects. If you are not sure, ask your healthcare provider.
  • are taking medicines called moderate or strong CYP3A4 inhibitors. Using these medicines with BLUJEPA may cause serious side effects. If you are not sure, ask your healthcare provider.

Tell your healthcare provider right away if you have any of the following symptoms:

  • fast, pounding, or uneven heartbeat
  • feeling dizzy
  • you lose consciousness (pass out)
  • feeling lightheaded
  • feeling faint
  • an increase of a certain chemical in your nervous system (cholinergic effects). BLUJEPA can cause an increase of a certain chemical in your nervous system, which may cause the following symptoms:
    • diarrhea
    • vomiting
    • fainting
    • trouble saying words clearly
    • muscle spasms
    • nausea
    • more saliva in the mouth
    • more sweating
    • stomach pain

Call your healthcare provider right away if you have trouble saying words clearly, have shortness of breath, or if you faint. These symptoms may be cholinergic effects of BLUJEPA.

The increased chemical in your nervous system can also be connected to other symptoms. Call your healthcare provider right away if you have any of these additional symptoms:

  • irregular heartbeat (heart block)
  • slow heartbeat (bradycardia)
  • seizures
  • fainting
  • chest tightness causing difficulty breathing
  • allergic reactions. Allergic reactions can happen in people who take BLUJEPA, including a severe allergic reaction called anaphylaxis. Stop taking BLUJEPA and get medical help right away if you have any symptoms of a severe allergic reaction, including:
    • hives
    • feeling faint or dizzy
    • rash
    • swelling of your lips, tongue, or throat
  • diarrhea. Diarrhea is a common side effect caused by antibiotics including BLUJEPA. The diarrhea may happen at the beginning of your treatment with BLUJEPA and usually stops after the antibiotic is stopped. In most cases, the diarrhea will go away without treatment. In some cases, diarrhea may be caused by Clostridioides difficile infection (CDI). CDI is a severe infection of the intestines (bowels) that can happen up to 2 months after finishing treatment with antibiotic medicines, including BLUJEPA. CDI can be life-threatening and can lead to death. Do not take medicines to treat diarrhea without first checking with your healthcare provider. Call your healthcare provider right away if you have the following symptoms:
    • stomach cramps
    • fever
    • watery diarrhea
    • diarrhea that does not go away
    • bloody stools

Who should not take BLUJEPA?

Do not take BLUJEPA if:

you have had a severe allergic reaction to BLUJEPA.

Before taking BLUJEPA, tell your healthcare provider about all of your medical conditions, including if you:

  • have heart rhythm problems. See “What is the most important information I should know about BLUJEPA?”
  • have a slow heartbeat (bradycardia)
  • have recently had a heart attack
  • have low potassium in your blood (hypokalemia)
  • are planning to have a medical or surgical procedure that puts you to sleep (general anesthesia) that will use a type of medicine given through your veins (IV) that relaxes your muscles
  • have liver problems
  • have kidney problems, kidney failure, or are on dialysis
  • are pregnant or plan to become pregnant. It is not known if BLUJEPA will harm your unborn baby

Tell your healthcare provider if you become pregnant or think you are pregnant during your treatment with BLUJEPA

- are breastfeeding or plan to breastfeed. It is not known if BLUJEPA passes into breast milk. Talk to your healthcare provider about the best way to feed your baby during your treatment with BLUJEPA

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BLUJEPA and other medicines may affect each other, causing side effects.

Especially tell your healthcare provider if you take medicines to treat heart rhythm problems. Ask your healthcare provider or pharmacist if you are not sure if you are taking any of these medicines. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of BLUJEPA?

BLUJEPA can cause serious side effects, including:

· See the “What is the most important information I should know about BLUJEPA?”

The most common side effects of BLUJEPA include:

  • diarrhea
  • nausea
  • stomach pain
  • gas
  • headache
  • soft stools
  • dizziness
  • vomiting
  • yeast infections

These are not all the possible side effects of BLUJEPA. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please see the full Prescribing Information, including Medication Guide, for BLUJEPA.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report negative side effects to GSK at gsk.public.reportum.com or 1-888-825-5249.

Important Safety Information: BLUJEPA/gepotidacin