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relugolix/estradiol/norethindrone acetate

relugolix/estradiol/norethindrone acetate

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Manufactured by various FDA-approved generic manufacturers.

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relugolix/estradiol/norethindrone acetate Uses, Side Effects, Interactions, Warnings & Dosing

What dosages is relugolix/estradiol/norethindrone acetate available in?

What dosages is relugolix/estradiol/norethindrone acetate available in?

relugolix/estradiol/norethindrone acetate is a fixed-dose combination oral tablet containing relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg.

What is relugolix/estradiol/norethindrone acetate used for?

What is relugolix/estradiol/norethindrone acetate used for?

relugolix/estradiol/norethindrone acetate is a GnRH antagonist / Estrogen replacement / Progestin and is used to treat the following:

  • Heavy menstrual bleeding related to uterine fibroids in women who haven’t reached menopause
  • Moderate-to-severe pain related to endometriosis in women who haven’t reached menopause
How does relugolix/estradiol/norethindrone acetate work?

How does relugolix/estradiol/norethindrone acetate work?

relugolix/estradiol/norethindrone acetate is a combination of three medications. Relugolix is a gonadotropin-releasing hormone (GnRH) antagonist. GnRH is a natural hormone in the body that plays a role in making estrogen and progesterone hormones. These hormones all play a role in maintaining your reproductive system. Relugolix blocks the actions of GnRH, which lowers the estrogen and progesterone levels in your body. This lessens bleeding that happens with uterine fibroids and pain from endometriosis. Estradiol is an estrogen replacement. It replaces some of the estrogen in your body that’s lost from relugolix. Replacing estrogen might help prevent bone loss. Norethindrone is a progestin (a lab-made form of progesterone). It replaces some of the progesterone in your body that’s lost from relugolix. This might help protect the uterus from damage from the effects of estrogen alone, which might help prevent uterine (endometrial) cancer.

How do I take relugolix/estradiol/norethindrone acetate?

How do I take relugolix/estradiol/norethindrone acetate?

relugolix/estradiol/norethindrone acetate is typically taken as 1 tablet by mouth once a day around the same time each day, with or without food. It’s recommended to take the medication for a maximum of 2 years because of the risk for bone loss.

Is it safe for me to take relugolix/estradiol/norethindrone acetate?

Is it safe for me to take relugolix/estradiol/norethindrone acetate?

relugolix/estradiol/norethindrone acetate is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication in the following:

  • High risk of arterial, venous thrombotic, or thromboembolic disorder
  • Pregnancy
  • Known osteoporosis
  • Current or history of breast cancer or other hormone-sensitive malignancies
  • Known hepatic impairment or disease
  • Undiagnosed abnormal uterine bleeding
  • Known hypersensitivity to components of relugolix/estradiol/norethindrone acetate
relugolix/estradiol/norethindrone acetate Common Side Effects

relugolix/estradiol/norethindrone acetate Common Side Effects

Common side effects of relugolix/estradiol/norethindrone acetate:

  • New or worsening high blood pressure
  • Unusual or irregular vaginal bleeding
  • Hair loss or hair thinning
  • Headache
  • Hot flashes, a lot of sweating, or night sweats
  • Mood problems or mood swings
  • Unusual vaginal bleeding
  • Nausea
relugolix/estradiol/norethindrone acetate Serious Side Effects

relugolix/estradiol/norethindrone acetate Serious Side Effects

Serious side effects are rare with relugolix/estradiol/norethindrone acetate. Contact your healthcare provider immediately if you experience any of the following.

  • Blood clot: swelling or redness in the leg, shortness of breath, chest pain
  • Heart attack: shortness of breath, arm or chest pain, sweating
  • Stroke: slurred speech, vision changes, facial drooping, sudden weakness on one side of the body, sudden headache
  • Liver or gallbladder problems: yellowing of your skin or eyes (jaundice), pain in the upper right part of your stomach, nausea, vomiting, dark urine
  • Uterine fibroid that comes out into the vagina: heavy menstrual bleeding, severe cramping
  • Suicidal thoughts or behavior
  • Serious allergic reaction: swelling in the face, tongue, or throat; trouble breathing; hives
Effects of other drugs, drug classes and over-the-counter products on relugolix/estradiol/norethindrone acetate

Effects of other drugs, drug classes and over-the-counter products on relugolix/estradiol/norethindrone acetate

The following medications may interact with relugolix/estradiol/norethindrone acetate:

  • Avoid use of relugolix/estradiol/norethindrone acetate with oral P-gp inhibitors
  • Avoid use with combined P-gp and strong CYP3A inducers, as the exposure of the components of relugolix/estradiol/norethindrone acetate may be decreased
Who makes relugolix/estradiol/norethindrone acetate?

Who makes relugolix/estradiol/norethindrone acetate?

Various FDA-approved generic manufacturers

Is relugolix/estradiol/norethindrone acetate safe in pregnancy?

Is relugolix/estradiol/norethindrone acetate safe in pregnancy?

relugolix/estradiol/norethindrone acetate is contraindicated in pregnancy. Based on findings from animal studies and its mechanism of action, relugolix/estradiol/norethindrone acetate may cause early pregnancy loss. Discontinue relugolix/estradiol/norethindrone acetate if pregnancy occurs during treatmentThere is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to relugolix/estradiol/norethindrone acetate during pregnancy. Pregnant females exposed to relugolix/estradiol/norethindrone acetate and healthcare providers are encouraged to call the relugolix/estradiol/norethindrone acetate Pregnancy Exposure Registry at 1-855-428-0707.

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What to do if you missed your relugolix/estradiol/norethindrone acetate dose

The FDA's medical product safety reporting program for health professionals, patients and consumers.

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NowPatient has taken all reasonable steps to ensure that all material is factually accurate, complete, and current. However, the knowledge and experience of a qualified healthcare professional should always be sought after instead of using the information on this page. Before taking any drug, you should always speak to your doctor or another qualified healthcare provider.

The information provided here about medications is subject to change and is not meant to include all uses, precautions, warnings, directions, drug interactions, allergic reactions, or negative effects. The absence of warnings or other information for a particular medication does not imply that the medication or medication combination is appropriate for all patients or for all possible purposes.

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