WARNING

The risk of heart attack, stroke, and blood clots in the legs and lungs can be raised by medications that contain norethindrone and estradiol. Inform your physician about your smoking habits, heart valve disease, blood clots in your legs, lungs, or eyes, migraine headaches, high blood pressure, high blood fat or cholesterol levels, or diabetes that has affected your circulation. Not to mention, thrombophilia, which is a condition where blood clots easily. In the event that you currently have or have ever had any of these conditions, your doctor may advise against taking this prescription. It is possible that your doctor will advise you to cease taking this medicine four to six weeks prior to surgery or bed rest if you are scheduled for either of these procedures.

Make an instant appointment with your physician if you encounter any of the following adverse effects: a sharp, intense headache; sudden partial or whole blindness; double vision; difficulty speaking; lightheadedness or fainting; numbness or weakness in one arm or leg; heavy or crushing chest pain; blood in the cough; abrupt dyspnea; or leg discomfort, soreness, or redness.

The manufacturer’s patient information sheet (Medication Guide), which you will receive from your doctor or pharmacist when you start treatment with relugolix, estradiol, and norethindrone, as well as each time you refill your prescription. If you have any questions, make sure to approach your pharmacist or doctor after thoroughly reading the material.

Why is this medication prescribed?

Relugolix, estradiol, and norethindrone together are used to treat heavy menstrual bleeding brought on by uterine fibroids, which are non-cancerous growths in the uterus. Infertility-causing endometriosis, a disorder in which the tissue lining the uterus (womb) develops in other parts of the body, is treated with it as well. Relugolix belongs to a group of drugs known as antagonists of the gonadotropin-releasing hormone (GnRH) receptor. Estradiol belongs to a group of drugs known as estrogen hormones. Progestins are a class of drugs that includes norethindrone. Relugolix functions by reducing the body’s production of specific hormones. Estradiol functions by substituting the estrogen that the body would otherwise manufacture. Norethindrone works by forcing the uterus to produce specific hormones and by inhibiting the growth of the uterine lining.

How should this medicine be used?

Relugolix, estradiol, and norethindrone are combined into a tablet that is taken orally. Typically, it is given once day for up to 24 months, with or without food. Take norethindrone, estradiol, and relugolix at approximately the same time each day. Pay close attention to the instructions on the label of your prescription and ask your pharmacist or doctor to explain anything you do not understand. Adhere to the recommended dosage for norethindrone, estradiol, and relugolix. Never take more or less of it, or take it more frequently than your doctor has instructed.

Relugolix, estradiol, and norethindrone should be started on day seven after the onset of your menstrual cycle if you are just commencing treatment. For the first month following therapy, your period may be thick or irregular if you start taking relugolix, estradiol, and norethindrone on a different day.

During your therapy, your doctor could advise you to take calcium and vitamin D supplements. Take these vitamins as prescribed by your physician.

Other uses for this medicine

Relugolix, Estradiol, and Norethindrone are primarily used for specific medical conditions, and their use is generally guided by healthcare professionals. It’s important to note that new uses for medications may emerge over time as research and clinical trials progress. Always consult with your healthcare provider for the most current and accurate information regarding medication uses and precautions.

What special precautions should I follow?

Regarding special precautions for Relugolix, Estradiol, and Norethindrone, it’s crucial to follow your healthcare provider’s advice and consider the following general precautions:

• If you have an allergy to any of the substances in relugolix, estradiol, or norethindrone tablets, any other medications, or any combination of these, let your doctor and pharmacist know. For an ingredient list, consult the Medication Guide or ask your pharmacist.
• Inform your physician and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal remedies you now take or intend to use. Your doctor might need to carefully monitor you for any negative effects or adjust the dosages of your medications.
• Inform your physician if you currently have or have ever had breast cancer; cancer of the cervix, vagina, or uterine lining; osteoporosis (a disorder in which bones are brittle and prone to breaking); abnormal vaginal bleeding without an apparent cause; peripheral vascular disease (inadequate blood vessel circulation); liver, heart, or other diseases. It’s likely that your doctor will advise against taking relugolix, estradiol, and norethindrone together.
• Inform your physician about any history of broken bones, anxiety, depression, unusual behavioral or mood changes, suicidal thoughts or attempts, gall bladder disease, jaundice (yellowing of the skin or eyes), thyroid issues, or adrenal insufficiency (a condition in which the adrenal glands fail to produce enough of certain hormones required for critical bodily functions).
• Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Relugolix, estradiol, and norethindrone should not be taken if you are pregnant or suspect you may be. To make sure you are not pregnant when you start taking relugolix, estradiol, and norethindrone, your doctor will either run a pregnancy test before starting medication or advise you to start it right away. You should not use relukolix, estradiol, or norethindrone as birth control while undergoing therapy since they can exacerbate side effects and interfere with the effectiveness of some hormonal contraceptives. During your therapy and for one week following your last dosage, you must use a trustworthy non-hormonal birth control technique to avoid getting pregnant. To select a birth control technique that is effective for you, ask your doctor for advice. Contact your physician right once if you become pregnant while taking norethindrone, estradiol, and relugolix. The fetus may suffer injury or early pregnancy loss as a result of relugolix, estradiol, and norethindrone.
• When taking relugolix, estradiol, and norethindrone, you should be aware that your mental health may alter in unexpected ways and that you may develop suicidal thoughts (thinking about injuring or killing oneself, or planning or attempting to do so). If you encounter any of the following symptoms, you, your family, or your caregiver should contact your doctor immediately: sudden or heightened irritability, anxiety, or depression; talking or thinking about wanting to harm yourself or end your life; retreating from friends and family; obsession with death and dying; or any other unusual changes in behavior or mood. To ensure that they can contact the doctor in the event that you are unable to get treatment on your own, make sure your family or caretaker is aware of which symptoms could be dangerous.

It’s important to emphasize that the information provided here is based on knowledge. New developments may have occurred, and guidelines could have been updated since then. Always consult your healthcare provider or a qualified medical professional for the most current information tailored to your specific situation.

What special dietary instructions should I follow?

There are generally no specific dietary restrictions associated with these medications. However, maintaining a healthy and balanced diet is essential for overall well-being.

What should I do if I forget a dose?

As soon as you remember, take the missed dose. On the other hand, if the next dose is almost here, skip the one you missed and stick to your usual dosage plan. Never take two doses to make up for something you forgot to take.

What side effects can this medication cause?

Some general information about the potential side effects of Relugolix, Estradiol, and Norethindrone, but it’s important to note that individual responses to medications can vary, and you should consult with a healthcare professional for personalized advice.

Common side effects associated with Relugolix, estradiol, and norethindrone may include:

• Hair loss or hair thinning
• Hot flashes (a sudden wave of mild or intense body heat)
• Increased sweating or night sweats
• Changes in menstrual periods (irregular bleeding or spotting, little or no bleeding, decreased length of periods)
• Hair loss or hair thinning
• Headache
• Decreased sexual desire
• Drowsiness or tiredness
• Toothache
• Joint or back pain

Serious side effects are rare but can occur. If you experience any severe or persistent side effects, contact your healthcare provider immediately. This may include symptoms such as:

• Swelling of the face, lips, mouth or tongue; trouble breathing; rash; red or swollen skin
• Yellowing of the skin or eyes
• Unusual bruising or bleeding
• Loss of appetite
• Dark-colored urine
• Light-colored stool
• Pain in the upper right part of stomach
• Nausea
• Vomiting
• Swelling of the hands, feet, or lower legs

Relugolix, estradiol, and norethindrone together have the potential to either cause or exacerbate osteoporosis. It may cause your bones to become less dense, which raises the risk of fractures and shattered bones. Discuss the possible side effects of taking this drug with your doctor.

This is not an exhaustive list, and other side effects may occur. Your healthcare provider can provide detailed information on potential side effects based on your individual health status. It’s crucial to consult with healthcare professionals for the most current information regarding medication and its potential side effects.

What should I know about storage and disposal of this medication?

Storage and disposal of Relugolix, Estradiol, and Norethindrone:

Storage:

• Relugolix, Estradiol, and Norethindrone should be stored in a cool, dry place. Ensure they are kept away from direct sunlight, moisture, and heat, as these factors can affect their stability.
• Follow the storage instructions on the medication’s packaging. Some medications may have specific requirements, such as refrigeration.
• Keep medications out of reach of children and pets. Use child-resistant containers when available.
• Do not store medications in the bathroom or kitchen. These areas can expose the medications to moisture and heat.

Disposal:

• Do not flush medications down the toilet or pour them down the drain. This can contribute to water contamination.
• Check with your local pharmacy or healthcare provider for proper disposal methods. Many communities have programs for safe medication disposal.
• Follow any specific disposal instructions provided with the medication. Some medications may have unique disposal guidelines.

In case of emergency/overdose

• If you suspect an overdose or experience severe side effects, seek immediate medical attention. Call your local emergency number or a poison control center.
• Keep a list of emergency contact numbers readily available. This can include your local emergency services, poison control center, and your healthcare provider.
• Provide healthcare professionals with information about the medications taken, including the names and dosages.

What other information should I know?

• Take medications as prescribed by your healthcare provider. Follow the recommended dosage and schedule.
• Inform your healthcare provider of any other medications, supplements, or herbal products you are taking. Some medications can interact with each other.
• Attend regular check-ups with your healthcare provider. They can monitor your progress and address any concerns or side effects.
• Be aware of potential side effects and contact your healthcare provider if you experience anything unusual.

Remember, this information is general, and you should always follow the specific guidance provided by your healthcare provider or pharmacist. They can offer advice tailored to your individual health needs and circumstances.