What is the most important information I should know about leuprolide and norethindrone?
You should not use this medicine if you have: undiagnosed vaginal bleeding, liver disease or liver cancer, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.
Do not use if you are pregnant or breast-feeding.
What is leuprolide and norethindrone?
Leuprolide and norethindrone is a combination medicine used to treat symptoms of endometriosis (overgrowth of uterine lining outside of the uterus).
Leuprolide helps treat pain caused by endometriosis.
Norethindrone helps prevent thinning bones (a side effect of leuprolide).
Leuprolide and norethindrone is not for use in women who are older than 65.
Leuprolide and norethindrone may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before using leuprolide and norethindrone?
You should not use this medicine if you are allergic to leuprolide or norethindrone, or if you have:
- abnormal vaginal bleeding that has not been checked by a doctor;
- liver disease or liver cancer;
- a history of heart attack, stroke, or blood clot; or
- a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.
Tell your doctor if you have ever had:
- osteoporosis or low bone mineral density (in you or a family member);
- heart problems, high blood pressure, high cholesterol;
- migraine headaches;
- epilepsy;
- depression;
- diabetes;
- kidney disease; or
- if you smoke.
You may need to have a negative pregnancy test before starting this treatment.
Do not use leuprolide and norethindrone if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine. Tell your doctor right away if you become pregnant.
Do not use a hormonal form of birth control (pills, injections, implants, skin patches, vaginal rings) to prevent pregnancy while you are receiving leuprolide injections. Use nonhormonal birth control such as a copper intrauterine device (IUD), or a condom or diaphragm with spermicide.
Leuprolide is likely to cause you not to ovulate or have menstrual periods during the 6-month treatment period. However, you may still be able to get pregnant.
Do not breast-feed while using this medicine.
Leuprolide and norethindrone is not approved for use by anyone younger than 18 years old.
How should I take leuprolide and norethindrone?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
This medication is a combined treatment that includes a leuprolide injection and norethindrone tablets taken by mouth. A healthcare provider will give you the leuprolide injection. You will take the norethindrone tablets at home.
Leuprolide is usually given as a single injection into a muscle every 1 to 3 months for up to 6 months. Norethindrone tablets are taken every day for 1 to 3 months after your leuprolide injection.
You may have worsening symptoms of endometriosis when you first start using leuprolide and norethindrone. Symptoms should improve as you continue to use the medicine. Call your doctor if your symptoms do not eventually begin to improve.
You will need frequent medical tests.
This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using leuprolide and norethindrone.
Store norethindrone tablets at room temperature away from moisture and heat.
Based on your response to leuprolide and norethindrone treatment, your doctor may want you to have a second 6-month treatment.
What happens if I miss a dose?
Take the missed norethindrone dose as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Call your doctor for instructions if you miss an appointment for your leuprolide injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using leuprolide and norethindrone?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of leuprolide and norethindrone?
Get emergency medical help if you have signs of an allergic reaction: hives, skin redness, severe itching; fast or pounding heartbeats; sweating, feeling like you might pass out; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.
Seek medical attention if you have signs of a pituitary gland problem: headache, vision problems, vomiting, changes in your mental status, severe weakness, cold or clammy skin, weak pulse, or feeling like you might pass out.
Call your doctor at once if you have:
- sudden vision problems, sudden eye changes or discomfort;
- sudden and severe headache;
- mood changes, depression;
- swelling, rapid weight gain;
- ongoing symptoms of endometriosis;
- a seizure;
- chest pain or pressure, pain spreading to your jaw or shoulder;
-
liver problems --loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes); or
-
signs of a blood clot --sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg, cough, wheezing, coughing up blood.
Common side effects may include:
- headache;
- weakness;
- depressed mood;
- minor vaginal bleeding or spotting, vaginal discharge or itching;
- hot flashes, sweating;
- nausea, vomiting, diarrhea, constipation;
- feeling anxious or nervous;
- sleep problems (insomnia);
- weight gain; or
- acne.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect leuprolide and norethindrone?
Tell your doctor about all your other medicines, especially:
- seizure medication; or
- steroids (prednisone and others).
This list is not complete. Other drugs may affect leuprolide and norethindrone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Where can I get more information?
Your pharmacist can provide more information about leuprolide and norethindrone.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2021 Cerner Multum, Inc. Version: 2.01. Revision date: 1/10/2019.
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