This product contains 2 medications: leuprolide and norethindrone. Leuprolide is used to treat pain due to a certain uterus disorder (endometriosis). It works by shrinking the abnormal uterine tissue that causes the pain. Uterine tissue needs the female hormone estrogen to grow and spread. Leuprolide helps to decrease the amount of estrogen that is made in the body. Norethindrone helps to decrease the bone thinning effect of leuprolide. Norethindrone is a type of female hormone (progestin). It is like the hormone progesterone that your body makes naturally.
Read the Patient Information Leaflet provided by your pharmacist before you start using this kit and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Leuprolide is given by injection into a muscle (intramuscularly) by a health care professional. It is given as directed by your doctor, usually once every 3 months. Leuprolide is slowly released into your blood over a 3-month period. Take norethindrone by mouth as directed by your doctor, usually once daily with or without food. These medications are used together for up to 6 months of treatment.
Use these medications regularly to get the most benefit from them. To help you remember, take norethindrone at the same time each day. Mark your calendar to keep track of when to receive the next dose of leuprolide.
During the first few weeks of treatment, your hormone levels will actually increase before they decrease. This is a normal response by your body to leuprolide. This may cause a temporary worsening of your symptoms for a few weeks.
Tell your doctor if your condition does not improve or if it worsens. It may take at least 3 months to see an improvement in symptoms.
Hot flashes (flushing), increased sweating, night sweats, headache, upset stomach, nausea/vomiting, weight gain, breast changes (such as tenderness, pain), acne, joint/muscle aches, trouble sleeping, reduced sexual interest, hair loss, abnormal vaginal bleeding, dizziness, or mild burning/pain/bruising at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as new or worsening depression, thoughts of suicide, mood swings, memory problems), bone pain, easily broken bones, swelling of the hands/feet, vaginal pain/itching/discharge, frequent/burning/painful urination, yellowing eyes/skin, dark patches on the skin or face (melasma).
Get medical help right away if you have any very serious side effects, including: seizures.
Rarely, a very serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first 2 weeks after your first injection of leuprolide. Get medical help right away if any of these very serious side effects occur: sudden severe headache, sudden severe mental/mood changes (such as severe confusion, difficulty concentrating), vision changes, severe vomiting, fainting.
Norethindrone may rarely cause very serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, heart attack, pulmonary embolism, stroke). Get medical help right away if you have: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden severe headaches, slurred speech, weakness on one side of the body, sudden vision changes.
A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before using this product, tell your doctor or pharmacist if you are allergic to leuprolide or norethindrone; or to other drugs similar to leuprolide (GnRH or GnRH-like hormones such as goserelin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this product, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, high blood fat levels (high cholesterol/triglycerides), heart disease (such as heart attack, coronary artery disease, heart failure), high blood pressure, obesity, diabetes, stroke, your family medical history (especially breast lumps/cancer or blood clots), depression, cancer of the breast or other female organs, liver disease (such as liver cancer), kidney disease, blood clots, migraine headaches, asthma, seizures, lupus.
Leuprolide may weaken your bones and increase your risk for bone loss (osteoporosis) if used for a long time, because it reduces estrogen levels. Therefore, it is recommended that you do not use this medication for more than a total of 12 months. Your doctor will monitor the health of your bones closely. Before using this medication, tell your doctor or pharmacist if you have osteoporosis or if you have any of the following risk factors for osteoporosis: long-term alcohol use, smoking, family history of osteoporosis and broken bones, use of certain medications (for example, corticosteroids such as prednisone, certain anti-seizure drugs such as phenytoin).
The medications in this kit may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Tell your doctor if you will be having surgery or will be confined to a chair or bed for a long time (such as on a long plane flight). You may need to stop norethindrone for a time or take special precautions.
Do not smoke. Smoking combined with norethindrone further increases your risk for strokes, blood clots, high blood pressure, and heart attacks.
Norethindrone may cause blotchy, dark areas on your skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen, and wear protective clothing when outdoors.
This kit must not be used during pregnancy. Leuprolide and norethindrone may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. Consult your doctor for more details and to discuss reliable forms of birth control. Non-hormonal birth control methods (such as condoms, diaphragm with spermicide) are recommended during treatment.
It is unknown if leuprolide passes into breast milk. Norethindrone passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this product is not recommended. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
The medications in this kit may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this medication.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share these medications with others.
Laboratory and/or medical tests (such as hormone levels, bone tests, cholesterol/triglyceride blood levels) should be performed periodically to monitor your progress and check for side effects. Consult your doctor for more details.
Keep all regular medical and laboratory appointments. You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, and screening for cervical cancer (Pap smear) as directed by your doctor. Follow your doctor's instructions for examining your own breasts, and report any lumps immediately. Consult your doctor for more details.
If you miss a dose of norethindrone, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. If you miss a dose of leuprolide, contact your doctor promptly to establish a new dosing schedule.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised March 2014. Copyright(c) 2014 First Databank, Inc.
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