Generic Name: leuprolide and norethindrone (LOO-proe-lide/nor-ETH-in-drone)
Brand Name: Lupaneta Pack
Lupaneta Pack is used for:
Treating endometriosis. It may also be used for other conditions as determined by your doctor.
Lupaneta Pack is a gonadotropin-releasing hormone (GnRH) agonist and progestin. The GnRH suspension works to decrease pain due to endometriosis. The progestin tablet works to lower the effect of bone thinning caused by the suspension.
Do NOT use Lupaneta Pack if:
- you are allergic to any ingredient in Lupaneta Pack, to GnRH, or to another GnRH analog (eg, histrelin)
- you are pregnant, think you may be pregnant, are able to become pregnant, or are breast-feeding
- you have unusual vaginal bleeding of an unknown cause
- you have a history of breast cancer or other hormone-dependent cancers
- you have liver disease or liver tumors
- you have or have had blood clots
Contact your doctor or health care provider right away if any of these apply to you.
Before using Lupaneta Pack:
Some medical conditions may interact with leuprolide and/or norethindrone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you drink alcohol, smoke, use tobacco regularly, or are very overweight
- if you or a family member has a history of blood clots (eg, in the legs or lung)
- if you have a history of mood or mental problems (eg, depression)
- if you have bone problems (eg, osteoporosis, brittle bones) or a family history of bone problems
- if you have a history of asthma, diabetes or high blood sugar, high blood cholesterol or lipid levels, high blood pressure, migraine headaches, kidney problems, liver problems, seizures, heart problems (eg, heart attack), or a stroke
- if you take corticosteroids (eg, prednisone), anticonvulsants (eg, carbamazepine), or other medicines that may reduce bone strength
Some MEDICINES MAY INTERACT with Lupaneta Pack. However, no specific interactions with leuprolide and/or norethindrone are known at this time.
Ask your health care provider if Lupaneta Pack may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Lupaneta Pack:
Use Lupaneta Pack as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Lupaneta Pack. Talk to your pharmacist if you have questions about this information.
- Lupaneta Pack contains 2 different medicines. The suspension is given once a month as an injection at your doctor's office, hospital, or clinic. It must be administered under the supervision of a doctor. The tablet is taken by mouth every day for 1 month after you receive your injection.
- Do not use Lupaneta Pack longer than 6 months at a time and for more than a total of 12 months.
- If you miss a dose of the injection, contact your doctor right away. If you miss a dose of the tablet, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Lupaneta Pack.
Important safety information:
- Lupaneta Pack may cause dizziness. This effect may be worse if you use it with alcohol or certain medicines. Use Lupaneta Pack with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Lupaneta Pack may cause birth defects, or fetal or newborn death if you take it while you are pregnant. You should have a negative pregnancy test before you start Lupaneta Pack. Talk with your doctor for more information.
- Lupaneta Pack usually stops menstruation (periods). Missing doses of Lupaneta Pack may cause breakthrough bleeding. Notify your doctor if regular menstruation continues.
- Ovulation usually stops while using Lupaneta Pack; however, this is not a reliable form of birth control because breakthrough ovulation may occur during treatment. Birth control pills may also not be effective. To prevent pregnancy, use a nonhormonal form of birth control (eg, condom, diaphragm) during treatment with Lupaneta Pack. Talk to your doctor.
- Certain hormone levels may increase during the first few weeks of treatment with Lupaneta Pack. You may notice an increase in symptoms or onset of new symptoms during this time. Tell your doctor if any new symptoms occur or if you have worsened symptoms that last longer than a few weeks after you start to use Lupaneta Pack.
- Lupaneta Pack lowers the amount of certain hormones in your body. This may result in certain effects such as changes in breast size, breast soreness or tenderness, decreased sexual ability, hot flashes, or night sweats. Discuss any questions or concerns with your doctor.
- Lupaneta Pack may cause your bones to weaken (decreased bone density) or become more prone to fractures, especially if you use it for a long time. Contact your doctor if you notice bone pain or if you have questions or concerns.
- A serious pituitary gland problem (pituitary apoplexy) has rarely been reported with the use of Lupaneta Pack. Most cases developed within 2 weeks after the first dose. Contact your doctor right away if you experience a sudden headache, vomiting, fainting, mental or mood changes, eye weakness, inability to move your eyes, or vision changes.
- Lab tests, including bone density, may be performed while you use Lupaneta Pack. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Lupaneta Pack may interfere with certain lab tests, including certain hormone and pituitary gland function tests. Be sure your doctor and lab personnel know you are using Lupaneta Pack.
- Lupaneta Pack is not approved for use in postmenopausal women. Lupaneta Pack should be used with extreme caution in WOMEN older than 65 years old; safety and effectiveness has not been confirmed.
- Lupaneta Pack is not approved for use in females who have not had their first menstrual period. Lupaneta Pack should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Lupaneta Pack if you are pregnant. It may cause birth defects, or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if this medicine is found in breast milk. Do not breast-feed while using Lupaneta Pack.
Possible side effects of Lupaneta Pack:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Acne; breast tenderness; constipation; diarrhea; dizziness; headache; hot flashes; mild pain at the injection site; nausea; sweating; trouble sleeping; vomiting; weakness; weight gain.
Severe allergic reactions (rash; hives; itching; difficulty breathing; fast heartbeat; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing); bulging eyes; burning, numbness, or tingling; chest pain; fainting; memory problems; new or worsening bone pain; new or worsening mood or mental changes (eg, anxiety, depression, nervousness); seizures; severe dizziness or light-headedness; severe drowsiness; severe headache or migraine; severe or persistent nausea or vomiting; shortness of breath; slow, fast, or irregular heartbeat; swelling of the hands, ankles, or feet; symptoms of infection (eg, chills, fever); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech); trouble urinating (eg, loss of bladder control, unable to urinate, painful urination); unusual sweating; unusual vaginal itching, irritation, discharge, or odor; vision changes (eg, blurred or double vision, sudden vision loss).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Lupaneta Pack:
The suspension is usually handled and stored by a health care provider. Store the tablets at room temperature between 68 to 77 degrees F (20 to 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lupaneta Pack out of the reach of children and away from pets.
- If you have any questions about Lupaneta Pack, please talk with your doctor, pharmacist, or other health care provider.
- Lupaneta Pack is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Lupaneta Pack or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Lupaneta Pack. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Lupaneta Pack. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Lupaneta Pack.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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