Safety
General information, not medical advice
Your prescriber and the leaflet in your pack know your situation. This page does not.
- Follow your prescriber and the leaflet
- Don't start, stop, or change a dose on your own
- Doses and warnings differ by country and product
Lupaneta Pack Injection: Uses, Dosage, Side Effects, Precautions and Alternates
| Generic name | leuprolide acetate and norethindrone acetate |
|---|---|
| Drug class | Sex hormone combinations (GnRH agonist / Progestin) |
| Forms | Powder for Suspension, 1 Month (injection), Powder for Suspension, 3 Month (injection), Tablet |
Quick overview
Lupaneta Pack Injection is a kit combining leuprolide acetate, given as an injection into a muscle, with norethindrone acetate tablets taken by mouth. It is used to treat endometriosis pain and help prevent the pain from returning, with norethindrone included to help reduce bone thinning caused by leuprolide. Treatment with this combination should generally not be used for longer than 12 months.
What is Lupaneta Pack Injection
Lupaneta Pack is a kit containing two prescription medicines that are used together: leuprolide, given as an injection into a muscle, and norethindrone, taken as a tablet by mouth.
Lupaneta Pack Injection uses
- Treats pain caused by endometriosis
- Helps prevent endometriosis pain symptoms from coming back
- Norethindrone is included to help reduce bone thinning caused by leuprolide
Benefits of Lupaneta Pack Injection
- Helps relieve painful symptoms of endometriosis
- Helps reduce pelvic pain and painful menstrual periods associated with endometriosis
- Can be used for initial treatment and recurrence of endometriosis symptoms
- The norethindrone add-back therapy helps reduce bone mineral loss and hot flashes caused by leuprolide treatment
How Lupaneta Pack Injection works
Leuprolide is a man-made hormone similar to one made in the brain. It lowers the amount of estrogen in the body, which helps treat endometriosis. Norethindrone is a man-made progestin hormone that helps protect against the bone thinning that leuprolide can cause.
Lupaneta Pack Injection dosage
The leuprolide injection is given into a muscle by a nurse or other trained health professional in a hospital or clinic, not at home. The injection is a long-acting form that may be given once a month or once every 3 months. Norethindrone tablets are taken by mouth every day after you receive the leuprolide injection. Treatment with this combination should not be used for longer than 12 months.
If you miss a dose of the tablet, take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue your regular schedule without doubling up. If you miss a scheduled injection appointment, call your healthcare provider right away to reschedule. Continue your normal diet unless your doctor tells you otherwise. This medicine has not been studied in children or in women 65 years and older.
| Age group | Dose |
|---|---|
| Under 18 years | Safety and effectiveness for endometriosis not established |
| Adult women – Initial treatment | Leuprolide depot 11.25 mg IM once every 3 months + norethindrone acetate 5 mg orally once daily |
| Adult women – Endometriosis pain | Continue the same combination regimen for the prescribed treatment period |
| Retreatment | May use an additional treatment course when clinically appropriate, with bone-density considerations |
| Maximum duration | Total treatment with leuprolide plus norethindrone add-back therapy should generally not exceed 12 months |
Available forms and strengths
- Powder for Suspension, 1 Month (injection)
- Powder for Suspension, 3 Month (injection)
- Tablet
Side effects of Lupaneta Pack Injection
Common
- Hot flashes and sweats
- Headaches or migraine headaches
- Depression and mood swings
- Nausea and vomiting
- Problems sleeping
- Nervousness or feeling anxious
- Pain
- Acne
- Weakness
- Vaginal infection or inflammation
- Weight gain
- Constipation or diarrhea
- Crying spells
- Feeling of warmth
- Redness of the face, neck, arms, and sometimes upper chest
- Sudden sweating
- Swelling
- Breast tenderness or pain
- Decrease in sexual desire
- Hair loss or thinning hair
- Headache
Serious
- Bone thinning (decreased bone mineral density)
- Signs of a serious allergic reaction such as rash, itching, hoarseness, trouble breathing, trouble swallowing, or swelling of hands, face, or mouth
- Seizures, including muscle spasms or jerking of the arms or legs, sudden loss of consciousness, or loss of bladder control
- New or worsening depression, including feeling sad, empty, irritable, losing interest in things, or trouble concentrating or sleeping
- Sudden loss of vision, double vision, bulging eyes, or migraine headache
- Chest pain or tightness, fast or irregular heartbeat
- Signs of a blood clot such as pain, redness, or swelling in an arm or leg, or sudden shortness of breath
- Thoughts of self-harm or suicide
- Yellowing of the eyes or skin
Warnings and precautions
- You should not receive this medicine if you are pregnant or could become pregnant, since it can harm an unborn baby. Use an effective non-hormonal method of birth control while on treatment, and tell your doctor right away if you think you have become pregnant.
- This medicine should not be used while breastfeeding, because studies have shown it can harm a nursing infant.
- Tell your doctor if you have kidney disease, since this medicine should be used with caution in that case.
- This medicine should not be used if you have liver disease or liver tumors.
- Tell your doctor if you have a history of alcohol abuse, as this medicine should be used with caution in that situation.
- This medicine can cause serious allergic reactions, including anaphylaxis, which can be life-threatening.
- This medicine can decrease bone mineral density, which may lead to osteoporosis or weakened bones.
- Using this medicine may increase the risk of having seizures.
- This medicine may cause depression.
- This medicine should not be used by women who have unexplained vaginal bleeding, blood clotting disorders, known or suspected breast cancer or other hormone-sensitive cancer, a recent heart attack, liver disease or tumors, or a history of stroke.
- Do not take other medicines, including over-the-counter drugs, herbal products, or vitamins, unless you have discussed them with your doctor first.
Storage
- Store the leuprolide depot injection at 20–25°C (68–77°F); follow the package label for permitted temperature excursions.
- Store the norethindrone tablets at 20–25°C (68–77°F) in a dry place.
- Keep both components in their original packaging and protect from excessive heat and moisture.
- Do not freeze the injection or expose it to extreme temperatures.
- Once the leuprolide suspension is mixed, administer immediately and discard any unused portion.
- Keep the entire pack securely stored and out of reach of children.
When to see a doctor
- Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or swelling of your hands, face, or mouth.
- Check with your doctor right away if you have muscle spasms or jerking of the arms or legs, sudden loss of consciousness, or loss of bladder control.
- Check with your doctor right away if you feel discouraged, sad, empty, irritable, lose interest in things, feel tired, have trouble concentrating, or have trouble sleeping.
- Call your doctor right away if you have sudden loss of vision, double vision, bulging eyes, or a migraine headache.
- If you think you may have become pregnant while using this medicine, tell your doctor right away.
Alternatives
- Combined Hormonal Contraceptives
- Norethindrone Acetate
- Lupron Depot (Leuprolide)
- Myfembree
- Orilissa (Elagolix)
Watch the video
FAQs
What is Lupaneta Pack Injection used for?
It is used to treat pain caused by endometriosis and to help prevent the pain from returning. Norethindrone is included to help reduce bone thinning caused by leuprolide.
How long can Lupaneta Pack Injection be used?
Treatment with this combination should generally not be used for longer than 12 months.
How is Lupaneta Pack Injection given?
The leuprolide injection is given into a muscle by a nurse or trained health professional in a hospital or clinic, either once a month or once every 3 months, while norethindrone tablets are taken by mouth every day after the injection.
What happens if I miss a dose of norethindrone tablets?
Take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue your regular schedule without doubling up.
What are the serious side effects of Lupaneta Pack Injection?
Serious side effects include bone thinning, allergic reactions, seizures, new or worsening depression, sudden vision changes, chest pain or irregular heartbeat, signs of blood clots, thoughts of self-harm, and yellowing of the eyes or skin.
General information, not medical advice
Your prescriber and the leaflet in your pack know your situation. This page does not.
- Follow your prescriber and the leaflet
- Don't start, stop, or change a dose on your own
- Doses and warnings differ by country and product
Sources
Video
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