What is LUPANETA PACK™ (leuprolide acetate for depot suspension and norethindrone acetate tablets)?
LUPANETA PACK is used for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms. It contains 2 different prescription medicines:
- Leuprolide acetate for depot suspension, a medicine injected into your muscle and used to treat pain due to endometriosis
- Norethindrone acetate tablets, a medicine taken by mouth and used to help lower the side effect of bone thinning that is caused by leuprolide acetate for depot suspension
LUPANETA PACK should not be used longer than 6 months at a time after you first start treatment for your endometriosis symptoms.
LUPANETA PACK should not be used for more than a total of 12 months during your treatment.
It is not known if LUPANETA PACK is safe and effective in children under 18 years of age.
Important Safety Information
Who should not take LUPANETA PACK?
Do not take LUPANETA PACK if you:
- Have had an allergic reaction to medicines like leuprolide norethindrone acetate tablets
- Have uterine bleeding for which a cause has not been found
- Are pregnant or may be pregnant
- Are breast-feeding or plan to breast-feed
- Had or have breast cancer or other cancers that are sensitive to hormones
- Have problems with blood clots, a stroke, or a heart attack
- Have liver problems
What should I tell my doctor before taking LUPANETA PACK?
Before you take LUPANETA PACK, tell your doctor if you:
- Drink alcohol
- Have a family history of bone loss (osteoporosis)
- Have or have had depression
- Have high cholesterol
- Have had blood clots, a stroke, or a heart attack
- Have migraine headaches
- Have diabetes
- Have epilepsy
- Have kidney problems
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Especially tell your doctor if you take anticonvulsant (seizure) or corticosteroid medicines.
Before you take LUPANETA PACK, talk to your doctor about a birth control method that is right for you. You will need to use a form of birth control that does not contain hormones, such as:
- A diaphragm with spermicide
- Condoms with spermicide
- A copper IUD
If you become pregnant while taking LUPANETA PACK, stop taking the norethindrone acetate tablets and call your doctor right away.
What are the possible side effects of LUPANETA PACK?
LUPANETA PACK may cause serious side effects, including:
- Bone thinning (decreased bone mineral density)
- Harm to your unborn baby
- Vision problems. Call your doctor right away if you have sudden loss of vision, double vision, bulging eyes, or migraine headaches
- Depression or worsening depression
- Worsening endometriosis symptoms when you start taking LUPANETA PACK
- Swelling (fluid retention)
Allergic reactions. Get medical help right away if you have any of these symptoms:
- trouble breathing
- swelling of your face, lips, mouth, or tongue
- severe itching
- skin rash, redness, or swelling
- dizziness or fainting
- fast heartbeat or pounding in your chest (tachycardia)
The most common side effects of LUPANETA PACK include:
- Hot flashes and sweats
- Headaches or migraine headaches
- Depression and mood swings
- Nausea and vomiting
- Problems sleeping
- Nervousness or feeling anxious
- Vaginal infection or inflammation
- Weight gain
- Constipation or diarrhea
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of LUPANETA PACK. For more information, ask your doctor or pharmacist.
Please see full Prescribing Information.
You are encouraged to report negative adverse effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
If you cannot afford your medication, contact www.pparx.org.
1. LUPANETA PACK [package insert]. North Chicago, IL: AbbVie Inc.