TM Owner AbbVie
Lupaneta Pack 3.75mg+5mg Kit
Global Shipping : Reliable Global Distribution Network
Express Delivery : Priority Shipping for Every Order
Secure Payments : Trusted Payment Protection System
Disclaimer
Secure Handling
24/7 Worldwide Support
Global Access
Worldwide Access to Health
Cold-Chain Expert
Excellence in Cold-Chain
Trusted Supply
Certified Medical Supply
Indications & Clinical Uses
- Lupaneta Pack (leuprolide acetate 3.75 mg depot injection plus norethindrone acetate 5 mg tablets) is DISCONTINUED in the United States: Drugs@FDA records NDA 203696, approved to AbbVie Endocrine on 14 December 2012, with a marketing status of Discontinued for both the 3.75 mg one-month kit and the 11.25 mg three-month kit, and there is no current DailyMed label under this brand name.
- While marketed it was a co-packaged product for the management of moderate to severe pain associated with endometriosis in adult women.
- Leuprolide acetate is a gonadotropin-releasing hormone (GnRH) agonist depot given as an intramuscular injection by a healthcare provider, which switches off ovarian oestrogen production; norethindrone acetate is an oral progestin 'add-back' taken daily to limit bone loss and hot flushes.
- The initial course was limited to 6 months, with one further 6-month retreatment course at most.
- It is a gynaecological treatment, not a cancer medicine.
Side Effects
- Neither component of Lupaneta Pack carried a boxed warning, and this is stated so that its absence is not mistaken for an omission.
- In endometriosis trials more than 1 in 10 women reported hot flushes and sweats, headache or migraine, vaginitis, depression or emotional lability, general pain, weight gain or loss, nausea or vomiting, reduced libido and dizziness.
- The norethindrone acetate add-back tablet reduces hot flushes and bone loss but may cause breakthrough bleeding, breast tenderness, acne and mood change.
- Loss of bone mineral density is the main long-term concern and is the reason the course is time-limited.
- Get urgent help for a severe skin reaction with blistering, peeling or mouth sores, because Stevens-Johnson syndrome has been reported; for swelling of the face or tongue or difficulty breathing; for new or worsening depression or thoughts of self-harm; or for a seizure.
- Symptoms may briefly worsen in the first weeks as hormone levels rise before falling.
Precautions & Warnings
- Lupaneta Pack must never be used in pregnancy and must not be started if you are or could be pregnant, because it can harm an unborn baby; a pregnancy test is needed before the injection and effective non-hormonal contraception must be used throughout.
- It was also contraindicated in undiagnosed abnormal vaginal bleeding, in hypersensitivity to GnRH agonists or to norethindrone, and in breastfeeding.
- Route matters: the depot suspension is given intramuscularly by a healthcare provider, is never self-injected and is never given intravenously, while the tablets are swallowed once daily.
- Bone mineral density should be assessed before any repeat course and total treatment must not exceed 12 months.
- Tell your healthcare provider about osteoporosis, heavy alcohol or tobacco use, anticonvulsant or corticosteroid treatment, depression, epilepsy, liver disease, high blood pressure or previous blood clots.
- Periods usually stop during treatment and return within about two months of the last injection.
Avoid Interactions
- Tell your healthcare provider about every medicine, herbal product and supplement you take.
- Levels of the norethindrone acetate tablet, and so the chance of side effects, are increased by strong CYP3A4 inhibitors such as ketoconazole, itraconazole and clarithromycin, and by grapefruit juice.
- The tablet's protective effect is reduced by CYP3A4 inducers including rifampicin, carbamazepine, phenytoin, phenobarbital and St John's wort, which may also cause breakthrough bleeding.
- Bone loss is made worse by long-term corticosteroids, anticonvulsants, and heavy alcohol or tobacco use.
- No formal drug interaction studies were conducted with the depot leuprolide component, which is a peptide and is not expected to affect cytochrome P450 enzymes, but it suppresses the pituitary-gonadal system, so pituitary and sex-hormone test results taken during treatment and for up to three months afterwards can be misleading.
- The reconstituted depot suspension must not be mixed with any other medicine in the syringe.
References
Frequently Asked Questions
Lupaneta Pack (leuprolide acetate plus norethindrone acetate) treated moderate to severe pain caused by endometriosis in adult women. It is now discontinued in the United States. The kit paired a monthly leuprolide depot injection, which lowers oestrogen, with a daily norethindrone tablet that limited bone loss and hot flushes.
Lupaneta Pack used two routes at once. A healthcare provider gave the leuprolide acetate 3.75 mg depot as an intramuscular injection once a month, and you swallowed one norethindrone acetate 5 mg tablet every day. The injection was never self-given and never injected into a vein.
More than 1 in 10 women using Lupaneta Pack (leuprolide and norethindrone) had hot flushes and sweats, headache, vaginitis, low mood, general pain, weight change, nausea and reduced sex drive. Bone thinning is the main long-term risk. Seek urgent help for a blistering rash, seizures or thoughts of self-harm.
Avoid pregnancy above all: Lupaneta Pack (leuprolide and norethindrone) can harm an unborn baby, so effective non-hormonal contraception is essential. Avoid grapefruit juice and strong CYP3A4 inhibitors such as ketoconazole, which raise norethindrone levels. Rifampicin, carbamazepine, phenytoin and St John's wort can reduce the tablet's benefit.
Treatment with Lupaneta Pack (leuprolide and norethindrone) was limited to 6 months, with at most one further 6-month course, so 12 months in total. The limit exists because leuprolide lowers oestrogen and causes loss of bone mineral density. Bone density was checked before any repeat course.
No. Drugs@FDA lists Lupaneta Pack (NDA 203696, AbbVie Endocrine, approved 14 December 2012) as Discontinued for both the 3.75 mg and 11.25 mg kits. This is a manufacturer discontinuation rather than a safety withdrawal of the approval. Neither component carried a boxed warning.
Trusted & Reliable – Your Partner in Global Distribution.
We provide comprehensive lines of pharmaceutical products to support all your healthcare distribution needs.
