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Leuprolide Acetate And Norethindrone Acetate (Lupaneta Pack)

Trade Name : Lupaneta Pack

AbbVie Inc.

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Leuprolide Acetate And Norethindrone Acetate (Lupaneta Pack) which is also known as Lupaneta Pack and Manufactured by AbbVie Inc.. It is available in strength of per ml. Read more

Leuprolide Acetate And Norethindrone Acetate (Lupaneta Pack) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • LUPANETA PACK (leuprolide acetate for depot suspension and norethindrone acetate tablets) is indicated for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms.
  • Limitation of Use: Duration of use is limited due to concerns about adverse impact on bone mineral density . The initial treatment course of LUPANETA PACK is limited to six months. A single retreatment course of not more than six months may be administered after the initial course of treatment if symptoms recur. Use of LUPANETA PACK for longer than a total of 12 months is not recommended.
  • LUPANETA PACK contains leuprolide acetate, a gonadotropin-releasing hormone (GnRH) agonist and norethindrone acetate, a progestin, indicated for
  • Limitations of Use:
  • Initial management of the painful symptoms of endometriosis n
  • Management of recurrence of symptoms n
  • No data
  • Leuprolide acetate for depot suspension 3.75 mg given by a healthcare provider as a single intramuscular injection every month for up to six injections (6 months of therapy) n
  • Norethindrone acetate 5 mg tablets taken orally by the patient once per day for up to 6 months n
  • If endometriosis symptoms recur after initial course of therapy, consider retreatment for up to another six months n
  • Assess bone density before retreatment begins n n
  • Reconstitute leuprolide acetate prior to use, see important administration instructionsn
  • LUPANETA PACK 1-month copackaged kit contains two separate components:
  • Leuprolide acetate for depot suspension 3.75 mg syringe n
  • Norethindrone acetate 5 mg tablets; 30 count bottle n
  • LUPANETA PACK is contraindicated in women with the following:
  • Hypersensitivity to GnRH, GnRH agonist or any of the excipients in leuprolide acetate for depot suspension or norethindrone acetate n
  • Undiagnosed abnormal uterine bleeding n
  • Pregnancy or suspected pregnancy n n
  • Women who are breast-feeding n
  • Known, suspected or history of breast or other hormone-sensitive cancer n
  • Thrombotic or thromboembolic disorders n
  • Liver tumors or liver disease n
  • No data
  • Loss of bone mineral density: do not use for more than two six-month treatment courses. n n n
  • Exclude pregnancy before starting treatment and discontinue use if pregnancy occurs; use non-hormonal methods of contraception only. n
  • Discontinue in case of sudden loss of vision or onset of proptosis, diplopia or migraine. n
  • Carefully observe patients with history of depression and discontinue the drug if the depression recurs to a serious degree. n
  • Assess and manage risk factors for cardiovascular disease before starting LUPANETA PACK. n
  • Leuprolide acetate for depot suspension:
  • Progestins:
  • To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • No data
  • Pediatric: Safety and effectiveness of LUPANETA PACK has not been established in pediatric patients. n
  • Geriatric: LUPANETA PACK has not been studied in women over 65 years of age and is not indicated in this population. n
  • LUPANETA PACK (leuprolide acetate for depot suspension; norethindrone acetate tablets) 1-month contains one dual chamber syringe with leuprolide acetate for depot suspension 3.75 mg and norethindrone acetate tablets USP: 5 mg (bottle of 30 tablets).
  • Leuprolide Acetate for Depot Suspension
  • Leuprolide acetate for depot suspension is a synthetic nonapeptide analog of gonadotropin-releasing hormone (GnRH or LH-RH), a GnRH agonist. The chemical name is 5- oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:
  • Leuprolide acetate for depot suspension 3.75 mg is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection.
  • The front chamber of leuprolide acetate for depot suspension 3.75 mg prefilled dual-chamber syringe contains leuprolide acetate for depot suspension (3.75 mg), gelatin (0.65 mg), DL-lactic and glycolic acids copolymer (33.1 mg), and D-mannitol (6.6 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH.
  • During the manufacture of leuprolide acetate for depot suspension, acetic acid is lost, leaving the peptide.
  • Norethindrone Acetate
  • Norethindrone acetate tablets USP - 5 mg oral tablets.
  • Norethindrone acetate USP, (17-hydroxy-19-nor-17u03b1-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white, or creamy white, crystalline powder.
  • Norethindrone acetate tablets USP, 5 mg contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc.
  • No data
  • Leuprolide Acetate for Depot Suspension
  • A two-year carcinogenicity study was conducted in rats and mice. In rats, a dose-related increase of benign pituitary hyperplasia and benign pituitary adenomas was noted at 24 months when the drug was administered subcutaneously at high daily doses (0.6 to 4 mg/kg). There was a significant but not dose-related increase of pancreatic islet-cell adenomas in females and of testicular interstitial cell adenomas in males (highest incidence in the low dose group). In mice, no leuprolide acetate-induced tumors or pituitary abnormalities were observed at a dose as high as 60 mg/kg for two years. Patients have been treated with leuprolide acetate for up to three years with doses as high as 10 mg/day and for two years with doses as high as 20 mg/day without demonstrable pituitary abnormalities.
  • Mutagenicity studies have been performed with leuprolide acetate using bacterial and mammalian systems. These studies provided no evidence of a mutagenic potential.
  • Clinical and pharmacologic studies in adults (>18 years) with leuprolide acetate and similar analogs have shown reversibility of fertility suppression when the drug is discontinued after continuous administration for periods of up to 24 weeks. Although no clinical studies have been completed in children to assess the full reversibility of fertility suppression, animal studies (prepubertal and adult rats and monkeys) with leuprolide acetate and other GnRH analogs have shown functional recovery.
  • Leuprolide Acetate for Depot Suspension
  • Initial endometriosis efficacy data for leuprolide acetate for depot suspension were based on the 3.75 mg dose administered once monthly.
  • A pharmacokinetic/pharmacodynamic study in 41 women that included both the 3.75 mg dose administered once monthly and the 11.25 mg dose administered once every three months did not reveal clinically significant differences in terms of efficacy in reducing painful symptoms of endometriosis or magnitude of the decrease in bone mineral density (BMD) associated with use of leuprolide acetate.
  • Leuprolide Acetate for Depot Suspension Plus Norethindrone Acetate
  • Two clinical studies with treatment duration of 12 months were conducted to evaluate the effect of coadministration of leuprolide acetate for depot suspension and norethindrone acetate on the loss of bone mineral density (BMD) associated with leuprolide acetate for depot suspension and on the efficacy of leuprolide acetate for depot suspension in relieving symptoms of endometriosis. (All patients in these studies received calcium supplementation with 1000 mg elemental calcium). A total of 242 women were treated with monthly administration of leuprolide acetate 3.75 mg (13 injections) and with 5 mg norethindrone acetate taken daily. The population age range was 17-43 years old.u00a0 The majority of patients were Caucasian (87%).
  • One coadministration study was a controlled, randomized and double-blind study included 51 women treated monthly with leuprolide acetate for depot suspension alone and 55 women treated monthly with leuprolide acetate for depot suspension plus norethindrone acetate daily. Women in this trial were followed for up to 24 months after completing one year of treatment.u00a0The other study was an open-label single arm clinical study in 136 women of one year of treatment with leuprolide acetate for depot suspension and norethindrone acetate, with follow-up for up to 12 months after completing treatment.
  • The second study was an open label, single arm study in which 136 women were treated monthly with leuprolide acetate for depot suspension plus norethindrone acetate daily, with follow-up for up to 12 months after completing treatment.
  • The assessment of efficacy was based on the investigatoru2019s or the patientu2019s monthly assessment of five signs or symptoms of endometriosis (dysmenorrhea, pelvic pain, deep dyspareunia, pelvic tenderness and pelvic induration).
  • Table 6 below provides detailed efficacy data regarding relief of symptoms of endometriosis based on the two studies of coadministration of leuprolide acetate and norethindrone acetate.
  • Suppression of menses (menses was defined as three or more consecutive days of menstrual bleeding) was maintained throughout treatment in 84% and 73% of patients receiving leuprolide acetate and norethindrone acetate, in the controlled study and open label study, respectively. The median time for menses resumption after treatment with leuprolide acetate and norethindrone acetate was 8 weeks.
  • Changes in Bone Density
  • The effect of leuprolide acetate for depot suspension and norethindrone acetate on bone mineral density was evaluated by dual energy x-ray absorptiometry (DXA) scan in the two clinical trials. For the open-label study, success in mitigating BMD loss was defined as the lower bound of the 95% confidence interval around the change from baseline at one year of treatment not to exceed u20132.2%. The bone mineral density data of the lumbar spine from these two studies are presented in Table 7.
  • The change in BMD following discontinuation of treatment is shown in Table 8.
  • These clinical studies demonstrated that coadministration of leuprolide acetate and norethindrone acetate 5 mg daily is effective in significantly reducing the loss of bone mineral density that occurs with leuprolide acetate for depot suspension treatment, and in relieving symptoms of endometriosis.
  • Leuprolide Acetate for Depot Suspension
  • LUPANETA PACK for 1-month copackaged kit (NDC 0074-1052-05) is available in
  • cartons containing: leuprolide acetate for depot suspension 3.75 mg for 1-month
  • administration Kit (NDC 0074-3641-04)
  • norethindrone acetate 5 mg tablets; 30 count bottle (NDC 0074-1049-02)
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15 to 30u00b0C (59 to 86u00b0F) [See USP Controlled Room Temperature]
  • See FDA-approved patient labeling (Patient Information)
  • PATIENT INFORMATION
  • LUPANETA PACK (loo-pan-e-tu04d9 pu00e6k)(leuprolide acetate for depot suspension and norethindrone acetate tablets)
  • Read this Patient Information before you start taking LUPANETA PACK and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
  • What is LUPANETA PACK?
  • LUPANETA PACK contains 2 different prescription medicines:
  • 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.
  • Who should not take LUPANETA PACK?
  • Do not take LUPANETA PACK if you:
  • What should I tell my doctor before taking LUPANETA PACK?
  • Before you take LUPANETA PACK, tell your doctor if you:
  • Tell your doctor about all the medicines you take,
  • Especially tell your doctor if you take anticonvulsant (seizure) or corticosteroid medicines.
  • Ask your doctor for a list of these medicines if you are not sure.
  • Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
  • How should I take LUPANETA PACK?
  • How well does LUPANETA PACK work?
  • LUPANETA PACK is used to treat pain due to endometriosis. The pain from endometriosis can happen when you have your period, during other times of the month, or during intercourse (sex). Most women feel some relief from their endometriosis pain after taking both drugs in LUPANETA PACK.
  • The tablets in LUPANETA PACK help lower the side effect of bone thinning that is caused by leuprolide acetate for depot suspension. Women taking both drugs in LUPANETA PACK lost an average of 1% of their bone density after about 1 year of treatment. Women regained some of their bone density about 1 year after they stopped treatment with LUPANETA PACK.
  • What are the possible side effects of LUPANETA PACK?
  • LUPANETA PACK may cause serious side effects, including:
  • The most common side effects of LUPANETA PACK include:
  • Tell your doctor if you have any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of LUPANETA PACK. For more information, ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store norethindrone acetate tablets in the LUPANETA PACK?
  • Keep LUPANETA PACK and all medicines out of the reach of children.
  • General information about the safe and effective use of LUPANETA PACK.
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use LUPANETA PACK for a condition for which it was not prescribed. Do not give LUPANETA PACK to other people, even if they have the same symptoms that you have. It may harm them.
  • This Patient Information leaflet summarizes the most important information about LUPANETA PACK. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about LUPANETA PACK that is written for health professionals.
  • For more information, go to or call 1-800-633-9110.
  • What are the ingredients in LUPANETA PACK?
  • leuprolide acetate for depot suspension:
  • norethindrone acetate tablets:
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Leuprolide Acetate for Depot Suspension:
  • By Takeda Pharmaceutical Company Limited Osaka, Japan 540-8645
  • Norethindrone acetate:
  • By Glenmark Pharmaceuticals Ltd.Colvale-Bardez, Goa 403 513, India
  • 03-B096 June, 2015
  • NDC 0074-1052-05
  • 1-MONTH
  • Lupaneta Packn
  • leuprolide acetate for depot suspension, 3.75 mg for intramuscular injection only and norethindrone acetate tablets, 5 mg for oral administration
  • This Package Contains:
  • u2022 1 Kit Lupron Depot 1-month 3.75 mg, NDC 0074-3641-04
  • Each Lupron Depot 1-month 3.75 mg Kit contains:
  • One pre-filled dual-chamber syringe containing needle with LuproLoc safety device u2022 One plunger u2022Two alcohol swabs.
  • The front chamber of the syringe contains:
  • leuprolide acetate 3.75 mg u2022 purified gelatin 0.65 mg u2022 DL-lactic and glycolic acids copolymer 33.1 mg u2022 D-mannitol 6.6 mg.
  • The second chamber contains:
  • D-mannitol 50 mg u2022 carboxymethylcellulose sodium 5 mg u2022 polysorbate 80 1 mg u2022 water for injection USP and glacial acetic acid USP to control pH.
  • Do not remove from clamshell until ready to use.
  • Usual dose: After mixing immediately administer entire contents of syringe by intramuscular injection once a month under physicianu2019s supervision.
  • See package insert for full prescribing information.
  • If removed from this Kit carton, Store at 25u00b0C (77u00b0F). Excursions permitted to 15-30u00b0C (59-86u00b0F)
  • Only activate safety Device -Injection
  • Not made with natural rubber latex.
  • u2022 1 Bottle- Norethindrone Acetate Tablets USP, 5 mg 30 Tablets. NDC 0074-1049-02
  • Usual dose: 5 mg (one tablet) orally once daily for 1 month. See package insert for full prescribing information.
  • If removed from this Kit carton, Store at 20-25u00b0C (68-77u00b0F).
  • Dispense in well closed containers
  • For 1 MONTH ADMINISTRATION FOR ADULT USE ONLY
  • Store at 25u00b0C (77u00b0F), excursion permitted to 15u00b0-30u00b0C (59u00b0-86u00b0F) [See USP Controlled Room Temperature].
  • Rx only abbvie
  • NDC 0074-1052-10
  • 1-MONTH
  • Physician Sample - NOT for sale or billing
  • Lupaneta Packn
  • leuprolide acetate for depot suspension, 3.75 mg for intramuscular injection only and norethindrone acetate tablets, 5 mg for oral administration
  • This Physician Sample Package Contains:
  • u2022 1 Kit Lupron Depot 1-month 3.75 mg, NDC 0074-3641-07
  • Each Lupron Depot 1-month 3.75 mg Kit contains:
  • One pre-filled dual-chamber syringe containing needle with LuproLoc safety device u2022 One plunger u2022 Two alcohol swabs.
  • The front chamber of the syringe contains:
  • leuprolide acetate 3.75 mg u2022 purified gelatin 0.65 mg u2022 DL-lactic and glycolic acids copolymer 33.1 mg u2022 D-mannitol 6.6 mg.
  • The second chamber contains:
  • D-mannitol 50 mg u2022 carboxymethylcellulose sodium 5 mg u2022 polysorbate 80 1 mg u2022 water for injection USP and glacial acetic acid USP to control pH.
  • Do not remove from clamshell until ready to use.
  • Usual dose: After mixing immediately administer entire contents of syringe by intramuscular injection once a month under physicianu2019s supervision.
  • See package insert for full prescribing information.
  • If removed from this Kit carton, Store at 25u00b0C (77u00b0F). Excursions permitted to 15-30u00b0C (59-86u00b0F)
  • Only activate safety Device -Injection
  • Not made with natural rubber latex.
  • u2022 1 Bottle- Norethindrone Acetate Tablets USP, 5 mg 30 Tablets. NDC 0074-1049-30
  • Usual dose: 5 mg (one tablet) orally once daily for 1 month. See package insert for full prescribing information.
  • If removed from this Kit carton, Store at 20-25u00b0C (68-77u00b0F).
  • Dispense in well closed containers
  • For 1 MONTH ADMINISTRATION FOR ADULT USE ONLY
  • Store at 25u00b0C (77u00b0F), excursions permitted to 15u00b0-30u00b0C (59u00b0-86u00b0F) [See USP Controlled Room Temperature].
  • Rx only abbvie

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