Pronunciation:

LOO-proe-lide AS-e-tate, nor-ETH-in-drone AS-e-tate

Brand Names:

• Lupaneta Pack

Dosage Forms:

• Powder for Suspension, 3 Month
• Tablet
• Powder for Suspension, 1 Month

Uses of This Medicine:

Leuprolide injection and norethindrone tablets are used together to treat pain caused by endometriosis. This combination is also used to prevent the symptoms of endometriosis from occurring again. This medicine should be used no longer than 12 months.

Leuprolide injection is a synthetic (man-made) hormone that is similar to a natural hormone that is produced in the brain. It decreases the amount of estrogen in the body and helps treat endometriosis. Norethindrone is a synthetic (man-made) progestin hormone that is used to treat thinning of the bones caused by leuprolide.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of Lupaneta Pack® in the pediatric population. Safety and efficacy have not been established.

Older adults—

Lupaneta Pack® is not indicated in postmenopausal women and has not been studied in women 65 years of age and older.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Cisapride
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Tranexamic Acid
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adagrasib
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Anagrelide
• Apalutamide
• Apomorphine
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Armodafinil
• Arsenic Trioxide
• Artemether
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bacampicillin
• Bedaquiline
• Belzutifan
• Betamethasone
• Bexarotene
• Boceprevir
• Bosentan
• Buprenorphine
• Buserelin
• Butabarbital
• Butalbital
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clofazimine
• Clomipramine
• Clothiapine
• Cloxacillin
• Clozapine
• Colesevelam
• Crizotinib
• Cyclacillin
• Cyclobenzaprine
• Cyclosporine
• Dabrafenib
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexamethasone
• Dexmedetomidine
• Dicloxacillin
• Dipyrone
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxycycline
• Droperidol
• Ebastine
• Efavirenz
• Elagolix
• Elvitegravir
• Enasidenib
• Encorafenib
• Entrectinib
• Enzalutamide
• Eribulin
• Erythromycin
• Escitalopram
• Eslicarbazepine Acetate
• Etrasimod
• Etravirine
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Fosamprenavir
• Fosaprepitant
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Grazoprevir
• Griseofulvin
• Guar Gum
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Indinavir
• Inotuzumab Ozogamicin
• Isotretinoin
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lapatinib
• Lefamulin
• Lenvatinib
• Lesinurad
• Levofloxacin
• Lixisenatide
• Lofexidine
• Lopinavir
• Lorlatinib
• Lumacaftor
• Lumefantrine
• Macimorelin
• Mavacamten
• Mefloquine
• Mephobarbital
• Meropenem
• Methadone
• Methohexital
• Methotrimeprazine
• Metronidazole
• Mifepristone
• Minocycline
• Mirtazapine
• Mitapivat
• Mitotane
• Mizolastine
• Mobocertinib
• Modafinil
• Moricizine
• Moxifloxacin
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafarelin
• Nafcillin
• Nelfinavir
• Nevirapine
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxacillin
• Oxaliplatin
• Oxcarbazepine
• Oxytetracycline
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Pentamidine
• Pentobarbital
• Perphenazine
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pimavanserin
• Pipamperone
• Pitolisant
• Ponesimod
• Posaconazole
• Prednisolone
• Prednisone
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Red Clover
• Relugolix
• Repotrectinib
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Risperidone
• Ritonavir
• Rufinamide
• Saquinavir
• Secobarbital
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Simeprevir
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sugammadex
• Sulpiride
• Sultamicillin
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tazemetostat
• Telaprevir
• Telavancin
• Telithromycin
• Telotristat Ethyl
• Tetrabenazine
• Tetracycline
• Theophylline
• Thiopental
• Thioridazine
• Ticarcillin
• Tigecycline
• Tipranavir
• Tirzepatide
• Tizanidine
• Tolterodine
• Topiramate
• Toremifene
• Trazodone
• Triclabendazole
• Trimipramine
• Triptorelin
• Troglitazone
• Ulipristal
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Voxilaprevir
• Zotepine
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline
• Atazanavir
• Atorvastatin
• Clomipramine
• Diazepam
• Doxepin
• Imipramine
• Lamotrigine
• Licorice
• Lorazepam
• Parecoxib
• Selegiline
• Temazepam
• Triazolam
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal uterine bleeding, not diagnosed or
• Blood clotting disorders, or history of or
• Breast cancer or other hormone-sensitive cancer, known, suspected, or history of or
• Heart attack, recent or
• Liver disease or tumors or
• Stroke—Should not be used in patients with these conditions.

• Alcohol abuse or
• Blood clotting problems, family history of or
• Cigarette smoking or
• Diabetes or
• Hypercholesterolemia (high cholesterol in the blood) or
• Hypertension (high blood pressure) or
• Obesity—Use with caution. May cause side effects to become worse.

• Asthma, history of or
• Depression, history of or
• Epilepsy (seizures) or
• Fluid retention (body swelling) or
• Heart or blood vessel disease or
• Kidney disease or
• Migraine headache or
• Papilledema (swelling of the optic disc of the eyes) or
• Osteoporosis (thinning of the bones) or
• Retinal vascular lesions (eye problem)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Lupaneta Pack® is a kit that contains two medicines: leuprolide injection and norethindrone tablets.

Leuprolide injection is given as a shot into a muscle by a nurse or other trained health professional in a hospital or clinic. It is a long acting form (depot) that may be given once every month or once every 3 months for up to 6 months of treatment.

Norethindrone tablets are to be taken by mouth every day for up to 6 months after you receive your leuprolide injection.

This medicine usually comes with a patient information leaflet. Read the information carefully and make sure you understand them before receiving this medicine. If you have any questions, ask your doctor.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For pain due to endometriosis:
    • Adults—5 mg once a day, for up to 6 months.
    • Children—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check the your progress at regular visits to make sure that this medicine is working properly.

You should not receive this medicine if you are pregnant or may become pregnant. Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control (eg, diaphragm with spermicide, condoms with spermicide, IUD) to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine can cause your bone mineral density to decrease, which may lead to osteoporosis or weakened bones. Talk with your doctor about how this risk will affect you.

Using this medicine may increase your risk of having seizures. Check with your doctor right away if you start to have muscle spasm or jerking of the arms or legs, sudden loss of consciousness, or loss of bladder control.

This medicine may cause depression. Check with your doctor right away if you have discouragement, feeling sad or empty, irritability, lack or appetite, loss of interest or pleasure, tiredness, trouble concentrating, or trouble sleeping.

Call your doctor right away if you have sudden loss of vision, double vision, bulging eyes, or a migraine headache.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Crying

depersonalization

dysphoria

euphoria

feeling of warmth

mental depression

paranoia

quick to react or overreact emotionally

rapidly changing moods

redness of the face, neck, arms, and occasionally, upper chest

sudden sweating

swelling

Incidence not known

Anxiety

bladder pain

bloody or cloudy urine

blurred vision

chest pain or tightness

confusion

cough

dark urine

difficult, burning, or painful urination

difficulty speaking

difficulty swallowing

dizziness or lightheadedness

double vision

fainting

fast heartbeat

flu-like symptoms

frequent urge to urinate

headache

hives or welts

inability to move the arms, legs, or facial muscles

increased sensitivity of the skin to sunlight

itching

joint or muscle pain or stiffness

lower back or side pain

nausea and vomiting

numbness or tingling in the face, arms, or legs

pain in the groin or genitals

pain, redness, or swelling in the arm or leg

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

seizures

severe sunburn

sharp back pain just below the ribs

skin rash

slow or fast heartbeat

slow speech

stomach tenderness

sudden shortness of breath or trouble breathing

sweating

thoughts or attempts at killing oneself

trouble breathing

trouble sleeping

trouble thinking or walking

unusual tiredness or weakness

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

being forgetful

belching

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

blemishes on the skin

bloated or full feeling

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

changes in appetite

decreased interest in sexual intercourse

diarrhea

difficulty having a bowel movement (stool)

excess air or gas in the stomach or intestines

feeling of constant movement of self or surroundings

hair loss or thinning of the hair

headache, severe and throbbing

heartburn

inability to have or keep an erection

indigestion

lack or loss of strength

loss in sexual ability, desire, drive, or performance

pain or tenderness from the breasts

passing gas

pimples

sensation of spinning

stomach discomfort, upset, or pain

weight gain

Less common

Absent missed or irregular menstrual periods

itching of the vagina or genital area

pain during sexual intercourse

stopping of menstrual bleeding

thick, white vaginal discharge with no odor or with a mild odor

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.