Leuprolide and norethindrone (Intramuscular, Oral)

Generic name: leuprolide and norethindrone [ LOO-proe-lide-AS-e-tate, nor-ETH-in-drone-AS-e-tate ]
Brand name: Lupaneta Pack
Drug class: Sex hormone combinations

Medically reviewed by Drugs.com. Last updated on Aug 7, 2024.

Uses for leuprolide and norethindrone

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 leuprolide and norethindrone

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.

Pediatric

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.

Geriatric

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.

Interactions with 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
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
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

Interactions with Food/Tobacco/Alcohol

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

Proper use of leuprolide and norethindrone

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 leuprolide and norethindrone

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 leuprolide and norethindrone

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