Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Lupaneta Pack

Descriptions


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.

This product is available in the following dosage forms:

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

Before Using

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.

Pregnancy

Information about this leuprolide-and-norethindrone-intramuscular-route-oral-route
Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

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.

  • Amifampridine
  • Bepridil
  • Cisapride
  • Dronedarone
  • 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.

  • Alfuzosin
  • Amiodarone
  • Amitriptyline
  • Anagrelide
  • Apomorphine
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Atazanavir
  • Azithromycin
  • Bedaquiline
  • Carbamazepine
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dasatinib
  • Delamanid
  • Desipramine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Doxepin
  • Droperidol
  • Ebastine
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Famotidine
  • Felbamate
  • Fentanyl
  • Fingolimod
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Formoterol
  • Foscarnet
  • Fosphenytoin
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Hydroquinidine
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Isotretinoin
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Levofloxacin
  • Lumefantrine
  • Mefloquine
  • Methadone
  • Metronidazole
  • Mifepristone
  • Mizolastine
  • Moxifloxacin
  • Nelfinavir
  • Nilotinib
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Ondansetron
  • Paliperidone
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Perflutren Lipid Microsphere
  • Perphenazine
  • Pipamperone
  • Posaconazole
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Rilpivirine
  • Risperidone
  • Ritonavir
  • Sertindole
  • Sertraline
  • Sevoflurane
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Tetrabenazine
  • Theophylline
  • Tizanidine
  • Tolterodine
  • Toremifene
  • Trazodone
  • Trimipramine
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Venlafaxine
  • Vilanterol
  • Vinflunine
  • Voriconazole
  • Vorinostat

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.

  • Alprazolam
  • Amprenavir
  • Aprepitant
  • Atazanavir
  • Bacampicillin
  • Betamethasone
  • Bexarotene
  • Bosentan
  • Colesevelam
  • Cyclosporine
  • Darunavir
  • Delavirdine
  • Etravirine
  • Fosamprenavir
  • Fosaprepitant
  • Fosphenytoin
  • Griseofulvin
  • Lamotrigine
  • Licorice
  • Modafinil
  • Mycophenolate Mofetil
  • Mycophenolic Acid
  • Nelfinavir
  • Oxcarbazepine
  • Phenobarbital
  • Phenytoin
  • Pioglitazone
  • Prednisolone
  • Primidone
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Rosuvastatin
  • Rufinamide
  • Selegiline
  • St John's Wort
  • Telaprevir
  • Topiramate
  • Troglitazone
  • 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.
  • 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.
  • Blood clotting problems, family history of 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.

Proper Use

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.

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.

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

It is very important that you return to your doctor’s office at the right time for your leuprolide injections. Be sure to keep all appointments.

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. Anaphylaxis can be life-threatening and requires 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.

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

Tell your doctor if you drink alcohol on a regular basis, or if you smoke or use tobacco products.

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

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

  1. Crying
  2. depersonalization
  3. dysphoria
  4. euphoria
  5. feeling of warmth
  6. mental depression
  7. paranoia
  8. quick to react or overreact emotionally
  9. rapidly changing moods
  10. redness of the face, neck, arms, and occasionally, upper chest
  11. sudden sweating
  12. swelling

Incidence not known

  1. Anxiety
  2. bladder pain
  3. bloody or cloudy urine
  4. blurred vision
  5. chest pain
  6. confusion
  7. convulsions
  8. cough
  9. dark urine
  10. difficult, burning, or painful urination
  11. difficulty speaking
  12. difficulty swallowing
  13. dizziness or lightheadedness
  14. double vision
  15. fainting
  16. fast heartbeat
  17. flu-like symptoms
  18. frequent urge to urinate
  19. headache
  20. hives or welts
  21. inability to move the arms, legs, or facial muscles
  22. increased sensitivity of the skin to sunlight
  23. itching
  24. joint or muscle pain or stiffness
  25. lower back or side pain
  26. nausea and vomiting
  27. numbness or tingling in the face, arms, or legs
  28. pain in the groin or genitals
  29. pain, redness, or swelling in the arm or leg
  30. pounding in the ears
  31. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  32. redness of the skin
  33. right upper quadrant tenderness
  34. severe sunburn
  35. sharp back pain just below the ribs
  36. skin rash
  37. slow or fast heartbeat
  38. slow speech
  39. sudden shortness of breath or trouble breathing
  40. sweating
  41. thoughts or attempts at killing oneself
  42. tightness in the chest
  43. trouble breathing
  44. trouble sleeping
  45. trouble thinking or walking
  46. unusual tiredness or weakness
  47. 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

  1. Acid or sour stomach
  2. being forgetful
  3. belching
  4. 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
  5. blemishes on the skin
  6. bloated or full feeling
  7. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  8. changes in appetite
  9. decreased interest in sexual intercourse
  10. diarrhea
  11. difficulty having a bowel movement (stool)
  12. excess air or gas in the stomach or intestines
  13. feeling of constant movement of self or surroundings
  14. hair loss or thinning of the hair
  15. headache, severe and throbbing
  16. heartburn
  17. inability to have or keep an erection
  18. indigestion
  19. lack or loss of strength
  20. loss in sexual ability, desire, drive, or performance
  21. pain or tenderness from the breasts
  22. passing gas
  23. pimples
  24. sensation of spinning
  25. stomach discomfort, upset, or pain
  26. weight gain

Less common

  1. Absent missed or irregular menstrual periods
  2. itching of the vagina or genital area
  3. pain during sexual intercourse
  4. stopping of menstrual bleeding
  5. 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.