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Leuprolide and norethindrone (Intramuscular route, oral route)

Pronunciation:

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

Brand Names:

  • Lupaneta Pack

Dosage Forms:

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

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersXStudies 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.

Breast-feeding—

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.

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.

  • Tranexamic Acid

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.

  • Carbamazepine
  • Dabrafenib
  • Fentanyl
  • Isotretinoin
  • Theophylline
  • Tizanidine

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 of This Medicine:

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 While Using This Medicine:

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 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
confusion
convulsions
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
right upper quadrant tenderness
severe sunburn
sharp back pain just below the ribs
skin rash
slow or fast heartbeat
slow speech
sudden shortness of breath or trouble breathing
sweating
thoughts or attempts at killing oneself
tightness in the chest
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.


Last Updated: 4/4/2014

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