In the U.S.—

In Canada—

Other commonly used names are luteinizing hormone–releasing hormone; luteinizing hormone–releasing factor dihydrochloride; luteinizing hormone–releasing factor diacetate tetrahydrate; luteinizing hormone–/follicle-stimulating hormone–releasing hormone(LH/FSH-RH).

• Diagnostic aid, hypothalamic-pituitary-gonadal axis function
• Gonadotropin-releasing hormone
• Infertility therapy agent

Gonadorelin ( goe-nad-oh-RELL-in) is a medicine that is the same as gonadotropin-releasing hormone (GnRH) that is naturally released from the hypothalamus gland. GnRH causes the pituitary gland to release other hormones (luteinizing hormone [LH] and follicle-stimulating hormone [FSH]). LH and FSH control development in children and fertility in adults.

Gonadorelin is used to test how well the hypothalamus and the pituitary glands are working. It is also used to cause ovulation (release of an egg from the ovary) in women who do not have regular ovulation and menstrual periods because the hypothalamus gland does not release enough GnRH.

Gonadorelin may also be used for other conditions as determined by your doctor.

Gonadorelin is available in the following dosage form:

Parenteral
• Injection (U.S. and Canada)

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to gonadorelin. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Gonadorelin has not been shown to cause birth defects or problems in humans when given in the first three months of pregnancy. If you become pregnant while using this medicine, there is an increased chance of a multiple pregnancy, such as having twins and triplets. Also, gonadorelin has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding—It is not known if gonadorelin passes into the breast milk. Gonadorelin has not been reported to cause problems in nursing babies.

Children—Gonadorelin, used as a test, has been studied only in children 12 years of age and older. The medicine has not caused different side effects or problems in children 12 years of age and older than it does in adults. Children up to 12 years of age may not be sensitive to the effects of gonadorelin. Infants may be very sensitive to the effects of gonadorelin and use in infants is not recommended.

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 using gonadorelin, it is especially important that your health care professional know if you are taking any of the following:

• Infertility therapy agents, such as clomiphene (e.g., Clomid)—When using gonadorelin to cause ovulation, the use of other infertility therapy agents at the same time may increase the chance of causing problems of the ovaries

• Gonadotropin-releasing hormone adenoma—Although this condition is rare, use of gonadorelin when this condition exists may cause problems in the pituitary gland and could result in sudden blindness
• Any condition that may be made worse by estrogens, progestins, or androgens, such as a hormone-dependent tumor—The increase of estrogens and progestins in women or androgens in men that can result from use of multiple doses of gonadorelin may make a tumor worse if the tumor depends on estrogens, progestins, or androgens for growth

If you are having a test done with gonadorelin, one or more samples of your blood will be taken. Then gonadorelin is given by an intravenous (into a vein) or a subcutaneous (under the skin) injection. At regular times after the medicine is given, more blood samples will be taken. Then the results of the test will be studied.

Some medicines given by injection or by injection pump may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, make sure you clearly understand and carefully follow your doctor's instructions.

For Lutrepulse pump

The Lutrepulse pump is a device containing gonadorelin. It automatically injects the medicine into a vein. The pump will be attached to a belt that is placed around your waist. Tubing from the pump will be taped to your chest, shoulder, and arm, as the tubing goes up your chest to your shoulder and then comes down your arm. A needle will be attached to the end of the tubing. It is inserted into a vein on the inner part of the crook of your elbow. A dressing is used to keep the needle protected. You will need to know how to take care of the equipment and the injection site.

To care for the pump:

• When showering or bathing, remove the belt with the device from your abdomen and any tape attached to your stomach and chest without removing the tape, tubing, or needle from your arm. The device is not water-proof. You will need to hang it outside on the railing of the shower and carefully shower without pulling the needle and tubing from your arm.
• When getting into bed, you must also remove the device from the abdomen as stated above, without removing the tape, tubing, or needle from your arm. Place the device above your pillow, then pin it to your bedsheets so that it does not fall off the bed. This will give you freedom of movement while sleeping.
• Know the warning signals that your pump can produce to alert you to problems, such as low battery, among other messages. Do not try to take the pump apart yourself. Call your health care professional for directions if warning signals sound.

To care for the injection site:

• Inspect the injection site daily. Report to doctor if the skin at the injection site becomes red or swollen, if you experience fever or chills, if the needle comes out of your arm, if blood is seen in the tubing, or if the tubing becomes disconnected from the pump.
• Keep the protective dressing in place over the needle, replacing it if it gets wet or dirty.
• Avoid putting pressure on the needle placed in your arm.
• Carefully keep the tubing taped to your skin to keep it securely in place and to prevent it from kinking.
• The needle should be replaced every 48 hours.

Dosing—

The dose of gonadorelin will be different for different patients. Follow your doctor's orders. The following information includes only the average doses of gonadorelin.

• For injection dosage form (for Lutrepulse pump):
  • For treating amenorrhea or infertility in women caused by pituitary or hypothalamus problems:
    • Adults—5 microgram (mcg) injected by the pump into a vein or under the skin slowly over 1 minute, every ninety minutes for twenty-one days. As determined by doctor, dose may be changed slowly, decreased to 1 mcg or increased to 20 mcg if needed.
    • Children up to 18 years of age—Use and dose must be determined by the doctor.

• For injection dosage form (single-dose injection):
  • For testing the hypothalamus and pituitary glands:
    • Adults—0.1 milligram (mg) injected once as a single dose under the skin or into a vein.
    • Children 12 years of age and older—2 micrograms (mcg) per kilogram (kg) (0.9 mcg per pound) of body weight, not to exceed a single dose of 100 mcg, injected once under the skin or into vein.
    • Children up to 12 years of age—Use and dose must be determined by doctor.

For Lutrepulse pump

It is very important that your doctor check your progress at regular visits. This will allow the doctor to see if the medicine is working properly and to decide if you should continue to use it.

If you are using gonadorelin to help you become pregnant, closely follow your doctor's advice on the best times to have sexual intercourse . Your doctor can help you decide when having sexual intercourse will not result in a pregnancy with twins or triplets.

Tell your doctor when you suspect you are pregnant .

Along with its needed effects, a medicine may cause some unwanted effects. Although the following side effects usually occur rarely with the use of repeated injections, they require immediate medical attention. Get emergency help immediately if any of the following side effects occur:

• With repeated doses
  • Difficulty in breathing;  flushing (continuing) ;  rapid heartbeat 
  
  

Check with your doctor as soon as possible if any of the following side effects occur:

• With repeated doses
  • Hardening of skin at place of injection;  hives 
  
  

• With single or repeated doses
  • Itching, pain, redness or swelling of skin at place of injection ;  skin rash (at place of injection or over entire body) 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• Less common
  • With single dose
    • Abdominal or stomach discomfort;  flushing (lasting only a short time);  headaches;  lightheadedness;  nausea 
    
    

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although not specifically included in product labeling, gonadorelin is used in certain patients with the following medical conditions:

• Delayed puberty
• Infertility in males caused by pituitary or hypothalamus problems

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.