Factrel

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 .

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

This product is available in the following dosage forms:

• Powder for Solution


• Kit

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

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 .

Pregnancy

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Gonadotropin-releasing hormone adenomaa€”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 tumora€”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

Proper Use

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.

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 injection dosage form (for Lutrepulse pump):
  
  
  
  • For treating amenorrhea or infertility in women caused by pituitary or hypothalamus problems:
    
    
    
    • Adultsa€”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 agea€”Use and dose must be determined by the doctor .
    
    
    
    
  
  
  
  

• For injection dosage form (single-dose injection):
  
  
  
  • For testing the hypothalamus and pituitary glands:
    
    
    
    • Adultsa€”0.1 milligram (mg) injected once as a single dose under the skin or into a vein .
    
    
    • Children 12 years of age and oldera€”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 agea€”Use and dose must be determined by doctor .
    
    
    
    
  
  
  
  

Precautions

For Lutrepulse pumpa€”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 your are pregnant .

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 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)

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:

Less commonWith single dose

• Abdominal or stomach discomfort


• Flushing (lasting only a short time)


• Headaches


• Lightheadedness


• Nausea

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.