GONADORELIN (Systemic)

Some commonly used brand names are:

In the U.S.?

• Factrel

In Canada?

• Factrel
• Lutrepulse
• Relisorm

Other commonly used names are luteinizinghormone-releasing hormone (LHRH), luteinizinghormone-releasing factor dihydrochloride (for gonadorelinhydrochloride), luteinizing hormone-releasing factor diacetatetetrahydrate (for gonadorelin acetate), and luteinizinghormone-/follicle-stimulating hormone-releasing hormone(LH/FSH-RH).

Category

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

Description

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

Gonadorelin is used to test how well the hypothalamus and the pituitaryglands are working. It is also used to cause ovulation (release of an eggfrom the ovary) in women who do not have regular ovulation and menstrual periodsbecause the hypothalamus gland does not release enough GnRH.

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

Gonadorelin is available in the following dosage form:

Parenteral
• Injection (U.S. and Canada)

Before Using This Medicine

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 followingshould be considered:

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

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

Breast-feeding?It is not known if gonadorelin passes into thebreast milk. Gonadorelin has not been reported to cause problems in nursingbabies.

Children?Gonadorelin, used as a test, has been studied onlyin children 12 years of age and older. The medicine has not caused differentside effects or problems in children 12 years of age and older than it doesin adults. Children up to 12 years of age may not be sensitive to the effectsof gonadorelin. Infants may be very sensitive to the effects of gonadorelinand use in infants is not recommended.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are usinggonadorelin, it is especially important that your health care professionalknow if you are taking any of the following:

• Infertility therapy agents, such as clomiphene (e.g., Clomid)?Whenusing gonadorelin to cause ovulation, the use of other infertility therapyagents at the same time may increase the chance of causing problems of theovaries

Other medical problems?The presence of other medicalproblems may affect the use of gonadorelin. Make sure you tell your doctorif you have any other medical problems, especially:

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

Proper Use of This Medicine

If you arehaving a test done with gonadorelin, one or more samples of your blood willbe 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 begiven at home to patients who do not need to be in the hospital. If you areusing this medicine at home, make sure you clearly understandand carefully follow your doctor's instructions.

For Lutrepulse pump?The Lutrepulse pump is a device containing gonadorelin. It automaticallyinjects the medicine into a vein. The pump will be attached to a belt thatis 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 thencomes down your arm. A needle will be attached to the end of the tubing. Itis inserted into a vein on the inner part of the crook of your elbow. A dressingis used to keep the needle protected. You will need toknow 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 yourabdomen and any tape attached to your stomach and chest without removing thetape, tubing, or needle from your arm. The device is not water-proof. Youwill need to hang it outside on the railing of the shower and carefully showerwithout pulling the needle and tubing from your arm.
• When getting into bed, you must also remove the device from the abdomenas 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 thatit does not fall off the bed. This will give you freedom of movement whilesleeping.
• Know the warning signals that your pump can produce to alert youto problems, such as low battery, among other messages. Do not try to take the pump apart yourself. Call your health care professionalfor directions if warning signals sound.

To care for the injection site:

• Inspect the injection site daily. Report to doctorif the skin at the injection site becomes red or swollen, if you experiencefever or chills, if the needle comes out of your arm, if blood is seen inthe tubing, or if the tubing becomes disconnected from the pump.
• Keep the protective dressing in place over the needle, replacingit 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 securelyin place and to prevent it from kinking.
• The needle should be replaced every 48 hours.

Dosing?The dose of gonadorelin will be different fordifferent 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 pituitaryor hypothalamus problems:
    • Adults?5 microgram (mcg) injected by the pump into a vein orunder 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 orincreased to 20 mcg if needed.
    • Children up to 18 years of age?Use and dose must be determinedby the doctor.

• For injection dosage form (single-doseinjection):
  • For testing the hypothalamus and pituitary glands:
    • Adults?0.1 milligram (mg) injected once as a single dose underthe 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 100mcg, injected once under the skin or into vein.
    • Children up to 12 years of age?Use and dose must be determinedby doctor.

Precautions While Using This Medicine

For Lutrepulse pumpIt is very importantthat your doctor check your progress at regular visits. This will allowthe doctor to see if the medicine is working properly and to decide if youshould 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 willnot result in a pregnancy with twins or triplets.

Tell your doctor when you suspect you are pregnant.

Side Effects of This Medicine

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

With repeated doses

Difficulty in breathing; flushing (continuing); rapid heartbeat

Check with your doctor as soon as possibleif 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 entirebody)

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof 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 effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although not specifically included in productlabeling, gonadorelin is used in certain patients with the following medicalconditions:

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

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