Gonadorelin (Intravenous, Injection)

Gonadorelin 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 trigger 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.

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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional if you have 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 compared to 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 its use in infants is not recommended.

Breast Feeding

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

Interactions with Medicines

While some 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 situations, your doctor may want to adjust the dose or take other precautions. When using this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance 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.

• Bepridil
• Cisapride
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Adagrasib
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Buprenorphine
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Delamanid
• Desipramine
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Etrasimod
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Granisetron
• Halofantrine
• Haloperidol
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lumefantrine
• Macimorelin
• Mefloquine
• Methadone
• Metronidazole
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moxifloxacin
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Pimavanserin
• Pipamperone
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Rilpivirine
• Risperidone
• Ritonavir
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tolterodine
• Toremifene
• Trazodone
• Triclabendazole
• Trimipramine
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around the same time as eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Gonadotropin-releasing hormone adenoma—Although this condition is rare, using gonadorelin with this condition may cause issues in the pituitary gland and could lead to sudden blindness.
• Any condition that could be worsened 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 occur from multiple doses of gonadorelin may aggravate a tumor if it relies on estrogens, progestins, or androgens for growth.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require 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 the place of injection
• Hives

With single or repeated doses

• Itching, pain, redness, or swelling of skin at the place of injection
• Skin rash (at the place of injection or over the 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. Your health care professional may also 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, are bothersome, or if you have any questions about them:

Less common

With 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.

In the U.S.

• Factrel

Pharmacologic Class: Gonadotropin Releasing Hormone Agonist

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: 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.