Factrel (Intravenous, Injection)

Gonadorelin is a medicine that is the same as gonadotropin-releasing hormone (GnRH) which is naturally released from the hypothalamus gland. GnRH makes the pituitary gland 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 check how well the hypothalamus and 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 due to insufficient GnRH release from the hypothalamus gland.

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

For Lutrepulse pump—It is very important that your doctor checks your progress at regular visits. This will help the doctor see if the medicine is working properly and to decide if you should keep using 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 determine when having sexual intercourse will not lead to a pregnancy with twins or triplets.

Tell your doctor if you think you might be pregnant.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits of the medicine. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform 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 only been studied in children aged 12 years and older. The medicine has not caused different side effects or problems in children 12 years of age and older compared to adults. Children younger than 12 years may not respond to gonadorelin. Infants may be very sensitive to 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

Some medicines should not be used together at all, while others can be used together even if there may be an interaction. In these cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and may not include all possible interactions.

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 how often you use one or both of the 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

Some medicines should not be taken when eating certain foods or at mealtimes because interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use 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 when this condition exists may cause problems in the pituitary gland and could lead to sudden blindness.
• Any condition that may be worsened by estrogens, progestins, or androgens, such as a hormone-dependent tumor—Using multiple doses of gonadorelin may increase estrogens and progestins in women or androgens in men, which could worsen a tumor if it relies on these hormones for growth.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical attention.

Check with your doctor right away if any of the following side effects happen:

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 happen:

With repeated doses

• Hardening of skin at the injection site
• Hives

With single or repeated doses

• Itching, pain, redness, or swelling of skin at the injection site
• Skin rash (at the injection site or over the entire body)

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your healthcare professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your healthcare 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 happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can 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.