Pronunciation:

bue-se-REL-in

Dosage Forms:

• Injectable
• Implant
• Spray

Classifications:

Pharmacologic—

Human Follicle Stimulating Hormone

Uses of This Medicine:

Buserelin is used to treat cancer of the prostate gland.

It is similar to a hormone normally released from the hypothalamus gland. When given regularly, buserelin decreases testosterone levels. Reducing the amount of testosterone in the body is one way of treating cancer of the prostate.

Buserelin is available only with your doctor's prescription.

Before Using This Medicine:

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.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of buserelin in the elderly to use in other age groups, it has been used mostly in elderly patients and is not expected to cause different side effects or problems in older people than it does in younger adults.

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 taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance 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.

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

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfuzosin
• Amiodarone
• Amitriptyline
• Anagrelide
• Apomorphine
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Delamanid
• Desipramine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Doxepin
• Droperidol
• Ebastine
• Eribulin
• Erythromycin
• Escitalopram
• Famotidine
• Felbamate
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Granisetron
• Halofantrine
• Haloperidol
• Hydroquinidine
• Ibutilide
• Iloperidone
• Imipramine
• Itraconazole
• Ivabradine
• Ketoconazole
• Lapatinib
• Levofloxacin
• Lumefantrine
• Mefloquine
• Methadone
• Metronidazole
• Mifepristone
• Mizolastine
• Moxifloxacin
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Paliperidone
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perflutren Lipid Microsphere
• Perphenazine
• Pipamperone
• Posaconazole
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Rilpivirine
• Risperidone
• Ritonavir
• Sertindole
• Sertraline
• Sevoflurane
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tizanidine
• Tolterodine
• Toremifene
• Trazodone
• Trimipramine
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voriconazole
• Vorinostat

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.

Proper Use of This Medicine:

Buserelin comes with patient directions. Read these instructions carefully.

For patients using the injection form of this medicine:

• Use the syringes provided in the kit. Other syringes may not provide the correct dose. These disposable syringes and needles are already sterilized and designed to be used one time only and then discarded. If you have any questions about the use of disposable syringes, check with your health care professional.
• After use, dispose of the syringes and needles in a safe manner. If a special container is not provided, ask your health care professional about the best way to dispose of syringes and needles.

For patients using the nasal solution form of this medicine:

• Use the nebulizer (spray pump) provided. Directions about how to use it are included. If you have any questions about the use of the nebulizer, check with your health care professional.

Use this medicine only as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Using too much may increase the chance of side effects, while using too little may not improve your condition.

Buserelin sometimes causes unwanted effects such as hot flashes or decreased sexual ability. It may also cause a temporary increase in pain, trouble in urinating, or weakness in your legs when you begin to use it. However, it is very important that you continue to use the medicine, even after you begin to feel better. Do not stop using this medicine without first checking with your doctor.

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 prostate cancer:
  • For nasal dosage forms:
    • Adults: 200 micrograms (mcg) (2 sprays) into each nostril every eight hours.
  • For injection dosage forms:
    • Adults: In the beginning, 500 mcg (0.5 milligrams [mg]) injected under the skin every eight hours. After a time, your doctor may lower your dose to 200 mcg (0.2 mg) once a day.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Dispose of used syringes properly in the container provided.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Buserelin causes sterility which may be permanent. If you intend to have children, discuss this with your doctor before receiving this medicine.

Side Effects of This Medicine:

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 as soon as possible if any of the following side effects occur:

Bone pain

numbness or tingling of the hands or feet

trouble with urinating

weakness in the legs

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:

More common

Decrease in sexual desire

impotence

sudden sweating and feelings of warmth ("hot flashes")

Less common

Burning, itching, redness, or swelling at the place of injection

diarrhea

dry or sore nose (with nasal solution)

headache (with nasal solution)

increased sweating (with nasal solution)

loss of appetite

nausea or vomiting

swelling and increased tenderness of breasts

swelling of the feet or lower legs

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.