Description
Goserelin is a hormone similar to the one normally released from the hypothalamus gland in the brain. It is used to treat a number of medical problems. These include:
- Cancer of the prostate in men
- Cancer of the breast in women if it develops before or around the time of menopause
- Endometriosis, a painful condition caused by extra tissue growing inside or outside of the uterus, and
- Thinning of the lining of the uterus before surgery on the uterus.
When given regularly as an implant, goserelin works every day to decrease the amount of estrogen and testosterone in the blood.
Reducing the amount of estrogen in the body is one way of treating endometriosis and cancer of the breast, and can help thin the uterus lining before surgery. Goserelin prevents the growth of tissue associated with endometriosis in adult women during treatment and for up to 6 months after treatment is discontinued.
Reducing the amount of testosterone in the body is one way of treating cancer of the prostate.
Suppressing estrogen can thin the bones or slow their growth. This is a problem for adult women whose bones are no longer growing like the bones of children. This is why goserelin is used only for up to 6 months in adult women treated for endometriosis.
This medicine is to be given only by or under the supervision of your doctor.
This product is available in the following dosage forms:
- Implant
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
Appropriate studies have not been performed on the relationship of age to the effects of goserelin in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of goserelin in elderly men. However, safety and efficacy have not been established for elderly women.
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. When you are receiving 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.
- 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 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.
- 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
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:
- Alcohol abuse or
- Osteoporosis, family history of or
- Tobacco cigarette smoking—May increase risk for osteoporosis (thinning of the bones).
- Depression, history of or
- Diabetes or
- Electrolyte imbalance or
- Heart attack, recent or
- Heart or blood vessel problems or
- Heart rhythm problems (eg, long QT syndrome), family history of or
- Hypercalcemia (high calcium in the blood) or
- Hyperglycemia (high blood sugar) or
- Stroke, history of—Use with caution. May make these conditions worse.
- Nerve problems caused by bone lesions in the spine (in treatment of cancer of the prostate) or
- Problems in passing urine (in treatment of cancer of the prostate)—Conditions may get worse for a short time after goserelin treatment is started.
Proper Use
A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under your skin near your stomach. This medicine may be given once every 28 days or once every 3 months. Your schedule depends on the reason you are using this medicine. To stay on the right schedule with the medicine, make sure you keep all appointments.
It is very important that you continue to receive the medicine, even after you begin to feel better.
Precautions
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.
For female patients: You should not receive this medicine if you are pregnant or may become pregnant. Using this medicine while you are pregnant can harm your unborn baby. Your birth control pills may not work as well while you are receiving this medicine. Use a nonhormonal form of birth control together with your pills to keep from getting pregnant while you are receiving this medicine and for at least 12 weeks after treatment. Nonhormonal birth control includes vaginal spermicides, condoms, diaphragms, and cervical caps. If you think you have become pregnant while using the medicine, tell your doctor right away.
For female patients: During the time you are receiving goserelin, your menstrual period may not be regular or you may not have a menstrual period at all. This is to be expected when being treated with this medicine. If regular menstrual periods continue during treatment or do not begin within 2 to 3 months after you stop using this medicine, check with your doctor.
When you first start using this medicine for cancer treatment, some of your symptoms might get worse for a short time. You might also have new symptoms. You might have bone pain, back pain, or trouble urinating. These symptoms should improve within a few weeks. Tell your doctor if you have any new symptoms or your symptoms get worse.
For male patients: This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.
For male patients: This medicine may increase risk of having a heart attack or stroke. Check with your doctor right away if you have chest pain or discomfort, confusion, double vision, headache, nausea or vomiting, slow speech, sweating, trouble speaking, or trouble moving the arms, legs, or facial muscles.
This medicine can cause decreases in bone mineral density, which may lead to osteoporosis or weakened bones. Talk with your doctor about how this risk will affect you.
This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem including QT prolongation.
Injection site injury (eg, pain, hematoma, hemorrhage, and hemorrhage shock) may occur after receiving this medicine. Call your doctor right away if you have abdominal or stomach pain, bloated or full feeling, lightheadedness, dizziness, or fainting, or trouble breathing.
This medicine may cause depression especially in women. Check with your doctor right away if you have discouragement, feeling sad or empty, irritability, lack of appetite, loss of interest or pleasure, tiredness, trouble concentrating, or trouble sleeping.
Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.
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 or nurse immediately if any of the following side effects occur:
For all adults
More common
- Discouragement
- feeling sad or empty
- lack of appetite
- loss of interest or pleasure
- tiredness
- trouble concentrating
- trouble sleeping
Less common
- Bladder pain
- bloody or cloudy urine
- blurred vision
- difficult, burning, or painful urination
- dizziness
- fast or irregular heartbeat
- frequent urge to urinate
- headache
- lower back or side pain
- nervousness
- pounding in the ears
- slow or fast heartbeat
- trouble in urinating
Rare
- Bone, muscle, or joint pain
- changes in skin color of the face
- chest tightness
- fainting
- fast or irregular breathing
- numbness or tingling of the hands or feet
- puffiness or swelling of the eyelids or around the eyes
- skin rash, hives, or itching
- sudden, severe decrease in blood pressure and collapse
- trouble breathing
For females only
More common
- Breast pain
- itching of the vaginal or genital area
- pain during sexual intercourse
- thick, white vaginal discharge with no odor or with a mild odor
Rare
- Anxiety
- deepening of voice
- increased hair growth
- mental depression
- mood changes
For males only
More common
- Abnormal ejaculation
- black, tarry stools
- blood in the stools
- bloody or cloudy urine
- continuing diarrhea
- continuing stomach pain
- decreased sexual performance or desire
Less common
- Ankle, knee, or great toe joint pain
- anxiety
- breast swelling and tenderness
- chest pain or discomfort
- chills
- cold hands and feet
- constipation
- dry mouth
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- increased weight
- joint stiffness or swelling
- nausea
- pain or discomfort in the arms, jaw, back, or neck
- pale skin
- swelling of the face, fingers, or lower legs
- unexplained weight loss
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
Rare
- Chest pain
- pain in the groin or legs (especially in the calves of 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:
For all adults
More common
- Sudden sweating and feelings of warmth (also called hot flashes)
Less common
- Blurred vision
- burning, itching, redness, or swelling at the place of injection
- decreased interest in sexual intercourse
- dizziness
- headache
- nausea or vomiting
- swelling and increased tenderness of the breasts
- swelling of the feet or lower legs
- trouble sleeping
- weight gain
For females only
More common
- Back pain
- body aches or pain
- cough
- crying
- depersonalization
- difficulty in moving
- dryness or soreness of the throat
- dysphoria
- euphoria
- excessive muscle tone
- increased hair growth, especially on the face
- lack or loss of strength
- light, irregular vaginal bleeding
- muscle aches, stiffness, pains, or cramps
- paranoia
- quick to react or overreact emotionally
- rapidly changing moods
- stopping of menstrual periods
- stuffy or runny nose
- tender, swollen glands in the neck
- trouble in swallowing
- voice changes
Less common
- Acid or sour stomach
- belching
- bloated
- bloody nose
- burning, dryness, or itching of the vagina
- dry mouth
- dry skin
- excess air or gas in the stomach or intestines
- full feeling
- heartburn
- impaired vision
- indigestion
- loss or thinning of the hair
- passing gas
- pelvic pain
- stomach discomfort, upset, or pain
For males only
Less common
- Bone pain
- constipation
- decreased size of the testicles
- inability to have or keep an erection
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.
CON-XXXXXXXX
