Description
Triptorelin is used to treat advanced prostate cancer. It is a hormone that is similar to the one normally released from the hypothalamus gland in the brain. When given on a regular basis to men, triptorelin decreases testosterone levels which helps treat prostate cancer.
Triptorelin is also used to treat central precocious puberty (CPP), a condition which causes early puberty in boys (before 9 years of age) and girls (before 8 years of age).
This medicine is to be given only by or under the supervision of a doctor.
This product is available in the following dosage forms:
- Powder for Suspension
- Powder for Suspension, 6 Month
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 triptorelin injection to treat advanced prostate cancer in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of triptorelin injection to treat central precocious puberty in children 2 years of age and older. Safety and efficacy have not been established in children younger than 2 years of age.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of triptorelin injection to treat advanced prostate cancer in the elderly.
No information is available on the relationship of age to the effects of Triptodur® in the elderly.
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.
- Bacillus of Calmette and Guerin Vaccine, Live
- Bepridil
- Cisapride
- Dengue Tetravalent Vaccine, Live
- Dronedarone
- Levoketoconazole
- Measles Virus Vaccine, Live
- Mesoridazine
- Mumps Virus Vaccine, Live
- Pimozide
- Piperaquine
- Rubella Virus Vaccine, Live
- Saquinavir
- Smallpox Monkeypox Vaccine
- Sparfloxacin
- Terfenadine
- Thioridazine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
- 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
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Azithromycin
- Bedaquiline
- Buprenorphine
- Ceritinib
- Chloroquine
- Chlorpromazine
- Cholera Vaccine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clothiapine
- Clozapine
- Crizotinib
- Cyclobenzaprine
- Dabrafenib
- Dasatinib
- Delamanid
- Desflurane
- Desipramine
- Deutetrabenazine
- Dexmedetomidine
- Disopyramide
- Dofetilide
- Dolasetron
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:
- Bladder blockage or
- Depression, history of or
- Diabetes or
- Heart or blood vessel disease or
- Hyperglycemia (high blood sugar) or
- Mental illness, history of or
- Spinal cord problems—Use with caution. May make these conditions worse.
- Brain or brain vessel problems or tumors, history of or
- Seizures, history of—May increase the risk for seizures.
- Congestive heart failure or
- Electrolyte imbalance or
- Heart rhythm problems (eg, congenital long QT syndrome)—May cause side effects to become worse.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
A nurse or other trained health professional will give you this medicine. It is given as a shot into your muscle (usually in the buttocks or thighs). This medicine needs to be given on a fixed schedule. Make sure you keep all of your appointments.
Triptodur® comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the medicine.
Patients receiving triptorelin injection for advanced prostate cancer:
- When you first start using this medicine, some of your symptoms might get worse or you might have new symptoms for a short time. Tell your doctor right away if you have bone pain, back pain, a tingling or numbness in the body, blood in the urine, sensation of pins and needles, stabbing pain, or trouble urinating.
- 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.
- This medicine may increase your risk of high blood sugar or cholesterol levels, or non-alcoholic fatty liver disease. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.
- This medicine may increase your risk of having a heart attack or stroke. Call your doctor right away if you have chest pain or discomfort, pain or discomfort in the arms, jaw, back, or neck, nausea, sweating, trouble breathing, or vomiting.
- This medicine may cause seizures. Check with your doctor right away if you have loss of bladder control, muscle spasm or jerking of all extremities, or sudden loss of consciousness.
- Talk with your doctor before using this medicine if you plan to have children. Some males who use this medicine have become infertile (unable to have children).
Patients receiving triptorelin injection for central precocious puberty (CPP):
- This medicine can cause a brief increase in blood levels of some hormones. During this time, you may notice more signs of puberty in your child, including light vaginal bleeding in girls. If your child's symptoms do not improve within 2 months, or if they get worse, call your doctor.
- Monitor your child's height every 3 to 6 months while on treatment with this medicine.
- This medicine may cause your child to be agitated, irritable, or display other abnormal behaviors. Make sure the doctor knows if your child has trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if your child has sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.
- Using this medicine may increase your child's risk of having seizures. Check with your doctor right away if your child starts to have convulsions, muscle spasm or jerking of all extremities, sudden loss of consciousness, or loss of bladder control.
- This medicine may cause intracranial hypertension or pseudotumor cerebri (increased pressure in the head) in children. Check with your doctor right away if your child has blurred or double vision, change in ability to see colors, especially blue or yellow, continuing ringing or buzzing or other unexplained noise in the ears, dizziness, eye pain, hearing loss, nausea and vomiting, or severe headache.
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:
More common
For children
- Diarrhea
- loss of appetite
- nausea
- stomach pain
- weakness
Less common
For children
- Anxiety
- body aches or pain
- chest tightness
- chills
- cough
- cough producing mucus
- difficulty with breathing
- ear congestion
- fever
- general feeling of discomfort or illness
- headache
- joint pain
- loss of voice
- mood or mental changes, including abnormal crying, aggression, agitation, delusions, irritability, nervousness, or restlessness
- muscle aches and pains
- nasal congestion
- runny nose
- shivering
- sneezing
- sore throat
- sweating
- trouble sleeping
- unusual tiredness or weakness
- vomiting
For adult men
- Bladder pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- blurred vision
- chest pain or tightness
- cough producing mucus
- decrease in urine volume or frequency of urination
- difficult or labored breathing
- difficult, burning, or painful urination
- difficulty in passing urine
- dizziness
- dry mouth
- flushed, dry skin
- frequent urge to urinate
- fruit-like breath odor
- headache
- increased hunger
- increased thirst
- increased urination
- loss of consciousness
- lower back or side pain
- nausea
- nervousness
- pale skin
- pounding in the ears
- rapid weight gain
- slow or fast heartbeat
- stomach ache
- sweating
- tingling of the hands or feet
- trouble breathing
- unexplained weight loss
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting
Incidence not known
For children
- Blurred or loss of vision
- change in ability to see colors, especially blue or yellow
- depression
- difficulty with swallowing
- disturbed color perception
- dizziness
- double vision
- eye pain
- halos around lights
- hives, itching, skin rash
- nervousness
- night blindness
- overbright appearance of lights
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- seizures
- slow or fast heartbeat
- thoughts of killing oneself
For adult men
- Anxiety
- changes in skin color
- changes in vision
- chest discomfort
- cold, clammy, or pale skin
- confusion
- dizziness or lightheadedness
- fainting
- inability to speak
- irregular heartbeat
- loss of bladder control
- muscle spasm or jerking of all extremities
- numbness or tingling in the face, arms, or legs
- pain
- pain or discomfort in the arms, jaw, back, or neck
- pain, redness, or swelling in the arm or leg
- seizures
- severe or sudden headache
- slow heart rate
- slurred speech
- sudden loss of consciousness
- temporary blindness
- tenderness
- trouble speaking, thinking, or walking
- weakness in the arm or leg on one side of the body, sudden and severe
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
For children
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- stuffy or runny nose
For adult men
- Bone pain
- chills
- decrease in testicle size
- decreased interest in sexual intercourse
- diarrhea
- feeling of warmth or redness of the face, neck, arms, and occasionally, upper chest
- fever
- general feeling of discomfort or illness
- inability to have or keep an erection
- joint pain
- leg pain
- loss in sexual ability, desire, drive, or performance
- loss of appetite
- muscle aches and pains
- redness of the face, neck, arms, and occasionally, upper chest
- runny nose
- shivering
- sore throat
- sudden sweating
- trouble sleeping
Less common
For children
- Change in hearing
- dryness or soreness of the throat
- ear drainage
- earache
- hoarseness
- itching of the ears
- pain or tenderness around the eyes and cheekbones
- tender, swollen glands in the neck
- voice changes
For adult men
- Back pain
- belching
- body aches or pain
- breast pain
- burning, dry, or itching eyes
- congestion
- crying
- depersonalization
- difficulty having a bowel movement
- difficulty with moving
- discharge or excessive tearing
- dysphoria
- euphoria
- eye pain
- heartburn
- hoarseness
- indigestion
- injection site pain
- itching or rash
- lack or loss of strength
- leg cramps
- loss of appetite
- muscle aching or cramping
- muscle pains or stiffness
- paranoia
- quick to react or overreact emotionally
- rapidly changing moods
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- runny nose
- stomach discomfort, upset, or pain
- swelling of the breasts or breast soreness in both females and males
- swollen joints
- tender, swollen glands in the neck
- trouble swallowing
- voice changes
- weight loss
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.
DRG-20066536
