Trelstar Depot (Intramuscular)

Triptorelin is used to treat advanced prostate cancer in men. It is a hormone similar to one that is usually released from the hypothalamus gland in the brain. When given regularly to men, triptorelin lowers testosterone levels, which helps treat prostate cancer.

Triptorelin is also used to treat central precocious puberty (CPP), a condition that causes early puberty in boys (before 9 years of age) and girls (before 8 years of age).

This medicine should only be given by a doctor or under a doctor's supervision.

It is very important that your doctor checks your progress at regular visits to ensure that this medicine is working properly. You may need blood and urine tests to check for unwanted effects.

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 after receiving the medicine.

Patients receiving triptorelin injection for advanced prostate cancer:

• When you first start using this medicine, some of your symptoms might worsen or you might experience new symptoms for a short period. Tell your doctor right away if you have bone pain, back pain, tingling or numbness in the body, blood in the urine, or trouble urinating.
• Contact your doctor immediately if you notice any changes in 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, such as QT prolongation.
• This medicine may cause changes in your blood sugar levels. Check with your doctor if you notice a change in your blood or urine sugar test results.
• This medicine may increase your risk of having a heart attack or stroke. Call your doctor right away if you experience chest pain or discomfort, pain or discomfort in the arms, jaw, back, or neck, nausea, sweating, trouble breathing, or vomiting.

Patients receiving triptorelin injection for central precocious puberty (CPP):

• This medicine can cause a temporary 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 worsen, call your doctor.
• Monitor your child's height every 3 to 6 months while they are being treated with this medicine.
• This medicine may cause your child to be agitated, irritable, or show other unusual behaviors. Make sure the doctor knows if your child has trouble sleeping, gets upset easily, has a significant increase in energy, or starts to act recklessly. Also inform the doctor if your child has sudden or intense 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. Contact your doctor immediately if your child starts to have convulsions, muscle spasms 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. Contact your doctor immediately if your child experiences blurred or double vision, changes in the ability to see colors, especially blue or yellow, persistent 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, inform the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. Here are some important points to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care provider know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on the effects of triptorelin injection for treating advanced prostate cancer in children. Its safety and effectiveness for this purpose have not been established.

There have not been appropriate studies showing any pediatric-specific problems that would limit the use of triptorelin injection for treating central precocious puberty in children aged 2 years and older. Its safety and efficacy have not been established in children younger than 2 years old.

Geriatric

There have not been appropriate studies showing any geriatric-specific problems that would limit the use of triptorelin injection for treating advanced prostate cancer in older adults.

No information is available on how age affects the use of Triptodur® in older adults.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction might occur. If you are receiving this medicine, it is very important that your healthcare provider knows if you are taking any of the medicines listed below. The following interactions are significant and are not necessarily all-inclusive.

It is not recommended to use this medicine with any of the following medicines. 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, 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

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk with your healthcare provider about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect how this medicine works for you. Make sure to inform your doctor about any other medical issues you have, especially:

• Bladder blockage or
• History of depression or
• Diabetes or
• Heart or blood vessel disease or
• Hyperglycemia (high blood sugar) or
• History of mental illness or
• Spinal cord problems—Use with caution. This may worsen these conditions.

• History of brain or brain vessel problems or tumors or
• History of seizures—May increase the risk of having seizures.

• Congestive heart failure or
• Electrolyte imbalance or
• Heart rhythm problems (e.g., congenital long QT syndrome)—May worsen side effects.

• Kidney disease or
• Liver disease—Use with caution. The effects may be stronger due to slower elimination of the medicine from your body.

Along with its necessary benefits, this medicine may cause some unwanted effects. Not all of these side effects will occur, but if they do, they may require medical attention.

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

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
• 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
• 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Also, your health care professional may help you find ways to prevent or lessen 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.

In the U.S.

• Trelstar
• Trelstar Depot
• Trelstar LA
• Triptodur

Available Dosage Forms:

• Powder for Suspension
• Powder for Suspension, 6 Month

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Luteinizing Hormone Releasing Hormone Agonist

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.

• How long can I take Trelstar (triptorelin) for prostate cancer?
• Why is triptorelin used for prostate cancer?