Pronunciation:

trip-toe-REL-in

Brand Names:

• Trelstar
• Trelstar Depot
• Trelstar LA
• Triptodur

Dosage Forms:

• Powder for Suspension
• Powder for Suspension, 6 Month

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Luteinizing Hormone Releasing Hormone Agonist

Uses of This Medicine:

Triptorelin is used to treat advanced prostate cancer in men. 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.

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.

Children—

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.

Older adults—

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.

Breast-feeding—

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.

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 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
• 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

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 of This Medicine:

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 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. 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.
• Talk with your doctor before using this medicine if you plan to have children. Some men 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 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 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

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 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.