Description
Histrelin is a synthetic (man-made) hormone that is similar to a natural hormone that is produced in the brain. This medicine works in the brain to reduce the blood levels of sex hormones, such as testosterone and estrogen. It is inserted just beneath the skin of the upper arm where it releases small amounts of histrelin in the body every day for 12 months.
Histrelin (Vantas®) is used to treat advanced prostate cancer in adults. It will reduce the level of testosterone, a male hormone, in the blood. Testosterone makes most prostate cancers grow. Histrelin is not a cure for prostate cancer, but it may help relieve the symptoms.
Histrelin (Supprelin® LA) is used to treat central precocious puberty (CPP) in children. CPP is a condition wherein puberty begins at an unusually early age. This usually means puberty occurs before 8 years of age in girls and before 9 years of age in boys.
This medicine is to be given only by or under the direct supervision of a trained healthcare professional.
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
The Vantas® form of histrelin should not be used in children.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Supprelin® LA in children 2 years of age and older. However, use in children younger than 2 years of age is not recommended. Safety and efficacy have not been established.
Geriatric
No information is available on the relationship of age to the effects of Supprelin® LA or Vantas® 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.
- 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:
- Bladder blockage or
- Diabetes or
- Heart attack, history of or
- Heart disease or
- Hyperglycemia (high blood sugar) or
- Kidney problems (reduced urine flow) or
- Nerve problems in the spine from cancer lesions in the bones or
- Problems passing urine or
- Spinal cord problems or
- Stroke, history of—Use with caution. May make these conditions worse in men.
- Brain tumor, history of or
- Seizures or epilepsy, history of—Use with caution. May cause side effects to become worse.
- Congestive heart failure or
- Electrolyte imbalance or
- Heart rhythm problems (eg, congenital long QT syndrome)—May cause side effects to become worse.
- Depression, history of or
- Mental illness, history of—Use with caution. May make these conditions worse.
Proper Use
A doctor or other trained health professional will give you this medicine. The histrelin implant will be placed under the skin in the inner area of the upper arm.
Your doctor will treat the upper arm with a numbing medicine (anesthetic) and then cut a small incision to insert the implant. The incision will be closed with either stitches or surgical strips. A pressure bandage will be placed over the arm and left in place for 24 hours.
Do not remove the surgical strips. Allow them to fall off on their own after several days. If the incision has been stitched, your doctor will remove the stitches or they will dissolve after several days.
After the implant is inserted, you should keep the arm clean and dry. Do not swim or bathe for 24 hours. You should avoid any heavy lifting or strenuous exercise for the first 7 days after the implant is inserted.
The implant will be left in place for one year (12 months) and then removed. If needed, your doctor will insert a new implant to continue treatment for another year.
This medicine may come with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
Precautions
It is very important that your doctor check the progress of you or your child at regular visits to make sure the implant is in the proper place and is working properly. Blood tests may be needed 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. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
You may have some pain, redness, or bruising at the site where the implant is placed. If your arm has not healed within 2 weeks after you received the implant or if you continue to have redness or pain, call your doctor.
For children using Supprelin® LA:
- The 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 and breast enlargement in girls. If your child's symptoms do not improve within 4 weeks, or if they get worse, call your doctor.
- This medicine may cause some children to be agitated, irritable, or display other abnormal behaviors. Make sure the doctor knows if your child is having trouble sleeping, gets upset easily, has a big increase in energy, or starts 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.
For male patients:
- When you start using Vantas®, some of your symptoms might get worse for a short time. You might also have new symptoms such as bone pain, back pain, a tingling or numbness in the body, blood in the urine, or trouble urinating. The symptoms should improve in a few weeks. Tell your doctor if you have any new symptoms or your symptoms get worse.
- This medicine may cause your blood sugar level to increase. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.
- This medicine may increase your risk of having a heart attack or stroke. Check with your doctor right away if you have chest pain or discomfort, difficulty with speaking, headache, pain or discomfort in the arms, jaw, back or neck, sweating, trouble breathing, or vomiting while using the 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 such as QT prolongation.
- This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
Before you have any medical tests, tell the medical doctor in charge that you are using histrelin implant. 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:
Rare
- Bloody urine
- decreased frequency or amount of urine
- increased thirst
- loss of appetite
- lower back or side pain
- nausea
- swelling of the face, fingers, or lower legs
- trouble breathing
- unusual tiredness or weakness
- vomiting
- weight gain
Incidence not known
- Bloating of the stomach
- blurred or double vision
- change in ability to see colors, especially blue or yellow
- dark urine
- discouragement
- dizziness
- eye pain
- feeling sad or empty
- irritability
- light-colored stools
- loss of interest or pleasure
- seizures
- severe headache
- stomach pain
- trouble concentrating
- trouble sleeping
- yellow eyes or skin
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 testicle size
- feeling of warmth
- local infection, irritation, pain, redness, or swelling on the skin where the implant was placed
- redness of the face, neck, arms, and upper chest
- sudden sweating
Less common
- Decreased interest in sexual intercourse
- difficulty having a bowel movement
- flushing or redness of the skin
- headache
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
- swelling of the breast or breast soreness in both females and males
- unusually warm skin
Rare
- Bruising
- confusion
- constipation
- depression
- difficulty in moving
- dry mouth
- general feeling of discomfort or illness
- metallic taste
- muscle pain, stiffness, or weakness
- night sweats
- pain in the joints
- pale skin
- thirst
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
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.
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