Gonadotropin Releasing Hormone Agonist
Histrelin is a man-made version of a hormone that is similar to the one normally released from the hypothalamus gland in the brain. It works in the brain to reduce the blood levels of sex hormones, such as testosterone and estrogen. The histrelin implant is placed under the skin. The implant 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 where 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. Histrelin works by reducing the amount of sex hormones (eg, estrogen and testosterone) in the blood.
This medicine is available only with your doctor's prescription.
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:
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.
The Vantas® form of histrelin should not be used in children.
Appropriate studies have not been performed on the relationship of age to the effects of the Supprelin® LA form of histrelin in children younger than 2 years of age. Safety and efficacy have not been established.
No information is available on the relationship of age to the effects of histrelin (eg, Supprelin® LA, Vantas®) in geriatric patients.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
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.
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.
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.
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:
A doctor or other trained health professional will give you this medicine. The histrelin implant will be placed under the skin of the upper arm.
Your doctor will treat the upper arm with a numbing medicine 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.
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.
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 comes with patient instructions. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the implant is in the proper place and if it is working properly. Certain medical 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. If you think you have become pregnant while using the medicine, tell your doctor right away.
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.
For male patients:
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before you have medical tests.
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:
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:
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.