histrelin Subcutaneous

his-TREL-in

Commonly used brand name(s)

In the U.S.

• Supprelin LA


• Vantas

Available Dosage Forms:

• Kit


• Implant

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Gonadotropin Releasing Hormone Agonist

Uses For histrelin

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.

histrelin is available only with your doctor's prescription.

Before Using histrelin

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 histrelin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to histrelin 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 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.

Geriatric

No information is available on the relationship of age to the effects of histrelin (eg, Supprelin® LA, Vantas®) in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
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.

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.

Interactions with 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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 histrelin. Make sure you tell your doctor if you have any other medical problems, especially:

• 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


• Stroke, history of—Use with caution. May make these conditions worse in men.

Proper Use of histrelin

A doctor or other trained health professional will give you or your child histrelin. 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 or your child 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 or your child 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.

histrelin 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.

Precautions While Using histrelin

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.

For female patients: You should not receive histrelin if you are pregnant or may become pregnant. Using histrelin 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:

• When you start using histrelin, 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.


• histrelin 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.


• histrelin 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; shortness of breath; sweating; or vomiting while using the medicine.

histrelin 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 with breathing


• unusual tiredness or weakness


• vomiting


• weight gain

Incidence not known

• Abdominal or stomach pain


• bloating of the abdomen or stomach


• dark urine


• light-colored stools


• 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, 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 (stool)


• flushing or redness of the skin


• headache


• inability to have or keep an erection


• loss in sexual ability, desire, drive, or performance


• sleeplessness


• swelling of the breast or breast soreness in both females and males


• trouble sleeping


• unusually warm skin

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.

See also: histrelin Subcutaneous side effects (in more detail)

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More histrelin Subcutaneous resources

• Histrelin Subcutaneous Side Effects (in more detail)
• Histrelin Subcutaneous Use in Pregnancy & Breastfeeding
• Histrelin Subcutaneous Drug Interactions
• Histrelin Subcutaneous Support Group
• 3 Reviews for Histrelin Subcutaneous - Add your own review/rating

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