Brand Names:

• Supprelin LA
• Vantas

Dosage Forms:

• Kit
• Implant

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Histrelin

Uses of This Medicine:

Histrelin is a type of medicine called a gonadotropin-releasing hormone (GnRH) antagonist. Histrelin (Vantas™) lowers the male hormone testosterone in your blood. Testosterone makes most prostate cancers grow. The histrelin implant is a drug-delivery system that contains the medicine histrelin and is placed under the skin. After it is placed under the skin it releases histrelin to the body continuously for 12 months. Histrelin is not a cure for prostate cancer but it may help to relieve the symptoms of prostate cancer.

Histrelin (Supprelin® LA) is also used to treat central precocious puberty (CPP), a condition in which puberty begins at an unusually early age (before 8 years of age in girls and before 9 years of age in boys). It works by reducing the amount of hormones in the blood to delay early puberty. Signs of early puberty may include breast enlargement, pubic and underarm hair, and rapid height increase .

This medicine is available only with your doctor's prescription.

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—

Histrelin (Vantas™) is not for use in children.

Appropriate studies have not been performed on the relationship of age to the effects of histrelin (Supprelin® LA) in children below 2 years of age. Safety and efficacy have not been established .

Older adults—

This medicine has been tested and has not been shown to cause different side effects or other problems in older people than it does in younger adults.

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.

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

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:

• Nerve problems caused by bone lesions in spine or
• Problems in passing urine—Conditions may get worse for a short time after histrelin treatment is started.

Proper Use of This Medicine:

Histrelin comes with patient instructions. Read these instructions carefully.

This medicine is an implant that is surgically placed under the skin of the upper arm. Your doctor will treat the arm with numbing medicine and then cut a small incision to insert the implant with a special tool. The incision will be closed either with stitches or surgical strips. A pressure bandage will be placed over the arm and should be left on for 24 hours .

Do not remove any surgical strips, rather 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 put in place, you or your child should keep the arm clean and dry, and should not swim or bathe for 24 hours. You or your child should avoid any heavy lifting or strenuous exercise for the first 7 days after the implant is put into the arm.

The implant will be left in place for one year and then removed. If needed, your doctor will then insert a new implant to continue treatment for another year.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to ensure histrelin implant is in place and functioning in your body.

This medicine may cause loss in bone mineral density with extended treatment. Loss in bone mineral density can lead to the thinning of bones (osteoporosis). If you have any questions about this, ask your doctor.

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 .

Histrelin (Supprelin® LA) can cause a brief increase in some hormones, and 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. .

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 as soon as possible if any of the following side effects occur:

Rare

Bloody urine

decreased frequency or amount of urine

increased blood pressure

increased thirst

loss of appetite

lower back or side pain

nausea

swelling of face, fingers, or lower legs

trouble breathing

unusual tiredness or weakness

vomiting

weight gain

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 of skin

redness of the face, neck, arms and occasionally, upper chest

sudden sweating

Less common

Decreased interest in sexual intercourse

difficulty having a bowel movement (stool)

flushing, redness of 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

unable to sleep

unusually warm skin

Rare

Redness, feeling of heat

swelling

Reported during clinical trials

Abnormal ejaculation

appetite increased

bone pain

breast pain

breast tenderness

burning while urinating

cholesterol in the blood

collection of blood under the skin

confusion

dark urine

deep dark purple bruise

difficult or painful urination

difficulty in moving

discouragement

dizziness

dry mouth

dullness

extra heartbeat

fast, irregular, pounding, or racing heartbeat or pulse

feeling cold

feeling of sluggishness

feeling sad or empty

fever with or without chills

food craving

general feeling of discomfort or illness

incoherent speech

increased need to urinate

irritability

itching or pain of the genital area

itching, pain, redness, or swelling

joint pain

large, flat, blue or purplish patches in the skin

light-colored stools

loss if interest of pleasure

metallic taste

muscle aching or cramping

muscle pain or stiffness

muscle twitching

muscle weakness

neck pain

night sweats

noisy, rattling breathing

pain

pain in limb

pain or burning while urinating

pale skin shakiness in legs, arms, hands, or feet

shortness of breath

stent occlusion

stomach pain

stomach soreness or discomfort

sweating increased

swollen joints

tightness in chest

tingling of hands and feet

trembling or shaking of hand or feet

trouble concentrating

trouble sleeping

unusual bleeding or busing

unusual drowsiness

unusual weight loss

wheezing

yellow eyes or skin