Histrelin implant

Histrelin comes as an implant (a small, thin, flexible tube containing medication) that is inserted by a doctor on the inside of the upper arm. The doctor will use a medication to numb the arm, make a small cut in the skin, then insert the implant subcutaneously (just under the skin). The cut will be closed with stitches or surgical strips and covered with a bandage. The implant may be inserted every 12 months. After 12 months, the current implant should be removed and can be replaced with another implant to continue treatment. Histrelin implant (Supprelin LA) when used in children with precocious puberty, will likely be stopped by your child's doctor before 11 years of age in girls and 12 years of age in boys.

Keep the area around the implant clean and dry for 24 hours after insertion. Do not swim or bathe during this time. Leave the bandage in place for at least 24 hours. If surgical strips are used, leave them on until they fall off on their own. Avoid heavy lifting and physical activity (including heavy play or exercise for children) with the treated arm for 7 days after receiving the implant. Avoid bumping the area around the implant for a few days after insertion.

Histrelin may cause an increase in certain hormones in the first few weeks after insertion of the implant. Your doctor will monitor you carefully for any new or worsening symptoms during this time.

Sometimes histrelin implant is hard to feel under the skin so the doctor may have to use certain tests, such as ultrasound or MRI scans (radiology techniques designed to show the images of body structures) to find the implant when it is time to remove it. Occasionally, histrelin implant may come out through the original insertion site on its own. You may or may not notice this happening. Call your doctor right away if you think this may have happened to you.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

If you miss an appointment to receive an implant of histrelin or to have histrelin implant removed, you should call your healthcare provider right away to reschedule your appointment. If continuing treatment, the new histrelin implant should be inserted within a few weeks.

You should not receive this medicine if you are allergic to histrelin or to similar hormone medications such as leuprolide (Lupron, Eligard, Viadur), nafarelin (Synarel), or ganirelix (Antagon).

Vantas should not be used in women or children.

Do not use histrelin if you are pregnant. It could harm the unborn baby or cause a miscarriage. Use effective birth control to prevent pregnancy and tell your doctor right away if you become pregnant. Vantas is not for use in women.

To make sure Supprelin LA is safe for you, tell your doctor if you have ever had:

• mental illness or psychosis;

• epilepsy or other seizure disorder;

• a tumor or blood vessel disorder in your brain; or

• if you take a medicine that can cause seizures (such as an antidepressant).

To make sure Vantas is safe for you, tell your doctor if you have ever had:

• painful or difficult urination;

• diabetes;

• heart problems, heart attack, or stroke;

• a personal or family history of long QT syndrome;

• an electrolyte imbalance (such as low levels of potassium in your blood);

• low bone mineral density (osteoporosis); or

• a condition affecting your spine.

It is not known whether histrelin passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Supprelin LA should not be used in a child younger than 2 years old. Vantas is not approved for use by anyone younger than 18 years old.

Histrelin is given in a tiny implant inserted under the skin on the inside of your upper arm. You will receive this implant with a minor surgical procedure in a clinic or doctor's office.

It is best to place the implant into your non-dominant arm (your left arm if you are right-handed). Be sure to tell your doctor which arm you use most often.

While lying on your back, your arm will be positioned with your elbow bent and held still while the implant is inserted. The skin of your upper arm will be treated with a numbing medicine to keep you from feeling pain during the insertion. Once your arm is numb, your doctor will use a scalpel to cut a small incision where the implant will be inserted.

The histrelin implant is inserted using a special tool that pushes the implant into place through the incision in your skin. After injecting the implant and removing the insertion tool, your doctor will then feel your arm to make sure the implant has been correctly placed.

The incision in your skin may be closed with stitches or surgical strips. Follow your doctor's instructions about caring for the incision and keeping it bandaged and clean until it heals completely. Keep your arm dry for at least 24 hours.

You will most likely be able to feel the implant through your skin, but it should not cause pain or discomfort.

A histrelin implant is usually left in place for 12 months and then must be removed through a surgical incision. Do not try to remove the implant yourself. Your doctor will determine whether you need another implant for continued treatment.

Call your doctor if you have any pain, swelling, tenderness, itching, tingling, bruising, or redness where the implant was inserted, or if the implant comes through the skin or falls out.

You may have a temporary increase in precocious puberty symptoms for a week or so after you have received the Supprelin LA implant.

To be sure this medicine is helping your condition, you may need frequent blood tests. Your blood work will help your doctor determine how long to treat you with histrelin.

Histrelin can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using histrelin.

For at least 7 days after your implant is inserted, avoid strenuous exercise or heavy lifting.

Irritation at the implant site (such as bruising, pain, redness), mood swings, or headache may occur. In men using this medication for prostate cancer, hot flashes (flushing), increased sweating, night sweats, tiredness, swelling of the ankles/feet, or constipation may occur. In girls using this medication for early puberty, breast tenderness or abnormal vaginal bleeding may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Infrequently, breast tenderness/swelling may occur in men and boys as a result of lowered testosterone levels. Shrinking of the testicles and reduced sexual interest/ability may also occur in men. Talk to your doctor if these effects occur.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

If you are a man using this medication for prostate cancer, tell your doctor right away if you have any serious side effects, including: new/worsening bone pain, easily broken bones, increased thirst/urination.

Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, fast/irregular heartbeat, severe dizziness, fainting, weakness on one side of the body, slurred speech, seizures.

Rarely, a very serious problem with the pituitary gland (pituitary apoplexy) has been reported with similar drugs, usually in the first 2 weeks after starting treatment. Get medical help right away if any of these very serious side effects occur: sudden severe headache, sudden severe mental/mood changes (e.g., severe confusion, difficulty concentrating), vision changes, severe vomiting, fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Data not available

More common side effects

The more common side effects of Vantas include:

• hot flashes

• tiredness

• skin reactions at the implent insertions site

• testicles becoming smaller

• urnination problems

• breast enlargement

• erectile dysfunction (impotence)

• constipation

• headache

The more common side effects of Supprelin LA include:

• bruising, soreness, pain, tingling, itching, or swelling at the insertion site

• light vaginal bleeding or breast enlargement in girls during the first few weeks

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 9-1-1 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects of Vantas and their symptoms can include the following:

• Increased levels of testosterone. Symptoms can include:

  • bone pain
  • weakness or numbness in your legs
  • blood in your urine
  • trouble urinating

• High blood sugar. Symptoms can include:

  • frequent urination
  • increased thirst
  • blurry vision
  • headaches
  • increased tiredness

• Heart attack. Symptoms can include:

  • chest pain
  • shortness of breath
  • discomfort in your upper body

• Stroke. Symptoms can include:

  • weakness in one part or side of your body
  • slurred speech