Vantas 50mg Implant

Vantas 50 mg implant

histrelin acetate

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed on this leaflet, please tell your doctor.

In this leaflet:

• 1. What Vantas is and what it is used for


• 2. Before you use Vantas


• 3. How to use Vantas


• 4. Possible side effects


• 5. How to store Vantas


• 6. Further information

What Vantas Is And What It Is Used For

• Vantas is a medicine delivery system which is surgically placed (or implanted) under the skin and contains an active substance called histrelin.



• It is used for the treatment of advanced prostate cancer because it may help to relieve your prostate cancer symptoms.



• Each Vantas implant contains 50 milligrams of histrelin acetate. After insertion under your skin, it releases 41 micrograms of histrelin (equivalent to 50 micrograms of histrelin acetate) per day into your body, over a period of 12 months.



• Histrelin blocks your body from making and secreting hormones so that testosterone levels are reduced or cannot be detected in your blood.

Before You Use Vantas

Do not use Vantas:

• If you are allergic (hypersensitive) to the active substance, histrelin acetate, to other medicines called GnRH (Gonadotropin Releasing Hormone) agonists or to any of the other ingredients. (See section 6 for a list of other ingredients.)



• If you are a woman. Vantas has not been studied in women and is not for use in women.



• If you are a child (under 18). Vantas has not been studied in children and is not for use in children.

If you think any of these apply to you, talk to your doctor before having the implant. Then follow the advice given to you.

Take special care with Vantas

It is possible that your symptoms may get worse or new symptoms occur, during the first week of treatment (See Section 4 - Side Effects). If this happens, phone your doctor immediately.

Taking Vantas with other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, or are thinking of taking any other medicines, including medicines obtained without a prescription. It is not known whether Vantas and other medicines can affect one another.

Pregnancy and breast-feeding

Vantas has not been studied in pregnant or breast-feeding women as it is not for use in women.

Driving and using machines

Immediately after receiving the implant, extra care should be taken when driving, because of the cut and stitches which you have just had.

There have been no studies completed on the effects of Vantas on driving.

Important information about some of the ingredients of Vantas

The container of this medicinal product contains latex rubber. May cause severe allergic reactions.

How To Use Vantas

• Only Vantas implantation device can be used for insertion of the implant.


• The implant is placed under the skin of the inside of your upper arm by your doctor.


• Your doctor will numb your arm, make a small cut (incision) and place the implant under the skin.


• The cut will be closed with stitches and special surgical tape and then covered with a bandage.

During the first week:

• Keep the bandage in place for at least one day.


• Do not remove the surgical steri-strips. Steri-strips look like thread and your doctor used them to close the cut which he made in your skin in order to put the implant in. They will drop off by themselves.


• Avoid heavy lifting and exercising of the treated arm for 7 days after the insertion of the implant.


• For 24 hours after the insertion of the implant, keep the treated arm clean and dry. Do not bathe or swim for 24 hours.

During the first year:

• Remember to see your doctor for routine checks, which are offered to make sure that the implant is still in place and is still working.



• The implant could work its way out of your body through the cut where it was originally put in. This does not happen often. You may actually notice it coming out, or, rarely, it may come out without you noticing it. If you think it has come out, phone your doctor.



• Your doctor will do blood tests to confirm that you are responding to the treatment, for example by having your prostate specific antigen (PSA) or testosterone levels checked.



• After 12 months, the implant must be removed.



• The implant may be difficult to feel under your skin. If it cannot be felt under your skin at the time when it is to be removed, your doctor may order a special test, such as ultrasound or a CT scan, in order to locate it.



• After removal, your doctor may then insert a new implant to continue your treatment.

If you use more Vantas than you should

There have been no reported cases of overdose. The implant is given to you under strict medical supervision.

If you stop using Vantas

If you wish to stop taking this medicine, please talk to your doctor.

If you have any further questions about the use of this product, please ask your doctor.

Possible Side Effects

Like all medicines Vantas can cause side effects, though not everybody gets them.

This medicine can cause an increase in testosterone during the first week after insertion. Your symptoms may get worse for a few weeks. You may get new symptoms.

Contact your doctor immediately if you:

• get new, or worse, bone pain;


• feel weak;


• get feelings of weakness in your legs;


• have blood in your urine;


• have problems urinating or cannot urinate.

You may get some pain, bruising and redness at the place where the implant is inserted, at the time it is being inserted or removed and for a while afterwards. These reactions usually go away within two weeks, without any treatment.

If your incision is not healing but looks and feels as if it is getting worse (bleeding, redness, soreness), contact your doctor.

If you notice any of the following side effects, contact your doctor:

Very common side effects (more than 1 in every 10 patients treated) are:

• hot flushes (reddening of the face and/or neck).

Common side effects (less than 1 in every 10 patients treated) are:

• the kidneys not working as well as they should , frequent urinating, difficulties in passing any urine;


• shortness of breath after exercising;


• depression, problems getting to sleep , less interest in sex;


• dizziness, headache;


• blushing;


• testicles becoming smaller, enlargement of breasts, impotence;


• skin reactions where the implant was inserted, such as pain, tenderness, redness;


• other reactions to the implantation procedure, such as weakness and tiredness;


• some temporary damage to the liver cells;


• pain in the joints, pain in the arms and legs;


• constipation;


• weight gain, raised blood sugar level;


• growth of excess hair.

Uncommon side effect (less than 1 in every 100 patients treated) are:

• anaemia, abdominal discomfort,


• nausea;


• fluid retention, food cravings, high calcium levels, high cholesterol, increased appetite;


• irritability;


• shaking;


• weight loss;


• irregular heart beating and/or a premature beat of the heart (palpitations);


• abnormal bleeding;


• bruising, night sweats, itching, excessive sweating;


• back pain, muscle spasms, muscle infiltration, neck pain;


• painful and difficult urination, blood in urine, kidney stone, kidney failure;


• breast pain, breast tenderness, genital itching, sexual dysfunction;


• feelings of cold, tiredness, feeling unwell, peripheral oedema, pain, swelling;


• stent blockage;


• detectable as a result of various blood tests, including: higher liver enzymes (elevated aspartate-aminotransferase), elevated blood lactate dehydrogenase, elevated blood testosterone, abnormality in kidney function tests (lowered creatinine clearance), elevated acid phosphatase in the prostate.

Rare side effects (less than 1 in every 1,000 patients treated) are:

• skin infection;


• inflammation.

Vantas can also cause a loss in bone mineral density. This can lead to frailty of the bones (osteoporosis).

If you notice any side effects not mentioned in this leaflet, please contact your doctor.

How To Store Vantas

• Keep out of the reach and sight of children.



• Do not use Vantas after the expiry date, which is stated on the carton and on the vial. The expiry date refers to the last day of the month.



• Store implant in a refrigerator (2 °C - 8 °C). Do not freeze.



• Store implant in the original package in order to protect from light.



• Store implantation device at room temperature (20 °C - 25 °C), and keep out of direct sunlight

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed. These measures will help to protect the environment.

Further Information

What Vantas contains:

• The active substance is 50 mg of histrelin acetate.


• The other ingredients are in the medicine core pellet. This contains the ingredient stearic acid (E570). There are four drug core pellets inserted into an acrylic co-polymer shell. This acrylic co-polymer shell consists of 2-hydroxyethyl methacrylate, 2-hydroxypropyl methacrylate and trimethylolpropane trimethacrylate. All of these are plastics which have been used previously in implants.

What Vantas looks like and contents of the pack

Vantas is an implant and is supplied in a carton containing an amber plastic pouch, which in turn carries the vial containing the Vantas implant.

The implantation device is contained in a polyethylene sachet, which is placed in a carton.

The glass vial containing the implant has a Teflon-coated stopper and an aluminium seal. The implant is immersed in 2 ml of 1.8% sterile sodium chloride solution and looks like a thin tube.

A Package Insert, with insertion and removal instructions for your doctor, together with this Package Leaflet is provided with the product.

Marketing Authorisation Holder and Manufacturer

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

This leaflet was last approved in: 11-May -2009