VANTAS 50 MG IMPLANT

Active substance: HISTRELIN ACETATE

View full screen / Print PDF » Download PDF ⇩

Transcript
Pvm: 20.7.2012
Työnumero: i41103603 / vedos 4
Mat.nro:128677-4
Koko:160x640 Fontti: Myriad Pro 9/9 pt
Värillisyys: musta
Hyväksyjä:
Hyväksymispvm:

PACKAGE LEAFLET: INFORMATION FOR THE
USER

Vantas 50 mg implant
histrelin acetate
Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.
- 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
only. Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
- If you get any side effects, talk to your
doctor. This includes any possible side
effects not listed on this leaflet.
What is in this leaflet:
1. What Vantas is and what it is used for
2. What you need to know before you use Vantas
3. How to use Vantas
4. Possible side effects
5. How to store Vantas
6. Contents of the pack and other information

1. What Vantas is and what it is used for
· Vantas is a medicine delivery system which is
surgically placed (or implanted) under the skin.
· It is used for the treatment of advanced prostate
cancer because it may help to relieve your
prostate cancer symptoms.
· The active substance is histrelin acetate. Each
Vantas implant contains approximately 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.

2. What you need to know 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.
Warnings and precautions
It is possible that your symptoms may get worse or
new symptoms occur during the first week of
treatment (See Section 4 – Possible side effects). If
this happens, phone your doctor immediately.
Tell your doctor if you might be at risk or if you
have any of the following as you may need more
frequent check ups if:
· you have metabolic disease
· you have heart problems
· you have diabetes
There have been reports of depression in patients
taking Vantas which may be severe. If you are using
Vantas and develop depressed mood, inform your
doctor.
Other medicines and Vantas
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 breastfeeding 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.

3. 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. Steristrips 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 medicine, please ask your doctor.

Very common side effects are:
· hot flushes (reddening of the face and/or neck).
Common side effects are:
· the kidneys not working as well as they should,
frequent urinating;
· difficulties in passing any urine;
· shortness of breath after exercising;
· mood changes, 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 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;
· ureteral stent occlusion;
· bruising;
· 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 are:
· skin infection;
· application site inflammation.
Vantas can also cause a loss in bone mineral density.
This can lead to frailty of the bones (osteoporosis).
In addition Vantas may increase the risk of
cardiovascular events.
If you notice any side effects not mentioned in this
leaflet, please contact your doctor.

5. How to store Vantas
· Keep this medicine out of the sight and reach of
children.
· Do not use this medicine after the expiry date,
which is stated on the carton and vial label after
EXP:. The expiry date refers to the last day of the
month.
· Store implant in a refrigerator (2 °C – 8 ºC). Do not
freeze.
· Store implant in the original package in order to
protect from light.
· Do not store implantation device above 25 °C. Do
not refrigerate or freeze.
· Store implantation device in the original package
in order to protect from light.
· Dispose of vial and implantation device after use.
Single use only.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other
information
What Vantas contains:
· The active substance is histrelin acetate. Each
implant contains approximately 50 mg histrelin
acetate corresponding to 41 mg histrelin.
· 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.
· Sterile storage solution of the implant consists of
sodium chloride and water for injections.
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 1 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 Tefloncoated stopper (chlorobutyl isoprene rubber) and
an aluminium seal. The stopper contains latex
rubber. 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
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Austria, Bulgaria, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Ireland,
Italy,
Hungary, Latvia, Lithuania, Norway, Poland,
Portugal, Romania, Slovenia, Slovak Republic,
Spain, Sweden, UK: Vantas
Belgium, Luxembourg, The Netherlands: Vantasse
This leaflet was last approved in: 06/2012

4. Possible side effects
Like all medicines, this medicine 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:
The frequencies are defined as:
very common: may affect more than 1 user in 10
common: may affect 1 to 10 users in 100
uncommon: may affect 1 to 10 users in 1,000
rare: may affect 1 to 10 users in 10,000
very rare: may affect less than 1 user in 10,000
not known: frequency cannot be estimated from
the available data
128677-4

i41103603_Vantas_GB.indd 1

20.7.2012 10.15

THE FOLLOWING INFORMATION IS INTENDED
FOR HEALTHCARE PROFESSIONALS ONLY:
Instructions for Insertion and Removal
Vantas is supplied in a sterile vial within an opaque
plastic bag, which in turn is in a carton. The
implantation device is contained in a polyethylene
sachet, which is placed in a carton.

withdraw from the incision, leaving the implant in
the dermis. Withdraw the implanter from the
incision. Release of the implant can be checked by
palpation.

It is important to use aseptic techniques to
minimize any chance of infection. Sterile gloves are
required for the insertion procedure and
subsequent removal of the implant.
Identifying the insertion site
The patient should be on his back, with the arm
least used (e.g. left arm of a right-handed person)
flexed so the physician has ready access to the
inner part of the upper arm. Prop the arm with
pillows so the patient can easily hold that position.
The optimum site for insertion is approximately
half way between the shoulder and the elbow and
in the crease between the biceps and triceps.

Note: Do not try to push the device in deeper once
the retraction process has started to avoid severing
the implant. If you wish to re-start the process,
withdraw the device, grasp the implant by the tip
to extract it, reset the retraction button to its most
forward position, reload the implant and start
again.
Closing the incision
To close the incision, use one or two sutures
(optional), knots facing inside the incision. Apply
light coating of antibiotic ointment directly onto
the incision. Close with two surgical strips. Apply a
4” gauze pad over the incision and secure with a
bandage.
Removal procedure and new implant insertion
The Vantas implant must be removed after 12
months of therapy.

Loading the implantation device
Load the implantation device prior to prepping the
insertion field and insertion. Remove the
implantation device from its sterile bag. The device
is shipped with the cannula fully extended. Verify
this by inspecting the position of the green
retraction button. The button should be all the way
forward, towards the cannula, away from the
handle.

Remove the metal band from the vial, remove the
rubber stopper and use a mosquito clamp to grasp
either tip of the implant. Avoid grabbing or
clamping the middle of the implant to prevent
distortion of the implant.
Insert the implant into the implantation device. It
will seat in cannula so that just the tip is visible at
the bottom of the bevel.

Inserting the Implant
Swab the insertion site with povidone-iodine
swabs, then lay a fenestrated drape over the
insertion site (for clarity of illustration, not shown in
the accompanying photograph).

Anesthetic
Determine that the patient has no lidocaine/
epinephrine (adrenaline) allergies. Inject a few ml’s
of anesthetic, starting at the planned incision site,
then infiltrating up to the length of the implant, 32
mm, in a fan like fashion.

Incision
Using a scalpel make a 2-3 mm shallow skin
incision on in the inner aspect of the upper arm
perpendicular to length of the biceps.

Locating the implant
The implant may be located by palpating the area
near the incision from the prior year. Generally, the
implant is readily palpated. Press the distal end of
the implant to determine the location of the
proximal tip relative to the old incision.

In the event the implant is difficult to locate,
ultrasound can be used. If ultrasound fails to locate
the implant, other imaging techniques such as CT
or MRI may be used to locate it.
Preparing the site
Patient position and site preparation are the same
as for the initial insertion. Swab the area above and
around the implant with povidone-iodine swabs.
Drape the area with a fenestrated drape.
Anesthetic
After determining the absence of known allergies
to lidocaine/epinephrine (adrenaline), press down
on the implant tip furthest from the old incision.
Inject a small amount of lidocaine/epinephrine at
the tip near the incision, then advance the needle
along the length, but beneath the implant, steadily
injecting a small amount of anesthetic along the
way. The anesthetic will raise up the implant within
the dermis. If you are inserting a new implant, you
have the option of either putting the new one in
the same “pocket” as the removed one, or using the
same incision, insert the new implant in the
opposite direction. If you are placing the implant in
the opposite direction, apply anesthetic along the
length of the path for the new implant prior to
explantation.
Incision/explantation
Using a #11 scalpel, make a 2-3 mm incision near
the tip and about 1-2 mm deep. Generally, the tip
of the implant will be visible through a thin
pseudo- capsule of tissue. If not, push down on the
distal tip of the implant and massage it forward
towards the incision. Carefully “nick” the pseudo
capsule to reveal the polymer tip.

Grasp the tip with a mosquito clamp and extract
the implant.

If inserting a new implant, proceed according to
the initial insertion instructions. The new implant
may be placed through the same incision site.
Alternatively, the contralateral arm may be used.
Storage
The implantation device supplied is sterile in its
pouch. Do not store above 25 °C. Do not refrigerate
or freeze. Store in the original package in order to
protect from light.

Insertion
Grasp the implantation device by its handle, as
shown.

Marketing Authorisation Holder:
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Insert the tip of the implantation device into the
incision with the bevel up and advance the device
subcutaneously along the path of the anesthetic, up
to the inscribed line on the cannula. To ensure
subcutaneous placement, the implanter should
visibly raise the skin at all times during insertion. Be
sure that the implanter does not enter muscle
tissue.

Hold the implantation device in place as you move
your thumb to the green retraction button. Press
the button down to release the locking mechanism,
then draw the button back to the back stop all the
while holding the device in place. The cannula will

i41103603_Vantas_GB.indd 2

20.7.2012 10.15

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)