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PLENAXIS 100 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PLENAXIS® 100 mg powder and solvent for suspension for injection
abarelix

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 in this leaflet, please
tell your doctor or pharmacist.

In this leaflet:
1.
What PLENAXIS is and what it is used for
2.
Before you take PLENAXIS
3.
How to take PLENAXIS
4.
Possible side effects
5.
How to store PLENAXIS
6.
Further information

1.

WHAT PLENAXIS IS AND WHAT IT IS USED FOR

PLENAXIS is an injectable medicinal product which belongs to the gonadotropin-releasing hormone
antagonist class of medicines (GnRH antagonists). In men, this class of medicines leads to a decrease in
male hormones, including testosterone. Prostate cancer is treated by reducing the testosterone level.
PLENAXIS is used to initiate (up to 85 days of treatment) medicinally a reduction in the testosterone level
in advanced or metastasising, hormone-dependent prostate carcinoma, when androgen suppression
(suppression of the male sex hormone) is necessary.

2.

BEFORE YOU TAKE PLENAXIS

Do not take PLENAXIS
if you are allergic (hypersensitive) to abarelix or any of the other ingredients of PLENAXIS.
if you have any problems with your liver and/or kidney function.

Take special care with PLENAXIS
After every PLENAXIS injection, you should remain at the doctor’s for at least 30 minutes, so that
you can be kept under observation and appropriate measures can be taken in the event of an
immediate-type allergic reaction.
Since PLENAXIS may cause changes in an ECG, the doctor should weigh carefully the risks involved
in using PLENAXIS against the benefits of treatment, especially if your so-called QTc values are
longer than 450 milliseconds.
Your serum transaminase values (a type of liver function test) will be ascertained by the doctor before
treatment begins, as well as periodically during treatment with PLENAXIS. If the values ascertained
are markedly higher than normal, your doctor must carry out additional investigations before any
further treatment.
PLENAXIS should not be administered to children.
Pregnancy and breast-feeding
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PLENAXIS must not be administered to women.
Using other medicines
No studies of the interaction of PLENAXIS with other medicinal products have been carried out, and no
interactions have been observed up to now.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Driving and using machines
Tiredness and dizziness immediately following administration of PLENAXIS are common side effects that
may impair your ability to drive and use machines. These effects may be due to the treatment or effects
resulting from the underlying disease.
Important information about some of the ingredients of PLENAXIS
PLENAXIS contains sodium, but less than 1 mmol (23 mg) of sodium per dosage unit, which means that it
is virtually “sodium-free”.

3.

HOW TO TAKE PLENAXIS

PLENAXIS is administered by a doctor or nurse in the form of an injection in the buttock muscle. During
the first month, this takes place on Day 1, Day 15, Day 29 (week 4) and subsequently once every four
weeks. It is important that you make an appointment with your doctor on the date on which your injection is
due. Ensure that your treatment with PLENAXIS is continued, even when you feel well, until your doctor
decides that treatment can be ended.
If treatment lasts for longer than three months, your body’s response to treatment with PLENAXIS must be
closely checked, because its efficacy decreases between the 3rd and 12th month in some patients and it has
also not yet been adequately investigated for a period in excess of 12 months. Particular attention should be
paid to this in patients with a body weight > 100 kg. The success of PLENAXIS therapy can be monitored
by means of certain clinical signs and the periodic measurement of serum testosterone and PSA levels.
If you have any further questions about the use of this product, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, PLENAXIS can cause side effects, although not everybody gets them.
PLENAXIS can cause allergic reactions leading to a drop in blood pressure and fainting fits. Since these
reactions occur shortly after the administration of an injection, your doctor should monitor you for a period
of 30 minutes after the injection. Should you feel weak at another time shortly after an injection, seek
medical assistance immediately.
Since PLENAXIS affects the testosterone level, other side effects can generally be attributed to a change in
hormonal balance. These side-effects may include the following: swelling and sensitivity of the breast, hot
flushes, weight gain, depression, impotence, reduced sexual desire and sleep disturbances. Some men may
suffer pain or a change in the size of the testicles, as well as changes in passing water. Additional frequent
side-effects are: pain at the injection site, tiredness, weakness, dizziness, headache, tingling sensation, rash
and itching. In addition, disturbance of the hormonal balance may also be connected with gastrointestinal

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symptoms such as stomach ache, nausea, diarrhoea or constipation, and flatulence. In certain circumstances,
regular checks of liver function are necessary.
The following frequencies were used as a basis in assessing undesirable effects:
Very common: more than 1 in 10 treated
Common: less than 1 in 10 but more than 1 in 100 treated
Uncommon: less than 1 in 100 but more than 1 in 1,000 treated
Rare: less than 1 in 1,000 but more than 1 in 10,000 treated
Very rare: less than 1 in 10,000 treated, or unknown
System Organ Class

Very Common (≥1/10)

Common
(≥1/100 to <1/10)

Blood and lymphatic
system disorders
Cardiac disorders

Vascular disorders

Hot flushes.

Ear and labyrinthine
disorders
Eye disorders

Gastrointestinal
disorders

General disorders and
administration site
conditions

Stomach pain, vomiting,
constipation, flatulence,
diarrhoea, stomach
distension.

Weakness.

Injection site pain,
swelling, chest pain.

Immune system
disorders
Infections and
Infestations
Injury, poisoning and
investigational
complications
Investigations

Allergic reactions,
itching.

Uncommon (≥1/1,000
to ≤1/100)
Abnormal blood clotting,
anaemia.
Heart enlarged,
abnormal heart rhythm
(fast or slow),
palpitations, disease of
the blood vessels of the
heart.
Nose bleed, bruising,
high blood pressure,
flushing, low blood
pressure.
Ear pain.
Cataracts, eye
abnormalities, sight
impairment, dry eyes.
Inflammation of the
lining of the abdominal
cavity, sickness, dry
mouth, indigestion,
frequent bowel
movements, faecal
incontinence, rectal
bleeding, haemorrhoids,
inflammation of the
gums, toothache,
inflammation of the
lower bowel.
Injection site bruising
and inflammation, pain,
tiredness, raised
temperature, swelling.
Itchy rash.
Shingles, bladder
infection.
Other injuries.

Liver enzyme increased,
weight gain.

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Changes in blood
chemistry, weight loss,
heart murmur, abnormal

breathing sounds.
Metabolic and nutrition
disorders

Musculoskeletal and
connective tissue
disorders
Nervous system
disorders

Muscle weakness,
muscle pain, leg pain.

Psychiatric disorders

Anorexia, depression,
abnormal sleep patterns,
drowsiness.

Renal and urinary
disorders

Overactive bladder, urge
to pass urine during the
night, painful urination.

Reproductive system and
breast disorders

Dizziness, headaches,
pins and needles.

Development of breasts.

Nipple pain, erectile
dysfunction, reduced
sexual interest, testicular
pain, testicular disorders.
Breathlessness.

Respiratory system,
thoracic and mediastinal
disorders

Skin and subcutaneous
tissue disorders

Hair loss, rash.

Increased appetite,
abnormal blood fats,
worsening of diabetes,
gout.
Back pain, joint pain,
inflamed joints, muscle
wasting.
Disturbed:
balance, and coordination,
speech, walking
touch sensation,
leg cramps,
increased
migraine, face
pain, fainting.
Agitation, anxiety,
memory loss,
concentration loss,
confusion, worsening of
depression, abnormal
dreams, abnormal mood,
nervousness, neurosis.
Abnormalities of passing
urine including:
incontinence, reduced
flow, pain, inability to
pass urine and blood in
the urine.
Painful testicles,
disorders of the penis
and prostate.
Bronchitis, coughing,
catarrh, fluid on the
lung, increased mucus of
nose and throat, sinus
and upper airway
inflammation.
Acne, rash, dermatitis,
reddening of the skin, dry
skin, genital itching, hair
disorder, increased
sweating, chills, skin
nodules, skin reaction.

Treatment with PLENAXIS over a long period can lead to a reduction in bone mineral density.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

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5.

HOW TO STORE PLENAXIS

Keep out of the reach and sight of children.
You may be given a prescription for obtaining PLENAXIS from a pharmacy. You should not obtain the
prescription until shortly before your next visit to the doctor. Keep PLENAXIS in a safe place in its original
packaging until your next treatment.
PLENAXIS does not require any special storage conditions.
Do not use PLENAXIS after the expiry date which is stated on the vials and the carton after EXP
(abbreviation used for expiry date). The expiry date refers to the last day of that month.
After reconstitution
Chemical and physical in-use stability has been demonstrated for 8 hours at 25ºC.
From a microbiological point of view, unless the method of reconstitution precludes the risk of
contaminiation, the product should be used immediately. If not used immediately, in-use storage times and
conditions are the responsibility of the user.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

6.

FURTHER INFORMATION

What PLENAXIS contains
The active substance in PLENAXIS is abarelix.
The other ingredient in Plenaxis® is the solvent. The solvent is sodium chloride 9 mg/mL (0.9%) solution for
injection.

What PLENAXIS looks like and contents of the pack
PLENAXIS is supplied as a kit and contains:




A glass vial containing a whitish powder.
An ampoule containing 3 ml of a clear, colourless solvent (sodium chloride 9 mg/mL (0.9%) solution
for injection) for suspension for injection.
In addition, a syringe and 2 needles for reconstitution and administration.

Package sizes:
Kit for 1 injection
Kit for 3 injections

Marketing Authorisation Holder
Speciality European Pharma Limited
14 Took’s Court
London
EC4A 1LB
United Kingdom
Tel.: +44(0) 20 7421 7400

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Manufacturer
Fisher Clinical Services UK Limited
Langhurstwood Road
Horsham
West Sussex
RH12 4QD
United Kingdom
Tel.: +44 (0) 1403 212 700
Chester Medical Solutions
3-4 Apex Court
Bassendale Road
Bromborough
Wirral
CH62 3RE
United Kingdom
Tel.: +44 (0) 151 343 1181

This medicinal product is authorised in the Member States of the EEA under the following names:
Belgium: Plenaxis 100 mg poeder en oplosmiddel voor suspensie voor injectie / Plenaxis 100 mg de poudre
et solvant pour suspension injectable / Plenaxis 100 mg Pulver und Lösungsmittel zur Herstellung einer
Injektionssuspension
Germany: Plenaxis 100 mg Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension
Luxembourg: Plenaxis 100 mg de poudre et solvant pour suspension injectable / Plenaxis 100 mg Pulver und
Lösungsmittel zur Herstellung einer Injektionssuspension
Netherlands: Plenaxis 100 mg poeder en oplosmiddel voor suspensie voor injectie
United Kingdom: Plenaxis 100 mg powder and solvent for suspension for injection

This leaflet was last approved in 08/2012
Detailed information on this medicine is available on the website of www.specialityeuropeanpharma.com
----------------------------------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:
Instructions for use
Important! It is essential to follow these instructions fully to ensure that the full therapeutic dose is
administered.
1.
2.

Use aseptic technique for all steps.
PLENAXIS powder may have aggregated during storage. To ensure that the patient receives the full
dose (100 mg), it is critical that PLENAXIS powder be as fine as possible prior to addition of solvent.
Hold the vial at an angle of 45° and tap repeatedly on a hard surface or shake vigorously to fully
disperse the powder.
Important! Look for clumps of powder by inspecting the vial whilst rolling it back and forth on its
side. Do not proceed to the next stage without ensuring that all the lumps have been removed and the
contents are in the form of a fine powder.

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3.
4.

5.
6.

7.
8.

Withdraw 2.2 ml of the solvent (0.9% sodium chloride for injection purposes) using the enclosed
syringe and 18G needle. Discard the remaining solvent.
Important! Keeping the vial upright (base down), insert the needle all the way into the vial until it
cannot be inserted any further. Position the tip of the needle over the dimple at the base of the vial.
Inject the solvent vigorously to ensure maximum dispersion of powder.

Before withdrawing the needle, remove 2.2 ml of air. Now remove the needle from the vial and expel
the air.
Important! Do not shake the vial as this causes foaming. Foaming must be avoided to ensure that all
the suspension is taken up into the syringe. Tip, roll and swirl the vial for 15 seconds and allow to stand
for 2 minutes. During the 2 minutes, tap the vial and swirl it occasionally to reduce any foam.

Repeat step 6 one more time.
Insert the 18G needle back into the vial. Invert the vial and ‘wash’ the walls by withdrawing and gently
reinjecting the suspension. Inspect the walls for any particulate matter. Repeat reinjection of
suspension as many times as necessary to ensure all PLENAXIS powder is completely in suspension.

9.

Holding the vial at a 45° angle, withdraw the entire contents (at least 2 ml). Do not withdraw the needle
until all the PLENAXIS suspension has been drawn into the syringe. There should be no residual lumps
or powder on the inner wall of the vial.
10. After withdrawing the needle, pull the syringe plunger back to draw up the residual suspension in the
18G needle into the syringe.
11. Now replace the 18G needle with the supplied 22G needle.

12. Insert the needle at the desired injection site and pull back the plunger to check for back-flow of blood.
If blood flows into the syringe, do not inject at this site. Select another injection site.
13. Immediately administer the entire reconstituted suspension intramuscularly.
14. Observe the patient for approximately 30 minutes for any sign of an allergic or hypersensitive reaction.
Unused medicinal products or waste materials should be disposed of in accordance with local requirements.

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Expand Transcript

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.

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