JEVTANA cabazitaxel 60 mg/1.5 mL concentrated injection vial

Main information

  • Trade name:
  • JEVTANA cabazitaxel 60 mg/1.5 mL concentrated injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • JEVTANA cabazitaxel 60 mg/1.5 mL concentrated injection vial
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 175500
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

175500

JEVTANA cabazitaxel 60mg/1.5mL concentrated injection vial

ARTG entry for

Medicine Registered

Sponsor

Sanofi-Aventis Australia Pty Ltd

Postal Address

Locked Bag 2227,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

8/12/2011

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. JEVTANA cabazitaxel 60 mg/1.5 mL concentrated injection vial

Product Type

Composite Pack

Effective date

11/05/2018

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration resistant prostate cancer

previously treated with a docetaxel containing regimen.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Multiple containers

Not recorded

3 Years

Store below 30

degrees Celsius

Not recorded

Do not Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

1 drug concentrate vial and 1 diluent vial

(S4) Prescription Only Medicine

Components

1. Diluent

Dosage Form

Diluent, not applicable

Route of Administration

Intravenous

Visual Identification

Clear, colourless solution

2. concentrate

Dosage Form

Injection, concentrated

Route of Administration

Intravenous

Visual Identification

Clear oily yellow to brownish yellow solution

Active Ingredients

cabazitaxel acetone solvate

64.17 mg

Public Summary

Page 1 of

Produced at 23.05.2019 at 04:22:01 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 23.05.2019 at 04:22:01 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Jevtana

®

(JEV-TA-NA)

Cabazitaxel (ca-ba-zi-tax-el)

Consumer Medicine Information (CMI)

What is in this leaflet

This leaflet answers some common

questions about Jevtana.

It does not contain all the available

information. It does not take the

place of talking to your doctor.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you being given this

medicine against the benefits they

expect it will have for you.

If you have any concerns about

being given this medicine, ask your

doctor.

Keep this leaflet in a safe place as

you may need to read it again.

What Jevtana is used

for

The name of your medicine is

Jevtana. It belongs to a group of

medicines called 'taxanes' used to

treat cancers. Jevtana is used to treat

prostate cancer that has progressed

after having had other chemotherapy.

It works by stopping cells from

growing and multiplying.

Ask your doctor if you have any

questions about why it has been

prescribed for you.

This medicine is only available with

a doctor's prescription.

There is no evidence that this

medicine is addictive.

Before you are given

Jevtana

Do not receive Jevtana if:

the number of your white blood

cells is too low (neutrophil counts

of 1,500 per cubic millimetre, or

less - your doctor will advise you

on this),

you have a liver disease

you are pregnant or breast-

feeding

you have recently received or are

about to receive a vaccine against

yellow fever.

Do not receive Jevtana if you are

allergic to it or any of the

ingredients listed at the end of this

leaflet.

Some symptoms of an allergic

reaction include skin rash, itching,

shortness of breath or swelling of the

face, lips or tongue, which may cause

difficulty in swallowing or breathing.

Do not receive Jevtana if you are

pregnant or intend to become

pregnant.

Jevtana may affect your developing

baby if you are given Jevtana during

pregnancy. If your partner is

pregnant or is planning on becoming

pregnant, ensure to use a condom.

The use of effective contraception in

male patients with partners who may

become pregnant is recommended

during treatment and for 6 months

after the final treatment is given.

Jevtana might be present in your

semen. Therefore, the use of a

condom is always recommended

during sexual intercourse.

Do not receive Jevtana if you are

breastfeeding or planning to

breastfeed.

Jevtana could pass into breast milk

and there is a possibility your baby

may be affected.

Do not give Jevtana to a child or

adolescent.

Do not receive Jevtana after the

expiry date (EXP) printed on the

vial.

If you receive it after the expiry date

has passed, it may not work as well.

Do not receive Jevtana if the

packaging is damaged or shows

signs of tampering.

Before you are given

Jevtana

Tell your doctor if:

you have allergies to the

ingredients listed at the end of

this leaflet

you are taking other medicines

including medicines used to

prevent blood clots and oral non-

steroidal anti-inflammatories

(NSAIDS).

Tell your doctor if you are

pregnant or intend to become

pregnant.

Like most medicines of this kind,

Jevtana is not recommended to be

used during pregnancy. Your doctor

will discuss the risks and benefits of

receiving Jevtana if you are pregnant.

Tell your doctor if you are

breastfeeding or planning to

breastfeed.

It is not known whether Jevtana

passes into breast milk. Your doctor

JEVTANA

will discuss the risks and benefits of

receiving Jevtana if you are

breastfeeding or planning to

breastfeed.

Tell your doctor if you have or

have had any medical conditions,

especially the following:

a fever (during treatment with

Jevtana, it is more likely that your

white blood cell count may be

reduced). Your doctor will

monitor your blood and general

condition for signs of infections.

any allergies

lung, liver or kidney problems

any stomach problems past or

present (including ulcers)

severe or long-lasting diarrhoea,

nausea or vomiting. Any of these

events could cause dehydration.

Your doctor may need to treat

you.

if you have a feeling of

numbness, tingling, burning or

decreased sensation in your hands

or feet

if you have any bleeding from the

gut that may cause changes in the

colour of your stool or stomach

pain.

This medicine contains 13% w/w

ethanol (alcohol), equivalent to 14 ml

of beer or 6 ml of wine. To be taken

into account if:

if suffer from alcoholism

have a liver disease

have epilepsy/seizures

Tell your doctor if you plan to have

surgery.

If you have not already told your

doctor about any of the above, tell

them before you are given Jevtana.

Taking other medicines

Tell your doctor if you are taking

any other medicines including

herbal supplements and vitamins

and those that you buy without a

prescription from your pharmacy,

supermarket or health food store.

This is because some medicines can

affect the way Jevtana works or

Jevtana can affect how other

medicines work. These include:

medicines used to treat bacterial,

fungal or viral infections (e.g.

clarithromycin, ketoconazole,

rifampicin)

medicines used to treat seizures

or epilepsy (e.g. carbamazepine,

phenobarbital, phenytoin)

herbal remedy for depression and

other conditions (St John's Wort

(Hypericum perforatum)

Talk to your doctor before getting

vaccinations while you are

receiving Jevtana.

Your doctor or pharmacist has more

information on medicines to be

careful with or to avoid while being

given Jevtana.

How Jevtana is given

How much to be given

The dose will depend on your height

and weight. Your doctor will

calculate your body surface area in

square meters (m2) and will

determine the dose you should

receive.

The standard dose of Jevtana is 20

mg per square metre. Your doctor

may decide on an alternative dose

depending on your condition.

Additional medications

As part of your treatment for prostate

cancer, you will also take an oral

corticosteroid medicine (prednisone

or prednisolone) daily.

Half an hour before you receive

Jevtana, you will be given the

following medications to reduce your

chance of developing an allergic

reaction or nausea:

antihistamine (diphenhydramine

or equivalent)

corticosteroid (dexamethasone or

equivalent)

H2 antagonist (ranitidine or

equivalent)

anti-nausea medication (if

required)

How Jevtana is given

Jevtana will be given by infusion into

one of your veins (intravenous use).

The infusion will last approximately

1 hour during which you will be in

the hospital.

Duration of treatment

You should usually receive your

infusion once every 3 weeks.

Each 3 week period is called one

cycle of chemotherapy. Your doctor

will decide how many of these cycles

you will need.

If you have any further questions

about how you will receive this

medicine, ask your doctor,

pharmacist or nurse.

If you receive too much

(overdose)

As Jevtana is given to you under

the supervision of your doctor, it is

very unlikely that you will receive

too much. However, if you

experience any unexpected or

worrying side effects after being

given Jevtana immediately

telephone your doctor, or the

Poisons Information Centre

(telephone Australia 13 11 26 or go

to Accident and Emergency at

your nearest hospital.

If you receive too much Jevtana, you

may experience one or more of the

following symptoms: fever, nausea,

diarrhoea, vomiting, constipation,

abdominal pain, including upper

abdominal pain, indigestion, and

reflux.

While you are being

given Jevtana

Things you must do

Use a condom during sex if your

partner is or could become

pregnant. Jevtana could be present

in your semen and may affect the

JEVTANA

foetus. You are advised not to

father a child during and up to 6

months after treatment and to seek

advice on conservation of sperm

prior to treatment because Jevtana

may alter male fertility.

If your partner becomes pregnant

while you are being given this

medicine, tell your doctor

immediately.

Tell all the doctors, dentists and

pharmacists who are treating you

that you are being given Jevtana.

If you are about to be started on

any new medicine, tell your doctor

and pharmacist that you are being

given Jevtana.

If you plan to have surgery that

needs a general anaesthetic, tell

your doctor or dentist that you are

being given this medicine.

Things you must not do

Do not receive more than the

recommended dose unless your

doctor tells you to.

Do not stop using Jevtana without

checking with your doctor.

If you do not complete the full course

prescribed by your doctor, Jevtana

may not work as well as it's supposed

Things to be careful of

Be careful driving or operating

machinery until you know how

Jevtana affects you.

Jevtana may cause side effects such

as fatigue or dizziness that may affect

your ability to drive and use

machinery. Make sure you know how

you react to Jevtana before you drive

a car, operate machinery, or do

anything else that could be dangerous

if you feel dizzy or fatigued.

If you experience these symptoms,

do not drive or use any tools or

machines until they have fully

resolved.

Side effects

Jevtana helps most people with

prostate cancer, but it may have

unwanted side effects in some

people.

All medicines have some unwanted

side effects. Sometimes they are

serious, but most of the time they are

not. Your doctor or pharmacist has

weighed the risks of using this

medicine against the benefits they

expect it will have for you.

Tell your doctor, nurse or

pharmacist as soon as possible if

you do not feel well while you are

being given Jevtana.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

If any of the following happen

while you are being given Jevtana

in the hospital/clinic, Jevtana

should be stopped immediately.

Tell your doctor or nurse

immediately. If you are outside of

the hospital/clinic go to Accident

and Emergency at your nearest

hospital:

swelling of the face, lips, mouth

or throat, which may cause

difficultly in swallowing or

breathing.

hives

fainting

yellowing of the skin and eyes

(jaundice)

These are very serious side effects. If

you have them, you may have had a

serious allergic reaction to Jevtana.

You may need urgent medical

attention or hospitalisation.

These side effects are very rare.

See a doctor immediately if you

notice any of the following side

effects:

fever (high temperature). This is

very common (affects more than

1 in 10 patients)

severe loss of body fluids

(dehydration). This is common

(affects less than 1 in 10 patients).

This can occur if you have severe

diarrhoea (increase of more than

4 or more stools more than usual

a day) or long-lasting diarrhoea,

or fever, or if you are vomiting

Tell your doctor, nurse or

pharmacist if you notice any of the

following:

Very common side effects (affects

more than 1 in 10 patients):

feeling tired, weak or lack of

energy

symptoms of anaemia like

tiredness, and inability to perform

daily tasks (due to a decrease in

the number of red blood cells)

increased bleeding (due to a

decrease in the number of

platelets)

loss of appetite (anorexia)

alteration in sense of taste

shortness of breath

cough

stomach upsets including nausea,

vomiting and diarrhoea,

constipation

abdominal pain

short term hair loss (in most cases

normal hair growth should return

after treatment has stopped)

back pain

joint pain

blood in the urine

Common side effects (affects less

than 1 in 10 patients):

urinary tract infection

fever and infection (associated

with a reduction of white blood

cells)

feeling of numbness, tingling,

burning or decreased sensations

in hands and feet

dizziness

headache

decrease or increase in blood

pressure

uncomfortable feeling in the

stomach or belching after eating

JEVTANA

gastro-oesophageal reflux or

heartburn

stomach pain

haemorrhoids

muscle spasm

pain when passing urine

urinary incontinence

sores in the mouth or on the lips

high blood sugar

low blood potassium

rapid or irregular heartbeat

kidney disease or problems

ringing in the ear

trouble with balance

blood clot in the leg

pain in mouth or throat

rectal bleeding

redness of skin

skin infections

skin feeling hot or flushed

muscle discomfort, aches or pain

swelling of the feet or legs

lung infection

chills

Inflammation of the bladder may also

occur if you have previously received

radiation therapy. Tell your doctor,

nurse or pharmacist if you have

burning sensation when passing

urine.

Tell your doctor, nurse or

pharmacist if you notice anything

else that is making you feel unwell.

Other side effects not listed above

may occur in some patients.

Ask your doctor, nurse or

pharmacist to answer any

questions you may have if you

experience any side effects.

After being given

Jevtana

If you have any queries about any

aspect of your medicine, or any

questions regarding the

information in this leaflet, discuss

them with your doctor, nurse or

pharmacist.

Storage

Jevtana is stored in the pharmacy

or on the ward. Do not store at

home.

Product description

What Jevtana looks like

One pack of Jevtana consists of:

One vial of 60mg/1.5ml

concentrate (which is a clear

yellow to brownish-yellow oily

solution)

One vial of 60mg/1.5ml diluent

(which is a clear and colourless

solution)

Ingredients

Active Ingredient:

The active substance is cabazitaxel.

One ml of concentrate contains 40mg

cabazitaxel. Each vial of concentrate

contains 60mg cabazitaxel.

Inactive Ingredients:

The other ingredients are polysorbate

80 and citric acid in the concentrate

and ethanol 96% and water for

injections in the diluent.

Jevtana does not contain gluten,

sucrose, lactose, tartrazine or any

other azo dyes.

Manufacturer/Sponsor

Jevtana is supplied in Australia by:

sanofi-aventis australia pty ltd

12-24 Talavera Road

Macquarie Park NSW 2113

This leaflet was prepared in May

2018.

Australian Register Number(s)

AUST R 175500

jevtana-ccdsv10-cmiv5-11may18

JEVTANA