CARBOPLATIN

Main information

  • Trade name:
  • CARBOPLATIN ACCORD carboplatin 150 mg/15 mL solution for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CARBOPLATIN ACCORD carboplatin 150 mg/15 mL solution for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215853
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215853

CARBOPLATIN ACCORD carboplatin 150 mg/15 mL solution for injection vial

ARTG entry for

Medicine Registered

Sponsor

Accord Healthcare Pty Ltd

Postal Address

Level 24 570 Bourke Street,Melbourne, VIC, 3000

Australia

ARTG Start Date

21/11/2014

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. CARBOPLATIN ACCORD carboplatin 150 mg/15 mL solution for injection vial

Product Type

Single Medicine Product

Effective date

27/01/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Carboplatin is indicated in the treatment of: advanced stage ovarian cancer of epithelial origin. Small cell lung carcinoma. Carcinoma of the head and

neck. Carcinoma of the testis. Paediatric cerebral tumours. Soft tissue sarcoma. Neuroblastoma.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Coloured 2 Years

Store below 25

degrees Celsius

Not recorded

Do not Freeze

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 x 20 mL vial

(S4) Prescription Only Medicine

Components

1. CARBOPLATIN ACCORD carboplatin 150 mg/15 mL solution for injection vial

Dosage Form

Injection, solution

Route of Administration

Intravenous

Visual Identification

A clear colourless to slight pale yellow solution in an amber glass vial.

Active Ingredients

Carboplatin

150 mg

© 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 1 of

Produced at 26.11.2017 at 07:58:03 AEDT

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

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CARBOPLATIN ACCORD

Carboplatin Injection 50 mg/5 mL, 150 mg/15 mL and 450 mg/45 mL

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Carboplatin Accord

Injection. It does not contain all the

available information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and benefits.

Your doctor has weighed the risks of you

being given carboplatin against the

benefits they expect it will have for you.

If you have any concerns about being

given this medicine, ask your doctor or

pharmacist.

Keep this leaflet.

You may need to read it again.

What Carboplatin Accord

Injection is used for

This medicine is used to treat:

ovarian cancer

cancer of the testes

some types of lung cancer

cancer of the brain and/or spinal cord

cancer of the head and neck

neuroblastoma (a cancer of the

nerves and adrenal glands)

a type of cancer called sarcoma.

Carboplatin belongs to a group of

medicines called antineoplastic or

cytotoxic medicines. You may also hear

of these being called chemotherapy

medicines. This medicine is classified as

a platinum-complex cytotoxic.

It works by killing cancer cells and/or

stopping cancer cells from growing and

multiplying.

Carboplatin is often used in combination

with other medicines to treat cancer.

Ask your doctor if you have any

questions about why this medicine has

been prescribed for you.

Your doctor may have prescribed it for

another reason.

This medicine is not addictive.

This medicine is available only with a

doctor’s prescription.

Before you are given

Carboplatin Accord

Injection

When you must not be given

it

You should not be given Carboplatin

Accord Injection if you have an allergy

any medicine containing carboplatin

other platinum-containing

compounds such as cisplatin or

oxaliplatin

mannitol.

Some of the symptoms of an allergic

reaction may include shortness of breath,

wheezing or difficulty breathing;

swelling of the face, lips, tongue or other

parts of the body; rash, itching or hives

on the skin; dizziness or light-

headedness.

Females: tell your doctor or

pharmacist if you are pregnant or

intend to become pregnant.

Like most cytotoxic medicines

carboplatin is not recommended for use

during pregnancy. If there is any need to

consider carboplatin during your

pregnancy, your doctor or pharmacist

will discuss the benefits and risks of

using it.

Males: tell your doctor or pharmacist

if your partner intends to become

pregnant while you are being given

carboplatin, or shortly after you have

stopped treatment with Carboplatin

Accord Injection.

Carboplatin may cause birth defects if

either the male or female is using it at the

time of conception. It is recommended

that you use some kind of birth control

while you are using carboplatin and for at

least 12 weeks after you stop treatment.

A barrier method of birth control, such as

a condom, should be used while you are

being given carboplatin and for the first

week of this 12 week period. Your doctor

will discuss this with you.

Do not breast-feed if you are being

treated with this medicine.

It is not known whether carboplatin

passes into breast milk and there is a

possibility that the breast-fed baby may

be affected.

You must not be given this medicine if

you have any of the following

conditions:

very low numbers of white blood

cells, red blood cells or platelets

severe kidney problems (your dose

may be reduced with some milder

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conditions).

Severe bleeding

Tell your doctor if you have an

infection or high temperature.

Your doctor may decide to delay your

treatment until the infection has gone. A

mild illness, such as a cold, is not usually

a reason to delay treatment.

If you are not sure whether you should

be given this medicine, talk to your

doctor

.

Before you are given it

Tell your doctor if you have allergies to

any other medicines, foods,

preservatives or dyes.

Tell your doctor if you have any of the

following medical conditions:

kidney problems

hearing problems

condition of the blood with a reduced

number of red blood cells, white

blood cells, or platelets

bleeding problems or problems with

blood clotting

neurological problems (problems

with the nervous system)

herpes zoster infections (also known

as shingles)

chicken pox (now or recently), or if

you have been in recent contact with

someone who has chicken pox.

Tell your doctor if you have had

previous treatment with cisplatin.

If you have not told your doctor about

any of the above, tell him/her before

you are given carboplatin.

Taking other medicines

Tell your doctor or pharmacist if you

are taking or using any other

medicines, including any that you get

without a prescription from your

pharmacy, supermarket or health food

shop.

Some medicines and carboplatin may

interfere with each other. These include:

other medicines used to treat cancer

(such as paclitaxel and

cyclophosphamide), radiation

therapy or any other treatment which

weakens your immune system

some antibiotics used to treat serious

infections, including

aminoglycosides (such as

gentamicin, tobramycin or amikacin)

some vaccines (ask your doctor).

These medicines may be affected by

carboplatin, or may affect how well it

works. You may need different amounts

of your medicines, or you may need to

take or use different medicines.

Do not have any vaccinations

(immunisations) without your doctor’s

approval while you are being treated

with

Carboplatin Accord Injection

, and

for up to 12 months after you stop

treatment with it.

Carboplatin may lower your body’s

resistance to infection and there is a

chance that you may get the infection the

immunisation is meant to prevent.

In addition, other people living in your

household should not take oral polio

vaccine (Sabin) since there is a chance

they could pass the polio virus on to you.

Your doctor and pharmacist have more

information on medicines to be careful

with or avoid while you are being given

this medicine.

How Carboplatin Accord

Injection is given

How much is given

Your doctor will decide what dose you

will receive. This depends on your

condition and other factors, such as your

weight, height, kidney function, blood

counts and other chemotherapy

medicines you are being given.

Carboplatin may be given alone or in

combination with other drugs.

Several courses of carboplatin therapy

may be needed depending on your

response to treatment.

Additional treatment may not be

repeated until your blood cell numbers

return to acceptable levels and any

unwanted effects have been controlled.

Ask your doctor if you want to know

more about the dose of carboplatin you

receive.

How it is given

Carboplatin Accord Injection is diluted in

a fluid bag and then given as an infusion

(drip) into your veins, over 15 to 60

minutes. It must only be given by a

doctor or nurse.

How long it is given

Carboplatin is usually given as a single

infusion on one day. This is called one

‘cycle’ of chemotherapy. A cycle is

usually repeated 4 weeks after the

previous cycle. Your doctor will decide

how many of these cycles you need.

If you receive too much

(overdose)

As carboplatin is given to you under

the supervision of your doctor, it is

very unlikely that you will receive an

overdose. However, if you experience

any side effects after being given

Carboplatin Accord injection tell your

doctor immediately or go to Accident

and Emergency at the nearest hospital

In case of overdose, immediately contact

the poisons information center for advice

(phone 13 11 26 in Australia or 0800 764

766 in New Zealand).

Symptoms of an overdose may include

the side effects listed below in the ‘Side

Effects’ section, but are usually of a more

severe nature.

Ask your doctor, nurse or pharmacist

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if you have any concerns.

While you are being

given Carboplatin

Accord Injection

Things you must do

If you are about to be started on any

new medicine, remind your doctor and

pharmacist that you are being given

carboplatin.

Tell any other doctors, dentists, and

pharmacists who treat you that you are

being given this medicine.

If you are going to have surgery, tell

the surgeon or anaesthetist you are

being given this medicine.

If you become pregnant while you are

being treated with this medicine, tell

your doctor immediately.

Keep all of your doctor’s appointments

so that your progress can be checked.

Your doctor may want to check your

blood pressure and do some blood,

hearing and other tests from time to time

to check on your progress and detect any

unwanted side effects.

Keep follow up appointments with

your doctor.

It is important to have your follow-up

cycles of carboplatin at the appropriate

times to get the best effects from your

treatments.

Carboplatin can lower the number of

white blood cells and platelets in your

blood. This means that you have an

increased chance of getting an infection

or bleeding. The following precautions

should be taken to reduce your risk of

infection or bleeding:

avoid people with infections. Check

with your doctor immediately if you

think you are getting an infection, or

if you get a fever or chills, cough or

hoarseness, lower back or side pain,

or find it painful or difficult to

urinate;

check with your doctor immediately

if you notice any unusual bleeding or

bruising, black stools, blood in urine

or stools or pinpoint red spots on

your skin;

be careful when using a regular

toothbrush, dental floss or toothpick.

Your doctor or nurse may

recommend other ways to clean your

teeth and gums. Check with your

doctor before having any dental

work done;

be careful not to cut yourself when

you are using sharp objects such as a

safety razor or nail cutters;

avoid contact sports or other

situations where you may get bruised

or injured.

Carboplatin and its breakdown products

may be excreted in body fluids and

waste, including blood, urine, faeces,

vomitus and semen. In general,

precautions to protect other people should

be taken while you are receiving

chemotherapy and for one week after the

treatment period:

Flush the toilet twice to dispose of

any body fluids and waste

Wear gloves to clean any spill of

body fluid or waste. Use paper

towels or old rags, a strong solution

of non-bleaching detergent and large

amounts of water to mop up the spill.

Discard the towels or rags into a

separate waste bag and dispose of

fluids in the toilet.

Wash linen or clothing that is heavily

contaminated by body fluids or

waste separately from other items.

Use a strong solution of non-

bleaching detergent and large

amounts of water.

Place soiled disposable nappies and

other pads in a plastic bag, seal and

dispose into the garbage.

For sexual intercourse, use a barrier

method such as a condom.

While you are being given carboplatin

your doctor should order regular tests to

check the number of blood cells in your

blood. The results of these tests will be

used to determine the amount of

carboplatin you will be given for your

next dose.

Things to be careful of

Be careful driving or operating

machinery until you know how

carboplatin affects you.

This medicine may cause dizziness, light-

headedness, tiredness and drowsiness in

some people. If you have any of these

symptoms, do not drive, operate

machinery, or do anything else that could

be dangerous.

Be careful when drinking alcohol while

you are taking this medicine.

If you drink alcohol, dizziness or light-

headedness may be worse.

Side Effects

Tell your doctor, pharmacist or nurse

as soon as possible if you do not feel

well while you are being treated with

carboplatin.

Like other medicines, carboplatin may

have unwanted side effects, some of

which may be serious. You may need

medical attention if you get some of the

side effects.

If you are over 65 years of age you may

have an increased chance of getting side

effects.

Ask your doctor or pharmacist to

answer any questions you may have.

Tell your doctor, pharmacist or nurse

if you notice any of the following and

they worry you:

mild nausea or vomiting

diarrhoea or constipation

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weakness, tiredness or fatigue

sore muscles or joints

pain or irritation at the injection site

taste abnormalities.

The above list includes the more common

side effects of this medicine. They are

usually mild and short-lived. Temporary

loss of hair, particularly that on the scalp

is a less common but upsetting side effect

of carboplatin and occurs in a small

number of patients (about 2 patients per

100 treated). The severity of hair loss will

depend on the dose of carboplatin given.

It is more common when other anticancer

medicines are used together with

carboplatin.

Tell your doctor or nurse as soon as

possible if you notice any of the

following:

hearing problems

muscle irritability or cramps

blurred vision or other visual

disturbances

tingling in the fingers or toes

flaking or peeling of the skin, rash or

itchy rash

The above list includes serious side

effects which may require medical

attention.

If any of the following happen, tell

your doctor or nurse immediately or

go to Accident and Emergency at your

nearest hospital:

signs of an allergic reaction (such as

shortness of breath, wheezing or

difficulty breathing; swelling of the

face, lips, tongue or other parts of the

body; rash, itching or hives on the

skin; dizziness or light-headedness)

signs of infection, such as fever,

chills, sore throat or mouth ulcers

shortness of breath

tremor

unusual bleeding or bruising

problems with urination e.g. pain or

difficulty

yellowing of the skin or eyeballs

severe nausea and vomiting

a feeling of tightness, pressure or

heaviness in the chest.

The above list includes very serious side

effects. You may need urgent medical

attention or hospitalisation.

Tell your doctor, nurse or pharmacist

if you notice anything that is making

you feel unwell.

Other side effects not listed above may

also occur in some people. Some of these

side effects can only be found when your

doctor does tests from time to time to

check your progress.

The benefits and side effects of

carboplatin may take some time to occur.

Therefore, even after you have finished

receiving your carboplatin treatment you

should tell your doctor immediately if

you notice any of the side effects listed

above.

Storage

Carboplatin Injection will be stored in the

pharmacy or on the ward. The injection is

kept in a cool dry place, protected from

light, where the temperature stays below

25°C.

Product Description

What it looks like

Carboplatin Accord Injection is a clear

colourless solution which will be diluted

in a fluid bag and given as an infusion

(‘drip’). It is available in 3 presentations;

50 mg/5 mL, 150 mg/15 mL and

450 mg/45 mL in single packs.

Ingredients

Carboplatin Accord Injection contains

carboplatin as the active ingredient. It

also contains water for injections.

This medicine does not contain lactose,

sucrose, gluten, tartrazine or any other

azo dyes.

Name and Address of the

Sponsor

Accord Healthcare Pty Ltd

Level 24, 570 Bourke Street

Melbourne, VIC, 3000

Australia

Australian Registration Numbers

50 mg/5 mL: AUST R 215852

150 mg/15 mL: AUST R 215853

450 mg/45 mL: AUST R 215854

Date of Preparation

This leaflet was prepared on 27 January

2017.

18-5-2018

Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement - Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy

Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement - Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy

Early reviews found patients in the monotherapy arms of both trials with PD-L1 low status had decreased survival compared to patients who received cisplatin- or carboplatin-based chemotherapy.

FDA - U.S. Food and Drug Administration

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety