New Zealand - English - Medsafe (Medicines Safety Authority)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about Carboplatin 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 using Carboplatin Injection against
the benefits it is expected to have for
If you have any concerns about using
this medicine, ask your doctor or
Keep this leaflet.
You may need to read it again.
Injection is used for
Carboplatin belongs to a group of
anticancer medicines known as
platinum complexes. Carboplatin
works by preventing the growth of
cancer cells and eventually destroying
them. It is used for cancer of the ovary.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed it for
This medicine is available only with a
Before you are given
When you must not be given
Do not use Carboplatin Injection if:
you have an allergy to carboplatin,
cisplatin or other medicines
you have kidney disease or poor
you have a low blood count
Do not use this medicine if you are
pregnant or planning to become
It may affect your developing baby if
you take it during pregnancy.
Do not breast feed if you are using
If you are not sure you should be
given Carboplatin, talk to your
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 are pregnant
or plan to become pregnant.
Tell your doctor if you are breast-
feeding or plan to breast-feed.
Tell your doctor if you have or have
had any of the following medical
any sort of infection e.g. sinusitis,
tooth abscess, etc
abnormal or heavy bleeding
poor kidney function
problems with hearing.
Tell your doctor if you are going to
be vaccinated (have an injection to
prevent a certain disease).
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 if you are taking
any other medicines, including any
that you buy without a prescription
from your pharmacy, supermarket
or health food shop.
Some medicines and Carboplatin may
interfere with each other. These
other anticancer drugs
drugs that affect the kidneys such
as some antibiotics
some vaccinations (injections to
prevent you getting a certain
You may need different amounts of
your medicines or you may need to
take different medicines. Your doctor
will advise you.
How Carboplatin is
Carboplatin is given by slow injection
into a vein. It must only be given by a
doctor or a nurse.
Your doctor will decide what dose,
how often and how long you will
This depends on your condition and
other factors, such as your weight, age,
blood tests, how well your kidneys are
working and whether or not other
medicines are being given at the same
If you are given too much
Overdose is unlikely as treatment is
given in hospital under the supervision
of a doctor.
However, if you are given too much
Carboplatin, you may experience some
of the effects listed under “Side Effects”
Ask your doctor if you have any
Your doctor has information on how to
recognise and treat an overdose.
While you are being
Things you must do
Keep all of your doctor’s
appointments so that your progress
can be checked.
You will also have blood tests to check
for side effects.
Tell any other doctors, dentists and
pharmacists who treat you that you
are using this medicine.
If you become pregnant while using
this medicine, tell your doctor
Tell your doctor, nurse or
pharmacist as soon as possible if you
do not feel well while you are using
Like other medicines, Carboplatin can
cause some side effects. If they occur,
most are likely to be minor or
temporary. However, some may be
serious and need medical attention.
Tell your doctor immediately if you
notice any of the following:
fever and chills, sore throat, sweats
or feel generally unwell
wheezing or shortness of breath
pain and redness at site of injection
bleeding, unusual bruising,
bleeding gums, blood in the urine
or stools, or pinpoint red spots
rash, fever or itching
hearing loss or ringing in the ears
tingling or a loss of sensation in the
fingers or toes
hair loss, especially of the scalp
a feeling of tiredness
joint pain, muscle pain
chest pain, stroke
decrease in urine
These may be serious side effects.
You may need urgent medical
attention. Serious side effects are rare.
Other side effects not listed above may
also occur in some patients.
Tell your doctor if you notice any
Some side effects may only be seen by
What it looks like
Carboplatin Injection is a clear,
colourless solution in a plastic vial.
It comes in three sizes: 50 mg of
carboplatin in 5 mL, 150 mg in 15 mL
and 450 mg in 45 mL.
Carboplatin Injection contains
carboplatin as the active ingredient.
It also contains Water for Injections. It
does not contain a preservative.
Carboplatin is supplied in Australia by:
Pfizer Australia Pty Ltd
ABN 50 008 422 348
38-42 Wharf Road
West Ryde NSW 2114
Toll Free Number: 1800-675 229
It is supplied in New Zealand by:
Pfizer New Zealand Ltd
PO Box 3998
Toll Free Number: 0800-736 363
Australian Registration Numbers
50 mg /5 mL
AUST R 42853
150 mg /15 mL
AUST R 49348
450 mg /45 mL
AUST R 49349
Date of preparation
This leaflet was prepared in December
Page 1 of 10
NEW ZEALAND DATA SHEET
Carboplatin Injection, 50 mg/5 mL, 150 mg/15 mL and 450 mg/45 mL.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Carboplatin is a sterile, hypotonic, preservative-free solution of carboplatin 10 mg/mL in Water
For the full list of excipients, see section 6.1.
Solution for injection.
4.1 Therapeutic indications
For the treatment of advanced ovarian carcinoma of epithelial origin.
4.2 Dose and method of administration
The recommended dosage for previously untreated adults (normal renal function) is 400mg/m²
as a single intravenous infusion over 15-60 minutes.
Therapy should not be repeated again until four weeks have elapsed.
In patients with risk factors such as previous myelosuppressive therapy or in the aged, the initial
dosage may need to be reduced to 20-25%.
Determination of the haematological nadir by weekly blood counts is recommended for
adjusting future doses and scheduling of carboplatin.
Patients with Impaired Renal Function
As carboplatin is excreted by the kidney and is nephrotoxic the optimum dosage should be
determined by frequent monitoring of the haematological nadir and renal function.
The suggested dosage schedule for patients with impaired renal function based on creatinine
> 40 mL/min
Page 2 of 10
Insufficient information is available to make specific recommendations.
Carboplatin may be used in combination with other anti-neoplastic agents and hence the dosage
will vary according to the protocol used.
The optimal use of carboplatin in combination with other myelosuppressive drugs will require
dosage adjustments and frequent haematological monitoring.
Method of Administration
Aluminium reacts with carboplatin causing precipitate formation and loss of potency, therefore
aluminium-containing equipment should not be used for preparation or administration of
Prior to administration, carboplatin solutions should be inspected visually for particulate
matter. Dilutions may be made in Glucose 5% Intravenous Infusion to concentrations as low
as 0.1 mg/mL. The product and admixture contain no antimicrobial agent. In order to reduce
microbiological hazards it is recommended that further dilution should be effected immediately
prior to use and infusion commenced as soon as practicable after preparation of the admixture.
Infusion should be completed within 24 hours of preparation and any residue discarded (see
Treatment with carboplatin is contraindicated in the following conditions:
platinum-containing compounds (e.g. cisplatin)
in the presence of severe renal impairment
in the presence of severe bone marrow depression
in the presence of substantial bleeding
in pregnancy and lactation.
4.4 Special warnings and precautions for use
Carboplatin should be administered only by a qualified physician experienced in the use of
chemotherapeutic agents. Close monitoring for toxicity is mandatory, particularly in the case
of administration of high drug dosages.
Carboplatin is a highly toxic drug with a narrow therapeutic index and a therapeutic effect is
unlikely to occur without some evidence of toxicity.
Page 3 of 10
Bone Marrow Function
Bone marrow suppression (leucopenia, neutropenia and thrombocytopenia) is dose-dependent
and is the dose-limiting toxicity of carboplatin. Peripheral blood cell counts should be
performed at frequent intervals (before start of therapy and weekly thereafter) in patients
receiving carboplatin. Although at the recommended drug doses the haematologic toxicity of
thrombocytopenia) may occur in patients with renal impairment and in patients who are
concurrently receiving (or have received) other myelosuppressive drugs or radiation therapy.
Dose adjustment criteria for patients who experience myelosuppression following a dose of
carboplatin are provided under Dosage and Administration. As an alternative to dosage
reduction, administration of the full therapeutic dose of the drug may be delayed until recovery
of neutrophil and platelet counts (values ≥ 2000/mm3 and 100,000/mm3 respectively).
Treatment of severe haematologic toxicity may consist of supportive care, anti-infective agents
for complicating infections, transfusions of blood products, autologous bone marrow rescue,
peripheral stem cell transplantation and haematopoietic agents (colony-stimulating factors).
Blood and Lymphatic System Disorders
Haemolytic anaemia with the presence of serologic drug-induced antibodies has been reported
in patients treated with carboplatin. This event can be fatal.
Haemolytic-uremic syndrome (HUS) is a potentially life-threatening side effect. Carboplatin
should be discontinued at the first sign of any evidence of microangiopathic haemolytic
anaemia, such as rapidly falling haemoglobin with concomitant thrombocytopenia, elevation
of serum bilirubin, serum creatinine, blood urea nitrogen, or lactate dehydrogenase (LDH).
Renal failure may not be reversible with discontinuation of therapy and dialysis may be
Acute promyelocytic leukaemia (APL) and myelodysplastic syndrome (MDS)/acute myeloid
Cases of hepatic veno-occlusive disease (sinusoidal obstructive syndrome) have been reported.
Some of them were fatal.
Carboplatin is excreted primarily in the urine and renal function must be monitored in patients
receiving the medicine. Creatinine clearance appears to be the most sensitive measure of
kidney function in patients receiving carboplatin. Dose adjustment criteria for patients with
impaired renal function are provided under Dosage and Administration. Unlike cisplatin, pre-
and post-treatment hydration is not necessary with carboplatin as the drug has a relatively low
nephrotoxic potential, however, previous therapy with cisplatin or concomitant administration
of other nephrotoxic drugs
aminoglycoside antibiotics) may
nephrotoxicity (see Section 4.5).
Central Nervous System (CNS)/Hearing Functions
Routine neurologic examination is advisable during carboplatin therapy, particularly in patients
previously treated with cisplatin and in patients over 65 years of age. Carboplatin may produce
Page 4 of 10
cumulative ototoxicity. Audiograms should be performed prior to initiating therapy and during
treatment or when auditory symptoms occur. Clinically important deterioration of auditory
ototoxicity may be increased by concomitant administration of other ototoxic drugs (e.g.,
aminoglycosides) (see section 4.5).
Delayed onset hearing loss has been reported in paediatric patients. Long-term audiometric
follow-up in this population is recommended.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
chemotherapy. RPLS is a rare, reversible after treatment discontinuation, rapidly evolving
blindness, and other visual and neurological disturbances. Diagnosis of RPLS is based upon
confirmation by brain imaging, preferably MRI.
Carboplatin can induce emesis. The incidence and severity of emesis may be reduced by
pre-treatment with antiemetics or by carboplatin administration as a continuous IV infusion
over 24 hours, or as IV administration of divided doses over 5 consecutive days rather than as
a single infusion. Selective inhibitors of type 3 (5-HT3), serotonergic receptors (e.g.,
ondansetron) or substituted benzamides (e.g., metoclopramide) may be particularly effective
antiemetics, and combination therapy may be considered for patients experiencing severe or
refractory emetogenic effects.
Tumour Lysis Syndrome (TLS)
Patients at high risk of TLS such as patients with high proliferative rate, high tumor burden and
high sensitivity to cytotoxic agents should be monitored closely and appropriate precaution
As in the case of other platinum complexed compounds, allergic reactions to carboplatin have
been reported. Patients should be monitored for possible anaphylactoid reactions and
appropriate equipment and medication should be readily available to treat such reactions (e.g.,
antihistamines, corticosteroids, epinephrine, oxygen) whenever carboplatin is administered.
Immunosuppressant Effects/Increased Susceptibility to Infections
chemotherapeutic agents including carboplatin, may result in serious or fatal infections.
Vaccination with a live vaccine should be avoided in patients receiving carboplatin. Killed or
inactivated vaccines may be administered; however, the response to such vaccines may be
4.5 Interaction with other medicines and other forms of interaction
Carboplatin is mostly used in combination with antineoplastic drugs having similar cytotoxic
effects. In these circumstances additive toxicity is likely to occur. Concomitant use of
carboplatin and other myelosuppressive agents or radiation therapy
may potentiate the
Page 5 of 10
An increased incidence of emesis has been reported when carboplatin and other emetogenic
drugs are given concurrently or carboplatin is administered to patients who previously received
Concomitant administration of carboplatin and aminoglycosides results in an increased risk of
nephrotoxicity and/or ototoxicity and the drugs should be used concurrently with caution. The
use of other nephrotoxic drugs results in a potentiation of renal effects by carboplatin.
Carboplatin interacts with aluminium to form a black precipitate of platinum and loss of
potency. Aluminium-containing IV sets, needles, catheters and syringes should not be used for
A decrease in phenytoin serum levels has been observed with concurrent administration of
carboplatin and phenytoin/fosphenytoin. This may lead to exacerbation of seizures.
4.6 Fertility, pregnancy and lactation
Women of childbearing potential should be advised to avoid becoming pregnant while
receiving carboplatin and to use effective contraception during treatment with carboplatin and
for at least six months after the last dose. Men with female partners of childbearing potential
should be advised to use effective contraception during treatment with carboplatin and for at
least three months after the last dose.
Male and female fertility may be impacted by treatment with carboplatin. Both men and
women should seek advice for fertility preservation before treatment with carboplatin.
Pregnancy - Category D
Carboplatin has been shown to be embryo-toxic and mutagenic, and its use in pregnant women
is not recommended. Women of child-bearing potential should use adequate contraception and
carboplatin should only be used in women of child-bearing potential if the expected benefits
outweigh the risks of such therapy. If the patient becomes pregnant whilst receiving the drug
she should be advised of the potential hazard to the foetus.
It is not clearly established whether carboplatin or its platinum-containing metabolites are
distributed into human milk. However, because of the potential for serious adverse reactions in
infants should the drug pass into the milk, nursing should be discontinued during therapy.
4.7 Effects on ability to drive and use machinery
The effect of carboplatin on the ability to drive or use machinery has not been systematically
4.8 Undesirable effects
Many side effects of carboplatin therapy are unavoidable due to the pharmacological actions
of the drug. However, the adverse effects are generally reversible if detected early.
Adverse reactions as reported for the various organ systems are as follows:
Page 6 of 10
Neoplasms benign, malignant and unspecified
There have been rare reports of acute myelogenous leukemias and myelodysplastic syndromes
arising in patients who have been treated with carboplatin, mostly when given in combination
with other potentially leukemogenic agents.
Blood and lymphatic system disorders
The major and dose-limiting toxicity of carboplatin is bone marrow suppression, which is
manifested by thrombocytopenia, leucopenia, neutropenia and/or anaemia. Myelosuppression
is dose-related. Platelet and leucocyte/granulocyte nadirs usually occur two to three weeks
from drug administration. Recovery is generally adequate to allow the administration of the
(haemoglobin less than 11 g/dL), which may be symptomatic, occurs in a substantial proportion
of patients. This effect may be cumulative and transfusions may be needed particularly in
patients receiving prolonged therapy (e.g., more than 6 cycles).
Haemolytic anaemia (sometimes fatal) has also been reported.
Clinical sequelae of bone marrow/haematologic toxicity such as fever, infections, sepsis/septic
shock and haemorrhage may be expected.
Haemolytic uremic syndrome (HUS) has been reported.
Metabolism and nutrition disorders
Nausea and/or vomiting, which generally are mild to moderate in severity, may occur within
6-12 hrs after carboplatin administration and may persist up to 24 hours or longer. Other GI
effects such as mucositis, stomatitis, diarrhoea, constipation and abdominal pain have also been
Nervous system disorders
Peripheral neuropathies may occur, mainly in the form of paraesthesias and decreased deep
tendon reflexes. The effect, more common in patients over 65 years of age, appears to be
cumulative, occurring mainly in patients receiving prolonged therapy and/or in those who have
received prior cisplatin therapy. CNS effects may also occur. In some cases the neurotoxicity
seen with carboplatin may be the result of a combination with some delayed effect of prior
cisplatin therapy. Dysgeusia has been reported in patients taking carboplatin.
Ear and labyrinth disorders
Tinnitus and hearing loss has been reported in patients receiving carboplatin.
Visual abnormalities, such as transient sight loss (which can be complete for light and colours)
or other disturbances may occur in patients treated with carboplatin. Improvement and/or total
recovery of vision usually occurs within weeks after the drug is discontinued. Cortical
blindness has been reported in patients with impaired renal function receiving high-dose
Page 7 of 10
Cardiac failure; ischaemic coronary artery disorders (e.g., myocardial infarction, cardiac arrest,
angina, myocardial ischaemia), Kounis syndrome.
Renal and urinary disorders
Acute renal failure has been reported rarely. Mild and transient elevations of serum creatinine
nephrotoxicity (e.g., impaired creatinine clearance) becomes more prominent at relatively high
dosages or in patients previously treated with cisplatin.
aminotransferase or bilirubin concentrations may occur. Substantial abnormalities in liver
function test have been reported in patients treated with carboplatin at high doses and
autologous bone marrow transplantation.
Immune system disorders
Allergic reactions to carboplatin have been reported. These include anaphylaxis/anaphylactoid
reactions, hypotension, bronchospasm, and pyrexia. Hypersensitivity reactions may occur
within a few minutes after IV administration of carboplatin.
Skin and subcutaneous tissue disorders
Exfoliative dermatitis may rarely occur. Erythematous rash, pruritus, urticaria, and alopecia
have also been reported in association with carboplatin.
Musculoskeletal and connective tissue disorders
General disorders and administration site conditions
Asthenia, flu-like symptoms, reactions at injection site.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows
continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are
asked to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/.
There are no known antidotes for carboplatin overdosage; thus every possible measure should
be taken to avoid an overdose including full awareness of the potential danger of an overdose,
careful calculation of the dose to be administered and availability of adequate diagnostic and
treatment facilities. Acute overdosage with carboplatin may result in an enhancement of its
expected toxic effects (e.g., severe myelosuppression, intractable nausea and vomiting, severe
neurosensorial toxicities, liver failure, kidney failure, etc). Death may follow. Haemodialysis
Page 8 of 10
is only effective, even then partially, up to 3 hours after administration because of the rapid
and extensive binding of platinum to plasma proteins. Signs and symptoms of overdosage
should be managed with supportive measures.
For advice on the management of overdose please contact the National Poisons Centre on 0800
POISON (0800 764766).
5.1 Pharmacodynamic properties
Carboplatin is an antineoplastic agent. It is an analogue of cisplatin, but it seems to be less
toxic. Like cisplatin, it appears to form intra- and inter-strand crosslinks in cells which modifies
DNA structure and inhibits DNA synthesis. It does not appear to be phase-specific in the cell
5.2 Pharmacokinetic properties
Protein binding is less than with cisplatin, initially protein binding is low with up to 29% of
carboplatin bound during the first 4 hours. However, platinum from carboplatin is irreversibly
bound to plasma proteins (by 24 hours 85-89% is bound) and is slowly eliminated with a
minimum half-life of 5 days.
Elimination and Excretion
After intravenous infusion of single doses over one hour, plasma concentrations of total
platinum and free platinum decline biphasically following first order kinetics. For free
platinum, reported values for the initial phase of the half-life (t
) are about 90 minutes and
in the later phase the half-life (t
) is about 6 hours. Total platinum elimination has a similar
initial half-life, while in the later phase the half-life of total platinum may be greater than 24
hours. All free platinum is in the form of carboplatin in the first four hours.
The kidney is the major route of excretion. Most excretion occurs within the first 6 hours after
administration with 50% to 70% excreted within 24 hours. 32% of the dose is excreted as
unchanged medicine. A reduction in dosage is recommended for patients with poor renal
5.3 Preclinical safety data
Carcinogenicity and Mutagenicity
Secondary malignancies are potential delayed effects of many antineoplastic agents although
it is not clear whether the effect is related to their mutagenic or immunosuppressive action.
The effect of dose and duration of therapy is also unknown although risk seems to increase
with long-term use. Although information is limited, available data seems to indicate that the
carcinogenic risk is greatest with the alkylating agents.
studies have shown carboplatin to be mutagenic.
Page 9 of 10
6.1 List of excipients
Water for injection
Carboplatin may interact with aluminium to form a black precipitate. Needles, syringes,
catheters or IV administration sets that contain aluminium parts which may come in contact
with carboplatin should not be used for preparation or administration of the medicine.
6.3 Shelf life
24 months from date of manufacture stored at or below 25°C.
6.4 Special precautions for storage
Store at or below 25ºC. Protect from light.
6.5 Nature and contents of container
Carboplatin injection is available as follows:
50 mg/5 mL
1 × 5 mL plastic vial
150 mg/15 mL
1 × 15 mL plastic vial
450 mg/45 mL
1 × 45 mL plastic vial
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
The usual precautions for handling and preparing cytotoxic drugs should be observed when
Personnel should be trained in good technique for handling. Pregnant staff should be excluded
from working with carboplatin.
Preparation should be performed in a designated area ideally in a vertical laminar flow hood,
with the work surface covered with disposable plastic-backed absorbent paper.
Care should be taken to prevent inhaling particles and exposing the skin to carboplatin.
Adequate protective clothing should be worn, such as PVC gloves, safety glasses, disposable
gowns and masks.
Page 10 of 10
It is recommended that lock fittings are used in the assembly of syringes and giving sets to
In the event of contact with the eyes, wash with water or saline. If the skin comes into contact
with the drug wash thoroughly with water and in both cases seek medical advice. Seek
immediate medical attention if the drug is ingested or inhaled.
All used material, needles, syringes, vials and other items which have come into contact with
cytotoxic drugs should be incinerated. Excreta should be similarly treated. Contaminated
surfaces should be washed with copious amounts of water.
Use immediately upon opening. Discard any unused portion.
Pfizer New Zealand Limited
P O Box 3998
Auckland, New Zealand
Toll Free number: 0800 736 363
DATE OF FIRST APPROVAL
01 October 1992
10. DATE OF REVISION OF THE TEXT
21 January 2020
Summary table of changes
Summary of new information
Minor editorial changes.
Addition of information concerning reversible posterior leukoencephalopathy