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Rx 4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Carboplatin Injection BP Antineoplastic agent indicated in the treatment
50mg/5ml, 150mg/15ml, of:
450mg/45ml, 600mg/60ml • ovarian carcinoma of epithelial origin

1. NAME OF THE MEDICINAL • small cell lung carcinoma.

PRODUCT 4.2 Posology and method of administration
Posology
Carboplatin Injection BP 50mg/5ml Taj Pharma
Carboplatin Injection BP 150mg/15ml Taj The recommended dose of carboplatin in
Pharma previously untreated adults with normal renal
Carboplatin Injection BP 450mg/45ml Taj function is 400 mg/m2, given as a single short
Pharma term intravenous Injection over 15 to 60
Carboplatin Injection BP 600mg/60ml Taj minutes. Alternatively, the Calvert formula
Pharma shown below may be used to determine dosage:

2. QUALITATIVE AND Dose (mg) = target AUC (mg/ml x min) x [GFR

ml/min + 25]
QUANTITATIVE COMPOSITION
a) Carboplatin Injection BP 50mg/5ml Taj Target Patient Planned
Pharma AUC Treatment Chemotherapy
Each ml contains status
Carboplatin BP 10 mg 5-7 single agent previously
Water for Injection BP q.s. mg/ml.min carboplatin untreated
b) Carboplatin Injection BP 150mg/15ml Taj 4-6 single agent previously
Pharma mg/ml.min carboplatin treated
Each ml contains 4-6 carboplatin plus previously
Carboplatin BP 10 mg mg/ml.min cyclophosphamide untreated
Water for Injection BP q.s. Note: With the Calvert formula, the total dose of
carboplatin is calculated in mg, not mg/m2.
c) Carboplatin Injection BP 450mg/45ml Taj
Pharma Therapy should not be repeated until 4 weeks
Each ml contains after the previous carboplatin course and/or until
Carboplatin BP 10 mg the neutrophil count is at least 2,000 cells/mm³
Water for Injection BP q.s. and the platelet count is at least 100,000
cells/mm³.
d) Carboplatin Injection BP 600mg/60ml Taj
Pharma Initial dosage should be reduced by 20-25% in
Each ml contains patients with risk factors such as previous
Carboplatin BP 10 mg myelosuppressive therapy and/or poor
Water for Injection BP q.s. performance status (ECOG-Zubrod 2-4 or
Karnofsky below 80).
For the full list of excipients, see 6.1
Determination of hematologic nadir by weekly
3. PHARMACEUTICAL FORM blood counts during initial courses is
Liquid Injection. recommended for future dosage adjustment and
scheduling of carboplatin.
 Carboplatin 50mg /5ml, 150 mg/15 ml, 450 mg/ 45ml, 6 00 mg/60 ml Liquid Inj ection TajPhar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warning s, Carboplatin Dosage & Rx I nfo | Carboplatin Uses, Side E ffects - Anticancer, Car boplatin : I ndications, Side E ffects, Warnings, Carboplatin - Drug Infor mati on - TajP harma, Carboplatin dose Taj phar mace uticals Carboplatin interactions, Taj Phar mace utical Car boplatin contraindications, Carboplatin pri ce, Carboplatin TajP harma Antica ncer Powder for Inj ection SmP C - TajP harma Stay conne cted to all updated on Carboplatin Taj Phar ma ceuticals Taj pharmace uticals Mumbai. Patient Informati on Lea flets, S mPC.

Needles or intravenous sets containing In patients of more than 65 years of age,

aluminium parts that may come in contact with adjustment of the carboplatin dose to the general
carboplatin injection should not be used for condition is necessary during the first and the
preparation or administration. Aluminium reacts subsequent therapeutic courses.
with carboplatin injection causing precipitate
formation and/or loss of potency. Paediatric population

The safety measures for dangerous substances There is insufficient information to support a
are to be complied with preparation and dosage recommendation in the paediatric
administration. Preparation must be carried out population.
by personnel who have been trained in the safe Method of administration
use while wearing protective gloves, face mask
and protective clothes. Carboplatin injection should be used by the
intravenous route only.
Impaired renal function: In patients with
impaired renal function, dosage of carboplatin 4.3 Contraindications
should be reduced (refer to Calvert formula) and Carboplatin is contraindicated in:
haematological nadirs and renal function - hypersensitivity to the active substance or to
monitored. any of the excipients listed in 6.1
Patients with creatinine clearance values below - patients with severe myelosuppression
60 ml/min are at increased risk of severe
myelosuppression. The frequency of severe - patients with pre-existing severe renal
leukopenia, neutropenia, or thrombocytopenia impairment (with creatinine clearance of < 30
has been maintained at about 25% with the ml per minute) unless in the judgment of the
following dosage recommendations: physician and patient, the possible benefits of
treatment outweigh the risks
Baseline Creatinine Clearance Initial Dose (Day 1)
- patients with bleeding tumours
41-59 ml/min 250 mg/m2 I.V.
16-40 ml/min 200 mg/m2 I.V. - concomitant use with yellow fever vaccine (see
Insufficient data exist on the use of carboplatin section 4.5)
injection in patients with creatinine clearance of - patients with a history of severe allergic
15 ml/min or less to permit a recommendation reaction to carboplatin or other platinum
for treatment. containing compounds.
All of the above dosing recommendations apply Dosage adjustment may allow use in the
to the initial course of treatment. Subsequent presence of mild renal impairment (see section
dosages should be adjusted according to the 4.2).
patient's tolerance and to the acceptable level of
myelosuppression. 4.4 Special warnings and precautions for use
Warnings:
Combination Therapy
Myelosuppression
The optimal use of carboplatin in combination
with other myelosuppressive agents requires Myelosuppression as a result of carboplatin
dosage adjustments according to the regimen treatment is closely related to the renal clearance
and schedule to be adopted. of the drug. Therefore, in patients with abnormal
renal function, or who are receiving concomitant
Elderly population therapy with nephrotoxic drugs,
myelosuppression, especially thrombocytopenia,
may be more severe and prolonged.
 Carboplatin 50mg /5ml, 150 mg/15 ml, 450 mg/ 45ml, 6 00 mg/60 ml Liquid Inj ection TajPhar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warning s, Carboplatin Dosage & Rx I nfo | Carboplatin Uses, Side E ffects - Anticancer, Car boplatin : I ndications, Side E ffects, Warnings, Carboplatin - Drug Infor mati on - TajP harma, Carboplatin dose Taj phar mace uticals Carboplatin interactions, Taj Phar mace utical Car boplatin contraindications, Carboplatin pri ce, Carboplatin TajP harma Antica ncer Powder for Inj ection SmP C - TajP harma Stay conne cted to all updated on Carboplatin Taj Phar ma ceuticals Taj pharmace uticals Mumbai. Patient Informati on Lea flets, S mPC.

The occurrence, severity and protraction of The vial stopper contains dry natural rubber (a
toxicity is likely to be greater in patients who derivative of latex), which may cause allergic
have received extensive prior treatment with the reactions.
drug for their disease or with cisplatin, have
poor performance status and are advanced in Renal Toxicity
years. Renal function parameters should be In patients with impaired renal function, the
assessed prior to, during and after carboplatin effect of carboplatin on the haematopoietic
therapy Initial carboplatin dosages in these system is more pronounced and longer-acting
groups of patients should be appropriately than in patients with normal renal function. In
reduced (see section 4.2) and the effects this risk group, therapy with carboplatin must be
carefully monitored through frequent blood performed with special caution (see section 4.2).
counts between courses. Myelosuppressive
effects may be additive to those of concomitant Precautions:
chemotherapy. Carboplatin should only be administered under
Peripheral blood counts (including platelets, the supervision of a qualified physician who is
white blood cells and haemoglobin) should be experienced in the use of chemotherapeutic
followed during and after therapy. Combination agents. Diagnostic and treatment facilities
therapy with other myelosuppressive drugs may should be readily available for management of
require modification of dosage/timing of therapy and possible complications.
schedules in order to minimise additive effects. Peripheral blood counts, renal and hepatic
Carboplatin courses should not, in general, be function tests should be monitored closely.
repeated more frequently than every 4 weeks in Blood counts should be performed prior to
order to ensure that the nadir in blood counts has commencement of carboplatin therapy and at
occurred and there has been recovery to a weekly intervals thereafter. The drug should be
satisfactory level. discontinued if abnormal depression of the bone
marrow or abnormal renal or hepatic function is
Patients with severe and persistent seen.
myelosuppression are at high risk of infectious
complications including fatal outcomes (see Hematologic Toxicity
section 4.8). If any of these events occurs, Leukopenia, neutropenia, and thrombocytopenia
carboplatin should be interrupted and dose are dose-dependent and dose-limiting. Peripheral
modification or discontinuation should be blood counts should be monitored during
considered. carboplatin treatment. This will monitor toxicity
Allergic Reactions and help determine the nadir and recovery of
haematological parameters and assist in
As with other platinum-based drugs, allergic subsequent dosage adjustments. Median day of
reactions appearing most often during nadir is day 21 in patients receiving single agent
administration may occur and necessitate carboplatin and day 15 in patients receiving
discontinuation of Injection. Patients should be carboplatin in combination with other
observed carefully and an appropriate chemotherapeutic agents. In general, single
symptomatic treatment (including intermittent courses of carboplatin should not be
antihistamines, adrenaline and/or repeated until leukocyte, neutrophil, and platelet
glucocorticoids) must also be initiated in such counts have returned to normal. Lowest levels of
cases. Cross reactions, sometimes fatal, have platelets are generally seen between days 14 and
been reported with all the platinum compounds 21 of initial therapy. A greater reduction is seen
(see sections 4.3 and 4.8). in patients who previously received extensive
myelosuppressive chemotherapy. Lowest levels
 Carboplatin 50mg /5ml, 150 mg/15 ml, 450 mg/ 45ml, 6 00 mg/60 ml Liquid Inj ection TajPhar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warning s, Carboplatin Dosage & Rx I nfo | Carboplatin Uses, Side E ffects - Anticancer, Car boplatin : I ndications, Side E ffects, Warnings, Carboplatin - Drug Infor mati on - TajP harma, Carboplatin dose Taj phar mace uticals Carboplatin interactions, Taj Phar mace utical Car boplatin contraindications, Carboplatin pri ce, Carboplatin TajP harma Antica ncer Powder for Inj ection SmP C - TajP harma Stay conne cted to all updated on Carboplatin Taj Phar ma ceuticals Taj pharmace uticals Mumbai. Patient Informati on Lea flets, S mPC.

of white cells occur generally between days 14 Visual disturbances, including loss of vision,
and 28 of initial therapy. If neutrophil levels fall have been reported after the use of carboplatin in
below 2000 cells/mm3 or platelets are less than doses higher than those recommended in
100,000 cells/mm3 then postponement of patients with renal impairment. Vision appears
carboplatin therapy until bone barrow recovery to recover totally or to a significant extent within
is evident, should be considered. This recovery weeks of stopping these high doses.
usually takes 5 to 6 weeks. Transfusions may be
necessary and dosage reductions recommended Reversible Posterior Leukoencephalopathy
for subsequent treatment. Syndrome (RPLS)

Anaemia is frequent and cumulative, however Cases of Reversible Posterior

Leukoencephalopathy Syndrome (RPLS) have
rarely requires a transfusion.
been reported in patients receiving carboplatin in
Haemolytic-uremic syndrome (HUS) combination chemotherapy. RPLS is a rare,
reversible (after treatment discontinuation),
Haemolytic-uremic syndrome (HUS) is a life-
rapidly evolving neurological condition, which
threatening side effect. Carboplatin should be can include seizure, hypertension, headache,
discontinued at the first signs of any evidence of confusion, blindness, and other visual and
micro-angiopathichaemolyticanaemia, such as neurological disturbances (see section 4.8).
rapidly falling haemoglobin with concomitant Diagnosis of RPLS is based upon confirmation
thrombocytopenia, elevation of serum bilirubin,
by brain imaging, preferably MRI (Magnetic
serum creatinine, blood urea nitrogen, or LDH. Resonance Imaging).
Renal failure may not be reversible with
discontinuation of therapy and dialysis may be Geriatric Use
required.
In studies involving combination therapy with
Renal toxicity carboplatin and cyclophosphamide, elderly
patients treated with carboplatin were more
The incidence and severity of nephrotoxicity
likely to develop severe thrombocytopenia than
may increase in patients who have impaired
younger patients. Because renal function is often
kidney function before carboplatin treatment. It decreased in the elderly, renal function should
is not clear whether an appropriate hydration be considered when determining dosage.
programme might overcome such an effect but
dosage reduction or discontinuation of therapy is Other
required in the presence of severe alteration in
renal function test. Impairment of renal function Auditory defects have been reported during
is more likely in patients who have previously carboplatin therapy. Ototoxicity may be more
pronounced in children and is more likely seen
experienced nephrotoxicity as a result of
in patients previously treated with cisplatin.
cisplatin therapy.
Cases of hearing loss with a delayed onset have
Neurologic Toxicity been reported in pediatric patients. A long-term
audiometric follow-up in this population is
Although peripheral neurologic toxicity is recommended.
generally common and mild, limited to
paresthesia and decreases in osteotendinous Administration of live or live-attenuated
reflexes, its frequency is increased in patients vaccines in patients immunocompromised by
older than 65 years and/or in patients previously chemotherapeutic agents including carboplatin
treated with cisplatin. Monitoring and may result in serious or fatal infections.
neurological examinations should be carried out Vaccination with a live vaccine should be
at regular intervals. avoided in patients receiving carboplatin. Killed
or inactivated vaccines may be administered;
 Carboplatin 50mg /5ml, 150 mg/15 ml, 450 mg/ 45ml, 6 00 mg/60 ml Liquid Inj ection TajPhar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warning s, Carboplatin Dosage & Rx I nfo | Carboplatin Uses, Side E ffects - Anticancer, Car boplatin : I ndications, Side E ffects, Warnings, Carboplatin - Drug Infor mati on - TajP harma, Carboplatin dose Taj phar mace uticals Carboplatin interactions, Taj Phar mace utical Car boplatin contraindications, Carboplatin pri ce, Carboplatin TajP harma Antica ncer Powder for Inj ection SmP C - TajP harma Stay conne cted to all updated on Carboplatin Taj Phar ma ceuticals Taj pharmace uticals Mumbai. Patient Informati on Lea flets, S mPC.

however, the response to such vaccines may be - Concurrent therapy with nephrotoxic or
diminished. ototoxic drugs such as aminoglycosides,
vancomycin, capreomycin and diuretics, may
Aluminium-containing equipment should not be increase or exacerbate toxicity, particularly in
used during preparation and administration of renal failure patients, due to carboplatin induced
carboplatin (see section 4.5). changes in renal clearance.
4.5 Interaction with other medicinal products - Loop diuretics: The concomitant use of
and other forms of interaction carboplatin with loop diuretic should be
Carboplatin may interact with aluminium to approached with caution due to the cumulative
form a black precipitate. Needles, syringes, nephrotoxicity and ototoxicity.
catheters or IV administration sets that contain
aluminium parts which may come into contact Combination therapy with other
with carboplatin, should not be used for the myelosuppressive agents may require dose
preparation or administration of the drug. changes or rescheduling of doses in order to
minimise the additive myelosuppressive effects.
Due to the increase of thrombotic risk in cases of
tumoral diseases, the use of anticoagulative 4.6 Fertility, pregnancy and lactation
treatment is frequent. The high intra-individual Pregnancy
variability of the coagulabilty during diseases,
and the possibility of interaction between oral Carboplatin can cause foetal harm when
administered to a pregnant woman. Carboplatin
anticoagulants and anticancer chemotherapy,
has been shown to be embryo toxic and
may require an increase in frequency of INR
monitoring if a patient is treated with oral teratogenic in rats receiving the drug during
anticoagulants. organogenesis. No controlled studies in pregnant
women have been conducted.
Concomitant use contraindicated
Safe use of carboplatin in pregnancy has not
Yellow fever vaccine: risk of generalised disease been established. Both men and women
mortal (see section 4.3). receiving carboplatin should be informed of the
potential risk of adverse effects on reproduction
Concomitant use not recommended
(see section 5.3). Women of childbearing
- Live attenuated vaccines (except yellow fever): potential should be fully informed of the
Risk of systemic, possible fatal disease. This risk potential hazard to the foetus should they
is increased in subjects who are already become pregnant during carboplatin therapy.
immunosuppressed by their underlying disease. Carboplatin should not be used in pregnant
Use an inactivated vaccine where this exist women or women of childbearing potential who
(poliomyelitis). might become pregnant unless the potential
benefits to the mother outweigh the possible
- Phenytoin, fosphenytoin: Risk of exacerbation risks to the foetus.
of convulsions (resulting from the decrease of
phenytoin digestive absorption by the cytotoxic Breast-feeding
drug), risk of toxicity enhancement or loss of It is not known whether carboplatin is excreted
efficacy of the cytotoxic drug (due to increased in breast milk. To avoid possible harmful effects
hepatic metabolism by phenytoin). in the infant, breast-feeding must be stopped
Concomitant use to take into consideration during carboplatin therapy.
- Ciclosporin (and by extrapolation tacrolimus Fertility
and sirolimus): Excessive immunosuppression Gonadal suppression resulting in amenorrhoea
with risk of lymph proliferation. or azoospermia may occur in patients receiving
 Carboplatin 50mg /5ml, 150 mg/15 ml, 450 mg/ 45ml, 6 00 mg/60 ml Liquid Inj ection TajPhar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warning s, Carboplatin Dosage & Rx I nfo | Carboplatin Uses, Side E ffects - Anticancer, Car boplatin : I ndications, Side E ffects, Warnings, Carboplatin - Drug Infor mati on - TajP harma, Carboplatin dose Taj phar mace uticals Carboplatin interactions, Taj Phar mace utical Car boplatin contraindications, Carboplatin pri ce, Carboplatin TajP harma Antica ncer Powder for Inj ection SmP C - TajP harma Stay conne cted to all updated on Carboplatin Taj Phar ma ceuticals Taj pharmace uticals Mumbai. Patient Informati on Lea flets, S mPC.

antineoplastic therapy. These effects appear to Infections and Common Infections*

be related to dose and length of therapy and may infestations Not Pneumonia
be irreversible. Prediction of the degree of
known
testicular or ovarian functional impairment is
complicated by the common use of Blood and Very Thrombocytopenia,
combinations of several antineoplastics, which lymphatic common neutropenia,
makes it difficult to assess the effects of system leukopenia, anaemia
individual agents. disorders Common Haemorrhage*
Men of sexually mature age treated with Not Bone marrow
carboplatin are advised not to father a child known failure, febrile
during treatment and up to 6 months afterwards. neutropenia,
Male patients should seek advice about sperm haemolytic-uraemic
preservation prior to initiation of the therapy syndrome
because of the possibility of irreversible Immune Common Hypersensitivity,
infertility due to therapy with carboplatin. system anaphylactoid type
disorders reaction
4.7 Effects on ability to drive and use
machines Metabolism Not Dehydration,
No studies of the effects on the ability to drive and nutrition known anorexia,
and use machines have been performed. disorders hyponatraemia
However, carboplatin may cause nausea, Nervous Common Neuropathy
vomiting, vision abnormalities and ototoxicity; system peripheral,
therefore, patients should be warned of the disorders paraesthesia,
potential effect of these events on the ability to decrease of
drive or to use machines. osteotendinous
reflexes, sensory
4.8 Undesirable effects
disturbance,
The frequency of adverse reactions reported is
dysgeusia
based on a cumulative database of 1,893 patients
receiving single agent carboplatin injection and Not Cerebrovascular
post-marketing experience. known accident*,
encephalopathy,
The list is presented by system organ class, Reversible Posterior
MedDRA preferred term, and frequency using Leukoencephalopath
the following frequency categories: very y Syndrome (RPLS)
common (≥1/10), common (≥1/100, < 1/10),
uncommon, (≥1/1,000, <1/100), rare (≥1/10,000, Eye disorders Common Visual disturbance
<1/1,000), very rare (< 1/10,000), and not (incl. rare cases of
known (cannot be estimated from the available loss of vision)
data). Ear and Common Ototoxicity
labyrinth
System Organ Frequenc MedDRA Term disorders
Class y Cardiac Common Cardiovascular
Neoplasms, Not Treatment related disorders disorder*
benign and known secondary Not Cardiac failure*
malignant and malignancy known
unspecified
(incl cysts and Vascular Not Embolism*,
polyps) disorders known hypertension,
 Carboplatin 50mg /5ml, 150 mg/15 ml, 450 mg/ 45ml, 6 00 mg/60 ml Liquid Inj ection TajPhar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warning s, Carboplatin Dosage & Rx I nfo | Carboplatin Uses, Side E ffects - Anticancer, Car boplatin : I ndications, Side E ffects, Warnings, Carboplatin - Drug Infor mati on - TajP harma, Carboplatin dose Taj phar mace uticals Carboplatin interactions, Taj Phar mace utical Car boplatin contraindications, Carboplatin pri ce, Carboplatin TajP harma Antica ncer Powder for Inj ection SmP C - TajP harma Stay conne cted to all updated on Carboplatin Taj Phar ma ceuticals Taj pharmace uticals Mumbai. Patient Informati on Lea flets, S mPC.

hypotension calcium decreased,

Respiratory, Common Respiratory disorder, blood magnesium
thoracic and interstitial lung decreased.
mediastinal disease, Common Blood bilirubin
disorders bronchospasm increased, blood
Gastrointestina Very Vomiting, nausea, creatinine increased,
l disorders common abdominal pain blood uric acid
increased
Common Diarrhoea,
constipation, * Fatal in <1%, fatal cardiovascular events in
mucous membrane <1% included cardiac failure, embolism, and
disorder cerebrovascular accident combined.
Not Stomatitis, Blood and lymphatic system disorders:
known pancreatitis Myelosuppression is the dose-limiting toxicity
Skin and Common Alopecia, skin of carboplatin injection. In patients with normal
subcutaneous disorder baseline values, thrombocytopenia with platelet
tissue disorders Not Urticaria, rash, counts below 50,000/mm3 occurs in 25% of
known erythema, pruritus patients, neutropenia with granulocyte counts
below 1,000/mm3 in 18% of patients, and
Musculoskelet Common Musculoskeletal
leukopenia with WBC counts below
al and disorder
2,000/mm3 in 14% of patients. The nadir usually
connective
occurs on day 21. Myelosuppression can be
tissue disorders
worsened by combination of carboplatin
Renal and Common Urogenital disorder injection with other myelosuppressive
urinary compounds or forms of treatment.
disorders
Myelotoxicity is more severe in previously
General Common
Asthenia
treated patients, in particular in patients
disorders and Not Injection site previously treated with cisplatin and in patients
administration known necrosis, injection with impaired kidney function. Patients with
site conditions site reaction, poor performance status have also experienced
injection site increased leukopenia and thrombocytopenia.
extravasation, These effects, although usually reversible, have
injection site resulted in infectious and hemorrhagic
erythema, malaise complications in 4% and 5% of patients given
Investigations Very Creatinine renal carboplatin injection, respectively. These
Common clearance decreased, complications have led to death in less than 1%
blood urea of patients.
increased, blood
Anaemia with haemoglobin values below 8 g/dL
alkaline phosphatase
has been observed in 15% of patients with
increased, aspartate
normal baseline values. The incidence of
aminotransferase
anaemia is increased with increasing exposure to
increased, liver
carboplatin injection.
function test
abnormal, blood Neoplasms, benign, malignant and unspecified
sodium decreased, (including cysts and polyps):
blood potassium
decreased, blood
 Carboplatin 50mg /5ml, 150 mg/15 ml, 450 mg/ 45ml, 6 00 mg/60 ml Liquid Inj ection TajPhar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warning s, Carboplatin Dosage & Rx I nfo | Carboplatin Uses, Side E ffects - Anticancer, Car boplatin : I ndications, Side E ffects, Warnings, Carboplatin - Drug Infor mati on - TajP harma, Carboplatin dose Taj phar mace uticals Carboplatin interactions, Taj Phar mace utical Car boplatin contraindications, Carboplatin pri ce, Carboplatin TajP harma Antica ncer Powder for Inj ection SmP C - TajP harma Stay conne cted to all updated on Carboplatin Taj Phar ma ceuticals Taj pharmace uticals Mumbai. Patient Informati on Lea flets, S mPC.

Secondary acute malignancies after cytostatic Parasthesias present prior to treatment,

combination therapies containing carboplatin especially if caused by cisplatin, may persist or
have been reported. worsen during carboplatin therapy (see section
4.4).
Respiratory, thoracic and mediastinal
disorders: Eye disorders:
Pulmonary fibrosis has been reported very Visual disturbances, including sight loss, are
rarely, manifested by tightness of the chest and usually associated with high dose therapy in
dyspnoea. This should be considered if a renally impaired patients.
pulmonary hypersensitivity state is excluded
(see General disorders below). Ear and labyrinth disorders:
A subclinical decrease in hearing acuity in the
Gastrointestinal disorders:
high frequency range (4000-8000 Hz),
Vomiting occurs in 65% of patients, in one-third determined by audiogram, occurred in 15% of
of whom it is severe. Nausea occurs in an patients. Very rare cases of hypoacusia have
additional 15%. Previously treated patients (in been reported.
particular patients previously treated with
Tinnitus was also commonly reported. Hearing
cisplatin) appear to be more prone to vomiting.
Nausea and vomiting are generally delayed until loss as a result of cisplatin therapy may give rise
6 to 12 hours after administration of carboplatin, to persistent or worsening symptoms. At higher
are readily controlled or prevented with than recommended doses, in common with other
ototoxic agents, clinically significant hearing
antiemetics and disappear within 24 hours.
Vomiting is more likely when carboplatin loss has been reported to occur in paediatric
injection is given in combination with other patients when carboplatin is administered.
emetogenic compounds. Hepatobiliary disorders:
The other gastrointestinal complaints Modification of liver function in patients with
corresponded to pain in 8% of patients, normal baseline values was observed, including
diarrhoea, and constipation in 6 % of patients. elevation of total bilirubin in 5%, SGOT in 15%,
Cramps have also been reported. and alkaline phosphatase in 24% of patients.
These modifications were generally mild and
Nervous system disorders:
reversible in about one-half the patients.
Peripheral neuropathy (mainly paresthesias and
decrease of osteotendinous reflexes) has In a limited series of patients receiving very high
occurred in 4% of patients administered dosages of carboplatin injection and autologous
carboplatin injection. Patients older than 65 bone marrow transplantation, severe elevation of
years and patients previously treated with liver function tests has occurred.
cisplatin, as well as those receiving prolonged Cases of an acute, fulminant liver cell necrosis
treatment with carboplatin injection, appear to occurred after high-dose administration of
be at increased risk. carboplatin.
Clinically significant-sensory disturbances (ie, Renal and urinary disorders:
visual disturbances and taste modifications) have
occurred in 1% of patients. When given in usual doses, development of
abnormal renal function has been uncommon,
The overall frequency of neurologic side effects despite the fact that carboplatin injection has
seems to be increased in patients receiving been administered without high-volume fluid
carboplatin injection in combination. This may hydration and/or forced diuresis. Elevation of
also be related to longer cumulative exposure. serum creatinine occurs in 6% of patients,
 Carboplatin 50mg /5ml, 150 mg/15 ml, 450 mg/ 45ml, 6 00 mg/60 ml Liquid Inj ection TajPhar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warning s, Carboplatin Dosage & Rx I nfo | Carboplatin Uses, Side E ffects - Anticancer, Car boplatin : I ndications, Side E ffects, Warnings, Carboplatin - Drug Infor mati on - TajP harma, Carboplatin dose Taj phar mace uticals Carboplatin interactions, Taj Phar mace utical Car boplatin contraindications, Carboplatin pri ce, Carboplatin TajP harma Antica ncer Powder for Inj ection SmP C - TajP harma Stay conne cted to all updated on Carboplatin Taj Phar ma ceuticals Taj pharmace uticals Mumbai. Patient Informati on Lea flets, S mPC.

elevation of blood urea nitrogen in 14%, and of connection with extravasation) have been
uric acid in 5% of patients. These are usually reported.
mild and are reversible in about one-half the
patients. Creatinine clearance has proven to be Fever, chills and mucositis have occasionally
the most sensitive renal function measure in been observed.
patients receiving carboplatin injection. Twenty- Reporting of suspected adverse reactions
seven percent (27%) of patients who have a
baseline value of 60 mL/min or greater, Reporting suspected adverse reactions after
experience a reduction in creatinine clearance authorisation of the medicinal product is
during carboplatin injection therapy. Impairment important. It allows continued monitoring of the
of renal function is more likely in patients who benefit/risk balance of the medicinal product.
have previously experienced nephrotoxicity as a 4.9 Overdose
result of cisplatin therapy. There is no known antidote for carboplatin
Immune system disorders: overdosage. No overdosage occurred during
clinical trials. If necessary, however, the patient
Anaphylactic-type reactions, sometimes fatal, may need supportive treatment relating to
may occur in the minutes following injection of myelosuppression, renal, hepatic and auditory
the product: facial oedema, dyspnoea, function impairment. Reports of doses up to
tachycardia, low blood pressure, urticaria, 1600mg/m2 indicate patients feeling extremely
anaphylactic shock, bronchospasm. ill with diarrhoea and alopecia developing. Use
of higher than recommended doses of
Fever with no apparent cause has also been
reported. carboplatin has been associated with loss of
vision (see section 4.4).
Skin and subcutaneous tissue disorders:
5. PHARMACOLOGICAL
Erythematous rash, fever and pruritis have been
observed. These were reactions similar to those
PROPERTIES
seen after cisplatin therapy but in a few cases no 5.1 Pharmacodynamic properties
cross-reactivity was present. Pharmacotherapeutic group: Antineoplastic
agent.
Investigations:
Decreases in serum sodium, potassium, calcium, Carboplatin, like Cisplatin, interferes with DNA
and magnesium occur in 29%, 20%, 22%, and intra-strand and inter-strand crosslinks in cells
29% of patients, respectively. In particular, cases exposed to the drug. DNA reactivity has been
of early hyponatraemia have been reported. The correlated with cytotoxicity.
electrolyte losses are minor and mostly take a Paediatric population
course without any clinical symptoms.
Safety and efficacy in children have not been
Cardiac disorders: established.
Isolated cases of cardiovascular incidents 5.2 Pharmacokinetic properties
(cardiac insufficiency, embolism) as well as Absorption
isolated cases of cerebrovascular accidents have
been reported. After a 1-hour Injection (20-520mg/m2), plasma
levels of total platinum and free (ultra filterable)
General disorders and administration site platinum decay biphasically following first order
conditions: kinetics. For free platinum, the initial phase (t
Reactions at the site of injection (burning, pain, alpha) half life is approximately 90 minutes and
reddening, swelling, urticaria, necrosis in the later phase (t beta) half life approximately 6
 Carboplatin 50mg /5ml, 150 mg/15 ml, 450 mg/ 45ml, 6 00 mg/60 ml Liquid Inj ection TajPhar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warning s, Carboplatin Dosage & Rx I nfo | Carboplatin Uses, Side E ffects - Anticancer, Car boplatin : I ndications, Side E ffects, Warnings, Carboplatin - Drug Infor mati on - TajP harma, Carboplatin dose Taj phar mace uticals Carboplatin interactions, Taj Phar mace utical Car boplatin contraindications, Carboplatin pri ce, Carboplatin TajP harma Antica ncer Powder for Inj ection SmP C - TajP harma Stay conne cted to all updated on Carboplatin Taj Phar ma ceuticals Taj pharmace uticals Mumbai. Patient Informati on Lea flets, S mPC.

hours. All free platinum is in the form of intravenous Injection. Chemical and physical in-
carboplatin in the first 4 hours after use stability has been demonstrated for 56 days
administration. to final concentrations of 0.2 mg/ml and
3.5mg/ml when stored at 2-8 °C in non-PVC
Distribution (polyolefin) Injection bags when protected from
Protein binding of carboplatin reaches 85-89% light.
within 24 hours of administration, although Carboplatin solution for Injection may also be
during the first 4 hours, only up to 29% of the further diluted in Sodium Chloride 0.9% and
dose is protein bound. Patients with poor renal administered as an intravenous Injection. The
function may require dosage adjustments due to Injection solution is chemically stable for up to
altered pharmacokinetics of carboplatin.
24 hours when stored at 2-8°C and up to 8 hours
Elimination when stored at 22°C.
Carboplatin is excreted primarily by glomerular From a microbiological point of view however,
filtration in urine, with recovery of 65% of a the product should be used immediately. If not
dose within 24 hours. Most of the drug is used immediately, in-use storage times and
excreted within the first 6 hours. Approximately conditions prior to use are the responsibility of
32% of a given dose of carboplatin is excreted the user and would normally not be longer than
unchanged. 24 hours at 2 to 8°C, unless dilution has taken
place in controlled and validated aseptic
Carboplatin clearance has been reported to vary conditions.
by 3- to 4- fold in paediatric patients. As for
adult patients, literature data suggest that renal 6.4 Special precautions for storage
function may contribute to the variation in Clear glass and Onco-Tain® vials;
carboplatin clearance. Do not store above 25°C. Keep the vial in the
5.3 Preclinical safety data outer carton in order to protect from light.
Carboplatin has been shown to be embryo toxic Onco-Vials®;
and teratogenic in rats. It is mutagenic in
vivo and in vitro and although the carcinogenic Store in a refrigerator (2-8°C). Keep the vial in
potential of carboplatin has not been studied, the outer carton in order to protect from light.
compounds with similar mechanisms of action
and mutagenicity have been reported to be 6.5 Nature and contents of container
carcinogenic. Carboplatin Intravenous Injection is supplied in
individually packed clear glass, Onco-
6. Pharmaceutical particulars Tain® vials and Onco-Vials®, containing either 5
ml, 15 ml, 45 ml or 60 ml of a sterile solution of
6.1 List of excipients carboplatin 10 mg per ml.
Water for injections BP.
Not all pack sizes may be marketed.
6.2 Incompatibilities
Aluminium-containing equipment should not be 6.6 Special precautions for disposal and other
used (see section 4.5). handling
Parenteral drugs should be inspected visually for
6.3 Shelf life particulate matter and discoloration prior to
2 years administration, whenever solution and container
permit. If particular matter is observed, shake
In use: and re-inspect. Vials with visible particulate
Carboplatin solution for Injection may be further matter should not be used.
diluted in Glucose 5% and administered as an Handling:
 Carboplatin 50mg /5ml, 150 mg/15 ml, 450 mg/ 45ml, 6 00 mg/60 ml Liquid Inj ection TajPhar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warning s, Carboplatin Dosage & Rx I nfo | Carboplatin Uses, Side E ffects - Anticancer, Car boplatin : I ndications, Side E ffects, Warnings, Carboplatin - Drug Infor mati on - TajP harma, Carboplatin dose Taj phar mace uticals Carboplatin interactions, Taj Phar mace utical Car boplatin contraindications, Carboplatin pri ce, Carboplatin TajP harma Antica ncer Powder for Inj ection SmP C - TajP harma Stay conne cted to all updated on Carboplatin Taj Phar ma ceuticals Taj pharmace uticals Mumbai. Patient Informati on Lea flets, S mPC.

Carboplatin should be prepared for

administration only by professionals who have
been trained in the safe use of chemotherapeutic
agents.
Contamination
In the event of contact of carboplatin with eyes
or skin, wash affected area with copious
amounts of water or normal saline. A bland
cream may be used to treat transient stinging of
skin. Medical advice should be sought if the
eyes are affected.
In the event of a spillage, two operators should
put on gloves and mop up the spilled material
with a sponge kept for that purpose. In the event
of a powder spillage, cover with a cloth and
moisten with water before mopping up. Rinse
the area twice with water. Put all solutions and
sponges in a plastic bag, seal and label with the
words 'CYTOTOXIC WASTE' and incinerate.
7. Manufactured in India By:
TAJ PHARMACEUTICALS LIMITED
at SURVEY NO.188/1 TO 189/1,190/1 TO 4,
ATHIYAWAD, DABHEL, DAMAN- 396210
(INDIA).