l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 21
▶ Lonsurf (Servier Laboratories Ltd) A
Tipiracil (as Tipiracil hydrochloride) 6.14 mg, Trifluridine
15 mg Lonsurf 15mg/6.14mg tablets | 20 tablet P £500.00 | 60 tablet P £1,500.00
Tipiracil (as Tipiracil hydrochloride) 8.19 mg, Trifluridine
20 mg Lonsurf 20mg/8.19mg tablets | 20 tablet P £666.67 | 60 tablet P £2,000.00
ANTINEOPLASTIC DRUGS › CYTOTOXIC
ANTIBIOTICS AND RELATED SUBSTANCES
Squamous cell carcinoma | Metastatic germ cell cancer |
▶ BY INTRAMUSCULAR INJECTION, OR BY INTRAVENOUS
INJECTION, OR BY INTRAVENOUS INFUSION, OR BY INTRAARTERIAL INFUSION, OR BY LOCAL INFILTRATION
▶ Adult: (consult product literature or local protocols)
l CAUTIONS Caution in handling—irritant to tissues
l INTERACTIONS → Appendix 1: bleomycin
SIDE-EFFECTS, FURTHER INFORMATION Progressive
pulmonary fibrosis Progressive pulmonary fibrosis is
dose-related, and may occur at lower doses in the elderly.
Suspicious chest X-ray changes are an indication to stop
Pulmonary toxicity Patients who have received
bleomycin may be at risk of developing pulmonary toxicity
if exposed to high inspired oxygen concentrations, for
example peri-operatively, or during lung function testing.
l CONCEPTION AND CONTRACEPTION Contraceptive advice
required, see Pregnancy and reproductive function in
l PREGNANCY Avoid (teratogenic and carcinogenic in
animal studies). See also Pregnancy and reproductive
function in Cytotoxic drugs p. 888
l BREAST FEEDING Discontinue breast feeding.
Dose adjustments Reduce dose by half if serum creatinine
177–354 micromol/litre; reduce dose further if serumcreatinine greater than 354 micromol/litre.
l PRESCRIBING AND DISPENSING INFORMATION To conform
to the European Pharmacopoeia vials previously labelled
as containing ‘15 units’ of bleomycin are now labelled as
containing 15 000 units. The amount of bleomycin in the
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Powder for solution for injection
Bleomycin (as Bleomycin sulfate) 15000 unit Bleomycin
15,000unit powder for solution for injection vials | 10 vial P £170.00
▶ Bleo-Kyowa (Kyowa Kirin Ltd)
Bleomycin (as Bleomycin sulfate) 15000 unit Bleo-Kyowa
15,000unit powder for solution for injection vials | 10 vial P £190.60
Recurrent superficial bladder tumours (bladder
▶ BY INTRAVESICAL INSTILLATION
▶ Adult: (consult product literature or local protocols)
Upper gastro-intestinal cancers | Breast cancers
▶ Adult: (consult product literature or local protocols)
l CAUTIONS Caution in handling—irritant to tissues
l INTERACTIONS → Appendix 1: mitomycin
▶ Common or very common Skin reactions
▶ With intravesical use Bladder irritation . cystitis . haemorrhage . urinary disorders
▶ With intravenous use Alopecia . appetite decreased . diarrhoea . fever. mucositis . stomatitis
▶ With intravesical use Bladder disorders . urinary tract
▶ With intravenous use Neoplasms
SIDE-EFFECTS, FURTHER INFORMATION Mitomycin is
usually administered at 6-weekly intervals because it
causes delayed bone-marrow toxicity. Prolonged use may
result in a cumulative effect.
l CONCEPTION AND CONTRACEPTION Contraceptive advice
required, see Pregnancy and reproductive function in
l PREGNANCY Avoid (teratogenic in animal studies). See
also Pregnancy and reproductive function in Cytotoxic drugs
l BREAST FEEDING Discontinue breast-feeding.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Powder for solution for injection
Mitomycin 2 mg Mitomycin 2mg powder for solution for injection
Mitomycin 10 mg Mitomycin 10mg powder for solution for injection
▶ Mitomycin-C (Kyowa Kirin Ltd)
Mitomycin 2 mg Mitomycin-C Kyowa 2mg powder for solution for
injection vials | 10 vial P £58.83
Mitomycin 10 mg Mitomycin-C Kyowa 10mg powder for solution for
injection vials | 1 vial P £21.37
Mitomycin 20 mg Mitomycin-C Kyowa 20mg powder for solution for
injection vials | 1 vial P £39.94
Mitomycin 40 mg Mitomycin-C Kyowa 40mg powder for solution for
injection vials | 1 vial P £79.88
BNF 78 Cytotoxic responsive malignancy 919
Immune system and malignant disease
Hairy cell leukaemia (initiated in specialist centres)
▶ BY INTRAVENOUS INJECTION, OR BY INTRAVENOUS INFUSION
▶ Adult: To be given on alternate weeks (consult product
l INTERACTIONS → Appendix 1: pentostatin
disorder. bone marrow disorders . breast mass . cardiac
(withhold if severe).renal impairment.respiratory
disorders .retinopathy . seborrhoea . seizures . sensation
failure .tumour lysis syndrome
SIDE-EFFECTS, FURTHER INFORMATION Pentostatin can
cause myelosuppression, immunosuppression, and a
number of other side-effects that may be severe.
Treatment should be withheld in patients who develop a
severe rash, and withheld or discontinued in patients
showing signs of neurotoxicity.
l CONCEPTION AND CONTRACEPTION Manufacturer advises
that men should not father children during and for
l PREGNANCY Avoid (teratogenic in animal studies). See
also Pregnancy and reproductive function in Cytotoxic drugs
l BREAST FEEDING Discontinue breast-feeding.
l HEPATIC IMPAIRMENT Manufacturer advises caution
(limited information available).
l RENAL IMPAIRMENT Avoid if creatinine clearance less than
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Powder for solution for injection
Pentostatin 10 mg Nipent 10mg powder for solution for injection
vials | 1 vial P £734.21 (Hospital only)
ANTINEOPLASTIC DRUGS › PLANT ALKALOIDS
Treatment of advanced soft-tissue sarcoma when
treatment with anthracyclines and ifosfamide has failed
▶ Adult: (consult product literature or local protocols)
l CONTRA-INDICATIONS Elevated creatine phosphokinase
l INTERACTIONS → Appendix 1: trabectedin
▶ Common or very common Alopecia . anaemia . appetite
altered .thrombocytopenia . vomiting . weight decreased
▶ Uncommon Capillary leak syndrome . septic shock
▶ Rare or very rare Hepatic failure
▶ Frequency not known Extravasation necrosis . rhabdomyolysis
SIDE-EFFECTS, FURTHER INFORMATION A corticosteroid,
such as dexamethasone by intravenous infusion, must be
given 30 minutes before therapy for its antiemetic and
hepatoprotective effects (consult product literature).
l CONCEPTION AND CONTRACEPTION Effective
contraception recommended during and for at least
3 months after treatment in women and during and for at
least 5 months after treatment in men.
l PREGNANCY See Pregnancy and reproductive function in
l BREAST FEEDING Manufacturer advises avoid breastfeeding during and for 3 months after treatment.
l HEPATIC IMPAIRMENT Manufacturer advises caution (risk
Dose adjustments Manufacturer advises consider dose
l RENAL IMPAIRMENT Avoid monotherapy if creatinine
clearance less than 30 mL/minute. Avoid combination
regimens if creatinine clearance less than 60 mL/minute.
▶ Specific haematological, renal and hepatic parameters
must be monitored and within certain ranges prior to
starting treatment and repeated weekly during the first
2 cycles and at least once between treatments in
subsequent cycles—consult product literature for full
▶ Monitor for signs and symptoms of rhabdomyolysis
(including myelotoxicity, severe liver function disorder,
renal failure, muscle weakness or pain)—monitor creatine
phosphokinase closely and discontinue treatment (consult
920 Cytotoxic responsive malignancy BNF 78
Immune system and malignant disease
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Trabectedin for the treatment of advanced soft tissue
sarcoma (February 2010) NICE TA185
Trabectedin (Yondelis ®) is an option for advanced soft
tissue sarcoma when treatment with anthracyclines and
ifosfamide has failed, is inappropriate or is not tolerated.
The cost of trabectedin for treatment after the fifth cycle is
www.nice.org.uk/guidance/ta185
▶ Topotecan, pegylated liposomal doxorubicin hydrochloride,
paclitaxel, trabectedin and gemcitabine for treating recurrent
ovarian cancer (April 2016) NICE TA389
Trabectedin (Yondelis ®) in combination with pegylated
liposomal doxorubicin hydrochloride (PLDH) is not
recommended for treating the first recurrence of
platinum-sensitive ovarian cancer.
Patients currently receiving trabectedin in combination
with PLDH should have the option to continue their
treatment until they or their NHS clinician consider it
www.nice.org.uk/guidance/ta389
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Powder for solution for infusion
Trabectedin 250 microgram Yondelis 0.25mg powder for
concentrate for solution for infusion vials | 1 vial P £363.00
Trabectedin 1 mg Yondelis 1mg powder for concentrate for solution
for infusion vials | 1 vial P £1,366.00 (Hospital only)
ANTINEOPLASTIC DRUGS › PLATINUM
Treatment of advanced ovarian cancer and lung cancer
(particularly the small cell type)
▶ Adult: The dose of carboplatin is determined according
to renal function rather than body surface area (consult
l INTERACTIONS → Appendix 1: platinum compounds
▶ Rare or very rare Cardiac discomfort. dyspnoea
▶ Frequency not known Appetite decreased . bone marrow
l CONCEPTION AND CONTRACEPTION Contraceptive advice
required, see Pregnancy and reproductive function in
l PREGNANCY Avoid (teratogenic and embryotoxic in animal
studies). See also Pregnancy and reproductive function in
l BREAST FEEDING Discontinue breast-feeding.
l RENAL IMPAIRMENT Avoid if creatinine clearance less than
Monitoring Monitor haematological parameters in renal
Monitor renal function in renal impairment.
l PRESCRIBING AND DISPENSING INFORMATION Carboplatin
can be given in an outpatient setting.
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Bevacizumab in combination with paclitaxel and carboplatin
for the first-line treatment of advanced ovarian cancer (May
Bevacizumab in combination with paclitaxel and
carboplatin is not recommended for the first-line
treatment of advanced ovarian cancer (including fallopian
tube and primary peritoneal cancer).
▶ Bevacizumab in combination with gemcitabine and
carboplatin for the treatment of the first recurrence of
platinum-sensitive advanced ovarian cancer (May 2013)
Bevacizumab in combination with gemcitabine and
carboplatin is not recommended within its marketing
authorisation, that is, for the treatment of the first
recurrence of platinum-sensitive advanced ovarian cancer
(including fallopian tube and primary peritoneal cancer)
that has not been previously treated with bevacizumab or
other vascular endothelial growth factor (VEGF) inhibitors
or VEGF receptor-targeted agents.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Carboplatin (Non-proprietary)
Carboplatin 10 mg per 1 ml Carboplatin 50mg/5ml concentrate for
solution for infusion vials | 1 vial P £20.67–£22.04 (Hospital only)
Carboplatin 150mg/15ml concentrate for solution for infusion vials |
1 vial P £53.39–£56.92 (Hospital only) | 1 vial P £60.59
Carboplatin 50mg/5ml solution for infusion vials | 1 vial P £22.86
(Hospital only) | 1 vial P £22.86
Treatment of testicular, lung, cervical, bladder, head and
neck, and ovarian cancer (alone or in combination)
▶ Adult: (consult product literature)
▶ Hydration Cisplatin requires intensive intravenous
hydration and treatment may be complicated by severe
l INTERACTIONS → Appendix 1: platinum compounds
▶ Common or very common Anaemia . arrhythmias . bone
marrow failure . electrolyte imbalance . extravasation
BNF 78 Cytotoxic responsive malignancy 921
Immune system and malignant disease
necrosis .fever. leucopenia . nephrotoxicity (dose-related
and potentially cumulative). sepsis .thrombocytopenia
l CONCEPTION AND CONTRACEPTION Manufacturer advises
effective contraception during and for at least 6 months
after treatment in men or women.
l PREGNANCY Avoid (teratogenic and toxic in animal
studies. See also Pregnancy and reproductive function in
l BREAST FEEDING Discontinue breast-feeding.
l RENAL IMPAIRMENT Avoid if possible—nephrotoxic.
▶ Monitor plasma electrolytes.
▶ Nephrotoxicity Monitoring of renal function is essential.
l DIRECTIONS FOR ADMINISTRATION Cisplatin is
increasingly given in a day care setting.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Cisplatin 1 mg per 1 ml Cisplatin 50mg/50ml concentrate for
solution for infusion vials | 1 vial P £25.11–£28.11 DT = £26.51
Cisplatin 10mg/10ml solution for infusion vials | 1 vial P £5.90
(Hospital only) | 1 vial P £5.90
Cisplatin 50mg/50ml solution for infusion vials | 1 vial P £25.37–
£28.11 DT = £26.51 | 1 vial P £25.37 DT = £26.51 (Hospital only)
Cisplatin 10mg/10ml concentrate for solution for infusion vials |
1 vial P £5.36 (Hospital only)
Treatment of metastatic colorectal cancer (in combination
with fluorouracil and folinic acid)| Treatment of colon
cancer after resection of the primary tumour (adjuvant
▶ Adult: (consult product literature)
l CONTRA-INDICATIONS Peripheral neuropathy with
l INTERACTIONS → Appendix 1: platinum compounds
▶ Common or very common Alopecia . anaemia . appetite
risk of infection . insomnia . meningism . mucositis . nail
disorders . vomiting . weight changes
▶ Uncommon Metabolic acidosis . nervousness . ototoxicity
▶ Rare or very rare Acute kidney injury . acute tubular
thrombocytopenia . nephritis acute interstitial . nodular
regenerative hyperplasia . pancreatitis . posterior
reversible encephalopathy syndrome (PRES) (with
oxaliplatin combination chemotherapy).respiratory
disorders . sinusoidal obstruction syndrome . vision loss
(reversible on discontinuation)
▶ Frequency not known Autoimmune pancytopenia . chest
discomfort. dysphagia . extravasation necrosis . gait
abnormal . hypersensitivity vasculitis . movement
disorders . muscle complaints . muscle contractions
involuntary . QT interval prolongation .rhabdomyolysis . throat complaints
SIDE-EFFECTS, FURTHER INFORMATION Neurotoxicity is
If unexplained respiratory symptoms occur, oxaliplatin
should be discontinued until investigations exclude
interstitial lung disease and pulmonary fibrosis.
l CONCEPTION AND CONTRACEPTION Effective
contraception required during and for 4 months after
treatment in women and 6 months after treatment in men.
l PREGNANCY Manufacturer advises avoid—toxicity in
animal studies. See also Pregnancy and reproductive
function in Cytotoxic drugs p. 888.
l BREAST FEEDING Discontinue breast-feeding.
l RENAL IMPAIRMENT Avoid if creatinine clearance less than
Dose adjustments Reduce dose in mild to moderate
impairment (consult product literature).
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Capecitabine and oxaliplatin in the adjuvant treatment of
stage III (Dukes’ C) colon cancer (April 2006) NICE TA100
Capecitabine alone or oxaliplatin combined with
fluorouracil and folinic acid are options for adjuvant
treatment following surgery for stage III (Dukes’ C) colon
▶ Irinotecan, oxaliplatin, and raltitrexed for advanced colorectal
cancer (August 2005) NICE TA93
A combination of fluorouracil and folinic acid with either
irinotecan or oxaliplatin are options for first-line
treatment for advanced colorectal cancer.
Irinotecan alone or fluorouracil and folinic acid with
oxaliplatin are options for patients who require further
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Oxaliplatin (Non-proprietary)
Oxaliplatin 5 mg per 1 ml Oxaliplatin 50mg/10ml concentrate for
solution for infusion vials | 1 vial P £155.98–£156.75 (Hospital
only) | 1 vial P £147.82–£165.00
922 Cytotoxic responsive malignancy BNF 78
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