L i c e n s e d a n d
Ready To Administer
d a n d
Administer
Licensed Gemcitabine ready-to-administer infusion bags
Aligned with
NHS
England dosing
bands 1
2 -year
shelf life
Available on
CMU
Framework
Only licensed
ready-to-
administer
gemcitabine
WWW.INFUSMART.CO.UK
Sun Pharma ([email protected])
Baxter ([email protected])
Mawdsleys ([email protected])
Can be stored
at room
temperature
Available
from
Mawdsleys
and Baxter
Reference: 1. www.england.nhs.uk/commissioning/wp-content/uploads/sites/12/2017/01/national-tables-100-mgml-v3.pdf (last accessed March 2018)
Prescribing Information: Gemcitabine 10 mg/ml, solution for infusion
Refer to the Summary of Product Characteristics (SMPC) before prescribing.
Name of the medicinal product: Gemcitabine 10 mg/ml, solution for infusion.
Qualitative and quantitative composition: Each infusion bag of 120ml / 140ml / 160ml / 170ml / 180ml /
200ml / 220ml contains respectively 1200mg / 1400mg /1600mg / 1700mg / 1800mg / 2000mg / 2200mg
Gemcitabine (as hydrochloride). One ml of the solution for infusion contains 10 mg Gemcitabine. Excipient:
One ml of the solution for infusion contains 4.575 mg sodium.
Therapeutic indications: Gemcitabine, in combination with Cisplatin is indicated as first line treatment of
patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Posology and method of administration: Gemcitabine should only be prescribed by a physician qualified
in the use of anticancer chemotherapy. Infusion bags of Gemcitabine 10 mg/ml solution for infusion allow
delivery of 120ml / 160 ml / 170 ml / 180 ml / 200 ml / 220 ml of solution (equivalent to 1200 mg / 1600mg
/ 1700 mg /1800 mg / 2000 mg / 2200 mg, respectively).
Non small Cell lung cancer Monotherapy The recommended dose of Gemcitabine is 1000 mg/m2, given
by 30-minute intravenous infusion. This should be repeated once weekly for 3 weeks, followed by a 1-week
rest period. This 4-week cycle is then repeated. Dosage reduction with each cycle or within a cycle may be
applied based upon the grade of toxicity experienced by the patient.
Combination use The recommended dose for Gemcitabine is 1,250 mg/m2 body surface area given as a
30-minute intravenous infusion on Days 1 and 8 of the treatment cycle (21 days).Dosage reduction with each
cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient.
Method of administration Gemcitabine solution for infusion is for intravenous use only. The solution may be
administered directly to the patient without further preparation. Gemcitabine solution for infusion is compatible
with IV infusion set when administered over a period of 30minutes. For single use only. Gemcitabine is
tolerated well during infusion and may be administered ambulant. If extravasation occurs, generally the
infusion must be stopped immediately and started again in another blood vessel. The patient should be
monitored carefully after the administration Cisplatin has been used at doses between 75-100 mg/m2 once
every 3 weeks.
Special populations Patients with renal or hepatic impairment Gemcitabine should be used with caution in
patients with hepatic or renal insufficiency as there is insufficient information from clinical studies to allow for
clear dose recommendations for these patient populations.
Elderly population (> 65 years) Gemcitabine has been well tolerated in patients over the age of 65.
Paediatric population (< 18 years) Gemcitabine is not recommended for use in children under 18 years of age
due to insufficient data on safety and efficacy.
Contraindications: Hypersensitivity to Gemcitabine or to any of the excipients.
Special warnings and precautions for use: Warnings: Prolongation of the infusion time and increased
dosing frequency have been shown to increase toxicity.
Haematological toxicity Gemcitabine can suppress bone marrow function as manifested by leucopoenia,
thrombocytopenia and anaemia.
Hepatic and renal impairment Gemcitabine should be used with caution in patients with hepatic insufficiency
or with impaired renal function as there is insufficient information from clinical studies to allow clear dose
recommendation for this patient population. Concomitant radiotherapy (given together or ≤ 7 days apart):
Toxicity has been reported.
Live vaccinations Yellow fever vaccine and other live attenuated vaccines are not recommended in patients
DOP March 2018 code 2018SunUK046
treated with Gemcitabine.
Posterior reversible encephalopathy syndrome Reports of posterior eversible encephalopathy syndrome (PRES)
with potentially severe consequences have been reported in patients receiving Gemcitabine as single agent
or in combination with other chemotherapeutic agents. Gemcitabine should be permanently discontinued
and supportive measures implemented, including blood pressure control and anti-seizure therapy, if PRES
develops during therapy.
Cardiovascular Due to the risk of cardiac and/or vascular disorders with Gemcitabine, particular caution must
be exercised with patients presenting a history of cardiovascular events.
Capillary leak syndrome Capillary leak syndrome has been reported in patients receiving Gemcitabine as
single agent or in combination with other chemotherapeutic agents. Gemcitabine should be discontinued and
supportive measures implemented if capillary leak syndrome develops during therapy.
Pulmonary pulmonary effects, sometimes severe (such as pulmonary oedema, interstitial pneumonitis or adult
respiratory distress syndrome (ARDS)) have been reported in association with Gemcitabine therapy. If such
effects develop, consideration should be made to discontinuing Gemcitabine therapy. Early use of supportive
care measure may help ameliorate the condition.
Renal Haemolytic uraemic syndrome Gemcitabine should be discontinued at the first signs of any
evidence of microangiopathic haemolytic anaemia, such as rapidly falling haemoglobin with concomitant
thrombocytopaenia, elevation of serum bilirubin, serum creatinine, blood urea nitrogen, or LDH. Renal failure
may not be reversible with discontinuation of therapy and dialysis may be required.
Fertility Men being treated with Gemcitabine are advised not to father a child during and up to 6 months after
treatment and to seek further advice regarding cryoconservation of sperm prior to treatment because of the
possibility of infertility due to therapy with Gemcitabine.
Pregnancy Women should be advised not to become pregnant during treatment with gemcitabine and to notify
their attending physician immediately, should this occur.
Sodium One ml of the solution for infusion contains 4.575 mg sodium.
Undesirable effects: The most commonly reported adverse drug reactions associated with Gemcitabine
treatment include: nausea with or without vomiting, raised liver transaminases (AST/ALT) and alkaline
phosphatase, reported in approximately 60% of patients; proteinuria and haematuria reported in approximately
50% patients; dyspnoea reported in 10-40% of patients (highest incidence in lung cancer patients); allergic
skin rashes occur in approximately 25% of patients and are associated with itching in 10% of patients.
Shelf life 2 Years.
Special precautions for storage This medicinal product does not require any special storage conditions.
Do not refrigerate or freeze.
Legal Category: POM. Marketing Authorisation Numbers, Pack sizes and basic NHS cost:
Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands. PL
31750/0062. 1200mg £120.00 1400mg £130.00 1600mg £140.00 1800mg £160.00 2000mg £180.00
2200mg £200.00
Date of Preparation: Nov 2017 2017 SUNUK038.
Adverse Events Should be reported. Reporting of adverse events can be communicated via
the Yellow Card Scheme https://yellowcard.mhra.gov.uk/
Adverse events should also be reported to Ranbaxy UK Tel: 02088485052