Individual generic drug information

gemcitabine

Reference monograph

Part of registered formulation

GEMCITABINE

Reference record: Gemcitabine
Source: BNF 80 (2020–2021)
Printed source pages: 984, 985
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Gemcitabine only.

Indications And Dose

First-line treatment for locally advanced or metastatic non-small cell lung cancer (as monotherapy in elderly patients and in palliative treatment; otherwise in combination with cisplatin) | Treatment of locally advanced or metastatic pancreatic cancer | Treatment of advanced or metastatic bladder cancer (in combination with cisplatin) | Treatment of locally advanced or metastatic epithelial ovarian cancer which has relapsed after a recurrence-free interval of at least 6 months following previous platinum-based therapy (in combination with carboplatin) | Treatment of metastatic breast cancer which has relapsed after previous chemotherapy including an anthracycline (in combination with paclitaxel) ▶BY INTRAVENOUS INFUSION ▶Adult: (consult local protocol)

Source page 984

National Funding Access Decisions

NICE decisions ▶Gemcitabine for the treatment of pancreatic cancer (May 2001) NICE TA25 Gemcitabine is an option for ﬁrst-line chemotherapy for patients with advanced or metastatic adenocarcinoma of the pancreas and a Karnofsky score of at least 50 [Karnofsky score is a measure of the ability to perform ordinary tasks]. Gemcitabine is not recommended for patients who can have potentially curative surgery. There is insufﬁcient evidence to support its use for second-line treatment of pancreatic adenocarcinoma. www.nice.org.uk/guidance/ta25 ▶Gemcitabine for the treatment of metastatic breast cancer (January 2007) NICE TA116 Gemcitabine, in combination with paclitaxel, is an option for the treatment of metastatic breast cancer only when docetaxel monotherapy or docetaxel plus capecitabine are also considered appropriate. www.nice.org.uk/guidance/ta116 ▶Bevacizumab in combination with gemcitabine and carboplatin for the treatment of the first recurrence of platinum-sensitive advanced ovarian cancer (May 2013) NICE TA285 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. www.nice.org.uk/guidance/ta285 ▶Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer (April 2016) NICE TA389 Gemcitabine, in combination with carboplatin, is not recommended for treating the ﬁrst recurrence of platinum-sensitive ovarian cancer. Patients currently receiving gemcitabine in combination with carboplatin should have the option to continue their treatment until they and their clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta389 ▶Paclitaxel as albumin-bound nanoparticles with gemcitabine for untreated metastatic pancreatic cancer (September 2017) NICE TA476 Gemcitabine with paclitaxel as albumin-bound nanoparticles (nab-paclitaxel) is recommended as an option for untreated metastatic adenocarcinoma of the pancreas in adults, only if: . other combination chemotherapies are unsuitable and they would otherwise have gemcitabine monotherapy, and . the manufacturer provides nab-paclitaxel with the discount agreed in the patient access scheme. Patients whose treatment with nab-paclitaxel was started before this guidance was published, should have the option to continue treatment until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta476 Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (December 2006) that gemcitabine (Gemzar ®) is accepted for restricted use within NHS Scotland for the treatment of metastatic breast cancer, which has relapsed following previous chemotherapy including an anthracycline (unless contra-indicated).

Source page 984

Safety

Extracted information for Gemcitabine only.

Interactions

→Appendix 1: gemcitabine

Source page 984

Side Effects

▶Common or very common Alopecia. anaemia. appetite decreased. asthenia. back pain. bone marrow depression. chills. constipation. cough. diarrhoea. drowsiness. dyspnoea. fever. haematuria. headache. hyperhidrosis. inﬂuenza like illness. insomnia. leucopenia. myalgia. nausea. neutropenia. oedema. oral disorders. proteinuria . rhinitis. skin reactions. thrombocytopenia. vomiting ▶Uncommon Respiratory disorders ▶Rare or very rare Capillary leak syndrome. hypotension. myocardial infarction. posterior reversible encephalopathy syndrome (PRES). severe cutaneous adverse reactions (SCARs). skin ulcer. thrombocytosis ▶Frequency not known Arrhythmias. colitis ischaemic. gangrene. haemolytic uraemic syndrome. heart failure. hepatic disorders. pulmonary oedema. radiation injuries. renal failure. stroke. vasculitis SIDE-EFFECTS, FURTHER INFORMATION Gemcitabine should be discontinued if signs of microangiopathic haemolytic anaemia occur.

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Conception And Contraception

Manufacturer advises effective contraception during treatment. Men must avoid fathering a child during and for 6 months after treatment.

Source page 984

Pregnancy

Avoid (teratogenic in animal studies). See Pregnancy and reproductive function in Cytotoxic drugs p. 938.

Source page 984

Breast Feeding

Discontinue breast-feeding.

Source page 984

Hepatic Impairment

Manufacturer advises caution (limited information available).

Source page 984

Renal Impairment

Manufacturer advises caution.

Source page 984

Dose and formulations

Extracted information for Gemcitabine only.

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Solution for infusion ▶Gemcitabine (Non-proprietary) Gemcitabine (as Gemcitabine hydrochloride) 10 mg per 1 ml Gemcitabine 1.6g/160ml infusion bags | 1 bag P £140.00 Gemcitabine 2.2g/220ml infusion bags | 1 bag P £200.00 Gemcitabine 2g/200ml infusion bags | 1 bag P £180.00 Gemcitabine 1.2g/120ml infusion bags | 1 bag P £120.00 Gemcitabine 1.8g/180ml infusion bags | 1 bag P £160.00 Gemcitabine 1.4g/140ml infusion bags | 1 bag P s Gemcitabine (as Gemcitabine hydrochloride) 38 mg per 1 ml Gemcitabine 1g/26.3ml concentrate for solution for infusion vials | 1 vial P £160.30 (Hospital only) Gemcitabine 2g/52.6ml concentrate for solution for infusion vials | 1 vial P £320.63 (Hospital only) Gemcitabine 200mg/5.26ml concentrate for solution for infusion vials | 1 vial P £32.09 (Hospital only) Gemcitabine (as Gemcitabine hydrochloride) 100 mg per 1 ml Gemcitabine 2g/20ml concentrate for solution for infusion vials | 1 vial P £26.86 (Hospital only) Gemcitabine 1g/10ml concentrate for solution for infusion vials | 1 vial P £13.09 (Hospital only) Gemcitabine 200mg/2ml concentrate for solution for infusion vials | 1 vial P £6.40 (Hospital only) Powder for solution for infusion ▶Gemcitabine (Non-proprietary) Gemcitabine (as Gemcitabine hydrochloride) 200 mg Gemcitabine 200mg powder for solution for infusion vials | 1 vial P £32.00–£32.55 (Hospital only) | 1 vial P £32.09 Gemcitabine (as Gemcitabine hydrochloride) 1 gram Gemcitabine 1g powder for solution for infusion vials | 1 vial P £162.00– £162.76 (Hospital only) | 1 vial P £155.67 Gemcitabine (as Gemcitabine hydrochloride) 2 gram Gemcitabine 2g powder for solution for infusion vials | 1 vial P £324.00 (Hospital only) | 1 vial P £413.51

Source pages 984, 985

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

(consult local protocol)

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 984

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

gemcitabine

Reference monograph

Part of registered formulation

GEMCITABINE

Reference record: Gemcitabine
Source: BNF 80 (2020–2021)
Printed source pages: 984, 985
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Gemcitabine only.

Indications And Dose

Source page 984

National Funding Access Decisions

Source page 984

Safety

Extracted information for Gemcitabine only.

Interactions

→Appendix 1: gemcitabine

Source page 984

Side Effects

Source page 984

Conception And Contraception

Manufacturer advises effective contraception during treatment. Men must avoid fathering a child during and for 6 months after treatment.

Source page 984

Pregnancy

Avoid (teratogenic in animal studies). See Pregnancy and reproductive function in Cytotoxic drugs p. 938.

Source page 984

Breast Feeding

Discontinue breast-feeding.

Source page 984

Hepatic Impairment

Manufacturer advises caution (limited information available).

Source page 984

Renal Impairment

Manufacturer advises caution.

Source page 984

Dose and formulations

Extracted information for Gemcitabine only.

Medicinal Forms

Source pages 984, 985

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

(consult local protocol)

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 984

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.