Gemzar 200 mg/5 ml 1 Vial

Gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas.

• • Gemcitabine, in combination with cisplatin is indicated as first line treatment of patients with locally advanced or metastatic non small cell lung cancer (NSCLC).

• • Gemcitabine monotherapy can be considered in elderly patients or those with performance status

• • Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence free interval of at least 6 months after platinum based, first line therapy.

• • Gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy.

• Prior chemotherapy should have included an anthracycline unless clinically contraindicated.

Caution & 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 manifeste by leucopaenia,thrombocytopaenia and anaemia.

• • Patients receiving gemcitabine should be monitored prior to each dose for platelet, leucocyte and granulocyte counts.

Hepatic and renal impairment

• • Gemcitabine should be used with caution in patients with hepatic or renal function impairment.

• • Administration of gemcitabine in patients with concurrent liver metastases or a preexisting medical history of hepatitis, alcoholism or liver cirrhosis may lead to exacerbation of the underlying hepatic impairment.

• • Laboratory evaluation of renal and hepatic function (including virological tests) should be performed periodically.

Live vaccinations

• • Yellow fever vaccine and other live attenuated vaccines are not recommended in patients treated with gemcitabine.

Posterior reversible encephalopathy syndrome

• • Reports of posterior reversible encephalopathy syndrome (PRES) with potentially severe consequences have been reported in patients receiving gemcitabine as single agent or in combination with other chemotherapeutic agents.

• • Acute hypertension and seizure activity were reported in most gemcitabine patients experiencing PRES, but other symptoms such as headache, lethargy, confusion and blindness could also be present. Diagnosis is optimally confirmed by magnetic resonance imaging (MRI). PRES was typically reversible with appropriate supportive measures.

• • Gemcitabine should be permanently discontinued and supportive measures implemented, including blood pressure control and antiseizure 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.

• • The condition is usually treatable if recognised early and managed appropriately, but fatal cases have been reported.

• • The condition involves systemic capillary hyperpermeability during which fluid and proteins from the intravascular space leak into the interstitium.

• • The clinical features include generalised oedema, weight gain, hypoalbuminaemia, severe hypotension, acute renal impairment and pulmonary oedema.

• • Gemcitabine should be discontinued and supportive measures implemented if capillary leak syndrome develops during therapy.

• • Capillary leak syndrome can occur in later cycles and has been associated in the literature with adult respiratory distress syndrome.

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.

Fertility

• • In fertility 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

• • Should not be used during pregnancy unless clearly necessary.

• • Women should be advised not to become pregnant during treatment with gemcitabine and to warn their attending physician immediately, should this occur after all.

Breastfeeding

• • It is not known whether gemcitabine is excreted in human milk and adverse effects on the suckling child cannot be excluded.

• • Breastfeeding must be discontinued during gemcitabine therapy.

Sodium

• • Gemzar 200 mg contains 3.5 mg (<1 mmol) sodium per vial ie essentially sodium free.

• Gemzar 1000 mg contains 17.5 mg (< 1 mmol) sodium per vial ie essentially sodium free.

Ingredients:

• Gemzar (gemcitabine), Mannitol, Sodium acetate , Hydrochloric acid and Sodium hydroxid.