General use and storage

Each vial of Herceptin^® contains 150 mg trastuzumab (lyophilised), 3.36 mg histidine hydrochloride, 2.16 mg histidine, 136.2 mg trehalose dehydrate and 0.6 mg polysorbate 20. The shelf life of lyophilised Herceptin^® is 2 years.

After reconstitution with sterile water for injections, the Herceptin^® solution is physically and chemically stable for 48 hours at 2–8ºC. The solution must not be frozen and any unused solution must be discarded. Solutions of Herceptin^® ready for infusion are physically and chemically stable in polyvinylchloride or polythene bags containing 0.9% sodium chloride for 24 hours at temperatures not exceeding 30ºC but should preferably be used immediately.

Instructions for preparing and administering the correct dose of Herceptin^® are given in Dosage and administration.

Herceptin^® administration can occasionally result in serious infusion reactions and pulmonary toxicity. In most cases, symptoms occur within 2.5 hours of the start of the first infusion. Interruption of infusion may help relieve symptoms and they can usually be resolved with standard treatment.

The use of Herceptin^® has also been associated with low rates of cardiac dysfunction and all candidates for treatment should undergo cardiac monitoring/assessment.