Active Ingredient: Sipuleucel-T
Autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (Sipuleucel-T) are indicated for treatment of asymptomatic or minimally symptomatic metastatic (nonvisceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 50,000,000 sipuleucel-T, once every 2 weeks, 3 doses in total.
One dose of sipuleucel-T contains a minimum of 50 × 106 autologous CD54+ cells activated with PAP-GM-CSF, suspended in 250 mL of Lactated Ringer’s Injection, in a sealed, patient-specific polyolefin bag.
The recommended course of treatment is 3 doses at approximately 2-week intervals. Each dose of sipuleucel-T is preceded by a standard leukapheresis procedure approximately 3 days prior to the scheduled infusion date. Prior to the first leukapheresis procedure, a complete blood count (CBC) test should be performed and be within ranges acceptable for the local facility. Additional CBC tests may be performed in accordance with local requirements.
If, for any reason, the patient is unable to receive a scheduled infusion of sipuleucel-T, the patient will need to undergo an additional leukapheresis procedure if the course of treatment is to be continued. Patients should be advised of this possibility prior to initiating treatment. In controlled clinical trials, 25.4% of patients treated with sipuleucel-T required more than 3 leukapheresis procedures in order to receive 3 infusions. In post-marketing experience of greater than 5,000 patients treated, this incidence is approximately 19%. In controlled clinical trials, the dosing interval range was 1–15 weeks.
Acute infusion reactions such as chills, fatigue, fever, nausea, and joint ache were frequently observed in clinical studies. To mitigate such reactions, premedication, consisting of paracetamol and an antihistamine was administered in clinical studies prior to infusion.
To minimize potential acute infusion reactions such as chills and/or fever, it is recommended that patients be pre-medicated orally with paracetamol and an antihistamine approximately 30 minutes prior to administration of sipuleucel-T. The doses of paracetamol and antihistamine given should be in accordance with local practice.
In case of using premedication, the status of the patient and possible contraindications/interactions should be taken into account.
In the event of an acute infusion reaction, the infusion may be interrupted or slowed, depending on the severity of the reaction. Appropriate medical therapy, which could include paracetamol, intravenous H1 and/or H2 blockers, and low dose intravenous pethidine, should be administered as needed.
In controlled clinical trials, 23.8% of patients treated with sipuleucel-T required opioids (a single dose of pethidine) on the day of infusion for infusion reactions.
If the infusion of sipuleucel-T must be interrupted, it should not be resumed if the infusion bag has been held at room temperature (25°C) for more than 3 hours.
Sipuleucel-T is solely intended for autologous use via intravenous infusion.
Sipuleucel-T should be infused intravenously over a period of approximately 60 minutes. The entire volume of the bag should be infused. A cell filter should not be used. Vital signs should be taken at least 30 minutes prior to and 30 minutes following each infusion. Patients should be observed for at least 30 minutes following each infusion. For patients with cardiovascular disease or those at risk for cardiac ischaemia, physicians should consider observing patients for at least 60 minutes following each infusion with vital signs taken at 30 minutes and 60 minutes following the infusion.
If the infusion must be interrupted, it should not be resumed if the infusion bag has been held at room temperature (25°C) for more than 3 hours.
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