What is Sipuleucel T?
Sipuleucel T is an immunotherapy medication used to treat men with advanced prostate carcinoma.
Sipuleucel T is a product made by removing a small quantity of white blood cells from the blood drawn from you. Sipuleucel T is given when other treatments or surgery have failed. Sipuleucel T may be used in other ways not mentioned in this guide.
Side effects of Sipuleucel-T
If you experience any of the following signs and symptoms of an allergic reaction: difficulty breathing, hives, swelling of face, lips or throat and difficulty swallowing (all which should prompt medical intervention immediately)
Some side effects can occur immediately after the injection or even during the procedure. You should tell your carer if your symptoms include fatigue, nausea, lightheadedness, fever, chills, and dizziness.
Sipuleucel-T may cause serious side effects. If you experience:
- Feeling dizzy or lightheaded as though they could faint.
- Heartbeats that are irregular or racing;
- Signs of Infection: Fever: pain or redness around the needle used for the collection or infusion of blood cells;
- Signs of a stroke: sudden numbness, weakness, or vision problems (especially on one side), slurred language;
- Signs of a deep blood clot—pain or swelling in an arm or limb, or discoloration;
- Signs of a blood clot in the lungs include chest discomfort that increases with deep breathing and shortness of breath.
Side effects of sipuleucel T may include:
- Fever, chills, tiredness;
- Backache
- Nausea;
- Headache
- Joint Pain.
There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.
Warnings
Tell your doctor before receiving sipuleucel T about any medical conditions, allergies, medicines that you take, or if you're pregnant or nursing.
Before you take this drug
Tell your doctor about any of the following:
- Heart problems
- A stroke;
- Breathing problems
How to take Sipuleucel T?
Sipuleucel-T is administered through a process known as leukapheresis (LOO-kuh-fuh-REE-sis). Leukapheresis is the process of collecting some of your own blood through a catheter that's placed in a vein. The catheter is attached to a machine that separates white blood cells and other blood components.
After leukapheresis, the collected blood cells will be mixed with sipuleucel T and injected into your body approximately 3 days later. These treated blood cells can help your immune system target and attack prostate cancer by injecting them into your body. This infusion takes approximately 60 minutes. You will be closely monitored for at least 30 minutes to ensure you don't have an infusion response. Other medications may be prescribed to prevent allergic reactions or serious side effects. Continue to use these medications as prescribed by your doctor.
The treatment is typically given three times, about two weeks apart. Your doctor will decide the schedule for your sipuleucel T injection and cell collection. Please follow your doctor's directions very closely. It is important to time the collection of cells in relation to the sipuleucel T infusion. You cannot use your infusion prepared if you miss an appointment.
Sipuleucel-T dosing information
Adult dose for prostate cancer:
Three complete doses are given approximately every two weeks; inject intravenously for 60 minutes.
Comments:
Leukapheresis is used to obtain peripheral blood mononuclear cells from the patient. This procedure should be done approximately 3 days before each infusion.
To minimise the risk of acute reactions to infusions, patients should be given an antihistamine such as diphenhydramine approximately 30 minutes before administration.
After each infusion, the patient should be monitored for any acute reactions.
The maximum interval between doses has not yet been determined.
This drug is only intended for autologous use.
This drug should only be administered by IV. A cell filter is not recommended.
Use: Treatment for asymptomatic or mildly symptomatic metastatic castrate resistance (hormone-refractory prostate cancer).
What happens if I miss the dose?
If you are unable to keep an appointment for your sipuleucel T infusion or cell collection, call your doctor.
What happens if I overdose?
Overdoses are unlikely because this medication is administered by a health professional in a medical environment.
What should be avoided?
If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.
Interaction with other drug
Tell your doctor if any of the following drugs weaken your immune system:
- Other cancer medications
- Steroids (prednisone, and others)
- Medicines to prevent the rejection of an organ transplant
This list is incomplete. Sipuleucel T may be affected by other drugs, such as vitamins and herbs. This list does not include all possible drug interactions.
