Sipuleucel-T

Sipuleucel-T is autologous cellular immunotherapy indicated for asymptomatic or minimally symptomatic prostate cancer with metastases that is resistant to standard hormone treatment.

• Sipuleucel-T is available under the following different brand names: Provenge

Common side effects of Sipuleucel-T include:

• chills
• fatigue
• fever
• back pain
• nausea
• joint ache
• body aches
• headache

Serious side effects of Sipuleucel-T include:

• hives
• difficult breathing
• swelling of your face, lips, tongue, or throat
• redness or swelling at the site of infusion or where cells were collected
• a light-headed feeling
• racing or irregular heartbeats
• signs of infection such as fever, pain, or redness where a needle was placed for blood cell collection or infusion
• signs of a stroke such as sudden numbness or weakness (especially on one side of the body), vision problems, slurred speech
• signs of a blood clot deep in the body like pain, swelling, warmth, or discoloration in an arm or leg
• signs of a blood clot in the lung like chest pain that gets worse with deep breathing, shortness of breath

Rare side effects of Sipuleucel-T include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Intravenous injection

• Minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF and suspended in 250 mL lactated Ringer solution
• Potency is determined by measuring the increased expression of CD54 molecules (ICAM-1) on the surface of APCs

Prostate Cancer

Adult and geriatric dosage

• Administer 3 doses (more than 50 million autologous CD54+ activated cells/dose) IV at approximately 2-week intervals (median dosing interval, 2 weeks; range, 1-15 weeks)
• Infuse IV over 60 mins

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Sipuleucel-T has severe interactions with no other drugs
• Sipuleucel-T has serious interactions with the following drug:
  • belatacept
• Sipuleucel-T has moderate interactions with at least 119 other drugs
• Sipuleucel-T has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Sipuleucel-T?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Sipuleucel-T?”

Cautions

• Intended solely for autologous use
• Acute infusion reactions have been observed (decrease infusion rate or stop infusion if severe, and administer supportive therapy)
• Monitor patient for 30 minutes following infusion
• Closely monitor if cardiac or pulmonary conditions coexist
• Because preparation is autologous in nature, it is not routinely tested for transmissible infectious diseases and may transmit diseases to healthcare professionals handling the product (follow universal precautions)
• Use with concomitant chemotherapy and immunosuppressive medications has not been studied
• Because of the autologous nature of product preparation, adhering to personalized leukapheresis and infusion schedules is important

Pregnancy and Lactation

• Information not available
• Lactation
  • Information not available