- April 27, 2022
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Brand Name :
Provenge
Synonyms :
sipuleucel-T
Class :
Chemotherapy Modulating Agents, Immunostimulants
Dosage Forms & Strengths
Intravenous injection
At least 50 million CD54+ cells, that have been stimulated with PAP-GM-CSF, are to be mixed in 250 ml of lactated ringer solution
Not suggested
Refer to adult dosing
may decrease the therapeutic effect when combined with sipuleucel-t
may decrease the therapeutic effect when combined with sipuleucel-t
may decrease the therapeutic effect when combined with sipuleucel-t
may decrease the therapeutic effect when combined with sipuleucel-t
may decrease the therapeutic effect when combined with sipuleucel-t
may decrease the therapeutic effect when combined with sipuleucel-t
may decrease the therapeutic effect when combined with sipuleucel-t
may decrease the therapeutic effect when combined with sipuleucel-t
sipuleucel-T: they may decrease the therapeutic effect of corticosteroids
sipuleucel-T: they may decrease the therapeutic effect of corticosteroids
sipuleucel-T: they may decrease the therapeutic effect of corticosteroids
sipuleucel-T: they may decrease the therapeutic effect of corticosteroids
sipuleucel-T: they may decrease the therapeutic effect of corticosteroids
sipuleucel-T: they may decrease the therapeutic effect of corticosteroids
sipuleucel-T: they may decrease the therapeutic effect of corticosteroids
sipuleucel-T: they may decrease the therapeutic effect of corticosteroids
sipuleucel-T: they may decrease the therapeutic effect of corticosteroids
sipuleucel-T: they may decrease the therapeutic effect of corticosteroids
sipuleucel-T: they may decrease the therapeutic effect of corticosteroids
sipuleucel-T: they may decrease the therapeutic effect of corticosteroids
sipuleucel-T: they may decrease the therapeutic effect of corticosteroids
sipuleucel-T: they may decrease the therapeutic effect of immunostimulants
sipuleucel-T: they may decrease the therapeutic effect of immunostimulants
sipuleucel-T: they may decrease the therapeutic effect of immunostimulants
sipuleucel-T: they may decrease the therapeutic effect of immunostimulants
sipuleucel-T: they may decrease the therapeutic effect of immunostimulants
may decrease the therapeutic effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
may decrease the therapeutic effect of immunosuppressants
may decrease the therapeutic effect of Immunosuppressive agents
may decrease the therapeutic effect of Immunosuppressants
may decrease the therapeutic effect of immunosuppressants
methotrexate: they may decrease the therapeutic effect of sipuleucel-T
It may diminish the effect when combined with beclomethasone, inhaled by unspecified interactions mechanism
melphalan decreases the activity of sipuleucel-T by antagonism.
when both drugs are combined, there may be a decreased therapeutic efficacy of sipuleucel-t
when both the drugs are combined, the therapeutic efficacy of sipuleucel-t decreases
when both drugs are combined, there may be a reduced therapeutic efficacy of sipuleucel-T
diminish therapeutic effects of sipuleucel-T
may diminish the therapeutic effects of sipuleucel-T
decreases effects of sipuleucel-T
may diminish therapeutic effects of sipuleucel-T
the antagonistic activity between sipuleucel-T and gemcitabine decreases the effect of sipuleucel-T
may diminish therapeutic effects of sipuleucel-T
may diminish therapeutic effects of sipuleucel-T
the antagonistic activity between sipuleucel-T and fluorouracil decreases the effect of sipuleucel-T
may increase the risk of excessive bone marrow suppression
when both drugs are combined, there may be an increased risk or severity of adverse effects
may diminish the therapeutic effects of sipuleucel-T
the immunosuppressants decrease the activity of sipuleucel-T
Actions and Spectrum
An immunotherapy medicine called sipuleucel-T works by encouraging the patient’s immune system to find and attack prostate cancer cells. It is intended to precisely activate the patient’s dendritic cells, which are antigen-presenting cells and oversee mounting an immunological response.
The treatment of metastatic castration-resistant prostate cancer (mCRPC) that is asymptomatic or just mildly symptomatic is the only indication for the use of sipuleucel-T. Other cancers, including localised prostate cancer, are not treated with it.
Frequency defined
1-10%
Hot flush (8.2%)
Neck pain (5.7%)
Bone pain (6.3%)
Musculoskeletal chest pain (6%)
Cough (5.8%)
Weight loss (5.7%)
Sweating (5%)
Asthenia (10.8%)
Anorexia (6.5%)
Urinary tract infection (5.5%)
Tremor (5%)
Insomnia (6.2%)
Musculoskeletal pain (9%)
Rash (5%)
Upper respiratory tract infection (6.3%)
Peripheral edema (8.3%)
Diarrhea (10%)
Hematuria (7.7%)
Hypertension (7.5%)
Influenza-like illness (9.7%)
Dyspnea (8.7%)
Muscle spasms (7.7%)
>10%
Joint ache (19.6%)
Headache (18.1%)
Chills (53.1%)
Pain in extremity (12.1%)
Muscle ache (11.8%)
Anemia (12.5%)
Paresthesia oral (12.3%)
Back pain (29.6%)
Dizziness (11.8%)
Citrate toxicity (14.8%)
Constipation (12.3%)
Pain (12.3%)
Paresthesia (14.1%)
Vomiting (13.3%)
Fatigue (41.1%)
Nausea (21.5%)
Fever (31.3%)
Black Box Warning
There is no black box warning for sipuleucel-T drug.
Contraindication/Caution:
Contraindication:
Caution:
Pregnancy warnings:
Pregnancy category: N/A
Lactation: N/A
Pregnancy Categories:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
<b>Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category.
Pharmacology
sipuleucel-T works as therapeutic cancer vaccination. Its goal is to activate the patient’s immune system and destroy prostate cancer cells. The medication is made up of autologous antigen-presenting cells from peripheral blood.
Pharmacodynamics
The PAP antigen is processed by the activated APCs and presented to T cells, starting an immunological response. The patient’s T-cells, specifically cytotoxic T lymphocytes (CTLs), are primed and activated by the APCs’ presentation of the PAP antigen to recognize and attack prostate cancer cells that are PAP antigen-positive.
The PAP-specific activated T cells move to the tumor site and attack PAP-expressing prostate cancer cells there. The cancer cells are destroyed as a result of their cytotoxic actions.
Pharmacokinetics
Absorption
sipuleucel-T is not administered orally or through traditional routes of drug absorption. Instead, leukapheresis is used to collect the patient’s own peripheral blood mononuclear cells, including antigen-presenting cells.
Distribution
By subjecting the patient’s PBMCs to a fusion protein termed PA2024 that contains prostatic acid phosphatase (PAP) connected to granulocyte-macrophage colony-stimulating factor, the patient’s PBMCs are processed ex vivo.
Metabolism
The main metabolic processes that sipuleucel-T undergoes are the activation and control of the patient’s immune system.
Elimination and excretion
The patient’s body continues to experience the immunostimulatory and anticancer effects of the immune cells that have been activated, including T-cells and antigen-presenting cells.
Administration
Leukapheresis and reinfusion are used in a specific procedure to give sipuleucel-T.
Leukapheresis, a procedure where the patient’s blood is drawn and processed to separate peripheral blood mononuclear cells, is the initial step.
Patient information leaflet
Generic Name: sipuleucel-T
Why do we use sipuleucel-T?
sipuleucel-T is used in the treatment of advanced prostate cancer. It is indicated to treat metastatic castration-resistant prostate cancer that is asymptomatic or barely symptomatic.
It is used when the cancer has migrated to other body regions and the condition worsens despite hormone therapy to reduce testosterone levels. Patients with mCRPC who have prostate-specific antigen levels that indicate their disease is progressing are treated with sipuleucel-T.
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