Sipuleucel-t is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. It is available as injection for intravenous use. MedsAcross supplies Sipuleucel-t for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
PROVENGE ® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.
Source: US FDA prescribing information
PROVENGE is classified as an autologous cellular immunotherapy. While the precise mechanism of action is unknown, PROVENGE is designed to induce an immune response targeted against PAP, an antigen expressed in most prostate cancers. During ex vivo culture with PAP-GM-CSF, APCs take up and process the recombinant target antigen into small peptides that are then displayed on the APC surface. In Study 1, 237 out of the 512 patients randomized were evaluated for the development of humoral and T cell immune responses (proliferative and gamma-interferon (γIFN) ELISPOT) to the target antigens at Baseline, and at Weeks 6, 14, and 26. Antibody (IgM and IgG) responses against PAP-GM-CSF and PAP antigen alone were observed through the follow-up period in the PROVENGE group. Neutralizing antibody responses to GM-CSF were transient.
Source: US FDA prescribing information
For autologous use only. For intravenous use only. Administer 3 doses at approximately 2-week intervals. Premedicate patients with oral acetaminophen and an antihistamine such as diphenhydramine. Before infusion, confirm that the patient's identity matches the patient identifiers on the infusion bag. Infuse PROVENGE intravenously over a period of approximately 60 minutes. Do Not Use a Cell Filter. Interrupt or slow infusion for acute infusion reactions, depending on the severity of the reaction.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Acute infusion reactions may occur. If reactions occur, decrease the rate or stop the infusion and administer appropriate medical treatment. Syncope and hypotension have also been observed. Closely monitor patients with cardiac or pulmonary conditions. PROVENGE should be used with caution in patients with risk factors for thromboembolic events. PROVENGE is not tested for transmissible infectious diseases and may transmit diseases to health care professionals handling the product. Universal precautions should be followed. Concomitant use of chemotherapy and immunosuppressive medications with PROVENGE has not been studied.
Source: US FDA prescribing information
The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache. The most common adverse reactions (incidence ≥ 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache.
Source: US FDA prescribing information
The insulated container and gel packs within the container are designed to maintain the appropriate transportation and storage temperature of PROVENGE until infusion.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Sipuleucel-t, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Provenge 50000000 injectionIntravenous | Dendreon Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | Not recorded | — |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Sipuleucel-t and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Sipuleucel-t, including Provenge.
No listed presentation of Sipuleucel-t is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Sipuleucel-t is classified under ATC code L03AX17 (Sipuleucel-t).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.