Patient Profiles

Learn about patient types who may be candidates for OGSIVEO.

Explore this hypothetical patient profile using the tabs below, or scroll down to view other profiles.

Zoe

Age: 31 | Patient With a Recurrent Desmoid Tumor Who Had Prior Surgery

Not an actual patient.

  • Zoe first noticed a mass on her right thigh two years ago
  • After initially being misdiagnosed with a lipoma, a core needle biopsy was performed and the mass was confirmed to be a desmoid tumor
  • Due to the location of her desmoid tumor, Zoe and her care team decided to proceed with surgery in an attempt to remove the desmoid tumor. Zoe’s desmoid tumor was surgically resected with R1 margins
  • Approximately 1 year after Zoe’s surgery, an MRI showed a recurrence of the desmoid tumor in her right thigh
  • Due to Zoe’s recurrent desmoid tumor, her care team explored other treatment options
  • OGSIVEO is the first and only FDA-approved targeted therapy for patients with progressing desmoid tumors who require systemic treatment
  • The DeFi trial studied OGSIVEO in a broad range of patients, including those with medical histories similar to Zoe:
    • 53% of patients had prior surgery for their desmoid tumor1

See DeFi study design >

  • Based on Zoe’s medical history and case details, including the location of her tumor and progressing symptoms, her care team recommended OGSIVEO. Before starting treatment with OGSIVEO, Zoe’s care team advised her:1
    • OGSIVEO can cause ovarian toxicity and impair fertility, and that these effects may continue following discontinuation of OGSIVEO
    • Her care team should be informed of changes in menstrual cycle regularity or symptoms of ovarian toxicity, including hot flashes or night sweats, and vaginal dryness
    • Females of reproductive potential should use effective contraception during treatment with OGSIVEO and for 1 week after the last dose
  • Zoe understood that the long-term effects on fertility have not been established, but decided to move forward with treatment
  • Setting expectations at treatment initiation, including discussing the most common adverse reactions with OGSIVEO and potential dose modifications, could help support Zoe if she experiences side effects. See Safety Profile >

Consider OGSIVEO for your patients with recurring, progressing desmoid tumors like Zoe.

APC, adenomatous polyposis coli; DeFi, Desmoid Fibromatosis; FAP, familial adenomatous polyposis; FDA, US Food and Drug Administration; MRI, magnetic resonance imaging; R1, microscopic positive margin; T2, transverse relaxation time; TKI, tyrosine kinase inhibitor.

Explore more hypothetical patient profiles.

Emily

Treatment-naïve patient with a desmoid tumor

View Profile

Carlos

Patient with a progressing desmoid tumor who previously received chemotherapy

View Profile

Jason

Patient with a progressing desmoid tumor who previously received a TKI

View Profile

Download the DeFi Study Publication

OGSIVEO was evaluated in DeFi—the largest completed Phase 3 trial of an FDA-approved therapy in adult patients with desmoid tumors. Review the results of this landmark study in The New England Journal of Medicine.

Download

Efficacy & Safety

Explore the data from DeFi, including safety information about OGSIVEO, and long-term data from a post-hoc analysis.

Efficacy & Safety

Dosing Modifications

Learn about the recommended starting dosage of OGSIVEO and dose modifications for certain adverse reactions.

View Dosing

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Indication
Important Safety Information

Indication 

OGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment.

Important Safety Information

Warnings And Precautions

Diarrhea: Diarrhea, sometimes severe, can occur in patients treated with OGSIVEO. Diarrhea occurred in 84% of patients treated with OGSIVEO, and included Grade 3 events in 16% of patients. Median time to first diarrhea event was 9 days (range: 2 to 434 days). Monitor patients and manage using antidiarrheal medications. Modify dose as recommended.

Ovarian Toxicity: Female reproductive function and fertility may be impaired in patients treated with OGSIVEO. Impact on fertility may depend on factors like duration of therapy and state of gonadal function at time of treatment. Long-term effects of OGSIVEO on fertility have not been established. Advise patients on the potential risks for ovarian toxicity before initiating treatment. Monitor patients for changes in menstrual cycle regularity or the development of symptoms of estrogen deficiency, including hot flashes, night sweats, and vaginal dryness.

Hepatotoxicity: ALT or AST elevations occurred in 30% and 33% of patients, respectively. Grade 3 ALT or AST elevations (>5 x ULN) occurred in 6% and 2.9% of patients. Monitor liver function tests regularly and modify dose as recommended.

Non-Melanoma Skin Cancers: New cutaneous squamous cell carcinoma and basal cell carcinoma occurred in 2.9% and 1.4% of patients, respectively. Perform dermatologic evaluations prior to initiation of OGSIVEO and routinely during treatment.

Electrolyte Abnormalities: Decreased phosphate (65%) and potassium (22%) occurred in OGSIVEO-treated patients. Phosphate <2 mg/dL occurred in 20% of patients. Grade 3 decreased potassium occurred in 1.4% of patients. Monitor phosphate and potassium levels regularly and supplement as necessary. Modify dose as recommended.

Embryo-Fetal Toxicity: OGSIVEO can cause fetal harm when administered to pregnant women. Oral administration of nirogacestat to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity and death at maternal exposures below human exposure at the recommended dose of 150 mg twice daily. Advise pregnant women of the potential risk to a fetus. Advise females and males of reproductive potential to use effective contraception during treatment with OGSIVEO and for 1 week after the last dose.

Adverse Reactions

The most common (≥15%) adverse reactions were diarrhea (84%), ovarian toxicity (75% in the 36 females of reproductive potential), rash (68%), nausea (54%), fatigue (54%), stomatitis (39%), headache (30%), abdominal pain (22%), cough (20%), alopecia (19%), upper respiratory tract infection (17%), and dyspnea (16%).

Serious adverse reactions occurred in 20% of patients who received OGSIVEO. Serious adverse reactions occurring in ≥2% of patients were ovarian toxicity (4%).

The most common laboratory abnormalities (≥15%) were decreased phosphate, increased urine glucose, increased urine protein, increased AST, increased ALT, and decreased potassium.

Drug Interactions

CYP3A Inhibitors and Inducers: Avoid concomitant use with strong or moderate CYP3A inhibitors (including grapefruit products, Seville oranges, and starfruit) and strong or moderate CYP3A inducers.

Gastric Acid Reducing Agents: Avoid concomitant use with proton pump inhibitors and H2 blockers. If concomitant use cannot be avoided, OGSIVEO can be staggered with antacids (e.g., administer OGSIVEO 2 hours before or 2 hours after antacid use).

Consult the full Prescribing Information prior to and during treatment for important drug interactions.

Use in Specific Populations

Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with OGSIVEO and for 1 week after the last dose.

Please click here for full Prescribing Information.

Indication 

OGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment.

Please click here for full Prescribing Information.

References
  1. OGSIVEO. Prescribing Information. SpringWorks Therapeutics, Inc.