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Resources

See below to find helpful information for your practice and important resources to support your patients who are prescribed OGSIVEO.

OGSIVEO Resources

ICD-10-CM Codes for Desmoid Tumors

Location-specific ICD-10-CM codes for desmoid tumors went into effect on October 1, 2023. The codes can help you document location-specific desmoid tumor diagnoses in your patients.

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OGSIVEO FDA-Approved Therapy and ICD-10-CM Codes for Desmoid Tumors

How to Order/Rx Guide

Discover how to prescribe OGSIVEO for your adult patients with progressing desmoid tumors who require systemic treatment.

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OGSIVEO Product Fact Sheet and Ordering Guide

Patient Brochure

This brochure provides an overview of OGSIVEO for patients considering or starting treatment. It includes safety information, dosing instructions, educational content on desmoid tumors, and more.

English Version
Spanish Version
OGSIVEO Patient Brochure

DeFi Study Publication

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

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Desmoid Tumor Experts Discuss OGSIVEO and the DeFi Trial

Watch presentations about desmoid tumors and the clinical data for OGSIVEO in the Phase 3 DeFi trial by Dr. Noah Federman, M.D., Director of the Pediatric Bone and Soft Tissue Sarcoma Program at UCLA, and Dr. Robert Lawrence Randall, M.D., FACS, Professor and Chair of the Department of Orthopedic Surgery at the University of California, Davis.

Unmet Need

Watch Dr. Federman and Dr. Randall discuss the burden of desmoid tumors, patient characteristics, signs of disease progression, and management considerations.

OGSIVEO Overview and Patient Case Study

Watch Dr. Federman and Dr. Randall discuss the DeFi trial design, review efficacy and safety results, and present a hypothetical case study of a patient treated with OGSIVEO.

Advocacy Groups

The following advocacy organizations can provide additional support and information for your patients with desmoid tumors.

The Desmoid Tumor Research Foundation logo
The Desmoid Tumor Research Foundation (DTRF)
Rein in Sarcoma logo
Rein in Sarcoma
National Organization for Rare Disorders (NORD) logo
National Organization for Rare Disorders (NORD)
Sarcoma Alliance for Research through Collaboration (SARC) logo
Sarcoma Alliance for Research through Collaboration (SARC)
Global Genes logl
Global Genes
NCCN logo
NCCN Guidelines for Patients®
Northwest Sarcoma Foundation logo
Northwest Sarcoma Foundation
Sarcoma Foundation of America
Sarcoma Foundation of America

The organizations listed are independent of SpringWorks Therapeutics. SpringWorks Therapeutics is providing these links to help patients find more information about desmoid tumors, but inclusion on this list does not represent an endorsement or a recommendation from SpringWorks Therapeutics for any group or organization. Logos are used with permission.

Sarcoma Centers

You can find a registry of sarcoma centers on the website for Sarcoma Alliance for Research through Collaboration (SARC), a non-profit organization.*

Find a Center

SARC is independent of SpringWorks Therapeutics, Inc. SpringWorks Therapeutics is providing this resource to help patients find healthcare professionals by location who have experience treating adults with desmoid tumors. Inclusion of a healthcare setting in this registry does not represent an endorsement, referral, or recommendation from SpringWorks Therapeutics and is not intended as medical advice. The healthcare professionals or institutions included in this registry do not necessarily prescribe or endorse any SpringWorks Therapeutics products. This registry is not comprehensive and other providers with experience treating adults with desmoid tumors may be available.

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About OGSIVEO
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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.

Important Safety Information

DeFi, Desmoid Fibromatosis; HCP, healthcare professional; ICD-10-CM, International Classification of Diseases, Tenth Revision, Clinical Modification; NCCN, National Comprehensive Cancer Network® (NCCN®).

References