Getting Started

Find information for initiating treatment on OGSIVEO.

OGSIVEO offers convenient oral dosing1

The recommended dosage of OGSIVEO is 150 mg administered orally twice daily until disease progression or unacceptable toxicity

OGSIVEO may be taken with or without food

Instruct patients to swallow OGSIVEO tablets whole and not to break, crush, or chew prior to swallowing

If a patient vomits or misses a dose, instruct the patient to take the next dose at its scheduled time

Avoid concomitant use of OGSIVEO with grapefruit products, Seville oranges, and starfruit

OGSIVEO is available in 150 mg and 100 mg tablets in blister packs

  • Each blister pack contains a 7-day supply
  • Four blister packs provide a 28-day supply

May help simplify tracking of AM/PM dosing

The OGSIVEO® (nirogacestat) 150 mg blister pack and OGSIVEO® (nirogacestat) 100 mg blister pack

Tablets shown are not actual size. Packages shown are for illustration only.

NDC numbers1

  • 14-count blister pack (150 mg): 82448-150-14
  • 14-count blister pack (100 mg): 82448-100-14

Storage and handling1

  • Store at 20°C-25°C (68°F-77°F)
  • Temperature excursions permitted between 
15°C-30°C (59°F-86°F)
  • See USP Controlled Room Temperature

Recommended Dosing

The recommended starting dose of OGSIVEO is 150 mg BID until disease progression or unacceptable toxicity.1

Dose modifications

For patients who experience certain adverse reactions, the dose of OGSIVEO may be withheld then reduced to 100 mg BID.1

See Dose Modifications

BID, twice daily.

OGSIVEO® (nirogacestat) blister cards

Packages shown are for illustration only.

Drug Interactions With OGSIVEO

Exposure to OGSIVEO may be affected by other drugs1

  • Strong or moderate CYP3A Inhibitors: OGSIVEO is a CYP3A substrate. Strong or moderate CYP3A inhibitors increase OGSIVEO exposure, which may increase the risk of OGSIVEO adverse reactions. Avoid concomitant use of OGSIVEO with strong or moderate CYP3A inhibitors, including grapefruit products, Seville oranges, and starfruit
  • Strong or moderate CYP3A Inducers: OGSIVEO is a CYP3A substrate. Strong or moderate CYP3A inducers decrease serum OGSIVEO exposure, which may reduce the effectiveness of OGSIVEO. Avoid concomitant use of OGSIVEO with strong or moderate CYP3A inducers
  • Gastric acid reducing agents: OGSIVEO is poorly soluble at pH ≥6. Gastric acid reducing agents may decrease serum OGSIVEO exposure, which may reduce the effectiveness of OGSIVEO. 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)*,†
  • For additional information about potential drug interactions with OGSIVEO, see Table 4 (Section 7.1) and Table 5 (Section 7.2) of the full Prescribing Information

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

Gastric acid reducing agents include PPIs (e.g., omeprazole, lansoprazole, esomeprazole), H2 blockers (e.g., cimetidine, famotidine, nizatidine), and antacids (e.g., Mylanta®, Rolaids®, Tums®). In accordance with the guidance in the OGSIVEO Prescribing Information, antacids should be administered either 2 hours before or 2 hours after OGSIVEO.

Prior to use of any concomitant medication, please refer to Section 7 (Drug Interactions) of the OGSIVEO Prescribing Information.
PPIs, proton pump inhibitors.

See More Safety Information

“As with all medications, we do expect some potential side effects from OGSIVEO. It’s important to proactively educate patients on these side effects and be available to provide guidance on how to best manage them. This will help patients through their treatment journey.”

Kristi Lara, Physician’s Assistant, Medical Oncoloy USC Norris

How to Order and Prescribe

OGSIVEO is available through a limited Specialty Pharmacy Network. OGSIVEO is also available for eligible medically integrated dispensing pharmacies by ordering directly through one of our Specialty Distributor partners.

How to Order/Rx Guide

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

Download
OGSIVEO® (nirogacestat) product fact sheet and ordering guide pdf

You can prescribe OGSIVEO using one of the following options:

SpringWorks CareConnections – Complete the enrollment form, including the Prescription for OGSIVEO, choose a fulfillment option from our in-network Specialty Pharmacy partners, and OGSIVEO will be shipped directly to the patient.

Prescribe directly through a Specialty Pharmacy network or medically integrated dispensing (MID) pharmacy – Eligible MID pharmacy practices may purchase OGSIVEO direct through our Specialty Distributors.‡

May not be available for all practices or organizations.

Specialty Pharmacies
Name
Phone
Fax
Website
Biologics by McKesson
Phone: 800-850-4306
Fax: 800-823-4506
biologics.mckesson.com
Onco360
Phone: 877-662-6633
Fax: 877-662-6355
onco360.com
Specialty Distributors
Name
Phone
Fax
Website
Item Number
AmerisourceBergen
ASD Healthcare (Hospitals)
Phone: 800-746-6273
Fax: 800-547-9413
abcorder.amerisourcebergen.com/
150 mg tablets – 10288186
100 mg tablets – 10288282
Oncology Supply (Clinics)
Phone: 800-633-7555
Fax: 800-248-8205
Cardinal Health
Cardinal Health SPD (Acute)
Phone: 855-855-0708
Fax: 614-553-6301
orderexpress.cardinalhealth.com/
150 mg tablets – 5917604
100 mg tablets – 5917596
Cardinal Health SPD (Provider)
Phone: 877-453-3972
Fax: 877-274-9897
specialtyonline.cardinalhealth.com/
McKesson
McKesson Specialty Health
Phone: 800-482-6700
Fax: 855-824-9489
mscs.mckesson.com/
150 mg tablets – 5017349
100 mg tablets – 5017348
McKesson Plasma and Biologics
Phone: 877-625-2566
Fax: 888-752-7626
connect.mckesson.com/
150 mg tablets – 2932275
100 mg tablets – 2932218

Share the Patient Brochure

This brochure can help your patients learn about OGSIVEO, including efficacy and safety information, dosing instructions, and more.

Download
OGSIVEO® (nirogacestat) patient brochure PDF
SpringWorks CareConnections® logo

Patient Support

SpringWorks CareConnections® provides personalized support to help your patients get started and stay on track with OGSIVEO.

View Patient Support

Managing Side Effects

Review the Side Effect Management Resource Guide to learn about practical strategies for helping patients stay on track with their therapy.

Download

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Monitoring & Managing
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Resources
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.
  2. Gounder M, Ratan R, Alcindor T, et al. Nirogacestat, a gamma-secretase inhibitor for desmoid tumors. N Engl J Med. 2023;388(10):898-912.
  3. Alcindor T, Kasper B, Gounder M, et al. Tumor volume and T2 hyperintensity changes from DeFi: a phase 3, randomized, controlled trial of nirogacestat in patients with desmoid tumors. Poster presentation at: ASCO Annual Meeting; June 2-6, 2023; Chicago, IL