OGSIVEO 100 mg/1
nirogacestat · TABLET, FILM COATED · SpringWorks Therapeutics, Inc.
OGSIVEO is a tablet, film coated containing nirogacestat at 100 mg/1, taken oral. Manufactured by SpringWorks Therapeutics, Inc..
Key Facts
- Brand Name
- OGSIVEO
- Generic Name
- nirogacestat
- NDC Code (Product)
82448-100- Manufacturer
- SpringWorks Therapeutics, Inc.
- Strength
- 100 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA217677
- Drug Class
- Gamma Secretase Inhibitor [EPC]
- Marketing Start
- 11/27/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE OGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment. OGSIVEO is a gamma secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage is 150 mg orally twice daily until disease progression or unacceptable toxicity. ( 2.1 ) See Full Prescribing Information for dosage modifications due to adverse reactions. ( 2.2 ) 2.1 Recommended Dosage 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. 2.2 Dos ag e Modifications for Adverse Reactions The recommended dose modifications for OGSIVEO for selected severe adverse reactions are summarized in Table 1 [ see Warnings and Precautions ( 5 ) , Adverse Reactions ( 6 ) ]. For other severe adverse reactions, life-threatening adverse reactions, or persistent intolerable Grade 2 adverse reactions, withhold drug until resolved to Grade ≤ 1 or baseline. Only restart at a dosage of 100 mg twice daily after considering the potential benefit and likelihood of recurrence of the adverse reaction. Permanently discon…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Strong or moderate CYP3A inhibitors : Avoid concomitant use. ( 7.1 ) Strong or moderate CYP3A inducers : Avoid concomitant use. ( 7.1 ) Gastric acid reducing agents : Avoid concomitant use with proton pump inhibitors and H2-receptor antagonists. If concomitant use cannot be avoided, OGSIVEO administration can be staggered with antacids. ( 7.1 ) 7.1 Effect s of Other Drugs on OGSIVEO Table 4. Effects of Other Drugs on OGSIVEO Strong or Moderate CYP3A Inhibitors Prevention or Management Avoid concomitant use of OGSIVEO with strong or moderate CYP3A inhibitors including grapefruit products, Seville oranges, and starfruit. Clinical Effect Nirogacestat is a CYP3A substrate. Strong or moderate CYP3A inhibitors increase nirogacestat exposure [see Clinical Pharmacology ( 12.3 ) ], which may increase the risk of OGSIVEO adverse reactions . Strong or Moderate CYP3A Inducers Prevention or Management Avoid concomitant use of OGSIVEO with strong or moderate CYP3A inducers. Clinical Effect Nirogacestat is a CYP3A substrate. Strong or moderate CYP3A inducers decrease serum nirogacestat exposure [ see Clinical Pharmacology ( 12.3 ) ], which may reduce the effectiveness of OGSIV…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Diarrhea [ see Warnings and Precautions ( 5.1 )] Ovarian Toxicity [ see Warnings and Precautions ( 5.2 )] Hepatotoxicity [see Warnings and Precautions ( 5.3 )] Non-Melanoma Skin Cancers [see Warnings and Precautions ( 5.4 )] Electrolyte Abnormalities [ see Warnings and Precautions ( 5.5 )] The most common ( > 15 %) adverse reactions are diarrhea, ovarian toxicity, rash, nausea, fatigue, stomatitis, headache, abdominal pain, cough, alopecia, upper respiratory tract infection and dyspnea. ( 6.1 ) The most common laboratory abnormalities (≥15%) are decreased phosphate, increased urine glucose, increased urine protein, increased AST, increased ALT, and decreased potassium. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact SpringWorks Therapeutics at 1-888-400-7989 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates …
Frequently Asked Questions
What is OGSIVEO used for?
OGSIVEO contains nirogacestat. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is OGSIVEO a controlled substance?
OGSIVEO is not classified as a controlled substance by the DEA.
What is the generic name for OGSIVEO?
The generic name for OGSIVEO is nirogacestat. There are no other listed brand versions of nirogacestat.
What is the NDC code for OGSIVEO 100 mg/1?
The NDC (National Drug Code) for OGSIVEO 100 mg/1 is 82448-100, listed by SpringWorks Therapeutics, Inc..
Other OGSIVEO Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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