Orgovyx 120 mg/1
relugolix · TABLET, FILM COATED · Sumitomo Pharma America, Inc.
Orgovyx is a tablet, film coated containing relugolix at 120 mg/1, taken oral. Manufactured by Sumitomo Pharma America, Inc..
Key Facts
- Brand Name
- Orgovyx
- Generic Name
- relugolix
- NDC Code (Product)
72974-120- Manufacturer
- Sumitomo Pharma America, Inc.
- Strength
- 120 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA214621
- Drug Class
- Gonadotropin Releasing Hormone Receptor Antagonist [EPC]
- Marketing Start
- 12/18/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ORGOVYX is indicated for the treatment of adult patients with advanced prostate cancer. ORGOVYX is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended Dosage: A loading dose of 360 mg on the first day of treatment followed by 120 mg taken orally once daily, at approximately the same time each day ( 2.1 ). ORGOVYX can be taken with or without food ( 2.1 , 12.3 ). Instruct patients to swallow tablets whole and not to crush or chew tablets ( 2.1 ). 2.1 Recommended Dosage Initiate treatment of ORGOVYX with a loading dose of 360 mg on the first day and continue treatment with a 120 mg dose taken orally once daily at approximately the same time each day. ORGOVYX can be taken with or without food [see Clinical Pharmacology ( 12.3 )] . Instruct patients to swallow tablets whole and not to crush or chew tablets. Advise patients to take a missed dose of ORGOVYX as soon as they remember. If the dose was missed by more than 12 hours, patients should not take the missed dose and resume with the next scheduled dose. If treatment with ORGOVYX is interrupted for greater than 7 days, restart ORGOVYX with a loading dose of 360 mg on the first day, and continue with a dose of 120 mg once daily. In patients treated with GnRH receptor agonists and antagonists for prostate cancer, treatment is usually continued …
Contraindications
4 CONTRAINDICATIONS ORGOVYX is contraindicated in patients with severe hypersensitivity to relugolix or to any of the product components. Known severe hypersensitivity to relugolix or to any of the product components ( 4 ).
Drug Interactions
7 DRUG INTERACTIONS P-gp Inhibitors: Avoid co-administration. If unavoidable, take ORGOVYX first, separate dosing by at least 6 hours, and monitor patients more frequently for adverse reactions ( 2.2 , 7.1 ). Combined P-gp and Strong CYP3A Inducers: Avoid co-administration. If unavoidable, increase the ORGOVYX dose to 240 mg once daily ( 2.3 , 7.1 ). 7.1 Effect of Other Drugs on ORGOVYX P-gp Inhibitors Relugolix is a P-gp substrate. Co-administration of ORGOVYX with an oral P-gp inhibitor increases relugolix exposure [see Clinical Pharmacology ( 12.3 )], which may increase the risk of adverse reactions associated with ORGOVYX. Avoid co-administration of ORGOVYX with oral P-gp inhibitors. If co-administration with an oral P-gp inhibitor cannot be avoided, take ORGOVYX first and separate dosing by at least 6 hours. Monitor patients for increased adverse reactions [see Dosage and Administration ( 2.2 )] . Treatment with ORGOVYX may be interrupted for up to two weeks if a short course of treatment with a P-gp inhibitor is required. Resume ORGOVYX after the P-gp inhibitor is discontinued. If treatment with ORGOVYX is interrupted for greater than 7 days, restart ORGOVYX with a loading do…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: QT/QTc Interval Prolongation [see Warnings and Precautions ( 5.1 )] . The most common adverse reactions (≥ 10%) and laboratory abnormalities (≥ 15%) were hot flush, glucose increased, triglycerides increased, musculoskeletal pain, hemoglobin decreased, alanine aminotransferase (ALT) increased, fatigue, aspartate aminotransferase (AST) increased, constipation, and diarrhea ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Sumitomo Pharma America, at 1-833-696-8268 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 observed in practice. The safety of ORGOVYX was evaluated in HERO, a randomized (2:1), open-label, clinical study in patients with advanced prostate cancer [see Clinical Studies ( 14 )] . Patients received orally administered ORGOVYX as a loading dose of 360 mg on the first day followe…
Frequently Asked Questions
What is Orgovyx used for?
Orgovyx contains relugolix. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Orgovyx a controlled substance?
Orgovyx is not classified as a controlled substance by the DEA.
What is the generic name for Orgovyx?
The generic name for Orgovyx is relugolix. There are 1 other brand versions of relugolix.
What is the NDC code for Orgovyx 120 mg/1?
The NDC (National Drug Code) for Orgovyx 120 mg/1 is 72974-120, listed by Sumitomo Pharma America, Inc..