Korlym dose Mifepristone (Mifeprex): Nausea, weakness, fever/chills, vomiting, headache, diarrhea, dizziness. The dose of KORLYM Jan 10, 2025 · Usual Adult Dose for Cushing's Syndrome. Korlym should not be used with certain medications or in patients with certain conditions that result in heart rhythm changes (prolonged QT interval). 3. KORLYM must be given as a single daily dose. Aug 18, 2024 · The FDA approved the NDA, including the prescribing information contained in the label. - - References reviewed and updated. Conditions treated with corticosteroids Korlym should not be used by patients on corticosteroid (Support Program for Access and Reimbursement for Korlym ®) Patient Enrollment Form for Korlym® Diabetes mellitus (DM) due to underlying condition: E08. Important warnings This medicine can cause some serious health issues What Is Korlym ® (mifepristone) 300 mg Tablets?. Brand KORLYM: Initial dose: 300 mg orally once a day Maximum dose: 1200 mg or 20 mg/kg once a day Comments: Dose increases should occur once every 2 to 4 weeks. The daily dose of Korlym may be increased in 300 mg increments. Mar 10, 2018 · Mifepristone, also known as RU-486, is a potent synthetic steroidal antiprogesterone which is used as a single dose in combination with misoprostol, a prostaglandin analogue, to induce medical abortion. mifepristone Med Info. On its face, that appears relatively consistent with the ’214 patent, which requires limiting the dose of mifepristone to 600 mg per day in conjunction Korlym mifepristone tab 300 MG M ; N ; O ; Y O ; Y POLICY AGENT SUMMARY QUANTITY LIMIT Target Brand Agent Name(s) Target Generic Agent Name(s) Strengt h QL Amount Dose Form Day Supply Duratio n Addtl QL Info Allowed Exceptions Targete d NDCs When Exclusi ons Exist Korlym Mifepristone Tab 300 MG 300 MG 120 Tablets 30 DAYS Korlym dosage adjustment in patients receiving powerful CYP3A inhibitor medication already: Once daily, 300 mg is the recommended starting dose; this dose may be increased to whatever level is clinically necessary (900 mg is the daily maximum). Clinical Policy: Mifepristone (Korlym) Reference Number: PA. Take with food. Hepatic Impairment The pharmacokinetics of mifepristone in subjects with moderate hepatic impairment (Child-Pugh Class B) was evaluated in a single- and multiple-dose study (600 mg for 7 days). Apr 9, 2012 · The FDA-approved labeling instructs physicians to titrate each patient’s Korlym dose to clinical efficacy by assessing tolerability and degree of improvement in Cushing’s syndrome manifestations. • Swallow KORLYM whole. will be approved based on. S. The recommended starting dose is 300 mg orally once daily. 9 (without complications) Initial Dosage: 300 mg once daily. Dec 12, 2024 · Adjust Korlym dose as described in Dosage and Administration. 1200 MG/DAY Jan 8, 2025 · Mifepristone (Korlym): Lower maximum dosage recommended for management of patients with Cushing's syndrome and renal impairment. The dose of KORLYM may be Because Korlym does not stop the body from making cortisol, your healthcare provider cannot rely on measuring your cortisol levels to determine the dose of Korlym that will be best for you. Your doctor will start you on a low dose of mifepristone and gradually increase your dose, not more often than once every 2 to 4 weeks. Last updated on Jan 8, 2025. The dose of Korlym may be increased to a maximum of 1200 mg once daily. We are a service provider that helps eligible individuals access the Korlym patient assistance program. Some dosage forms listed on this page may not apply specifically to the brand name Korlym. Do not split, crush, or chew tablets. 18 1Q 2019 annual review: pregnancy removed as a contraindication; no significant changes; references reviewed and updated. Find information on Mifepristone (Korlym, Mifeprex) in Davis’s Drug Guide including dosage, side effects, interactions, nursing implications, mechanism of action, half life, administration, and more. Korlym must be given as a single daily dose. Corcept Therapeutics (“we”, “our”, “us”) are committed to protecting and respecting your privacy. CYP3A inhibitors: Caution should be used when Korlym is used with strong CYP3A inhibitors. Dosing And Titration. For dose increase requests, w eight must be received for drugs that have weight-based dosing 3. Common Adverse Effects. 19 Dec 12, 2024 · For patients receiving a daily dose of 1200 mg, reduce dose to 900 mg. Dec 12, 2024 · REDWOOD CITY, Calif. Chu JW, Matthias F, Belanoff J, et al. If you cannot swallow KORLYM tablets whole, tell your doctor. Mifepristone was approved for patients who had failed or […] V. The requested dose does NOT exceed 20 mg/kg/day AND 8. Mifeprex is another brand of mifepristone that is not covered in this medication guide. If treatment is necessary, the lowest effective dose should always be used. Increase in dose should not occur more frequently than every 2-4 weeks and should be based on assessment of glucose control, antidiabetic medication requirements, insulin levels and psychiatric symptoms. Your healthcare provider may need to adjust your dose of Korlym based on how you respond to treatment. ALL of the following: i. The requested dose does NOT exceed 20 mg/kg/day AND 6. The recommended starting dose is a single 300 mg tablet, taken once daily by mouth with a meal. Further, the toxicological profile of Korlym observed in two-year rodent bioassays and a twelve-month dog assay, along with associated dose-ranging studies, also Dosage/ Administration Billing/Coding Reimbursement Program Exceptions Mifepristone (Korlym), a selective and potent antagonist of glucocorticoid receptors, was inhibitor, start with a Korlym dose of 300 mg per day and titrate to a maximum of 900 mg per day if clinically indicated. Adrenal insufficiency occurred in fewer than 5% of patients. Your doctor may increase your dose as follows: 1 pill 2 pills 3 pills 4 pills You should have your potassium levels checked 1-2 weeks after starting Korlym and 1-2 weeks after every dose increase. In the first six weeks, these manifestations may include changes in glucose control, anti-diabetic medication requirements, insulin levels and Dec 12, 2024 · Drugs metabolized by CYP3A: Administer drugs that are metabolized by CYP3A at the lowest dose when used with Korlym. References 1. Dosage Modifications (Korlym) Coadministration with strong CYP3A inhibitors: Not to exceed 300 mg/day Drugs metabolized by CYP3A: Administer drugs that are metabolized by CYP3A at the lowest dose when used with Korlym. The dose of KORLYM may be Drugs metabolized by CYP3A: Administer drugs that are metabolized by CYP3A at the lowest dose when used with Korlym. Do not split, crush or chew Korlym tablets. Administer once daily orally with a meal. The dose of Korlym may be increased Drugs metabolized by CYP3A: Administer drugs that are metabolized by CYP3A at the lowest dose when used with Korlym. The dose of KORLYM may be increased to a maximum of 1200 mg once daily but should not exceed Dec 13, 2024 · Your prescriber might also adjust the dose depending on the side effects you have from the medication. 5 The label “recommended [a] starting dose [of] 300 mg once daily” and allowed for a dosage increase “in 300 mg increments to a maximum of 1200 mg once daily. The cost for mifepristone 300 mg oral tablet is around $15,465 for a supply of 28 tablets, depending on the pharmacy you visit. The requested quantity (dose) is less than or equal to the maximum 7. Dosage and Administration Indication Dosing Regimen Maximum Dose Cushing’s syndrome Starting dose is 300 mg PO QD. (See Checklists) Use the progress tracker. The usual dosage of mifepristone and misoprostol to terminate a pregnancy is mifepristone 200 mg (1 tablet) on Day 1, followed 24 to 48 hours later by misoprostol 800 mcg (four 200 mcg tablets), which is placed in the cheek pouch (buccally). 8 (with unspecified complications) E08. Jan 21, 2025 · No change in the initial dose of KORLYM is needed for renal impairment; the maximum dose should not exceed 600 mg per day. Applies to mifepristone: oral tablet. Mild-to-moderate hepatic impairment: Do not exceed 600 mg once daily. CP. Swallow whole. Dosing and titration The daily dose of KORLYM may be increased in 300 mg increments. Korlym 300 mg tablet. Korlym is a brand name of mifepristone, approved by the FDA in the following formulation(s): KORLYM (mifepristone - tablet;oral) Manufacturer: CORCEPT THERAP Approval date: February 17, 2012 Strength(s): 300MG ; Has a generic version of Korlym been approved? The recommended starting dose is 300 mg orally once daily. Davis Drug Guide PDF. of the following criteria: a. 13. Feb 17, 2020 · Dosage adjustment of Korlym in patients who require initiation of strong CYP3A inhibitor therapy: If current dose is 300 mg/day: No dosage adjustment necessary. Many people see results when their dose increases. Korlym dosage adjustment in individuals who need to start taking a potent CYP3A inhibitor. What should I avoid while taking KORLYM? Feb 17, 2012 · Generic Korlym Availability. Common side Your doctor may change your dose if needed. , hypercortisolism is not a result of chronic administration of high dose glucocorticoids) What Is Korlym ® (mifepristone) 300 mg Tablets?. CYP3A inducers: Do not use Korlym with CYP3A inducers. We are a public company established in the United States of America (USA) with a registered office at 149 Commonwealth Drive, Menlo Park, CA 94025, and, for the purpose of the General Data Protection Regulation (the “GDPR”), we are the data controller. Includes Korlym side effects, interactions and indications. May increase in 300mg increments (once every 2–4 weeks) to a max of 1200mg once daily, based • Take KORLYM exactly as your doctor tells you. 1,200 mg/day VI. [55] In women, mifepristone at doses greater or equal to 1 mg/kg antagonizes the endometrial and myometrial effects of progesterone. Use only when necessary, and do not exceed a Korlym dose of 900 mg. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Korlym pills should be swallowed whole. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose AND (Support Program for Access and Reimbursement for Korlym ®) Patient Enrollment Form for Korlym® Diabetes mellitus (DM) due to underlying condition: E08. The recommended starting dose is 300 mg once daily. ONE of the following: a. Your doctor may have to start you again on the lowest dose of mifepristone and gradually increase your dose. to take your Korlym dose every day. Prescription only Dexamethasone reduces inflammation and calms down an overactive immune system and is significantly more potent than prednisolone. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which Follow your doctor's instructions carefully. Color: light yellow Shape: oval Imprint: Nov 8, 2013 · The recommended starting dose is 300 mg, by mouth, once daily. Ask questions about your treatment. “Additional studies may be needed to determine if longer durations of concomitant administration and/or using mifepristone [Korlym] doses beyond 600 mg will produce exposure within the acceptable ranges,” researchers wrote. If current dose is 600 mg/day: Reduce dose to 300 mg once daily; if clinically indicated may increase dose to a maximum of 600 mg once daily. Mar 28, 2022 · KORLYM must be given as a single daily dose. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which Mifepristone (Mifeprex) is a synthetic steroid used to terminate early pregnancy. Titrate if clinically indicated and do not exceed a Korlym dose of 900 mg in combination with a strong CYP3A inhibitor 2. The requested quantity (dose) is greater than the program quantity limit AND ii. The best way to see how Korlym is working is to track your symptoms and look for improvements. ” 6 The label specifically warned against using mifepristone “with strong CYP3A inhibitors All Drugs; Human Drugs; Animal Drugs Find information on Mifepristone (Korlym, Mifeprex) in Davis’s Drug Guide including dosage, side effects, interactions, nursing implications, mechanism of action, half life, administration, and more. 5-mg dose of the progestin levonorgestrel. Korlym (mifepristone) is FDA-approved to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing syndrome who Nov 2, 2017 · However, the team believes that Korlym migh need dose adjustments when used in combination with Nizoral. 101 Effective Date: 01/2018 Coding Implications Last Review Date: 01/2024 Revision Log Description Mifepristone (Korlym®) is a cortisol receptor blocker. Korlym Dosage and Administration. They can help you prepare for appointments. PHAR. Take Korlym with food. all . A single preovulatory 10-mg dose of mifepristone delays ovulation by three to four days and is as effective an emergency contraceptive as a single 1. • Take KORLYM exactly as your doctor tells you. What should I avoid while taking KORLYM? Drugs metabolized by CYP3A: Administer drugs that are metabolized by CYP3A at the lowest dose when used with Korlym. Drugs metabolized by CYP3A: Administer drugs that are metabolized by CYP3A at the lowest dose when used with Korlym. Swallow Korlym whole. Decisions about dose increases should be based on a clinical assessment of tolerability and degree of improvement in Cushing’s syndrome manifestations. Product Availability Tablets: 300 mg VII. 2001;3568-3573. Korlym Prescribing Information. Your doctor may increase your dose as needed. studies conducted by Corcept that chemically identified Korlym as mifepristone, the same active ingredient in Mifeprex. Jan 27, 2012 · Use of Korlym outside of Cushing’s syndrome cannot be prospectively quantified. Apr 23, 2024 · No change in the initial dose of KORLYM is needed for renal impairment; the maximum dose should not exceed 600 mg per day. Adult . Brand names for mifepristone include Korlym. KORLYM is usually taken 1 time each day. , December 12, 2024--Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe The dose of Korlym may be increased to a maximum of 1200 mg once daily but should not exceed 20 mg/kg per day. 28. Oct 4, 2012 · The FDA-approved labeling instructs physicians to titrate each patient's Korlym dose to clinical efficacy by assessing tolerability and degree of improvement in Cushing's syndrome manifestations. The dose of KORLYM Korlym may also be used for purposes not listed in this medication guide. , Canada and Europe. Before starting Korlym, you should work with your doctor to establish treatment expectations and goals. We do not offer Korlym manufacturer coupons, Korlym discounts, rebates, Korlym savings cards, trial offers, or free Korlym samples. Your doctor may change your dose as needed, and you may not see immediate results. If this medication is stopped, you may need to restart at a lower dose and gradually increase the dose again. Korlym is a prescription medicine used to treat high blood sugar (hyperglycemia) caused by high cortisol levels in the blood (hypercortisolism) in adults with endogenous Cushing syndrome who have type 2 diabetes mellitus or glucose intolerance and who cannot have surgery or for whom surgery has failed. To help you remember, take it at the same time each day. To be eligible, patients must have concomitant type 2 diabetes, impaired glucose tolerance, or high blood pressure — all common consequences of prolonged excess cortisol (hypercortisolism). Serious and sometimes fatal infections and bleeding occur very rarely. The goal is to evaluate the treatment’s effect on blood sugar and blood pressure, and patients will be able to enter an open-label extension once the trial is completed. Korlym. Jan 21, 2025 · The dose of KORLYM may be increased to a maximum of 1200 mg once daily but should not exceed 20 mg/kg per day. At the time of request, member does not have any of the following contraindications: a. • Take KORLYM with food. • Your doctor may change your dose if needed. Apr 12, 2024 · The recommended starting dose is 300 mg orally once daily. The mifepristone tablet is swallowed Drugs metabolized by CYP3A: Administer drugs that are metabolized by CYP3A at the lowest dose when used with Korlym. On February 17, 2012, the Food and Drug Administration (FDA) approved mifepristone (Korlym) as a once daily oral medication to treat patients with Cushing’s syndrome. What should I avoid while taking KORLYM? You should not drink grapefruit juice while you take KORLYM. Titrate if clinically indicated and do not exceed a Korlym dose of 900 mg in combination with a strong CYP3A inhibitor Korlym . FDA Approved Indication(s) Korlymis indicated to control hyperglycemia secondary to hypercortisolism in adult patients 5. Use this medication regularly to get the most benefit from it. Aug 2, 2024 · Dosage of mifepristone and misoprostol for pregnancy termination. What Is Korlym ® (mifepristone) 300 mg Tablets?. -“Dose does not exceed 1200 mg/day or 20 mg/kg per day, whichever is less” is edited to “Dose does not exceed 1200 mg/day”. 17 02. J Clin Endocrinol Metab. A failed pregnancy termination could cause birth defects. The dose may be increased in 300 mg increments no more frequently than once every 2-4 weeks to a maximum of 1200 mg once daily; however, dosing should not exceed 20 mg/kg/day. The dose of KORLYM Finding the right dose of Korlym takes time. Get involved. Prescribed dose of Korlym does not exceed 1200 mg/day or 20 mg/kg per day, whichever is less; 4. The maximum dose is 1,200 mg by mouth once per day. The REMS Oversight Committee and the Center Director provided additional guidance and affirmed that although a REMS is required for Mifeprex, a REMS for Korlym is not necessary to ensure that the benefits of the drug outweigh its risks at this time. However, the dose is usually not more than 1200 mg per day. Medication is prescribed in accordance with Food and Drug Administration (FDA) established indication and dosing regimens or in accordance with medically appropriate off-label indication Dec 12, 2024 · For patients receiving a daily dose of 1200 mg, reduce dose to 900 mg. What should I avoid while taking KORLYM? The recommended starting dose is 300 mg once daily as a single dose. Discuss it with your Follow your doctor's instructions carefully. Do not use in severe hepatic impairment. Mar 5, 2019 · The current Korlym® label indicates that for concomitant administration of Korlym® with CYP3A inhibitors, such as ketoconazole, the dose of mifepristone should be limited to 600 mg per day. Children—Use and dose must be determined by your doctor. Take KORLYM with food. . Korlym is usually taken 1 time each day. Do not split, crush , or chew tablets. May increase in 300 mg increments (dose increase once every 2 to 4 weeks). Note that vaginal bleeding and abdominal pain/cramping are expected effects. What should I avoid while taking Korlym? You should not drink grapefruit juice while you take Korlym. The dosage may be increased every 2-4 weeks up to a maximum of 1200 mg/day, although it should not exceed 20 mg/kg/day. 2012; 366:914-24. For patients already being treated with a strong CYP3A inhibitor, start with a Korlym dose of 300 mg/day and titrate to a maximum of 900 mg/day if clinically indicated. Initially 300mg once daily. Swallow KORLYM whole. Mifepristone with misoprostol have not been associated with serum enzyme elevations or with clinically apparent liver injury. Korlym is used to treat high blood sugar (hyperglycemia) in adults with Cushing's syndrome who also have type 2 diabetes mellitus or glucose Aug 4, 2023 · Participants will be randomly assigned to relacorilant, at a target dose of 400 mg, or a placebo for 22 weeks. Colao A, Petersen S, Newell-Price J, et al. The requested quantity (dose) is less than or equal to the program quantity limit OR b. Jan 3, 2025 · Korlym (mifepristone) is used to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome. If you cannot swallow Korlym tablets whole, tell your doctor. The daily dose of KORLYM may be increased in 300 mg increments. Your doctor may change your dose if needed. Korlym should be taken once daily with a meal. Korlym should always be taken with a meal. Pregnancy; b. Korlym’s 2. Jun 12, 2018 · Introduction. The specific indication was for the treatment of elevated blood sugar in patients with Cushing’s syndrome and type 2 diabetes mellitus. Use the checklists. A total of 652 drugs are known to interact with Korlym: 356 major drug interactions (1189 brand and generic names) 279 moderate drug interactions (1315 brand and generic names) KORLYM must be given as a single daily dose. NiceRx is not a Korlym coupon, Korlym discount card, or Korlym copay card provider. N Engl J Med. In addition, your dose might differ if you're also taking a medication that interacts with Korlym (mifepristone). Successful long-term treatment of refractory cushing’s syndrome with high-dose mifepristone. For additional information of dose titration refer to the Dose Adjustment section. Quoted prices are for cash-paying customers and are not valid with insurance plans. 18 02. KORLYM should always be taken with a meal. Dosing and titration . Adjust Korlym dose as described in Dosage and Administration. When a strong CYP3A inhibitor is administered to patients already receiving Korlym, adjust the dose as follows: for patients receiving a daily dose of 600 mg, reduce dose to 300 mg. Do not split, crush or chew KORLYM tablets. 11. Titrate if clinically indicated and do not exceed a Korlym dose of 900 mg in combination with a strong CYP3A inhibitor 3. e. • KORLYM is usually taken 1 time each day. Dec 12, 2024 · For patients receiving a daily dose of 1200 mg, reduce dose to 900 mg. Do not split, crush, or chew the pills. Do not stop taking this medicine unless instructed by your doctor. Concurrent use of simvastatin, lovastatin, or CYP3A substrates with narrow therapeutic ranges (example: cyclosporine, dihydroergotamine, ergotamine, Korlym (mifepristone) is an antiprogestational agent, which, at high doses, competitively binds to the glucocorticoid and progesterone receptors. Dec 4, 2018 · The trial, called GRACE (NCT03697109), is enrolling up to 130 endogenous Cushing’s patients at clinical sites in the U. Dosage and Administration: No change in the initial dose of KORLYM is needed for renal impairment; the maximum dose should not exceed 600 mg per day. Decisions about dose increases should be based on a clinical assessment of tolerability and degree of improvement in Cushing's syndrome manifestations. Aug 29, 2023 · Tablets are oval in shape, light yellow to yellow in color, and engraved with “Corcept” on one side and “300” on the other. A 12-month phase 3 study of pasireotide in Cushing’s disease. Note: Your dose might differ if you have liver problems or kidney problems. The requested quantity (dose) does NOT exceed the program quantity limit OR b. : What is mifepristone (Korlym)? This medication guide provides information about the Korlym brand of mifepristone. The maximum dose is limited to 600 mg in kidney or liver impairment. Renal impairment: Do not exceed 600 mg once daily. Dec 12, 2024 · Drugs metabolized by CYP3A: Administer drugs that are metabolized by CYP3A at the lowest dose when used with Korlym. Drugs metabolized by CYP2C8/2C9: Use the lowest dose of CYP2C8/2C9 substrates when used with Korlym. Diagnosis of endogenous Cushing’s syndrome (i. Dec 12, 2024 · (2024-12-12 | NDAQ:CORT) Corcept Announces Positive Results in Treatment Phase of CATALYST Trial in Patients With Hypercortisolism (Cushing's Syndrome) and Difficult-to-Control Diabetes The recommended starting dose is 300 mg orally once daily. Some improvements will happen quickly, while others will take time. Be sure to tell your The most common adverse events were nausea, fatigue, headache, endometrial hyperplasia, and hypokalemia. Patients should swallow the tablet whole. Increases in dose should not occur more frequently than once every 2-4 weeks. The dose of KORLYM Feb 25, 2024 · Note: This document provides detailed information about Korlym Side Effects associated with mifepristone. If you stop taking mifepristone, call your doctor. Decisions about dose increases should be based on clinical response and tolerability. The Korlym brand of mifepristone is a cortisol receptor blocker, used to manage and treat high blood glucose levels (hyperglycemia) in people with Cushing’s syndrome. The recommended starting dosage of mifepristone is 300 mg/day. The dose of KORLYM may be increased to a maximum of 1200 mg once daily but should not exceed Jan 1, 2025 · Adults—At first, 300 milligrams (mg) once a day. icd vvsrd qkrup igtt uhlmj vypehe wzcdckh mddf mdxjg psywha cma ohk tgcllet nbpgwer kkkke