Trade Name: Reyvow

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Eli Lilly and Company

Presentation: TABLET, HUMAN PRESCRIPTION DRUG

Strength: 50 mg/1

Storage and handling

LASMIDITAN

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
  3. Read more
  • No data
  • REYVOWu2122 is indicated for the acute treatment of migraine with or without aura in adults.n
  • Limitations of Use
  • REYVOW is not indicated for the preventive treatment of migraine.n
  • REYVOWu2122 is a serotonin (5-HT) 1F receptor agonist indicated for the acute treatment of migraine with or without aura in adults. ()n
  • Limitations of Use
  • REYVOW is not indicated for the preventive treatment of migraine. ()n
  • The recommended dose of REYVOW is 50u00a0mg, 100u00a0mg, or 200u00a0mg taken orally, as needed. No more than one dose should be taken in 24u00a0hours, and REYVOW should not be taken unless the patient can wait at least 8u00a0hours between dosing and driving or operating machinery .n
  • A second dose of REYVOW has not been shown to be effective for the same migraine attack.n
  • The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established.n
  • REYVOW may be taken with or without food.n
  • The recommended dose is 50u00a0mg, 100u00a0mg, or 200u00a0mg taken orally, as needed. ()n
  • No more than one dose should be taken in 24u00a0hours. (, )n
  • REYVOW (lasmiditan) tablets are available in two strengths:n
  • Tablets: 50u00a0mg, 100u00a0mg ()n
  • None.n
  • None. ()n
  • No data
  • Driving Impairment: Advise patients not to drive or operate machinery until at least 8u00a0hours after taking each dose of REYVOW. Patients who cannot follow this advice should not take REYVOW. Patients may not be able to assess their own driving competence and the degree of impairment caused by REYVOW. ()n
  • Central Nervous System (CNS) Depression: REYVOW may cause CNS depression and should be used with caution if used in combination with alcohol or other CNS depressants. (, )n
  • Serotonin Syndrome: Reactions consistent with serotonin syndrome were reported in patients treated with REYVOW. Discontinue REYVOW if symptoms of serotonin syndrome occur. ()n
  • Medication Overuse Headache: Detoxification may be necessary. ()n
  • The following clinically significant adverse reactions are described elsewhere in the labeling:n
  • Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.n
  • The safety of REYVOW has been evaluated in 4,878 subjects who received at least one dose of REYVOW. In 2 placebo-controlled, Phase 3 trials in adult patients with migraine (Studies 1 and 2), a total of 3,177 patients received REYVOW 50, 100, or 200u00a0mg . Of the REYVOW-treated patients in these 2 studies, approximately 84% were female, 78% were White, 18% were Black, and 18% were of Hispanic or Latino ethnicity. The mean age at study entry was 42.4u00a0years (range 18 to 81).n
  • Long-term safety was assessed for 2,030 patients, dosing intermittently for up to 12u00a0months in a long-term safety study. Of these, 728 patients were exposed to 100u00a0mg or 200u00a0mg for at least 3u00a0months, 361 patients were exposed to these doses for at least 6u00a0months, and 180 patients were exposed to these doses for at least 12u00a0months, all of whom treated at least 2 migraine attacks per month on average. In that study, 14% (148 out of 1,039) in the 200u00a0mg dose group, and 11% (112 out of 991) in the 100u00a0mg dose group withdrew from the trial because of an adverse event. The most common adverse event resulting in discontinuation in the long-term safety study (greater than 2%) was dizziness.n
  • Most common adverse reactions (u22655% and > placebo) were dizziness, fatigue, paresthesia, and sedation. ()n
  • To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • REYVOW may further lower heart rate when administered with heart rate lowering drugs. ()n
  • Avoid concomitant use with P-gp and Breast Cancer Resistant Protein (BCRP) substrates. ()n
  • No data
  • Based on animal data, may cause fetal harm. ()n
  • REYVOW has not been studied in patients with severe hepatic impairment (Child-Pugh C) and its use in these patients is not recommended. ()n
  • No data
  • REYVOW (lasmiditan) is a serotonin (5-HT) 1F receptor agonist for oral administration. The chemical name of lasmiditan hemisuccinate is 2,4,6-trifluoro-N-[6-(1-methylpiperidine-4-carbonyl)pyridine-2-yl]benzamide hemisuccinate. It has the empirical formula of CHFNOu20220.5[CHO] and a molecular weight of 436.41 (hemisuccinate). Lasmiditan hemisuccinate has the following structural formula:n
  • Lasmiditan hemisuccinate is a white, crystalline powder that is sparingly soluble in water, slightly soluble in ethanol, and soluble in methanol. A 1u00a0mg/mL aqueous solution of lasmiditan hemisuccinate has a pH of 6.8 at ambient conditions.n
  • REYVOW 50u00a0mg tablets contain 50u00a0mg lasmiditan (equivalent to 57.824u00a0mg lasmiditan hemisuccinate) and the inactive ingredients as follows:n
  • Excipients u2013 croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate.n
  • Color mixture ingredients u2013 black ferric oxide, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.n
  • REYVOW 100u00a0mg tablets contain 100u00a0mg lasmiditan (equivalent to 115.65u00a0mg lasmiditan hemisuccinate) and the inactive ingredients as follows:n
  • Excipients u2013 croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate.n
  • Color mixture ingredients u2013 black ferric oxide, polyethylene glycol, polyvinyl alcohol, red ferric oxide, talc, titanium dioxide.n
  • No data
  • No data
  • No data
  • No data
  • Advise the patient to read the FDA-approved patient labeling ().
  • REY-0001-MG-202001n
  • PACKAGE LABEL - REYVOW 50 mg 8ct carton
  • NDC 0002-4312-08ntttttt
  • 8 tablets (2 cards of 4 tablets)ntttttt
  • REYVOWu2122n
  • (lasmiditan) CVn
  • tablets 50 mgn
  • Each tablet contains 50 mg of lasmiditan.n
  • Rx onlyntttttt
  • www.REYVOW.comn
  • 50 mgn
  • Dispense enclosed Medication Guide to each patient.n
  • Lillyn
  • PACKAGE LABEL - REYVOW 100 mg 8ct carton
  • NDC 0002-4491-08ntttttt
  • 8 tablets (2 cards of 4 tablets)ntttttt
  • REYVOWu2122n
  • (lasmiditan) CVn
  • tablets 100 mgn
  • Each tablet contains 100 mg of lasmiditan.n
  • Rx onlyntttttt
  • www.REYVOW.comn
  • 100 mgn
  • Dispense enclosed Medication Guide to each patient.n
  • Lillyn

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of lasmiditan (Reyvow) which is also known as Reyvow and Manufactured by Eli Lilly and Company. It is available in strength of 50 mg/1.

lasmiditan (Reyvow) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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