NOW APPROVED

Indication

SEGLENTIS contains tramadol hydrochloride, an opioid agonist, and celecoxib, a nonsteroidal anti-inflammatory drug, and is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve SEGLENTIS for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:

SEGLENTIS will be available to prescribe to adult patients in March 2022.

Approval Announcement
Prescribing Information
Patient Medication Guide

Kowa is committed to the responsible use of analgesics in acute pain management

Opioid analgesics can be an important option for healthcare professionals to appropriately manage acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Notwithstanding the medical need, Kowa recognizes that the use of prescription opioid medications is associated with the risks of abuse, addiction, and diversion. Kowa is committed to achieving high ethical standards and acting in accordance with all applicable laws, regulations, and industry codes.

SEGLENTIS will be available March 2022.

Please fill out the form below to receive important updates.

First name is required.

Last name is required.

Please enter a valid NPI.

*Required field.

I agree to the statement below and have read and understand the Privacy Policy and Terms of Use.

I agree that I am a healthcare professional over the age of 18. I authorize Kowa Pharmaceuticals America, Inc. (KPA), and companies working with KPA, to contact me for marketing purposes or otherwise provide me with information about KPA’s products, services, and programs or other topics of interest; to conduct market research; or to otherwise ask me about my experience with or thoughts about such topics. I understand that I may revoke this authorization and choose not to receive information from KPA by clicking the “unsubscribe” link provided in the emails I receive or by following the “unsubscribe” instructions included in other forms of communications from KPA.

Thank you for signing up.

You will soon receive updates and information about SEGLENTIS.

Important Safety Information, including Boxed Warning

Expand

+

Close

+

WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; CARDIOVASCULAR THROMBOTIC EVENTS; GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION; ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse

SEGLENTIS exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing SEGLENTIS and monitor all patients regularly for the development of these behaviors and conditions.

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.

Life-threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of SEGLENTIS. Monitor for respiratory depression, especially during initiation of SEGLENTIS.

Accidental Ingestion

Accidental ingestion of even one dose of SEGLENTIS, especially by children, can be fatal.

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use.
  • SEGLENTIS is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious (GI) events.

Ultra-rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in Children

Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases followed tonsillectomy and/or adenoidectomy; in at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism. SEGLENTIS is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of SEGLENTIS in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of SEGLENTIS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Interactions with Drugs Affecting Cytochrome P450 Isoenzymes

The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with SEGLENTIS requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1.

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

  • Reserve concomitant prescribing of SEGLENTIS and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit treatment to the minimum duration.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

Indication

SEGLENTIS contains tramadol hydrochloride, an opioid agonist, and celecoxib, a nonsteroidal anti-inflammatory drug, and is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve SEGLENTIS for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:

  • Have not been tolerated, or are not expected to be tolerated.
  • Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Contraindications

  • Children younger than 12 years of age.
  • Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy.
  • Significant respiratory depression.
  • In the setting of CABG surgery.
  • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment.
  • Known or suspected gastrointestinal obstruction, including paralytic ileus.
  • Hypersensitivity to tramadol, celecoxib, any other component of this product, or sulfonamides, or opioids.
  • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days.
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

Warnings and Precautions

  • Serotonin Syndrome: May be life-threatening. Can occur with use of tramadol alone, with concomitant use of serotonergic drugs, with drugs that impair metabolism of serotonin or tramadol.
  • Risk of Seizure: Can occur at the recommended dose of tramadol. Concomitant use with other drugs may increase seizure risk. Risk may increase in patients with epilepsy, a history of seizures, and in patients with a recognized risk for seizures.
  • Risk of Suicide: Do not prescribe for suicidal or addiction-prone patients.
  • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off the opioid.
  • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration.
  • Severe Hypotension with Tramadol: Monitor during dosage initiation. Avoid use of SEGLENTIS in patients with circulatory shock.
  • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of SEGLENTIS in patients with impaired consciousness or coma.
  • Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.
  • Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
  • Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.
  • Heart Failure and Edema: Avoid use of SEGLENTIS in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.
  • Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of SEGLENTIS in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.
  • Exacerbation of Asthma Related to Aspirin Sensitivity: SEGLENTIS is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
  • Serious Skin Reactions: Discontinue SEGLENTIS at first appearance of skin rash or other signs of hypersensitivity.
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically.
  • Fetal Toxicity: Limit use of NSAIDs, including SEGLENTIS, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus.
  • Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.

Adverse Reactions

Most common adverse reactions (incidence > 5% and > placebo) for SEGLENTIS are nausea, vomiting, dizziness, headache, somnolence.

Drug Interactions

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with SEGLENTIS because they may reduce analgesic effect of SEGLENTIS or precipitate withdrawal symptoms.

Drugs that Interfere with Hemostasis (e.g., warfarin, aspirin, selective serotonin reuptake inhibitors [SSRIs]/serotonin norepinephrine reuptake inhibitors [SNRIs]): Monitor patients for bleeding who are concomitantly taking SEGLENTIS with drugs that interfere with hemostasis. Concomitant use of SEGLENTIS and analgesic doses of aspirin is not generally recommended.

Angiotensin Converting Enzyme (ACE) Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with SEGLENTIS may diminish the antihypertensive effect of these drugs. Monitor blood pressure.

ACE Inhibitors and ARBs: Concomitant use with SEGLENTIS in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, monitor for signs of worsening renal function.

Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.

Digoxin: Concomitant use with SEGLENTIS can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels.

Drug Abuse and Dependence

SEGLENTIS contains tramadol, a Schedule IV controlled substance with a high potential for abuse similar to other opioids and can be abused and is subject to misuse, addiction, and criminal diversion. All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Overdosage

SEGLENTIS is a combination drug composed of tramadol and celecoxib. The clinical presentation of overdose may include the signs and symptoms of tramadol toxicity, celecoxib toxicity or both.

Tramadol:

Acute overdosage with tramadol can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, QT prolongation, hypotension, partial or complete airway obstruction, atypical snoring, seizures, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.

Deaths due to overdose have been reported with abuse and misuse of tramadol. Review of case reports has indicated that the risk of fatal overdose is further increased when tramadol is abused concurrently with alcohol or other CNS depressants, including other opioids.

Celecoxib:

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare.

For more information on appropriate treatment of overdose with SEGLENTIS, see the full Prescribing Information.

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

To ensure that the benefits of opioid analgesics, including SEGENTIS, outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers.

To obtain further information on the opioid analgesic REMS and for a list of accredited REMS continuing education, call 1-800-503-0784, or log on to www.opioidanalgesicrems.com.

To report SUSPECTED ADVERSE REACTIONS, contact Kowa Pharmaceutics America, Inc. at 1-888-SEGLENTIS or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For additional information please see full Prescribing Information, including Boxed Warning, and Medication Guide, for SEGLENTIS.

Intended for healthcare professionals of the United States of America only.

ISI-SEG-US-00001 10/2021

SEGLENTIS® is a registered trademark of Esteve Pharmaceuticals, S.A. and is used under license.

© Kowa Pharmaceuticals America, Inc. (2021)

Important Safety Information, including Boxed Warning

Close

+

WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; CARDIOVASCULAR THROMBOTIC EVENTS; GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION; ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse

SEGLENTIS exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing SEGLENTIS and monitor all patients regularly for the development of these behaviors and conditions.

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.

Life-threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of SEGLENTIS. Monitor for respiratory depression, especially during initiation of SEGLENTIS.

Accidental Ingestion

Accidental ingestion of even one dose of SEGLENTIS, especially by children, can be fatal.

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use.
  • SEGLENTIS is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious (GI) events.

Ultra-rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in Children

Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases followed tonsillectomy and/or adenoidectomy; in at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism. SEGLENTIS is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of SEGLENTIS in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of SEGLENTIS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Interactions with Drugs Affecting Cytochrome P450 Isoenzymes

The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with SEGLENTIS requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1.

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

  • Reserve concomitant prescribing of SEGLENTIS and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit treatment to the minimum duration.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

Indication

SEGLENTIS contains tramadol hydrochloride, an opioid agonist, and celecoxib, a nonsteroidal anti-inflammatory drug, and is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve SEGLENTIS for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:

  • Have not been tolerated, or are not expected to be tolerated.
  • Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Contraindications

  • Children younger than 12 years of age.
  • Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy.
  • Significant respiratory depression.
  • In the setting of CABG surgery.
  • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment.
  • Known or suspected gastrointestinal obstruction, including paralytic ileus.
  • Hypersensitivity to tramadol, celecoxib, any other component of this product, or sulfonamides, or opioids.
  • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days.
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

Warnings and Precautions

  • Serotonin Syndrome: May be life-threatening. Can occur with use of tramadol alone, with concomitant use of serotonergic drugs, with drugs that impair metabolism of serotonin or tramadol.
  • Risk of Seizure: Can occur at the recommended dose of tramadol. Concomitant use with other drugs may increase seizure risk. Risk may increase in patients with epilepsy, a history of seizures, and in patients with a recognized risk for seizures.
  • Risk of Suicide: Do not prescribe for suicidal or addiction-prone patients.
  • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off the opioid.
  • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration.
  • Severe Hypotension with Tramadol: Monitor during dosage initiation. Avoid use of SEGLENTIS in patients with circulatory shock.
  • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of SEGLENTIS in patients with impaired consciousness or coma.
  • Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.
  • Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
  • Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.
  • Heart Failure and Edema: Avoid use of SEGLENTIS in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.
  • Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of SEGLENTIS in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.
  • Exacerbation of Asthma Related to Aspirin Sensitivity: SEGLENTIS is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
  • Serious Skin Reactions: Discontinue SEGLENTIS at first appearance of skin rash or other signs of hypersensitivity.
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically.
  • Fetal Toxicity: Limit use of NSAIDs, including SEGLENTIS, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus.
  • Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.

Adverse Reactions

Most common adverse reactions (incidence > 5% and > placebo) for SEGLENTIS are nausea, vomiting, dizziness, headache, somnolence.

Drug Interactions

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with SEGLENTIS because they may reduce analgesic effect of SEGLENTIS or precipitate withdrawal symptoms.

Drugs that Interfere with Hemostasis (e.g., warfarin, aspirin, selective serotonin reuptake inhibitors [SSRIs]/serotonin norepinephrine reuptake inhibitors [SNRIs]): Monitor patients for bleeding who are concomitantly taking SEGLENTIS with drugs that interfere with hemostasis. Concomitant use of SEGLENTIS and analgesic doses of aspirin is not generally recommended.

Angiotensin Converting Enzyme (ACE) Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with SEGLENTIS may diminish the antihypertensive effect of these drugs. Monitor blood pressure.

ACE Inhibitors and ARBs: Concomitant use with SEGLENTIS in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, monitor for signs of worsening renal function.

Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.

Digoxin: Concomitant use with SEGLENTIS can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels.

Drug Abuse and Dependence

SEGLENTIS contains tramadol, a Schedule IV controlled substance with a high potential for abuse similar to other opioids and can be abused and is subject to misuse, addiction, and criminal diversion. All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Overdosage

SEGLENTIS is a combination drug composed of tramadol and celecoxib. The clinical presentation of overdose may include the signs and symptoms of tramadol toxicity, celecoxib toxicity or both.

Tramadol:

Acute overdosage with tramadol can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, QT prolongation, hypotension, partial or complete airway obstruction, atypical snoring, seizures, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.

Deaths due to overdose have been reported with abuse and misuse of tramadol. Review of case reports has indicated that the risk of fatal overdose is further increased when tramadol is abused concurrently with alcohol or other CNS depressants, including other opioids.

Celecoxib:

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare.

For more information on appropriate treatment of overdose with SEGLENTIS, see the full Prescribing Information.

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

To ensure that the benefits of opioid analgesics, including SEGENTIS, outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers.

To obtain further information on the opioid analgesic REMS and for a list of accredited REMS continuing education, call 1-800-503-0784, or log on to www.opioidanalgesicrems.com.

To report SUSPECTED ADVERSE REACTIONS, contact Kowa Pharmaceutics America, Inc. at 1-888-SEGLENTIS or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For additional information please see full Prescribing Information, including Boxed Warning, and Medication Guide, for SEGLENTIS.

Intended for healthcare professionals of the United States of America only.

ISI-SEG-US-00001 10/2021

SEGLENTIS® is a registered trademark of Esteve Pharmaceuticals, S.A. and is used under license.

© Kowa Pharmaceuticals America, Inc. (2021)

Close

+

PRIVACY POLICY

Last updated February 6, 2019

Kowa Pharmaceuticals America, Inc. (“Kowa”), respects the privacy of every individual visiting our websites. This Privacy Policy discloses the online information gathering and dissemination practices of Kowa. Please be sure to read this entire Privacy Policy before using or submitting information to this website.

Our Privacy Policy only applies to Kowa-owned and -licensed websites, which include www.livalorx.com, www.livalohcp.com, www.takecholesteroltoheart.com, www.kowapharma.com, and any other Kowa product website that links to this Privacy Policy.

Personally Identifiable Information

Kowa may collect personally identifiable information (such as name, address, telephone/fax number, and e-mail address) only when voluntarily provided by a visitor to our websites. This information will not be used for any direct marketing or unsolicited follow-up unless we have previously informed you of this possible use and you have given us your express permission when submitting it. Kowa may use this information for such purposes as:

  • Sending you paper publications or other correspondence
  • Sending you e-mail press releases or notification
  • Delivering goods or prizes

Collection of Browser, Log, and Statistical Information

We may collect and/or track information provided to us by your browser, including the website you came from, the type of browser you use, the time and date of access, and other information that does not personally identify you. In addition, we may gather information about you that is automatically collected by our web server, such as your IP address and domain name.

Kowa may make use of non-personally identifiable statistical information collected from users (browser type, geographical location, age, gender) for optimization of its websites as part of its continual internal review process and in a general way to learn more about its clients. We may use IP addresses to analyze trends, administer the site, track users’ movements, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information. This information will not be disclosed to third parties by Kowa. This data will only be used for the stated purpose and will not be used for any unsolicited communication unless you give us permission.

Cookies

Kowa may utilize “cookies,” web beacons, and other similar technologies on our website. We may use first- and/or third-party “browser” or “HTTP” cookies, which are unique text files that may be used for data analysis and enable our website to tailor information for the visitor. We may use browser cookies for purposes such as to personalize the user’s experience on our site, to remember a user when the user registers for products or services, for fraud prevention, or to track visits to our websites. We also may use “web beacons” (also referred to as pixel tags, clear gifs, or other terms) or similar technologies to collect information such as how long a visitor remains on a particular page. If you do not want us to deploy browser cookies to your device when you visit our websites, you may set the browser to reject cookies or to notify the user when a website tries to place cookies in the browser program (see below). Rejecting cookies may affect your ability to use some of the features offered by the website. If you use our website without setting your browser to block cookies, you consent to the placement of cookies on your device.

Third parties, including our service providers or marketing partners, may collect information about a visitor to our site over time and/or across different websites when the visitor uses our website. This information often is aggregate data or individual information that is tied to a browser or device rather than specific identifiers such as the visitor’s name and address, but some of this information might be considered to be personally identifiable under some federal or state laws.

Some Internet browsers offer what often is referred to as “do-not-track” mechanisms for browser users to automatically signal privacy preferences to websites that they visit. Our site(s) do not currently respond to do-not-track signals; however, you can exercise other choices available to you, including limiting the placement of browser cookies on your device using your browser’s cookie control features and other choices described in this Policy.

Use of Information

Kowa may use the information we collect through our website(s) for the following purposes:

  • To respond to requests for information or to facilitate transactions or communications that users of our website(s) request;
  • To improve and administer our websites and mobile applications;
  • To better understand the needs of the users of our sites and mobile applications and create content that is relevant to the user;
  • For marketing and market research purposes;
  • To generate statistics and de-identified data;
  • To personalize content for the user;
  • To notify the user of any changes to our website(s) that may affect the user;
  • To enforce the Terms of Use for our website(s);
  • For historical, statistical, or business planning purposes;
  • To prevent fraud and investigate potential misconduct; or
  • To comply with law and legal process.

Disclosure of Information

We may disclose information with your consent or as otherwise necessary or appropriate to process a transaction that you may request.

We may disclose information to comply with FDA or other regulatory requirements.

We may disclose information that we collect through our website(s) with agents, affiliated businesses, and service providers providing services on our behalf.

In the event that our company or some of our assets are sold or transferred or used as security or to the extent we engage in business negotiations with our business partners, the information collected on our websites or mobile applications, including this site, may be transferred or shared with third parties as part of that transaction or negotiation.

If we receive a request from law enforcement officials or judicial authorities to provide information on individuals, we may provide such information. In matters involving claims of personal or public safety or in litigation where the data is pertinent, we may use or disclose your personal information without a court order. We may use information you submit to investigate security breaches, misconduct, or otherwise cooperate with authorities pursuant to a legal matter.

We do not share, sell, or lease personal information about you except as set forth in this Policy.

Security Measures

Kowa has implemented reasonable security features to help protect the personally identifiable information that you have submitted from unauthorized access, use, alteration, or release. Please note, however, that although Kowa has endeavored to create a secure and reliable Site for users, we cannot guarantee the confidentiality of any communication or material transmitted to and/or from Kowa via the Site or e-mail. Accordingly, we are not responsible for the security of information transmitted via the Internet.

Access and Correction

It is our policy, with certain exceptions, to provide individuals with access to personal information that Kowa collects through our website(s). In some cases, the site you used may allow you to log in to directly access and/or correct information you have provided. In other cases, such as web forms that you may submit through the site, if you would like to obtain a copy of the information you provided or request a correction, you can contact us at info@kowapharma.com. When you update information, we may keep a copy of the prior version for our records.

Children

Children and young people under 18 are requested to get permission from their parent or guardian before they submit personal data to Kowa websites.

Third-party websites

On Kowa’s website, we may provide links to third-party websites with content that we think may be of interest to you. Third-party websites are not controlled by Kowa and have their own privacy practices. You should read the Privacy Policy at each website that you visit after you leave our website. We do not endorse, and are not responsible for, the privacy practices or the content of any third-party websites.

Changes

This policy may be modified from time to time, and changes will be communicated promptly on this page.

General Information

For more information about Kowa’s Privacy Policy, please contact us:

Kowa Pharmaceuticals America, Inc.

530 Industrial Park Boulevard

Montgomery, AL 36117

1-334-288-1288

marketinginfo@kowapharma.com

Close

+

TERMS OF USE

These Terms of Use (“Terms”) were last updated on February 6, 2019.

Kowa Pharmaceuticals America, Inc. (“Kowa”), maintains the website located at KowaPharma.com (“Site”) to provide information and education about the Kowa Pharmaceuticals America, Inc., mission, products, and careers. You agree to comply with the Terms in effect at the time of each such access or other use. You also acknowledge that Kowa may, from time to time, in its sole discretion and without notification to you, change these Terms. You should review the Terms each time you visit or use the Site. If you do not agree to these Terms, do not use the Site. As used in these Terms, “we” includes Kowa, each of its affiliates, and any third-party vendors we hire to assist in the administration of the Site; the collection, cataloging, and/or analysis of data; and/or the processing or handling of any visitor transactions.

No person under the age of eighteen (18) is authorized to access or use this Site. User access to, and use of, the Site is subject to all applicable laws and regulations. Use of this Site is void where prohibited. By using this Site, you represent and warrant that you are eighteen (18) years of age and that you have the right, authority, and capacity to enter into this Agreement and abide by the Terms.

Use of the Site

The Site is for informational and educational uses only. You may print, download, or otherwise reproduce the information contained on the Site for your personal use only. Any commercial use of the information contained on the Site is strictly prohibited. The above license shall not include any resale or commercial use of the Site or its contents; any derivative use of the Site or its contents; or any use of data mining, robots, or similar data gathering and extraction tools. You may not frame or utilize framing techniques to enclose any trademark, logo, or other proprietary information (including images, text, page layout, or form) of Kowa or our affiliates without our prior express written consent.

We make no guarantees regarding the availability of the Site. Furthermore, we reserve the right, within our sole discretion, to discontinue the Site. You agree that we will not be liable to you for any such discontinuance or modification of the Site. Any rights not expressly granted by these Terms are reserved by us.

You are under no obligation to use or continue to use the Site and may temporarily or permanently cease using the Site without notice to Kowa. Any use of the Site, or any portion thereof, in violation of the foregoing shall constitute a violation of these Terms and may result in, among other things, termination or suspension of your rights to use the Site or any portion thereof.

Content

Kowa will use reasonable efforts to provide information that is timely and accurate. Kowa makes no warranty of any kind regarding the site and/or any materials provided on the site, all of which are provided on an “as-is” “as-available” basis. Kowa does not warrant the accuracy, completeness, currency, or reliability of any of the content or data found on the site and expressly disclaims all warranties, including implied warranties of merchantability, fitness for a particular purpose and non-infringement, and those arising by statute or otherwise in law or from a course of dealing or usage of trade. Kowa does not warrant that the site, its servers, or any e-mail sent from it are free of viruses or other harmful components. Neither Kowa, nor its affiliates, makes any representations, warranties, or guarantees regarding (1) the operation or performance of the site or (2) the internet generally.

Some jurisdictions do not allow the exclusion of implied warranties, so the above exclusions may not apply to you. You may also have other rights that vary from jurisdiction to jurisdiction and that may not be limited by these terms, provided, however, you agree and acknowledge that to the extent permissible under applicable law, you waive any such statutory rights with respect to implied warranties.

Limitation of Liability

Kowa assumes no responsibility, and shall not be liable, for any damages to, or viruses that may infect, your computer equipment or other property on account of your access to, use of, or browsing in the site or your downloading of any materials, data, text, images, video, or audio from the website. In no event shall Kowa be liable for any injury, loss, claim, damages, or any special, exemplary, punitive, direct, indirect, incidental, or consequential damages of any kind (including, but not limited to, lost profits or lost savings), whether based in contract, tort, strict liability, or otherwise, which arises out of or is in any way connected with any use of the website or content found therein.

Intellectual Property

All content contained on the Site is copyrighted and/or trademarked by Kowa. All content is the property of Kowa unless otherwise stated. All trademarks are the property of Kowa unless otherwise stated. The Terms do not grant any license to modify or alter the content on the Site that is viewed, downloaded, or otherwise accessed by you. You shall keep intact all proprietary notices, including copyright notices, contained on any downloadable materials. You shall be solely liable for any damages resulting from any infringement of copyright, trademark, or other proprietary right, or any and all harm resulting from your use of the Site.

Medical Information

The Site may contain information relating to diseases, disorders, or other medical conditions as well as pharmaceutical compounds, preparations, or products. The information is intended for general or educational use. Consult your healthcare practitioner for more specific information regarding your health.

Privacy

Any personal information or other information about you collected by Kowa through, or in connection with, this Site is subject to our Privacy Policy. The Kowa Privacy Policy is incorporated into the terms of these Terms by this reference. As indicated in these Terms, this Site is designed for adults of legal age (18 years and over). For questions about our online privacy policy for children, please refer to the Privacy Policy.

Third-Party Websites and Links

The Site may contain, from time to time, links to other third-party websites. These links are provided for your convenience only. Kowa has no control over the content of these sites or their policies. You should review the terms and conditions, and privacy policies, of each site you visit after you leave the Site. You further acknowledge and agree that Kowa shall not be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with use of or reliance on any such content or sites available on or through any such site or resource.

Void Where Prohibited

Although this Site may be accessed from anywhere in the world, the information provided on this Site is intended to comply with the laws and regulations of the United States and its Territories. The information contained on the Site is for use by residents of the United States and its Territories. All offers for products or services contained on this Site are void where prohibited by law. See specific offers for further details.

Indemnity and Release

By using this Site, you agree to indemnify Kowa and its partners, officers, employees, and agents and hold them harmless from any and all claims and expenses, including attorneys’ fees, arising from your use of the Site. By using the Site, you are hereby agreeing to release Kowa and its partners, officers, employees, and agents from any and all claims, demands, debts, obligations, damages (actual or consequential), costs, and expenses of any kind or nature whatsoever, whether known or unknown, suspected or unsuspected, disclosed or undisclosed, that you may have against them arising out of or in any way related to your use of the Site.

Governing Law

This Terms of Use Agreement and your use of this Site are governed by the laws of the United States of America and the State of Alabama, without regard to its conflicts of law principles. Any legal action or proceeding related to this Site shall be brought exclusively in a federal or state court of competent jurisdiction sitting in the State of Alabama.

Changes to the Terms

We may periodically modify and supplement these Terms, and the notice provided to you will be the updating of these Terms. You are responsible for regularly checking these Terms for revisions. All amended Terms become effective upon our posting to the Site, and any use of the Site after such revisions have been posted signifies your consent and agreement to the modified Terms.

General Information

For more information about Kowa’s Terms of Use, please contact us:

Kowa Pharmaceuticals America, Inc.

530 Industrial Park Boulevard

Montgomery, AL 36117

1-334-288-1288

marketinginfo@kowapharma.com