Privacy Policy

This Privacy Policy is meant to help you understand what data we collect, why we collect it, and what we do with it. This is important; we hope you will take time to read it carefully. Our Privacy Policy applies to United Therapeutics Corporation and its affiliates. 

This Privacy Policy was last revised March 1, 2017. We may change this Privacy Policy at any time and for any reason. If we make a significant change to our Privacy Statement, we will post a notice on the homepage of our website for thirty (30) days after the change is made. Please periodically revisit this page to stay current on any changes and to update your preferences accordingly. 

By using this website, you agree to the terms of the most recent version of this Privacy Policy. Please read our Terms of Use to understand the general rules about your use of this website. Except as written in any other disclaimers, policies, Terms of Use, or other notices on this website, this Privacy Policy and the Terms of Use are the complete agreement between you and United Therapeutics with respect to your use of this website. 

Introduction 

We are pleased to post this policy so that website visitors will understand how we utilize the information they provide us. For other important information concerning your use of our site, please refer to our Terms of Use. United Therapeutics respects the privacy of those who use its site. Users should understand, however, that by the very nature of the medium, their communications with us, such as postings to the site or e-mail, reveal their e-mail addresses and other potentially identifying information. The information we receive, and how we use it, depends on what you do when visiting our website. We collect and use your non-personal information (information that is not identifiable to you personally) differently than your personal information. 

United Therapeutics has self-certified to the EU-U.S. Privacy Shield Framework. Please click here to view our Privacy Shield Notice. 

What is non-personal information? 

Non-personal information is information we collect through this website that does not identify you as an individual person. It includes any of the following items: 

  • the type of web browser software you use 
  • the name of the domain from which you access the Internet (including client and server IP addresses, usernames, ports, queries, or other status-related information) 
  • the Internet address of the website from which you linked directly to our website • the date and time you access our website 
  • which pages you have visited on our website 

How does United Therapeutics use non-personal information? 

Because non-personal information cannot identify you or be tied to you in any way, there are few restrictions on the ways that we can use or share non-personal information. Primarily, we will use this data to make enhancements to the website that are specifically tailored to improve the experience of the user community. One way that we use non-personal information is to demonstrate user trends on the website. Often, this is done by aggregating the data gleaned from non-personal information. This aggregated, de-identified data might be shared with outside parties who are employed to implement improvements to the site. 

What is personal information? 

Personal information as used in privacy law and information security, is information that can be used on its own or with other information to identify, contact, or locate a single person, or to identify an individual in context. Personal information is information we collect through this website that we can use to specifically identify you, such as your: 

  • name 
  • telephone number 
  • e-mail address 
  • state of residence 
  • age or age range 
  • gender 
  • name of your physician 
  • whether you are a patient or caregiver 
  • purpose for participating in a United Therapeutics-sponsored program 

In some places on this website you have the opportunity to send us personal information about yourself. For example, you may fill out a registration form, a survey, or an e-mail form. 

How does United Therapeutics keep and use personal information? 

We may keep and use your personal information: 

  • to send you information you requested 
  • to respond to your requests 
  • to develop records, including records of your personal information 
  • for internal program monitoring 
  • to remove your personal identifiers (your name, e-mail address, etc.) In this case, you would no longer be identified as a single unique individual. Once we have de-identified information, it is non-personal information and is treated as such 
  • to protect our rights or property 
  • to protect someone's health, safety or welfare 
  • to comply with a law or regulation, court order or other legal process 

We respect the information you submit. Your information will be used only for internal program monitoring. 

We will not use, sell, or assign your e-mail address for any purpose other than to communicate with you about United Therapeutics and its products. 

Your password will be used to keep your information secure and help us build your personalized web page when you log in. 

Does United Therapeutics share personal information with third parties? 

United Therapeutics will not share your personal information collected from this website with an unrelated third party without your permission. 

In the ordinary course of business, we will share some personal information with companies that we hire to perform services or functions on our behalf. For example, we employ a company to develop and maintain this website. In this case, the company will have access to your personal information in the ordinary course of business. However, in this instance, and all instances in which your personal information is shared with a third party, we will not authorize them to keep, disclose or use your information with others except for the purpose of providing the services we asked them to provide. 

We will not sell, exchange or publish your personal information, except in conjunction with a corporate sale, merger, dissolution, or acquisition.

We may be legally compelled to release your personal information in response to a court order, subpoena, search warrant, law or regulation. We may cooperate with law enforcement authorities in investigating and prosecuting website visitors who violate our rules or engage in behavior which is harmful to other visitors or is illegal. 

We may disclose your personal information to third parties if we feel that the disclosure is necessary to: 

  • enforce this Privacy Policy and the other rules about your use of this website 
  • protect our rights or property 
  • protect someone's health, safety or welfare 
  • comply with a law or regulation, court order or other legal process 

Please note: In addition to the ways that we may keep, disclose, and use information described in this Privacy Policy, we also may keep, disclose, and use personally identifiable information that you give us through this website in ways that we believe are consistent with Federal Drug Administration (FDA) and other governmental guidance, directions, regulations, and laws. 

What about privacy on other websites? 

This website may contain links to other websites. Some of those websites may be operated by United Therapeutics, and some may be operated by third parties. We provide the links for your convenience, but we do not review, control, or monitor the activities or privacy practices of websites operated by others, and we do not endorse, condone, adopt, or accept liability for any statements made on websites to which we provide links. We are not responsible for the performance of websites operated by third parties or for your business dealings with them. Therefore, whenever you leave this website, we recommend that you review each website's privacy practices and make your own conclusions regarding the adequacy of these practices. 

Does United Therapeutics communicate directly with visitors to this website? 

With your express permission, we may contact you periodically by e-mail, mail or telephone to provide information regarding programs, services and content that may be of interest to you. In addition, some of the features on this website allow you to communicate with us using an online form. If your communication requests a response from us, we will send you a response via email. The e-mail response or confirmation may include your personal information, including personal information about your health, your name, address, etc. As indicated below, we take reasonable security precautions, however, we cannot guarantee that our e-mails to you will be secure from unauthorized interception. 

What about cookies? 

We and our affiliates may use various technologies, such as cookies, to collect and store information when you visit a United Therapeutics service, and this may include identifying your browser or device. We also use these technologies to collect and store information when you interact with services we offer to our partners, such as product updates and information that may appear on other sites. 

Are there special rules about children’s privacy? 

We care about protecting the online privacy of children. This website is not intended for use by children under the age of 18. We will not intentionally collect any personal information (such as a child's name or e-mail address) from children under the age of 18. If you are a child under age 18, please do not send us any information about yourself. If you think that we have collected personal information from a child under the age of 18, please contact us. If we become aware of information we hold from children under the age of 18, we will permanently delete it. We encourage all parents and guardians to monitor their children’s use of the Internet. 

What about website security? 

We take reasonable steps to protect your personal information from loss, misuse, and unauthorized access, disclosure, alteration, or destruction. You should keep in mind that no Internet transmission is ever 100% secure or error-free. In particular, e-mail sent to or from this site may not be secure, and you should therefore take special care in deciding what information you send to us via e-mail. 

We work hard to protect United Therapeutics and our website visitors from unauthorized access to or unauthorized alteration, disclosure or destruction of information we hold. In particular: 

  • We encrypt many of our services using SSL. 
  • We review our information collection, storage and processing practices, including physical security measures, to guard against unauthorized access to systems. 
  • We restrict access to personal information to United Therapeutics employees, contractors and agents who need to know that information in order to process it for us, and who are subject to strict contractual confidentiality obligations and may be disciplined or terminated if they fail to meet these obligations. 

How to contact United Therapeutics? 

If you have questions or comments about this Privacy Statement, please contact the United Therapeutics Privacy Office at privacyoffice@unither.com. 

For customer service inquiries, please call the Customer Service Line at 877-UNITHER (877- 864-8437) 

CORPORATE HEADQUARTERS 
1040 Spring Street 
Silver Spring, Maryland 20910 
Tel. (301) 608-9292 
Fax. (301) 608-9291 

RESEARCH TRIANGLE PARK OFFICES 
55 T.W. Alexander Drive 
P.O. Box 14186 
Research Triangle Park, North Carolina 27709 
Tel. (919) 485-8350 
Fax. (919) 485-8352
 

Indication

Unituxin is used to treat children with high-risk neuroblastoma who have had some success with prior first-line treatments. Granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA) are part of the treatment regimen with Unituxin.

Important Safety Information for Unituxin
  • Boxed WARNING
  • Serious Infusion Reactions
    • Unituxin can cause serious and potentially life-threatening infusion reactions. These include excess fluid in tissue, noisy or difficult breathing, a feeling of narrowing in the throat, rash, and low blood pressure.
    • Tell your healthcare professional right away if you notice any of the following on the day of, or the day after, the infusion: facial or lip swelling, rash, difficulty breathing, lightheadedness, or dizziness. Patients who experience severe infusion reactions should stop receiving treatment with Unituxin.
  •  
  • Neurotoxicity
    • Unituxin causes serious neurologic adverse reactions including severe neuropathic pain (nerve pain) and peripheral neuropathy (weakness, pain and/or numbness in hands, feet, legs or arms).
    • Severe neuropathic pain occurs in the majority of patients. Pain medication given prior to, during, and for 2 hours following treatment can help manage the pain.
    • Tell your healthcare professional about severe or worsening pain and signs and symptoms of neuropathy such as numbness, tingling, burning, or weakness experienced during treatment with Unituxin. Depending on the severity of pain, patients may need to stop treatment.

CONTRAINDICATIONS

Patients who are allergic to dinutuximab should not take Unituxin.

WARNINGS AND PRECAUTIONS

Serious Infusion Reactions

  • In a clinical study, 35 (26%) patients taking Unituxin experienced severe (Grade 3 or 4) infusion reactions. Serious infusion reactions included swelling of the face and upper airway, difficult or abnormal breathing, bronchospasm, rash and hives, and low blood pressure. Urgent intervention included blood pressure support, bronchodilator therapy, corticosteroids, infusion rate reduction, infusion interruption, or permanent discontinuation of Unituxin.
  • Infusion reactions generally happen during or within 24 hours after treatment with Unituxin. Tell your healthcare professional right away if you notice any signs or symptoms of serious infusion reactions, including facial or lip swelling, rash, difficulty breathing, lightheadedness, or dizziness, that occur during or within 24 hours following infusion. Your healthcare professional will decide whether treatment should be stopped temporarily or permanently.

Neurotoxicity

  • Pain:
    • Your healthcare professional will administer medication before, during, and after treatment to help manage pain. Tell your healthcare professional right away about any severe or worsening pain.
    • In a clinical study, 114 (85%) patients taking Unituxin experienced pain despite pre-treatment with pain medicine including morphine sulfate infusion. Severe (Grade 3) pain occurred in 68 (51%) patients taking Unituxin compared to 5 (5%) patients who were not taking Unituxin. Pain typically occurred during the Unituxin infusion and was most commonly reported as stomach pain, generalized pain, pain in the arms or legs, back pain, nerve pain, muscle and bone pain of the chest, and joint pain.
    • If severe pain is experienced, your healthcare professional may reduce the speed at which Unituxin is given. Unituxin may be stopped if pain is not adequately controlled through medical intervention.
  • Peripheral Neuropathy:
    • Symptoms of neuropathy (may include numbness, tingling, burning), or weakness. Report any signs or symptoms of neuropathy immediately to your healthcare provider.
    • In a clinical study, severe (Grade 3) peripheral sensory neuropathy occurred in 2 (1%) patients and severe peripheral motor neuropathy occurred in 2 (1%) patients taking Unituxin compared to zero patients who were not taking Unituxin.
    • Treatment with Unituxin may need to be permanently discontinued in patients with Grade 2 peripheral motor neuropathy, Grade 3 sensory neuropathy that interferes with daily activities for more than 2 weeks, or Grade 4 sensory neuropathy.
  • Neurological Disorders of the Eye:
    • Neurological disorders of the eye can be serious. Tell your healthcare professional immediately if you experience blurred vision, sensitivity to light, drooping of the upper eyelid, double vision, optic disc swelling, or fixed or unequal pupil size as these can be signs and symptoms of a neurological disorder of the eye. Patients who experience neurological disorders of the eye may need to have the Unituxin dose reduced or permanently stopped.
    • In clinical studies, neurological disorders of the eye experienced by 2 or more patients treated with Unituxin included blurred vision, sensitivity to light, dilated pupils, an inability to move the eyelid, fixed or unequal pupils, optic nerve disorder, drooping of the eyelid, and swelling.
  • Prolonged Urinary Retention:
    • Urinary retention (inability to completely empty the bladder) that persists for weeks to months after stopping opioids has occurred in patients treated with Unituxin. Report to your healthcare provider persistent urinary retention that does not resolve after having stopped opioid therapy. If you experience prolonged urinary retention, your healthcare professional will decide whether treatment should be stopped.
  • Transverse Myelitis:
    • Transverse myelitis has occurred in patients treated with Unituxin. Symptoms may include weakness, tingling or burning sensation, reduced sensation, or inability to control urine. Report signs or symptoms of transverse myelitis immediately to your healthcare provider. Your healthcare professional will determine if you have transverse myelitis and stop treatment as necessary.
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS):
    • RPLS is swelling in the back part of the brain. It has occurred in patients treated with Unituxin. Symptoms may include severe headache, high blood pressure, change in vision, feeling drowsy or tired, or seizures (fits). Report signs or symptoms immediately to your healthcare provider. Unituxin may be stopped in patients with signs and symptoms of RPLS.

Capillary Leak Syndrome

  • Capillary leak syndrome is a potentially life-threatening condition in which fluid and proteins leak out of tiny blood vessels and flow into surrounding tissue. This leads to dangerously low blood pressure. If severe capillary leak syndrome is experienced, the speed at which Unituxin is given may need to be interrupted, reduced, or permanently stopped.
  • Signs and symptoms of capillary leak syndrome include swelling of the arms, legs, and other parts of the body; shock; lightheadedness; weakness; fatigue; nausea; and rapid drop in blood pressure. Immediately report any signs or symptoms of capillary leak syndrome to your healthcare professional.
  • In a clinical study, severe (Grades 3 to 5) capillary leak syndrome occurred in 31 (23%) patients taking Unituxin and in no patients who were not taking Unituxin.

Low Blood Pressure

  • In a clinical study, 22 (16%) patients taking Unituxin experienced severe (Grade 3 or 4) low blood pressure. Fluids will be given by your healthcare professional prior to treatment with Unituxin. Blood pressure should be watched closely during Unituxin treatment. Tell your healthcare professional right away if you experience any changes in breathing, dizziness or lightheadedness, fainting, or dehydration (symptoms may include unusual thirst, urinating less often than usual, dark colored urine, dry skin, or tiredness). Patients who get low blood pressure may need to have the speed at which Unituxin is given reduced or permanently stopped.

Infection

  • In a clinical study, 17 (13%) patients experienced severe (Grade 3 or 4) bacteremia that required urgent intervention, and 24 (18%) patients experienced sepsis. Closely monitor for signs and symptoms of systemic infection such as fever or tiredness. Tell your healthcare professional if you notice any signs of an infection.
  • Patients who develop systemic infection will need to temporarily stop treatment with Unituxin until the infection resolves.

Bone Marrow Suppression

  • Patients taking Unituxin may have slow blood clotting. This is due to a lowering of the number of platelets in the blood. Unituxin may also cause low red blood cell count (anemia) and low white blood cell count. This may make patients more likely to develop an infection.
  • In a clinical study, severe (Grade 3 or 4) platelet deficiency (39% vs. 25%), low red blood cell count (34% vs. 16%), low white blood cell count (34% vs. 13%), and fever along with a low white blood cell count (4% vs. 0 patients) occurred more commonly in patients who were taking Unituxin than in patients who were not taking Unituxin.

Electrolyte Abnormalities

  • In a clinical study, electrolyte abnormalities occurring in at least 25% of patients who received Unituxin included low levels of sodium, low levels of potassium, and low levels of calcium in the bloodstream. Your healthcare professional will monitor these levels. Tell your healthcare professional about any seizures; a feeling that the heart is beating too hard or too fast, skipping a beat, or fluttering; or muscle cramping.

Atypical Hemolytic Uremic Syndrome

  • Patients taking Unituxin may experience kidney problems, electrolyte abnormalities, low red blood cell count, or high blood pressure. Patients who experience these side effects may need to permanently stop treatment with Unituxin. Tell your healthcare professional about any fatigue, dizziness, fainting, extreme skin paleness, swelling, less urine output than normal, or blood in the urine.

Tell your healthcare professional if you are pregnant before taking Unituxin.

  • Unituxin may cause harm to an unborn child. Women who are taking Unituxin should use effective birth control measures during treatment and for 2 months after the last dose of Unituxin.

COMMON SERIOUS ADVERSE REACTIONS

The following is a list of the most common serious adverse reactions seen in 5% or more of patients taking Unituxin:

  • Infections
  • Infusion reactions
  • Low levels of potassium in the blood
  • Low blood pressure
  • Pain
  • Fever
  • Capillary leak syndrome (a potentially life-threatening condition in which fluid and proteins leak out of tiny blood vessels and flow into surrounding tissue, leading to dangerously low blood pressure)

COMMON ADVERSE REACTIONS

The following is a list of the most common adverse reactions seen in 25% or more of patients taking Unituxin:

  • Pain
  • Fever
  • Slow blood clotting
  • Reduced ability to fight infections (low levels of white blood cells of various kinds)
  • Infusion reactions
  • Low blood pressure
  • Low levels of sodium in the blood
  • Increased levels of the enzyme alanine aminotransferase in the blood
  • Low red blood cell count
  • Vomiting
  • Diarrhea
  • Low levels of potassium in the blood
  • Capillary leak syndrome
  • Hives
  • Low levels of albumin in the blood
  • Increased levels of the enzyme aspartate aminotransferase
  • Low levels of calcium in the blood

The following side effects have also been observed in patients taking Unituxin after approval: prolonged urinary retention (inability to completely empty the bladder), transverse myelitis, and reversible posterior leukoencephalopathy (swelling in the back part of the brain).

Tell your healthcare professional about any side effect seen during treatment with Unituxin. These are not all the possible side effects of Unituxin. For more information, talk to your healthcare professional.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

UTXISIdtcMAR17

Please see Full Prescribing Information, including Boxed WARNING, for Unituxin.

UNITUXIN® (dinutuximab) INJECTION, FOR INTRAVENOUS USE
Indication

Unituxin is used to treat children with high-risk neuroblastoma who have had some success with prior first-line treatments. Granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA) are part of the treatment regimen with Unituxin.

Important Safety Information for Unituxin
  • Boxed WARNING
  • Serious Infusion Reactions
    • Unituxin can cause serious and potentially life-threatening infusion reactions. These include excess fluid in tissue, noisy or difficult breathing, a feeling of narrowing in the throat, rash, and low blood pressure.
    • Tell your healthcare professional right away if you notice any of the following on the day of, or the day after, the infusion: facial or lip swelling, rash, difficulty breathing, lightheadedness, or dizziness. Patients who experience severe infusion reactions should stop receiving treatment with Unituxin.
  •  
  • Neurotoxicity
    • Unituxin causes serious neurologic adverse reactions including severe neuropathic pain (nerve pain) and peripheral neuropathy (weakness, pain and/or numbness in hands, feet, legs or arms).
    • Severe neuropathic pain occurs in the majority of patients. Pain medication given prior to, during, and for 2 hours following treatment can help manage the pain.
    • Tell your healthcare professional about severe or worsening pain and signs and symptoms of neuropathy such as numbness, tingling, burning, or weakness experienced during treatment with Unituxin. Depending on the severity of pain, patients may need to stop treatment.

CONTRAINDICATIONS

Patients who are allergic to dinutuximab should not take Unituxin.

WARNINGS AND PRECAUTIONS

Serious Infusion Reactions

  • In a clinical study, 35 (26%) patients taking Unituxin experienced severe (Grade 3 or 4) infusion reactions. Serious infusion reactions included swelling of the face and upper airway, difficult or abnormal breathing, bronchospasm, rash and hives, and low blood pressure. Urgent intervention included blood pressure support, bronchodilator therapy, corticosteroids, infusion rate reduction, infusion interruption, or permanent discontinuation of Unituxin.
  • Infusion reactions generally happen during or within 24 hours after treatment with Unituxin. Tell your healthcare professional right away if you notice any signs or symptoms of serious infusion reactions, including facial or lip swelling, rash, difficulty breathing, lightheadedness, or dizziness, that occur during or within 24 hours following infusion. Your healthcare professional will decide whether treatment should be stopped temporarily or permanently.

Neurotoxicity

  • Pain:
    • Your healthcare professional will administer medication before, during, and after treatment to help manage pain. Tell your healthcare professional right away about any severe or worsening pain.
    • In a clinical study, 114 (85%) patients taking Unituxin experienced pain despite pre-treatment with pain medicine including morphine sulfate infusion. Severe (Grade 3) pain occurred in 68 (51%) patients taking Unituxin compared to 5 (5%) patients who were not taking Unituxin. Pain typically occurred during the Unituxin infusion and was most commonly reported as stomach pain, generalized pain, pain in the arms or legs, back pain, nerve pain, muscle and bone pain of the chest, and joint pain.
    • If severe pain is experienced, your healthcare professional may reduce the speed at which Unituxin is given. Unituxin may be stopped if pain is not adequately controlled through medical intervention.
  • Peripheral Neuropathy:
    • Symptoms of neuropathy (may include numbness, tingling, burning), or weakness. Report any signs or symptoms of neuropathy immediately to your healthcare provider.
    • In a clinical study, severe (Grade 3) peripheral sensory neuropathy occurred in 2 (1%) patients and severe peripheral motor neuropathy occurred in 2 (1%) patients taking Unituxin compared to zero patients who were not taking Unituxin.
    • Treatment with Unituxin may need to be permanently discontinued in patients with Grade 2 peripheral motor neuropathy, Grade 3 sensory neuropathy that interferes with daily activities for more than 2 weeks, or Grade 4 sensory neuropathy.
  • Neurological Disorders of the Eye:
    • Neurological disorders of the eye can be serious. Tell your healthcare professional immediately if you experience blurred vision, sensitivity to light, drooping of the upper eyelid, double vision, optic disc swelling, or fixed or unequal pupil size as these can be signs and symptoms of a neurological disorder of the eye. Patients who experience neurological disorders of the eye may need to have the Unituxin dose reduced or permanently stopped.
    • In clinical studies, neurological disorders of the eye experienced by 2 or more patients treated with Unituxin included blurred vision, sensitivity to light, dilated pupils, an inability to move the eyelid, fixed or unequal pupils, optic nerve disorder, drooping of the eyelid, and swelling.
  • Prolonged Urinary Retention:
    • Urinary retention (inability to completely empty the bladder) that persists for weeks to months after stopping opioids has occurred in patients treated with Unituxin. Report to your healthcare provider persistent urinary retention that does not resolve after having stopped opioid therapy. If you experience prolonged urinary retention, your healthcare professional will decide whether treatment should be stopped.
  • Transverse Myelitis:
    • Transverse myelitis has occurred in patients treated with Unituxin. Symptoms may include weakness, tingling or burning sensation, reduced sensation, or inability to control urine. Report signs or symptoms of transverse myelitis immediately to your healthcare provider. Your healthcare professional will determine if you have transverse myelitis and stop treatment as necessary.
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS):
    • RPLS is swelling in the back part of the brain. It has occurred in patients treated with Unituxin. Symptoms may include severe headache, high blood pressure, change in vision, feeling drowsy or tired, or seizures (fits). Report signs or symptoms immediately to your healthcare provider. Unituxin may be stopped in patients with signs and symptoms of RPLS.

Capillary Leak Syndrome

  • Capillary leak syndrome is a potentially life-threatening condition in which fluid and proteins leak out of tiny blood vessels and flow into surrounding tissue. This leads to dangerously low blood pressure. If severe capillary leak syndrome is experienced, the speed at which Unituxin is given may need to be interrupted, reduced, or permanently stopped.
  • Signs and symptoms of capillary leak syndrome include swelling of the arms, legs, and other parts of the body; shock; lightheadedness; weakness; fatigue; nausea; and rapid drop in blood pressure. Immediately report any signs or symptoms of capillary leak syndrome to your healthcare professional.
  • In a clinical study, severe (Grades 3 to 5) capillary leak syndrome occurred in 31 (23%) patients taking Unituxin and in no patients who were not taking Unituxin.

Low Blood Pressure

  • In a clinical study, 22 (16%) patients taking Unituxin experienced severe (Grade 3 or 4) low blood pressure. Fluids will be given by your healthcare professional prior to treatment with Unituxin. Blood pressure should be watched closely during Unituxin treatment. Tell your healthcare professional right away if you experience any changes in breathing, dizziness or lightheadedness, fainting, or dehydration (symptoms may include unusual thirst, urinating less often than usual, dark colored urine, dry skin, or tiredness). Patients who get low blood pressure may need to have the speed at which Unituxin is given reduced or permanently stopped.

Infection

  • In a clinical study, 17 (13%) patients experienced severe (Grade 3 or 4) bacteremia that required urgent intervention, and 24 (18%) patients experienced sepsis. Closely monitor for signs and symptoms of systemic infection such as fever or tiredness. Tell your healthcare professional if you notice any signs of an infection.
  • Patients who develop systemic infection will need to temporarily stop treatment with Unituxin until the infection resolves.

Bone Marrow Suppression

  • Patients taking Unituxin may have slow blood clotting. This is due to a lowering of the number of platelets in the blood. Unituxin may also cause low red blood cell count (anemia) and low white blood cell count. This may make patients more likely to develop an infection.
  • In a clinical study, severe (Grade 3 or 4) platelet deficiency (39% vs. 25%), low red blood cell count (34% vs. 16%), low white blood cell count (34% vs. 13%), and fever along with a low white blood cell count (4% vs. 0 patients) occurred more commonly in patients who were taking Unituxin than in patients who were not taking Unituxin.

Electrolyte Abnormalities

  • In a clinical study, electrolyte abnormalities occurring in at least 25% of patients who received Unituxin included low levels of sodium, low levels of potassium, and low levels of calcium in the bloodstream. Your healthcare professional will monitor these levels. Tell your healthcare professional about any seizures; a feeling that the heart is beating too hard or too fast, skipping a beat, or fluttering; or muscle cramping.

Atypical Hemolytic Uremic Syndrome

  • Patients taking Unituxin may experience kidney problems, electrolyte abnormalities, low red blood cell count, or high blood pressure. Patients who experience these side effects may need to permanently stop treatment with Unituxin. Tell your healthcare professional about any fatigue, dizziness, fainting, extreme skin paleness, swelling, less urine output than normal, or blood in the urine.

Tell your healthcare professional if you are pregnant before taking Unituxin.

  • Unituxin may cause harm to an unborn child. Women who are taking Unituxin should use effective birth control measures during treatment and for 2 months after the last dose of Unituxin.

COMMON SERIOUS ADVERSE REACTIONS

The following is a list of the most common serious adverse reactions seen in 5% or more of patients taking Unituxin:

  • Infections
  • Infusion reactions
  • Low levels of potassium in the blood
  • Low blood pressure
  • Pain
  • Fever
  • Capillary leak syndrome (a potentially life-threatening condition in which fluid and proteins leak out of tiny blood vessels and flow into surrounding tissue, leading to dangerously low blood pressure)

COMMON ADVERSE REACTIONS

The following is a list of the most common adverse reactions seen in 25% or more of patients taking Unituxin:

  • Pain
  • Fever
  • Slow blood clotting
  • Reduced ability to fight infections (low levels of white blood cells of various kinds)
  • Infusion reactions
  • Low blood pressure
  • Low levels of sodium in the blood
  • Increased levels of the enzyme alanine aminotransferase in the blood
  • Low red blood cell count
  • Vomiting
  • Diarrhea
  • Low levels of potassium in the blood
  • Capillary leak syndrome
  • Hives
  • Low levels of albumin in the blood
  • Increased levels of the enzyme aspartate aminotransferase
  • Low levels of calcium in the blood

The following side effects have also been observed in patients taking Unituxin after approval: prolonged urinary retention (inability to completely empty the bladder), transverse myelitis, and reversible posterior leukoencephalopathy (swelling in the back part of the brain).

Tell your healthcare professional about any side effect seen during treatment with Unituxin. These are not all the possible side effects of Unituxin. For more information, talk to your healthcare professional.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

UTXISIdtcMAR17

Please see Full Prescribing Information, including Boxed WARNING, for Unituxin.