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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 a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.

Important Safety Information for Unituxin
  • Boxed WARNING
  • Serious Infusion Reactions
    • Serious and potentially life-threatening infusion reactions (facial and upper airway edema, dyspnea, bronchospasm, stridor, urticaria, and hypotension) occurred in 26% of patients treated with Unituxin.
    • Administer required prehydration and premedication including antihistamines prior to each Unituxin infusion.
    • Monitor patients closely for signs and symptoms of an infusion reaction during and for at least four hours following completion of each Unituxin infusion.
    • Immediately interrupt Unituxin for severe infusion reactions and permanently discontinue Unituxin for anaphylaxis.
  •  
  • Neurotoxicity
    • Unituxin causes serious neurologic adverse reactions including severe neuropathic pain and peripheral neuropathy.
    • Severe neuropathic pain occurs in the majority of patients.
    • Administer intravenous opioid prior to, during, and for 2 hours following completion of the Unituxin infusion.
    • In clinical studies of patients with high-risk neuroblastoma, severe (Grade 3) peripheral sensory neuropathy ranged from 2% to 9%.
    • In clinical studies of Unituxin and related GD2-binding antibodies, severe motor neuropathy has occurred. Resolution of motor neuropathy did not occur in all cases.
    • Discontinue Unituxin for severe unresponsive pain, severe sensory neuropathy, and moderate to severe peripheral motor neuropathy.

CONTRAINDICATIONS

Unituxin is contraindicated in patients with a history of anaphylaxis to dinutuximab.

WARNINGS AND PRECAUTIONS

Serious Infusion Reactions

  • Serious infusion reactions requiring urgent intervention including blood pressure support, bronchodilator therapy, corticosteroids, infusion rate reduction, infusion interruption, or permanent discontinuation of Unituxin included facial and upper airway edema, dyspnea, bronchospasm, stridor, urticaria, and hypotension. Infusion reactions generally occurred during or within 24 hours of completing the Unituxin infusion. Due to overlapping signs and symptoms, it was not possible to distinguish between infusion reactions and hypersensitivity reactions in some cases.
  • Severe (Grade 3 or 4) infusion reactions occurred in 35 (26%) patients in the Unituxin/13-cis-retinoic acid (RA) group compared to 1 (1%) patient receiving RA alone. Severe urticaria occurred in 17 (13%) patients in the Unituxin/RA group but did not occur in the RA group. Serious adverse reactions consistent with anaphylaxis and resulting in permanent discontinuation of Unituxin occurred in 2 (1%) patients in the Unituxin/RA group. Additionally, 1 (0.1%) patient had multiple cardiac arrests and died within 24 hours after having received Unituxin in Study 2.

Neurotoxicity

  • Pain: 114 (85%) patients treated in the Unituxin/RA group experienced pain despite pre-treatment with analgesics including morphine sulfate infusion. Severe (Grade 3) pain occurred in 68 (51%) patients in the Unituxin/RA group compared to 5 (5%) patients in the RA group. For severe pain, decrease the Unituxin infusion rate to 0.875 mg/m2/hour. Discontinue Unituxin if pain is not adequately controlled despite infusion rate reduction and institution of maximum supportive measures.
  • Peripheral Neuropathy: Severe (Grade 3) peripheral sensory neuropathy occurred in 2 (1%) patients and severe peripheral motor neuropathy occurred in 2 (1%) patients in the Unituxin/RA group. Permanently discontinue Unituxin in patients with peripheral motor neuropathy of Grade 2 or greater severity, 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 experienced by two or more patients treated with Unituxin included blurred vision, photophobia, mydriasis, fixed or unequal pupils, optic nerve disorder, eyelid ptosis, and papilledema. In Study 1, 3 (2%) patients in the Unituxin/RA group experienced blurred vision, compared to no patients in the RA group. Diplopia, mydriasis, and unequal pupillary size occurred in 1 patient each in the Unituxin/RA group, compared to no patients in the RA group. The duration of eye disorders occurring in Study 1 was not documented. In Study 3, eye disorders occurred in 16 (15%) patients, and in 3 (3%) patients resolution of the eye disorder was not documented. Among the cases with documented resolution, the median duration of eye disorders was 4 days (range: 0, 221 days).
    • Interrupt Unituxin in patients experiencing dilated pupil with sluggish light reflex or other visual disturbances that do not cause visual loss.
    • Upon resolution and if continued treatment with Unituxin is warranted, decrease the Unituxin dose by 50%.
    • Permanently discontinue Unituxin in patients who experience loss of vision and in patients with recurrent eye disorder following dose reduction.
  • Prolonged Urinary Retention: Urinary retention that persists for weeks to months following discontinuation of opioids has occurred in patients treated with Unituxin. Permanently discontinue Unituxin in patients with prolonged urinary retention that does not resolve with discontinuation of opioids.
  • Transverse Myelitis: Transverse myelitis has occurred in patients treated with Unituxin. Promptly evaluate any patient with signs or symptoms such as weakness, paresthesia, sensory loss, or incontinence. Permanently discontinue Unituxin in patients who develop transverse myelitis.
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS has occurred in patients treated with Unituxin. Institute appropriate medical treatment and permanently discontinue Unituxin in patients with signs and symptoms of RPLS (e.g., severe headache, hypertension, visual changes, lethargy, or seizures).

Capillary Leak Syndrome

  • Severe (Grade 3 to 5) capillary leak syndrome occurred in 31 (23%) patients in the Unituxin/RA group and in no patients treated with RA alone.
  • Depending on severity, manage by immediate interruption, infusion rate reduction or permanent discontinuation of Unituxin and institute supportive management in patients with symptomatic or severe capillary leak syndrome.

Hypotension

  • Severe (Grade 3 or 4) hypotension occurred in 22 (16%) patients in the Unituxin/RA group compared to no patients in the RA group.
  • Prior to each Unituxin infusion, administer required intravenous hydration.
  • Closely monitor blood pressure during Unituxin treatment.
  • Depending on severity, manage by immediate interruption, infusion rate reduction or permanent discontinuation of Unituxin and institute supportive management in patients with symptomatic hypotension.

Infection

  • Severe (Grade 3 or 4) bacteremia requiring intravenous antibiotics or other urgent intervention occurred in 17 (13%) patients in the Unituxin/RA group compared to 5 (5%) patients treated with RA alone. Sepsis occurred in 24 (18%) of patients in the Unituxin/RA group and in 10 (9%) patients in the RA group.
  • Monitor patients closely for signs and symptoms of systemic infection and temporarily discontinue Unituxin in patients who develop systemic infection until resolution of the infection.

Bone Marrow Suppression

  • Severe (Grade 3 or 4) thrombocytopenia (39% vs. 25%), anemia (34% vs. 16%), neutropenia (34% vs. 13%), and febrile neutropenia (4% vs. 0 patients) occurred more commonly in patients in the Unituxin/RA group compared to patients treated with RA alone.
  • Monitor peripheral blood counts closely during Unituxin therapy.

Electrolyte Abnormalities

  • Electrolyte abnormalities occurring in at least 25% of patients who received Unituxin/RA in Study 1 included hyponatremia, hypokalemia, and hypocalcemia. Severe (Grade 3 or 4) hypokalemia and hyponatremia occurred in 37% and 23% of patients in the Unituxin/RA group, respectively, compared to 2% and 4% of patients in the RA group.
  • Monitor serum electrolytes daily during therapy with Unituxin.

Atypical Hemolytic Uremic Syndrome

  • Hemolytic uremic syndrome in the absence of documented infection and resulting in renal insufficiency, electrolyte abnormalities, anemia, and hypertension occurred in two patients following receipt of the first cycle of Unituxin.
  • Permanently discontinue Unituxin and institute supportive management.

Embryo-Fetal Toxicity

  • Unituxin may cause fetal harm.
  • Advise pregnant women of the potential risk to a fetus.
  • Advise females of reproductive potential to use effective contraception during treatment, and for two months after the last dose of Unituxin.

ADVERSE REACTIONS

The most common serious adverse reactions (≥ 5%) are infections, infusion reactions, hypokalemia, hypotension, pain, fever, and capillary leak syndrome.

The most common adverse drug reactions (≥ 25%) in Unituxin/RA compared with RA alone are pain (85% vs. 16%), pyrexia (72% vs. 27%), thrombocytopenia (66% vs. 43%), lymphopenia (62% vs. 36%), infusion reactions (60% vs. 9%), hypotension (60% vs. 3%), hyponatremia (58% vs. 12%), increased alanine aminotransferase (56% vs. 31%), anemia (51% vs. 22%), vomiting (46% vs. 19%), diarrhea (43% vs. 15%), hypokalemia (43% vs. 4%), capillary leak syndrome (40% vs. 1%), neutropenia (39% vs. 16%), urticaria (37% vs. 3%), hypoalbuminemia (33% vs. 3%), increased aspartate aminotransferase (28% vs. 7%), and hypocalcemia (27% vs. 0%). In post-approval use of Unituxin, the adverse reactions of prolonged urinary retention, transverse myelitis, and reversible posterior leukoencephalopathy syndrome were observed. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

UTXISIhcpJAN18

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

UNITUXIN® (dinutuximab) INJECTION, FOR INTRAVENOUS USE
Indication

Unituxin is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.

Important Safety Information for Unituxin
  • Boxed WARNING
  • Serious Infusion Reactions
    • Serious and potentially life-threatening infusion reactions (facial and upper airway edema, dyspnea, bronchospasm, stridor, urticaria, and hypotension) occurred in 26% of patients treated with Unituxin.
    • Administer required prehydration and premedication including antihistamines prior to each Unituxin infusion.
    • Monitor patients closely for signs and symptoms of an infusion reaction during and for at least four hours following completion of each Unituxin infusion.
    • Immediately interrupt Unituxin for severe infusion reactions and permanently discontinue Unituxin for anaphylaxis.
  •  
  • Neurotoxicity
    • Unituxin causes serious neurologic adverse reactions including severe neuropathic pain and peripheral neuropathy.
    • Severe neuropathic pain occurs in the majority of patients.
    • Administer intravenous opioid prior to, during, and for 2 hours following completion of the Unituxin infusion.
    • In clinical studies of patients with high-risk neuroblastoma, severe (Grade 3) peripheral sensory neuropathy ranged from 2% to 9%.
    • In clinical studies of Unituxin and related GD2-binding antibodies, severe motor neuropathy has occurred. Resolution of motor neuropathy did not occur in all cases.
    • Discontinue Unituxin for severe unresponsive pain, severe sensory neuropathy, and moderate to severe peripheral motor neuropathy.

CONTRAINDICATIONS

Unituxin is contraindicated in patients with a history of anaphylaxis to dinutuximab.

WARNINGS AND PRECAUTIONS

Serious Infusion Reactions

  • Serious infusion reactions requiring urgent intervention including blood pressure support, bronchodilator therapy, corticosteroids, infusion rate reduction, infusion interruption, or permanent discontinuation of Unituxin included facial and upper airway edema, dyspnea, bronchospasm, stridor, urticaria, and hypotension. Infusion reactions generally occurred during or within 24 hours of completing the Unituxin infusion. Due to overlapping signs and symptoms, it was not possible to distinguish between infusion reactions and hypersensitivity reactions in some cases.
  • Severe (Grade 3 or 4) infusion reactions occurred in 35 (26%) patients in the Unituxin/13-cis-retinoic acid (RA) group compared to 1 (1%) patient receiving RA alone. Severe urticaria occurred in 17 (13%) patients in the Unituxin/RA group but did not occur in the RA group. Serious adverse reactions consistent with anaphylaxis and resulting in permanent discontinuation of Unituxin occurred in 2 (1%) patients in the Unituxin/RA group. Additionally, 1 (0.1%) patient had multiple cardiac arrests and died within 24 hours after having received Unituxin in Study 2.

Neurotoxicity

  • Pain: 114 (85%) patients treated in the Unituxin/RA group experienced pain despite pre-treatment with analgesics including morphine sulfate infusion. Severe (Grade 3) pain occurred in 68 (51%) patients in the Unituxin/RA group compared to 5 (5%) patients in the RA group. For severe pain, decrease the Unituxin infusion rate to 0.875 mg/m2/hour. Discontinue Unituxin if pain is not adequately controlled despite infusion rate reduction and institution of maximum supportive measures.
  • Peripheral Neuropathy: Severe (Grade 3) peripheral sensory neuropathy occurred in 2 (1%) patients and severe peripheral motor neuropathy occurred in 2 (1%) patients in the Unituxin/RA group. Permanently discontinue Unituxin in patients with peripheral motor neuropathy of Grade 2 or greater severity, 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 experienced by two or more patients treated with Unituxin included blurred vision, photophobia, mydriasis, fixed or unequal pupils, optic nerve disorder, eyelid ptosis, and papilledema. In Study 1, 3 (2%) patients in the Unituxin/RA group experienced blurred vision, compared to no patients in the RA group. Diplopia, mydriasis, and unequal pupillary size occurred in 1 patient each in the Unituxin/RA group, compared to no patients in the RA group. The duration of eye disorders occurring in Study 1 was not documented. In Study 3, eye disorders occurred in 16 (15%) patients, and in 3 (3%) patients resolution of the eye disorder was not documented. Among the cases with documented resolution, the median duration of eye disorders was 4 days (range: 0, 221 days).
    • Interrupt Unituxin in patients experiencing dilated pupil with sluggish light reflex or other visual disturbances that do not cause visual loss.
    • Upon resolution and if continued treatment with Unituxin is warranted, decrease the Unituxin dose by 50%.
    • Permanently discontinue Unituxin in patients who experience loss of vision and in patients with recurrent eye disorder following dose reduction.
  • Prolonged Urinary Retention: Urinary retention that persists for weeks to months following discontinuation of opioids has occurred in patients treated with Unituxin. Permanently discontinue Unituxin in patients with prolonged urinary retention that does not resolve with discontinuation of opioids.
  • Transverse Myelitis: Transverse myelitis has occurred in patients treated with Unituxin. Promptly evaluate any patient with signs or symptoms such as weakness, paresthesia, sensory loss, or incontinence. Permanently discontinue Unituxin in patients who develop transverse myelitis.
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS has occurred in patients treated with Unituxin. Institute appropriate medical treatment and permanently discontinue Unituxin in patients with signs and symptoms of RPLS (e.g., severe headache, hypertension, visual changes, lethargy, or seizures).

Capillary Leak Syndrome

  • Severe (Grade 3 to 5) capillary leak syndrome occurred in 31 (23%) patients in the Unituxin/RA group and in no patients treated with RA alone.
  • Depending on severity, manage by immediate interruption, infusion rate reduction or permanent discontinuation of Unituxin and institute supportive management in patients with symptomatic or severe capillary leak syndrome.

Hypotension

  • Severe (Grade 3 or 4) hypotension occurred in 22 (16%) patients in the Unituxin/RA group compared to no patients in the RA group.
  • Prior to each Unituxin infusion, administer required intravenous hydration.
  • Closely monitor blood pressure during Unituxin treatment.
  • Depending on severity, manage by immediate interruption, infusion rate reduction or permanent discontinuation of Unituxin and institute supportive management in patients with symptomatic hypotension.

Infection

  • Severe (Grade 3 or 4) bacteremia requiring intravenous antibiotics or other urgent intervention occurred in 17 (13%) patients in the Unituxin/RA group compared to 5 (5%) patients treated with RA alone. Sepsis occurred in 24 (18%) of patients in the Unituxin/RA group and in 10 (9%) patients in the RA group.
  • Monitor patients closely for signs and symptoms of systemic infection and temporarily discontinue Unituxin in patients who develop systemic infection until resolution of the infection.

Bone Marrow Suppression

  • Severe (Grade 3 or 4) thrombocytopenia (39% vs. 25%), anemia (34% vs. 16%), neutropenia (34% vs. 13%), and febrile neutropenia (4% vs. 0 patients) occurred more commonly in patients in the Unituxin/RA group compared to patients treated with RA alone.
  • Monitor peripheral blood counts closely during Unituxin therapy.

Electrolyte Abnormalities

  • Electrolyte abnormalities occurring in at least 25% of patients who received Unituxin/RA in Study 1 included hyponatremia, hypokalemia, and hypocalcemia. Severe (Grade 3 or 4) hypokalemia and hyponatremia occurred in 37% and 23% of patients in the Unituxin/RA group, respectively, compared to 2% and 4% of patients in the RA group.
  • Monitor serum electrolytes daily during therapy with Unituxin.

Atypical Hemolytic Uremic Syndrome

  • Hemolytic uremic syndrome in the absence of documented infection and resulting in renal insufficiency, electrolyte abnormalities, anemia, and hypertension occurred in two patients following receipt of the first cycle of Unituxin.
  • Permanently discontinue Unituxin and institute supportive management.

Embryo-Fetal Toxicity

  • Unituxin may cause fetal harm.
  • Advise pregnant women of the potential risk to a fetus.
  • Advise females of reproductive potential to use effective contraception during treatment, and for two months after the last dose of Unituxin.

ADVERSE REACTIONS

The most common serious adverse reactions (≥ 5%) are infections, infusion reactions, hypokalemia, hypotension, pain, fever, and capillary leak syndrome.

The most common adverse drug reactions (≥ 25%) in Unituxin/RA compared with RA alone are pain (85% vs. 16%), pyrexia (72% vs. 27%), thrombocytopenia (66% vs. 43%), lymphopenia (62% vs. 36%), infusion reactions (60% vs. 9%), hypotension (60% vs. 3%), hyponatremia (58% vs. 12%), increased alanine aminotransferase (56% vs. 31%), anemia (51% vs. 22%), vomiting (46% vs. 19%), diarrhea (43% vs. 15%), hypokalemia (43% vs. 4%), capillary leak syndrome (40% vs. 1%), neutropenia (39% vs. 16%), urticaria (37% vs. 3%), hypoalbuminemia (33% vs. 3%), increased aspartate aminotransferase (28% vs. 7%), and hypocalcemia (27% vs. 0%). In post-approval use of Unituxin, the adverse reactions of prolonged urinary retention, transverse myelitis, and reversible posterior leukoencephalopathy syndrome were observed. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

UTXISIhcpJAN18

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

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