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Please see Important Safety Information below

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.
Severe (Grade 3) peripheral sensory neuropathy ranged from 2% to 9% in patients with neuroblastoma.
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.
  • 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.
  • 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.
  • 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.
  • 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
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.

UTXISIhcpMAR17

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

References: 1. FDA approves first therapy for high-risk neuroblastoma [news release]. Silver Spring, MD: US Food and Drug Administration; March 10, 2015. http://www.fda.gov/ newsevents/ newsroom/ pressannouncements/ ucm437460.htm. Accessed February 10, 2016. 2. Unituxin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2017.

References: 1. Yu AL, Gilman AL, Ozkaynak MF, et al; the Children's Oncology Group. Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma. N Engl J Med. 2010;363(14):1324-1334. 2. Unituxin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2017.

Reference: 1. Unituxin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2017.

References: 1. Unituxin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2017. 2. Data on file. United Therapeutics Corporation. Research Triangle Park, NC 27709. March 2014.

References: 1. Data on file. United Therapeutics Corporation. Research Triangle Park, NC 27709. March 2014. 2. Unituxin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2017.

References: 1. Unituxin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2017. 2. Yu AL, Gilman AL, Ozkaynak MF, et al; the Children's Oncology Group. Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma. N Engl J Med. 2010;363(14):1324-1334.

Reference: 1. Unituxin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2017.

Reference: 1. Data on file. United Therapeutics Corporation. Research Triangle Park, NC 27709. March 2014.

References: 1. Unituxin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2017. 2. Data on file. United Therapeutics Corporation. Research Triangle Park, NC. October 2014.

References: 1. Data on file. United Therapeutics Corporation. Research Triangle Park, NC 27709. March 2014. 2. Unituxin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2017.

Reference: 1. Unituxin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2017.

References: 1. Unituxin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2017. 2. Yu AL, Gilman AL, Ozkaynak MF, et al; the Children's Oncology Group. Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma. N Engl J Med. 2010;363(14):1324-1334. 3. FDA approves first therapy for high-risk neuroblastoma [news release]. Silver Spring, MD: US Food and Drug Administration; March 10, 2015. http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm437460.htm. Accessed March 24, 2015. 4. FDA approves Unituxin™ (dinutuximab) for the treatment of pediatric high-risk neuroblastoma. Research Triangle Park, MD: United Therapeutics Corporation; March 10, 2015. http://ir.unither.com/ releasedetail.cfm? ReleaseID=900819. Accessed April 28, 2015.

Reference: 1. Unituxin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2017.

IMPORTANT: SAFETY INFORMATION. Tap to read now.

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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.
Severe (Grade 3) peripheral sensory neuropathy ranged from 2% to 9% in patients with neuroblastoma.
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.
  • 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.
  • 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.
  • 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.
  • 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
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.

UTXISIhcpMAR17

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

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