INDICATIONS
BLINCYTO® (blinatumomab) is a prescription medication used to treat a certain type of acute lymphoblastic leukemia (ALL) in patients with remaining traces of cancer after chemotherapy.
The approval of BLINCYTO® in these patients is based on a study that measured response rate and duration of response. There is an ongoing study to confirm clinical benefit.

BLINCYTO® (blinatumomab) is a prescription medication used to treat a certain type of acute lymphoblastic leukemia (ALL) in adults and children. ALL is a cancer of the blood and bone marrow in which a particular kind of white blood cell is replicating out of control.

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PLEASE SEE THE IMPORTANT SAFETY INFORMATION IN THE SECTION BELOW.

COLLAPSE

IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES
  • Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® as recommended.
  • Neurological toxicities, which may be severe, life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® as recommended.

Contraindications

BLINCYTO® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.

Warnings and Precautions

  • Cytokine Release Syndrome (CRS): CRS, which may be life-threatening or fatal, occurred in patients receiving BLINCYTO®. Infusion reactions have occurred and may be clinically indistinguishable from manifestations of CRS. Closely monitor patients for signs and symptoms of serious adverse events such as pyrexia, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), and increased total bilirubin (TBILI). In some cases, disseminated intravascular coagulation (DIC), capillary leak syndrome (CLS), and hemophagocytic histiocytosis/macrophage activation syndrome (MAS) have been reported in the setting of CRS. Interrupt or discontinue BLINCYTO® as outlined in the Prescribing Information (PI).
  • Neurological Toxicities: Approximately 65% of patients receiving BLINCYTO® in clinical trials experienced neurological toxicities. The median time to the first event was within the first 2 weeks of BLINCYTO® treatment and the majority of events resolved. The most common (≥ 10%) manifestations of neurological toxicity were headache and tremor. Severe, life-threatening, or fatal neurological toxicities occurred in approximately 13% of patients, including encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders. Monitor patients for signs or symptoms and interrupt or discontinue BLINCYTO® as outlined in the PI.
  • Infections: Approximately 25% of patients receiving BLINCYTO® in clinical trials experienced serious infections such as sepsis, pneumonia, bacteremia, opportunistic infections, and catheter-site infections, some of which were life-threatening or fatal. Administer prophylactic antibiotics and employ surveillance testing as appropriate during treatment. Monitor patients for signs or symptoms of infection and treat appropriately, including interruption or discontinuation of BLINCYTO® as needed.
  • Tumor Lysis Syndrome (TLS), which may be life-threatening or fatal, has been observed. Preventive measures, including pretreatment nontoxic cytoreduction and on-treatment hydration, should be used during BLINCYTO® treatment. Monitor patients for signs and symptoms of TLS and interrupt or discontinue BLINCYTO® as needed to manage these events.
  • Neutropenia and Febrile Neutropenia, including life-threatening cases, have been observed. Monitor appropriate laboratory parameters (including, but not limited to, white blood cell count and absolute neutrophil count) during BLINCYTO® infusion and interrupt BLINCYTO® if prolonged neutropenia occurs.
  • Effects on Ability to Drive and Use Machines: Due to the possibility of neurological events, including seizures, patients receiving BLINCYTO® are at risk for loss of consciousness, and should be advised against driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO® is being administered.
  • Elevated Liver Enzymes: Transient elevations in liver enzymes have been associated with BLINCYTO® treatment with a median time to onset of 3 days. In patients receiving BLINCYTO®, although the majority of these events were observed in the setting of CRS, some cases of elevated liver enzymes were observed outside the setting of CRS, with a median time to onset of 19 days. Grade 3 or greater elevations in liver enzymes occurred in approximately 7% of patients outside the setting of CRS and resulted in treatment discontinuation in less than 1% of patients. Monitor ALT, AST, gamma-glutamyl transferase (GGT), and TBILI prior to the start of and during BLINCYTO® treatment. BLINCYTO® treatment should be interrupted if transaminases rise to > 5 times the upper limit of normal (ULN) or if TBILI rises to > 3 times ULN.
  • Pancreatitis: Fatal pancreatitis has been reported in patients receiving BLINCYTO® in combination with dexamethasone in clinical trials and the post-marketing setting. Evaluate patients who develop signs and symptoms of pancreatitis and interrupt or discontinue BLINCYTO® and dexamethasone as needed.
  • Leukoencephalopathy: Although the clinical significance is unknown, cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO®, especially in patients previously treated with cranial irradiation and antileukemic chemotherapy.
  • Preparation and administration errors have occurred with BLINCYTO® treatment. Follow instructions for preparation (including admixing) and administration in the PI strictly to minimize medication errors (including underdose and overdose).
  • Immunization: Vaccination with live virus vaccines is not recommended for at least 2 weeks prior to the start of BLINCYTO® treatment, during treatment, and until immune recovery following last cycle of BLINCYTO®.
  • Risk of Serious Adverse Reactions in Pediatric Patients due to Benzyl Alcohol Preservative: Serious and fatal adverse reactions including “gasping syndrome,” which is characterized by central nervous system depression, metabolic acidosis, and gasping respirations, can occur in neonates and infants treated with benzyl alcohol-preserved drugs including BLINCYTO® (with preservative). When prescribing BLINCYTO® (with preservative) for pediatric patients, consider the combined daily metabolic load of benzyl alcohol from all sources including BLINCYTO® (with preservative) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Due to the addition of bacteriostatic saline, 7-day bags of BLINCYTO® solution for infusion with preservative contain benzyl alcohol and are not recommended for use in any patients weighing < 22 kg.

Adverse Reactions

  • The most common adverse reactions (≥ 20%) in clinical trial experience of patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL (TOWER Study) treated with BLINCYTO® were infections (bacterial and pathogen unspecified), pyrexia, headache, infusion-related reactions, anemia, febrile neutropenia, thrombocytopenia, and neutropenia. Serious adverse reactions were reported in 62% of patients. The most common serious adverse reactions (≥ 2%) included febrile neutropenia, pyrexia, sepsis, pneumonia, overdose, septic shock, CRS, bacterial sepsis, device related infection, and bacteremia.
  • Adverse reactions that were observed more frequently (≥ 10%) in the pediatric population compared to the adult population were pyrexia (80% vs. 61%), hypertension (26% vs. 8%), anemia (41% vs. 24%), infusion-related reaction (49% vs. 34%), thrombocytopenia (34% vs. 21%), leukopenia (24% vs. 11%), and weight increased (17% vs. 6%).
  • In pediatric patients less than 2 years old (infants), the incidence of neurologic toxicities was not significantly different than for the other age groups, but its manifestations were different; the only event terms reported were agitation, headache, insomnia, somnolence, and irritability. Infants also had an increased incidence of hypokalemia (50%) compared to other pediatric age cohorts (15-20%) or adults (17%).

Dosage and Administration Guidelines

  • BLINCYTO® is administered as a continuous intravenous infusion at a constant flow rate using an infusion pump which should be programmable, lockable, non-elastomeric, and have an alarm.
  • It is very important that the instructions for preparation (including admixing) and administration provided in the full Prescribing Information are strictly followed to minimize medication errors (including underdose and overdose).

Indication

BLINCYTO® is indicated for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for BLINCYTO®.

BLINCYTO® is a registered trademark of Amgen Inc.

Intervene earlier—

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IMPORTANT SAFETY INFORMATION

What is the most important information I should know about BLINCYTO®?

  • Call your health care provider or get emergency medical help right away if you get any of the symptoms listed below:
    • BLINCYTO® may cause serious side effects that can be severe, life-threatening, or lead to death, including:
      • Cytokine Release Syndrome (CRS) and infusion reactions. Symptoms of CRS and infusion reactions may include: fever, tiredness or weakness, dizziness, headache, low blood pressure, nausea, vomiting, chills, face swelling, wheezing or trouble breathing, and skin rash.
      • Neurologic problems. Symptoms of neurologic problems may include: seizures, difficulty in speaking or slurred speech, loss of consciousness, trouble sleeping, confusion and disorientation, loss of balance, headache and difficulty with facial movements, hearing, vision, or swallowing.
    • Your health care provider will check for these problems during treatment with BLINCYTO®. Your health care provider may temporarily or completely stop your treatment with BLINCYTO® if you have severe side effects.

Who should not receive BLINCYTO®?

  • Do not receive BLINCYTO® if you are allergic to blinatumomab or to any of the ingredients of BLINCYTO®.

What should I avoid while receiving BLINCYTO®?

  • Do not drive, operate heavy machinery, or do other dangerous activities while you are receiving BLINCYTO® because BLINCYTO® can cause neurological symptoms such as dizziness, seizures, and confusion.

Before receiving BLINCYTO®, tell your health care provider about all of your medical conditions, including if you or your child:

  • have a history of neurological problems, such as seizures, confusion, trouble speaking or loss of balance
  • have an infection
  • have ever had an infusion reaction after receiving BLINCYTO® or other medications
  • have a history of radiation treatment to the brain, or chemotherapy treatment
  • are scheduled to receive a vaccine. You should not receive a “live vaccine” within 2 weeks before you start treatment with BLINCYTO®, during treatment, and until your immune system recovers after you receive your last cycle of BLINCYTO®. If you are not sure about the type of vaccine, ask your health care provider.
  • are pregnant or plan to become pregnant. BLINCYTO® may harm your unborn baby. Tell your health care provider if you become pregnant during treatment with BLINCYTO®.
    • If you are able to become pregnant, your health care provider should do a pregnancy test before you start treatment with BLINCYTO®.
    • Females who are able to become pregnant should use an effective form of birth control during treatment with BLINCYTO®, and for at least 48 hours after the last dose of BLINCYTO®.
  • are breastfeeding or plan to breastfeed. It is not known if BLINCYTO® passes into your breast milk. You should not breastfeed during treatment with BLINCYTO® and for at least 48 hours after your last treatment.
  • Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • BLINCYTO® may cause serious side effects, including:
    • Infections. BLINCYTO® may cause life-threatening infections that may lead to death. Tell your health care provider right away in case you develop any signs or symptoms of an infection.
    • Low white blood cell counts (neutropenia). Neutropenia is common with BLINCYTO® treatment and may sometimes be life-threatening. Low white blood cell counts can increase your risk of infection. Your health care provider will do blood tests to check your white blood cell count during treatment with BLINCYTO®. Tell your health care provider right away if you get a fever.
    • Abnormal liver blood tests. Your health care provider will do blood tests to check your liver before you start BLINCYTO® and during treatment with BLINCYTO®.
    • Inflammation of the pancreas (pancreatitis). Pancreatitis may happen in people treated with BLINCYTO® and corticosteroids. It may be severe and lead to death. Tell your health care provider right away if you have severe stomach-area pain that does not go away. The pain may happen with or without nausea and vomiting.
  • Your health care provider will do blood tests during treatment to check for side effects.
  • The most common side effects of BLINCYTO® include:
    • infections
    • fever
    • headache
    • low red blood cell count (anemia)
    • low white blood cell count (neutropenia)
    • low white blood cell count with fever (febrile neutropenia)
    • low platelet count (thrombocytopenia)
    • reactions related to infusion of the medicine such as face swelling, low blood pressure, and high blood pressure (infusion-related reactions)
  • These are not all the possible side effects of BLINCYTO®.
  • Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • Please read the accompanying Medication Guide before you or your child receives BLINCYTO® and before each BLINCYTO® infusion and discuss it with your doctor.

INDICATIONS

BLINCYTO® (blinatumomab) is a prescription medication used to treat a certain type of acute lymphoblastic leukemia (ALL) in patients with remaining traces of cancer after chemotherapy.

The approval of BLINCYTO® in these patients is based on a study that measured response rate and duration of response. There is an ongoing study to confirm clinical benefit.

BLINCYTO® (blinatumomab) is a prescription medication used to treat a certain type of acute lymphoblastic leukemia (ALL) in adults and children. ALL is a cancer of the blood and bone marrow in which a particular kind of white blood cell is replicating out of control.