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INDICATIONS FOR BLINCYTO®

BLINCYTO® (blinatumomab) is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult
and pediatric patients one month and older with:

Indication
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By clicking “I agree/submit” below, the entity named above agrees as follows: In order to provide healthcare professionals with information about local injection sites that are able to administer Amgen therapies, Amgen has created this informational database. Through this informational resource, users will receive a list of treatment sites and their contact information, based on geographical parameters that they identified. Enrollment in the Amgen Therapy Locator is open to all providers that meet the treatment site terms and conditions of participation described below Terms and conditions: In order to participate in the treatment site locator of Amgen Therapy Locator™, sites must be willing to accept faxed medical orders and insurance coverage information, accept a call from a patient making the injection appointment, purchase and administer ARANESP®, BLINCYTO®,IMDELLTRA®, Nplate®, and/or XGEVA®, and bill the appropriate insurance company through the patient’s insurance plans. Entities that enroll in the Amgen Therapy Locator™ treatment site locator must not be listed on any federal exclusion or debarment lists (such as OIG’s List of Excluded Individuals/and Entities on the Excluded Parties List). Choices are based on proximity to the patient/provider requesting assistance and/or criteria provided by the requesting provider/patient. Participation Authorization The entity named above understands the terms and conditions above for listing the treatment site in the Amgen Therapy Locator™, and that those terms and conditions are subject to change without notice. The entity named above certifies that it has the appropriate licensure to carry out these services as required by applicable state laws. By providing the requested information, the entity named above represents and warrants that it is authorized to disclose such information to a third part such as Amgen. The entity named also represents and warrants that the information submitted in the registration form is accurate and up to date. Listing a treatment site in the Amgen Therapy Locator™ is not a guarantee that any particular healthcare professional or patient will choose the treatment site. It is understood that listing a treatment site in the Amgen Therapy Locator™ is not a guarantee of business and that Amgen is providing referrals. In the event a treatment site is chosen through the Amgen Therapy Locator™, it is the duty of each provider, patient, and treatment site to understand payer-specific policies. Prior Authorization may be required. Amgen assumes no liability for payment or care. The entity named above agrees to be listed in the Amgen Therapy Locator™ and to receive communication related to Amgen Therapy Locator™ and similar Amgen services. Both Amgen and the entity named above reserve the right to end this agreement with 30 days advance notice to ensure patient treatment is not disrupted. If there is “cause,” then agreement may be terminated immediately. By submitting this form, I verify that I am an employee or agent of the site listed above and I am authorized to add, edit, or delete this account profile.
Update an existingsite

Use the form below to add an treatment site. Fields marked * are required.

Business Information*

Required*

Contact Information*

Please complete the fields below and a representative may contact you within 2 business days to verify the provided business information. Using a professional email address may help expedite the process.
By clicking “I agree/submit” below, the entity named above agrees as follows: In order to provide healthcare professionals with information about local injection sites that are able to administer Amgen therapies, Amgen has created this informational database. Through this informational resource, users will receive a list of treatment sites and their contact information, based on geographical parameters that they identified. Enrollment in the Amgen Therapy Locator is open to all providers that meet the treatment site terms and conditions of participation described below Terms and conditions: In order to participate in the treatment site locator of Amgen Therapy Locator™, sites must be willing to accept faxed medical orders and insurance coverage information, accept a call from a patient making the injection appointment, purchase and administer BLINCYTO®,IMDELLTRA®, Nplate®, and/or XGEVA®, and bill the appropriate insurance company through the patient’s insurance plans. Entities that enroll in the Amgen Therapy Locator™ treatment site locator must not be listed on any federal exclusion or debarment lists (such as OIG’s List of Excluded Individuals/and Entities on the Excluded Parties List). Choices are based on proximity to the patient/provider requesting assistance and/or criteria provided by the requesting provider/patient. Participation Authorization The entity named above understands the terms and conditions above for listing the treatment site in the Amgen Therapy Locator™, and that those terms and conditions are subject to change without notice. The entity named above certifies that it has the appropriate licensure to carry out these services as required by applicable state laws. By providing the requested information, the entity named above represents and warrants that it is authorized to disclose such information to a third part such as Amgen. The entity named also represents and warrants that the information submitted in the registration form is accurate and up to date. Listing a treatment site in the Amgen Therapy Locator™ is not a guarantee that any particular healthcare professional or patient will choose the treatment site. It is understood that listing a treatment site in the Amgen Therapy Locator™ is not a guarantee of business and that Amgen is providing referrals. In the event a treatment site is chosen through the Amgen Therapy Locator™, it is the duty of each provider, patient, and treatment site to understand payer-specific policies. Prior Authorization may be required. Amgen assumes no liability for payment or care. The entity named above agrees to be listed in the Amgen Therapy Locator™ and to receive communication related to Amgen Therapy Locator™ and similar Amgen services. Both Amgen and the entity named above reserve the right to end this agreement with 30 days advance notice to ensure patient treatment is not disrupted. If there is “cause,” then agreement may be terminated immediately. By submitting this form, I verify that I am an employee or agent of the site listed above and I am authorized to add, edit, or delete this account profile.
Remove an infusion site

Use the form below to remove an Treatment site. Fields marked * are required.

Business Information*

Required*
Stand-Alone Infusion Center Clinic/Hospital Outpatient Home Infusion Pharmacy

Contact Information*

Please complete the fields below and a representative may contact you within 2 business days to verify the provided business information. Using a professional email address may help expedite the process.
By clicking “I agree/submit” below, the entity named above agrees as follows: In order to provide healthcare professionals with information about local injection sites that are able to administer Amgen therapies, Amgen has created this informational database. Through this informational resource, users will receive a list of treatment sites and their contact information, based on geographical parameters that they identified. Enrollment in the Amgen Therapy Locator is open to all providers that meet the treatment site terms and conditions of participation described below Terms and conditions: In order to participate in the treatment site locator of Amgen Therapy Locator™, sites must be willing to accept faxed medical orders and insurance coverage information, accept a call from a patient making the injection appointment, purchase and administer BLINCYTO®,IMDELLTRA®, Nplate®, and/or XGEVA®, and bill the appropriate insurance company through the patient’s insurance plans. Entities that enroll in the Amgen Therapy Locator™ treatment site locator must not be listed on any federal exclusion or debarment lists (such as OIG’s List of Excluded Individuals/and Entities on the Excluded Parties List). Choices are based on proximity to the patient/provider requesting assistance and/or criteria provided by the requesting provider/patient. Participation Authorization The entity named above understands the terms and conditions above for listing the treatment site in the Amgen Therapy Locator™, and that those terms and conditions are subject to change without notice. The entity named above certifies that it has the appropriate licensure to carry out these services as required by applicable state laws. By providing the requested information, the entity named above represents and warrants that it is authorized to disclose such information to a third part such as Amgen. The entity named also represents and warrants that the information submitted in the registration form is accurate and up to date. Listing a treatment site in the Amgen Therapy Locator™ is not a guarantee that any particular healthcare professional or patient will choose the treatment site. It is understood that listing a treatment site in the Amgen Therapy Locator™ is not a guarantee of business and that Amgen is providing referrals. In the event a treatment site is chosen through the Amgen Therapy Locator™, it is the duty of each provider, patient, and treatment site to understand payer-specific policies. Prior Authorization may be required. Amgen assumes no liability for payment or care. The entity named above agrees to be listed in the Amgen Therapy Locator™ and to receive communication related to Amgen Therapy Locator™ and similar Amgen services. Both Amgen and the entity named above reserve the right to end this agreement with 30 days advance notice to ensure patient treatment is not disrupted. If there is “cause,” then agreement may be terminated immediately. By submitting this form, I verify that I am an employee or agent of the site listed above and I am authorized to add, edit, or delete this account profile.

Please see full Prescribing Information for Amgen® products.

* The information on this website is reported by independent third-party sites that administer or deliver treatment to patients. It is not comprehensive of all sites that handle the therapies listed, and Amgen does not confirm accuracy or otherwise endorse any of these sites.

Note: Coding and coverage policies change periodically and often without warning. The healthcare provider is solely responsible for determining coverage and reimbursement parameters and appropriate coding for his/her own patients and procedures. This information is not a guarantee of coverage or reimbursement.

IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

  • Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® and treat with corticosteroids as recommended.
  • Neurological toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS) 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®. The median time to onset of CRS is 2 days after the start of infusion and the median time to resolution of CRS was 5 days among cases that resolved. Closely monitor and advise patients to contact their healthcare professional for signs and symptoms of serious adverse events such as fever, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased total bilirubin, and disseminated intravascular coagulation (DIC). The manifestations of CRS after treatment with BLINCYTO® overlap with those of infusion reactions, capillary leak syndrome (CLS), and hemophagocytic histiocytosis/macrophage activation syndrome (MAS). Using all of these terms to define CRS in clinical trials of BLINCYTO, CRS was reported in 15% of patients with R/R ALL, in 7% of patients with MRD-positive ALL, and in 16% of patients receiving BLINCYTO® cycles in the consolidation phase of therapy. If severe CRS occurs, interrupt BLINCYTO® until CRS resolves. Discontinue BLINCYTO® permanently if life-threatening CRS occurs. Administer corticosteroids for severe or life-threatening CRS.
  • Neurological Toxicities, including Immune Effector Cell-Associated Neurotoxicity Syndrome: BLINCYTO® can cause serious or life-threatening neurologic toxicity, including ICANS. The incidence of neurologic toxicities in clinical trials was approximately 65%. The median time to the first event was within the first 2 weeks of BLINCYTO®treatment. The most common (≥10%) manifestations of neurological toxicity were headache and tremor. Grade 3 or higher neurological toxicities occurred in approximately 13% of patients, including encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders. Manifestations of neurological toxicity included cranial nerve disorders. The majority of neurologic toxicities resolved following interruption of BLINCYTO®, but some resulted in treatment discontinuation.

    The incidence of signs and symptoms consistent with ICANS in clinical trials was 7.5%. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. There is limited experience with BLINCYTO® in patients with active ALL in the central nervous system (CNS) or a history of neurologic events. Patients with a history or presence of clinically relevant CNS pathology were excluded from clinical studies. Patients with Down Syndrome over the age of 10 years may have a higher risk of seizures with BLINCYTO® therapy.

    Monitor patients for signs and symptoms of neurological toxicities, including ICANS, and interrupt or discontinue BLINCYTO® as outlined in the PI. Advise outpatients to contact their healthcare professional if they develop signs or symptoms of neurological toxicities.

  • 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 and ICANS, 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, and total blood bilirubin 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 total bilirubin 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®.
  • Benzyl Alcohol Toxicity in Neonates: Serious adverse reactions, including fatal reactions and the “gasping syndrome,” have been reported in very low birth weight (VLBW) neonates born weighing less than 1500 g, and early preterm neonates (infants born less than 34 weeks gestational age) who received intravenous drugs containing benzyl alcohol as a preservative. Early preterm VLBW neonates may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol.

    Use the preservative-free preparations of BLINCYTO® where possible in neonates. When prescribing BLINCYTO® (with preservative) for neonatal patients, consider the combined daily metabolic load of benzyl alcohol from all sources including BLINCYTO® (with preservative), other products containing benzyl alcohol or other excipients (e.g., ethanol, propylene glycol) which compete with benzyl alcohol for the same metabolic pathway.

    Monitor neonatal patients receiving BLINCYTO® (with preservative) for new or worsening metabolic acidosis. The minimum amount of benzyl alcohol at which serious adverse reactions may occur inneonates is not known. The BLINCYTO® 7-Day bag (with preservative) contains 7.4 mg of benzyl alcohol per mL

  • Embryo-Fetal Toxicity: Based on its mechanism of action, BLINCYTO® may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with BLINCYTO® and for 48 hours after the last dose.

Adverse Reactions

  • The safety of BLINCYTO® in adult and pediatric patients one month and older with MRD-positive B-cell precursor ALL (n=137), relapsed or refractory B-cell precursor ALL (n=267), and Philadelphia chromosome-negative B cell precursor ALL in consolidation (n=165) was evaluated in clinical studies. The most common adverse reactions (≥ 20%) to BLINCYTO® in this pooled population were pyrexia, infusion-related reactions, headache, infection, musculoskeletal pain, neutropenia, nausea, anemia, thrombocytopenia, and diarrhea.

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).

INDICATIONS FOR BLINCYTO®

BLINCYTO® (blinatumomab) is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older with:

  • Philadelphia chromosome-negative disease in the consolidation phase of multiphase chemotherapy
  • Minimal residual disease (MRD) greater than or equal to 0.1% in first or second complete remission
  • Relapsed or refractory disease

Please see BLINCYTO® full Prescribing Information, including BOXED WARNINGS.