Blincyto

Name: Blincyto

US Brand Name

  1. Blincyto

Blincyto Food Interactions

Medicines can interact with certain foods. In some cases this may be harmful and your doctor may advise you to avoid certain foods. In the case of Blincyto, there are no specific foods that you must exclude from your diet when receiving this medication.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of blinatumomab injection in the elderly. However, elderly patients are more likely to have unwanted effects (eg, confusion, encephalopathy, infections) in patients which may require caution in patients receiving blinatumomab injection.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Introduction

Antineoplastic agent; a CD3 T-cell-engaging anti-CD19 monoclonal antibody.1 11 12 13 15

Cautions for Blincyto

Contraindications

  • Known hypersensitivity to blinatumomab or any ingredient in the formulation.1

Warnings/Precautions

Warnings

Cytokine Release Syndrome

Cytokine release syndrome, sometimes life-threatening or fatal, reported;1 2 peak cytokine release observed within 2 days following initiation of blinatumomab.9

Serious adverse effects associated with cytokine release syndrome include pyrexia, headache, nausea, asthenia, hypotension, and elevated ALT, AST, and bilirubin concentrations; most patients in clinical studies did not require discontinuance of therapy.1 Disseminated intravascular coagulation, capillary leak syndrome, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome also reported.1 Infusion-related reactions may be clinically indistinguishable from manifestations of cytokine release syndrome.1

Closely monitor patients for signs and symptoms of cytokine release syndrome.1 (See Advice to Patients.) Interruption or discontinuance of therapy may be necessary.1 (See Cytokine Release Syndrome under Dosage and Administration.)

Neurologic Toxicity

Neurologic toxicities occur commonly;1 2 median time to onset is 7 days.1 Severe, life-threatening, or fatal toxicity (e.g., encephalopathy, seizures, speech impairment, disturbances in consciousness, confusion and disorientation, coordination and balance disorders) can occur.1 Patients should not drive a motor vehicle or engage in hazardous occupations or activities (e.g., operating hazardous machinery) while receiving the drug.1

Neurologic toxicity generally resolves following treatment interruption; however, discontinuance of therapy may be necessary.1 In the principal efficacy study, grade 1 or 2 neurologic toxicities were managed with dexamethasone without treatment interruption.2

Monitor patients for manifestations of neurologic toxicities.1 (See Advice to Patients.) Interruption or discontinuance of therapy may be necessary.1 (See Neurologic Toxicity under Dosage and Administration.)

Other Warnings and Precautions

Infectious Complications

Serious infections (e.g., sepsis, pneumonia, bacteremia, opportunistic infections, catheter-site infections), sometimes life-threatening or fatal, reported.1

Initiate prophylactic anti-infective therapy as appropriate and employ surveillance testing during blinatumomab therapy.1 Monitor patients for signs and symptoms of infection; initiate appropriate anti-infective treatment as clinically indicated.1

Tumor Lysis Syndrome

Tumor lysis syndrome, sometimes life-threatening or fatal, reported.1

Monitor patients for signs and symptoms of tumor lysis syndrome; interruption or discontinuance of blinatumomab therapy may be necessary.1 Initiate appropriate prophylactic measures (e.g., pretreatment nontoxic cytoreduction, adequate hydration during therapy).1

Neutropenia and Febrile Neutropenia

Neutropenia and febrile neutropenia, sometimes life-threatening, reported.1

Monitor CBC, including differential.1 If prolonged neutropenia occurs, interrupt therapy.1

Hepatic Effects

Transient increases in hepatic enzyme concentrations reported; median time to onset is 15 days.1 Mostly occurs in association with cytokine release syndrome.1

Evaluate serum ALT, AST, γ-glutamyltransferase (γ-glutamyltranspeptidase, GGT, GGTP), and total bilirubin concentrations prior to and during blinatumomab therapy.1 If ALT and/or AST concentrations >5 times the ULN or total bilirubin concentrations >3 times the ULN occur, interrupt blinatumomab therapy.1

Leukoencephalopathy

Cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy reported, particularly in those who previously received cranial irradiation and antileukemic chemotherapy (including systemic high-dose methotrexate or intrathecal cytarabine).1 The clinical importance of these changes is not known.1

Preparation and Administration Errors

Medication errors resulting in underdosage or overdosage of blinatumomab have occurred.1 Exercise extra care to ensure proper preparation and administration of the drug.1 (See Preparation and Administration Precautions under Dosage and Administration.)

Immunogenicity

Antibodies to blinatumomab, including neutralizing antibodies to the drug, reported.1 Pharmacokinetics may be affected.1 No clinically important effects on safety observed to date.1

Specific Populations

Pregnancy

Category C.1

May cause fetal harm, including B-cell lymphocytopenia.1 Embryofetal toxicity and teratogenicity not observed in animal studies; however, the surrogate molecule crossed the placenta.1 B-cell and T-cell depletion occurred in pregnant mice; however, hematologic effects were not assessed in fetuses.1

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.1

Lactation

Not known whether blinatumomab is distributed into milk.1 Discontinue nursing or the drug.1

Pediatric Use

Limited experience in pediatric patients.1

Dose-limiting toxicity was cytokine release syndrome in pediatric patients (2–17 years of age) with relapsed or refractory pre-B-ALL;1 6 7 10 incidence decreased with stepwise dosing of blinatumomab (5 mcg/m2 daily initially for 7 days, then 15 mcg/m2 daily).6 Fatal respiratory failure and grade 4 cytokine release syndrome resulting in fatal cardiac failure and life-threatening GI hemorrhage reported following administration of blinatumomab 15–30 mcg/m2 daily.1 6 7

Pharmacokinetic parameters similar to those reported in adults with relapsed or refractory pre-B-ALL who received equivalent dosages based on body surface area.1 6 (See Special Populations under Pharmacokinetics.)

Dosage of 5 mcg/m2 daily on days 1–7 followed by 15 mcg/m2 daily on days 8–28 of cycle 1, then 15 mcg/m2 daily on days 1–28 of subsequent cycles, recommended for phase 2 studies.1 7

Geriatric Use

In clinical studies in patients with relapsed or refractory ALL, approximately 13% of patients were ≥65 years of age.1 Efficacy and safety of the drug was generally similar regardless of patient age, except for increased incidence of neurologic toxicities (e.g., cognitive disorder, encephalopathy, confusion) and serious infections in patients ≥65 years of age.1

Hepatic Impairment

Pharmacokinetics not studied in patients with hepatic impairment.1

Renal Impairment

Formal pharmacokinetic studies not conducted in patients with renal impairment.1 Clearance affected by moderate renal impairment; however, high interpatient variability was apparent.1 (See Special Populations under Pharmacokinetics.)

Not studied in patients with severe renal impairment (Clcr <30 mL/minute) or in those receiving hemodialysis.1

Common Adverse Effects

Pyrexia,1 2 infection,1 headache,1 2 peripheral edema,1 2 febrile neutropenia,1 2 nausea,1 2 hypokalemia,1 2 rash,1 constipation,1 2 diarrhea,1 tremor.1

Before Using Blincyto

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of blinatumomab injection in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of blinatumomab injection in the elderly. However, elderly patients are more likely to have unwanted effects (eg, confusion, encephalopathy, infections) in patients which may require caution in patients receiving blinatumomab injection.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfentanil
  • Aminophylline
  • Artemether
  • Astemizole
  • Carbamazepine
  • Cisapride
  • Cyclosporine
  • Dihydroergotamine
  • Ergotamine
  • Fentanyl
  • Fosphenytoin
  • Iloperidone
  • Lumefantrine
  • Paclitaxel
  • Phenytoin
  • Pimozide
  • Quinidine
  • Sirolimus
  • Tacrolimus
  • Terfenadine
  • Theophylline
  • Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Encephalopathy or
  • Liver disease or
  • Neutropenia (low number of white blood cells) or
  • Pancreatitis (inflammation of the pancreas) or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Infections—May decrease your body's ability to fight infections.

Precautions While Using Blincyto

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control during treatment and for at least 48 hours after your treatment ends to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause cytokine release syndrome (CRS) and infusion reactions. This may be life-threatening and requires immediate attention. Tell your doctor right away if you or your child have any of the following symptoms: a fever, chills, headache, nausea, lightheadedness, dizziness, fainting, skin rash, trouble breathing, or tiredness or weakness.

Check with your doctor right away if you or your child have seizures, loss of balance, loss of consciousness, confusion, disorientation, difficulty with speaking, or slurred speech.

This medicine can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you or your child are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may cause a serious reaction, called tumor lysis syndrome (TLS). Your doctor may give you a medicine to help prevent this. Call your doctor right away if you or your child have a change in how much or how often you urinate, muscle or joint pain, rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

This medicine may make youdizzy, confused, or less alert than youare normally. Do not drive or do anything else that could be dangerous until you or your child know how this medicine affects you.

While you are being treated with blinatumomab, do not have any immunizations (vaccinations) without your doctor's approval. Live virus vaccinations should not be given for at least 2 weeks before start of treatment, during treatment, and until recovery following the last cycle of this medicine.

Some preparations of this medicine may contain benzyl alcohol which may cause serious reactions (including gasping syndrome) to newborn or premature infants.

Blincyto Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
  • Agitation
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • chest pain
  • confusion
  • cough or hoarseness
  • dizziness
  • fever or chills
  • headache
  • irritability
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • rapid, shallow breathing
  • seeing, hearing, or feeling things that are not there
  • seizures
  • sore throat
  • stiff neck
  • tightness in the chest
  • tingling of the hands or feet
  • troubled breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting
Incidence not known
  • Cloudy urine
  • darkened urine
  • discouragement
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • extremely high fever or body temperature
  • eye pain
  • feeling sad or empty
  • general feeling of illness
  • irritability
  • lack or loss of strength
  • loss of interest or pleasure
  • mood or mental changes
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • persistent bleeding or oozing from puncture sites, mouth, or nose
  • pounding in the ears
  • problems with speech or speaking
  • rash
  • slow or fast heartbeat
  • stomach pain
  • sweating
  • swelling of the hands, ankles, feet, or lower legs
  • trouble sleeping
  • ulcers, sores, or white spots in the mouth
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Bone, joint, or muscle pain
  • change in urination
  • decreased appetite
  • diarrhea
  • difficulty having a bowel movement
  • dry mouth
  • increased hunger or thirst
  • irregular heartbeat
  • muscle pain or cramps
  • pain in the arms or legs
  • shakiness in the legs, arms, hands, or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Overdosage

Overdoses have been observed, including one adult patient who received 133-fold the recommended therapeutic dose of Blincyto delivered over a short duration.

In the dose evaluation phase of the Phase 1/2 study in pediatric and adolescent patients with relapsed or refractory B-cell precursor ALL, one patient experienced a fatal cardiac failure event in the setting of life-threatening cytokine release syndrome (CRS) at a 30 mcg/m2/day (higher than the maximum tolerated/recommended) dose [see Warnings and Precautions (5.1) and Adverse Reactions (6)]. 

Overdoses resulted in adverse reactions, which were consistent with the reactions observed at the recommended therapeutic dose and included fever, tremors, and headache. In the event of overdose, interrupt the infusion, monitor the patient for signs of toxicity, and provide supportive care [see Warnings and Precautions (5.10)]. Consider re-initiation of Blincyto at the correct therapeutic dose when all toxicities have resolved and no earlier than 12 hours after interruption of the infusion [see Dosage and Administration (2.1)].

Patient counseling information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Cytokine Release Syndrome (CRS)
Advise patients of the risk of CRS and infusion reactions, and to contact their healthcare professional for signs and symptoms associated with CRS or infusion reactions (pyrexia, fatigue, nausea, vomiting, chills, hypotension, rash, and wheezing) [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

Neurological Toxicities
Advise patients of the risk of neurological toxicities, and to contact their healthcare professional for signs and symptoms associated with this event (convulsions, speech disorders, and confusion) [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].

Infections
Advise patients of the risk of infections, and to contact their healthcare professional for signs or symptoms of infection [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)].

Inform patients of the importance of keeping the skin clean around the intravenous catheter to reduce the risk of infection.

Pancreatitis
Advise patients of the risk of pancreatitis and to contact their healthcare provider for signs or symptoms of pancreatitis which include severe and persistent stomach pain, with or without nausea and vomiting [see Warnings and Precautions (5.8) and Adverse Reactions (6.2)].

Driving and Engaging in Hazardous Occupations
Advise patients to refrain from driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while Blincyto is being administered.  Patients should be advised that they may experience neurological events [see Warnings and Precautions (5.6)]. 

Infusion Pump Errors
Inform patients they should not adjust the setting on the infusion pump. Any changes to pump function may result in dosing errors. If there is a problem with the infusion pump or the pump alarms, patients should contact their doctor or nurse immediately.

Blincyto® (blinatumomab)

Manufactured by:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
U.S. License No. 1080

Patent: http://pat.amgen.com/Blincyto/

© 2014-2017 Amgen Inc. All rights reserved.

v5            

Medication Guide
Blincyto® (blin sye' toe)
(blinatumomab)
for injection
What is the most important information I should know about Blincyto?
Call your healthcare 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 ° vomiting
° tiredness or weakness ° chills
° dizziness ° face swelling
° headache ° wheezing or trouble breathing
° low blood pressure ° skin rash
° nausea
  • Neurologic problems. Symptoms of neurologic problems may include:
° seizures ° confusion and disorientation
° difficulty in speaking or slurred speech ° loss of balance
° loss of consciousness ° headache
° trouble sleeping
Your healthcare provider will check for these problems during treatment with Blincyto. Your healthcare provider may temporarily stop or completely stop your treatment with Blincyto, if you have severe side effects.
See “What are the possible side effects of Blincyto?” below for other side effects of Blincyto.
What is Blincyto?
Blincyto is a prescription medicine used to treat a certain type of acute lymphoblastic leukemia (ALL) in adults and children. ALL is a cancer of the blood in which a particular kind of white blood cell is growing out of control.
Who should not receive Blincyto?
Do not receive Blincyto if you are allergic to blinatumomab or to any of the ingredients of Blincyto. See the end of this Medication Guide for a complete list of ingredients in Blincyto.
Before receiving Blincyto, tell your healthcare 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 healthcare provider.
  • are pregnant or plan to become pregnant. Blincyto may harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with Blincyto.
    ° If you are able to become pregnant, your healthcare 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 healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive Blincyto?
  • Blincyto will be given to you by intravenous (IV) infusion into your vein by an infusion pump.
  • Your healthcare provider will decide the number of treatment cycles of Blincyto.
    ○ You will receive Blincyto by continuous IV infusion for 4 weeks (28 days), followed by a 2 week (14 days) break during which you will not receive Blincyto. This is 1 treatment cycle (42 days). You may receive up to 5 treatment cycles.
  • Your healthcare provider may prescribe continued therapy.
    ○ You will receive Blincyto by continuous IV infusion for 4 weeks (28 days), followed by an 8 week (56 days) break during which you will not receive Blincyto. You may receive up to 4 treatment cycles of continued therapy.
  • Your healthcare provider may give you Blincyto in a hospital or clinic for the first 9 days of the first treatment cycle and for the first 2 days of the second cycle to check you for side effects. If you receive additional treatment cycles of Blincyto or if your treatment is stopped for a period of time and restarted, you may also be treated in a hospital or clinic.
  • Your healthcare provider may change your dose of Blincyto, delay, or completely stop treatment with Blincyto if you have certain side effects.
  • Your healthcare provider will do blood tests during treatment with Blincyto to check you for side effects.
  • Before you receive Blincyto, you will be given a corticosteroid medicine to help reduce infusion reactions.
  • It is very important to keep the area around the IV catheter clean to reduce the risk of getting an infection. Your healthcare provider will show you how to care for your catheter site.
  • Do not change the settings on your infusion pump, even if there is a problem with your pump or your pump alarm sounds. Any changes to your infusion pump settings may cause a dose that is too high or too low to be given.  
Call your healthcare provider or nurse right away if you have any problems with your pump or your pump alarm sounds.
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.
What are the possible side effects of Blincyto?
Blincyto may cause serious side effects, including:
See “What is the most important information I should know about Blincyto?”
  • Infections. Blincyto may cause life-threatening infections that may lead to death. Tell your healthcare provider right away if 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 healthcare provider will do blood tests to check your white blood cell count during treatment with Blincyto. Tell your healthcare provider right away if you get a fever.
  • Abnormal liver blood tests. Your healthcare 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 healthcare 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.
The most common side effects of Blincyto include:
• infections • low platelet count (thrombocytopenia)
• fever •  reactions related to infusion of the medicine such as face swelling, low blood pressure, and high blood pressure (infusion-related reactions)
• headache
• low red blood cell count (anemia)
These are not all the possible side effects of Blincyto.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Blincyto?
Intravenous (IV) bags containing Blincyto for infusion will arrive in a special package.
  • Do not open the package.
  • Do not freeze the package.
  • The package containing Blincyto will be opened by your healthcare provider and stored in the refrigerator at 36°F to 46°F (2°C to 8°C) for up to 8 days.
  • Do not throw away (dispose of) any Blincyto in your household trash. Talk with your healthcare provider about disposal of Blincyto and used supplies.
  • Keep Blincyto and all medicines out of reach of children.
General information about safe and effective use of Blincyto
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Blincyto for a condition for which it was not prescribed. Do not give Blincyto to other people even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Blincyto that is written for health professionals.
What are the ingredients in Blincyto?
Active ingredient: blinatumomab
Inactive ingredients: citric acid monohydrate, lysine hydrochloride, polysorbate 80, trehalose dihydrate, sodium hydroxide and preservative-free sterile water for injection.
Manufactured by: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320-1799
U.S. License No. 1080 © 2014-2017 Amgen Inc. All rights reserved. v4
For more information, go to www.Blincyto.com or call Amgen at 1-800-772-6436.

This Medication Guide has been approved by the U.S. Food and Drug Administration.                         Revised: 07/2017

PRINCIPAL DISPLAY PANEL
1 Blincyto® Single-Dose Vial
1 IV Solution Stabilizer Vial
NDC 55513-160-01
AMGEN®
Blincyto®
(blinatumomab)
for Injection
35 mcg/vial
35 mcg/vial
For Intravenous Infusion Only
Store at 2°C to 8°C (36°F to 46°F).
Store in carton to protect from light.
DO NOT SHAKE reconstituted solution.
Dispense the enclosed Medication Guide to each patient.
No Preservative
Single-Dose Vial –
Discard unused portion.
Rx Only

 

Blincyto 
blinatumomab kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55513-160
Packaging
# Item Code Package Description
1 NDC:55513-160-01 1 KIT in 1 PACKAGE
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL 3.088 mL
Part 2 1 VIAL 10.6 mL
Part 1 of 2
Blincyto 
blinatumomab injection, powder, lyophilized, for solution
Product Information
Item Code (Source) NDC:55513-150
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLINATUMOMAB (BLINATUMOMAB) BLINATUMOMAB 12.5 ug  in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE 1.19 mg  in 1 mL
LYSINE HYDROCHLORIDE 8.27 mg  in 1 mL
POLYSORBATE 80 0.23 mg  in 1 mL
TREHALOSE DIHYDRATE 34 mg  in 1 mL
SODIUM HYDROXIDE  
Packaging
# Item Code Package Description
1 NDC:55513-150-01 3.088 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125557 12/18/2014
Part 2 of 2
IV STABILIZER 
iv stabilizer solution
Product Information
Item Code (Source) NDC:55513-155
Route of Administration INTRAVENOUS DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE 5.25 mg  in 1 mL
LYSINE HYDROCHLORIDE 228.38 mg  in 1 mL
POLYSORBATE 80 10 mg  in 1 mL
SODIUM HYDROXIDE  
WATER  
Packaging
# Item Code Package Description
1 NDC:55513-155-01 10.6 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125557 12/18/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125557 12/18/2014
Labeler - Amgen Inc (039976196)
Revised: 07/2017   Amgen Inc

For the Consumer

Applies to blinatumomab: intravenous powder for solution

Along with its needed effects, blinatumomab (the active ingredient contained in Blincyto) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking blinatumomab:

More common
  • Agitation
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • chest pain
  • confusion
  • cough or hoarseness
  • dizziness
  • fever or chills
  • headache
  • irritability
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • rapid, shallow breathing
  • seeing, hearing, or feeling things that are not there
  • seizures
  • sore throat
  • stiff neck
  • tightness in the chest
  • tingling of the hands or feet
  • troubled breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting
Incidence not known
  • Cloudy urine
  • darkened urine
  • discouragement
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • extremely high fever or body temperature
  • eye pain
  • feeling sad or empty
  • general feeling of illness
  • irritability
  • lack or loss of strength
  • loss of interest or pleasure
  • mood or mental changes
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • persistent bleeding or oozing from puncture sites, mouth, or nose
  • pounding in the ears
  • problems with speech or speaking
  • rash
  • slow or fast heartbeat
  • stomach pain
  • sweating
  • swelling of the hands, ankles, feet, or lower legs
  • trouble sleeping
  • ulcers, sores, or white spots in the mouth
  • yellow eyes or skin

Some side effects of blinatumomab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Bone, joint, or muscle pain
  • change in urination
  • decreased appetite
  • diarrhea
  • difficulty having a bowel movement
  • dry mouth
  • increased hunger or thirst
  • irregular heartbeat
  • muscle pain or cramps
  • pain in the arms or legs
  • shakiness in the legs, arms, hands, or feet

(web3)