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PREPARATION AND
ADMINISTRATION
OF BLINCYTO®
INDICATION
BLINCYTO® is indicated for the treatment of Philadelphia chromosome-negative relapsed or
refractory B-cell precursor acute lymphoblastic leukemia (ALL).
This indication is approved under accelerated approval. Continued approval for this indication
may be contingent upon verification of clinical benefit in subsequent trials.
This brochure does not take the place of the reconstitution and preparation instructions located
in the full Prescribing Information (PI). Please refer to the PI for specific instructions to prepare
BLINCYTO®.
Please see Important Safety Information, including Boxed WARNINGS, on pages 22 and 23.
TABLE OF
CONTENTS
P 3
Indication
P4
Dose & Administration
P5
Dosage Adjustments
P6
Package Contents & Storage
P7
Aseptic Preparation
P8
Gather Supplies
P9
Special Considerations
Reconstitution and Preparation of BLINCYTO® Solution for Continuous IV Infusion:
P 10
9 mcg/day Infused Over 24 Hours
P 12
9 mcg/day Infused Over 48 Hours
P 14
28 mcg/day Infused Over 24 Hours
P 16
28 mcg/day Infused Over 48 Hours
P 18 Calculation Table
P 20 Administration
P 21 Storage Requirements
P 22 IV Bag Labels and Prescribing Information
If you have questions about the reconstitution and preparation of
BLINCYTO®, refer to the package insert or call 1-800-77-AMGEN
(1-800-772-6436).
2
Please see Important Safety Information, including Boxed WARNINGS, on pages 22 and 23.
INDICATION
BLINCYTO® is indicated for the treatment of Philadelphia chromosome-negative relapsed or
refractory B-cell precursor acute lymphoblastic leukemia (ALL).
This indication is approved under accelerated approval. Continued approval for this indication may
be contingent upon verification of clinical benefit in subsequent trials.
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.
3
DOSE &
ADMINISTRATION
BLINCYTO® (blinatumomab) is administered as a continuous intravenous infusion delivered at
a constant flow rate using an infusion pump that is programmable, lockable, non-elastomeric,
and has an alarm. A single cycle of treatment of BLINCYTO® consists of 4 weeks of continuous
intravenous infusion followed by a 2-week treatment-free interval.
Patients may receive 2 cycles of induction treatment followed by 3 additional cycles of BLINCYTO®
consolidation treatment.
Dosage for patients at least 45 kg (99 lbs) in weight.
CYCLE 1
CYCLE S 2 TO 5*
Starting Dose
Subsequent Dose
Week 1 (first 7 days)
Weeks 2-4
9 mcg/day
Increase the dose
to 28 mcg/day
2-WEEK
TREATMENT-FREE
INTERVAL
Start at 28 mcg/day
*Each cycle is followed by a
2-week treatment-free interval.
Hospitalization is recommended at a minimum for the first 9 days of the first cycle and the first
2 days of the second cycle. For all subsequent cycle starts and reinitiation (eg, if treatment is
interrupted for 4 or more hours), supervision by a healthcare professional or hospitalization is
recommended.
PREMEDICATION
Premedicate with dexamethasone 20 mg intravenously 1 hour prior to the first dose of BLINCYTO®
of each cycle, prior to a step dose (such as cycle 1 day 8), or when restarting an infusion after an
interruption of 4 or more hours.
Do not flush the BLINCYTO® infusion line, especially when changing infusion bags. Flushing when
changing bags or at completion of infusion can result in excess dosage and complications thereof.
Preparation and administration errors resulting in overdose have occurred.
4
Please see Important Safety Information, including Boxed WARNINGS, on pages 22 and 23.
DOSAGE
ADJUSTMENTS
If the interruption after an adverse event is no longer than 7 days, continue the same cycle to a
total of 28 days of infusion inclusive of days before and after the interruption in that cycle. If an
interruption due to an adverse event is longer than 7 days, start a new cycle.
Toxicity
Grade*
Cytokine
Release
Syndrome
Grade 3
Withhold BLINCYTO® until resolved, then restart BLINCYTO® at 9 mcg/day.
Escalate to 28 mcg/day after 7 days if the toxicity does not recur.
Grade 4
Discontinue BLINCYTO® permanently.
Seizure
Discontinue BLINCYTO® permanently if more than one seizure occurs.
Grade 3
Withhold BLINCYTO® until no more than Grade 1 (mild) and for at least 3 days, then
restart BLINCYTO® at 9 mcg/day. Escalate to 28 mcg/day after 7 days if the toxicity does
not recur. If the toxicity occurred at 9 mcg/day, or if the toxicity takes more than 7 days to
resolve, discontinue BLINCYTO® permanently.
Grade 4
Discontinue BLINCYTO® permanently.
Grade 3
Withhold BLINCYTO® until no more than Grade 1 (mild), then restart BLINCYTO® at
9 mcg/day. Escalate to 28 mcg/day after 7 days if the toxicity does not recur. If the
toxicity takes more than 14 days to resolve, discontinue BLINCYTO® permanently.
Grade 4
Consider discontinuing BLINCYTO® permanently.
Neurological
Toxicity
Other
Clinically
Relevant
Adverse
Reactions
Action
=
*B ased on the Common Terminology Criteria for Adverse Events (CTCAE). Grade 3 is severe, and Grade 4 is life-threatening.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
• Cytokine Release Syndrome (CRS): Life-threatening or fatal CRS 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 events such
as pyrexia, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT),
increased aspartate aminotransferase (AST), increased total bilirubin (TBILI), disseminated
intravascular coagulation (DIC), capillary leak syndrome (CLS), and hemophagocytic
lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Interrupt or discontinue
BLINCYTO® as outlined in the Prescribing Information (PI).
5
PACKAGE
CONTENTS & STORAGE
Each BLINCYTO® package contains:
• 1 BLINCYTO® 35 mcg single-use vial containing
a sterile, preservative free, white to off-white
lyophilized powder and
• 1 IV Solution Stabilizer 10 mL single-use glass
vial containing a sterile, preservative free,
colorless-to-slightly yellow, clear solution.
Do not use the IV Solution Stabilizer to
reconstitute BLINCYTO®
Refrigerate at 2°C to 8°C
(36°F to 46°F)in the
original packaging.
Do not freeze.
Protect the vials of
BLINCYTO® and IVSS from
light until time of use.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
• Neurological Toxicities: Approximately 50% of patients receiving BLINCYTO® in clinical trials
experienced neurological toxicities. Severe, life-threatening, or fatal neurological toxicities
occurred in approximately 15% of patients, including encephalopathy, convulsions, speech
disorders, disturbances in consciousness, confusion and disorientation, and coordination and
balance disorders. The median time to onset of any neurological toxicity was 7 days. Monitor
patients for signs or symptoms and interrupt or discontinue BLINCYTO® as outlined in the PI.
• Infections: Approximately 25% of patients receiving BLINCYTO® experienced serious 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): Life-threatening or fatal TLS 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.
6
Please see Important Safety Information, including Boxed WARNINGS, on pages 22 and 23.
ASEPTIC
PREPARATION
Aseptic technique must be strictly observed when preparing the solution for infusion since
BLINCYTO® (blinatumomab) vials do not contain antimicrobial preservatives.
To prevent accidental contamination, prepare BLINCYTO® according to aseptic standards including,
but not limited to the following:
Aseptic Preparation and Admixing Area Checklist
•
USP <797> compliant facility
•
ISO Class 5 laminar flow hood or better
•
The admixing area conforms to appropriate environmental specifications confirmed through periodic monitoring
•
Personnel are appropriately trained in aseptic manipulations and admixing of oncology drugs
•
Appropriate protective clothing and gloves are worn
•
All gloves and surfaces should be disinfected
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
• Neutropenia and Febrile Neutropenia, including life-threatening cases, have been observed.
Monitor appropriate laboratory parameters during BLINCYTO® infusion and interrupt BLINCYTO® if
prolonged neutropenia occurs.
• Preparation and administration errors have occurred. Follow instructions for preparation (including
admixing) and administration in the PI strictly to minimize medication errors (including underdose
and overdose).
• 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.
7
It is very important that the instructions for preparation (including admixing) and
administration provided in this section are strictly followed to minimize medication errors
(including underdose and overdose).
GATHER
SUPPLIES
1 package of BLINCYTO® for preparation of:
• 9 mcg/day dose infused over 24 hours at a rate of 10 mL/hour
• 9 mcg/day dose infused over 48 hours at a rate of 5 mL/hour
• 28 mcg/day dose infused over 24 hours at a rate of 10 mL/hour
2 packages of BLINCYTO® for preparation of:
• 28 mcg/day dose infused over 48 hours at a rate of 5 mL/hour
Additional Supplies Below Are Not Included in the Package
•
Sterile single-use disposable 10 mL, 5 mL, 3 mL and 1 mL syringes (may not need all 4 depending on the
dosage prepared)
•
21-23 gauge needles (recommended)
•
Preservative-free Sterile Water for Injection (sWFI), USP
•
Prefilled 250 mL 0.9% Sodium Chloride IV bag. Use only polyolefin, PVC non-DEHP, or EVA infusion bags/pump
cassettes. To minimize the number of aseptic transfers, it is recommended to use a 250 mL-prefilled IV bag.
•
IV tubing with a 0.2 micron in-line filter. Note that the filter must be sterile, non-pyrogenic and low-protein
binding. Use only IV tubing that is polyolefin, PVC non-DEHP or EVA. Ensure that the IV tubing is compatible
with the infusion pump.
Non-DEHP: non-di-ethylhexylphthalate; EVA: ethyl vinyl acetate
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
• Elevated Liver Enzymes: Transient elevations in liver enzymes are associated with BLINCYTO®
treatment. The majority of these events were observed in the setting of CRS. The median time
to onset was 15 days. Grade 3 or greater elevations in liver enzymes occurred in 6% 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.
8
Please see Important Safety Information, including Boxed WARNINGS, on pages 22 and 23.
SPECIAL
CONSIDERATIONS
A
IV Solution Stabilizer is provided with the BLINCYTO® package and is used to coat the
prefilled IV bag prior to addition of reconstituted BLINCYTO® to prevent adhesion of
BLINCYTO® to IV bags and IV lines. Therefore, add IV Solution Stabilizer to the IV bag
containing 0.9% Sodium Chloride. Do not use IV Solution Stabilizer for reconstitution
of BLINCYTO®.
B
The entire volume of the admixed BLINCYTO® will be more than the volume administered to
the patient (240 mL) to account for the priming of the IV line and to ensure that the patient
will receive the full dose of BLINCYTO®.
C
When preparing an IV bag, remove air from IV bag. This is particularly important for use with
an ambulatory infusion pump.
D
Use the specific volumes described in the admixing instructions (see illustrations and
instructions on the following pages) to minimize errors in calculation.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
• 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 anti-leukemic
chemotherapy.
Adverse Reactions
• The most commonly reported adverse reactions (≥ 20%) in clinical trials were pyrexia (62%),
headache (36%), peripheral edema (25%), febrile neutropenia (25%), nausea (25%),
hypokalemia (23%), rash (21%), tremor (20%) and constipation (20%).
• Serious adverse reactions were reported in 65% of patients. The most common serious
adverse reactions (≥ 2%) included febrile neutropenia, pyrexia, pneumonia, sepsis, neutropenia,
­device-related infection, tremor, encephalopathy, infection, overdose, confusion, Staphylococcal
bacteremia, and headache.
9
This brochure does not take the place of the reconstitution and preparation instructions located
in the full Prescribing Information (PI). Please refer to the PI for specific instructions to
prepare BLINCYTO®.
RECONSTITUTION AND
PREPARATION OF BLINCYTO®
(BLINATUMOMAB) SOLUTION
FOR INFUSION
These instructions are specific for the preparation of BLINCYTO®
9 mcg/day continuously infused over 24 hours
at a rate of 10 mL/hour.
STEP 1
• Use a prefilled 250 mL 0.9% Sodium Chloride IV bag. 250 mL prefilled bags
typically contain overfill to a total volume of 265 to 275 mL.
• If necessary, adjust the IV bag volume by adding or removing 0.9% Sodium
Chloride to achieve a starting volume between 265 and 275 mL.
STEP 2
• Using a 10 mL syringe, aseptically transfer 5.5 mL of IV Solution Stabilizer to
the IV bag with 0.9% Sodium Chloride.
• Gently mix the contents of the bag to avoid foaming.
• Discard remaining IV Solution Stabilizer vial.
IMPORTANT SAFETY INFORMATION
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).
10
Please see Important Safety Information, including Boxed WARNINGS, on pages 22 and 23.
• Using a 5 mL syringe, reconstitute one vial of BLINCYTO® using 3 mL of
preservative-free Sterile Water for Injection, USP. Direct preservative-free Sterile
Water for Injection, USP, toward the side of the vial during reconstitution. Gently
swirl contents to avoid excess foaming. Do not shake.
• Do not reconstitute BLINCYTO® with IV Solution Stabilizer.
• The addition of preservative-free Sterile Water for Injection, USP, to the
lyophilized powder results in a final BLINCYTO® concentration of 12.5 mcg/mL.
STEP 4
• Visually inspect the reconstituted solution for particulate matter and
discoloration during reconstitution and prior to infusion. The resulting solution
should be clear to slightly opalescent, colorless to slightly yellow. Do not use if
solution is cloudy or has precipitated.
STEP 5
• Using a 1 mL syringe, aseptically transfer 0.83 mL of reconstituted
BLINCYTO® into the IV bag.
• Gently mix the contents of the bag to avoid foaming.
STEP 6
• Under aseptic conditions, attach the IV tubing to the IV bag with the sterile
0.2 micron in-line filter.
STEP 7
• Remove air from the IV bag and prime the IV line only with the prepared
solution for infusion. Do not prime with 0.9% Sodium Chloride.
STEP 8
• Store at 2°C to 8°C if not used immediately.
Important Note: Do not flush the infusion line, especially when changing infusion
bags. Flushing when changing bags or at completion of infusion can result in
excess dosage. BLINCYTO® should be infused through a dedicated lumen.
11
9 mcg/day over 24 hours
STEP 3
This brochure does not take the place of the reconstitution and preparation instructions located
in the full Prescribing Information (PI). Please refer to the PI for specific instructions to
prepare BLINCYTO®.
RECONSTITUTION AND
PREPARATION OF BLINCYTO®
(BLINATUMOMAB) SOLUTION
FOR INFUSION
These instructions are specific for the preparation of BLINCYTO®
9 mcg/day continuously infused over 48 hours
at a rate of 5 mL/hour.
STEP 1
• Use a prefilled 250 mL 0.9% Sodium Chloride IV bag. 250 mL prefilled bags
typically contain overfill to a total volume of 265 to 275 mL.
• If necessary, adjust the IV bag volume by adding or removing 0.9% Sodium
Chloride to achieve a starting volume between 265 and 275 mL.
STEP 2
• Using a 10 mL syringe, aseptically transfer 5.5 mL of IV Solution Stabilizer to
the IV bag with 0.9% Sodium Chloride.
• Gently mix the contents of the bag to avoid foaming.
• Discard remaining IV Solution Stabilizer vial.
IMPORTANT SAFETY INFORMATION
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).
12
Please see Important Safety Information, including Boxed WARNINGS, on pages 22 and 23.
STEP 3
• Using a 5 mL syringe, reconstitute one vial of BLINCYTO® using 3 mL of
preservative-free Sterile Water for Injection, USP. Direct preservative-free Sterile
Water for Injection, USP, toward the side of the vial during reconstitution. Gently
swirl contents to avoid excess foaming. Do not shake.
• Do not reconstitute BLINCYTO® with IV Solution Stabilizer.
• The addition of preservative-free Sterile Water for Injection, USP, to the
lyophilized powder results in a final BLINCYTO® concentration of 12.5 mcg/mL.
9 mcg/day over 48 hours
STEP 4
• Visually inspect the reconstituted solution for particulate matter and
discoloration during reconstitution and prior to infusion. The resulting solution
should be clear to slightly opalescent, colorless to slightly yellow. Do not use if
solution is cloudy or has precipitated.
STEP 5
• Using a 3 mL syringe, aseptically transfer 1.7 mL of reconstituted
BLINCYTO® into the IV bag.
• Gently mix the contents of the bag to avoid foaming.
STEP 6
• Under aseptic conditions, attach the IV tubing to the IV bag with the sterile
0.2 micron in-line filter.
STEP 7
• Remove air from the IV bag and prime the IV line only with the prepared
solution for infusion. Do not prime with 0.9% Sodium Chloride.
STEP 8
• Store at 2°C to 8°C if not used immediately.
Important Note: Do not flush the infusion line, especially when changing infusion
bags. Flushing when changing bags or at completion of infusion can result in
excess dosage. BLINCYTO® should be infused through a dedicated lumen.
13
This brochure does not take the place of the reconstitution and preparation instructions located
in the full Prescribing Information (PI). Please refer to the PI for specific instructions to
prepare BLINCYTO®.
RECONSTITUTION AND
PREPARATION OF BLINCYTO®
(BLINATUMOMAB) SOLUTION
FOR INFUSION
These instructions are specific for the preparation of BLINCYTO®
28 mcg/day continuously infused over 24 hours
at a rate of 10 mL/hour.
STEP 1
• Use a prefilled 250 mL 0.9% Sodium Chloride IV bag. 250 mL prefilled bags
typically contain overfill to a total volume of 265 to 275 mL.
• If necessary, adjust the IV bag volume by adding or removing 0.9% Sodium
Chloride to achieve a starting volume between 265 and 275 mL.
STEP 2
• Using a 10 mL syringe, aseptically transfer 5.6 mL of IV Solution Stabilizer to
the IV bag with 0.9% Sodium Chloride.
• Gently mix the contents of the bag to avoid foaming.
• Discard remaining IV Solution Stabilizer vial.
IMPORTANT SAFETY INFORMATION
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).
14
Please see Important Safety Information, including Boxed WARNINGS, on pages 22 and 23.
STEP 3
• Using a 5 mL syringe, reconstitute one vial of BLINCYTO® using 3 mL of
preservative-free Sterile Water for Injection, USP. Direct preservative-free Sterile
Water for Injection, USP, toward the side of the vial during reconstitution. Gently
swirl contents to avoid excess foaming. Do not shake.
• Do not reconstitute BLINCYTO® with IV Solution Stabilizer.
• The addition of preservative-free Sterile Water for Injection, USP, to the
lyophilized powder results in a final BLINCYTO® concentration of 12.5 mcg/mL.
STEP 4
• Visually inspect the reconstituted solution for particulate matter and
discoloration during reconstitution and prior to infusion. The resulting solution
should be clear to slightly opalescent, colorless to slightly yellow. Do not use if
solution is cloudy or has precipitated.
STEP 5
• Using a 3 mL syringe, aseptically transfer 2.6 mL of reconstituted
BLINCYTO® into the IV bag.
• Gently mix the contents of the bag to avoid foaming.
28 mcg/day over 24 hours
STEP 6
• Under aseptic conditions, attach the IV tubing to the IV bag with the sterile
0.2 micron in-line filter.
STEP 7
• Remove air from the IV bag and prime the IV line only with the prepared
solution for infusion. Do not prime with 0.9% Sodium Chloride.
STEP 8
• Store at 2°C to 8°C if not used immediately.
Important Note: Do not flush the infusion line, especially when changing infusion
bags. Flushing when changing bags or at completion of infusion can result in
excess dosage. BLINCYTO® should be infused through a dedicated lumen.
15
This brochure does not take the place of the reconstitution and preparation instructions located
in the full Prescribing Information (PI). Please refer to the PI for specific instructions to
prepare BLINCYTO®.
RECONSTITUTION AND
PREPARATION OF BLINCYTO®
(BLINATUMOMAB) SOLUTION
FOR INFUSION
These instructions are specific for the preparation of BLINCYTO®
28 mcg/day continuously infused over 48 hours
at a rate of 5 mL/hour.
STEP 1
• Use a prefilled 250 mL 0.9% Sodium Chloride IV bag. 250 mL prefilled bags
typically contain overfill to a total volume of 265 to 275 mL.
• If necessary, adjust the IV bag volume by adding or removing 0.9% Sodium
Chloride to achieve a starting volume between 265 and 275 mL.
STEP 2
• Using a 10 mL syringe, aseptically transfer 5.6 mL of IV Solution Stabilizer to
the IV bag with 0.9% Sodium Chloride.
• Gently mix the contents of the bag to avoid foaming.
• Discard remaining IV Solution Stabilizer vial.
IMPORTANT SAFETY INFORMATION
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).
16
Please see Important Safety Information, including Boxed WARNINGS, on pages 22 and 23.
STEP 3
• Use two vials of BLINCYTO®. Using a 5 mL syringe, reconstitute each vial of
BLINCYTO® using 3 mL of preservative-free Sterile Water for Injection, USP.
Direct preservative-free Sterile Water for Injection, USP, toward the side of the
vial during reconstitution. Gently swirl contents to avoid excess foaming.
Do not shake.
• Do not reconstitute BLINCYTO® with IV Solution Stabilizer.
• The addition of preservative-free Sterile Water for Injection, USP, to the
lyophilized powder results in a final BLINCYTO® concentration of 12.5 mcg/mL.
STEP 4
• Visually inspect the reconstituted solution for particulate matter and
discoloration during reconstitution and prior to infusion. The resulting solution
should be clear to slightly opalescent, colorless to slightly yellow. Do not use if
solution is cloudy or has precipitated.
STEP 5
• Using a 3 mL syringe, aseptically transfer 5.2 mL of reconstituted
BLINCYTO® into the IV bag (2.7 mL from one vial and the remaining 2.5 mL from
the second vial).
• Gently mix the contents of the bag to avoid foaming.
STEP 6
• Under aseptic conditions, attach the IV tubing to the IV bag with the sterile
0.2 micron in-line filter.
STEP 7
• Remove air from the IV bag and prime the IV line only with the prepared
solution for infusion. Do not prime with 0.9% Sodium Chloride.
STEP 8
• Store at 2°C to 8°C if not used immediately.
17
28 mcg/day over 48 hours
Important Note: Do not flush the infusion line, especially when changing infusion
bags. Flushing when changing bags or at completion of infusion can result in
excess dosage. BLINCYTO® should be infused through a dedicated lumen.
CALCULATION
TABLE
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).
Volumes of Reconstituted BLINCYTO® (blinatumomab) for a 250 mL IV Bag With ~10% Overfill
Prescribed Dose
Dose per day
9 mcg / day
9 mcg / day
28 mcg / day
28 mcg / day
Infusion time
24 hours
48 hours
24 hours
48 hours
Preparation Step
250 mL prefilled 0.9% Sodium Chloride IV bag: Volumes listed include an assumed overfill of ~10%
Volume of IV Solution Stabilizer to be added to the IV bag:
Reconstitute lyophilized powder with sWFI
Volume reconstituted BLINCYTO® to be added to the IV bag:
Preparation Values / Volumes
250 mL plus overfill
Range: 270 mL ± 5 mL
250 mL plus overfill
Range: 270 mL ± 5 mL
250 mL plus overfill
Range: 270 mL ± 5 mL
250 mL plus overfill
Range: 270 mL ± 5 mL
5.5 mL
5.5 mL
5.6 mL
5.6 mL
3 mL
3 mL
3 mL
3 mL
0.83 mL
1.7 mL
2.6 mL
5.2 mL*
*2.7 mL from one vial and the
remaining 2.5 mL from the
second vial.
Infusion Rate
10 mL / hour
5 mL / hour
10 mL / hour
5 mL / hour
IMPORTANT SAFETY INFORMATION
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).
18
Please see Important Safety Information, including Boxed WARNINGS, on pages 22 and 23.
19
ADMINISTRATION
CONTINUOUS INFUSION
BLINCYTO® (blinatumomab) is administered as a continuous intravenous infusion delivered at a
constant flow rate using an infusion pump that is programmable, lockable, non-elastomeric, and
has an alarm.
Important Note: Do not flush the infusion line, especially when changing infusion
bags. Flushing when changing bags or at completion of infusion can result in
excess dosage. BLINCYTO® should be infused through a dedicated lumen.
The BLINCYTO® solution for infusion must be administered using IV tubing that contains an in-line,
sterile, non-pyrogenic, low protein-binding 0.2 micron in-line filter.
A therapeutic dose of 9 mcg/day or 28 mcg/day should be administered to the patient by infusing a
total of 240 mL BLINCYTO® solution for infusion according to the instructions on the pharmacy label
on the bag at one of the following constant infusion rates:
Infusion Rate
Duration
10 mL/h
24 hours
5 mL/h
48 hours
At the end of the infusion, any unused BLINCYTO® solution in the IV bag and IV lines should be
disposed of in accordance with local requirements.
PUMP SPECIFICATIONS
The infusion pump used to administer BLINCYTO® solution for infusion should be programmable,
lockable, non-elastomeric, and have an alarm.
TREATMENT INTERRUPTION
LINE PRIMED WITH DRUG
If treatment is interrupted for 4 or more hours, supervision by a healthcare professional
or
hospitalization is recommended for treatment reinitiation.
DO NOT FLUSH LINE
To help ensure proper administration of BLINCYTO®, consider applying
one of the enclosed labels to the IV bag.
20
LINE PRIMED WITH DRUG
DO NOT FLUSH LINE
Please see Important Safety Information, including Boxed WARNINGS, on pages 22 and 23.
STORAGE
REQUIREMENTS
The following table indicates the storage requirements for the reconstituted BLINCYTO® vial and
prepared IV bag containing BLINCYTO® solution for infusion. Lyophilized BLINCYTO® vial and IV
Solution Stabilizer may be stored for a maximum of 8 hours at room temperature.
Storage Time for Reconstituted BLINCYTO® and IV Solution Stabilizer
Maximum Storage Time of
Reconstituted BLINCYTO® Vial*
Maximum Storage Time of Prepared IV Bag
Containing BLINCYTO® Solution for Infusion
Room Temperature
23ºC to 27ºC
(73ºF to 81ºF)
Refrigerated
2ºC to 8ºC
(36ºF to 46ºF)
Room Temperature
23ºC to 27ºC
(73ºF to 81ºF)
Refrigerated
2ºC to 8ºC
(36ºF to 46ºF)
4 hours
24 hours
48 hours†
8 days
*While stored, protect BLINCYTO® and IV Solution Stabilizer vials from light.
†
Storage time includes infusion time. If IV bag containing BLINCYTO® solution for infusion is not administered within the timeframes and
temperatures indicated, it must be discarded; it should not be refrigerated again.
IMPORTANT SAFETY INFORMATION
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).
14
21
INDICATION
BLINCYTO® (blinatumomab) is indicated for the treatment of Philadelphia chromosome-negative
relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
This indication is approved under accelerated approval. Continued approval for this indication may
be contingent upon verification of clinical benefit in subsequent trials.
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): Life-threatening or fatal CRS 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 events such
as pyrexia, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT),
increased aspartate aminotransferase (AST), increased total bilirubin (TBILI), disseminated
intravascular coagulation (DIC), capillary leak syndrome (CLS), and hemophagocytic
lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Interrupt or discontinue
BLINCYTO® as outlined in the Prescribing Information (PI).
• Neurological Toxicities: Approximately 50% of patients receiving BLINCYTO® in clinical trials
experienced neurological toxicities. Severe, life-threatening, or fatal neurological toxicities
occurred in approximately 15% of patients, including encephalopathy, convulsions, speech
disorders, disturbances in consciousness, confusion and disorientation, and coordination and
balance disorders. The median time to onset of any neurological toxicity was 7 days. Monitor
patients for signs or symptoms and interrupt or discontinue BLINCYTO® as outlined in the PI.
• Infections: Approximately 25% of patients receiving BLINCYTO® experienced serious 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): Life-threatening or fatal TLS 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.
22
• Neutropenia and Febrile Neutropenia, including life-threatening cases, have been observed.
Monitor appropriate laboratory parameters 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 are associated with BLINCYTO®
treatment. The majority of these events were observed in the setting of CRS. The median time
to onset was 15 days. Grade 3 or greater elevations in liver enzymes occurred in 6% 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.
• 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 anti-leukemic
chemotherapy.
• Preparation and administration errors have occurred. Follow instructions for preparation
(including admixing) and administration in the PI strictly to minimize medication errors
(including underdose and overdose).
Adverse Reactions
• The most commonly reported adverse reactions (≥ 20%) in clinical trials were pyrexia
(62%), headache (36%), peripheral edema (25%), febrile neutropenia (25%), nausea (25%),
hypokalemia (23%), rash (21%), tremor (20%) and constipation (20%).
• Serious adverse reactions were reported in 65% of patients. The most common serious
adverse reactions (≥ 2%) included febrile neutropenia, pyrexia, pneumonia, sepsis, neutropenia,
device-related infection, tremor, encephalopathy, infection, overdose, confusion, Staphylococcal
bacteremia, and headache.
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).
Please click here for full Prescribing Information, including Boxed WARNINGS, and Medication
Guide, for BLINCYTO®.
23
IV BAG LABELS
LINE PRIMED WITH DRUG
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PRIMED WITH DRUG
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USA-103-109215
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Please visit BLINCYTO.com for additional information and resources.
Call 1-800-77-AMGEN (1-800-772-6436) if you have questions about the reconstitution and
preparation of BLINCYTO®.
Please click here for full Prescribing Information, including Boxed WARNINGS,
and Medication Guide, for BLINCYTO®.
Reference: 1. BLINCYTO® (blinatumomab) Prescribing Information, Amgen.
© 2015 Amgen Inc. All rights reserved.
USA-103-109215 7/15