IMPORTANT RISK MINIMIZATION INFORMATION - FOR HEALTHCARE PROFESSIONALS
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
IMPORTANT RISK
MINIMIZATION INFORMATION
FOR HEALTHCARE PROFESSIONALS
This educational brochure contains important information regarding the administration of
blinatumomab and the risks of medication errors, neurologic events and cytokine release syndrome
This educational material is essential to ensure the safe and effective use of the product and
appropriate management of the important selected risks and therefore it is advised to be read
carefully before prescribing, preparing and administering the medicine
PLEASE ENSURE EACH PATIENT OR CAREGIVER IS PROVIDED A COPY OF THE PATIENT
EDUCATIONAL MATERIAL
The H.S.A.-approved Product Information for BLINCYTO® is appended to this document.
If you have any questions, require additional information regarding the use of BLINCYTO®,
or to report any adverse events or product quality complaints, please contact:
Amgen Medical Information
Tel.: 800 616 7094 | e-mail: medinfo.JAPAC@amgen.com
CONTENTS
IMPORTANT INFORMATION REGARDING
BLINCYTO® (BLINATUMOMAB) THERAPY
IMPORTANT RISK MINIMIZATION INFORMATION 3
FOR PHYSICIANS
• Approved BLINCYTO® Indication
• Overview of BLINCYTO treatment
• BLINCYTO dosage: Treatment of MRD-Positive B-cell Precursor ALL
• BLINCYTO dosage: Treatment of Relapsed or Refractory B-cell Precursor ALL
• Dose Adjustments
• Medication Errors
• Neurologic events
• Cytokine Release Syndrome (CRS)
IMPORTANT RISK MINIMISATION INFORMATION 8
FOR PHARMACISTS
Important information about the preparation of BLINCYTO
intravenous administration
• Table 1. For Patients Weighing 45 kg or More: Volumes to Add to Intravenous Bag
• Table 2. For Patients Weighing Less Than 45 kg: Volumes to Add to Intravenous Bag
• Steps to prepare BLINCYTO infusion solution under aseptic conditions using
aseptic techniques
- Reconstitution of BLINCYTO for 24-Hour, 48-Hour, 72-Hour or 96-Hour Infusion
- Preparation of BLINCYTO Infusion Bag for 24 Hour, 48-Hour, 72-Hour or
96-Hour Infusion
IMPORTANT RISK MINIMISATION INFORMATION 12
FOR NURSES
• Administration
• Counseling
2IMPORTANT INFORMATION REGARDING
BLINCYTO® (BLINATUMOMAB) THERAPY
• Hospitalization is recommended for the first 3 days of the first cycle and the first 2 days of the
IMPORTANT RISK MINIMIZATION INFORMATION second cycle. For all subsequent cycle starts and re-initiations (eg, if treatment is interrupted for
4 or more hours), supervision by a healthcare professional or hospitalization is recommended.
FOR PHYSICIANS
• Premedicate with prednisone or equivalent for MRD-positive B-cell Precursor ALL.
Approved BLINCYTO Indication
®
For adult patients, premedicate with prednisone 100 mg intravenously or equivalent (eg,
BLINCYTO is indicated for the treatment of: dexamethasone 16 mg) 1 hour prior to the first dose of BLINCYTO in each cycle.
• B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with
For pediatric patients, premedicate with 5 mg/m2 of dexamethasone, to a maximum dose of
minimal residual disease (MRD) greater than or equal to 0.1% in adults and children.
20 mg prior to the first dose of BLINCYTO in the first cycle and when restarting an infusion
• Relapsed or refractory B-cell precursor ALL in adults and children. after an interruption of 4 or more hours in the first cycle.
Treatment of Relapsed or Refractory B-cell Precursor ALL
Overview of BLINCYTO treatment:
• A treatment course consists of up to 2 cycles of BLINCYTO for induction followed by 3 additional
Patients will receive BLINCYTO by continuous intravenous infusion.
cycles for consolidation and up to 4 additional cycles of continued therapy.
• In patients with a history or presence of clinically relevant central nervous system (CNS)
pathology (see Warnings and Precautions [5.2] of the Product Information), hospitalization • A single cycle of treatment of BLINCYTO induction or consolidation consists of 28 days of
is recommended at a minimum for the first 14 days of the first cycle. In the second cycle, continuous intravenous infusion followed by a 14-day treatment-free interval (total 42 days).
hospitalization is recommended at a minimum for 2 days, and clinical judgement should be • A single cycle of treatment of BLINCYTO continued therapy consists of 28 days of continuous
based on tolerance to blinatumomab in the first cycle. Caution should be exercised as cases of intravenous infusion followed by a 56-day treatment-free interval (total 84 days).
late occurrence of first neurological events in the second cycle have been observed.
Recommended BLINCYTO Dose and Schedule for the Treatment of Relapsed or Refractory
• Recommended daily dose is by patient weight. Patients weighing 45 kg or more receive a fixed- B-cell Precursor ALL
dose and for patients weighing less than 45 kg, the dose is calculated using the patient’s body
surface area (BSA). PATIENTS WEIGHING PATIENTS WEIGHING
Cycle 45 kg or More Less Than 45 kg
(Fixed-dose) (BSA-based dose)
BLINCYTO dosage:
Treatment of MRD-Positive B-cell Precursor ALL Induction
Cycle 1
• A treatment course consists of 1 cycle of BLINCYTO for induction followed by up to 3 additional 5 mcg/m2/day
Days 1-7 9 mcg/day
cycles for consolidation. (not to exceed 9 mcg/day)
Days 8-28 28 mcg/day 15 mcg/m2/day
• A single cycle of treatment of BLINCYTO induction or consolidation consists of 28 days of (not to exceed 28 mcg/day)
continuous intravenous infusion followed by a 14-day treatment-free interval (total 42 days). Days 29-42 14-day treatment-free interval 14-day treatment-free interval
Recommended BLINCYTO Dose and Schedule for the Treatment of MRD-Positive B-cell Induction
Cycle 2
Precursor ALL
Days 1-28 28 mcg/day 15 mcg/m2/day
PATIENTS WEIGHING PATIENTS WEIGHING (not to exceed 28 mcg/day)
Cycle 45 kg or More Less Than 45 kg Days 29-42 14-day treatment-free interval 14-day treatment-free interval
(Fixed-dose) (BSA-based dose)
Consolidation
Induction
Cycles 3-5
Cycle 1
Days 1-28 28 mcg/day 15 mcg/m2/day
15 mcg/m2/day (not to exceed 28 mcg/day)
Days 1-28 28 mcg/day
(not to exceed 28 mcg/day)
Days 29-42 14-day treatment-free interval 14-day treatment-free interval
Days 29-42 14-day treatment-free interval 14-day treatment-free interval
Continued Therapy
Consolidation
Cycles 2-4 Cycles 6-9
Days 1-28 28 mcg/day 15 mcg/m2/day
15 mcg/m2/day (not to exceed 28 mcg/day)
Days 1-28 28 mcg/day (not to exceed 28 mcg/day)
Days 29-42 56-day treatment-free interval 56-day treatment-free interval
Days 29-42 14-day treatment-free interval 14-day treatment-free interval
3 4• Hospitalization is recommended for the first 9 days of the first cycle and the first 2 days The following actions should be taken to prevent or minimize the risk of medication
of the second cycle. For all subsequent cycle starts and re-initiation (eg, if treatment is errors, neurologic events and cytokine release syndrome.
interrupted for 4 or more hours), supervision by a healthcare professional or hospitalization is
recommended. • Medication errors are unintended errors in the prescribing,
MEDICATION dispensing, or administration of a medicinal product while in the
• Premedicate with dexamethasone
ERRORS control of the healthcare professional or patient.
For adult patients, premedicate with 20 mg of dexamethasone intravenously 1 hour prior to
• Ensure that patients receive the recommended daily dose according
the first dose of BLINCYTO of each cycle, prior to a step dose (such as Cycle 1 Day 8), and
to their weight. Patients weighing 45 kg or more receive a fixed
when restarting an infusion after an interruption of 4 or more hours. dose and for patients weighing less than 45 kg, the dose is
For pediatric patients, premedicate with 10 mg/m2 of dexamethasone (not to exceed 20 calculated using the patient’s body surface area (BSA). See Section
2, Dosage and Administration of the Product Information.
mg) orally or intravenously 6 to 12 hours prior to the start of BLINCYTO (Cycle 1 day 1),
followed by dexamethasone 5 mg/m2 (not to exceed 20 mg) orally or intravenously within • To minimize the potential events of medication errors, please
30 minutes prior to the start of BLINCYTO (Cycle 1 day 1), prior to a step dose (such as Cycle counsel patients on the following:
1 Day 8), and when restarting an infusion after an interruption of 4 or more hours in the Instruct patients not to unlock the pump
Patients will receive continuous intravenous infusion of BLINCYTO. Discuss the infusion duration with If the pump does not appear to perform properly (for example:
your patients as there is a choice of bag change frequency. However, the target therapeutic dose of alarm goes off) at any time, instruct patients and caregivers
BLINCYTO delivered does not change. not to try to fix the pump and tell them to contact you or the
nurse immediately
Planned bag change frequency Infusion rate Instruct patients not to change any pump settings on purpose
Every 24 hours 10 mL/hr (with the exception of stopping the pump in case of emergency)
Every 48 hours 5 mL/hr • In addition, you can help by reporting any medication errors that
Every 72 hours 3.3 mL/hr you or your patients have encountered or experienced to Amgen, via
the contact information provided in this material.
Every 96 hours 2.5 mL/hr
• Hospitalization is recommended for patients with a history or presence
NEUROLOGIC of clinically relevant CNS pathology:
Dose Adjustments EVENTS At a minimum for the first 14 days of the first cycle (clinical
In the case of adverse reactions, consideration can be made to interrupt or discontinue the infusion judgment should be based on tolerance to BLINCYTO).
of BLINCYTO. Please refer to Section 2.3 Dosage Modifications for Adverse Reaction of the Product At a minimum for 2 days in the second cycle. Caution should
Information for further details. be exercised as cases of late occurrence of first neurological
events in the second cycle have been observed.
If the interruption after an adverse reaction is no longer than 7 days, continue the same cycle to a total • See Section 2.3 Dosage Modifications for Adverse Reaction of the
of 28 days of infusion inclusive of days before and after the interruption in that cycle. If an interruption Product Information for management of severe (Grade 3) and
due to an adverse reaction is longer than 7 days, start a new cycle. If the adverse reaction does not life-threatening (Grade 4) neurologic events
resolve within 14 days, discontinue BLINCYTO permanently, except in those circumstances as described • Monitor patients for signs and symptoms of neurologic events (eg,
in the approved Product Information (Please refer to Section 2.3 Dosage Modifications for Adverse confusion, disorientation, dizziness, tremor, seizure) prior to and
Reaction). throughout the treatment cycle. Manifestations of neurological
toxicity also includes cranial nerve disorders. The majority of
neurologic events resolved following interruption of BLINCYTO, but
some resulted in treatment discontinuation.
• Consider utilizing a writing test periodically to evaluate for the early
detection of neurologic events
• Be aware that elderly patients experience a higher rate of neurologic
events, including cognitive disorder, encephalopathy, and confusion
5 6IMPORTANT RISK MINIMIZATION INFORMATION
• Discontinue BLINCYTO permanently if more than one seizure
NEUROLOGIC occurs FOR PHARMACISTS
EVENTS
• Withhold dose if Grade 3 (severe) neurologic event occurs This educational brochure contains important information regarding the reconstitution and
(continued) and discontinue permanently if Grade 4 (life-threatening) preparation procedures for BLINCYTO® (blinatumomab). To ensure the safe and effective use
neurologic event occurs
of the medicinal product and appropriate management of the important selected risks, please
• The median time to the first event was within the first 2 weeks of carefully read this material before reconstituting and preparing of the medicinal product.
BLINCYTO treatment, however symptoms may appear earlier or later
• It is essential to counsel patients regarding the potential neurologic If you have any questions about the reconstitution and preparation of blinatumomab please
effects and to advise patients: refer to the Product Information, which is provided with this educational brochure.
Not to drive, operate heavy machines or engage in hazardous
activities while receiving BLINCYTO
IMPORTANT INFORMATION ABOUT THE PREPARATION OF BLINCYTO
INTRAVENOUS ADMINISTRATION
To contact you if they experience neurologic symptoms
List of Materials
There is limited experience with BLINCYTO in patients with active ALL • 1 package BLINCYTO includes 1 vial of BLINCYTO and 1 vial of IV Solution Stabilizer (see Table 1
in the central nervous system (CNS) or a history of neurologic events and 2 for required number of vials).
(patients with a history or presence of clinically relevant CNS pathology
were excluded from clinical trials) • Preservative-free sterile water for injections.
• Supplies to make a 270 mL 0.9% Sodium Chloride IV bag (include an empty IV bag and 0.9%
• Cytokine Release Syndrome (CRS) which may be life-threatening Sodium Chloride Injection, USP [eg, 1000 mL])
CYTOKINE or fatal has been reported in patients receiving blinatumomab
RELEASE Use only polyolefin, PVC di-ethylhexylphthalate-free (DEHP-free), or ethyl vinyl acetate
SYNDROME • Monitor for signs and symptoms of CRS, some of which may (EVA) infusion bags /pump cassettes and polyolefin, PVC DEHP-free, or EVA intravenous
(CRS) be pyrexia, asthenia, headache, hypotension, total bilirubin tubing with a sterile, non-pyrogenic, low protein-binding 0.2 micron in-line filter.
increased, and nausea. In some cases, disseminated intravascular
coagulation, capillary leak syndrome, and hemophagocytic • Sterile, single-use disposable syringes
histiocytosis /macrophage activation syndrome have been • 21- to 23- gauge needle(s)
reported in the setting of CRS
• The median time to onset of CRS was 2 days following start of Table 1. For Patients Weighing 45 kg or More: Volumes to Add to Intravenous Bag
BLINCYTO and the median time to resolution of CRS was 5 days 0.9% Sodium Chloride Injection, USP (starting volume) 270 mL
among cases that resolved.
IV Solution Stabilizer (fixed volume for 24, 48, 72 and 96-hour
infusion durations) 5.5 mL
• Management of these events may require temporary interruption
or permanent discontinuation of BLINCYTO. RECONSTITUTED BLINCYTO
INFUSION DOSE INFUSION
DURATION RATE VOLUME VIALS
If a Grade 3 non-neurologic event occurs, interrupt BLINCYTO and
administer dexamethasone 5 mg/m2 (patients weighing < 45 kg) or 9 mcg/day 0.83 mL
8 mg (patients weighing 45 kg or more) every 8 hours intravenously 24 hours 10 mL/hour 1
28 mcg/day 2.6 mL
or orally for up to 3 days and taper thereafter over 4 days.
9 mcg/day 1.7 mL 1
48 hours 5 mL/hour
If a Grade 4 non-neurologic event occurs, discontinue BLINCYTO 28 mcg/day 5.2 mL 2
permanently. Administer dexamethasone as instructed for Grade 9 mcg/day 2.5 mL 1
3 CRS. 72 hours 3.3 mL/hour
28 mcg/day 8 mL 3
9 mcg/day 3.3 mL 2
96 hours 2.5 mL/hour
28 mcg/day 10.7 mL 4
7 8Table 2. For Patients Weighing Less Than 45 kg: Volumes to Add to Intravenous Bag
0.9% Sodium Chloride Injection, USP (starting volume) 270 mL 0.9% Sodium Chloride Injection, USP (starting volume) 270 mL
IV Solution Stabilizer (fixed volume for 24, 48, 72 and 96-hour infusion) 5.5 mL IV Solution Stabilizer (fixed volume for 24, 48, 72 and 96-hour infusion) 5.5 mL
RECONSTITUTED BLINCYTO RECONSTITUTED BLINCYTO
INFUSION DOSE INFUSION INFUSION DOSE INFUSION
BSA (m2) BSA (m2)
DURATION RATE VOLUME VIALS DURATION RATE VOLUME VIALS
1.5 – 1.59 0.7 mL 1.5 – 1.59 2.1 mL
1.4 – 1.49 0.66 mL 1.4 – 1.49 2 mL
1.3 – 1.39 0.61 mL 1.3 – 1.39 1.8 mL
1.2 – 1.29 0.56 mL 1.2 – 1.29 1.7 mL
1.1 – 1.19 0.52 mL 1.1 – 1.19 1.6 mL
24 hours 5 mcg/m2/day 10 mL/hour 1 – 1.09 0.47 mL 1 72 hours 5 mcg/m2/day 3.3 mL/hour 1 – 1.09 1.4 mL 1
0.9 – 0.99 0.43 mL 0.9 – 0.99 1.3 mL
0.8 – 0.89 0.38 mL 0.8 – 0.89 1.1 mL
0.7 – 0.79 0.33 mL 0.7 – 0.79 1 mL
0.6 – 0.69 0.29 mL 0.6 – 0.69 0.86 mL
0.5 – 0.59 0.24 mL 0.5 – 0.59 0.72 mL
0.4 – 0.49 0.2 mL 0.4 – 0.49 0.59 mL
1.5 – 1.59 2.1 mL 1.5 – 1.59 6.3 mL 3
1.4 – 1.49 2 mL 1.4 – 1.49 5.9 mL
1.3 – 1.39 1.8 mL 1.3 – 1.39 5.5 mL
1.2 – 1.29 1.7 mL 1.2 – 1.29 5.1 mL
1.1 – 1.19 1.6 mL 1.1 – 1.19 4.7 mL
1 – 1.09 1.4 mL 1 1 – 1.09 4.2 mL 2
24 hours 15 mcg/m2/day 10 mL/hour 72 hours 15 mcg/m2/day 3.3 mL/hour
0.9 – 0.99 1.3 mL 0.9 – 0.99 3.8 mL
0.8 – 0.89 1.1 mL 0.8 – 0.89 3.4 mL
0.7 – 0.79 1 mL 0.7 – 0.79 3 mL
0.6 – 0.69 0.86 mL 0.6 – 0.69 2.6 mL
0.5 – 0.59 0.72 mL 0.5 – 0.59 2.2 mL 1
0.4 – 0.49 0.59 mL 0.4 – 0.49 1.8 mL
1.5 – 1.59 1.4 mL 1.5 – 1.59 2.8 mL
1.4 – 1.49 1.3 mL 1.4 – 1.49 2.6 mL
1.3 – 1.39 1.2 mL 1.3 – 1.39 2.4 mL
1.2 – 1.29 1.1 mL 1.2 – 1.29 2.3 mL
1.1 – 1.19 1 mL 1.1 – 1.19 2.1 mL
48 hours 5 mcg/m2/day 5 mL/hour 1 – 1.09 0.94 mL 1 96 hours 5 mcg/m2/day 2.5 mL/hour 1 – 1.09 1.9 mL 1
0.9 – 0.99 0.85 mL 0.9 – 0.99 1.7 mL
0.8 – 0.89 0.76 mL 0.8 – 0.89 1.5 mL
0.7 – 0.79 0.67 mL 0.7 – 0.79 1.3 mL
0.6 – 0.69 0.57 mL 0.6 – 0.69 1.2 mL
0.5 – 0.59 0.48 mL 0.5 – 0.59 0.97 mL
0.4 – 0.49 0.39 mL 0.4 – 0.49 0.78 mL
1.5 – 1.59 4.2 mL 1.5 – 1.59 8.4 mL
1.4 – 1.49 3.9 mL 1.4 – 1.49 7.9 mL
1.3 – 1.39 3.7 mL 2 1.3 – 1.39 7.3 mL 3
1.2 – 1.29 3.4 mL 1.2 – 1.29 6.8 mL
1.1 – 1.19 3.1 mL 1.1 – 1.19 6.2 mL
48 hours 15 mcg/m2/day 5 mL/hour 1 – 1.09 2.8 mL 96 hours 15 mcg/m2/day 2.5 mL/hour 1 – 1.09 5.7 mL
0.9 – 0.99 2.6 mL 0.9 – 0.99 5.1 mL
0.8 – 0.89 2.3 mL 0.8 – 0.89 4.6 mL
0.7 – 0.79 2 mL 1 0.7 – 0.79 4 mL 2
0.6 – 0.69 1.7 mL 0.6 – 0.69 3.4 mL
0.5 – 0.59 1.4 mL 0.5 – 0.59 2.9 mL
0.4 – 0.49 1.2 mL 0.4 – 0.49 2.3 mL 1
9 10Steps to prepare BLINCYTO infusion solution under aseptic conditions using aseptic
techniques
IMPORTANT RISK MINIMIZATION INFORMATION
Reconstitution of BLINCYTO for 24-Hour, 48-Hour, 72-Hour or 96-Hour Infusion FOR NURSES
This educational brochure contains important information regarding the administration of
1. Determine the number of BLINCYTO vials needed for a dose and infusion duration.
BLINCYTO® (blinatumomab) and the risks of medication errors, cytokine release syndrome (CRS),
2. Reconstitute each BLINCYTO vial with 3 mL of preservative free Sterile Water for Injection,
and neurologic events. This educational material is essential to ensure the safe and effective use
USP by directing the water along the walls of the BLINCYTO vial and not directly on the lyophilized
powder. The resulting concentration per BLINCYTO vial is 12.5 mcg/mL. of the product and appropriate management of the important selected risks and therefore it is
- Do not reconstitute BLINCYTO vials with IV Solution Stabilizer. advised to be read carefully before administering the medicinal product.
3. Gently swirl contents to avoid excess foaming.
If you have any questions about the administration and the adverse events of BLINCYTO, refer to
- Do not shake.
the Product Information, which is provided with this educational brochure.
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. Important Information Regarding BLINCYTO
5. Repeat these steps according to the required number of BLINCYTO vials as reported in Table 1 or 2
above. The following actions should be taken to prevent or minimize the risk of medication
errors and to provide important counseling information on neurologic events and
Preparation of BLINCYTO Infusion Bag for 24-Hour, 48-Hour, 72-Hour or 96-Hour cytokine release syndrome.
Infusion
• Do not flush the infusion lines into the patient, especially
1. Aseptically add 270 mL 0.9% Sodium Chloride Injection, USP to the empty
when changing infusion bags. Flushing when changing bags
intravenous bag. IV lines or at completion of infusion can result in excess dosage.
Infuse BLINCYTO through a dedicated lumen.
2. Aseptically transfer 5.5 mL IV Solution Stabilizer to the intravenous bag containing
0.9% Sodium Chloride Injection, USP. Gently mix the contents of the bag to avoid • Only program the pump based on the printed infusion rate on the
foaming. Discard the vial containing the unused IV Solution Stabilizer. label attached to the infusion bag.
• For the infusion rate ask the consultant pharmacist/doctor. Do not
3. Aseptically transfer the required volume of reconstituted BLINCYTO solution into calculate the infusion rate yourself.
the intravenous bag containing 0.9% Sodium Chloride Injection, USP and IV Solution • Lock the pump and make sure the battery is adequately charged
Stabilizer. Gently mix the contents of the bag to avoid foaming. with each bag change.
• Instruct patients not to unlock the pump.
• Refer to Table 1 for patients weighing 45 kg or more for the specific volume of
• If the pump does not appear to perform properly (for example:
reconstituted BLINCYTO. alarm goes off) at any time, instruct patients and caregivers not
Pump
• Refer to Table 2 for patients weighing less than 45 kg (dose based on BSA) for the to try to fix the pump and tell them to get help from the treating
specifications
specific volume of reconstituted BLINCYTO. ADMINISTRATION and settings physician or from you immediately.
• Discard the vial containing unused BLINCYTO. • Instruct patients not to change any pump settings on purpose
(with the exception of stopping the pump in case of emergency).
4. Under aseptic conditions, attach the intravenous tubing to the intravenous bag with • Remember to check if the remaining volume of infusion bag
the sterile 0.2 micron in line filter. Ensure that the intravenous tubing is compatible correlates with the set infusion rate prior to each bag change. If the
remaining volume of infusion bag does not correlate with the set
with the infusion pump.
infusion rate prior to each bag change, please record discrepancy
and contact the physician for further instruction.
5. Remove air from the intravenous bag. This is particularly important for use with an
ambulatory infusion pump. • Healthcare professional supervision or hospitalization is
Therapy recommended in instances where treatment is being re-initiated
6. Prime the intravenous tubing only with the solution in the bag containing the interruption following an interruption of 4 or more hours (see Section 2, Dosage
FINAL prepared BLINCYTO solution for infusion. and Administration of the Product Information).
• BLINCYTO solution is a preservative-free solution. Aseptic technique
7. Store refrigerated at 2°C to 8°C for up to 10 days if not used immediately.
Catheter must always be adhered to when administering BLINCYTO.
site care • Instruct the patients and/or caregivers on how to perform catheter
site care as required.
11 12• BLINCYTO has been observed to cause neurological toxicities
in approximately 65% of patients. Assess patients for signs and
symptoms of neurological events (eg, convulsions, speech disorders,
and confusion) prior to and throughout the treatment cycle (see
Section 5.2 Neurological Toxicities of the Product Information for
further information). Consider using a writing test periodically to
Neurologic assist with monitoring for neurological events during BLINCYTO
events treatment.
• Elderly patients experience a higher rate of neurological events.
• Counsel patients on the potential neurologic effects.
• Advise patients:
• Not to drive, use heavy machinery, or engage in hazardous
COUNSELING activities while receiving BLINCYTO.
• To contact you or the doctor if they experience neurological
symptoms.
• Cytokine release syndrome, which may be life-threatening or fatal,
has occurred in patients taking BLINCYTO. Patients should be
Cytokine monitored for potential signs and symptoms of CRS or infusion
release reaction including pyrexia, fatigue, nausea, vomiting, chills,
syndrome hypotension, rash, and wheezing.
(CRS) • Counsel patients on the signs or symptoms of potential CRS.
• Advise patients to contact you or their doctor if they experience
signs or symptoms associated with CRS or infusion reactions.
This document is not a comprehensive list of Safety events; please refer to the Product
Information for BLINCYTO for further information.
This document has been approved by H.S.A. on 14 Jul 2021
13For Healthcare Professionals only
All images are for illustration purposes only.
Please read full prescribing information prior to administration.
Amgen Biotechnology Singapore Pte Ltd
For further information, please contact Medical Information at 3 Fraser Street
800 616 7094 or email: medinfo.JAPAC@amgen.com #15-26/27 DUO Tower
SG-02738-BLI-2021-Aug Singapore 189352You can also read
