[PPT] - n e i z d o h c y z r P z s a k u L f o y t r PowerPoint Presentation

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SLIDE 2

Lukasz Przychodzien 2015 PharmD Candidate Philadelphia College of Pharmacy

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SLIDE 3

Objectives

Discuss Synribo with its characteristics and clinical pearls Assess Diplomat’s reconstitution procedure for Synribo Analyze the verification process

f Diplomat to ensure patient

administration and adherence Discuss potential patient’s questions of interest

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SLIDE 4

Chronic Myeloid Leukemia (CML)

Classification: CML is the rarest form of leukemia (cancer of the blood) Pathophysiology: Starts in the bone marrow and disrupts production of normal blood cells: leading to anemia, bleeding, and infections Genetics: Caused by a genetic translocation that creates the BCR-ABL fusion gene, aka the “Philadelphia chromosome” Mortality: CML patients have a 87% 8-year survival

Teva. (2012). Synribo

Injection: Highlights of Prescribing Information. North Wales, Pa.: Teva pharmaceuticals USA.

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SLIDE 5

CML Pathophysiology

Teva MOA video. www.synribo hcp.com/MO A_Video.aspx

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SLIDE 6

CML Pathophysiology

Teva MOA video. www.synribo hcp.com/MO A_Video.aspx

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SLIDE 7

CML Pathophysiology

Teva MOA video. www.synribo hcp.com/MO A_Video.aspx

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SLIDE 8

CML Pathophysiology

Teva MOA video. www.synribo hcp.com/MO A_Video.aspx

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SLIDE 9

CML Pathophysiology

CML animation

Teva MOA video. www.synribo hcp.com/MO A_Video.aspx

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SLIDE 10

Synribo Background

Generic Name: Omacetaxine mepesuccinate Pharmacologic Category: Cephalotaxine ester Mechanism of Action: A reversible protein synthesis inhibitor used to reduce levels of BCR-ABL proteins. Indication: Chronic or accelerated stage Chronic myeloid leukemia (CML)

– In patients resistant or intolerant to 2+ tyrosine kinase inhibitors (3rd line agent)

Teva. (2012). Synribo Injection: Highlights of

Prescribing Information. North Wales, Pa.: Teva pharmaceuticals USA.

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SLIDE 11

Synribo MOA

Teva MOA video. www.synribo hcp.com/MO A_Video.aspx

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SLIDE 12

Synribo MOA

Teva MOA video. www.synribo hcp.com/MO A_Video.aspx

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SLIDE 13

CML Phases

Chronic

Myeloblasts <10% of WBCs
Asymptomatic
Therapeutically responsive
Majority of diagnosed patients

Accelerated

Myeloblasts 10-19% of WBCs
Symptomatic
Basophils ≥ 20% of blood cells
High/Low platelet count
Cytogenetic abnormalities

Blast

Myeloblast ≥ 20% of WBCs
Symptomatic
Post-marrow myeloblast division
Clusters of myeloblasts in bone marrow
Worst; like acute leukemia

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SLIDE 14

Synribo Dosing

Induction: 1.25 mg/m2 SQ twice daily for 14 days of 28 day treatment cycle

– Induction treatment cycles are continued until complete hematologic response is reached

Maintenance: 1.25 mg/m2 SQ twice daily for 7 days of 28 day treatment cycle

– Maintenance therapy is lifelong

Missed Dose: Skip missed dose and continue with next scheduled dose Renal Impairment Adjustment: None Hepatic Impairment Adjustment: None

Teva. (2012). Synribo Injection: Highlights of Prescribing Information. North

Wales, Pa.: Teva pharmaceuticals USA.

Complete hematologic response

WBC < 10,000 cells/uL
Platelet count < 450x109 cells/L
No immature cells in blood
No sign, symptoms of disease

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SLIDE 15

Synribo Calculations

BSA Equation – Mosteller Calculations done through

Synribo website:

www.synribohcp.com

Image: https://www.medicines.org.uk/emc/images/spc~12843~16~IMAGE001.JPG

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SLIDE 16

Synribo Calculations

Rounding

– Round to practical doses (100th decimal place) given the accuracy of 1 mL syringe – Example: 0.65 mL

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SLIDE 17

Synribo Label

SIG: Inject 1 pre-filled syringe (1.74mg/0.49ml) subcutaneously twice daily Dispensed: Partials dispensed instead of full quantity

– Depends on expiration time of medications – Depends on weekends

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SLIDE 18

Calendar Example

Induction Dosing

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Calendar Example

Maintenance Dosing

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SLIDE 20

Synribo Dosing Adjustments

Toxicity

– Neutropenia Grade 4 (ANC < 500/mm3) – Thrombocytopenia Grade 3+ (platelets < 50,000/mm3)

Adjustment

– Delay cycle until ANC ≥ 1000/mm3 and platelets ≥ 50,000/mm3 – Next treatment cycle is shortened by 2 days

Teva. (2012). Synribo Injection:

Highlights of Prescribing Information. North Wales, Pa.: Teva pharmaceuticals USA.

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SLIDE 21

Synribo Side Effects

Common (> 20% of studied patients): – Thrombocytopenia, neutropenia, anemia, lymphopenia, diarrhea, nausea, fatigue, asthenia, injection site reactions, pyrexia, and infection Serious (≥ 5% in chronic phase): – Thrombocytopenia, febrile neutropenia, bone marrow failure, and infections Serious (≥ 5% in accelerated phase): – Thrombocytopenia, febrile neutropenia, anemia, diarrhea, and infections

Teva. (2012). Synribo Injection:

Highlights of Prescribing Information. North Wales, Pa.: Teva pharmaceuticals USA.

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SLIDE 22

Synribo ADR Reporting

Page 1 – Overview of event Mandatory reporting of all events to Teva Teva requires all events to be warm transferred to them, and if not able to then fill out form 1-800-696-0192

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SLIDE 23

Synribo ADR Reporting

Page 2 – Details Have 24 hours to finish report if did not warm transfer

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SLIDE 24

Synribo How Supplied

Comes in an 8 mL single use vial that contains 3.5 mg of SYNRIBO Reconstituted with 1 mL 0.9% NS for a final concentration of 3.5 mg/mL at Compounding Center (NCC)

– Should be made in healthcare facility and must be reconstituted by healthcare professional

Shipped to patients as prefilled syringe(s) with supplemental kits following specific packing instructions for next-day delivery

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SLIDE 25

Synribo Enrollment Form

Requires prescriber signatures Patient signature for study but not required to fill Things to watch out for: Height and weight to verify BSA Most recent CML treatment Discontinuation reasons Dose greater than 1 mL require more than one vial Refills (yes/no)

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SLIDE 26

Initial Patient Support and Education

Topics covered by

ncology nurse:

– At time of first shipment:

Introduction to program
Therapy history
Drug education (dosing,

administration, ADE screening)

Importance of adherence
Missed dose protocol
Side effect management

– Within 7 days of first dose:

ADE screening and management
Importance of adherence

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SLIDE 27

Long-Term Patient Support and Education

Topics covered by oncology nurse:

– Prior to every maintenance cycle for first 6 months:

Recommendations
ADE screening and

management

– At interruptions of therapy:

Reason for self-discontinuation
Counselling to find a resolution
Documentation of report sent to

physician

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SLIDE 28

SYNCare™

Program designed to support patients with their at-home injections Exclusivity with Diplomat Specialty Pharmacy to distribute Synribo Diplomat’s responsibilities ranges from ensuring custom preparation

f each Synribo dose by a

healthcare professional to direct delivery to the patient’s home

– Synribo shipped in prefilled syringe and needle, all in a plastic tray

Chavis, Ryan. "Teva Launches SYNCareTM to Support Patients Taking Synribo." Drug Store News 3 Sept. 2014. Web. 26 Sept. 2014. <http://www.drugstorenews.com/article/teva- launches-syncaretm-support-patients-taking- synribo>.

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SLIDE 29

SYNCare™

Protocol to switch Rx from vial to Syringe

– How to tell if can be switched

Reconstituted solution means

Syringes

Enrollment form means syringes
Assume syringe unless proven otherwise

– Who is expected to address possibility of switch with patient and MD

Entry Tech
CHD
Onboarding

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SLIDE 30

SYNCare™

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SYNCare™

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SLIDE 32

SYNCare™

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SLIDE 33

Synribo Shipment

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SLIDE 34

Synribo Kits

Induction and Maintenance Cycle Synribo supply kit: First fill of the month Shipment

40 absorbent pads 40 pairs of sterile gloves 40 alcohol pads 40 2”x2” gauze pads 40 Adhesive bandages Teva and Diplomat print material

First shipment ever and a la carte

1 chemo spill kit 1 set of protective goggles One 3 gallon biohazard sharps container

Refill for that month Shipment

Teva and Diplomat print materials

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SLIDE 35

Instructions for Use

Step 1: Preparing work

area and the patient for administration

Step 2: Choose and

prepare injection site

Teva. (2012). Synribo Injection:

Highlights of Prescribing

Information. North Wales, Pa.:

Teva pharmaceuticals USA.

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SLIDE 36

Instructions for Use

Step 3: Inject Synribo Step 4: Disposal of syringe, needle, and

ther supplies
Teva. (2012). Synribo Injection: Highlights of

Prescribing Information. North Wales, Pa.: Teva pharmaceuticals USA.

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SLIDE 37

FAQ

Administration limitations?

– No limits on food

Storage Requirements

– Available for use within 6 days (144 hours) if refrigerated (23⁰F to 46⁰F) – Available for use within 12 hours if at room temperature (not to exceed 77⁰F)

Teva. (2012). Synribo Injection:

Highlights of Prescribing

Information. North Wales, Pa.:

Teva pharmaceuticals USA.

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SLIDE 38

FAQ

Fulfillment of prescription and Refills

– Calendar depends on next dose (AM vs PM) – AM dose is shipped 1 day prior to start of therapy and second shipment on Day 2 of therapy – PM dose is shipped day before the start of therapy and second shipment on Day 3 of therapy

Teva. (2012). Synribo Injection:

Highlights of Prescribing

Information. North Wales, Pa.:

Teva pharmaceuticals USA.

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SLIDE 39

FAQ

How full is full for the biohazard sharps container?

– Replace when ¾ full

How do I travel with Synribo?

– With a soft sided cooler with gel packs for freezing – Copy of Synribo prescription for TSA

Teva. (2012). Synribo Injection:

Highlights of Prescribing

Information. North Wales, Pa.:

Teva pharmaceuticals USA.

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SLIDE 40

Questions?

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