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n e i z d o h c y z r P z s a k u L f o y t r e p o r P n e i z d o h c y z r P z s a k Lukasz u L Przychodzien f 2015 PharmD o Candidate y t r e p Philadelphia o College of r P Pharmacy

  1. n e i z d o h c y z r P z s a k u L f o y t r e p o r P

  2. n e i z d o h c y z r P z s a k Lukasz u L Przychodzien f 2015 PharmD o Candidate y t r e p Philadelphia o College of r P Pharmacy

  3. n e Objectives i z d o h c Discuss Synribo with its y characteristics and clinical pearls z r P z Assess Diplomat’s reconstitution s procedure for Synribo a k u Analyze the verification process L of Diplomat to ensure patient f o administration and adherence y t r e Discuss potential patient’s p questions of interest o r P

  4. n e i z Chronic Myeloid Leukemia (CML) d o h c Classification: CML is the rarest y form of leukemia (cancer of the z r blood) P Pathophysiology: Starts in the z bone marrow and disrupts s a production of normal blood cells: k leading to anemia, bleeding, and u infections L f Genetics: Caused by a genetic o translocation that creates the y BCR-ABL fusion gene, aka the t r e “Philadelphia chromosome” p Mortality: CML patients have a o Teva. (2012). Synribo Injection: Highlights of r 87% 8-year survival P Prescribing Information. North Wales, Pa.: Teva pharmaceuticals USA.

  5. n e i CML Pathophysiology z d o h c y z r P z s a k u L f o y t r e Teva MOA p video. o www. synribo hcp.com/ MO r A _ Video .aspx P

  6. n e i CML Pathophysiology z d o h c y z r P z s a k u L f o y t r e Teva MOA p video. o www. synribo hcp.com/ MO r A _ Video .aspx P

  7. n e i CML Pathophysiology z d o h c y z r P z s a k u L f o y t r e Teva MOA p video. o www. synribo hcp.com/ MO r A _ Video .aspx P

  8. n e i CML Pathophysiology z d o h c y z r P z s a k u L f o y t r e Teva MOA p video. o www. synribo hcp.com/ MO r A _ Video .aspx P

  9. n e i CML Pathophysiology z d o h c y CML animation z r P z s a k u L f o y t r e p Teva MOA o video. r www. synribo P hcp.com/ MO A _ Video .aspx

  10. n e i Synribo Background z d o h c Generic Name: Omacetaxine y mepesuccinate z r Pharmacologic Category: P Cephalotaxine ester z s Mechanism of Action: A a reversible protein synthesis k inhibitor used to reduce levels of u L BCR-ABL proteins. f Indication: Chronic or accelerated o stage Chronic myeloid leukemia y t (CML) r e – In patients resistant or intolerant to p 2+ tyrosine kinase inhibitors (3 rd line o r agent) Teva. (2012). Synribo Injection: Highlights of P Prescribing Information. North Wales, Pa.: Teva pharmaceuticals USA.

  11. n e i z Synribo MOA d o h c y z r P z s a k u L f o y t r e Teva MOA p video. o www. synribo hcp.com/ MO r A _ Video .aspx P

  12. n e i z Synribo MOA d o h c y z r P z s a k u L f o y t r e Teva MOA p video. o www. synribo hcp.com/ MO r A _ Video .aspx P

  13. n e i CML Phases z d o h • Myeloblasts <10% of WBCs c • Asymptomatic y z • Therapeutically responsive Chronic r • Majority of diagnosed patients P z s • Myeloblasts 10-19% of WBCs a • Symptomatic k • Basophils ≥ 20% of blood cells u • High/Low platelet count L Accelerated • Cytogenetic abnormalities f o y • Myeloblast ≥ 20% of WBCs t r • Symptomatic e • Post-marrow myeloblast division p Blast • Clusters of myeloblasts in bone marrow o • Worst; like acute leukemia r P

  14. n e i Synribo Dosing z d o h Induction: 1.25 mg/m 2 SQ twice daily for c 14 days of 28 day treatment cycle y z – Induction treatment cycles are continued r until complete hematologic response is P reached z s Maintenance: 1.25 mg/m 2 SQ twice daily a for 7 days of 28 day treatment cycle k u – Maintenance therapy is lifelong Complete hematologic response L -WBC < 10,000 cells/uL f Missed Dose: Skip missed dose and -Platelet count < 450x10 9 cells/L o continue with next scheduled dose -No immature cells in blood y t -No sign, symptoms of disease r Renal Impairment Adjustment: None e p o Hepatic Impairment Adjustment: None r P Teva. (2012). Synribo Injection: Highlights of Prescribing Information. North Wales, Pa.: Teva pharmaceuticals USA.

  15. n e i Synribo Calculations z d o h c y BSA Equation – Mosteller z r P z s a k u Calculations done through L f • Synribo website: o www.synribohcp.com y t r e p o r P Image: https://www.medicines.org.uk/emc/images/spc~12843~16~IMAGE001.JPG

  16. n e i Synribo Calculations z d o h c y Rounding z r P – Round to practical doses (100 th z decimal place) given the s accuracy of 1 mL syringe a k – Example: 0.65 mL u L f o y t r e p o r P

  17. n e i Synribo Label z d o h c y z SIG: Inject 1 pre-filled syringe r P (1.74mg/0.49ml) z subcutaneously twice daily s a k u Dispensed: Partials L dispensed instead of full f o quantity y t r – Depends on expiration time of e medications p o – Depends on weekends r P

  18. n e i Calendar Example z d o h c y z Induction Dosing r P z s a k u L f o y t r e p o r P

  19. n e i Calendar Example z d o h c y z Maintenance Dosing r P z s a k u L f o y t r e p o r P

  20. n Synribo Dosing e i z d Adjustments o h c Toxicity y z – Neutropenia Grade 4 r P (ANC < 500/mm 3 ) – Thrombocytopenia Grade 3+ z s (platelets < 50,000/mm 3 ) a k u Adjustment L – Delay cycle until ANC ≥ f o 1000/mm 3 and platelets ≥ y 50,000/mm 3 t r e – Next treatment cycle is p shortened by 2 days o Teva. (2012). Synribo Injection: r Highlights of Prescribing Information. P North Wales, Pa.: Teva pharmaceuticals USA.

  21. n e i Synribo Side Effects z d o h c y Common (> 20% of studied patients): z r – Thrombocytopenia, neutropenia, P anemia, lymphopenia, diarrhea, z nausea, fatigue, asthenia, injection s a site reactions, pyrexia, and infection k Serious (≥ 5% in chronic phase): u L – Thrombocytopenia, febrile f neutropenia, bone marrow failure, o and infections y t Serious (≥ 5% in accelerated phase): r e – Thrombocytopenia, febrile p o neutropenia, anemia, diarrhea, and Teva. (2012). Synribo Injection: r Highlights of Prescribing Information. P infections North Wales, Pa.: Teva pharmaceuticals USA.

  22. n e Synribo ADR Reporting i z d o h c y z r P z s a k u Page 1 – Overview of event L f Mandatory reporting of all o events to Teva y t r e Teva requires all events to be p warm transferred to them, and o r if not able to then fill out form P 1-800-696-0192

  23. n e i Synribo ADR Reporting z d o h c y z r P z s a k u Page 2 – Details L f o Have 24 hours to y finish report if did t r not warm transfer e p o r P

  24. n e i Synribo How Supplied z d o h c Comes in an 8 mL single use vial y that contains 3.5 mg of SYNRIBO z r P Reconstituted with 1 mL 0.9% NS z s for a final concentration of 3.5 a mg/mL at Compounding Center k (NCC) u L – Should be made in healthcare facility and must be reconstituted by f o healthcare professional y t r Shipped to patients as prefilled e syringe(s) with supplemental kits p o following specific packing r instructions for next-day delivery P

  25. n e i Synribo Enrollment Form z d o h c y z r P z s a k Requires prescriber signatures u Patient signature for study but not L required to fill f o Things to watch out for: Height and weight to verify y t BSA r e Most recent CML treatment p Discontinuation reasons o Dose greater than 1 mL require r P more than one vial Refills (yes/no)

  26. n e Initial Patient Support and i z d Education o h c y Topics covered by z r P oncology nurse: z – At time of first shipment: s a • Introduction to program k • Therapy history u L • Drug education (dosing, administration, ADE screening) f o • Importance of adherence y t • Missed dose protocol r e • Side effect management p – Within 7 days of first dose: o r P • ADE screening and management • Importance of adherence

  27. n e Long-Term Patient Support i z d and Education o h c y Topics covered by oncology z r nurse: P – Prior to every maintenance z s cycle for first 6 months: a k • Recommendations u L • ADE screening and f management o – At interruptions of therapy: y t r • Reason for self-discontinuation e p • Counselling to find a resolution o • Documentation of report sent to r P physician

  28. n e i SYNCare™ z d o h c Program designed to support y z patients with their at-home r injections P z s Exclusivity with Diplomat Specialty a Pharmacy to distribute Synribo k u L Diplomat’s responsibilities ranges f o from ensuring custom preparation of each Synribo dose by a y Chavis, Ryan. "Teva Launches SYNCareTM to t healthcare professional to direct Support Patients Taking Synribo." Drug Store r News 3 Sept. 2014. Web. 26 Sept. 2014. e delivery to the patient’s home <http://www.drugstorenews.com/article/teva- p launches-syncaretm-support-patients-taking- – Synribo shipped in prefilled syringe synribo>. o and needle, all in a plastic tray r P

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