Presentation Outline ICHP Annual Meeting September 13-15
Presentation Outline ICHP Annual Meeting September 13-15
Presentation Outline ICHP Annual Meeting September 13-15
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Oncology » MTX Toxicity<br />
• MTX 1o kidney excretion<br />
• High dose<br />
– nephrotoxicity<br />
– Bone marrow suppression<br />
– Oral/GI ulceration<br />
– Liver toxicity<br />
• Goal: Reduce toxicity<br />
• Options: leucovorin, IV hydration,<br />
urine alkalinization … & …<br />
Reference: The Medical Letter 2012; <strong>13</strong>85:19.<br />
This presentation is provided for educational purposes only. Consult product specific prescribing information prior to application in the clinical setting.<br />
Graphics sourced from Google Image are used for educational purposes and may be protected by copyright law (Title 17 U.S. Code)<br />
©2012, Anovation, Inc. All rights reserved.<br />
Self‐Assessment 8<br />
Glucarpidase (VORAXAZE)<br />
1. Is a monoclonal antibody that lowers toxic<br />
methotrexate concentrations.<br />
22. Is usually ll well ll tolerated, l d but b can cause<br />
serious anaphylactic reactions.<br />
3. Can be stored for 24 hours after<br />
reconstitution, if refrigerated.<br />
4. All of the above.<br />
This presentation is provided for educational purposes only. Consult product specific prescribing information prior to application in the clinical setting.<br />
Graphics sourced from Google Image are used for educational purposes and may be protected by copyright law (Title 17 U.S. Code)<br />
©2012, Anovation, Inc. All rights reserved.<br />
pertuzumab<br />
PERJETA<br />
• Recombinant humanized mAb against HER2 receptor<br />
• Combo w/ trastuzumab and docetaxel for HER2+<br />
metastatic breast CA w/o prior metastatic tx; different<br />
binding site than trastuzumab<br />
• RMCDBPC Trial (CLEOPATRA), 808 pts” +6.1 mo PFS<br />
• Safety endpoints: febrile neutropenia, ↓sLVEF<br />
• 840 mg over 60 min i IV IV, then h 420mg 420 over 30‐60 30 60 min i q3w 3<br />
• Modify dose for delayed/missed doses, LVEF < 40%,<br />
trastuzumab hold/DC<br />
• Observe pt 60 min p/ #1, 30 min p/ subsequent infusions<br />
• Dilute in 250 mL NS, refrigerate x 24h –do NOT use D5W<br />
• Pt Ed: pregnancy prevention, pregnancy registry<br />
• HER2 status, pregnancy test, LVEF q3m, infusion<br />
reactions<br />
• $4075/vial<br />
References: (a) PERJETA (pertuzumab) [package insert]. South San Francisco CA: Genentech, Inc., May 2012. (b) Pertuzumab (Perjeta) for<br />
HER2‐Positive Metastatic Breast Cancer. The Medical Letter 2012; 54(<strong>13</strong>950:59. (c) Micromedex v<strong>15</strong>35, Accessed 8/7/2012.<br />
This presentation is provided for educational purposes only. Consult product specific prescribing information prior to application in the clinical setting.<br />
Graphics sourced from Google Image are used for educational purposes and may be protected by copyright law (Title 17 U.S. Code)<br />
©2012, Anovation, Inc. All rights reserved.<br />
25/34<br />
27/34<br />
Approved 6/8/2012<br />
Pregnancy<br />
Category D<br />
IV<br />
NOT FOR USE<br />
IN CHILDREN<br />
Keep in Refrigerator<br />
DO NOT FREEZE<br />
Mix Gently<br />
DO NOT SHAKE<br />
PROTECT<br />
��<br />
FROM LIGHT<br />
No Preservatives<br />
DISCARD unused portion<br />
29/34<br />
glucarpidase<br />
VORAXAZE®<br />
• Recombinant enzyme for toxic [MTX]<br />
– Converts to glutamate & DAMPA<br />
• 2 unpublished (PI) single‐arm, open‐label studies<br />
– Endpt: RSCIR [MTX] < 1 mcmol @ <strong>15</strong> min x 8 days; > 95%<br />
↓[MTX]<br />
– Safety data available for 290 pts; only 22 evaluated for<br />
efficacy<br />
• ADRs –rare serious allergic reactions; generally well<br />
tolerated<br />
• Continue leukovorin (not w/in 2h) &<br />
hydration/alkalinization<br />
• Preparation: reconstitute w/ 1 mL SWI; use w/in 4h if<br />
Refrig<br />
• Dose: 50 units/kg IV bolus over 5 minutes<br />
• Monitor: [MTX] normalization<br />
References: (a) VORAXAZE® (glucarpidase) [package insert]. West Conshohocken PA: BTG International, Inc.; January 2012. (b) The Medical Letter<br />
2012; <strong>13</strong>85:19. (c) Micromedex v<strong>15</strong>34, Accessed 7/27/2012.<br />
This presentation is provided for educational purposes only. Consult product specific prescribing information prior to application in the clinical setting.<br />
Graphics sourced from Google Image are used for educational purposes and may be protected by copyright law (Title 17 U.S. Code)<br />
©2012, Anovation, Inc. All rights reserved.<br />
Oncology » Breast Cancer<br />
Approved 1/17/2012<br />
Pregnancy<br />
Category C<br />
8/30/2012<br />
IV<br />
Keep in Refrigerator<br />
DO NOT FREEZE<br />
No Preservatives<br />
DISCARD unused portion<br />
• HER2 overexpression in 20% of breast cancers<br />
• More aggressive, worse prognosis before HER2‐<br />
targeted therapies (trastuzumab)<br />
• After 20 yrs of increasing incidence, now decreasing<br />
– Reduced use of HRT<br />
• 207,090 new F cases/yr in US (2010), 1970 new M<br />
• 39,840 F deaths in US (2010), 390 M deaths<br />
• Treatment Options; surgery for early‐stage, adjuvant<br />
therapy for micrometastasis.<br />
• HER2‐targeted therapies: trastuzumab, lapatinib …<br />
now … pertuzumab<br />
Reference: Breast Cancer. Emedicine.medscape.com. August 1, 2012.<br />
This presentation is provided for educational purposes only. Consult product specific prescribing information prior to application in the clinical setting.<br />
Graphics sourced from Google Image are used for educational purposes and may be protected by copyright law (Title 17 U.S. Code)<br />
©2012, Anovation, Inc. All rights reserved.<br />
Self‐Assessment 9<br />
Pertuzumab (PERJETA) …<br />
1. Is a recombinant monoclonal antibody<br />
against the HER2 receptor.<br />
22. Fits i on a diff different HER2 2 bi binding di site i than h<br />
trastuzumab (HERCEPTIN).<br />
3. Should not be diluted into D5W.<br />
4. All of the above.<br />
This presentation is provided for educational purposes only. Consult product specific prescribing information prior to application in the clinical setting.<br />
Graphics sourced from Google Image are used for educational purposes and may be protected by copyright law (Title 17 U.S. Code)<br />
©2012, Anovation, Inc. All rights reserved.<br />
26/34<br />
28/34<br />
30/34<br />
5
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