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Ali and Baker
Table 1. Ocrelizumab Dose Modifications to Manage Infusion-Related Reactions.1
Severity of infusion reaction
Mild to moderate infusion reactions
Severe infusion reactions

Life-threatening infusion reactions

Recommendation
The infusion rate may be reduced to half the rate and maintained at the reduced rate for at
least 30 minutes; the rate may then be increased by 30 mL/h every 30 minutes for the initial
dose, or by 40 mL/h every 30 minutes for the subsequent doses.
Interrupt the infusion and administer supportive treatment; restart the infusion only upon
symptom resolution. When restarting the infusion, begin at half the infusion rate at the time
of onset of infusion reaction. The infusion rate may then be increased as described for mild
to moderate infusion reactions.
Immediately stop the infusion and provide appropriate supportive care. Ocrelizumab must be
discontinued permanently in patients who experience life-threatening infusion reactions.

Drug Safety/Risk Evaluation and
Mitigation Strategy (REMS)
No REMS is required for ocrelizumab.1,2

6.

Conclusion
Ocrelizumab is a humanized anti-CD20 monoclonal antibody approved for the treatment of relapsing and progressive
forms of MS. It can reduce time to disease progression and
was more effective than interferon beta-1a in clinical trials.
No other anti-CD20 agent is currently approved for the treatment of MS. Preliminary results of studies in which ocrelizumab was administered IV every 24 weeks indicate
beneficial clinical effects that are sustained over 96 weeks of
treatment.

7.

8.

Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect
to the research, authorship, and/or publication of this article.

9.

Funding

10.

The author(s) received no financial support for the research, authorship, and/or publication of this article.

11.

References
1. Ocrevus (ocrelizumab) [prescribing information]. South San
Francisco, CA: Genentech Inc; March 2017.
2. Temple R. BLA approval letter: ocrelizumab (BLA 761053).
Food and Drug Administration. https://www.accessdata.fda.
gov/drugsatfda_docs/appletter/2017/761053Orig1s000ltr.pdf.
Published March 28, 2017. Accessed May 1, 2017.
3. Hauser SL, Bar-Or A, Comi G, et al; OPERA I and OPERA
II Clinical Investigators. Ocrelizumab versus interferon
beta-1a in relapsing multiple sclerosis. N Engl J Med.
2017;376(3):221-234.
4. Montalban X, Hauser SL, Kappos L, et al; ORATORIO Clinical
Investigators. Ocrelizumab versus placebo in primary progressive multiple sclerosis. N Engl J Med. 2017;376(3):209-220.
5. Wolinsky J, Arnold DL, Bar-Or A, et al. Ocrelizumab efficacy
in PPMS patients in the presence/absence of T1 gadoliniumenhancing lesions at baseline in a phase III, placebo-controlled

12.

13.

14.

trial [abstract]. 2016 Consortium of Multiple Sclerosis Centers
Annual Meeting; June 1-4, 2016; National Harbor, MD. https://
cmsc.confex.com/cmsc/2016/webprogram/Paper4221.html.
Poster DX06. Accessed September 28, 2016.
Goodin DS, Frohman EM, Garmany GP Jr, et al; Therapeutics
and Technology Assessment Subcommittee of the American
Academy of Neurology and the MS Council for Clinical
Practice Guidelines. Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology
Assessment Subcommittee of the American Academy of
Neurology and the MS Council for Clinical Practice Guidelines
[published correction appears in Neurology. 2002;59(3):480].
Neurology. 2002;58(2):169-178.
National Institute for Health and Care Excellence. Multiple
sclerosis in adults: management. http://nice.org.uk/guidance/
cg186. Published October 8, 2014. Accessed November 9,
2016.
Straus Farber R, Harel A, Lublin F. Novel agents for relapsing forms of multiple sclerosis. Annu Rev Med. 2016;67:309321.
Sturm D, Gurevitz SL, Turner A. Multiple sclerosis: a
review of the disease and treatment options. Consult Pharm.
2014;29(7):469-479.
Milo R. Therapeutic strategies targeting B-cells in multiple
sclerosis. Autoimmun Rev. 2016;15(7):714-718.
Phase 3 ofatumumab multiple sclerosis. ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/results?term=phase+3+ofatumumab
+multiple+sclerosis&Search=Search. Accessed September 28,
2016.
Kappos L, Li D, Calabresi PA, et al. Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet. 2011;378(9805):
1779-1787.
Hoffmann-La Roche. A study of ocrelizumab in participants
with primary progressive multiple sclerosis. ClinicalTrials.
gov. https://clinicaltrials.gov/ct2/show/NCT01194570. Updated
October 17, 2016. Accessed November 9, 2016.
Montalban X, Arnold DL, Bar-Or A, et al. Infusion-related
reactions in the phase III double-blind, placebo-controlled
ORATORIO study of ocrelizumab in primary progressive
multiple sclerosis [abstract]. 2016 Consortium of Multiple
Sclerosis Centers Annual Meeting; June 1-4, 2016; National
Harbor, MD. https://cmsc.confex.com/cmsc/2016/webprogram/Paper4277.html.Poster DX62. Accessed September
20, 2016.


https://cmsc.confex.com/cmsc/2016/webprogram/Paper4221.html https://cmsc.confex.com/cmsc/2016/webprogram/Paper4221.html http://nice.org.uk/guidance/cg186 http://nice.org.uk/guidance/cg186 http://www.ClinicalTrials.gov https://www.clinicaltrials.gov/ct2/results?term=phase+3+ofatumumab+multiple+sclerosis&Search=Search https://www.clinicaltrials.gov/ct2/results?term=phase+3+ofatumumab+multiple+sclerosis&Search=Search https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761053Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761053Orig1s000ltr.pdf https://www.clinicaltrials.gov/ct2/show/NCT01194570 https://cmsc.confex.com/cmsc/2016/webprogram/Paper4277.html https://cmsc.confex.com/cmsc/2016/webprogram/Paper4277.html

Table of Contents for the Digital Edition of Hospital Pharmacy - October 2017

Pharmacists and Medical Missions
Current FDA-Related Drug Information
Summaries of Safety Labeling Changes Approved By FDA- Boxed Warnings Highlights April-June 2017
Pharmaceutical Pipeline Update
Cholesterol Ester Transfer Protein Inhibitor Review
Formulary Drug Review
Ocrelizumab
Patient Outcomes Associated With Phenobarbital Use With or Without Benzodiazepines for Alcohol Withdrawal Syndrome: A Systematic Review
Development of a Pharmacy Technician–Driven Program to Improve Vaccination Rates at an Academic Medical Center
Safety and Efficacy of Enoxaparin Compared With Unfractionated Heparin for Venous Thromboembolism Prophylaxis in Hemodialysis Patients
Multilayer Model of Pharmacy Participation in the Antimicrobial Stewardship Program at a Large Academic Medical Center
Impact of Inpatient Automatic Therapeutic Substitutions on Postdischarge Medication Prescribing
Impact of Respiratory Viral Panel Polymerase Chain Reaction Assay Turnaround Time on Length of Stay and Antibiotic Use in Patients With Respiratory Viral Illnesses
Administration of Injectable Vitamin K Orally
Hospital Pharmacy - October 2017 - 577
Hospital Pharmacy - October 2017 - 578
Hospital Pharmacy - October 2017 - 579
Hospital Pharmacy - October 2017 - 580
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Hospital Pharmacy - October 2017 - 586
Hospital Pharmacy - October 2017 - 587
Hospital Pharmacy - October 2017 - 588
Hospital Pharmacy - October 2017 - Pharmacists and Medical Missions
Hospital Pharmacy - October 2017 - Current FDA-Related Drug Information
Hospital Pharmacy - October 2017 - Summaries of Safety Labeling Changes Approved By FDA- Boxed Warnings Highlights April-June 2017
Hospital Pharmacy - October 2017 - 592
Hospital Pharmacy - October 2017 - Pharmaceutical Pipeline Update
Hospital Pharmacy - October 2017 - Cholesterol Ester Transfer Protein Inhibitor Review
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Hospital Pharmacy - October 2017 - Formulary Drug Review
Hospital Pharmacy - October 2017 - Ocrelizumab
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Hospital Pharmacy - October 2017 - 601
Hospital Pharmacy - October 2017 - 602
Hospital Pharmacy - October 2017 - 603
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Hospital Pharmacy - October 2017 - Patient Outcomes Associated With Phenobarbital Use With or Without Benzodiazepines for Alcohol Withdrawal Syndrome: A Systematic Review
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Hospital Pharmacy - October 2017 - 607
Hospital Pharmacy - October 2017 - 608
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Hospital Pharmacy - October 2017 - Development of a Pharmacy Technician–Driven Program to Improve Vaccination Rates at an Academic Medical Center
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