Hospital Pharmacy - October 2017 - 603
Ali and Baker
not statistically significant, and subsequent end points,
including change in SF-36 quality-of-life PCS score and
measure of no evidence of disease activity, were considered nominally different, but nonconfirmatory.
Contraindications, Warnings, and
Precautions
Contraindications
Ocrelizumab is contraindicated in patients with active hepatitis B virus (HBV) infection, as well as in patients with a
history of a life-threatening infusion reaction to ocrelizumab.
Another potential contraindication is hypersensitivity to
ocrelizumab or to any of its inactive ingredients.1
Warnings and Precautions
Infusion reactions were reported in patients treated with
ocrelizumab, despite pretreatment with methylprednisolone
(or an equivalent steroid) and other premedications. Infusion
reactions included pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, oropharyngeal pain, dyspnea,
pharyngeal or laryngeal edema, flushing, hypotension,
pyrexia, fatigue, headache, dizziness, nausea, and tachycardia, and were reported in 34% to 40% of patients in clinical
trials, with the highest incidence occurring with the first
infusion. Infusion reactions can also occur up to 24 hours
after completion of the infusion. None of the reported infusion reactions were fatal, but hospitalization was required by
0.3% of patients who had an infusion reaction. Premedication
with methylprednisolone (or an equivalent steroid) and an
antihistamine (eg, diphenhydramine) 30 minutes prior to
each infusion may be administered to reduce the frequency
and severity of infusion reactions; addition of an antipyretic
(eg, acetaminophen) may also be considered. For mild to
moderate reactions, management may involve temporarily
stopping the infusion, reducing the infusion rate, and/or
administering symptomatic treatment. Ocrelizumab must be
discontinued permanently in patients who experience a lifethreatening infusion reaction.1
Ocrelizumab may increase the risk of infections, including upper and lower respiratory tract infections, skin infections, and herpes-related infections. The infection rate was
70% with ocrelizumab compared with 68% with placebo in a
PPMS trial, and was 58% with ocrelizumab versus 52% with
interferon beta-1a in relapsing MS trials. Respiratory tract
infections were mostly mild to moderate, consisting mainly
of upper respiratory tract infections and bronchitis. Herpes
infections included herpes zoster, herpes simplex, oral herpes, genital herpes, and herpes virus infection, but were
mostly mild to moderate in severity; there were no reports of
disseminated herpes.1
There were no reports of PML in clinical trials. Patients
treated with anti-CD20 antibodies may be at risk for this
603
viral infection, and ocrelizumab therapy should be withheld
at the first sign or symptom of PML (eg, progressive unilateral weakness; clumsiness of limbs; vision abnormalities;
changes in thinking, memory, and orientation leading to confusion; personality changes).1
There were no reports of HBV reactivation in patients
treated with ocrelizumab. Patients treated with anti-CD20
antibodies may be at increased risk for fulminant hepatitis,
hepatic failure, and death caused by HBV reactivation. HBV
screening is required for all patients prior to starting ocrelizumab. Active HBV must be confirmed with positive results
for hepatitis B serum antigen (HBsAg) and anti-hepatitis B
tests; liver disease experts may be consulted before starting
ocrelizumab if patients test negative for HBsAg but are positive for hepatitis B core antibody (HBcAb+) or are carriers of
HBV (HBsAg+).1
There is an increased risk of additive immunosuppression
if ocrelizumab is used concurrently with other immunosuppressive therapies, or if it is started after immunosuppressive
therapy.1
Concurrent use of live vaccines is not recommended with
ocrelizumab. Administer all vaccines, live or live-attenuated,
at least 6 weeks prior to initiating therapy. There are no data
on the effects of nonlive vaccines in patients receiving
ocrelizumab.1
Malignancies, including breast cancer, were reported with
higher frequency in patients treated with ocrelizumab. Breast
cancer occurred in 0.77% of patients treated with ocrelizumab and in 0% of patients treated with interferon beta-1a
or placebo. Patients should be monitored for breast cancer
using standard breast cancer screening guidelines.1
Ocrelizumab is a humanized monoclonal antibody with
the potential to cross the placental barrier. Although there
are no human data on the effects of ocrelizumab in human
neonates following maternal exposure, transient peripheral
B-cell depletion and lymphocytopenia have been reported
in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy. In addition, perinatal deaths
(some associated with bacterial infections), renal toxicity
(glomerulopathy and inflammation), lymphoid follicle formation in the bone marrow, and severe reductions in circulating B-lymphocytes in neonates were seen in embryofetal
and pre- and postnatal development studies in monkeys.
Women of childbearing potential should use contraception
during treatment and for 6 months after the last infusion of
ocrelizumab.1
There are no data on the presence of ocrelizumab in
human breast milk, or its effects on breastfeeding infants or
milk production. Ocrelizumab was detected in the milk of
treated monkeys. Potential adverse effects on infant development should be weighed against the clinical benefits of ocrelizumab use for the mother.1
In clinical trials, the small subset of patients 65 years of
age and older was not sufficient to determine age-related differences in the safety and efficacy of ocrelizumab.1
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 - 585
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
Hospital Pharmacy - October 2017 - 595
Hospital Pharmacy - October 2017 - Formulary Drug Review
Hospital Pharmacy - October 2017 - Ocrelizumab
Hospital Pharmacy - October 2017 - 598
Hospital Pharmacy - October 2017 - 599
Hospital Pharmacy - October 2017 - 600
Hospital Pharmacy - October 2017 - 601
Hospital Pharmacy - October 2017 - 602
Hospital Pharmacy - October 2017 - 603
Hospital Pharmacy - October 2017 - 604
Hospital Pharmacy - October 2017 - Patient Outcomes Associated With Phenobarbital Use With or Without Benzodiazepines for Alcohol Withdrawal Syndrome: A Systematic Review
Hospital Pharmacy - October 2017 - 606
Hospital Pharmacy - October 2017 - 607
Hospital Pharmacy - October 2017 - 608
Hospital Pharmacy - October 2017 - 609
Hospital Pharmacy - October 2017 - 610
Hospital Pharmacy - October 2017 - 611
Hospital Pharmacy - October 2017 - 612
Hospital Pharmacy - October 2017 - 613
Hospital Pharmacy - October 2017 - 614
Hospital Pharmacy - October 2017 - Development of a Pharmacy Technician–Driven Program to Improve Vaccination Rates at an Academic Medical Center
Hospital Pharmacy - October 2017 - 616
Hospital Pharmacy - October 2017 - 617
Hospital Pharmacy - October 2017 - 618
Hospital Pharmacy - October 2017 - 619
Hospital Pharmacy - October 2017 - 620
Hospital Pharmacy - October 2017 - Safety and Efficacy of Enoxaparin Compared With Unfractionated Heparin for Venous Thromboembolism Prophylaxis in Hemodialysis Patients
Hospital Pharmacy - October 2017 - 622
Hospital Pharmacy - October 2017 - 623
Hospital Pharmacy - October 2017 - 624
Hospital Pharmacy - October 2017 - 625
Hospital Pharmacy - October 2017 - Multilayer Model of Pharmacy Participation in the Antimicrobial Stewardship Program at a Large Academic Medical Center
Hospital Pharmacy - October 2017 - 627
Hospital Pharmacy - October 2017 - 628
Hospital Pharmacy - October 2017 - 629
Hospital Pharmacy - October 2017 - 630
Hospital Pharmacy - October 2017 - 631
Hospital Pharmacy - October 2017 - 632
Hospital Pharmacy - October 2017 - Impact of Inpatient Automatic Therapeutic Substitutions on Postdischarge Medication Prescribing
Hospital Pharmacy - October 2017 - 634
Hospital Pharmacy - October 2017 - 635
Hospital Pharmacy - October 2017 - 636
Hospital Pharmacy - October 2017 - 637
Hospital Pharmacy - October 2017 - Impact of Respiratory Viral Panel Polymerase Chain Reaction Assay Turnaround Time on Length of Stay and Antibiotic Use in Patients With Respiratory Viral Illnesses
Hospital Pharmacy - October 2017 - 639
Hospital Pharmacy - October 2017 - 640
Hospital Pharmacy - October 2017 - 641
Hospital Pharmacy - October 2017 - 642
Hospital Pharmacy - October 2017 - Administration of Injectable Vitamin K Orally
Hospital Pharmacy - October 2017 - 644
Hospital Pharmacy - October 2017 - 645
Hospital Pharmacy - October 2017 - 646
Hospital Pharmacy - October 2017 - 647
Hospital Pharmacy - October 2017 - 648
Hospital Pharmacy - October 2017 - 649
Hospital Pharmacy - October 2017 - 650
Hospital Pharmacy - October 2017 - 651
Hospital Pharmacy - October 2017 - 652
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