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Ocrevus is a brand name for Ocrelizumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ocrevus is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features (see section 5.1). Ocrevus is indicated for the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated and supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions and who have access to appropriate medical support to manage severe reactions such as serious infusion-related reactions (IRRs).
, paracetamol) may also be considered approximately 30-60 minutes prior to each infusion. Posology Initial dose The initial 600 mg dose is administered as two separate intravenous infusions; first as a 300 mg infusion, followed 2 weeks later by a second 300 mg infusion (see Table 1).
3 Subsequent doses Subsequent doses of ocrelizumab thereafter are administered as a single 600 mg intravenous infusion every 6 months (see Table 1). The first subsequent dose of 600 mg should be administered six months after the first infusion of the initial dose.
A minimum interval of 5 months should be maintained between each dose of ocrelizumab. Infusion adjustments in case of IRRs Life-threatening IRRs If there are signs of a life threatening or disabling IRR during an infusion, such as acute hypersensitivity or acute respiratory distress syndrome, the infusion must be stopped immediately and the patient should receive appropriate treatment.
3). Severe IRRs If a patient experiences a severe IRR (such as dyspnoea) or a complex of flushing, fever, and throat pain symptoms, the infusion should be interrupted immediately, and the patient should receive symptomatic treatment.
The infusion should be restarted only after all symptoms have resolved. The initial infusion rate at restart should be half of the infusion rate at the time of onset of the reaction. No infusion adjustment is necessary for subsequent new infusions, unless the patient experiences an IRR.
, headache), the infusion rate should be reduced to half the rate at the onset of the event. This reduced rate should be maintained for at least 30 minutes. If tolerated, the infusion rate may then be increased according to the patient’s initial infusion rate.
No infusion adjustment is necessary for subsequent new infusions, unless the patient experiences an IRR. Dose modifications during treatment The above examples of dose interruption and slowing (for mild/moderate and severe IRRs) will result in a change in the infusion rate and increase the total duration of the infusion, but not the total dose.
4). A total of 2,376 patients were included in the controlled period of the pivotal clinical trials; of these patients, 1,852 entered the OLE phase. All patients switched to ocrelizumab treatment during the OLE phase. 1,155 patients completed the OLE phase, resulting in approximately 10 years of continuous ocrelizumab treatment (15,515 patient-years of exposure) across the controlled period and OLE phase.
The overall safety profile observed during the controlled period and OLE phase remains consistent with that observed during the controlled period. Tabulated list of adverse reactions Adverse reactions reported in the controlled period of the pivotal clinical trials and derived from spontaneous reporting are listed below in Table 2.
The adverse reactions are listed by MedDRA system organ class and categories of frequency. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very 12 rare (< 1/10 000) and not known (cannot be estimated from the available data).
Within each System Organ Class, the adverse reactions are presented in order of decreasing frequency. Table 2 Adverse reactions MedDRA System Organ Class (SOC) Very common Common Not Known Infections and infestations Upper respiratory tract infection, nasopharyngitis, influenza Sinusitis, bronchitis, oral herpes, gastroenteritis, respiratory tract infection, viral infection, herpes zoster, conjunctivitis, cellulitis Blood and lymphatic system disorders Neutropenia Late onset of Neutropenia2 Respiratory, thoracic and mediastinal disorders Cough, catarrh Investigations Blood immunoglobulin M decreased Blood immunoglobulin G decreased Injury, poisoning and procedural complications Infusion-related reactions1 1 See Descriptions of selected adverse reactions.
2 Observed in the postmarketing setting. Description of selected adverse reactions Infusion-related reactions Across the RMS and PPMS trials, symptoms associated with IRRs included, but are not limited to: pruritus, rash, urticaria, erythema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, throat irritation, oropharyngeal pain, dyspnoea, pharyngeal or laryngeal oedema, nausea, tachycardia.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infusion-Related Reactions (IRRs) Ocrelizumab is associated with IRRs, which may be related to cytokine release and/or other chemical mediators.
Symptoms of IRRs may occur during any ocrelizumab infusion, but have been more frequently reported during the first infusion. 8). These reactions may present as pruritus, rash, urticaria, erythema, throat irritation, oropharyngeal pain, dyspnoea, pharyngeal or laryngeal oedema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea, tachycardia and anaphylaxis.
Before the infusion Management of severe reactions Appropriate resources for the management of severe reactions such as serious IRR, hypersensitivity reactions and/or anaphylactic reactions should be available. 7 Hypotension As a symptom of IRR, hypotension may occur during infusions.
Therefore, withholding of antihypertensive treatments should be considered for 12 hours prior to and throughout each infusion. Patients with a history of congestive heart failure (New York Heart Association III & IV) were not studied.
2). During the infusion The following measures need to be taken for patients who experience severe pulmonary symptoms, such as bronchospasm or asthma exacerbation: • their infusion must be interrupted immediately and permanently; • symptomatic treatment must be administered; • the patient must be monitored until the pulmonary symptoms have resolved because initial improvement of clinical symptoms could be followed by deterioration.
Hypersensitivity may be clinically indistinguishable from an IRR in terms of symptoms. If a hypersensitivity reaction is suspected during infusion, the infusion must be stopped immediately and permanently (see ‘Hypersensitivity reactions’ below).
1. 4). 4). 4).
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No dose reductions are recommended. Delayed or missed doses If an infusion is missed, it should be administered as soon as possible; do not wait until the next planned dose. The treatment interval of 6 months (with a minimum of 5 months) should be maintained between doses (see Table 1).
2), no posology adjustment is needed in patients over 55 years of age. Patients enrolled in the ongoing clinical trials continue to be dosed with 600 mg ocrelizumab every six months after they become older than 55 years old. Renal impairment The safety and efficacy of ocrelizumab in patients with renal impairment has not been formally studied.
Patients with mild renal impairment were included in clinical trials. There is no experience in 4 patients with moderate and severe renal impairment. e. 2). Hepatic impairment The safety and efficacy of ocrelizumab in patients with hepatic impairment has not been formally studied.
Patients with mild hepatic impairment were included in clinical trials. There is no experience in patients with moderate and severe hepatic impairment. 2). Paediatric population The safety and efficacy of ocrelizumab in children and adolescents aged 0 to 18 years has not yet been established.
No data are available. Method of administration Ocrevus 300 mg concentrate for solution for infusion is not intended for subcutaneous administration and should be administered via an intravenous infusion only. It is important to check the product labels to ensure that the correct formulation (intravenous or subcutaneous) is being administered to the patient, as prescribed.
Patients may start treatment using intravenous or subcutaneous ocrelizumab. After dilution, treatment is administered as an intravenous infusion through a dedicated line. Infusions should not be administered as an intravenous push or bolus.
If patients did not experience a serious infusion-related reaction (IRR) with any previous ocrelizumab infusion, a shorter (2-hour) infusion can be administered for subsequent doses (see Table 1, Option 2). 5 Table 1: Dose and schedule Amount of ocrelizumab to be administered Infusion instructions Initial dose (600 mg) divided into 2 infusions Infusion 1 300 mg in 250 mL • Initiate the infusion at a rate of 30 mL/hour for 30 minutes • The rate can be increased in 30 mL/hour increments every 30 minutes to a maximum of 180 mL/hour.
5 hours Infusion 2 (2 weeks later) 300 mg in 250 mL Subsequent doses (600 mg) single infusion once every 6 […]
In controlled trials there were no fatal IRRs. In addition, symptoms of IRR in the post-marketing setting included anaphylaxis. 9% in the interferon beta-1a treatment group (placebo infusion). 5%) and decreased over time to <10% at Dose 4.
The majority of IRRs in both treatment groups were mild to moderate. 1% of ocrelizumab treated patients experienced mild and moderate IRRs, respectively. 1% experienced life-threatening IRRs. 5% 13 in the placebo group. 4%) and decreased with subsequent doses to <10% at Dose 4.
A greater proportion of patients in each group experienced IRRs with the first infusion of each dose compared with the second infusion of that dose. The majority of IRRs were mild to moderate. 4% experienced severe IRRs. There were no life- threatening IRRs.
4. Over the controlled period and OLE phase of the RMS and PPMS clinical trials, patients were given approximately 20 doses of ocrelizumab. Incidence of IRRs decreased to <4% by Dose 4 of the OLE phase in RMS patients and to <5% by Dose 5 of the OLE phase in PPMS patients.
With subsequent doses administered during the OLE phase, incidence of IRR remained low. The majority of IRRs were mild during the OLE phase. 1). 7% vs. 8%, respectively). 5% of patients receiving interferon beta 1a. 9% of patients receiving interferon beta 1a.
9% of patients receiving placebo. 7% of patients receiving placebo. All patients switched to ocrelizumab during the OLE phase in both RMS and PPMS studies. Over the OLE phase in RMS and PPMS patients, the overall risk of SIs did not increase from that observed during the controlled period.
As observed during the controlled period, the rate of SIs in PPMS patients remained higher than that observed in RMS patients. In line with the previous analysis of risk factors for SIs in auto-immune conditions other than […]
After the infusion Patients should be observed for at least one hour after the completion of the infusion for any symptom of IRR. Physicians should alert patients that an IRR can occur within 24 hours of infusion. 2. Hypersensitivity reactions A hypersensitivity reaction could also occur (acute allergic reaction to medicinal product).
Type 1 acute hypersensitivity reactions (IgE-mediated) may be clinically indistinguishable from IRR symptoms. A hypersensitivity reaction may present during any administration, although typically would not present during the first administration.
For subsequent administrations, more severe symptoms than previously experienced, or new severe symptoms, should prompt consideration of a potential hypersensitivity reaction. 3). Infection Administration of ocrelizumab must be delayed in patients with an active infection until the infection is resolved.
8). 8). 6% vs 0%) infections. All life-threatening infections resolved without discontinuing ocrelizumab. In PPMS, patients with swallowing difficulties are at a higher risk of aspiration pneumonia. Treatment with ocrelizumab may further increase the risk of severe pneumonia in these patients.
Physicians should take prompt action for patients presenting with pneumonia. , lymphopenia, advanced age, polytherapy with immunosuppressants). Physicians should be vigilant for the early signs and symptoms of PML, which can include any new onset, or worsening of neurological signs or symptoms, as these can be similar to MS disease.
If PML is suspected, dosing with ocrelizumab must be withheld. Evaluation including Magnetic Resonance Imaging (MRI) scan preferably with contrast (compared with pre-treatment MRI), confirmatory cerebro-spinal fluid (CSF) testing for JCV Deoxyribonucleic acid (DNA) and repeat neurological assessments, should be considered.
If PML is confirmed, treatment must be discontinued permanently. Hepatitis B reactivation Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, has been reported in patients treated with anti-CD20 antibodies.
HBV screening should be performed in all patients before initiation of treatment as per local guidelines. e. 3). e. negative for HBsAg and positive for HB core antibody (HBcAb +); carriers of HBV (positive for surface antigen, HBsAg+) should consult liver disease experts before start of treatment and should be monitored and managed following local medical standards to prevent hepatitis B reactivation.
8). Although some cases were Grade 3 or 4, the […]