Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
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Treatment with subcutaneous ocrelizumab is associated with IRs, which may be related to cytokine release and/or other chemical mediators. Physicians should alert patients that IRs can occur during or within 24 hours of administration. Symptoms of IRs have been more frequently reported with the first injection. IRs can be local IRs or systemic IRs. Common symptoms of local IRs at the injection site include erythema, pain, swelling and pruritus. Common symptoms of systemic IRs include headache and nausea (see section 4.8).
Shortly before injection, patients should receive premedication to reduce the risk of IRs (see section 4.2). Patients should be observed for at least one hour after the initial dose of the medicinal product for any symptom of severe IR. Appropriate resources for the management of severe IRs, hypersensitivity reactions and/or anaphylactic reactions should be available for the initial dose of the medicinal product. For subsequent doses, the need for post-injection monitoring is at the treating physician's discretion. IRs can be managed with symptomatic treatment, should they occur.
If there are signs of a life-threatening IR, the injection should be stopped immediately, and the patient should receive appropriate treatment. Ocrelizumab treatment must be permanently discontinued in these patients. If a patient experiences a severe IR, the injection should be interrupted immediately, and the patient should receive symptomatic treatment. The injection should be completed only after all symptoms have resolved.
Intravenous ocrelizumab is associated with infusion-related reactions (IRRs), which may also be related to cytokine release and/or other chemical mediators. IRRs 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. Serious IRRs, some requiring hospitalisation, have been reported with the use of intravenous ocrelizumab.
Hypersensitivity may be clinically indistinguishable from an IR or an IRR in terms of symptoms. If a hypersensitivity reaction is suspected, the injection must be stopped immediately and permanently (see 'Hypersensitivity reactions' below).
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. Patients with known IgE-mediated hypersensitivity to ocrelizumab or any of the excipients must not be treated (see section 4.3).
Administration of ocrelizumab must be delayed in patients with an active infection until the infection is resolved.
It is recommended to verify the patient's immune status before dosing since severely immunocompromised patients (e.g., with lymphopenia, neutropenia, hypogammaglobulinemia) should not be treated (see sections 4.3 and 4.8).
The overall proportion of patients experiencing a serious infection (SI) was similar to comparators (see section 4.8) in studies with intravenous ocrelizumab. The frequency of grade 4 (life-threatening) and grade 5 (fatal) infections was low in all treatment groups, but in PPMS it was higher with intravenous ocrelizumab compared with placebo for life-threatening (1.6% vs 0.4%) and fatal (0.6% 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.
John Cunningham virus (JCV) infection resulting in PML has been observed very rarely in patients treated with anti-CD20 antibodies, including ocrelizumab, and mostly associated with risk factors (patient population e.g., 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 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. Patients with active HBV (i.e. an active infection confirmed by positive results for HBsAg and anti HB testing) should not be treated with ocrelizumab (see section 4.3). Patients with positive serology (i.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.
Cases of late onset of neutropenia have been reported at least 4 weeks after the latest intravenous ocrelizumab infusion (see section 4.8). Although some cases were Grade 3 or 4, the majority of the cases were Grade 1 or 2. In patients with signs and symptoms of infection, measurement of blood neutrophils is recommended.
An increased number of malignancies (including breast cancers) have been observed in the controlled period of the pivotal clinical trials in patients treated with intravenous ocrelizumab, compared to control groups. The incidence was within the background rate expected for an MS population. After approximately 10 years of continuous ocrelizumab treatment over the controlled period and Open-Label Extension (OLE) phase of the pivotal clinical trials, the incidence of malignancies remained within the background rate expected for an MS population. Patients with a known active malignancy should not be treated with ocrelizumab (see section 4.3). Individual benefit risk should be considered in patients with known risk factors for malignancies and in patients who are being actively monitored for recurrence of malignancy. Patients should follow standard breast cancer screening per local guidelines.
Patients in a severely immunocompromised state must not be treated until the condition resolves (see section 4.3.).
In other auto-immune conditions, use of ocrelizumab concomitantly with immunosuppressants (e.g., chronic corticosteroids, non-biologic and biologic disease-modifying antirheumatic drugs [DMARDS], mycophenolate mofetil, cyclophosphamide, azathioprine) resulted in an increase of SIs, including opportunistic infections. Infections included and were not limited to atypical pneumonia and pneumocystis jirovecii pneumonia, varicella pneumonia, tuberculosis, histoplasmosis. In rare cases, some of these infections were fatal. An exploratory analysis identified the following factors associated with risk of SIs: higher doses of ocrelizumab than recommended in MS, other comorbidities, and chronic use of immunosuppressants/corticosteroids.
It is not recommended to use other immunosuppressives concomitantly with ocrelizumab except corticosteroids for symptomatic treatment of relapses. Knowledge is limited as to whether concomitant steroid use for symptomatic treatment of relapses is associated with an increased risk of infections in clinical practice. In the intravenous ocrelizumab MS pivotal studies, the administration of corticosteroids for the treatment of relapse was not associated with an increased risk of SI.
When initiating ocrelizumab after an immunosuppressive therapy or initiating an immunosuppressive therapy after ocrelizumab, the potential for overlapping pharmacodynamic effects should be taken into consideration (see section 5.1). Caution should be exercised when prescribing ocrelizumab taking into consideration the pharmacodynamics of other disease modifying MS therapies.
The safety of immunisation with live or live-attenuated vaccines, following ocrelizumab therapy has not been studied and vaccination with live-attenuated or live vaccines is not recommended during treatment and not until B-cell repletion. In clinical trials, the median time for B-cell repletion was 72 weeks (see section 5.1).
In a randomised open-label study, RMS patients treated with intravenous ocrelizumab were able to mount humoral responses, although decreased, to tetanus toxoid, 23-valent pneumococcal polysaccharide with or without a booster vaccine, keyhole limpet haemocyanin neoantigen, and seasonal influenza vaccines (see section 4.5 and 5.1).
It is recommended to vaccinate patients treated with ocrelizumab with seasonal influenza vaccines that are inactivated.
Physicians should review the immunisation status of patients being considered for treatment with ocrelizumab. Patients who require vaccination should complete their immunisation at least 6 weeks prior to initiation of ocrelizumab treatment.
Due to the potential depletion of B cells in infants of mothers who have been exposed to ocrelizumab during pregnancy, it is recommended that vaccination with live or live-attenuated vaccines should be delayed until B-cell levels have recovered; therefore, measuring CD19-positive B-cell levels in neonates and infants prior to vaccination is recommended.
It is recommended that all vaccinations other than live or live-attenuated should follow the local immunisation schedule and measurement of vaccine-induced response titres should be considered to check whether individuals have mounted a protective immune response because the efficacy of the vaccination may be decreased.
The safety and timing of vaccination should be discussed with the infant's physician (see section 4.6).
rug-induced liver injury, including severe and life-threatening cases, has been observed in the post-marketing setting in patients treated with ocrelizumab. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred from days to months after administration of the first dose.
Liver function tests should be performed before initiation of treatment with ocrelizumab. Patients should be monitored for signs and symptoms of any hepatic injury during treatment. Liver function tests should be performed in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice.
If liver injury is confirmed, ocrelizumab should be discontinued. Treatment should not be resumed unless a plausible alternative aetiology for the signs and symptoms of liver injury can be established.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
TThis medicinal product contains 13.8 mg of polysorbate 20 in each vial, which is equivalent to 0.6 mg/mL. Polysorbates may cause allergic reactions.
No interaction studies have been performed, as no interactions are expected via cytochrome P450 enzymes, other metabolising enzymes or transporters.
The safety of immunisation with live or live-attenuated vaccines, following ocrelizumab therapy has not been studied.
Data are available on the effects of tetanus toxoid, 23-valent pneumococcal polysaccharide, keyhole limpet haemocyanin neoantigen, and seasonal influenza vaccines in patients receiving intravenous ocrelizumab (see sections 4.4 and 5.1).
After treatment over 2 years with intravenous ocrelizumab, the proportion of patients with positive antibody titres against S. pneumoniae, mumps, rubella and varicella were generally similar to the proportions at baseline.
It is not recommended to use other immunosuppressive therapies concomitantly with ocrelizumab except corticosteroids for symptomatic treatment of relapses (see section 4.4).
Females of childbearing potential should use contraception while receiving ocrelizumab and for 4 months after the last administered dose of ocrelizumab.
There is a limited amount of data from the use of ocrelizumab in pregnant women. Ocrelizumab is an immunoglobulin G (IgG). IgG is known to cross the placental barrier. Postponing vaccination with live or live-attenuated vaccines should be considered for neonates and infants born to mothers who have been exposed to ocrelizumab in utero. No B cell count data have been collected in neonates and infants exposed to ocrelizumab and the potential duration of B-cell depletion in neonates and infants is unknown (see section 4.4).
Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy. B-cell depletion in utero was also detected in animal studies.
Animal studies (embryo-foetal toxicity) do not indicate teratogenic effects. Reproductive toxicity was observed in pre- and post-natal development studies (see section 5.3).
Ocrelizumab should be avoided during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.
Human IgGs are known to be excreted in breastmilk the first few days after birth (colostrum period), which decreases to low concentrations soon afterwards.
In a prospective, multicenter, open-label study MN42989 (SOPRANINO), 13 lactating women received ocrelizumab at a median of 2.0 months postpartum (range 0.5-5.0 months). Low concentrations of ocrelizumab were detected in the breastmilk over 60 days following the mother's first postpartum infusion (median relative infant dose of 0.27% [range 0.0-1.8%]), indicating minimal transfer of ocrelizumab to breastmilk. At 30 days after the mother's first postpartum infusion, ocrelizumab was undetectable in all available serum samples of breastfed infants (n=9), and infant B-cell levels were within normal range in all available blood samples (n=10). No effects of ocrelizumab on health, growth and development were observed in breastfed infants over a follow-up period of 44.6 weeks (range 8.6-62.7 weeks).
While no clinical data on infants potentially exposed to ocrelizumab via breastmilk receiving live or live-attenuated vaccines are available, no risks are expected due to normal B-cell levels and undetectable serum ocrelizumab levels observed in those infants.
In a separate prospective clinical study, low ocrelizumab concentrations in breastmilk (median relative infant dose of 0.1% [range 0.07-0.7%]) over 90 days after the mother's first postpartum infusion were observed in 29 lactating women who received ocrelizumab at a median of 4.3 months postpartum (range 0.1-36 months). Follow-up of 21 infants breastfed for at least 2 weeks showed normal growth and development up to 1 year.
Ocrelizumab can be used during breastfeeding starting a few days after birth.
Preclinical data reveal no special hazards for humans based on studies of male and female fertility in cynomolgus monkeys exposed to ocrelizumab.
Ocrevus has no or negligible influence on the ability to drive and use machines.
The most important and frequently reported adverse reactions are IRRs (34.3%, 40.1% in RMS and PPMS, respectively) and infections (58.5%, 72.2% in RMS and PPMS, respectively) (see section 4.4). Other frequently reported adverse reactions are COVID-19 (16.0% in PPMS) and decreased blood immunoglobulin M (16.5%, 15.5% in RMS and PPMS, respectively).
The safety profile of Ocrevus solution for injection was consistent with the known safety profile of intravenous ocrelizumab below in Table 1 except for the very common adverse reaction of IRs.
Adverse reactions reported in clinical trials with intravenous ocrelizumab and derived from spontaneous reporting are listed below in Table 1. The frequencies of adverse reactions are based on the controlled period of the pivotal studies in RMS and PPMS and the controlled period of Study WA40404 in PPMS. 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 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 1. Adverse reactions:
| MedDRA System Organ Class (SOC) | Very common | Common | Not Known |
| Infections and infestations | Upper respiratory tract infection, COVID-19, nasopharyngitis, influenza | Sinusitis, bronchitis, oral herpes, gastroenteritis, respiratory tract infection, COVID-19 pneumonia, viral infection, herpes zoster, conjunctivitis, cellulitis | |
| Blood and lymphatic system disorders | Neutropenia | Late onset of Neutropenia3 | |
| Respiratory, thoracic and mediastinal disorders | Cough, catarrh | ||
| Hepatobiliary disorders | Drug-induced liver injury2 | ||
| Investigations | Blood immunoglobulin M decreased | Blood immunoglobulin G decreased | |
| Injury, poisoning and procedural complications | Infusion-related reactions1, injection reaction2,3 |
1 Observed only in the pooled intravenous ocrelizumab dataset
2 Observed in a study outside of the pooled intravenous ocrelizumab dataset (associated with subcutaneous administration).
3 Observed in the post-marketing setting.
Based on the observed symptoms, IRs are categorised into systemic IRs and local IRs.
In OCARINA II, 118 patients (ocrelizumab-naïve) received the first injection of the product. The most common symptoms reported with systemic IRs and local IRs included: headache (2.5%), nausea (1.7%), injection site erythema (29.7%), injection site pain (14.4%), injection site swelling (8.5%), and injection site pruritus (6.8%). IRs occurred in 48.3% of these patients after the first injection. Of the 118 patients, 11.0% and 45.8% of patients experienced at least one event of systemic IR and local IR, respectively. Among the patients with IR, the majority of patients (82.5%) had IRs occur within 24 hours after the end of injection as opposed to during the injection. All IRs were non serious and of mild (71.9%) or moderate (28.1%) severity. The median duration of IR was 3 days for systemic IRs and 4 days for local IRs. All patients recovered from IRs, of which 26.3% required symptomatic treatment.
In OCARINA I, 125 patients received one or more subcutaneous injections of ocrelizumab 1200 mg. Of the 125 patients who received the first injection, 16.0% of patients experienced at least one event of systemic IR and 64.0% of patients experienced at least one event of local IR. Of the 104 patients who received the second injection, the incidence of systemic IR and local IR decreased to 7.7% and 37.5%, respectively. All IRs were non serious and all except one IR were of mild or moderate severity for the first injection. All IRs were non serious and of mild or moderate severity for the second injection. 21.2% and 17.9% of patients experiencing IR required symptomatic treatment after the first and second injection, respectively.
Intravenous ocrelizumab is associated with infusion-related reactions (IRRs), which may also be related to cytokine release and/or other chemical mediators. IRRs 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. Serious IRRs, some requiring hospitalisation, have been reported with the use of intravenous ocrelizumab.
In the active-controlled studies in RMS, infections occurred in 58.5% of patients receiving intravenous ocrelizumab vs 52.5% of patients receiving interferon beta 1a. SIs occurred in 1.3% of patients receiving intravenous ocrelizumab vs 2.9% of patients receiving interferon beta 1a. In the placebo-controlled pivotal study in PPMS, infections occurred in 72.2% of patients receiving intravenous ocrelizumab vs 69.9% of patients receiving placebo. SIs occurred in 6.2% of patients receiving intravenous ocrelizumab vs 6.7% of patients receiving placebo.
All patients switched to intravenous ocrelizumab during the OLE phase in both RMS and PPMS pivotal intravenous ocrelizumab studies. Over the OLE phase in RMS and PPMS patients in the pivotal studies, 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 MS (see section 4.4), a multivariate analysis of risk factors for SIs was conducted in the approximately 10 years of cumulative exposure data from the controlled period and OLE phase of the pivotal clinical trials. Risk factors for SIs in RMS patients include having at least 1 comorbidity, recent clinical relapse, and Expanded Disability Status Scale (EDSS) ≥ 6.0. Risk factors for SIs in PPMS patients include body mass index greater than 25 kg/m², having at least 2 comorbidities, EDSS ≥ 6.0, and IgM < LLN. Comorbidities included, but were not limited to, cardiovascular, renal and urinary tract conditions, previous infections, and depression.
The proportion of respiratory tract infections was higher in intravenous ocrelizumab treated patients compared to interferon beta-1-a and placebo.
In the RMS clinical trials, 39.9% of intravenous ocrelizumab treated patients and 33.2% interferon beta-1-a treated patients experienced an upper respiratory tract infection and 7.5% of intravenous ocrelizumab treated patients and 5.2% of interferon beta-1-a treated patients experienced a lower respiratory tract infection.
In the pivotal PPMS clinical trial, 48.8% of intravenous ocrelizumab treated patients and 42.7% of patients who received placebo experienced an upper respiratory tract infection, and 9.9% of intravenous ocrelizumab treated patients and 9.2% of patients who received placebo experienced a lower respiratory tract infection.
The respiratory tract infections reported in patients treated with intravenous ocrelizumab were predominately mild to moderate (80–90%).
In a placebo-controlled phase IIIb study in patients with PPMS (Study WA40404), COVID-19 was observed more frequently in intravenous ocrelizumab treated patients compared to patients who received placebo. COVID-19 was observed in 16.0% of intravenous ocrelizumab treated patients and 11.3% of patients who received placebo. In patients treated with intravenous ocrelizumab, COVID-19 was predominantly mild to moderate in severity (14.2%).
COVID-19 pneumonia was observed more frequently in intravenous ocrelizumab treated patients compared to patients who received placebo. COVID-19 pneumonia was observed in 3.2% of intravenous ocrelizumab treated patients and 1.8% of patients who received placebo.
COVID-19 pneumonia was predominantly observed as a serious infection, which occurred in 2.6% of intravenous ocrelizumab treated patients and 1.6% of patients who received placebo. Fatalities due to COVID-19 pneumonia were uncommon, occurring in 0.8% of intravenous ocrelizumab treated patients and 0.2% of patients who received placebo, and were associated with known risk factors in both arms.
In active-controlled (RMS) clinical trials, herpes infections were reported more frequently in intravenous ocrelizumab treated patients than in interferon-beta-1a treated patients including herpes zoster (2.1% vs 1.0%), herpes simplex (0.7% vs 0.1%), oral herpes (3.0% vs 2.2%), genital herpes (0.1% vs 0%) and herpes virus infection (0.1% vs 0%). All infections were mild to moderate in severity, except one Grade 3 event, and patients recovered with treatment by standard therapies.
In the pivotal placebo-controlled (PPMS) clinical trial, a higher proportion of patients with oral herpes (2.7% vs 0.8%) were observed in the intravenous ocrelizumab treatment arm.
Drug-induced liver injury and increased liver enzymes have been reported during the post-marketing phase (see section 4.4).
Ocrelizumab treatment resulted in a decrease in total immunoglobulins over the controlled period of the pivotal clinical intravenous ocrelizumab trials, mainly driven by reduction in IgM.
Clinical trial data from the controlled period and OLE phase of the pivotal clinical trials have shown an association between decreased levels of IgG (and less so for IgM or IgA) and increased rate of SIs. 2.1% of RMS patients had a SI during a period with IgG < LLN and in 2.3% of PPMS patients had a SI during a period with IgG < LLN. The difference in rate of SIs between patients with IgG < LLN compared to patients with IgG ≥ LLN did not increase over time. The type, severity, latency, duration, and outcome of SIs observed during episodes of immunoglobulins below LLN were consistent with the overall SIs observed in patients treated with ocrelizumab during the controlled period and OLE phase. Throughout the 10 years of continuous ocrelizumab treatment, mean IgG levels of RMS and PPMS patients remained above LLN.
In RMS, a decrease in lymphocyte < LLN was observed in 20.7% of patients treated with intravenous ocrelizumab compared with 32.6% of patients treated with interferon beta-1a. In the pivotal PPMS clinical trial, a decrease in lymphocytes <LLN was observed in 26.3% of intravenous ocrelizumab treated patients vs 11.7% of placebo-treated patients.
The majority of these decreases reported in intravenous ocrelizumab treated patients were Grade 1 (<LLN – 800 cells/mm³) and 2 (between 500 and 800 cells/mm³) in severity. Approximately 1% of the patients in the intravenous ocrelizumab group had a Grade 3 lymphopenia (between 200 and 500 cells/mm³). None of the patients was reported with Grade 4 lymphopenia (< 200 cells/mm³).
An increased rate of SIs was observed during episodes of confirmed total lymphocytes counts decrease in intravenous ocrelizumab treated patients in the pivotal studies. The number of SIs was too low to draw definitive conclusions.
In the active-controlled (RMS) treatment period, a decrease in neutrophils < LLN was observed in 14.7% of patients treated with intravenous ocrelizumab compared with 40.9% of patients treated with interferon beta-1a. In the placebo-controlled pivotal (PPMS) clinical trial, the proportion of intravenous ocrelizumab patients presenting decreased neutrophils was higher (12.9%) than placebo patients (10.0%); among these a higher percentage of patients (4.3%) in the intravenous ocrelizumab group had Grade 2 or above neutropenia vs 1.3% in the placebo group; approximately 1% of the patients in the intravenous ocrelizumab group had Grade 4 neutropenia vs 0% in the placebo group.
The majority of the neutrophil decreases were transient (only observed once for a given patient treated with ocrelizumab) and were Grade 1 (between<LLN and 1500 cells/mm³) and 2 (between 1000 and 1500 cells/mm³) in severity. Overall, approximately 1% of the patients in the intravenous ocrelizumab group had Grade 3 or 4 neutropenia. One patient with Grade 3 (between 500 and 1000 cells/mm³) and one patient with Grade 4 (<500 cells/mm³) neutropenia required specific treatment with granulocyte-colony stimulating factor, and remained on ocrelizumab after the episode. Neutropenia can occur several months after the administration of ocrelizumab (see section 4.4).
One patient, who received 2000 mg of intravenous ocrelizumab, died of systemic inflammatory response syndrome (SIRS) of unknown aetiology, following a magnetic resonance imaging (MRI) examination 12 weeks after the last infusion; an anaphylactoid reaction to the MRI gadolinium-contrast agent could have contributed to the SIRS.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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