OCREVUS 920 mg SC

/ Roche

Important Administration Information
* For subcutaneous use in the abdomen only.
* Should be administered via subcutaneous injection by a healthcare professional
Recommended Premedication
Pre-medicate orally with 20 mg of dexamethasone (or an equivalent corticosteroid) and an antihistamine (e.g., desloratadine) administered at least 30 minutes prior to each administration to reduce the risk of local and systemic injection reactions.
The addition of an antipyretic (e.g., acetaminophen) may also be considered.
Recommended Dosage
The recommended dosage is 920 mg/23,000 units (920 mg ocrelizumab and 23,000 units of hyaluronidase) administered as a single 23 mL subcutaneous injection in the abdomen over approximately 10 minutes every 6 months.
Monitor the patient closely during injections, with access to appropriate medical support to manage severe injection reactions. For the initial dose, monitor the patient for at least one hour post-injection. For subsequent doses, monitor the patient for at least 15 minutes post-injection.
See prescribing information for full details.

Indicated for the treatment of adult patients with relapsing or primary progressive forms of multiple sclerosis.

* A history of hypersensitivity to ocrelizumab, hyaluronidase, or to any of the excipients
* Active HBV infection
* A history of life-threatening administration reaction to ocrelizumab

Injection Reactions
Injection reactions, which can be local or systemic. Common symptoms of
local injection reactions included erythema, pain, swelling, pruritus, headache and nausea. Monitor patients during and after injections. Inform patients that injection reactions can occur during or within 24 hours of the injection.
Infections
Serious, including life-threatening or fatal, bacterial, viral, parasitic, and fungal infections have been reported in patients receiving ocrelizumab. An increased risk of infections (including serious and fatal bacterial, fungal, and new or reactivated viral infections) has been observed in patients during and following completion of treatment with anti-CD20 B-cell depleting therapies.
Vaccinations
Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of ocrelizumab treatment for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of ocrelizumab for non-live vaccines.
Progressive Multifocal Leukoencephalopathy
PML is an opportunistic viral infection of the brain caused by the JC virus
(JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. PML has occurred in ocrelizumab-treated patients who had not been treated previously with natalizumab (which has a known association with PML), were not taking any immunosuppressive or immunomodulatory medications associated with the risk of PML prior to or concomitantly with ocrelizumab, and did not have any known ongoing systemic medical conditions resulting in compromised immune system function.
At the first sign or symptom suggestive of PML, withhold ocrelizumab and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
Reduction in Immunoglobulins
As expected with any B-cell depleting therapy, decreased immunoglobulin levels are observed with ocrelizumab treatment.
Monitor the levels of quantitative serum immunoglobulins during treatment and after discontinuation of treatment, until B-cell repletion, and especially in the setting of recurrent serious infections. Consider discontinuing therapy in patients with serious opportunistic or recurrent serious infections, and if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.
Malignancies
An increased risk of malignancy may exist. In controlled trials, malignancies,
including breast cancer, occurred more frequently in patients treated with intravenous ocrelizumab. Patients should follow standard breast cancer screening guidelines.
Immune-Mediated Colitis
Immune-mediated colitis, which can present as a severe and acute-onset form of colitis, has been reported in patients receiving ocrelizumab in the postmarketing setting. Some cases of colitis were serious, requiring hospitalization, with a few patients requiring surgical intervention. Systemic corticosteroids were required in many of these patients. The time from treatment initiation to onset of symptoms in these cases ranged from a few weeks to years. Monitor patients for immune-mediated colitis during treatment, and evaluate promptly if signs and symptoms that may indicate immune-mediated colitis, such as new or persistent diarrhea or other gastrointestinal signs and symptoms, occur.
See prescribing information for full details.

The most common adverse reactions in RMS trials (incidence ≥ 10%) were upper/ lower respiratory tract infections and infusion reactions, skin infections.
See prescribing information for full details.

Immunosuppressive or Immune-Modulating Therapies
The concomitant use of ocrelizumab and other immune-modulating or immunosuppressive therapies, including immunosuppressant doses of corticosteroids, is expected to increase the risk of immunosuppression.
Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with ocrelizumab. When switching from drugs with prolonged immune effects, such as daclizumab, fingolimod, natalizumab, teriflunomide, or mitoxantrone, consider the duration and mode of action of these drugs because of additive immunosuppressive effects when initiating ocrelizumab.
See prescribing information for full details.

Pregnancy: There are no adequate data on the developmental risk associated with use of ocrelizumab or ocrelizumab-containing products in pregnant women. However, transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy.
Women of childbearing potential should use effective contraception while receiving ocrelizumab and for 6 months after the last dose
Lactation: There are no data on the presence of ocrelizumab or hyaluronidase, from administration of ocrelizumab, in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need and any potential adverse effects on the breastfed infant from ocrelizumab or from the underlying maternal condition.