Roche Pharma launches ocrelizumab in India, six years after global release. Ocrelizumab is an FDA-approved CD20-directed humanized monoclonal antibody indicated to treat adult patients with primary progressive or relapsing multiple sclerosis.
Multiple sclerosis (MS) is a long-lasting (chronic) disease of the central nervous system. It is thought to be an autoimmune disorder, a condition in which the body attacks itself by mistake. The cost could range between Rs 9 lakh to Rs 12 lakh, depending on the patient’s weight and dosing requirements.
During IV administration, the drug has shown infusion reactions in more than one-third of patients; therefore, it is essential to monitor side effects such as coughing, dizziness, fast heart rate, fatigue, feeling faint, fever, flushing, headache, hives, itchy skin, nausea, rash, shortness of breath, swelling of the throat, throat irritation or pain, tiredness, trouble breathing and wheezing. In clinical trials, there was an incidence of life-threatening bronchospasm (which recovered with treatment) during the initial infusion of ocrelizumab. Therefore, because the drug can trigger a life-threatening infusion reaction, the interprofessional team needs to have the necessary medications and equipment in the room to ensure safe outcomes.
Before initiating ocrelizumab, Hepatitis B virus screening is necessary. There have been reports of ocrelizumab leading to reactivation of latent HBV in a previously resolved patient.All necessary immunizations should be given at least six weeks before initiating ocrelizumab, given the expected B-cell depletion. And consider previous immunosuppressive therapy for potential increased immunosuppressive effects.
An expert panel set up by the Central Drugs Standard Control Organisation, India’s drug regulatory authority, had last month approved Roche’s application to launch ocrelizumab in India on condition that it would conduct a post-launch study with a follow-up on patients for two years.
