typically [0.0001):<0.0001) Proportion Relapse-free 83% 71% 82% 72% Proportion of Patients with 12-week Confirmed Disability Progression * 9.8% Ocrevus vs 15.2% REBIF Risk Reduction (Pooled Analysis ) 40%; p=0.0006 MRI Endpoints Mean number of T1 Gd-enhancing lesions per MRI scan 0.016 0.286 0.021 0.416 Relative Reduction 94% (p> <0.0001) 95% (p> <0.0001) Mean number of new and/or enlarging T2 hyperintense lesions per MRI 0.323 1.413 0.325 1.904 Relative Reduction 77% (p> <0.0001) 83% (p> <0.0001) * Pre-specified pooled analysis of Study 1 and 2 Figure 1 Kaplan-Meier Plot * of Time to Onset of Confirmed Disability Progression Sustained for at Least 12 Weeks with the Initial Event of Neurological Worsening Occurring During the Double-blind Treatment Period in Pooled Studies 1 and 2 in Patients with RMS (Pooled ITT Population) In exploratory subgroup analyses of Study 1 and Study 2, the effect of Ocrevus on annualized relapse rate and disability progression was similar in male and female patients. Primary Progressive Multiple Sclerosis (PPMS) Study 3 was a randomized, double-blind, placebo-controlled clinical trial in patients with PPMS. Patients were randomized 2:1 to receive either Ocrevus 600 mg or placebo as two 300 mg intravenous infusions 2 weeks apart every 24 weeks for at least 120 weeks. Selection criteria required a baseline EDSS of 3 to 6.5 and a score of 2 or greater for the EDSS pyramidal functional system due to lower extremity findings. Neurological assessments were conducted every 12 weeks. An MRI scan was obtained at baseline and at Weeks 24, 48, and 120. In Study 3, the primary outcome was the time to onset of disability progression attributable to MS confirmed to be present at the next neurological assessment at least 12 weeks later. Disability progression occurred when the EDSS score increased by 1 point or more from the baseline EDSS if the baseline EDSS was 5.5 points or less, or by 0.5 points or more if the baseline EDSS was more than 5.5 points. In Study 3, confirmed disability progression also was deemed to have occurred if patients who had onset of disability progression discontinued participation in the study before the next assessment. Additional outcome measures included timed 25-foot walk, and percentage change in T2 hyperintense lesion volume. Study 3 randomized 488 patients to Ocrevus and 244 to placebo; 21% of Ocrevus-treated patients and 34% of placebo-treated patients did not complete the trial. The baseline demographic and disease characteristics were balanced between the two treatment groups. At baseline, the mean age of patients was 45; 49% were female. The mean time since symptom onset was 6.7 years, the mean EDSS score was 4.7, and 26% had one or more T1 Gd-enhancing lesions at baseline; 88% of patients had not been treated previously with a non-steroid treatment for MS. The time to onset of disability progression confirmed at 12 weeks after onset was significantly longer for Ocrevus-treated patients than for placebo-treated patients (see Figure 2 ). Results for Study 3 are presented in Table 5 and Figure 2 . Table 5 Key Clinical and MRI Endpoints in PPMS patients for Study 3 Endpoints Study 3 Ocrevus 600 mg (two 300 mg infusions two weeks apart every 24 weeks) Placebo N=488 N=244 * Defined as an increase of 1.0 point or more from the baseline EDSS score for patients with baseline score of 5.5 or less, or an increase of 0.5 or more when the baseline score is more than 5.5 Clinical Outcomes Proportion of patients with 12-week Confirmed Disability Progression * 32.9% 39.3% Risk reduction 24%; p=0.0321 MRI Endpoints Mean change in volume of T2 lesions, from baseline to Week 120 (cm 3 ) -0.39 0.79 p> <0.0001 * All patients in this analysis had a minimum of 120 weeks of follow-up. The primary analysis is based on all disability progression events accrued including 21 without confirmatory EDSS at 12 weeks. Figure 2 Kaplan-Meier Plot of Time to Onset of Confirmed Disability Progression Sustained for at Least 12 Weeks with the Initial Event of Neurological Worsening Occurring During the Double-blind Treatment Period in Study 3 * In the overall population in Study 3, the proportion of patients with 20 percent worsening of the timed 25-foot walk confirmed at 12 weeks was 49% in Ocrevus-treated patients compared to 59% in placebo-treated patients (25% risk reduction). In exploratory subgroup analyses of Study 3, the proportion of female patients with disability progression confirmed at 12 weeks after onset was similar in Ocrevus-treated patients and placebo-treated patients (approximately 36% in each group). In male patients, the proportion of patients with disability progression confirmed at 12 weeks after onset was approximately 30% in Ocrevus-treated patients and 43% in placebo-treated patients. Clinical and MRI endpoints that generally favored Ocrevus numerically in the overall population, and that showed similar trends in both male and female patients, included annualized relapse rate, change in T2 lesion volume, and number of new or enlarging T2 lesions. How Supplied/Storage and Handling Ocrevus (ocrelizumab) injection is a preservative-free, sterile, clear or slightly opalescent, and colorless to pale brown solution supplied as a carton containing one 300 mg/10 mL (30 mg/mL) single-dose vial (NDC 50242-150-01). Store Ocrevus vials at 2 C 8 C (36 F 46 F) in the outer carton to protect from light. Do not freeze or shake. Patient Counseling Information Advise the patient to read the FDA-approved patient labeling (Medication Guide). Infusion Reactions Inform patients about the signs and symptoms of infusion reactions, and that infusion reactions can occur up to 24 hours after infusion. Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion reactions [see Warnings and Precautions (5.1) ] . Infection Advise patients to contact their healthcare provider for any signs of infection during treatment or after the last dose [see Clinical Pharmacology (12.2) ]. Signs include fever, chills, constant cough, or signs of herpes such as cold sore, shingles, or genital sores [see Warnings and Precautions (5.2) ] . Advise patients that PML has happened with drugs that are similar to Ocrevus and may happen with Ocrevus. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct the patient of the importance of contacting their doctor if they develop any symptoms suggestive of PML. Inform the patient that 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 [see Warnings and Precautions (5.2) ]. Advise patients that Ocrevus may cause reactivation of hepatitis B infection and that monitoring will be required if they are at risk [see Warnings and Precautions (5.2) ] . Vaccination Advise patients to complete any required vaccinations at least 6 weeks prior to initiation of Ocrevus. Administration of live-attenuated or live vaccines is not recommended during Ocrevus treatment and until B-cell recovery [see Warnings and Precautions (5.2) ] . Malignancies Advise patients that an increased risk of malignancy, including breast cancer, may exist with Ocrevus. Advise patients that they should follow standard breast cancer screening guidelines [see Warnings and Precautions (5.3) ] . Pregnancy Instruct patients that if they are pregnant or plan to become pregnant while taking Ocrevus they should inform their healthcare provider [see Pregnancy (8.1) ]. Ocrevus [ocrelizumab] Manufactured by: Genentech, Inc . A Member of the Roche Group 1 DNA Way South San Francisco, CA 94080-4990 Ocrevus is a trademark of Genentech, Inc. 2017 Genentech, Inc. U.S. License No. 1048 This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 11/2017 MEDICATION GUIDE Ocrevus (oak-rev-us) (ocrelizumab) injection, for intravenous use What is the most important information I should know about Ocrevus? Ocrevus can cause serious side effects, including: Infusion reactions : Ocrevus can cause infusion reactions that can be serious and require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of Ocrevus for signs and symptoms of an infusion reaction. Tell your healthcare provider or nurse if you get any of these symptoms: itchy skin rash hives tiredness coughing or wheezing trouble breathing throat irritation or pain feeling faint fever redness on your face (flushing) nausea headache swelling of the throat dizziness shortness of breath fatigue fast heart beat These infusion reactions can happen for up to 24 hours after your infusion . It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion. If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion. Infection: Ocrevus increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, a cough that does not go away, or signs of herpes (such as cold sores, shingles, or genital sores). These signs can happen during treatment or after you have received your last dose of Ocrevus. If you have an active infection, your healthcare provider should delay your treatment with Ocrevus until your infection is gone. Progressive Multifocal Leukoencephalopathy (PML): Although no cases have been seen with Ocrevus treatment in clinical trials, PML may happen with Ocrevus. PML is a rare brain infection that usually leads to death or severe disability. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include problems with thinking, balance, eyesight, weakness on 1 side of your body, strength, or using your arms or legs. Hepatitis B virus (HBV) reactivation : Before starting treatment with Ocrevus, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with Ocrevus. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving Ocrevus. Weakened immune system : Ocrevus taken before or after other medicines that weaken the immune system could increase your risk of getting infections. What is Ocrevus? Ocrevus is a prescription medicine used to treat adults with relapsing or primary progressive forms of multiple sclerosis. It is not known if Ocrevus is safe or effective in children. Who should not receive Ocrevus? Do not receive Ocrevus if you have an active hepatitis B virus (HBV) infection. Do not receive Ocrevus if you have had a life threatening allergic reaction to Ocrevus. Tell your healthcare provider if you have had an allergic reaction to Ocrevus or any of its ingredients in the past. See " What are the ingredients in Ocrevus? " for a complete list of ingredients in Ocrevus. Before receiving Ocrevus, tell your healthcare provider about all of your medical conditions, including if you: have or think you have an infection. See " What is the most important information I should know about Ocrevus? " have ever taken, take, or plan to take medicines that affect your immune system, or other treatments for MS. These medicines could increase your risk of getting an infection. have ever had hepatitis B or are a carrier of the hepatitis B virus. have had a recent vaccination or are scheduled to receive any vaccinations. You should receive any required vaccines at least 6 weeks before you start treatment with Ocrevus . You should not receive certain vaccines (called 'live' or 'live attenuated' vaccines) while you are being treated with Ocrevus and until your healthcare provider tells you that your immune system is no longer weakened. are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if Ocrevus will harm your unborn baby. You should use birth control (contraception) during treatment with Ocrevus and for 6 months after your last infusion of Ocrevus. are breastfeeding or plan to breastfeed. It is not known if Ocrevus passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Ocrevus. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive Ocrevus? Ocrevus is given through a needle placed in your vein (intravenous infusion) in your arm. Before treatment with Ocrevus, your healthcare provider will give you a corticosteroid medicine and an antihistamine to help reduce infusion reactions (make them less frequent and less severe). You may also receive other medicines to help reduce infusion reactions. See " What is the most important information I should know about Ocrevus? " Your first full dose of Ocrevus will be given as 2 separate infusions, 2 weeks apart. Each infusion will last about 2 hours and 30 minutes. Your next doses of Ocrevus will be given as one infusion every 6 months. These infusions will last about 3 hours and 30 minutes. What are the possible side effects of Ocrevus? Ocrevus may cause serious side effects, including: See " What is the most important information I should know about Ocrevus? " Risk of cancers (malignancies) including breast cancer. Follow your healthcare provider's instructions about standard screening guidelines for breast cancer. Most common side effects include infusion reactions and infections. See " What is the most important information I should know about Ocrevus? " These are not all the possible side effects of Ocrevus. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General information about the safe and effective use of Ocrevus. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Ocrevus for a condition for which it was not prescribed. Do not give Ocrevus to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Ocrevus that is written for health professionals. What are the ingredients in Ocrevus? Active ingredient: ocrelizumab Inactive ingredients: glacial acetic acid, polysorbate 20, sodium acetate trihydrate, trehalose dihydrate. Manufactured by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990 U.S. License No. 1048 For more information, go to www.Ocrevus.com or call 1-844-627-3887. Representative sample of labeling (see the HOW SUPPLIED section for complete listing): PRINCIPAL DISPLAY PANEL - 300 mg/10 mL Vial Carton NDC 50242-150-01 Ocrevus (ocrelizumab) Injection 300 mg/10 mL (30 mg/mL) For Intravenous Infusion. Must Be Diluted Single-Dose Vial. Discard Unused Portion. Attention Pharmacist: Dispense the accompanying Medication Guide to each patient. 1 vial Rx only Genentech 10182525 Ocrevus ocrelizumab injection Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50242-150 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ocrelizumab (ocrelizumab) ocrelizumab 300 mg in 10 mL Inactive Ingredients Ingredient Name Strength Sodium Acetate 21.4 mg in 10 mL Acetic Acid 2.5 mg in 10 mL Trehalose Dihydrate 400 mg in 10 mL polysorbate 20 2 mg in 10 mL water Packaging # Item Code Package Description 1 NDC:50242-150-01 1 VIAL, SINGLE-USE in 1 CARTON 1 10 mL in 1 VIAL, SINGLE-USE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761053 03/28/2017 Labeler - Genentech, Inc. (080129000) Establishment Name Address ID/FEI Operations Genentech, Inc. (SSF) 080129000 ANALYSIS(50242-150) Establishment Name Address ID/FEI Operations Genentech, Inc. (Oceanside) 146373191 ANALYSIS(50242-150) Establishment Name Address ID/FEI Operations Genentech, Inc. (Vacaville) 004074162 API MANUFACTURE(50242-150), ANALYSIS(50242-150) Establishment Name Address ID/FEI Operations F. Hoffmann-La Roche Ltd. 485244961 LABEL(50242-150), PACK(50242-150) Establishment Name Address ID/FEI Operations Roche Singapore Technical Operation, Pte. Ltd. (RSTO) 937189173 ANALYSIS(50242-150) Establishment Name Address ID/FEI Operations Roche Diagnostics GmbH 315028860 MANUFACTURE(50242-150), ANALYSIS(50242-150) Establishment Name Address ID/FEI Operations Roche Diagnostics GmbH 323105205 ANALYSIS(50242-150) Revised: 11/2017 Genentech, Inc. Next Interactions Print this page Add to My Med List More about Ocrevus (ocrelizumab) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: CD20 monoclonal antibodies Consumer resources Ocrevus Ocrevus (Advanced Reading) Professional resources Ocrevus (AHFS Monograph) Related treatment guides Multiple Sclerosis> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Genentech, Inc. 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