Ocrelizumab
اوکرلیزوماب
🎗️ Antineoplastic And Immunomodulating AgentsAnti-CD20 antibody
Market / country: 🇺🇸 USA
Ocrevus (US)
🧮 Dose calculator
Multiple sclerosis (relapsing) · Regimen source: FDA Ocrevus · 2.3
- • Premedicate with methylprednisolone and an antihistamine before each infusion; observe for 1 h after. Screen HBV, immunoglobulins and liver tests first. FDA Ocrevus · 2.2FDA Ocrevus · 2.1
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Active HBV infection; history of life-threatening infusion reaction to ocrelizumab. FDA Ocrevus · 4
Warnings
- • Infections (screen HBV first); PML; reduced immunoglobulins; liver injury. FDA Ocrevus · 5
- • Infusion reactions; malignancies (breast); immune-mediated colitis. FDA Ocrevus · 5
Formulations
- 300 mg/10 mL (30 mg/mL) vial — injection 🇺🇸 USA FDA Ocrevus · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Ocrevus · 8.1
“Risk Summary OCREVUS is a humanized monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins are known to cross the placental barrier.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Ocrevus · 8.2
“Risk Summary There are no data on the presence of ocrelizumab in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Ocrevus · 8.4
“The safety and effectiveness of OCREVUS for the treatment of relapsing-remitting MS have been established in pediatric patients 10 years of age and older who weigh 25 kg or more.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Ocrevus · 8.5
“Clinical studies of OCREVUS did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Ocrevus · 8.3
“Contraception Females of reproductive potential should use effective contraception while receiving OCREVUS and for 6 months after the last infusion of OCREVUS [see Clinical Pharmacology (12.3) ] .”
🔗 Reference links
- FDA (approval record)BLA761053
- DailyMed (FDA label)FDA Ocrevus
- MedlinePlus (NIH)Ocrelizumab Injection
- WHO ATC/DDDL04AG08
- Darooyab (Iran)Ocrelizumab
🇮🇷 Registered in Iran Darooyab · G-1720/Ocrelizumab
Dosage forms with Iranian generic codes, per Darooyab.
- 52172 · OCRELIZUMAB 300 MG/10 ML INJECTION · فرآورده تزریقی اکرلیزومب ۳۰۰ میلیگرم / ۱۰ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Ocrevus · 3FDA Ocrevus · 2.3FDA Ocrevus · 2.2FDA Ocrevus · 2.1FDA Ocrevus · 4FDA Ocrevus · 5FDA Ocrevus · SPL approval / marketing categoryFDA Ocrevus · 8.1FDA Ocrevus · 8.2FDA Ocrevus · 8.4FDA Ocrevus · 8.5FDA Ocrevus · 8.3
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-1720/Ocrelizumab
- Clinical review⚠ Unverified