OFATUMUMAB

Ofatumumab received U.S. FDA approval on 26 October 2009. It is indicated for treatment of adult patients with relapsing forms of multiple sclerosis (RMS).

It is indicated to treat adult patients having relapsing forms of multiple sclerosis (RMS).

The medicine will be administered to you by a healthcare professional in a hospital setting. It is usually administered in the vein (intravenous). Your doctor will decide the dose, route of administration, and frequency based on your disease condition and other factors.

The common side effects that are experienced while you are on the treatment with ofatumumab upper respiratory tract infections (sore throat and runny nose), urinary tract infections, decrease in the level of immunoglobulin M protein in the blood, oral herpes, pain, redness, swelling and itching at the injection site.

Ofatumumab might be unsafe during pregnancy. If you are pregnant, think you might be pregnant or are planning to get pregnant then consult with your doctor before starting treatment with this medication. Effective contraception is to be followed while using this medication and must be used up to 6 months after the last dose. If you have used this medication while being pregnant, then consult your doctor for advice before getting your new born baby vaccinated.

Inform your doctor if you have any immune system problems, cancer, or any severe infection or if you are planning on getting vaccinated before starting treatment with this medication. If you have or had hepatitis B infection, then inform your doctor before you start treatment with this medication as this medication might cause the hepatitis B virus to become active again. Ofatumumab might be unsafe during breastfeeding as this medication can pass into the breast milk. Consult your doctor regarding any breastfeeding concerns you have before starting treatment with this medication.

If you have used Ofatumumab during pregnancy, consult your doctor for advice before your newborn baby receives vaccinations. If your multiple sclerosis symptoms worsen—such as weakness or vision changes—or if you experience any new or unusual symptoms while taking this medication, inform your doctor immediately. Fever, headache, muscle pain, chills and fatigue are common side effects that may occur during treatment with this medication.

Novartis Pharmaceuticals UK Limited, Electronic Medicines Compendium (EMC), [Revised on June 2022] [Accessed on 20th August 2022], https://www.medicines.org.uk/emc/files/pil.12433.pdf Novartis Pharmaceuticals Corporation, U.S. Food and Drug Administration, [ Revised on August 2020], [ Accessed on 20th August 2022], https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125326s070lbl.pdf Anton Wellstein, Giuseppe Giaccone, Michael B. Atkins, and Edward A. Sausville, Pathway-Targeted Therapies: Monoclonal Antibodies, Protein Kinase Inhibitors, and Various Small Molecules, Goodman & Gilman’s Pharmacological Basis of Therapeutics, 13th Edition, 2018, 1227-1229.