Why is this medication prescribed?

Ofatumumab injection is a medication prescribed for the treatment of multiple sclerosis (MS). Multiple sclerosis is a chronic autoimmune disease that affects the central nervous system, specifically the brain and spinal cord. It is characterized by inflammation, demyelination (damage to the protective covering of nerve fibers), and the formation of scar tissue.

Ofatumumab is a monoclonal antibody that targets a protein called CD20, which is present on the surface of certain immune cells called B cells. By binding to CD20, ofatumumab helps to selectively deplete B cells from the bloodstream. B cells are involved in the immune response and play a role in the inflammatory process that damages nerve cells in MS.

By reducing the number of B cells, ofatumumab helps to modulate the immune response and control the inflammation associated with MS. This can help to reduce the frequency and severity of relapses (flare-ups) and slow down the progression of the disease.

Ofatumumab is typically prescribed for adults with relapsing forms of MS, including relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS). It is administered as a subcutaneous (under the skin) injection at regular intervals, usually once a month. The exact dosing schedule and duration of treatment may vary depending on individual patient factors and the prescribing physician’s recommendations.

How should this medicine be used?

Ofatumumab injection for multiple sclerosis is typically prescribed as a subcutaneous (under the skin) injection. The medication comes in pre-filled syringes or pens, and the injection is self-administered by the patient or a caregiver after proper training from a healthcare professional. Here are the general guidelines for using ofatumumab:

1. Preparation:
   • Wash your hands thoroughly with soap and water.
   • Gather all the necessary supplies, including the ofatumumab injection, alcohol swabs, and a sharps container for disposal.
   • Check the expiration date and ensure the medication is not expired.
   • Allow the medication to come to room temperature if it has been refrigerated. Do not warm it using any external heat sources.
2. Selecting and preparing the injection site:
   • The recommended injection sites are the thigh, abdomen, or upper arm.
   • Choose a different site for each injection and rotate among different areas within the chosen site.
   • Clean the injection site with an alcohol swab and let it dry before proceeding.
3. Injection process:
   • Remove the ofatumumab injection device from its packaging.
   • Hold the device firmly and remove the cap.
   • Pinch the skin at the cleaned injection site to create a small fold.
   • Insert the needle into the skin fold at a 90-degree angle.
   • Press the plunger or button to inject the medication.
   • Keep the needle inserted for a few seconds after the injection to ensure all the medication is delivered.
   • Remove the needle from the skin and release the skin fold.
   • Do not rub or massage the injection site after the injection.

It is essential to follow the specific instructions provided by your healthcare professional or the medication’s prescribing information. They may provide additional guidance tailored to your individual needs and circumstances. If you have any questions or concerns about the administration of ofatumumab, consult your healthcare provider for clarification.

Other uses for this medicine

Ofatumumab injection is primarily used for the treatment of multiple sclerosis (MS). However, it may also have off-label uses or investigational applications that are not yet approved by regulatory authorities. It’s important to note that off-label uses should only be considered under the guidance of a healthcare professional with expertise in the specific condition being treated.

What special precautions should I follow?

As for special precautions, here are some important considerations when using ofatumumab injection for multiple sclerosis:

• Allergic reactions: Some individuals may be hypersensitive or allergic to ofatumumab or its components. If you have a history of allergic reactions to monoclonal antibodies or other medications, inform your healthcare provider before starting treatment.
• Infections: Ofatumumab can increase the risk of infections, including respiratory tract infections, urinary tract infections, and herpes viral infections. Prior to starting treatment, your healthcare provider may assess your immunization status and recommend vaccines as appropriate. Inform your healthcare provider promptly if you develop any signs of infection during treatment, such as fever, cough, or urinary symptoms.
• Hepatitis B virus reactivation: Ofatumumab may cause reactivation of the hepatitis B virus in individuals who have previously been infected. If you have a history of hepatitis B infection, your healthcare provider may monitor your liver function and viral load during treatment.
• Progressive multifocal leukoencephalopathy (PML): PML is a rare and serious viral infection that affects the brain. Although it is a rare side effect, there have been reports of PML in patients receiving ofatumumab or other medications that target CD20. Inform your healthcare provider immediately if you experience any neurological symptoms, such as changes in vision, weakness, or difficulty speaking.
• Vaccinations: Ofatumumab may affect the efficacy of certain vaccines. It is recommended to complete any necessary immunizations at least 6 weeks before starting treatment with ofatumumab. Live vaccines should generally be avoided during treatment.
• Pregnancy and breastfeeding: The use of ofatumumab during pregnancy or breastfeeding is not recommended due to limited data on its safety in these populations. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential risks and benefits with your healthcare provider.

These are general precautions, and individual circumstances may vary. It is crucial to discuss your medical history, current medications, and any concerns with your healthcare provider before starting treatment with ofatumumab or any other medication. They can provide personalized advice and guidance based on your specific situation.

What special dietary instructions should I follow?

There are no specific dietary instructions associated with the use of ofatumumab injection for multiple sclerosis. You can generally continue with your regular diet while undergoing treatment. However, it’s always a good idea to maintain a balanced and healthy diet to support your overall well-being.

What should I do if I forget a dose?

If you forget to take a dose of Ofatumumab, it’s essential to contact your healthcare provider or follow the instructions provided with your medication. They will be able to guide you on the best course of action. It’s generally recommended not to double up on doses to make up for a missed one unless explicitly instructed by your healthcare provider.

What side effects can this medication cause?

Ofatumumab injection for multiple sclerosis can cause several side effects. It’s important to note that not all individuals will experience these side effects, and their severity can vary. If you have any concerns about side effects, it’s best to consult your healthcare provider. Here are some potential side effects associated with ofatumumab:

• Injection-site reactions: Common side effects include injection-site reactions such as redness, itching, pain, swelling, or bruising. These reactions are usually mild to moderate in intensity and resolve on their own.
• Upper respiratory tract infections: In clinical trials, upper respiratory tract infections, including nasopharyngitis (common cold) and sinusitis, were commonly reported. Symptoms may include a sore throat, runny or stuffy nose, cough, or congestion.
• Headache: Headaches are a common side effect reported by individuals receiving ofatumumab. These headaches are typically mild to moderate in severity.
• Urinary tract infections: Urinary tract infections (UTIs) have been reported in some patients taking ofatumumab. Symptoms may include a frequent urge to urinate, pain or burning during urination, cloudy or strong-smelling urine, and lower abdominal pain.
• Diarrhea: Some individuals may experience diarrhea as a side effect of ofatumumab treatment. It is usually mild, but if severe or persistent, it’s important to inform your healthcare provider.
• Infusion-related reactions: Infusion-related reactions, including fever, chills, rash, itching, dizziness, and difficulty breathing, have been reported with ofatumumab and may occur during or after the infusion. Healthcare providers typically take precautions to minimize the risk and manage any reactions that may occur.
• Herpes viral infections: Ofatumumab can increase the risk of herpes viral infections, such as herpes simplex or herpes zoster (shingles). Inform your healthcare provider if you develop any symptoms such as painful blisters, rash, or tingling.
• Decreased immunoglobulin levels: Ofatumumab may decrease the levels of immunoglobulins (antibodies) in the blood, which could increase the risk of certain infections. Your healthcare provider may monitor your immunoglobulin levels during treatment.

It’s important to report any side effects or adverse reactions to your healthcare provider promptly. They can provide guidance, address your concerns, and help manage any side effects that you may experience during treatment.

What should I know about storage and disposal of this medication?

• Storage: Ofatumumab injections should be stored in the refrigerator at a temperature between 2°C and 8°C (36°F and 46°F). Protect the medication from light. Do not freeze. Keep it in its original packaging until ready to use. If the medication needs to be transported, it can be kept at room temperature (up to 30°C or 86°F) for a single period of up to 30 days. After removal from the refrigerator or temporary storage at room temperature, do not place the medication back in the refrigerator.
• Disposal: Safely dispose of used needles, syringes, and any unused ofatumumab injection according to local regulations and guidelines. Place them in a puncture-resistant container, such as a sharps container, to prevent accidental needle sticks. Consult your healthcare provider or local waste management authorities for proper disposal instructions.

In case of emergency/overdose

In case of an emergency or suspected overdose, such as accidental administration of a higher dose than prescribed, contact your local emergency services or poison control center immediately. Provide them with all the necessary information, including the name of the medication (ofatumumab), the dosage taken, and any symptoms or concerns you may have.

What other information should I know?

• Before starting ofatumumab or any new medication, inform your healthcare provider about all your current medications, including prescription drugs, over-the-counter medications, and any herbal supplements or vitamins you are taking.
• Regular monitoring and follow-up visits are important to assess the effectiveness of the treatment and manage any potential side effects.
• Keep all appointments with your healthcare provider, including laboratory tests and imaging scans, as scheduled.
• Inform all healthcare providers involved in your care that you are receiving ofatumumab treatment, including dentists or surgeons, as it may affect certain procedures or medications.
• It is important to discuss any pregnancy plans with your healthcare provider, as the use of ofatumumab during pregnancy or breastfeeding is generally not recommended.
• Follow all instructions and guidelines provided by your healthcare provider and the medication’s packaging regarding the administration, storage, and disposal of ofatumumab.

Remember, this information is meant to provide general guidance. Always consult your healthcare provider or pharmacist for specific instructions and advice regarding the use, storage, disposal, and emergencies associated with ofatumumab or any other medication.