Ofatumumab Pen Injector (OFATUMUMAB - SUBCUTANEOUS INJECTION)

Instructions

This medicine is injected into the skin. Ask your doctor, nurse, or pharmacist where on your body this medicine can be injected and how to inject it.

Carefully follow the instructions for preparing this medicine before injection.

Always inspect the medicine before using.

The liquid should be clear or light to dark yellow.

Do not use the medicine if it is cloudy, contains flakes or large particles, or if it has changed color.

Do not shake the medicine before using.

Keep medicine in refrigerator. Do not freeze. Protect from light.

Keep the medicine in its original container.

If needed, this medicine may be stored at room temperature for 7 days or less.

If your medicine is stored in the refrigerator, take it out of the refrigerator about 30 minutes before use to warm to room temperature.

Discard unused medicine after 7 days at room temperature.

Never use any medicine that has expired.

Do not inject into skin that is bruised, tender, red, hard or has scars or stretch marks.

Change the location of the injection each time. Choose a location at least 1 inch from the last injection.

Do not rub or massage the area where the injection was given.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

This medicine may rarely cause a life-threatening brain infection. Get medical help right away if you have weakness on one side of the body, loss of coordination, vision problems, changes in thinking or memory, confusion, or personality changes.

This medicine is associated with a rare, but serious problem of the liver. Speak to your doctor about the early signs of liver problems and the benefits and risks of using this medicine.

Do not use the medication any more than instructed.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

It is unknown if this medicine passes into breast milk. Ask your doctor before breastfeeding.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women must use reliable forms of birth control while taking this medicine and for 6 months after stopping to prevent pregnancy.

Always carry an ID card or wear a medical alert bracelet indicating your medical condition.

Ask your doctor, nurse or pharmacist how to safely discard unused medicines, needles and syringes.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• lack of energy and tiredness
• fever
• headaches
• pain, redness, swelling near injection

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• severe or persistent abdominal pain
• decreased appetite
• loss of balance
• changes in memory, mood, or thinking
• confusion
• cough that does not go away
• fever or chills
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• seizures
• sore throat
• difficulty speaking
• unsteadiness while walking
• blurring or changes of vision
• severe or persistent vomiting
• weakness on one side of the body

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.