Alemtuzumab Injection (ALEMTUZUMAB (MULTIPLE SCLEROSIS) - INJECTION)

Instructions

This medicine is given as an IV injection into a vein.

This medicine should be given by a trained health care provider.

You must be monitored by a healthcare professional for at least 2 hours after each dose is given.

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.

Your doctor may prescribe other medications to reduce side effects. Follow instructions carefully.

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.

May cause mouth sores. Brush teeth gently. Avoid products containing alcohol. Rinse mouth with a mixture of water and baking soda or salt.

Some patients on this medicine have developed severe, life-threatening infections. Please speak with your doctor about the risks and benefits of using this medicine.

This medicine may increase the risk of cancer. Ask your doctor about the benefits and risks.

There is an increased risk of bleeding while on this medicine, please tell your doctor or nurse if you notice any excessive bleeding or bruising.

Tell your doctor or nurse right away if any of these happen while the medicine is being given: fever, chills, feeling of heat or flushing, dizziness, fainting, nausea, or shortness of breath. The medicine may need to be stopped or given at a slower rate.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

If possible, avoid using with alcohol, marijuana, or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

After being on this medication, speak with your doctor about any new, unusual or strong thoughts or feelings.

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.

Do not breastfeed while on this medicine. You may safely start breastfeeding 4 months after stopping treatment.

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 using this medicine and for 4 months after stopping to prevent pregnancy.

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.

• agitated feeling or trouble sleeping
• decreased appetite
• constipation or diarrhea
• coughing
• dizziness
• lack of energy and tiredness
• feeling of heat or flushing
• headaches
• mouth sores or irritation
• nausea and vomiting
• stomach upset or abdominal pain
• sweating
• yeast infection of mouth

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

• decreased awareness or responsiveness
• loss of balance
• bleeding or bruising
• severe or persistent bone, joint or jaw pain
• wheezing or difficulty breathing
• chest pain
• difficulty concentrating
• coughing up blood or vomit that looks like coffee grounds
• severe, watery or bloody diarrhea
• swelling of the face, mouth, tongue, or throat
• swelling of the legs, feet, and hands
• fainting
• fever
• numbness or tingling in hands and feet
• fast or irregular heart beats
• unusual or long-lasting hoarseness
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• mood changes
• muscle aches, spasms or abnormal movements
• neck pain or stiffness
• pain near injection site
• seizures
• shakiness
• change in the size or color of a skin mole
• symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
• difficulty swallowing
• blood in urine
• blurring or changes of vision
• weakness
• weight loss

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.