Brodalumab Prefilled Syringe (BRODALUMAB - 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.

The liquid should be clear or light yellow.

Check the medicine before each use. If the liquid medicine has any particles in it, appears discolored, or if the vial appears damaged, do not use it.

Do not shake the medicine before using.

Keep medicine in refrigerator. Do not freeze. If frozen, throw away.

Keep the medicine in its original container.

You may store this medicine at room temperature for up to 14 days. Do not put back in refrigerator.

Do not store above 77 degrees F (25 degrees C).

Protect medicine from light.

Take the medicine out of the refrigerator about 30 minutes before use to warm to room temperature.

Injecting cold drug may be uncomfortable.

Discard unused medicine after 14 days at room temperature.

Never use any medicine that has expired.

Discard any remaining medicine after your dose is given.

Wash your hands before and after handling this medicine.

You or a family member can be trained to give this medicine at home.

Do not inject into skin that is red, swollen or itchy.

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.

Your doctor should check you for tuberculosis (TB) before you start this medicine and while you are using it. Tell your doctor if you are being treated for TB or any other infection.

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.

Do not use the medication any more than instructed.

Family should check on the patient often. Call the doctor if patient becomes more depressed, has thoughts of suicide, or shows changes in behavior.

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.

Please tell your doctor if you have moderate to severe diarrhea while on this medicine. Do not treat the diarrhea with over-the-counter diarrhea medicine.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

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

Do not share this medicine with anyone who has not been prescribed this medicine.

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.

• coughing
• diarrhea
• lack of energy and tiredness
• pain, redness, swelling near injection
• runny or stuffy nose
• fungal infection of the skin
• sore throat
• upper respiratory infection

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

• cough that does not go away
• depression or feeling sad
• severe, watery or bloody diarrhea
• fainting
• fever or chills
• mood changes
• shortness of breath
• severe stomach or bowel pain
• suicidal thoughts

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.