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Purpose and Safety Summary
PURPOSE AND SAFETY SUMMARY
Important Facts About Taltz®(tȯl-ts). It is a prescription medicine also known as ixekizumab. Taltz is an injectable medicine used to treat:
People six years of age and older with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
Adults with active psoriatic arthritis.
Adults with active ankylosing spondylitis.
Adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.
It is not known if Taltz is safe and effective in children for conditions other than plaque psoriasis or in children under 6 years of age.
Taltz affects the immune system. It may increase your risk of infections, which can be serious. Do not use Taltz if you have any symptoms of infection, unless your doctor tells you to. If you have a symptom after starting Taltz, call your doctor right away.
Your doctor should check you for tuberculosis (TB) before you start Taltz, and watch you closely for signs of TB during and after treatment with Taltz.
If you have TB, or had it in the past, your doctor may treat you for it before you start Taltz.
Do not use Taltz if you have had a serious allergic reaction to ixekizumab or any other ingredient in Taltz, such as: swelling of your eyelids, lips, mouth, tongue or throat, trouble breathing, feeling faint, throat or chest tightness, or skin rash. Get emergency help right away if you have any of these reactions. See the Medication Guide that comes with Taltz for a list of ingredients.
Crohn’s disease or ulcerative colitis (inflammatory bowel disease) can start or get worse with Taltz use. Tell your doctor if you have any of these symptoms or if they get worse: stomach pain, diarrhea, and weight loss.
You should not get live vaccines while taking Taltz. You should get the vaccines you need before you start Taltz.
Common side effects
The most common side effects of Taltz include:
Injection site reactions
Upper respiratory infections
Fungal skin infections
Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.
Before you use Taltz, review these questions with your doctor: ❑ Are you being treated for an infection? ❑ Do you have an infection that does not go away or keeps coming back? ❑ Do you have TB or have you been in close contact with someone with TB? ❑ Do you have possible symptoms of an infection such as fever, cough, sores, diarrhea, or other symptoms? Ask your doctor about other possible symptoms. ❑ Do you have Crohn’s disease or ulcerative colitis? Tell your doctor if: ❑ You need any vaccines or have had one recently. ❑ You take prescription or over-the-counter medicines, vitamins, or herbal supplements. ❑ You are pregnant or planning to become pregnant. It is not known if Taltz can harm an unborn baby. ❑ You are breastfeeding or planning to breastfeed. It is not known if Taltz passes into breastmilk.
How to take
See the instructions for use that come with Taltz. There you will find information about how to store, prepare, and inject Taltz. Adults may self-inject after receiving training from a healthcare provider. For people under 18 years of age:
Weighing less than 50 kg (i.e., 110 lb): Taltz must be given by a healthcare provider.
Weighing more than 50 kg (i.e., 110 lb): If your healthcare provider decides that your caregiver may give your injections of Taltz at home, your caregiver should ask and receive training from a healthcare provider on the right way to prepare and inject Taltz.
For more information, call 1-800-545-5979 or go to taltz.com. This summary provides basic information about Taltz and is not comprehensive. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Taltz and how to take it. Your doctor is the best person to help you decide if Taltz is right for you. Taltz® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries and affiliates. IX CON BS 29MAY2020
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