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Generic Name: ixekizumab
Date of Approval: March 22, 2015
Company: Eli Lilly and Company

Treatment for: Plaque Psoriasis

FDA Approves Taltz

The U.S. Food and Drug Administration (FDA) has approved Taltz (ixekizumab), a humanized interleukin-17A antagonist indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Medication Guide

Read this medication guide before you start treatment and every time you get a refill. There may be new information. If you have questions about this medicine, ask your healthcare provider or pharmacist.

Important information

Taltz is a medicine that affects your immune system. It may lower the ability of your immune system to fight infections and may increase your risk of infections, which can sometimes become serious.

  • Your healthcare provider should check you for tuberculosis (TB) before you start treatment.
  • Your healthcare provider may treat you with medicine for TB before you begin treatment with Taltz if you have a past history of TB or have TB.
  • Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with Taltz.

Before starting Taltz, tell your healthcare provider if you:

  • are being treated for an infection
  • have an infection that does not go away or that keeps coming back
  • have TB or have been in close contact with someone with TB
  • think you have an infection or have symptoms of an infection such as:
    • fever, sweats, or chills
    • muscle aches
    • cough
    • shortness of breath
    • blood in your phlegm (mucus)
    • weight loss
    • warm, red, or painful skin or sores on your body
    • diarrhea or stomach pain
    • burning when you urinate or urinate more often than normal

After starting Taltz, call your healthcare provider right away if you have any of the symptoms of infection listed above.

Do not use Taltz if you have any symptoms of infection unless you are instructed to by your healthcare provider.

See Taltz side effects for more information about side effects.

What is Taltz?

Taltz is a prescription medicine used to treat adults:

  • with moderate to severe plaque psoriasis, and
  • who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light)

It is not known if Taltz is safe and effective in children under 18 years of age.

Do not use Taltz if you have had a severe allergic reaction to ixekizumab or any of the other inactive ingredients.

See the end of this page for a complete list of ingredients.

Before using Taltz

Before using Taltz, tell your healthcare provider about all of your medical conditions, including if you:

  • have any of the conditions or symptoms listed in the section Important information.
  • have Crohn’s disease or ulcerative colitis
  • have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with Taltz.
  • are pregnant or plan to become pregnant. It is not known if this medicine can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use Taltz?

See the detailed Instructions for Use that comes with your prescription for information on how to prepare and inject a dose of Taltz, and how to properly throw away (dispose of) the used autoinjectors and prefilled syringes.

  • Use Taltz exactly as prescribed by your healthcare provider.
  • If your healthcare provider decides that you or a caregiver may give your injections of Taltz at home, you should receive training on the right way to prepare and inject Taltz. Do not try to inject yourself, until you or your caregiver have been shown how to inject Taltz.
  • Taltz comes in an autoinjector and a prefilled syringe that you or your caregiver may use at home to give injections. Your healthcare provider will decide which type of Taltz is best for you to use at home.
  • Taltz is given as an injection under your skin (subcutaneous injection), in your thighs or stomach area (abdomen) by you or a caregiver. A caregiver may also give you the injection of Taltz in the back of your arm.
  • Do not give an injection in an area of the skin that is tender, bruised, red or hard, or in an area of skin that is affected by psoriasis.
  • Each injection should be given at an alternate site. Do not use the one inch area around your navel (belly button).

If you forget to take your dose:

  • Do not miss any doses unless your healthcare provider says it is okay. If you forget to take your dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time.
  • If you inject more Taltz than prescribed, call your healthcare provider or go to the nearest emergency room right away.

Taltz side effects

Taltz may cause serious side effects, including:

  • See Important information.
  • Serious allergic reactions. If you have a severe allergic reaction, do not give another injection of Taltz. Get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction:
    • feel faint
    • swelling of your face, eyelids, lips, mouth, tongue, or throat
    • trouble breathing or throat tightness
    • chest tightness
    • skin rash
  • Crohn’s disease or ulcerative colitis (Inflammatory bowel disease) can happen during treatment with Taltz, including worsening symptoms. Tell your healthcare provider if you have new or worsening symptoms of inflammatory bowel disease during treatment, including:
    • stomach (abdomen) pain
    • diarrhea with or without blood
    • weight loss

The most common side effects include:

  • injection site reactions
  • upper respiratory infections
  • nausea
  • fungal infections

These are not all of the possible side effects. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Taltz?

  • Store Taltz in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Protect from light.
  • Do not freeze. Do not use if Taltz has been frozen.
  • Do not shake the injection.

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Taltz.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information that is written for health professionals.

What are the ingredients in Taltz?

Active ingredient: ixekizumab

Inactive ingredients: Citric Acid Anhydrous, Polysorbate 80, Sodium Chloride, Sodium Citrate Dihydrate, and Water for Injection

Not made with natural rubber latex.

More about Taltz (ixekizumab)

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