Generic name: ixekizumab (IX ee KIZ ue mab)
Brand name: Taltz Autoinjector, Taltz Prefilled Syringe
Drug class: Interleukin inhibitors
Taltz (ixekizumab) is an immunosuppressant that reduces the effects of a chemical substance in the body that can cause inflammation.
Taltz is used to treat plaque psoriasis in adults and children at least 6 years old.
Taltz is used in adults to treat active psoriatic arthritis or active ankylosing spondylitis.
Taltz is also used in adults to treat axial spondyloarthritis.
Warnings
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Before taking this medicine
You should not use Taltz if you are allergic to ixekizumab.
To make sure Taltz is safe for you, tell your doctor if you have:
- an active or recent infection;
- Crohn's disease, ulcerative colitis; or
- tuberculosis (or if you have close contact with someone who has tuberculosis).
Your doctor may perform tests to make sure you do not have tuberculosis or other infections.
It is not known whether Taltz will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether ixekizumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Ixekizumab is not approved for use by anyone younger than 6 years old.
How is Taltz given?
Take Taltz exactly as prescribed. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Taltz is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Taltz is not used daily. Your first dose may be given as 2 injections at the same time. Later doses are then given once every 2 to 4 weeks.
Ixekizumab doses are based on weight in children treated for moderate-to-severe plaque psoriasis. Your child's dose needs may change if the child gains or loses weight.
The timing of your injections will depend on the condition being treated. Follow your doctor's dosing instructions very carefully.
Your healthcare provider will show you where on your body to inject Taltz. Use a different place each time you give an injection. Do not inject into the same place two times in a row. Do not give an injection into a skin area with active psoriasis, or skin that is red, bruised, or tender.
Taltz should appear as a clear to light-yellow liquid. Do not use the medicine if it looks cloudy, has changed color, or has particles in it. Call your pharmacist for new medication.
Do not shake the syringe or injection pen.
Ixekizumab can weaken (suppress) your immune system, and you may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, weakness, cold or flu symptoms, skin sores, diarrhea, frequent or recurring illness).
Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.
Store this medicine in the original container in a refrigerator. Protect from light and do not freeze. Do not use the medicine if it has become frozen.
Before injecting your dose, take the injection pen or prefilled syringe out of the refrigerator and leave it at room temperature for 30 minutes. Do not heat this medicine in a microwave or under hot water, and do not leave it in direct sunlight.
Each single-use Taltz injection pen or prefilled syringe is for one use only. Throw away after one use, even if there is still some medicine left after injecting your dose.
Dosing information
Usual Adult Dose for Plaque Psoriasis:
- 160 mg (two 80 mg injections) subcutaneously at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks
- Evaluate patients for tuberculosis (TB) infection prior to initiating therapy.
- Use: For the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
Usual Adult Dose for Psoriatic Arthritis:
- 160 mg (two 80 mg injections) subcutaneously at Week 0, followed by 80 mg every 4 weeks
- Evaluate patients for tuberculosis (TB) infection prior to initiating therapy.
- For psoriatic arthritis patients with coexistent moderate-to-severe plaque psoriasis, use the dosing regimen for plaque psoriasis.
- This drug may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate).
- Use: For the treatment of adult patients with active psoriatic arthritis
Usual Adult Dose for Ankylosing Spondylitis:
- 160 mg (two 80 mg injections) subcutaneously at Week 0, followed by 80 mg every 4 weeks
What happens if I miss a dose?
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Taltz?
Do not share this medicine with another person, even if they have the same symptoms you have.
Do not receive a "live" vaccine while using ixekizumab. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Taltz side effects
Get emergency medical help if you have signs of an allergic reaction to Taltz: rash; chest tightness, difficult breathing; feeling like you might pass out; swelling of your face, eyelids, lips, mouth, tongue, or throat.
Call your doctor at once if you have:
- fever, chills, sweating, muscle pain, weight loss;
- diarrhea (may be bloody), stomach cramps;
- painful skin sores;
- cough, shortness of breath, cough with red or pink mucus;
- sores or white patches in your mouth or throat (yeast infection or "thrush");
- increased urination, pain or burning when you urinate;
- eye swelling, redness, crusting or drainage (may be signs of infection); or
- signs of a fungal infection (rash or red patches, itching, burning, cracked skin, hair loss).
Common Taltz side effects may include:
- pain or redness where the medicine was injected;
- nausea;
- ear infection; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Taltz?
Other drugs may interact with ixekizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.