Ixekizumab (Subcutaneous route)
Uses of This Medicine:
Ixekizumab injection is used to treat moderate-to-severe plaque psoriasis in patients who may benefit from receiving phototherapy (ultraviolet light treatment) or other treatments.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of ixekizumab injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ixekizumab injection in the elderly.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Inflammatory bowel disease (eg, Crohn disease or ulcerative colitis) Use with caution. May make this condition worse.
- Infection, or history of Ixekizumab is not recommended for patients with an active infection, including tuberculosis. Caution should be used if you have a chronic infection or history of a recurring infection.
- Tuberculosis infection, inactive Should be treated first before starting therapy with this medicine.
Proper Use of This Medicine:
A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under your skin, usually on the upper arms, abdomen (stomach), or thighs.
This medicine comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Ixekizumab may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.
Ixekizumab comes in 2 forms: a prefilled autoinjector and a prefilled syringe. Your doctor will tell you which dosage form you should use.
You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.
You might not use all of the medicine in each autoinjector or prefilled syringe. Use each autoinjector or prefilled syringe only one time. Do not save an open autoinjector or syringe. If the medicine in the autoinjector or prefilled syringe has changed color, or if you see particles in it, do not use it. Do not shake the medicine.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form:
- For plaque psoriasis:
- Adults 160 milligrams (two 80 mg) injected under your skin at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, and then 80 mg every 4 weeks.
- Children Use and dose must be determined by your doctor.
- For plaque psoriasis:
This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
Keep the medicine in the original carton until you are ready to use it. Let this medicine warm up to room temperature for 30 minutes after removal from the refrigerator.
Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container, or dispose of them as directed by your doctor.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
It is important to check with your doctor if you have any symptoms of an infection such as fever or chills, cough or hoarseness, lower back or side pain, painful or difficult urination.
You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test or been exposed to tuberculosis.
This medicine may cause serious allergic reactions, including angioedema. Tell your doctor if you have a rash, itching, or large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs.
While you are being treated with ixekizumab, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Ixekizumab may lower your body's resistance and the vaccine may not work as well, or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.
Inflammatory bowel disease may occur or worsen while you are using this medicine. Tell your doctor right away if you have rectal bleeding, severe abdominal or stomach pain, or severe diarrhea while using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
- More common
- Body aches or pain
- burning, dry, or itching eyes
- cough or hoarseness
- difficulty with breathing
- discharge or excessive tearing
- ear congestion
- fever or chills
- itching in the genital or other skin areas
- loss of voice
- lower back or side pain
- nasal congestion
- painful or difficult urination
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- runny nose
- sore mouth or tongue
- sore throat
- unusual tiredness or weakness
- white patches in the mouth or on the tongue
- Hives or welts, Itching, or skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- rectal bleeding
- redness of the skin
- severe diarrhea
- severe stomach pain
- More common
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- Less common
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/15/2016