Description
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 also used alone or together with other medicines (eg, methotrexate) to treat active psoriatic arthritis.
Ixekizumab injection is also used alone or together with other medicines (eg, sulfasalazine, steroids, NSAIDs, pain medicines) to treat ankylosing spondylitis.
Ixekizumab injection is also used to treat non-radiographic axial spondyloarthritis (a type of arthritis in the spine) with objective signs of swelling.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
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:
Allergies
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.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ixekizumab injection to treat plaque psoriasis in children 6 years of age and older. However, safety and efficacy have not been established to treat plaque psoriasis in children younger than 6 years of age and to treat psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis in children.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ixekizumab injection in the elderly.
Breastfeeding
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.
Drug Interactions
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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abatacept
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Anifrolumab-fnia
- Bacillus of Calmette and Guerin Vaccine, Live
- Baricitinib
- Cholera Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Ebola Zaire Vaccine, Live
- Infliximab
- Influenza Virus Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine, Live
- Varicella Virus Vaccine, Live
- Yellow Fever Vaccine
- Zoster Vaccine, Live
Other Interactions
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:
- Infection (eg, bacteria, fungus, virus), 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.
- Inflammatory bowel disease (eg, Crohn disease, ulcerative colitis)—Use with caution. May make this condition worse.
- Tuberculosis infection, inactive—Should be treated first before starting treatment with this medicine.
Proper Use
A nurse or other trained health professional will give you this medicine. It 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 injection may sometimes be given at home to patients who do not need to be in the hospital or clinic (eg, adults and children weighing more than 50 kilograms). 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. Do not inject into skin areas that are red, bruised, tender, hard, or affected by psoriasis.
Allow the medicine to warm to room temperature for 30 minutes before using it.
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.
Dosing
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 (autoinjector or prefilled syringe):
- For ankylosing spondylitis:
- Adults—160 milligrams (two-80 mg) injected under your skin at Week 0, followed by 80 mg every 4 weeks.
- Children—Use and dose must be determined by your doctor.
- For non-radiographic axial spondyloarthritis:
- Adults—80 milligrams (mg) injected under your skin every 4 weeks.
- Children—Use and dose must be determined by your doctor.
- 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 6 years of age and older weighing more than 50 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 160 mg (two-80 mg) injected under your skin at Week 0, followed by 80 mg every 4 weeks.
- Children 6 years of age and older weighing 25 to 50 kg—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 80 mg injected under your skin at Week 0, followed by 40 mg every 4 weeks.
- Children 6 years of age and older and weighing less than 25 kg—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 40 mg injected under your skin at Week 0, followed by 20 mg every 4 weeks.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For psoriatic arthritis:
- Adults—160 milligrams (two-80 mg) injected under your skin at Week 0, followed by 80 mg every 4 weeks.
- Children—Use and dose must be determined by your doctor.
- For ankylosing spondylitis:
Missed Dose
Call your doctor or pharmacist for instructions.
If you miss a dose of this medicine, use it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
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. You may also store this medicine at room temperature up to 30°C for up to 5 days. Do not put it back in the refrigerator once stored at room temperature. Throw away any unused medicine after 5 days.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause serious infections (eg, bacteria, fungus, virus). Check with your doctor right away if you have chest tightness, stomach pain, fever, itching, pain or redness of the skin, indigestion, nausea, vomiting, chills, confusion, dizziness, fast heartbeat, bone pain, diarrhea, loss of appetite, weakness, bleeding in the eye, blurred vision, trouble breathing, sneezing, or cough.
You will need to have a skin test for tuberculosis before you or your child starts 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. This may be life-threatening and require immediate medical attention. Tell your doctor if you or your child have a rash, itching, or large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs.
This medicine may cause serious skin reactions, including atopic dermatitis-like eruptions, dyshidrotic eczema, erythroderma. Check with your doctor right away if you have blistering, crusting, irritation, itching, or reddening of the skin, cracked, dry, or scaly skin, skin rash, encrusted, scaly and oozing, swelling.
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. You should receive all your vaccines before starting treatment with this medicine. 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. 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 or your child 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
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:
More common
- Body aches or pain
- burning, dry, or itching eyes
- chills
- cough
- difficulty with breathing
- discharge or excessive tearing
- ear congestion
- fever
- headache
- hoarseness
- itching in the genital or other skin areas
- loss of voice
- lower back or side pain
- painful or difficult urination
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- runny or stuffy nose
- scaling of the skin
- sneezing
- sore mouth or tongue
- sore throat
- unusual tiredness or weakness
- white patches in the mouth or on the tongue
Less common
- Chest tightness
- diarrhea
- difficulty swallowing
- dizziness
- fast heartbeat
- general feeling of discomfort or illness
- hives, itching, skin rash
- joint pain
- loss of appetite
- muscle aches and pains
- nausea
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- shivering
- sweating
- trouble sleeping
- vomiting
Rare
- 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
Incidence not known
- Chest pain or discomfort
- confusion
- irritability
- seizures
- skin rash
- stiff neck
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:
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
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.
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