Ixekizumab

• Ixekizumab is approved for treating adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or medications that are absorbed into the blood stream (systemic therapy).

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of ixekizumab, there are no specific foods you must exclude from your diet when receiving this medication.

Before using ixekizumab, tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if this medicine can harm your unborn baby.

Ixekizumab is an immunosuppressant that reduces the effects of a chemical substance in the body that can cause inflammation.

Ixekizumab is used to treat moderate to severe plaque psoriasis (raised, silvery flaking of the skin) in adults.

Ixekizumab may also be used for purposes not listed in this medication guide.

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.

You should not use ixekizumab if you are allergic to it.

To make sure ixekizumab 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).

It is not known whether this medicine 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 18 years old.

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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; feeling like you might pass out; swelling of your face, lips, 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 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.

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.

Plaque Psoriasis

Management of moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy.1 3 14

Absorption

Bioavailability

Bioavailability is 60–81% following sub-Q administration.1 Higher bioavailability attained when administered into thigh compared with other injection sites, including arm and abdomen.1

Peak plasma concentrations achieved by approximately 4 days after a single 160-mg sub-Q dose.1

Steady-state concentrations attained by week 8 in patients receiving initial 160-mg dose followed by 80 mg every 2 weeks.1 After dosage changed at week 12 to 80 mg every 4 weeks, new steady state achieved in approximately 10 weeks.1

Pharmacokinetics are dose proportional over a sub-Q dose range of 5–160 mg.1

Distribution

Extent

Not known whether distributed into human milk.1

Special Populations

Volume of distribution increases as body weight increases.1

Elimination

Metabolism

Metabolic pathway not characterized.1

Expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.1

Half-life

13 days.1

Special Populations

Pharmacokinetics not formally studied in renal or hepatic impairment.1

Age does not substantially alter clearance in adults with plaque psoriasis.1

Clearance increases as body weight increases.1

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about ixekizumab, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about ixekizumab. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using ixekizumab.

Review Date: October 4, 2017

AU, UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. US: This drug should be used during pregnancy only if the benefit outweighs the risk. Excreted into human milk: Unknown Excreted into animal milk: Yes Comment: The effects in the nursing infant are unknown.

Until more data become available, this drug should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Because it is a large protein molecule with a molecular weight of 146,000, absorption by the infant is unlikely after the first few weeks postpartum, and it will probably be destroyed in the infant GI tract.