Ustekinumab

Contraindications

Hypersensitivity

Active serious infection

Concomitant live vaccines

• Discontinue at least 15 weeks before live vaccines
• Resume at least 2 weeks later

Cautions

May increase risk of infections and reactivation of latent infections; serious bacterial, fungal, and viral infections observed with treatment; evaluate for TB infection prior to administration

Other serious infections requiring hospitalization reported including diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and UTIs

Increased risk of malignancy

Reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients with pre-existing risk factors for developing nonmelanoma skin cancer; monitor all patients for nonmelanoma skin cancer

Avoid pregnancy

Provide age-appropriate immunization prior to initiating therapy

Administration of live-virus to household contacts

Hypersensitivity reactions reported, including anaphylaxis and angioedema

Use caution in patients genetically deficient in IL-12/IL-23

Psoriasis studies the safety of ustekinumab in combination with immunosuppressive agents or phototherapy has not been evaluated; in psoriatic arthritis studies, concomitant methotrexate use did not appear to influence the safety or efficacy

May decrease the protective effect of allergen immunotherapy

Reversible posterior leukoencephalopathy syndrome reported (1 case)

Ustekinumab is injected under the skin.

• Patients weighing <100 kg (220 lbs) should receive 45 mg initially, 45 mg 4 weeks later then 45 mg every 12 weeks.
• Patients weighing >100 kg (220 lbs) should receive 90 mg initially, 90 mg 4 weeks later then 90 mg every 12 weeks.

Drug interaction studies have not been conducted with ustekinumab; however, since ustekinumab suppresses the immune system, it should not be used with other drugs that also suppress the immune system.

Live vaccines should not be administered to patients treated with ustekinumab because they may develop active disease from the live viruses contained in the vaccine because of their weakened immune system. Vaccine containing killed virus may not generate an adequate immune response because ustekinumab suppresses the immune system.

Common Side Effects of Stelara

Tell your doctor if any of the following side effects become severe or don't go away:

• Dizziness
• Headache
• Mild tiredness
• Stuffy nose or sneezing
• Back pain
• Redness or irritation at the injection site

Serious Side Effects of Stelara

Tell your doctor right away if you experience any of the symptoms listed in the Stelara Warnings section above, or any of the following serious side effects:

• A mole that changes in color or size
• Severe stomach pain
• Severe headache
• Confusion
• Vision problems
• Seizures
• Feeling faint
• Signs of an allergic reaction (may include hives, rash, itching, chest tightness, or swelling of the face, lips, tongue, or throat)

Before you receive ustekinumab, tell your doctor if you:

• have any of the conditions or symptoms listed in the section "Drug Precautions"
• ever had an allergic reaction to ustekinumab. 
• are allergic to latex. The needle cover on the prefilled syringe contains latex. 
• have recently received or are scheduled to receive an immunization (vaccine). People who take ustekinumab should not receive live vaccines. Tell your doctor if anyone in your house needs a vaccine. The viruses used in some types of vaccines can spread to people with a weakened immune system, and can cause serious problems. You should not receive the BCG vaccine during the one year before taking ustekinumab or one year after you stop taking ustekinumab.
• have any new or changing lesions within psoriasis areas or on normal skin.
• are receiving or have received allergy shots, especially for serious allergic reactions. Allergy shots may not work as well for you during treatment with ustekinumab. Ustekinumab may also increase your risk of having an allergic reaction to an allergy shot.
• receive phototherapy for your psoriasis.
• have any other medical conditions.
• are pregnant or planning to become pregnant. 
• are breastfeeding or plan to breastfeed.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Keep all medical and laboratory appointments. It is important you receive your scheduled ustekinumab doses to get the most benefit. 

You should not use ustekinumab if you are allergic to it, or if you have:

• active tuberculosis; or

• if you have received a BCG (Bacillus Calmette and Guérin) vaccine within the past 12 months.

Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

To make sure ustekinumab is safe for you, tell your doctor if you have:

• signs of infection (fever, chills, cough, muscle aches, diarrhea, pain when you urinate, feeling very tired);

• a history of chronic infections;

• a latex allergy;

• warmth, redness, or sores on your skin;

• if you are scheduled to receive any vaccine;

• if you have ever received phototherapy (light therapy); or

• if you have ever received allergy shots.

Some people using ustekinumab have developed skin cancer (non-melanoma). However, these people may have had a higher risk of skin cancer. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of ustekinumab on the baby.

Ustekinumab can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Ustekinumab is not approved for use by anyone younger than 18 years old.

• If you have an allergy to ustekinumab or any other part of ustekinumab.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have had the BCG vaccine in the past year.
• If you have an infection.
• If you have active TB (tuberculosis).

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take ustekinumab with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

Prefilled syringes:

• It is given as a shot into the fatty part of the skin.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Follow how to use as you have been told by the doctor or read the package insert.
• Wash your hands before and after use.
• Move the site where you give the shot with each shot.
• Throw away any part not used after use.
• This product may contain small white particles. Do not use if the solution is cloudy, leaking, or has large lumps, flakes, or other particles.
• This medicine is colorless to a faint yellow. Do not use if the solution changes color.
• Do not give into skin that is irritated, bruised, red, infected, or scarred.
• Do not shake.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

Infusion:

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling tired or weak.
• Headache.
• Throwing up.
• Nose and throat irritation.
• Signs of a common cold.
• Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• 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.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time ustekinumab is refilled. If you have any questions about this medicine, please talk with the doctor, 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 ustekinumab 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 this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ustekinumab. 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 this medicine.

Review Date: October 4, 2017

>10%:

Infection: Infection (psoriasis: 27% to 72%; severe infection: ≤3%)

Respiratory: Nasopharyngitis (Crohn disease: 11%)

1% to 10%:

Central nervous system: Headache (psoriasis: 5%), fatigue (psoriasis: 3%), dizziness (psoriasis: 2%), depression (psoriasis: 1%)

Dermatologic: Pruritus (2% to 4%), acne vulgaris (Crohn disease: 1%)

Gastrointestinal: Vomiting (Crohn disease: 4%), nausea (psoriatic arthritis: 3%), dental disease (infection; 1%)

Genitourinary: Vaginal mycosis (Crohn disease: ≤5%), vulvovaginal candidiasis (Crohn disease: ≤5%), urinary tract infection (Crohn disease: 4%)

Hematologic & oncologic: Skin carcinoma (nonmelanoma including squamous cell carcinoma; psoriasis: 2%)

Immunologic: Antibody development (<3% to 6%)

Local: Erythema at injection site (1% to 5%)

Neuromuscular & skeletal: Arthralgia (psoriatic arthritis: 3%), back pain (psoriasis: 2%), weakness (Crohn disease: 1%)

Respiratory: Bronchitis (Crohn disease: 5%), sinusitis (Crohn disease: 3%), pharyngolaryngeal pain (psoriasis: 2%)

Frequency not defined:

Gastrointestinal: Appendicitis, cholecystitis, gastroenteritis

Genitourinary: Perirectal abscess

Infection: Sepsis, viral infection

Neuromuscular & skeletal: Osteomyelitis

Respiratory: Pneumonia

<1%, postmarketing, and/or case reports: Anaphylaxis, angina pectoris, angioedema, bacterial infection, bleeding at injection site, bruising at injection site, cellulitis, cerebrovascular accident, dactylitis, diverticulitis, erythrodermic psoriasis, fungal infection, herpes zoster, hypersensitivity reaction, hypertension, induration at injection site, irritation at injection site, itching at injection site, malignant neoplasm, meningitis due to listeria monocytogenes, myocardial infarction, nephrolithiasis, ocular herpes simplex, pain at injection site, pustular psoriasis, reversible posterior leukoencephalopathy syndrome, skin rash, swelling at injection site, urticaria

Applies to ustekinumab: parenteral injection

Side effects include:

Patients with psoriasis: Nasopharyngitis, upper respiratory tract infection, headache, fatigue, diarrhea, back pain, dizziness, pharyngolaryngeal pain, pruritus, injection site erythema, myalgia, depression.

Patients with psoriatic arthritis: Arthralgia, nausea, dental infections.

Applies to ustekinumab: intravenous solution, subcutaneous solution

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, oropharyngeal pain
Uncommon (0.1% to 1%): Nasal congestion[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Facial palsy[Ref]

Other

Common (1% to 10%): Fatigue[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, myalgia, arthralgia[Ref]

Local

Common (1% to 10%): Injection site erythema, pain, bruising, irritation
Uncommon (0.1% to 1%): Injection site reactions (including hemorrhage, hematoma, induration, swelling, and pruritus)[Ref]

Dermatologic

Common (1% to 10%): Pruritus
Uncommon (0.1% to 1%): Pustular psoriasis, skin exfoliation
Rare (less than 0.1%): Exfoliative dermatitis
Postmarketing reports: Erythrodermic psoriasis[Ref]

Psychiatric

Common (1% to 10%): Depression[Ref]

Oncologic

Common (1% to 10%): Malignancies (1.7%)
Postmarketing reports: Rapidly appearing, multiple cutaneous squamous cell carcinomas[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions (including rash, urticaria)
Rare (less than 0.1%): Serious hypersensitivity reactions (including anaphylaxis and angioedema)[Ref]

Immunologic

Very common (10% or more): Infections (up to 27%)
Common (1% to 10%): About 6% of patients developed antibodies to this drug, dental infections
Uncommon (0.1% to 1%): Cellulitis, herpes zoster, viral upper respiratory tract infection[Ref]

Some side effects of ustekinumab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.