Pronunciation:

us-te-KIN-ue-mab - auub

Brand Names:

• Wezlana

Classifications:

Pharmacologic—

Ustekinumab

Uses of This Medicine:

Ustekinumab-auub injection is used to treat moderate to severe plaque psoriasis in patients who may benefit from receiving phototherapy (ultraviolet light treatment) or other treatment. This medicine is also used to treat active psoriatic arthritis.

Ustekinumab-auub injection is also used to treat moderate to severe active Crohn's disease and ulcerative colitis.

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:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ustekinumab-auub injection in children younger than 6 years of age to treat moderate to severe plaque psoriasis and psoriatic arthritis and in children to treat Crohn's disease and ulcerative colitis. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ustekinumab-auub injection in the elderly.

Breast-feeding—

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.

Other medicines—

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, Live
• Anifrolumab-fnia
• Bacillus of Calmette and Guerin Vaccine, Live
• Baricitinib
• Cholera Vaccine, Live
• Cyclosporine
• 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, Live Non-Replicating
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Warfarin
• 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:

• Cancer, or history of—Use with caution. May increase risk for cancer.

• Infection (eg, bacterial, fungal, viral)—Use is not recommended in patients with an active infection. 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:

Vial: A nurse or other trained health professional will give you or your child this medicine in a medical facility. It is given through an IV that is placed in one of your veins to treat Crohn's disease and ulcerative colitis.

Prefilled syringe: You may also be taught how to give your medicine at home. It is usually given as a shot under the skin of your stomach, thigh, or upper arm to treat Crohn's disease, plaque psoriasis, psoriatic arthritis, or ulcerative colitis.

This medicine comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

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 tender, red, bruised, or hard.

This medicine is available in 2 forms: a prefilled syringe or a vial (glass container).

To use the prefilled syringe:

• Wash your hands with soap and water before and after using this medicine.
• Allow 30 minutes for the syringe to warm up to room temperature. Do not warm using other heat sources (eg, hot water, sunlight, or microwave).
• Check the liquid in the syringe. It should be clear to white, like an opal, and colorless to light yellow. Do not use it if it is frozen, cloudy, discolored, or has particles in it. Do not use the syringe if it is damaged or has been dropped. It is normal to see air bubbles in the liquid. Do not shake.
• Remove the needle cap when you can inject this medicine right away (within 5 minutes) because the medicine can dry out.
• Do not hold the plunger or plunger head while removing the needle cap. Do not twist or bend the needle cap. Do not put the needle cap back on.
• Pinch the skin with one hand between the thumb and index finger to create a bump for the injection. Insert the needle into the pinched skin at about a 45 degree angle. Do not place your finger on the plunger rod while inserting the needle.
• Slowly press the plunger head all the way down with your thumb until it is completely between the needle guard clips. Do not pull back on the plunger rod any time. Do not remove the syringe until all medicine has been injected.
• Slowly take your thumb off the plunger head. This will let the empty syringe move up until the entire needle is automatically covered by the needle guard.

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 (prefilled syringe):
  • For Crohn's disease and ulcerative colitis:
    • Adults—At first, this vaccine is injected into your vein through an IV as a single dose. After 8 weeks, a maintenance dose of 90 milligrams (mg) is injected under your skin as a single dose, then every 8 weeks after.
    • Children—Use and dose must be determined by your doctor.
  • For psoriasis:
    • Adults—Dose is based on body weight and must be determined by your doctor:
      • Weighing more than 100 kilograms (kg)—At first, 90 milligrams (mg) injected under your skin as a single dose, and then one dose (90 mg) after 4 weeks, followed by 90 mg every 12 weeks.
      • Weighing 100 kg or less—At first, 45 mg injected under your skin as a single dose, and then one dose (45 mg) after 4 weeks, followed by 45 mg every 12 weeks.
    • Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor:
      • Weighing more than 100 kilograms (kg)—90 milligrams (mg) at Weeks 0 and 4, then every 12 weeks after.
      • Weighing 60 kg to 100 kg—45 mg at Weeks 0 and 4, then every 12 weeks after.
      • Weighing less than 60 kg—0.75 mg per kg body weight at Weeks 0 and 4, then every 12 weeks after.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For psoriatic arthritis:
    • Adults—Dose is based on body weight and must be determined by your doctor:
      • Weighing more than 100 kilograms (kg) who also have plaque psoriasis—At first, 90 milligrams (mg) injected under your skin as a single dose, and then one dose (90 mg) after 4 weeks, followed by 90 mg every 12 weeks.
      • Weighing less than 100 kg—At first, 45 mg injected under your skin as a single dose, and then one dose (45 mg) after 4 weeks, followed by 45 mg every 12 weeks.
    • Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor:
      • Weighing more than 100 kilograms (kg) who also have plaque psoriasis—90 milligrams (mg) at Weeks 0 and 4, then every 12 weeks after.
      • Weighing 60 kg to 100 kg—45 mg at Weeks 0 and 4, then every 12 weeks after.
      • Weighing less than 60 kg—0.75 mg per kg body weight at Weeks 0 and 4, then every 12 weeks after.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed dose—

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.

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.

If needed, you may store the prefilled syringe at room temperature for up to 30 days. Do not put it back in the refrigerator. Throw away unused medicine after 30 days.

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.

This medicine may cause serious infections (eg, bacterial, fungal, viral). 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 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 increase your risk of getting some forms of cancer (eg, non-melanoma skin cancer). This is more likely to occur if you are over 60 years of age or if you are receiving PUVA therapy (psoralen and ultraviolet A treatment) or medicines that weaken the immune system (eg, steroids) in the past. Talk to your doctor about this risk if you have concerns.

This medicine may cause serious types of allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after receiving the medicine.

Check with your doctor if you have headache, seizures, confusion, or blurred vision or other visual problems. These may be symptoms of a rare and serious condition called posterior reversible encephalopathy syndrome (PRES) or reversible posterior leukoencephalopathy syndrome (RPLS).

This medicine may cause non-infectious pneumonia (eg, interstitial pneumonia, eosinophilic pneumonia, cryptogenic organizing pneumonia). Check with your doctor right away if you have chest pain, cough, fever or chills, sneezing, sore throat, trouble breathing, or tightness in the chest.

While you are being treated with ustekinumab-auub and after you stop treatment with it, do not have any immunizations (especially live vaccines) without your doctor's approval. Ustekinumab-auub may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, the other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also avoid persons who have recently taken oral polio vaccine. Do not get close to them or stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective mask that covers the nose and mouth. You should not receive BCG vaccine 1 year before and 1 year after receiving this vaccine.

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:

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

chills

cough

ear congestion

fever

headache

loss of voice

sneezing

sore throat

stuffy or runny nose

trouble breathing

unusual tiredness or weakness

Less common

Bladder pain

bloody or cloudy urine

difficult, burning, or painful urination

frequent urge to urinate

itching of the vagina or genitals

lower back or side pain

persistent non-healing sore

pink growth

reddish patch or irritated area

shiny bump

thick, white vaginal discharge with mild or no odor

white, yellow or waxy scar-like area

Rare

Discouragement

feeling sad or empty

irritability

lack of appetite

loss of interest or pleasure

trouble concentrating

trouble sleeping

Incidence not known

Agitation

blisters on the skin

bloating

blurred vision

chest pain or tightness

cold flu-like symptoms

coma

confusion

cough or hoarseness

diarrhea

difficulty swallowing

dizziness

drowsiness

fainting

fast heartbeat

general feeling of illness

hallucinations

hives, itching, skin rash

increase in bone pain

indigestion

itching, pain, redness, swelling, tenderness, warmth on the skin

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

lightheadedness

mood or mental changes

muscle aches

nausea

night sweats

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

seizures

severe cramping

spots on your skin resembling a blister or pimple

stiff neck or back

stomach pain or tenderness

vomiting

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:

Less common

Cough producing mucus

difficulty in moving

joint pain

muscle cramps, pains, or stiffness

pain or tenderness around the eyes and cheekbones

swollen joints

Rare

Bleeding, blistering, burning, coldness, discoloration of 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.