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Ustekinumab (Subcutaneous Route)

US Brand Names

Description

Ustekinumab 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 to be administered only by or under the immediate supervision of your doctor.

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 have not been performed on the relationship of age to the effects of ustekinumab injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

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

Pregnancy

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 receiving 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.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

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—Use with caution. May increase risk for cancer.

• Infection—Ustekinumab is not recommended for 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

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, buttocks, abdomen (stomach), or thighs.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions

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 increase your risk of getting some forms of cancer. Talk to your doctor about this risk if you have concerns.

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

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

The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start receiving this medicine.

While you are being treated with ustekinumab, and after you stop treatment with it, do not have any immunizations (especially live vaccinations) without your doctor's approval. Ustekinumab 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.

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 or nurse immediately if any of the following side effects occur:

• Cough or hoarseness
• Fever or chills
• Lower back or side pain
• Painful or difficult urination

• Blurred or loss of vision
• Clear or bloody discharge from the nipple
• Confusion
• Difficult or frequent urination
• Dimpling of the breast skin
• Disturbed color perception
• Double vision
• Halos around lights
• Headache
• Inverted nipple
• Itching, pain, redness, swelling, tenderness, or warmth on the skin
• Lump in the breast or under the arm
• Night blindness
• Overbright appearance of lights
• Persistent crusting or scaling of the nipple
• Redness or swelling of the breast
• Seizures
• Sore on the skin of the breast that does not heal
• Tunnel vision

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:

• Back pain
• 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
• Depression
• Dizziness
• Sore throat
• Unusual tiredness or weakness

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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