Ustekinumab (Subcutaneous)

Ustekinumab is a biologic prescription medication injected in patients aged 12+ to treat moderate-to-severe plaque psoriasis, Crohn's Disease, and is often used in conjunction with phototherapy or other drugs such as methotrexate for treatment of active psoriatic arthritis.

Overview

What is Ustekinumab?

Ustekinumab is also known under the brand name of Stelara and is available only by prescription injection from your health care provider. Known as a biological treatment, it is a human monoclonal antibody that is used to treat chronic plaque psoriasis as well as other forms of psoriasis, psoriatic arthritis, and Crohn's Disease. The anti-inflammatory action of Ustekinumab makes it effective on other diseases as well and it may be prescribed per your doctor's advice if you have another condition than mentioned here.

How does Ustekinumab work?

Ustekinumab works by increasing the production of T-cells in the body and responds to cytokines, which are the messengers produced by skin cells. When the skin cell messengers tell the cells to grow too rapidly, plaques of psoriasis are formed or other inflammatory activities take place as the body tries to protect itself. Ustekinumab targets these false messengers and prevents them from being active and causing inflammation.

Ustekinumab therefore interferes with the body's inflammatory response by repression of these cytokines and has an effect on other inflammatory diseases found in the body in addition to psoriasis, which are just beginning to be discovered. Use of Ustekinumab for treatment of Crohn's Disease, for example, has been a recent discovery with recommendations occurring in 2016.

Ustekinumab is an injection received under the skin in adults under treatment. Use of Ustekinumab in children is to be determined by their healthcare professional after weighing the risks associated versus the benefits.

It may be 3-12 weeks before patients notice any benefits of being treated by Ustekinumab, with almost 67 percent of patients in clinical trials experiencing a good response from the treatment, which translates to a 75 percent improvement in psoriasis lesions after three months.

What is psoriasis?

Plaque psoriasis is a condition that begins under the surface of the skin and is exhibited in patients through symptoms of scaling and redness. It has been discovered to be caused by an overactive immune system and responds well in most cases to treatment by Ustekinumab.

Ustekinumab injection is often used in combination with ultraviolet light treatment (phototherapy) for maximum effectiveness. During the course of treatment, a special kind of light is used which emits UVB (ultraviolet B) or UVA (ultraviolet A) light and has been proven effective in psoriasis patients.

What is psoriatic arthritis?

Psoriatic arthritis is a type of arthritis that develops most commonly in patients who suffer from psoriasis. Psoriatic arthritis exhibits symptoms such as joint pain and stiffness. In patients with psoriatic arthritis, treatment with Ustekinumab in combination with the drug Methotrexate has been proven effective. Methotrexate is a chemotherapy agent used to suppress the immune system. Using Ustekinumab with this drug is proven to reduce the signs of psoriatic arthritis, improve physical function in patients under treatment and slow down the damage to the joints caused by the disease.

What is Crohn's Disease?

Crohn's Disease causes inflammation in the digestive system and affects all parts of the gut. Typically, though, Crohn's Disease affects the end portion of the small intestine known as the colon. Crohn's Disease is also a life-long condition with periods of remission and flare-ups.

Crohn's Disease patients commonly demonstrate the following symptoms:

Crohn's Disease sufferers often show signs of mouth ulcers as well as the symptoms above. Only a doctor can, after extensive testing, determine whether a patient has Crohn's Disease. Crohn's Disease does not have a cure and is typically treated with other medications known as TNF-alpha inhibitors such as Infliximab or Adalimumab to provide relief from the symptoms. Patients who do not respond or are intolerant of those medicines may be given Ustekinumab in an effort to find relief. Ustekinumab has proven to be an effective treatment both for clinical and cost reasons in Crohn's Disease patients.

Conditions treated

Type of medicine

  • Immunosuppressant

Side effects

Not all patients who are prescribed Ustekinumab have side effects. Most commonly, use of Ustekinumab can lead to the following side effects:

  • Fever, chills
  • Cough, scratchy or sore throat
  • Lower back or side pain
  • Painful or difficult urination
  • Body aches
  • Trouble breathing
  • Headache
  • Ear or nasal congestion and runny nose, sneezing
  • Tiredness or weakness

These side effects, if prolonged or severe, should be reported to your healthcare professional immediately in case an adjustment of the dose of Ustekinumab you are receiving must be discussed or in case you are experiencing underlying health issues.

The following side effects are typical signs of infections and should be immediately reported to your healthcare provider. Ustekinumab makes you less able to fight off infections due to the anti-inflammatory effects and immunosuppressant effects of the drug, so these side effects, if experienced, should be reported to your healthcare professional immediately so they can test for infection:

  • Fever and flu-like symptoms
  • Night sweats
  • Fatigue
  • Shortness of breath
  • Lingering cough
  • Warm, red, painful skin
  • Painful, blistered skin rash
  • Painful urination
  • Diarrhea

If the following severe side effects are exhibited, notify your healthcare professional immediately as they could be a sign of serious underlying health problems:

  • Blurred vision
  • Clear or bloody nipple discharge, crusting or scaling
  • Dimpling of the skin on the breasts
  • Inverted nipples
  • Confusion
  • Difficult or frequent urination
  • Color perception is off
  • Double vision
  • Halos around lights
  • Night blindness
  • Itchy, painful, red, swollen, tender or overly warm skin
  • Lumps under the arm or in the breast
  • Sores that do not heal, especially on the breasts or under the arms

Patients who experience seizures, dizziness, difficulty swallowing, irregularly fast heartbeats, hives, welts or itching should contact their doctor immediately.

Dosage

Ustekinumab will be injected under your skin by a trained health professional such as a doctor or nurse. Typically, Ustekinumab injections are given on the upper arms, buttocks, thighs or abdomen. Patients who are not hospitalized may sometimes be trained how to prepare and inject Ustekinumab at home themselves, but this is not common.

Patients and their symptoms vary so the following dosage information outlines the most common quantities and frequencies of Ustekinumab courses of treatment.

For plaque psoriasis

Adults who weigh more than 220 lbs are first given a dose of 90 milligrams followed by 90 milligrams after four weeks and maintained by a 90-milligram dose every 12 weeks. Adults under 220 lbs receive doses in the same frequency but in 45-milligram amounts. Children who are prescribed Ustekinumab for psoriasis have a dosage that is specific to their weight, age, and symptoms as prescribed by their healthcare professional.

For psoriatic arthritis

Adults being treated for psoriatic arthritis with Ustekinumab are injected with a 45-milligram dose to start, followed by 45 milligrams after 4 weeks and maintained by 45-milligram doses every 12 weeks. Children who may be prescribed Ustekinumab for psoriatic arthritis will be given a dose depending on their weight, age, and symptoms.

For Crohn's Disease

The first dose is typically 6 milligrams per kilogram of body weight given via IV infusion. The next dose of 90 milligrams is given 8 weeks after the first treatment with maintenance doses every 12 weeks. The second dose and maintenance doses are given as injections under the skin instead of through IV infusion. Alternatively, doctors may prescribe an 8-week maintenance dose of 90 milligrams, but this will depend on the patient, their symptoms and how they respond to Ustekinumab.

Interactions

Common drugs that have been proven to interact with Ustekinumab include the following:

  • Amlodipine
  • Clobetasol
  • Duloxetine
  • Fish Oil
  • Folic Acid
  • Gabapentin
  • Adalimumab
  • Lisinopril
  • Pregabalin
  • Meloxicam
  • Metformin
  • Methotrexate
  • Multi-vitamins
  • Acetaminophen
  • Hydrocodone
  • Omeprazole
  • Prednisone
  • Tramadol
  • Trazodone
  • Vitamin B12
  • Vitamin D3

While a comprehensive list, this is not the full listing of drug interactions. The documentation provided with your prescription as well as a full disclosure of all medications you are taking or have taken in the recent past are the safest way to determine if you are at risk for any drug interactions.

Patients who are being treated with psoriasis or psoriatic arthritis who also suffer from high blood pressure are at an increased risk of developing reversible posterior leukoencephalopathy syndrome (RPLS). Caution is advised for patients before taking a course of Ustekinumab as well as close monitoring for any symptoms of RPLS.

Warnings

Ustekinumab is an immunosuppressant drug and therefore patients who are on a course of this treatment should not be given live vaccines. It is important to notify your doctor if you have recently been vaccinated for any disease or group of diseases. It is also of vital importance that patients being treated with Ustekinumab who are sharing a household with a person who has received the oral polio vaccine, as there is a chance that the polio virus could be passed on to the patient. Do not get close to people who have had the oral polio vaccine or stay in the same room with them for very long. If you cannot avoid exposure to a person or persons who have had the oral polio vaccine, consider wearing a protective mask over the nose and mouth.

A skin test for tuberculosis must be performed prior to a course of treatment with Ustekinumab. Inform your doctor if you or anyone in your household has ever had a positive reaction to a tuberculosis test or if you or they have been exposed to tuberculosis.

Ustekinumab may increase the patient's risk for developing certain forms of cancers if they are over 60 years old or if they are receiving PUVA therapy (psoralen and ultraviolet A treatment) or other medications that weaken the immune system such as steroids.

There is an increased risk of severe allergic reaction known as anaphylaxis for patients being treated with Ustekinumab. If you exhibit symptoms such as rash, itching, hoarseness, labored breathing, difficulty swallowing or swelling in the hands, face or mouth after you receive treatment, notify your health care professional immediately.

Women that may potentially become pregnant are advised to use effective methods of contraception during treatment with Ustekinumab and for 15 weeks thereafter. No adequate data exists of the effects of Ustekinumab on pregnant women or effects on the fetus, but as a precaution, Ustekinumab should not be used during pregnancy. Additionally, there is no data on breastfeeding and how Ustekinumab is transferred via breast milk. Discuss breastfeeding with your doctor before being treated with Ustekinumab.

As with all medications, inform your doctor of any other medicines you are taking whether they are prescription, non-prescription, herbal, vitamin or holistic in nature. Your healthcare provider should be given a history of your treatment for any other diseases as well as a family history for any possible health interactions that could happen during or after treatment. Only then can the risks of treatment with Ustekinumab be weighed with the benefits that the drug can provide.

Storage

This medicine is typically injected by a healthcare professional and therefore is held in the proper storage at the hospital or clinic facility for you. If you are self-administering Ustekinumab, however, keep the drug and accompanying syringes out of sight and reach of children. Store in the original packaging in the refrigerator but do not allow Ustekinumab to freeze. Do not re-use syringes or needles and dispose of them properly using a puncture-resistant, disposable container or as directed by your healthcare professional.

Any unused Ustekinumab or out-of-date product should be disposed of properly. Contact your healthcare provider for instructions on safe disposal. Do not use this medicine after the expiration date noted on the pack. Additionally, if the liquid is discolored or cloudy or contains foreign particles, do not use the Ustekinumab. If you know the product has been exposed to extreme temperatures or has been vigorously shaken, do not use Ustekinumab.

Summary

Ustekinumab is an immunosuppressant drug that has been found to relieve the symptoms of plaque psoriasis, psoriatic arthritis as well as Crohn's disease through targeting skin cell messengers that are overactive and causing symptoms. Ustekinumab interferes with the body's inflammation response to these overactive cells and clears up skin lesions and plaques caused by psoriasis. Ustekinumab also prevents joint damage, pain, and inflammation in patients with psoriatic arthritis. In Crohn's Disease patients, the anti-inflammatory effects of Ustekinumab prove to be an effective treatment for symptoms of this incurable condition.

Available only through a medical doctor and injected under the skin, Ustekinumab is part of a treatment regimen that may include special light therapies, in the case of psoriasis, or other drugs, as in the case of psoriatic arthritis and Crohn's Disease. Dosage and frequency of doses are determined on an individual basis by a healthcare professional and are based on patient's age, weight and symptoms.

Ustekinumab is given in a dose dependant on the disease and patient's symptoms as well as their age and body weight. Typical doses are from 45 to 90 milligrams every 4, 8 or 12 weeks depending on the doctor's prescription.

Side effects can include nausea, diarrhea, and vomiting as well as body aches, headaches, fever, chills, trouble breathing and fatigue. If these side effects become prolonged or acute, it is advised that patients contact their health care professional immediately to be examined for any possible health risks.

Because Ustekinumab is an immunosuppressant, patients in treatment with this drug are at risk for infections as well as live immunizations. Patients are advised to inform their doctor if they have had any live immunizations in the recent past and to avoid them during treatment with Ustekinumab. Additionally, patients who are sharing a household with persons who have had the oral polio vaccine should take precautions to avoid sharing space with these people or, if this cannot be accomplished, protect themselves with nose and mouth covering masks.

Testing for Tuberculosis prior to being prescribed Ustekinumab is also highly recommended as is full disclosure to your doctor if you or anyone in your household has had a positive reaction to a tuberculosis test in the past.

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Last Reviewed:
December 22, 2017
Last Updated:
April 05, 2018
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