Ustekinumab

Generic name: Ustekinumab
Dosage form: injection, intravenous infusion
Drug class: Interleukin inhibitors

Usage of Ustekinumab

Ustekinumab (Stelara, Wezlana) is used to treat certain types of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Ustekinumab helps reduce the symptoms of these diseases but does not cure these inflammatory diseases. Wezlana is an interchangeable biosimilar of Stelara (ustekinumab).

Ustekinumab works by blocking certain proteins in your body called IL-12 (interleukin-12) and IL-23 (interleukin-23) that cause inflammation in these autoimmune conditions. By ustekinumab blocking these interleukin proteins helps reduce inflammation and improves the symptoms of these autoimmune conditions. Ustekinumab is from a class of medicines called interleukin inhibitors.

Stelara is a biologic medicine and was the first brand of ustekinumab approved by the FDA, and is called the reference product. Wezlana is an interchangeable biosimilar of Stelara this means that Weslana is a very close copy of Stelara. The FDA says that “Biosimilar and interchangeable biosimilar products are as safe and effective as their reference products”. An interchangeable biosimilar may be substituted for the reference product without consulting the prescriber, subject to state laws. This means that Wezlana can be dispensed when the prescription has been written for Stelara, Depending on local state laws.

Ustekinumab side effects

Common ustekinumab side effects

cough with mucus, shortness of breath, chest discomfort

Infection

fever, flu-like symptoms

headache, tiredness

Itching

redness at the injection site

vaginal itching or discharge

pain or burning when you urinate

stomach pain, nausea, vomiting, diarrhea.

Serious ustekinumab side effects

Get emergency medical help if you have signs of an allergic reaction to this medicine: hives; chest pain, difficulty breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Serious infections may occur during treatment with ustekinumab. Call your doctor right away if you have signs of infection including fever, chills, muscle pain, shortness of breath, weight loss, diarrhea or stomach pain, burning when you urinate, feeling very tired, skin warmth or redness, painful skin sores, or coughing up blood.

Also, call your doctor at once if you have:

a mole that has changed in size or color

swelling, pain, warmth, or redness anywhere on your body

stomach pain that is sudden and severe or comes on slowly, changes in bowel habits (diarrhea or constipation)

new or worsening cough, sudden chest pain, feeling short of breath

pain or burning when you urinate

severe headache, confusion, change in mental status, vision problems, and/or seizure (convulsions).

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

Before taking Ustekinumab

You should not use ustekinumab if you are allergic to it or any of the inactive ingredients or if you have:

active tuberculosis (TB)

if you have received a TB vaccine (BCG vaccine) in the last year.

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, painful skin sores, diarrhea, pain when you urinate, feeling very tired);

chronic infection

new or changing skin lesions

allergy shots

a latex allergy

phototherapy (light therapy) or

if you recently received or are scheduled to receive any vaccine.

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

Pregnancy

It is not known whether ustekinumab will 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 to track the effects of ustekinumab on the baby.

Breastfeeding

It may not be safe to breastfeed while using ustekinumab. It is thought that this medicine passes into your breast milk in small amounts. Talk to your doctor about the best way to feed your baby if you receive this medicine.

Relate drugs

How to use Ustekinumab

If you have psoriasis, you will be given ustekinumab as an injection under the skin (subcUTAneous injection). Once you have had your first injection, you will have your next injection after 4 weeks, and from then on you will have an injection every 12 weeks.

If you have Crohn’s disease or ulcerative colitis, your first dose is given slowly as an infusion into a vein by your doctor or nurse. The next doses you have will be every 8 weeks as an injection under the skin (subcutaneous injection).

You will be able to inject yourself or have a caregiver give you your injection once you have been shown how to do this by your doctor or nurse.

The dose your healthcare provider will give you will depend on how much you weigh and whether you have psoriasis, Crohn’s disease or ulcerative colitis.

How to use ustekinumab

Inject ustekinumab under the skin (subcutaneous injection) in your upper arms, buttocks, upper legs (thighs) or stomach area (abdomen).

Do not give an injection in an area of the skin that is tender, bruised, red or hard.

Use a different injection site each time you use ustekinumab.

If you inject more ustekinumab than prescribed, call your doctor right away.

Be sure to keep all of your scheduled follow-up appointments.

Warnings

You should not use this medicine if you have received a vaccine to prevent tuberculosis (BCG vaccine) within 1 year before using ustekinumab while using it, or 1 year after you have finished treatment. Before you start treatment with this medicine your doctor may perform tests to make sure you do not have tuberculosis.

When you are being treated with ustekinumab, it can make you more likely to get infections or make an infection that you have worse. Call your doctor right away if you have signs of infection, including fever, chills, muscle pain, shortness of breath, weight loss, diarrhea or stomach pain, burning when you urinate, feeling very tired, skin warmth or redness, painful skin sores, or coughing up blood. Ustekinumab may also cause a rare but serious condition affecting the brain. Tell your doctor right away if you have a headache, confusion, vision problems, or a seizure

What other drugs will affect Ustekinumab

Other drugs may interact with ustekinumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using. Not all possible interactions are listed here.

Disclaimer

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