Imuldosa Prefilled Syringe (Subcutaneous)
Imuldosa Prefilled Syringe (Subcutaneous)
Ustekinumab is used in adults and children who are at least 6 years old for the treatment of active psoriatic arthritis or to treat moderate to severe psoriasis who may also receive phototherapy or other treatments for psoriasis.
Ustekinumab is also used in adults to treat moderately to severely active Crohn's disease or ulcerative colitis.
Ustekinumab may also be used for purposes not listed in this medication guide.
uses
What is Imuldosa Prefilled Syringe (Subcutaneous) used for?
warnings
What is the most important information I should know about Imuldosa Prefilled Syringe (Subcutaneous)?
You should not use ustekinumab if you are allergic to it or any of its ingredients.
Before you start using ustekinumab, tell your doctor if you have any signs of infection such as fever, chills, sweating, muscle pain, cough, shortness of breath, bloody mucus, weight loss, redness, warmth, painful sores on your skin, diarrhea, stomach pain, increased urination, burning when you urinate.
Tell your doctor if you have or have ever had:
- an active, chronic, or recent infection;
- tuberculosis, been exposed to tuberculosis, or if you recently traveled;
- new or changing skin lesions;
- any type of cancer;
- an allergy to latex;
- phototherapy (light therapy);
- allergy shots; or
- if you recently received or are scheduled to receive a vaccine.
Using ustekinumab may increase your risk of developing certain types of cancer. Ask your doctor about your individual risk.
Tell your child's vaccination provider if you have used ustekinumab during pregnancy.
It is not known if ustekinumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Do not allow a young child to use ustekinumab without help from an adult.
Side Effects
What are the side effects of Imuldosa Prefilled Syringe (Subcutaneous)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as fever, chills, sore throat, mouth sores, red or swollen gums, pale skin, easy bruising, unusual bleeding, chest discomfort, wheezing, dry cough or hack, or rapid weight loss.
Also call your doctor at once if you have:
- changes in skin;
- new or worsening cough, sudden chest pain, feeling short of breath; or
- sudden confusion, severe headache, vision loss, or seizure.
Common side effects may include:
- flu or cold symptoms, such as a stuffy or runny nose, sneezing, sore throat, cough with mucus, wheezing, or chest discomfort;
- fever;
- joint pain;
- itching;
- stomach pain, nausea, vomiting, diarrhea;
- vaginal itching or discharge;
- pain and burning when you urinate;
- headache, tiredness; or
- redness where the medicine was injected.
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.
Pregnancy & Breastfeeding
Can I take Imuldosa Prefilled Syringe (Subcutaneous) if I’m pregnant or breastfeeding?
Tell your child's vaccination provider if you have used ustekinumab during pregnancy.
It is not known if ustekinumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Interactions
What drugs and food should I avoid while taking Imuldosa Prefilled Syringe (Subcutaneous)?
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
Avoid receiving a "live" vaccine, and avoid being near someone who recently received a live vaccine. Live vaccines may include measles, mumps, rubella (MMR), varicella (chickenpox), nasal flu vaccine, and others.
You should not receive a BCG vaccine during the 1 year before starting treatment or for at least 1 year after your last dose of ustekinumab.
Dosage Guidelines & Tips
How to take Imuldosa Prefilled Syringe (Subcutaneous)?
Use Imuldosa Prefilled Syringe (Subcutaneous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Remain under the care of a doctor while using ustekinumab.
Before you start treatment with ustekinumab, your doctor may test you for tuberculosis or other infections.
If you have Crohn's disease or ulcerative colitis, ustekinumab is given as an infusion into a vein by a healthcare provider for the first dose. Later doses are then injected under the skin once every 8 weeks.
If you have psoriasis or psoriatic arthritis, ustekinumab is injected under the skin. Your doctor will determine your treatment schedule.
A healthcare provider may give you this injection or may teach you how to properly use this medicine by yourself.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand how to use an injection.
Do not inject into areas where the skin is tender, bruised, red, or hard. Do not inject into the same place two times in a row.
Doses are based on weight. Your dose may change if you gain or lose weight.
Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.
Each prefilled syringe or vial is for one use only. Throw away after one use, even if there is still medicine left inside. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.
You may be given other medications to help prevent tuberculosis infection or treat certain side effects. Keep taking these medicines for as long as your doctor has prescribed.
Using ustekinumab may increase your risk of developing cancer. Tell your doctor if you notice any new skin symptoms.
You may need frequent medical tests and your doctor will need to check your progress on a regular basis.
Store this medicine in the original carton in the refrigerator. Store vial in an upright position. Protect from light and do not freeze or shake the medicine.
You may store prefilled syringe or vial at room temperature in the original carton, protected from light. Certain formulations may only be stable for a limited number of days after being removed from the refrigerator. Throw away any medicine not used within that time.
Call your doctor for instructions if you miss a dose.