Stelara
Is a New Crohn's Disease Treatment on the Horizon? »
"Oct. 17, 2012 -- A drug used to treat psoriasis may provide a much-needed option for people with bad cases of Crohn's disease.
In the new study, some people with moderate to severe Crohn's given Stelara (ustekinumab) began to see imp"...
Read the Is a New Crohn's Disease Treatment on the Horizon? article »
Stelara Injection
Stelara Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Stelara (ustekinumab) Injection is a monoclonal antibody used to treat plaque psoriasis. Common side effects of Stelara include bruising, itching, pain, redness, and swelling at the injection site.
The recommended dosage of Stelara is either 45 mg or 90 mg given on day one, then 4 weeks later, and every 12 weeks thereafter. Live vaccines such as the polio and flu vaccine may interact with Stelara. Tell your doctor all medications you use, all recent vaccines you have received, and all infections you have had. Stelara may weaken your body's ability to fight infections. If you are pregnant only take Stelara if clearly needed. Exercise caution if you are taking Stelara and are breastfeeding.
Our Stelara (ustekinumab) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Stelara in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have a serious side effect such as:
- signs of infection such as fever, chills, sore throat, flu symptoms, swollen glands, unusual weakness;
- mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;
- swelling, pain, tenderness, or redness anywhere on your body;
- pain or burning when you urinate, blood in your urine;
- stomach pain that is sudden and severe or comes on slowly, changes in bowel habits (diarrhea or constipation);
- cough with yellow or green mucus;
- stabbing chest pain, feeling short of breath; or
- severe headache, confusion, vision problems, and/or seizure (convulsions).
Less serious side effects may include:
- cold symptoms (runny or stuffy nose, sore throat);
- headache, tired feeling;
- mild diarrhea; or
- mild skin rash or itching.
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.
Read the entire detailed patient monograph for Stelara (Ustekinumab) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Stelara Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication can affect your immune system. It can lower your body's ability to fight an infection. You may be more likely to get serious infections, such as pneumonia, bone/joint infections, skin infections, or sinusitis. It may also be harder to fight an infection you already have. Tell your doctor promptly if you develop any signs of an infection, such as worsening redness/swelling/tenderness at the injection site after 2 days, fever/chills, or cold/flu symptoms. (See also Precautions section.)
Ustekinumab may cause a rare (sometimes fatal) condition called RPLS (reversible posterior leukoencephalopathy syndrome). Get medical help right away if you develop persistent headache, seizures, sudden vision changes, mental/mood changes (such as confusion).
There is a rare risk of developing cancer due to this medication. Discuss the risks and benefits of treatment with your doctor. Tell your doctor immediately if you develop symptoms such as unusual lumps/growths, swollen glands, unexplained weight loss.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Stelara (Ustekinumab)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Stelara FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The following serious adverse reactions are discussed elsewhere in the label:
- Infections [see WARNINGS AND PRECAUTIONS]
- Malignancies [see WARNINGS AND PRECAUTIONS]
Reversible Posterior Leukoencephalopathy Syndrome [see WARNINGS AND PRECAUTIONS]
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data reflect exposure to STELARA® in 3117 psoriasis subjects, including 2414 exposed for at least 6 months, 1852 exposed for at least one year,1650 exposed for at least two years, 1129 exposed for at least three years, and 619 exposed for at least four years.
Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the STELARA® groups than the placebo group during the placebo-controlled period of STUDY 1 and STUDY 2 [see Clinical Studies].
Table 1: Adverse reactions reported by ≥ 1% of
subjects through Week 12 in STUDY 1 and STUDY 2
| Placebo | STELARA® | ||
| 45 mg | 90 mg | ||
| Subjects treated | 665 | 664 | 666 |
| Nasopharyngitis | 51 (8%) | 56 (8%) | 49 (7%) |
| Upper respiratory tract infection | 30 (5%) | 36 (5%) | 28 (4%) |
| Headache | 23 (3%) | 33 (5%) | 32 (5%) |
| Fatigue | 14 (2%) | 18 (3%) | 17 (3%) |
| Diarrhea | 12 (2%) | 13 (2%) | 13 (2%) |
| Back pain | 8 (1%) | 9 (1%) | 14 (2%) |
| Dizziness | 8 (1%) | 8 (1%) | 14 (2%) |
| Pharyngolaryngeal pain | 7 (1%) | 9 (1%) | 12 (2%) |
| Pruritus | 9 (1%) | 10 (2%) | 9 (1%) |
| Injection site erythema | 3 (<1%) | 6 (1%) | 13 (2%) |
| Myalgia | 4 (1%) | 7 (1%) | 8 (1%) |
| Depression | 3 (<1%) | 8 (1%) | 4 (1%) |
Adverse reactions that occurred at rates less than 1% in the controlled period of STUDIES 1 and 2 through week 12 included: cellulitis, herpes zoster, diverticulitis and certain injection site reactions (pain, swelling, pruritus, induration, hemorrhage, bruising, and irritation).
One case of RPLS occurred during clinical trials [see WARNINGS AND PRECAUTIONS].
Infections
In the placebo-controlled period of clinical studies of psoriasis subjects (average follow-up of 12.6 weeks for placebo-treated subjects and 13.4 weeks for STELARA®-treated subjects), 27% of STELARA®-treated subjects reported infections (1.39 per subject-year of follow-up) compared with 24% of placebo-treated subjects (1.21 per subject-year of follow-up). Serious infections occurred in 0.3% of STELARA®-treated subjects (0.01 per subject-year of follow-up) and in 0.4% of placebo-treated subjects (0.02 per subject-year of follow-up) [see WARNINGS AND PRECAUTIONS].
In the controlled and non-controlled portions of psoriasis clinical trials (median follow up of 2.6 years), representing 6791 subject-years of exposure, 70% of STELARA®-treated subjects reported infections (0.98 per subject-years of follow-up). Serious infections were reported in 2% of subjects (0.01 per subject-years of follow-up).
Malignancies
In the controlled and non-controlled portions of psoriasis clinical trials (median follow up of 2.6 years, representing 6791 subject-years of exposure), 1.3% of STELARA®-treated subjects reported malignancies excluding non-melanoma skin cancers (0.62 per hundred subject-years of follow-up). Non-melanoma skin cancer was reported in 1.3% of STELARA®-treated subjects (0.61 per hundred subject-years of follow-up) [see WARNINGS AND PRECAUTIONS]. The most frequently observed malignancies other than non-melanoma skin cancer during the clinical trials were: prostate, colorectal, melanoma in situ, breast. Malignancies other than non-melanoma skin cancer in STELARA®-treated patients during the controlled and uncontrolled portions of studies were similar in type and number to what would be expected in the general U.S. population according to the SEER database (adjusted for age, gender and race).1
Immunogenicity
The presence of ustekinumab in the serum can interfere with the detection of anti-ustekinumab antibodies resulting in inconclusive results due to assay interference. In STUDIES 1 and 2, antibody testing was done at time points when ustekinumab may have been present in the serum. Table 2 summarizes the antibody results from STUDY 1 through year 3 and STUDY 2 through year 4.
Table 2: Presence of anti-ustekinumab antibodies in
STUDY 1 through Year 3 and STUDY 2 through Year 4.
| Antibody Results | STUDY 1 (N=746) |
STUDY 2 (N=1202) |
| Positive | 39 (5%) | 65 (5%) |
| Negative | 124 (17%) | 150 (12%) |
| Inconclusive | 583 (78%) | 987 (82%) |
The data reflect the percentage of subjects whose test results were positive for antibodies to ustekinumab in a bridging immunoassay, and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors, including sample handling, timing of sample collection, concomitant medications and underlying disease. For these reasons, comparison of the incidence of antibodies to ustekinumab with the incidence of antibodies to other products may be misleading.
Post-marketing Experience
Adverse reactions have been reported during post-approval use with STELARA®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to STELARA® exposure.
Immune system disorders: Serious hypersensitivity reactions (including anaphylaxis and angioedema), other hypersensitivity reactions (including rash and urticaria).
Skin reactions: Pustular psoriasis, erythrodermic psoriasis
REFERENCES
1Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) SEER*Stat Database: Incidence - SEER 6.6.2 Regs Research Data, Nov 2009 Sub (1973-2007) - Linked To County Attributes - Total U.S., 1969-2007 Counties, National Cancer Institute, DCCPS, Surveillance Research Program, Surveillance Systems Branch, released April 2010, based on the November 2009 submission.
Read the entire FDA prescribing information for Stelara (Ustekinumab) »
Additional Stelara Injection Information
Stelara Injection - User Reviews
Stelara Injection User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Here is a collection of user reviews for the medication Stelara Injection sorted by most helpful.
Report Problems to the Food and Drug Administration
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