Stelara vial 130 mg

/ Janssen

Ustekinumab treatment is to be initiated with a single intravenous dose based on body weight. Body weight under 55 kg recommended dose is 250 mg (2 vials), Body weight >55 kg to <85 kg recommended dose is 390 mg (3 vials), Body weight up to 85 kg recommended dose is 520 mg (4 vials). The first subcutaneous dose should be given at week 8 following the intravenous dose. Ustekinumab 130 mg is for intravenous use only. It should be administered over at least one hour.

This medical product is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.
This medical product is also indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.

Known hypersensitivity to the active substance or to any of the excipients.
Clinically important, active infection.

Infections
Ustekinumab may have the potential to increase the risk of infections and reactivate latent infections. Prior to initiating treatment with Ustekinumab, patients should be evaluated for tuberculosis infection, and must not be given to patients with active tuberculosis.
Malignancies
Immunosuppressants like ustekinumab have the potential to increase the risk of malignancy. Some patients who received STELARA in clinical studies and in a post-marketing observational study in patients with psoriasis developed cutaneous and non-cutaneous malignancies. All patients, in particular those greater than 60 years of age, patients with a medical history of prolonged immunosuppressant therapy or those with a history of PUVA treatment, should be monitored for the appearance of non-melanoma skin cancer.
Systemic and respiratory hypersensitivity reactions
Systemic
Serious hypersensitivity reactions have been reported in the postmarketing setting, in some cases several days after treatment. Anaphylaxis and angioedema have occurred. If an anaphylactic or other serious hypersensitivity reaction occurs, appropriate therapy should be instituted and administration of the drug should be discontinued.
Infusion-related reactions
Infusion-related reactions were observed in clinical trials. Serious infusion-related reactions including anaphylactic reactions to the infusion have been reported in the post-marketing setting. If a serious or life-threatening reaction is observed, appropriate therapy should be instituted and ustekinumab should be discontinued.
Respiratory
Cases of allergic alveolitis, eosinophilic pneumonia, and non-infectious organising pneumonia have been reported during post-approval use of Ustekinumab. Clinical presentations included cough, dyspnoea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalisation. Improvement has been reported after discontinuation of Ustekinumab and also, in some cases, administration of corticosteroids. If infection has been excluded and diagnosis is confirmed, discontinue Ustekinumab and institute appropriate treatment.
Cardiovascular events
Cardiovascular events including myocardial infarction and cerebrovascular accident have been observed in patients with psoriasis exposed to Ustekinumab in a post-marketing observational study. Risk factors for cardiovascular disease should be regularly assessed during treatment with Ustekinumab.
Vaccinations
It’s recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and Guérin (BCG)) should not be given concurrently with Ustekinumab.
Before live viral or live bacterial vaccination, treatment with Ustekinumab should be withheld for at least 15 weeks after the last dose and can be resumed at least 2 weeks after vaccination. Administration of live vaccines (such as the BCG vaccine) to infants exposed in utero to Ustekinumab is not recommended for six months following birth or until Ustekinumab infant serum levels are undetectable.
Patients receiving Ustekinumab may receive concurrent inactivated or non-live vaccinations. Long term treatment with Ustekinumab does not suppress the humoral immune response to pneumococcal polysaccharide or tetanus vaccines.
Concomitant immunosuppressive therapy
In Crohn’s disease and ulcerative colitis studies, concomitant use of immunosuppressants or corticosteroids did not appear to influence the safety or efficacy of this medical product. Caution should be exercised when considering concomitant use of other immunosuppressants and Ustekinumab or when transitioning from other immunosuppressive biologics.
Immunotherapy
Ustekinumab has not been evaluated in patients who have undergone allergy immunotherapy. It is not known whether STELARA may affect allergy immunotherapy.
Lupus-related conditions
Cases of lupus-related conditions have been reported in patients treated with Ustekinumab, including cutaneous lupus erythematosus and lupus-like syndrome. If lesions occur, especially in sun exposed areas of the skin or if accompanied by arthralgia, the patient should seek medical attention promptly. If the diagnosis of a lupus-related condition is confirmed, Ustekinumab should be discontinued and appropriate treatment initiated.
See prescribing information for full details.

Common: Upper respiratory tract infection, nasopharyngitis, sinusitis, Dizziness, headache, Oropharyngeal pain, Diarrhoea, nausea, vomiting, Pruritus, Back pain, myalgia, arthralgia, Fatigue, injection site erythema, injection site pain.
See prescribing information for full details.

Live vaccines should not be given concurrently with Ustekinumab.
See prescribing information for full details.

Women of childbearing potential
Women of childbearing potential should use effective methods of contraception during treatment and for at least 15 weeks after treatment.
Pregnancy: There are no adequate data from the use of Ustekinumab in pregnant women. Ustekinumab crosses the placenta and has been detected in the serum of infants born to female patients treated with ustekinumab during pregnancy. The clinical impact of this is unknown, however, the risk of infection in infants exposed in utero to ustekinumab may be increased after birth.
Administration of live vaccines (such as the BCG vaccine) to infants exposed in utero to ustekinumab is not recommended for 6 months following birth or until ustekinumab infant serum levels are undetectable. If there is a clear clinical benefit for the individual infant, administration of a live vaccine might be considered at an earlier timepoint, if infant ustekinumab serum levels are undetectable.
As a precautionary measure, it is preferable to avoid the use of ustekinumab in pregnancy.
Lactation: Limited data from published literature suggests that ustekinumab is excreted in human breast milk in very small amounts. It is not known if ustekinumab is absorbed systemically after ingestion. Because of the potential for adverse reactions in nursing infants from ustekinumab, a decision on whether to discontinue breast-feeding during treatment and up to 15 weeks after treatment or to discontinue therapy with ustekinumab must be made taking into account the benefit of breast-feeding to the child and the benefit of ustekinumab therapy to the woman.

Single doses up to 6 mg/kg have been administered intravenously in clinical studies without dose-limiting toxicity. In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.

Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.