Stelara - instructions for use, doses, side effects, contraindications

Active substanceUstekinumabUstekinumab

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Stelara®

solution PC

Johnson & Johnson, LLC Russia

Stelara®

solution PC

Johnson & Johnson, LLC Russia

Dosage form: & nbspSolution for subcutaneous administration.

Composition:Active ingredient: one filled syringe contains 45 mg (45 mg / 0.5 mL) or 90 mg (90 mg / 1.0 mL) of ustekinumab.
Excipients:
For dosage of 45 mg / 0.5 ml: sucrose - 38 mg, L-histidine (including L-histidine hydrochloride monohydrate) - 0.5 mg, polysorbate 80 - 0.02 mg, water for injection - up to 0.5 ml.
For the dosage of 90 mg / 1.0 ml: sucrose - 76 mg mg, L-histidine (including L-histidine hydrochloride monohydrate) - 1.0 mg, polysorbate 80 - 0.04 mg, water for injection - up to 1, 0 ml.

Description:The clear or slightly opalescent solution from colorless to pale yellow. The solution can contain single transparent protein particles.

Pharmacotherapeutic group:Psoriasis treatment

ATX: & nbsp

L.04.A Immunosuppressive drugs

L.04.A. C.05 Ustekinumab

Pharmacodynamics:Mechanism of action
Ustekinumab is a fully human monoclonal antibody of the IgGIk class with a molecular weight of about 148600 daltons, produced by a recombinant cell line and undergoing multistep purification, including inactivation and removal of viral particles. Ustekinumab has a high specificity for the p40 subunit of interleukins (IL) of human IL-12 and IL-23.The drug blocks the biological activity of IL-12 and IL-23, preventing the binding of p40 to the IL-12R-β1 receptor expressed on the surface of immune cells. Ustekinumab can not bind to IL-12 and IL-23, already associated with the IL-12Y-β1 receptor. Therefore, the drug is unlikely to affect the complement or antibody-dependent cytotoxicity of cells expressing receptors for IL-12 and / or IL-23.
IL-12 and IL-23 are heterodimeric cytokines that are secreted by activated antigen-presenting cells, in particular macrophages and dendritic cells. IL-12 activates NK cells, stimulates CD differentiation⁴⁺ T cells to T-helpers 1 (Th1), and also enhances the production of interferon gamma (IFNy). IL-23 stimulates the formation of T-helpers 17 (Th17) and increases the secretion of IL-17A, IL-21 and IL-22. Levels of IL-12 and IL-23 are elevated in blood and skin in patients with psoriasis. The concentration of IL12 / 23p40 in the serum is a fact of differentiation of patients with psoriatic arthritis, which confirms the participation of IL-12 and IL-23 in the pathogenesis of psoriatic diseases. Polymorphism of genes encoding IL-23A, IL-23Y and IL-12B, determines the predisposition to such diseases.In addition, the IL-12 and IL-23 genes have increased expression in psoriatic affected skin, and the IL-12-induced IFNγ production is directly proportional to the severity of the psoriatic disease. IL-23 sensitive T cells were detected in enteroses on mouse models of inflammatory arthritis, in which IL-23 caused enteric inflammation.
Stelara® is clinically effective in psoriasis and psoriatic arthritis, by binding the p40 subunit of IL-12 and IL-23 and disrupting the production of Th1 and Th17 cytokines, which are the key links in the pathogenesis of these diseases.
Pharmacodynamics
The use of Stelar® leads to a significant weakening of histological manifestations of psoriasis, including hyperplasia and proliferation of epidermal cells. These data are consistent with clinical efficacy.
In patients with psoriasis and / or psoriatic arthritis ustekinumab has no significant effect on the ratio of immune cells circulating in the blood,
including memory cells and non-activated T cells, as well as the concentration of cytokines in the blood. The concentration of systemic markers of inflammation in patients taking ustekinumab, is within the normal range, and the 4 markers (MDC, VEGF, MCSF-1 b YKL-40) are slightly different in patients taking the Stelara® drug compared to the placebo group.
Analysis of mRNA isolated from biopsy specimens of skin lesions of psoriasis initially and after 2 weeks of treatment showed that the use of Stelar® resulted in a decrease in the expression of genes encoding its molecular targets-IL-12 and IL-23, as well as genes encoding inflammatory cytokines and chemokines - monocyte chemotactic factor (MCP) -1, tumor necrosis factor (TNF) -alpha, interferon-gamma-inducible protein (IP) -10 and IL-8. These data are consistent with the significant clinical effect of treatment in patients with psoriasis.
The clinical effect of treatment of psoriasis and psoriatic arthritis, apparently, depends on the concentration of ustekinumab in the blood plasma. Patients with psoriasis with the best result of evaluation scale area and the severity of psoriasis PASI average value ustekinumab plasma concentrations were higher than those with less clinical effect. In general, the proportion of patients with improvement in PASI scale reached 75%, increased with increasing ustekinumab concentration in blood plasma.In patients with psoriatic arthritis who achieved an ACR score of 20, there is a higher mean plasma concentration of ustekinumab compared with patients who did not respond to treatment. The number of patients with psoriatic arthritis, reached improvement on a scale ACR 20 and ACR 50, increased with increasing ustekinumab concentration in blood plasma.
Immunization
In a long-term clinical trial of Phase 3, patients receiving Stelar® for at least 3.5 years developed an immune response similar to that of a control group of patients with psoriasis who did not undergo systematic treatment with a vaccine containing pneumococcal polysaccharide or tetanus vaccine.
Approximately the same number (%) of patients treated with Stelar® and patients in the control group achieved a protective concentration of anti-pneumococcal and tetanus antibodies. The antibody titres were also approximately the same.

Pharmacokinetics:Suction
The mean time to reach the maximum concentration in the blood plasma (Tmax) after a single subcutaneous administration of 90 mg of ustekinumab to healthy volunteers was 8.5 days.In patients with psoriasis, this value at doses of the drug 45 or 90 mg was comparable to that of healthy volunteers.
Absolute bioavailability of ustekinumab after a single subcutaneous injection of psoriasis patients was 57.2%.
Distribution
The mean value of the volume distribution of ustekinumab in the terminal phase of excretion after single intravenous administration of psoriasis patients ranged from 57 to 83 ml / kg.
Metabolism
The metabolic path of ustekinumab is not known.
Excretion
The average value of systemic clearance of ustekinumab after a single intravenous injection of psoriasis patients ranged from 1.99 to 2.34 ml / day / kg. Mean half-life (T_1/2) ustekinumab in patients with psoriasis and / or psoriatic arthritis was approximately 3 weeks, and varied from 15 to 32 days in different studies.
Linearity
System exposure of стекикинумамамамама (((C_max and the area under the concentration-time curve, AUC) in patients with psoriasis increased in proportion to the administered doses after a single intravenous dose in the range of 0.09 mg / kg to 4.5 mg / kg, and after a single subcutaneous dosing in range from 24 mg to 240 mg.
The change in the concentration of ustekinumab in the blood plasma over time after single or repeated repeated administration of the drug was basically predictable. The equilibrium concentration of ustekinumab in the blood plasma is reached by the 28th week with the proposed regimen of therapy (second injection 4 weeks after the first application, then every 12 weeks). On average, the equilibrium concentration of the drug in patients with psoriasis is 0,21-0,26 g / ml for a dose of 45 mg and 0,47-0,49 mg / ml for a dose of 90 mg. Cumulation of the drug in the serum was not observed during the treatment with the dosing regimen 1 injection every 12 weeks.
The influence of the patient's body weight on the pharmacokinetics of the drug
The concentration of drug in blood plasma is dependent on patient body weight with psoriasis and / or psoriatic arthritis. When administered the same dose (45 mg or 90 mg), patients weighing over 100 kg ustekinumab mean concentration in the plasma was less than in patients weighing less than 100 kg. However, the mean minimum plasma concentration ustekinumab patients weighing more than 100 kg, which was administered 90 mg dose was comparable to that in patients weighing less than 100 kg, which was administered 45 mg of the drug. Population pharmacokinetic analysis
The apparent clearance (CL / F) and the volume of distribution (V / F) were 0.465 l / day and 15.7 l, respectively, according to data obtained from patients with psoriasis. Half-life (T_1/2) of the drug was approximately 3 weeks. Sex, age and belonging to a particular race did not affect the apparent clearance of ustekinumab. The apparent clearance (CL / F) of the drug was influenced by the body weight of patients, while in patients with a larger body weight the CL / F value was greater. The average apparent clearance in patients with a body weight of more than 100 kg was approximately 55% higher than that in patients with a lower body weight. The volume of distribution (V / F) in patients with a body weight of more than 100 kg was approximately 37% higher than that of patients with a lower body weight. Similar results were obtained with confirmatory analysis of population data among patients with psoriatic arthritis.
The effect of comorbid conditions (diabetes mellitus, hypertension, hyperlipidemia) on the pharmacokinetics of the drug in patients with psoriasis was analyzed. In patients with diabetes, CL / F was an average of 29% higher than in healthy patients.
Population pharmacokinetic analysis showed that there is a tendency to increase the clearance of ustekinumab in patients with a positive immune response.
Special patient groups
Children (from 12 to 18 years)
The pharmacokinetics of ustekinumab in children aged 12 to 18 years, with psoriasis, taking the recommended dose, is comparable to the pharmacokinetics in adult patients with psoriasis.
Elderly patients (65 years and over)
Studies of pharmacokinetics in elderly patients have not been conducted. Population pharmacokinetic analysis among patients older than 65 years did not reveal the effect of age on apparent apparent clearance (CL / F) and volume of distribution (V / F).
Patients with impaired renal function
Data on the pharmacokinetics of the drug in patients with impaired renal function are absent.
Patients with impaired hepatic function
Data on the pharmacokinetics of the drug in patients with impaired liver function are absent.
Other patient groups
The pharmacokinetics of ustekinumab is comparable in patients of Asian descent with psoriasis and in non-Asian patients with psoriasis.
The use of alcohol or tobacco did not affect the pharmacokinetics of utekinumab.

Indications:Plaque psoriasis
Adult patients
Treatment of patients older than 18 years with moderate or severe degree of plaque psoriasis in the absence of treatment effect orpresence of contraindications, or with intolerance to other methods of systemic therapy or phototherapy.
Children
Treatment of children aged 12 to 18 years with moderate or severe degree of plaque psoriasis in the absence of treatment effect or in the presence of contraindications, or with intolerance to other methods of systemic therapy or phototherapy.
Psoriatic arthritis
Treatment of patients older than 18 years with active psoriatic arthritis (PsA) as a monotherapy or in combination with methotrexate.

Contraindications:- Clinically significant hypersensitivity to ustekinumab or any auxiliary drug substance;
- Children under 12 years of age (according to the indication of "plaque psoriasis"), up to 18 years (according to the indication "psoriatic arthritis");
- Pregnancy and lactation;
- Serious infectious diseases in the acute phase, including tuberculosis;
- Malignant neoplasms.

Carefully:- Chronic or recurrent parasitic and infectious diseases of a viral, fungal or bacterial nature.
- Malignant tumors in the anamnesis.
- Elderly age.

Pregnancy and lactation:Pregnancy
During the study of the drug, the animals were administered a dose 45 times higher than the recommended clinical dose for a person, and there were no signs of teratogenicity, congenital anomalies or developmental lag. However, the results of animal studies are not always applicable to humans.
It is not known whether ustekinumab when used in pregnant women lead to adverse effects on the fetus or affect reproductive function. Adequate and strictly controlled studies in pregnant women were not conducted.
It is not recommended to use the drug during pregnancy, effective methods of contraception should be used during and 15 weeks after treatment with the drug.
Lactation
Studies in monkeys have shown that ustekinumab excreted in breast milk. It is not known whether the drug is absorbed systematically after absorption. Because many drugs and immunoglobulins are excreted in breast milk, and since Stelara® can cause adverse reactions in infants, a decision should be made to stop breastfeeding during the period of taking the drug or to cancel the treatment with ustekinumab.

Dosing and Administration:The drug Stelara® is intended for subcutaneous injections.
Adult patients
Plaque psoriasis
The recommended dose is 45 mg. The second injection is done 4 weeks after the first application, then every 12 weeks.
In patients with a body weight of more than 100 kg, the drug is recommended to be used in a dose of 90 mg.
If the therapy is ineffective for 28 weeks, it is recommended to consider the expediency of using the drug.
Correction of dose
Patients in whom the clinical efficacy of the drug every 12 weeks is not enough, the dose should be increased to 90 mg every 12 weeks. If such a dosing regimen is not effective, a dose of 90 mg should be given every 8 weeks.
Resumption of treatment
It was shown that the resumption of therapy according to the scheme: the second injection 4 weeks after the first application, and then every 12 weeks, is effective and safe.
Psoriatic arthritis
The recommended dose is 45 mg. The second injection is done 4 weeks after the first application, then every 12 weeks.
In patients with a body weight of more than 100 kg, the drug is recommended to be used in a dose of 90 mg.
Children
Plaque psoriasis
The recommended dose depends on the patient's body weight, as shown in Table 1. The second injection is done 4 weeks after the first application, then every 12 weeks.
Table 1. Recommended dose of Stelar® in children with plaque psoriasis

Body mass	The recommended dose	Form of issue
Less than 60 kg	0.75 mg / kg *	Bottles
From 60 kg to 100 kg	45 mg	Syringes, bottles
More than 100 kg	90 mg	Syringes, bottles

* - to calculate the required volume of the drug (ml) for patients with a body weight of less than 60 kg, the following formula is used: body weight (kg) x 0.0083 (ml / kg). The calculated volume of the preparation is rounded to the one hundredth part of ml (0.01 ml). Injection is carried out by a graduated syringe with a capacity of 1 ml. For patients who require a dose of less than 45 mg, the preparation Stelara ® is available in vials with a dosage of 45 mg.
Children use the drug in a hospital.
If the therapy is ineffective for 28 weeks, it is recommended to consider the expediency of using the drug.
Special patient groups
Application in elderly patients (over 65 years)
Of the 4135 patients who received Stelara®, 252 were patients over the age of 65 (183 patients with psoriasis and 69 with psoriatic arthritis).In clinical trials, no effect of age on clearance or volume of drug distribution was found. Although the study of the drug showed no differences in safety and efficacy of the drug for elderly patients older than 65 years compared with younger patients, the number of elderly patients is not sufficient to conclusively conclude about the effect of age (or lack of influence) on clinical efficacy.
Use in children
The safety and efficacy of ustekinumab in children younger than 12 years of age have not been studied.
Application in renal and hepatic insufficiency
Studies of the drug in patients with renal or hepatic insufficiency have not been conducted.
Instructions for the administration of the drug
The drug is intended for subcutaneous administration.
Before administering the drug, carefully inspect the contents of the syringe. The solution may be clear or slightly opalescent from colorless to light yellow, may contain single transparent protein particles. This appearance is normal for protein solutions. When the color changes, turbidity or the presence of solid particles, the solution can not be used. Ustekinumab does not contain preservatives, so any unused drug residue in the syringe can not be used.
The drug should not be mixed with other injectable liquids. If two 45-mg syringes are used to administer a dose of 90 mg, two consecutive injections should be made. The second injection should be done immediately after the first injection. Injections should be done in different areas. Do not shake the drug. Prolonged vigorous shaking can damage the drug. Do not use if it is shaken. At the beginning of the injection treatment of the drug
Stelara® should only be made by medical personnel, however, if the doctor deems it possible, then the patient can inject himself with Stelara® on his own, observing all necessary precautions and having passed the mandatory training in the hypodermic injection technique, followed by the doctor's supervision. In children aged 12 to 18 years, all injections should be performed by medical personnel.
Recommended places for injection are the upper part of the thigh or abdomen about 5 cm below the navel. You can also use the shoulder area (see Figure 1).Avoid injections into the area affected by psoriasis.
Fig. 1 Recommended places for injection

Fig. 2 Syringe with Stelar®

Take the syringe with the drug from the cardboard bundle, keeping it in the direction of the needle from itself. Make sure the syringe is not damaged. Wash your hands thoroughly and treat the injection site with a cotton swab dipped in antiseptic. Remove the protective cap from the needle. You can see the air bubble in the syringe. This is acceptable, do not try to remove it. You can also see a droplet of liquid on the end of the needle. This is also permissible.
Never remove the protective cap until you have decided on the injection site. Do not allow the needle to come into contact with foreign objects.
Gently pinch the skin in the area of injection between the thumb and forefinger, insert the needle into the skin and slowly lower the syringe piston to the limit (Figure 3).

Fig. 3.
After that, release the skin and carefully remove the needle. As soon as you remove the finger from the piston, the needle automatically disappears in the syringe body (Fig. 4).

Fig. 4.
Apply a cotton swab moistened with antiseptic to the injection site and hold for a few seconds. Do not rub the injection site.If necessary, cover with adhesive tape. The used syringe must be disposed of in accordance with local requirements for the destruction of this type of waste. Re-use of the syringe and needle is prohibited.

Side effects:Adverse effects in adult patients
The most frequent adverse events (> 5%) in controlled clinical trials of the drug in psoriasis and psoriatic arthritis were nasopharyngitis, headache and upper respiratory tract infections. Most of these events were mild and did not require discontinuation of treatment.
Side effects of the drug are systematized relative to each of the organ systems depending on the frequency of occurrence, using the following classification: very often (> 1/10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, < 1/100), rarely (≥1 / 10000, <1/1000), very rarely (<1/10000), including isolated cases.
Infectious and parasitic diseases:
Often: odontogenic infections, upper respiratory tract infections, nasopharyngitis.
Infrequently: inflammation of subcutaneous fat, shingles, viral infections of the upper respiratory tract.
In placebo-controlled studies in patients with psoriasis and / or psoriatic arthritis, the incidence of infection and serious infection with Stelar and placebo was the same (infection rates were 1.27 and 1.17 per person-year of treatment, the incidence of serious infections - respectively 0.01 (5/616) and 0.01 (4/287) cases per person-year of treatment).
In controlled and uncontrolled clinical trials in patients with psoriasis and psoriatic arthritis, the incidence of infections with Stelar was 0.86 cases per person-year of treatment. The incidence of serious infection was 0.01 cases per person-year of treatment (107/9848). Serious infections included diverticulitis, inflammation of subcutaneous fat, appendicitis, cholecystitis and sepsis.
Mental disorders:
Infrequently: depression.
Impaired nervous system:
Often: dizziness, headache.
Infrequent: defeat of the facial nerve.
Disturbances from the respiratory system, chest and mediastinal organs:
Often: oropharyngeal pain.
Infrequent: nasal congestion.
Disorders from the gastrointestinal tract:
Often: diarrhea, vomiting, nausea.
Disturbances from the skin and subcutaneous tissues:
Often: itching.
Infrequent: skin peeling.
Rarely: exfoliative dermatitis.
Disorders from the musculoskeletal system and connective tissue:
Often: back pain, myalgia, arthralgia.
General disorders and reactions at the injection site:
Often: fatigue, erythema at the injection site, pain at the injection site.
Infrequent: reactions at the injection site (including hemorrhage, haemotoma, compaction, swelling and itching).
Description of some adverse reactions
Malignant tumors
In 3 clinical placebo-controlled trials in patients with psoriasis and psoriatic arthritis, the incidence of malignant tumors (not including non-melanoma skin cancer) in patients receiving ustekinumab and placebo, was acc. 0.16 (1/615) and 0.35 (1/287) cases per 100 people / year. The frequency of development of other forms of skin cancer than melanoma with the use of the drug Stelar® and placebo was acc. 0.65 (4/615) and 0.70 (2/287) cases per 100 people / year. The frequency of malignant tumors in patients treated with Stelar® was comparable to the incidence of tumors in the general population.
Most often, in addition to non-melanoma skin cancer, malignant tumors of the prostate, intestines, mammary glands and melanoma were observed.
The incidence of non-melanoma skin cancer in patients receiving Stelar® was 0.61 cases per 100 people / year (41/6770).
Hypersensitivity reactions
In clinical trials, rash and urticaria were observed in less than 1% of patients.
Immunogenicity
Approximately 6% of patients with psoriasis and psoriatic arthritis who received Stelar® received antibodies to ustekinumab, which usually had a low titer. There was no clear correlation between the formation of antibodies and the presence of reactions at the injection site. In the presence of antibodies to ustekinumab, patients often had a lower efficacy of the drug, although the presence of antibodies does not exclude the achievement of a clinical effect. Most patients with psoriasis who had antibodies to ustekinumab also had antibodies that neutralized such antibodies.
Side effects in children
The safety of Stelar® was studied in 110 patients aged 12 to 18 years with a duration of therapy up to 60 weeks. Undesirable reactions observed in children are similar to those in adults.
Undesirable phenomena revealed in the post-marketing application of Stelar®
From the immune system:
Infrequent: hypersensitivity reactions (including rash and hives);
Rarely: severe hypersensitivity reactions (including anaphylaxis and angioedema).
From the skin and subcutaneous tissue:
Infrequently: pustular psoriasis.
Rarely: psoriatic erythroderma.

Overdose:During clinical trials, patients were injected intravenously with doses of up to 6 mg / kg without development of dose-limiting toxicity. In case of an overdose, it is recommended to monitor the patient's condition to identify signs and symptoms of side effects and, when they develop, immediately begin appropriate symptomatic therapy.

Interaction:Studies of drug interactions in humans have not been conducted.
Effects of IL-12 and IL-23 on CYP450 enzymes were studied in vitro on human hepatocytes. The study showed that IL-12 and / or IL-23 at a concentration of 10 ng / ml did not affect the enzymes CYP450 (CYP1A2, 2B6, 2C9, 2C19, 2D6 or ZA4). The results obtained do not imply the need for dose adjustment in patients taking drugs simultaneously with the Stelara preparation, which are megabolized by CYP450 enzymes.
Do not use vaccines containing weakened pathogens of infectious diseases, concomitantly with ustekinumab.
With the joint use of the drug Stelar® and such drugs as paracetamol (acetaminophen), ibuprofen, acetylsalicylic acid, metformin, atorvastatin, naproxen, levothyroxine and hydrochlorothiazide interaction was not revealed. The safety and efficacy of the joint use of Stelar® with other immunosuppressants (methotrexate, ciclosporin) or biological agents for the treatment of psoriasis has not been evaluated.

Special instructions:Infections
Ustekinumab is a selective immunosuppressant and may increase the risk of infections and the reactivation of infections in the latent phase.
In clinical trials with the use of the drug Stelara ® in patients there were serious bacterial, fungal and viral infections. Ustekinumab Do not use in patients with clinically relevant, active infections. Care should be taken when using the drug in patients with chronic infections or the presence of recurrent infections in the anamnesis.Before starting the drug, the patient should be tested for tuberculosis. Do not use ustekinumab in patients with active tuberculosis. In the presence of latent or active tuberculosis (including history), it should be started before the use of the drug Stelar®. Also, it is necessary to begin treatment of tuberculosis in patients who have not had sufficient effect from their previous treatment. During the treatment with usekinumab and after that, we should carefully monitor the patients to identify signs and symptoms of active tuberculosis.
Patients should be warned about the need to see a doctor if signs and symptoms appear that suggest infection. With the development of a serious infection, the use of Stelar® should be canceled, the patient must be under the supervision of medical personnel. Do not use ustekinumab before the end of infection treatment.
Malignant neoplasms
The drug Stelara ® is a selective immunosuppressant. Immunosuppressants can increase the risk of developing malignant tumors. In some patients who received ustekinumab in clinical studies, the emergence of malignant neoplasms (cutaneous and non-dermal forms).
The use of the drug Stelar® has not been studied in patients with malignant tumors in the anamnesis. Caution should be exercised in prescribing patients with malignant tumors in an anamnesis, and also when considering the continuation of treatment with Stelar® for patients with diagnosed malignancies.
In all patients over the age of 60 years, as well as in patients who received long-term therapy with immunosuppressants or UV radiation, it is necessary to conduct a test for the presence of non-melanoma skin cancer.
Hypersensitivity reactions
In the post-marketing application of Stelar®, cases of serious hypersensitivity reactions are known, including angioedema and anaphylaxis. With the development of anaphylactic and other serious hypersensitivity reactions, the use of ustekinumab should be stopped immediately, and appropriate treatment should be prescribed.
Vaccination
Do not vaccinate the patient with live vaccines during the treatment with Stelar®,as well as 15 weeks before vaccination (after the last dose of Stelar®) and 2 weeks after vaccination.
Data on secondary infection with the use of live vaccines in patients receiving the preparation of Stelar® are absent. Caution should be exercised when using live vaccines to immunize family members of the patient receiving Stelar®, as there is a risk of viral or bacterial excretion and transmission of infection from these persons to patients.
Long-term treatment with Stelar® does not inhibit the humoral immune response to vaccines containing the pneumococcal polysaccharide and tetanus toxoid vaccine.
With usxinumab, vaccines containing inactivated microorganisms can be used, but the induced immune response may not be sufficient to prevent the disease.
Concomitant immunosuppressive therapy
The safety and efficacy of Stelar® in combination with immunosuppressive drugs and phototherapy has not been studied in patients with psoriasis. In studies in patients with psoriatic arthritis, co-administration with methotrexate did not affect the safety and efficacy of Stelar®.Caution should be exercised when considering the possibility of simultaneous use of other immunosuppressants and utekinumab, as well as during the transition from therapy with another antipsoriasis biological agent to ustekinumab therapy.
Immunotherapy
The safety and efficacy of Stelar® in patients who underwent immunotherapy for allergic diseases have not been established. Caution should be exercised in patients currently receiving or undergoing immunotherapy for allergic diseases, especially anaphylactic conditions.
General information
The protective cap for the needle contains in its composition natural rubber (latex derivative) and in the presence of hypersensitivity to latex can cause allergic reactions.

Effect on the ability to drive transp. cf. and fur:No studies have been conducted.

Form release / dosage:A solution for subcutaneous administration is 90 mg / ml.

Packaging:0.5 ml or 1.0 ml in syringes of borosilicate glass (type I) with the UltraSafe Passive® device.
Each syringe contains 45 mg (45 mg / 0.5 mL) or 90 mg (90 mg / 1.0 mL) of ustekinumab.
For 1 syringe, along with instructions for medical use, put in a pack of cardboard.

Storage conditions:Store in the original packaging in a dark place at a temperature of 2 to 8 ° C. Do not freeze.
Do not shake. Keep out of the reach of children.

Shelf life:2 years.
Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001104

Date of registration:03.11.2011 / 07.11.2016

Expiration Date:Unlimited

The owner of the registration certificate:Johnson & Johnson, LLC Johnson & Johnson, LLC Russia

Manufacturer: & nbsp

CILAG, AG Switzerland

Representation: & nbspJohnson & Johnson LLC Johnson & Johnson LLC Russia

Information update date: & nbsp2016-11-22

Illustrated instructions

Instructions

Stelara® (Stelara®)