- 45 mg of ustekinumab in 0,5 ml
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- Mildred Houston
- 5 years ago
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1 Package Insert SCHEDULING STATUS Schedule 4 PROPRIETARY NAME & DOSAGE FORM STELARA 45 mg solution for injection COMPOSITION STELARA contains ustekinumab, a fully human IgG1κ monoclonal antibody produced in murine myeloma cell line by a recombinant DNA technology. STELARA is available as: - 45 mg of ustekinumab in 0,5 ml The other ingredients are sucrose, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 and water for injection PHARMACOLOGICAL CLASSIFICATION A.30.1 Biologics Antibodies PHARMACOLOGICAL ACTION Pharmacodynamic properties Mechanism of action Ustekinumab is a fully human IgG1κ monoclonal antibody that binds with high affinity and specificity to the p40 protein subunit of the human cytokines interleukin (IL)-12 and IL-23. Ustekinumab inhibits the bioactivity of human IL-12 and IL-23 by preventing these cytokines from binding to their IL-12Rβ1 receptor protein expressed on the surface of immune cells. Ustekinumab cannot bind to IL-12 or IL-23 that is pre-bound to IL-12Rβ1 cell surface receptors. Thus, ustekinumab is not likely to contribute to complement or antibody mediated cytotoxicity of the receptor-bearing cell. IL-12 and IL-23 are heterodimeric cytokines secreted by activated antigen presenting cells, such as macrophages and dendritic cells. IL-12 and IL-23 participate in immune function by contributing to NK Page 1 of 14
2 cell activation and CD4+ T cell differentiation and activation. However, abnormal regulation of IL-12 and IL-23 has been associated with immune-mediated diseases, such as psoriasis. Ustekinumab prevents IL-12 and IL-23 contributions to immune cell activation, such as intracellular signaling and cytokine secretion. Thus ustekinumab is believed to interrupt signaling and cytokine cascades that are central to psoriasis pathology. Pharmacodynamic effects Treatment with ustekinumab resulted in improvement in histological measures of psoriasis including epidermal hyperplasia and cell proliferation. Ustekinumab had no apparent effect on the percentages of circulating immune cell populations including memory and naive T cell subsets or circulating cytokine levels. Clinical response (improvement in Psoriasis Area and Severity Index [PASI]) appeared to be related to serum ustekinumab levels. Patients with psoriasis with higher clinical responses as measured by PASI response had higher median serum concentrations of ustekinumab than those with lower clinical responses. Pharmacokinetic properties Absorption The median time to reach the maximum serum concentration (t ) was 8,5 days after a single 90 mg max subcutaneous administration in healthy subjects. The median t values of ustekinumab following a max single subcutaneous administration of either 45 mg or 90 mg in patients with psoriasis were comparable to that observed in healthy subjects. The absolute bioavailability of ustekinumab following a single subcutaneous administration was estimated to be 57,2 % in patients with psoriasis. Distribution Median volume of distribution during the terminal phase (Vz) following a single intravenous administration to patients with psoriasis ranged from 57 to 83 ml/kg. Page 2 of 14
3 Metabolism The exact metabolic pathway for ustekinumab is unknown. Elimination Median systemic clearance (CL) following a single intravenous administration to patients with psoriasis ranged from 1,99 to 2,34 ml/day/kg. Median half-life (t 1/2 ) of ustekinumab was approximately 3 weeks in patients with psoriasis, ranging from 15 to 32 days across all psoriasis studies. Dose Linearity The systemic exposure of ustekinumab (C and AUC) increased in an approximately doseproportional manner after a single intravenous administration at doses ranging from 0,09 mg/kg to 4,5 max mg/kg or following a single subcutaneous administration at doses ranging from approximately 24 mg to 240 mg in patients with psoriasis. Single Dose vs. Multiple Doses Serum concentration-time profiles of ustekinumab were generally predictable after single or multiple subcutaneous dose administrations. Steady-state serum concentrations of ustekinumab were achieved by Week 28 after initial subcutaneous doses at Weeks 0 and 4 followed by doses every 12 weeks. There was no apparent accumulation in serum ustekinumab concentration over time when given subcutaneously every 12 weeks. Impact of Weight on Pharmacokinetics Serum ustekinumab concentrations were affected by patient weight. Within each dose (45 mg or 90 mg), patients of higher weight (> 100 kg) had lower median serum ustekinumab concentrations compared with those in patients of lower weight ( 100 kg). However, across doses, the median trough serum concentrations of ustekinumab in patients with higher weight (> 100 kg) in the 90 mg group were comparable to those in patients with lower weight ( 100 kg) in the 45 mg group. Special Populations No pharmacokinetic data are available in patients with renal insufficiency or impaired hepatic function. Page 3 of 14
4 No specific studies have been conducted in elderly patients. A population pharmacokinetic analysis indicated there was no apparent changes in CL/F and V/F estimates in patients 65 years. The pharmacokinetics of ustekinumab were not affected by the use of tobacco or alcohol. Regulation of CYP450 enzymes The effects of IL-12 or IL-23 on the regulation of CYP450 enzymes were evaluated in an in vitro study using human hepatocytes, which showed that IL-12 and/or IL-23 at levels of 10 ng/ml did not alter human CYP450 enzyme activities (CYP1A2, 2B6, 2C9, 2C19, 2D6, or 3A4; see section Interactions ). INDICATIONS STELARA is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy. CONTRA-INDICATIONS Hypersensitivity to ustekinumab or to any of the excipients. WARNINGS AND SPECIAL PRECAUTIONS Infections STELARA is a selective immunosuppressant and may have the potential to increase the risk of infections and reactivate latent infections. In clinical studies, serious bacterial, fungal, and viral infections have been observed in patients receiving STELARA (see section Side-effects, Infections ). STELARA should not be given to patients with a clinically important, active infection. Caution should be exercised when considering the use of STELARA in patients with a chronic infection or a history of recurrent infection. Page 4 of 14
5 Prior to initiating treatment with STELARA, patients should be evaluated for tuberculosis infection. STELARA should not be given to patients with active tuberculosis. Treatment of latent tuberculosis infection should be initiated prior to administering STELARA. Anti-tuberculosis therapy should also be considered prior to initiation of STELARA in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Patients receiving STELARA should be monitored closely for signs and symptoms of active tuberculosis during and after treatment. Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection they should be closely monitored and STELARA should not be administered until the infection resolves. Malignancies STELARA is a selective immunosuppressant. Immunosuppressive agents have the potential to increase the risk of malignancy. Some patients who received STELARA in clinical studies developed cutaneous and non-cutaneous malignancies (see section Side-effects, Malignancies ). STELARA has not been studied in patients with a history of malignancy. Caution should be exercised when considering the use of STELARA in patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy. 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 (see section Side-effects, malignancies). Hypersensitivity reactions In post-marketing experience, serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported. If an anaphylactic or other serious hypersensitivity reaction occurs, administration of STELARA should be discontinued immediately and appropriate therapy instituted (see section Side-effects, Hypersensitivity reactions ). Page 5 of 14
6 Immunisations It is recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and Guérin (BCG)) should not be given concurrently with STELARA. No data are available on the secondary transmission of infection by live vaccines in patients receiving STELARA. Caution is advised when administering some live vaccines to household contacts of patients receiving STELARA because of the potential risk for shedding from the household contact and transmission to the patient. Patients receiving STELARA may receive concurrent inactivated or non-live vaccinations. Long term treatment with STELARA does not suppress the humoral immune response to pneumococcal polysaccharide or tetanus vaccines. Immunosuppression The safety and efficacy of STELARA in combination with immunosuppressive agents or phototherapy have not been evaluated. Caution should be exercised when considering concomitant use of immunosuppressive agents and STELARA (see section Interactions ). Immunotherapy STELARA has not been evaluated in patients who have undergone allergy immunotherapy. STELARA may affect allergy immunotherapy. Caution should be exercised in patients receiving or who have received allergy immunotherapy particularly for anaphylaxis. General: The needle cover on the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex. Special Populations Children and adolescents (< 18 years) Specific studies of STELARA in this patient group have not been conducted. Page 6 of 14
7 Elderly patients ( 65 years) No major age-related differences in clearance or volume of distribution were observed in clinical studies. No overall differences in efficacy or safety in patients age 65 and older who received STELARA were observed compared to younger patients. Hepatic insufficiency Specific studies have not been conducted in patients with hepatic insufficiency. Renal insufficiency Specific studies have not been conducted in patients with renal insufficiency Effects on ability to drive and use machines No studies on the effects on the ability to drive and use of machines have been performed. INTERACTIONS No specific interaction studies have been performed in humans. In a population pharmacokinetic analysis, the effect of the most frequently used concomitant medications in patients with psoriasis (including paracetamol / acetaminophen, ibuprofen, acetylsalicylic acid, metformin, atorvastatin, naproxen, levothyroxine, hydrochlorothiazide, and influenza vaccine) on pharmacokinetics of ustekinumab was explored and none of the concomitant medications exerted significant impact. The pharmacokinetics of ustekinumab was not impacted by the prior use of methotrexate, cyclosporine, or other biological therapeutics for the treatment of psoriasis. The safety and efficacy of STELARA in combination with immunosuppressive agents or phototherapy have not been evaluated. Caution should be exercised when considering concomitant use of immunosuppressive agents and STELARA. PREGNANCY & LACTATION Pregnancy The safety of STELARA has not been established during pregnancy or lactation. STELARA should not be given to a pregnant woman but only if the benefit clearly outweighs the risk. Page 7 of 14
8 Lactation It is unknown whether STELARA is excreted in human breast milk. Women are advised against breast-feeding while receiving STELARA. DOSAGE AND DIRECTIONS FOR USE STELARA is administered by subcutaneous injection. Adults (18-64 years): The recommended dose of STELARA is 45 mg administered subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90 mg may be used in patients with a body weight greater than 100 kg (see Pharmacokinetic Properties ). In patients weighing > 100 kg, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy in these patients. For patients who inadequately respond to dosing every 12 weeks, consideration may be given to treating every 8 weeks. Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment. Re-treatment: Re-treatment with a dosing regimen of weeks 0 and 4 after interruption of therapy has been shown to be safe and effective. Elderly patients ( 65 years): Dosage and administration are the same as for adults years of age. Children and adolescents (< 18 years): Safety and efficacy of STELARA have not been studied in this age group (< 18 years old). STELARA is therefore not recommended for use in children below age 18. Renal and hepatic impairment: STELARA has not been studied in these patient populations. Page 8 of 14
9 General Consideration for Administration STELARA is intended for use under the guidance and supervision of a medical practitioner. A patient may self-inject with STELARA if a physician determines that it is appropriate and after proper training in subcutaneous injection technique. See section Special Precautions for Disposal and Other Handling. Comprehensive instructions for the administration of STELARA are given in the Patient Information Leaflet. Patients should be instructed to inject the full amount of STELARA according to the directions provided under section INSTRUCTIONS FOR ADMINISTRATION of the patient information leaflet. The needle cover on the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex. Special precautions for disposal and other handling The solution in the STELARA vial should be visually inspected for particulate matter or discoloration prior to subcutaneous administration. The product is clear to slightly opalescent, colourless to light yellow and may contain a few small translucent or white particles of protein. This appearance is not unusual for proteinaceous solutions. The product should not be used if solution is discoloured or cloudy, or if foreign particulate matter is present. STELARA does not contain preservatives; therefore any unused product remaining in vial and the syringe should not be used. Unused product or waste material should be disposed of in accordance with local requirements. SIDE-EFFECTS The following serious adverse reactions were reported in controlled clinical studies: serious infections and malignancies. The most common adverse reactions (> 10 %) in controlled and uncontrolled portions of the psoriasis clinical studies with STELARA were nasopharyngitis and upper respiratory tract infection. Most were considered to be mild and did not necessitate STELARA discontinuation. Table 1 provides a summary of Adverse Drug Reactions from psoriasis clinical studies. The adverse drug reactions are ranked by frequency, using the following convention: Page 9 of 14
10 Very common ( 1/10); Common ( 1/100, < 1/10); Uncommon ( 1/1 000, < 1/100); Rare ( 1/10 000, < 1/1 000); Very rare (< 1/10 000) Not known (cannot be estimated from the available data) Table 1 SUMMARY OF ADRs IN PSORIASIS CLINICAL STUDIES Infections and infestations Very common: Upper respiratory tract infection, nasopharyngitis Common: Cellulitis, viral upper respiratory tract infection (pneumonia) and urinary tract infections. Uncommon: Herpes zoster Psychiatric disorders Nervous system disorders Respiratory, thoracic and Common: Depression Common: Dizziness, headache Common: Pharyngolaryngeal pain, nasal congestion mediastinal disorders Gastrointestinal disorders Skin and subcutaneous Common: Diarrhoea, diverticulitis, gastroenteritis Common: Pruritus tissue disorders Musculoskeletal, connective tissue and bone disorders General disorders and administration site conditions Common: Back pain, myalgia and osteomyelitis Common: Fatigue, injection site erythema Uncommon: injection site reactions (including pain, swelling, pruritus, induration, haemorrhage, bruising and irritation) Infections In controlled studies of psoriasis patients, the rates of infection or serious infection were similar between STELARA-treated patients and those treated with placebo. In the placebo-controlled period of clinical studies of psoriasis patients, the rate of infection was 1,39 per patient-year of follow-up in STELARA-treated patients, and 1,21 in placebo-treated patients. Serious infections occurred in 0,01 per patient-year of follow-up in STELARA-treated patients (5 serious infections in 407 patient-years of follow-up) and 0,02 in placebo-treated patients (3 serious infections in 177 patient-years of follow-up) (see section Special Precautions, Infections ). Page 10 of 14
11 In the controlled and non-controlled portions of psoriasis clinical studies, the rate of infection was 1,24 per patient-year of follow-up in STELARA-treated patients, and the incidence of serious infections was 0,01 per patient-year of follow-up in STELARA-treated patients (24 serious infections in patientyears of follow-up) and included Cellulites, diverticulitis, osteomyelitis, viral infections, gastroenteritis, pneumonia, and urinary tract infections. In clinical studies, patients with latent tuberculosis who were concurrently treated with isoniazid did not develop tuberculosis. Malignancies In the controlled period of 3 placebo-controlled the psoriasis clinical studies, the incidence of malignancies excluding non-melanoma skin cancer was 0,25 per 100 patient-years of follow-up for STELARA-treated patients (1 patient in 406 patient-years of follow-up) compared with 0,57 for placebo-treated patients (1 patient in 177 patient-years of follow-up). Among patients treated in 4 psoriasis clinical trials (median follow up of 3,2 years) of STELARA (1 569 patients treated for at least 3 years, patients for at least 4 years and 838 patients for at least 5 years), malignancies excluding non-melanoma skin cancers were reported in 54 patients in patient-years of follow-up (incidence of 0,60 per 100 patient-years of follow-up for STELARAtreated patients). The most frequently observed malignancies, other than non-melanoma skin cancer, were prostate, melanoma, colorectal and breast. The incidence of non-melanoma skin cancer was 0,52 per 100 patient-years of follow-up for STELARA-treated patients (47 patients in patient-years of followup). (See section Special Precautions, Malignancies ). Hypersensitivity reactions In clinical studies of STELARA, rash and urticaria have each been observed in < 2 % of patients. Immunogenicity Approximately 5 % of STELARA treated patients developed antibodies to ustekinumab, which were Page 11 of 14
12 generally low-titer. No apparent correlation of antibody development to injection site reactions was seen. The majority of patients who were positive for antibodies to ustekinumab had neutralising antibodies. Patients positive for antibodies to ustekinumab tended to have lower efficacy, however, antibody positivity does not preclude a clinical response. Post Marketing Experience Table 2 Post-Marketing Reports Immune system disorders Hypersensitivity reactions (including rash, urticaria) Serious hypersensitivity reactions (including anaphylaxis and angioedema) Skin and Exfoliative dermatitis; erythrodermic psoriasis subcutaneous tissue disorders KNOWN SYMPTOMS OF OVERDOSE AND PARTICULARS OF ITS TREATMENT In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment be instituted immediately. IDENTIFICATION The solution is clear to slightly opalescent, colourless to light yellow. The solution may contain a few small translucent or white protein particles. PRESENTATION STELARA is available as: - Single-use pre-filled syringe: STELARA is supplied as a sterile solution in a single-use, clear, colourless Type 1 glass syringe with a fixed 27G, half-inch needle with grey rubber needle shield. The needle shield is manufactured using a dry natural rubber (a derivative of latex). The syringe is stoppered with a grey butyl rubber stopper with a colourless Flurotec coating. The syringe is fitted with a passive safety guard. Page 12 of 14
13 STELARA is packed in a outer carton pack containing: - 1 single-use pre-filled syringe. STORAGE INSTRUCTIONS Store in a refrigerator (2 ºC 8 ºC). Keep the pre-filled syringe in the outer carton until time of use in order to protect from light. Do not freeze. Do not shake. KEEP OUT OF REACH OF CHILDREN REGISTRATION NUMBER 43/30.1/0727 NAME AND ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION JANSSEN PHARMACEUTICA (Pty) Ltd (Reg. No. 1980/011122/07) Building 6, Country Club Estate, 21 Woodlands Drive, Woodmead, 2191 Tel: +27 (11) DATE OF PUBLICATION OF THE PACKAGE INSERT October 2015 Page 13 of 14
14 VOUBILJET SKEDULERINGSTATUS Skedule 4 HANDELSNAAM EN DOSEERVORM STELARA 45 mg oplossing vir inspuiting SAMESTELLING STELARA bevat ustekinumab, n volledige mens - IgG1κ monoklonale antiliggaam, geproduseer in n muis-miëloomsellyn deur middel van rekombinante DNS-tegnologie. STELARA is beskikbaar as: 45 mg ustekinumab in 0,5 ml, Die ander bestanddele is sukrose, L-histidien, L-histidienmonohidrochloried-monohidraat, polisorbaat 80 en water vir inspuiting FARMAKOLOGIESE KLASSIFIKASIE A 30.1 Biologiese middels - Antiliggame FARMAKOLOGIESE WERKING Farmakodinamiese eienskappe Werkingsmeganisme Ustekinumab is n volledige mens- IgG1κ monoklonale antiliggaam wat met hoë affiniteit en spesifisiteit bind aan die p40-proteïen-subeenheid van mens-sitokiene, interleukien (IL)-12 en IL-23. Ustekinumab rem die bio-aktiwiteit van mens- IL-12 en IL-23 deur te keer dat hierdie sitokiene bind aan hul IL-12Rβ1-reseptorproteïen, wat uitgedruk word op die oppervlak van immuunselle. Ustekinumab kan nie bind aan IL-12 of IL-23 wat reeds gebind is aan IL-12Rβ1- reseptore op die seloppervlakte nie. Gevolglik is dit onwaarskynlik dat ustekinumab sal bydra tot die kompliment- of antiliggaam-bemiddelde sitotoksisiteit van die reseptordraende sel. Page 14 of 28
15 IL-12 en IL-23 is heterodimere sitokiene, afgeskei deur geaktiveerde antigeen-presenterende selle, soos makrofage en dendritiese selle. IL-12 en IL-23 speel n rol in die immuunfunksie deur by te dra tot die aktivering van NK selle en differensiasie en aktivering van CD4+ T-selle. Abnormale regulering van IL-12 en IL-23 is egter geassosieer met immuun-bemiddelde aandoenings, soos psoriase. Ustekinumab verhinder die bydra van IL-12 en IL-23 tot aktivering van immuunselle, soos intrasellulêre seining en afskeiding van sitokien. Gevolglik word daar geglo dat ustekinumab seining en sitokienkaskades onderbreek, wat van kardinale belang is by die patologie van psoriase. Farmakodinamiese effekte Behandeling met ustekinumab het gelei tot verbetering in histologiese bepalings van psoriase, insluitend epidermale hiperplasie en selproliferasie. Ustekinumab het geen waarneembare effek op die persentasie sirkulerende immuunselpopulasies, insluitend die geheue en naïewe T-sel substelle of sirkulerende sitokienvlakke, gehad nie. Kliniese respons (verbetering in Psoriase-Area-en-Intensiteit-Indeks [ PASI ]) was skynbaar verwant aan die serumvlakke van ustekinumab. Pasiënte met psoriase wat kliniese beter reageer, soos bepaal deur die PASI-reaksie, het hoër gemiddelde serumkonsentrasies van ustekinumab gehad as diegene wat klinies swakker reageer het. Farmakokinetiese eienskappe Absorpsie Die mediane tyd waarin die maksimale serumkonsentrasie (t maks ) bereik was, was 8,5 dae na 'n eenmalige subkutane toediening van 90 mg by gesonde proefpersone. Die mediane t maks -waardes van ustekinumab na 'n eenmalige subkutane toediening van óf 45 mg óf 90 mg aan pasiënte met psoriase was vergelykbaar met die wat by gesonde pasiënte waargeneem is. Die absolute biobeskikbaarheid van ustekinumab na 'n eenmalige subkutane toediening is geskat op 57,2 % by pasiënte met psoriase. Verspreiding Page 15 of 28
16 Na n eenmalige intraveneuse toediening aan pasiënte met psoriase het die mediane verspreidingsvolume tydens die laaste fase (Vz) gewissel vanaf 57 tot 83 ml/kg. Metabolisme Die presiese metaboliese roete vir ustekinumab is nie bekend nie. Uitskeiding Na n eenmalige intraveneuse toediening aan pasiënte met psoriase het die mediane sistemiese opklaring (CL) gewissel vanaf 1,99 tot 2,34 ml/dag/kg. By pasiënte met psoriase was die mediane halfleeftyd (t 1/2 ) van ustekinumab ongeveer 3 weke, dit het gewissel van 15 tot 32 dae dwarsoor alle studies oor psoriase. Dosislineariteit Die sistemiese blootstelling aan ustekinumab (K maks en AOK) het na 'n eenmalige intraveneuse toediening aan pasiënte met psoriase, by dosisse wisselend van 0,09 mg/kg tot 4,5 mg/kg, of na 'n eenmalige subkutane toediening by dosisse wisselend van ongeveer 24 tot 240 mg, op 'n ongeveer dosis-proporsionele wyse toegeneem. Eenmalige dosis versus herhalende dosisse Serumkonsentrasie-tyd profiele van ustekinumab na eenmalige of herhaalde subkutane dosistoediening was oor die algemeen voorspelbaar. Bestendige toestand serumkonsentrasies van ustekinumab is teen Week 28 bereik, na aanvanklike subkutane dosisse by Weke 0 en 4, gevolg deur 12-weeklikse dosisse. Toe dit 12-weekliks subkutaan toegedien was, was daar geen duidelike akkumulasie in ustekinumab-serumkonsentrasie met verloop van tyd nie. Effek van gewig op die farmakokinetika Die serumkonsentrasies van ustekinumab is deur die pasiënt se gewig beïnvloed. Met elke dosis (45 mg of 90 mg), het pasiënte wat meer weeg (> 100 kg) laer mediane konsentrasies van ustekinumab in die serum gehad as pasiënte wat minder weeg ( 100 kg). Oor al die dosisse was die mediane trog-serumvlakke van ustekinumab by pasiënte wat meer weeg (> 100 kg) in die Page 16 of 28
17 90 mg-groep egter vergelykbaar met dié van pasiënte wat minder weeg (< 100 kg) in die 45 mg groep. Spesiale populasies Daar is geen farmakokinetiese data beskikbaar oor pasiënte met nier- of lewerfunksie inkorting nie. Daar is geen spesifieke navorsingstudies uitgevoer by ouer pasiënte nie. n Populasiefarmakokinetiese analise het getoon dat daar geen duidelike veranderinge in CL/F en V/F beramings by pasiënte 65 jaar was nie. Die farmakokinetika van ustekinumab is nie deur die gebruik van tabak of alkohol aangetas nie. Regulering van CYP450-ensieme Die effekte van IL-12 of IL-23 op die regulering van CYP450-ensieme is beoordeel in 'n in vitro studie met behulp van mens hepatosiete, waaruit dit blyk dat IL-12 en/of IL-23, in konsentrasies van 10 ng/ml, nie die aktiwiteit van mens CYP450-ensieme (CYP1A2, 2B6, 2C9, 2C19, 2D6, of 3A4; kyk afdeling "Interaksies") verander nie. INDIKASIES STELARA is aangewese vir die behandeling van matige tot ernstige plaket-psoriase by volwasse pasiënte wat kwalifiseer vir fototerapie of sistemiese terapie. KONTRAÏNDIKASIES Hipersensitiwiteit vir ustekinumab of vir enige van die hulpstowwe. WAARSKUWINGS EN SPESIALE VOORSORGMAATREËLS Infeksies STELARA is n selektiewe immuun-onderdrukker en kan potensieel die risiko vir infeksies en die heraktivering van sluimerende infeksies verhoog. Page 17 of 28
18 In kliniese studies is daar by pasiënte wat STELARA ontvang het ernstige bakteriële, swam- en virusinfeksies waargeneem (kyk seksie Newe-effekte, Infeksies ). STELARA moet nie aan pasiënte met n klinies belangrike, aktiewe infeksie gegee word nie. Versigtigheid moet uitgeoefen word wanneer die gebruik van STELARA oorweeg word by pasiënte met n chroniese infeksie of n geskiedenis van herhalende infeksie. Voordat behandeling met STELARA begin word, moet pasiënte ondersoek word vir tuberkulose infeksie. STELARA moet nie aan pasiënte met aktiewe tuberkulose gegee word nie. Behandeling van latente tuberkulose infeksie moet ingestel word voordat STELARA toegedien word. Antituberkulose terapie moet ook oorweeg word voordat STELARA begin word by pasiënte met n geskiedenis van latente of aktiewe tuberkulose by wie n voldoende behandelingskursus nie bevestig kon word nie. Pasiënte wat STELARA gebruik, moet noulettend dopgehou word vir tekens en simptome van aktiewe tuberkulose tydens en na behandeling. Pasiënte moet ingelig word om mediese hulp te bekom as tekens of simptome opduik wat op infeksie kan dui. Indien n pasiënt n ernstige infeksie ontwikkel, moet hulle deeglik gemoniteer word en STELARA moet nie toegedien word voordat die infeksie opgeklaar het nie. Maligniteite STELARA is n selektiewe immuun-onderdrukker. Immuun-onderdrukkende middels het die moontlikheid om die risiko vir maligniteit te verhoog. Sommige pasiënte wat STELARA in kliniese studies ontvang het, het kutane en nie-kutane maligniteite ontwikkel (kyk afdeling Newe -effekte, Maligniteite). STELARA is nie bestudeer by pasiënte met n geskiedenis van maligniteit nie. Versigtigheid moet uitgeoefen word wanneer die gebruik van STELARA oorweeg word by pasiënte met n geskiedenis van maligniteit, of wanneer dit oorweeg word om voort te gaan met behandeling by pasiënte wat n maligniteit ontwikkel. Page 18 of 28
19 Alle pasiënte, in die besonder dié wat meer as 60 jaar oud is, pasiënte met 'n mediese geskiedenis van langdurige immuunonderdrukkende terapie of diegene met 'n geskiedenis van PUVA- behandeling, moet gemoniteer word vir die voorkoms van nie-melanoom velkanker (kyk seksie Newe-effekte, maligniteite ). Hipersensitiwiteitsreaksies Met ervaring na bemarking is ernstige hipersensitiwiteitsreaksies, insluitend anafilakse en angioedeem, aangemeld. Indien n anafilaktiese of ander ernstige allergiese reaksie voorkom, moet toediening van STELARA dadelik gestaak word en gepaste terapie ingestel word (kyk afdeling Neweeffekte, Hipersensitiwiteitsreaksies). Immunisering Daar word aanbeveel dat lewende virus- of lewende bakterie- entstowwe (soos Bacillus Calmette Guérin (BCG)) nie gelyktydig met STELARA gegee word nie. Geen data is beskikbaar oor die sekondêre oordrag van infeksie deur lewende entstowwe by pasiënte wat STELARA ontvang nie. Versigtigheid word aangeraai wanneer lewende entstowwe aan huishoudelike kontakte van pasiënte wat STELARA ontvang toegedien word, as gevolg van die potensiële risiko dat die huishoudelike kontak dit deur afskilfering aan die pasiënt kan oordra. Pasiënte wat STELARA gebruik, kan tegelykertyd geïnaktiveerde of nie-lewende inentings kry. Langtermyn behandeling met STELARA onderdruk nie die humorale immuunrespons tot pneumokokkale polisakkaried of tetanus entstowwe nie. Immuunonderdrukking Die veiligheid en doeltreffendheid van STELARA in kombinasie met immuunonderdrukkende middels of fototerapie is nie ondersoek nie. Versigtigheid moet uitgeoefen word wanneer daar oorweeg word om immuunonderdrukkende middels saam met STELARA te gee (kyk seksie 'Interaksies'). Page 19 of 28
20 Immunoterapie STELARA is nie geëvalueer by pasiënte wat allergie- immunoterapie ondergaan het nie. STELARA kan allergie- immunoterapie aantas. Sorg moet uitgeoefen word by pasiënte wat tans of voorheen allergie- immunoterapie ontvang het, veral vir anafilakse. Algemeen Die bedekking van die naald op die vooraf-gevulde spuit bestaan uit droë natuurlike rubber ( n derivaat van lateks), wat allergiese reaksies by enkelinge wat gevoelig is vir lateks kan veroorsaak. Spesiale populasies Kinders en adolessente (< 18 jaar oud) Spesifieke navorsingstudies is nie met STELARA in hierdie groep pasiënte uitgevoer nie. Bejaarde pasiënte ( 65 jaar) Geen belangrike ouderdomsverwante verskille in opklaring of verspreidingsvolume is waargeneem by kliniese studies nie. Oor die algemeen is geen verskil in doeltreffendheid of veiligheid waargeneem tussen pasiënte van 65 jaar en ouer wat STELARA ontvang het en jonger pasiënte nie. Lewerontoereikendheid Spesifieke navorsingstudies is nie oor pasiënte met lewerinkorting uitgevoer nie. Nierontoereikendheid Spesifieke navorsingstudies is nie oor pasiënte met nierinkorting uitgevoer nie. Effek op die vermoë om te bestuur en masjinerie te gebruik Geen navorsingstudies is uitgevoer oor die effek op die vermoë om te bestuur of masjinerie te hanteer nie. INTERAKSIES Daar is geen spesifieke interaksiestudies by mense uitgevoer nie. In n populasie-farmakokinetiese analise is die effek van die medisyne wat mees algemeen saam gebruik word by pasiënte met psoriase Page 20 of 28
21 (insluitende parasetamol/asetaminofeen, ibuprofeen, asetielsalisielsuur, metformien, atorvastatien, naprokseen, levotiroksien, hidrochloortiasied en griep- entstof) op die farmakokinetika van ustekinumab ondersoek en nie een van die gesamentlike medisyne het n beduidende impak gehad nie. Die farmakokinetika van ustekinumab is nie beïnvloed deur die voormalige gebruik van metotreksaat, siklosporien, of ander biologiese terapeutiese middels vir die behandeling van psoriase nie. Die veiligheid en doeltreffendheid van STELARA in kombinasie met immuunonderdrukkende middels of fototerapie is nie ondersoek nie. Versigtigheid moet uitgeoefen word wanneer daar oorweeg word om immuunonderdrukkende middels saam met STELARA te gee. SWANGERSKAP EN LAKTASIE Swangerskap Die veiligheid van STELARA met swangerskap en laktasie is nie ondersoek nie. STELARA moet nie aan 'n swanger vrou gegee word nie, maar dan moet die voordeel die risiko duidelik oortref. Laktasie Dit is nie bekend of STELARA in mens-melk uitgeskei word nie. Vroue word afgeraai om te borsvoed terwyl hulle STELARA ontvang. DOSIS EN GEBRUIKSAANWYSINGS STELARA word deur subkutane inspuiting toegedien. Volwassenes (18-64 jaar): Die aanbevole dosis van STELARA is 45 mg, onderhuids toegedien by Weke 0 en 4; daarna elke 12 weke. Alternatiewelik kan 90 mg gebruik word by pasiënte wat meer as 100 kg weeg (kyk Farmakokinetiese eienskappe ). By pasiënte wat > 100 kg weeg, is 45 mg ook as doeltreffend bewys. Beter doeltreffendheid het egter by hierdie pasiënte gevolg op n 90 mg dosis. Daar kan oorweeg word om pasiënte wat onvoldoende reageer op 12 weeklikse dosisse, 8 weekliks te behandel. Page 21 of 28
22 Daar moet oorweeg word om behandeling te staak by pasiënte wat na 28 weke van behandeling geen respons getoon het nie. Herbehandeling: Daar is aangetoon dat herbehandeling, na onderbreking van terapie, met n doseringsregimen van weke 0 en 4 veilig en doeltreffend is. Bejaarde pasiënte ( 65 jaar): Dosis en toediening is dieselfde as by volwassenes, jaar oud. Kinders en adolessente (< 18 jaar oud): Die veiligheid en doeltreffendheid van STELARA is nie by hierdie ouderdomsgroep (< 18 jaar oud) ondersoek nie. STELARA word dus nie aanbeveel vir kinders jonger as 18 nie. Nier- en lewerinkorting: STELARA is nie by hierdie groep pasiënte ondersoek nie. Algemene oorwegings by toediening STELARA word aangedui vir gebruik onder die leiding en toesig van n dokter. n Pasiënt kan hom- of haarself inspuit met STELARA, indien n dokter vasstel of dit toepaslik is en na behoorlike opleiding in die tegniek van onderhuidse inspuiting. Kyk seksie Spesiale voorsorgmaatreëls vir wegdoening en ander hantering. Volledige aanwysings vir die toediening van STELARA word in die Inligtingspamflet vir die Pasiënt weergegee. Pasiënte moet ingelig word om die volle hoeveelheid STELARA in te spuit, volgens die aanwysings wat voorsien word onder die afdeling AANWYSINGS VIR TOEDIENING in die pasiëntinligtingspamflet. Die bedekking van die naald op die vooraf-gevulde spuit bestaan uit droë natuurlike rubber ( n derivaat van lateks), wat allergiese reaksies by enkelinge wat gevoelig is vir lateks kan veroorsaak. Spesiale voorsorgmaatreëls vir wegdoening en ander hantering Die oplossing in die STELARA-flessie moet voor onderhuidse toediening visueel geïnspekteer word vir deeltjies of verkleuring. Die produk is helder tot effens troebel, kleurloos tot liggeel en kan n paar deursigtige of wit proteïen-deeltjies bevat. Hierdie voorkoms is nie ongewoon vir proteïenagtige Page 22 of 28
23 oplossings nie. Die produk moet nie gebruik word indien die oplossing verkleur het of troebel voorkom nie, of as daar vreemde deeltjies teenwoordig is nie. STELARA bevat geen preserveermiddels nie, gevolglik moet enige ongebruikte deel van die produk wat in die flessie en die spuit agterbly nie gebruik word nie. Ongebruikte produk of afvalmateriaal moet volgens plaaslike vereistes weggedoen word. NEWE-EFFEKTE Die volgende ernstige ongunstige reaksies is tydens gekontroleerde kliniese navorsingstudies aangemeld: ernstige infeksies en maligniteite. Die mees algemene ongunstige reaksies (> 10 %) in gekontroleerde en nie-gekontroleerde dele van die psoriase kliniese studies met STELARA was nasofaringitis en boonste lugweginfeksie. Die meeste was as lig van aard beskou en was nie n rede om STELARA te staak nie. Tabel 1 verskaf n opsomming van Ongunstige Geneesmiddelreaksies uit psoriase kliniese navorsingstudies. Die ongunstige geneesmiddelreaksies word gerangskik volgens frekwensie, in ooreenstemming met die volgende gebruik: Baie algemeen ( 1/10); Algemeen ( 1/100, < 1/10); Ongewoon ( 1/1 000, <1/100); Seldsaam ( 1/10 000, <1/1 000); Baie seldsaam (< 1/10 000) Onbekend (kan nie uit beskikbare data bepaal word nie) Tabel 1 OPSOMMING VAN OGRs IN PSORIASE KLINIESE STUDIES Infeksies en infestasies Baie algemeen: Boonste lugweginfeksie, nasofaringitis Algemeen: Sellulitis, virusinfeksie van die boonste lugweg (pneumonie) en urienweginfeksies Ongewoon: Herpes zoster Psigiatriese afwykings Senuweestelsel afwykings Algemeen Depressie Algemeen Duiseligheid, hoofpyn Page 23 of 28
24 Respiratoriese, bors en Algemeen: Keel-strottehoofpyn, verstopte neus mediastinale afwykings Gastroïntestinale afwykings Vel en onderhuidse weefsel Algemeen Diarree, divertikulitis, gastroënteritis Algemeen Pruritus afwykings Muskuloskeletale, bindweefsel en been Algemeen: Rugpyn, mialgie en osteomiëlitis afwykings Algemene afwykings en toestande by die plek van toediening Algemeen: Moegheid, eriteem by die plek van inspuiting Ongewoon: Reaksies by die plek van inspuiting (waaronder pyn, swelling, pruritus, verharding, bloeding, kneusing en irritasie) Infeksies In gekontroleerde studies met psoriase pasiënte was die voorkomssyfers van infeksies of ernstige infeksies onder pasiënte wat met ustekinumab behandel was en diegene wat met plasebo behandel was, vergelykbaar. In die plasebo-gekontroleerde tydperk van die kliniese navorsingstudies oor psoriase pasiënte was die infeksiesyfer 1,39 per pasiënt-jaar van opvolg by pasiënte behandel met STELARA, en 1,21 by pasiënte behandel met plasebo. Ernstige infeksies het by 0,01 per pasiënt-jaar van opvolg by pasiënte behandel met STELARA (5 ernstige infeksies per 407 pasiënt-jare van opvolg) en 0,02 by pasiënte behandel met plasebo (3 ernstige infeksies per 177 pasiënt-jare van opvolg) voorgekom (kyk seksie Spesiale voorsorgmaatreëls, Infeksies ). In die gekontroleerde en nie-gekontroleerde gedeeltes van die kliniese navorsingstudies oor psoriase, was die infeksiesyfer 1,24 per pasiënt jaar van opvolg by pasiënte behandel met STELARA en die voorkomssyfer van ernstige infeksies was 0,01 per pasiënt jaar van opvolg by pasiënte behandel met STELARA (24 ernstige infeksies per pasiënt jare van opvolg) en sluit in sellulitis, divertikulitis, osteomiëlitis, virusinfeksies, gastroënteritis, pneumonie, en urienweginfeksies. In kliniese navorsingstudies het pasiënte met latente tuberkulose, wat gelyktydig met isoniasied behandel is, nie tuberkulose ontwikkel nie. Page 24 of 28
25 Maligniteite In die gekontroleerde tydperk van die 3 plasebo-gekontroleerde psoriase navorsingstudies, was die voorkoms van maligniteite, met uitsluiting van nie-melanoom velkanker, 0,25 per 100 pasiënt-jare van opvolg vir pasiënte wat met STELARA behandel is (1 pasiënt per 406 pasiënt-jare van opvolg) vergeleke met 0,57 vir plasebo-behandelde pasiënte (1 pasiënt per 177 pasiënt-jare van opvolg). Onder pasiënte wat behandel is in 4 psoriase kliniese proewe (mediane opvolg van 3,2 jaar) met STELARA (1 569 pasiënte wat behandel is vir ten minste 3 jaar, pasiënte vir ten minste 4 jaar en 838 pasiënte vir ten minste 5 jaar) was maligniteite, uitgesluit nie-melanoom velkanker, gerapporteer by 54 pasiënte per pasiënt-jare van opvolging (voorkoms van 0,60 per 100 pasiënt-jare van opvolg vir pasiënte wat met STELARA behandel is). Die maligniteite wat mees dikwels waargeneem is, behalwe nie-melanoom velkanker, was prostaat, melanoom, kolorektaal en bors. Die voorkoms van nie-melanoom velkanker was 0,52 per 100 pasiënt-jare van opvolg vir pasiënte wat met STELARA behandel is (47 pasiënte uit pasiëntjaar opvolg). (Kyk 'Waarskuwings en spesiale voorsorgmaatreëls, Maligniteite'). Hipersensitiwiteitsreaksies In die kliniese studies oor STELARA, is veluitslag en urtikarie elk waargeneem by < 2 % van die pasiënte. Immunogenisiteit Ongeveer 5 % van die pasiënte wat met STELARA behandel is, het teenliggaampies teen ustekinumab ontwikkel, oor die algemeen met lae titer. Geen duidelike korrelasie is waargeneem tussen teenliggaam ontwikkeling en reaksies by die plek van inspuiting nie. Die meeste van die pasiënte wat positief was vir teenliggaampies teen ustekinumab het neutraliserende teenliggaampies gehad. Pasiënte positief vir teenliggaampies teen ustekinumab het geneig om minder doeltreffendheid te ervaar, alhoewel teenliggaam-positiwiteit nie 'n kliniese respons uitsluit nie. Ervaring na bemarking Tabel 2 Verslae na bemarking Page 25 of 28
26 Immuunstelsel Hipersensitiwiteitsreaksies (insluitende uitslag, urtikarie) afwykings Ernstige hipersensitiwiteitsreaksies (insluitende anafilakse en angioedeem) Vel- en onderhuidse Eksfoliatiewe dermatitis, eritrodermiese psoriase weefsel afwykings BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VAN DIE BEHANDELING DAARVAN In geval van oordosering word daar aangeraai dat die pasiënt gemoniteer word vir tekens of simptome van ongunstige reaksies of effekte en dat toepaslike behandeling dadelik ingestel word. IDENTIFIKASIE Die oplossing is helder tot effens troebel, kleurloos tot liggeel. Die oplossing kan n paar klein deursigtige of wit proteïen-deeltjies bevat. AANBIEDING STELARA is beskikbaar as: - Enkeldosis vooraf-gevulde spuit: STELARA word verskaf as n steriele oplossing in n enkeldosis, helder, kleurlose Tipe 1 glasspuit met 'n gevestigde 27G, halfduim naald met 'n grys rubberskede. Die skede van die naald word vervaardig deur gebruik te maak van n droë natuurlike rubber ( n derivaat van lateks). Die spuit word verseël met n grys butielrubberprop met n kleurlose Flurotec - bedekking. Die spuit is toegerus met n passiewe veiligheidsbeskutting. STELARA word verpak in n karton, bevattende: - 1 enkeldosis flessie BERGINGSINSTRUKSIES Bewaar in 'n yskas (2-8 C). Hou die vooraf-gevulde spuit in die karton totdat dit benodig word vir gebruik, om dit teen lig te Page 26 of 28
27 beskerm. Moenie vries nie. Moenie skud nie. HOU BUITE BEREIK VAN KINDERS REGISTRASIENOMMER 43/30.1/0727 NAAM EN BESIGHEIDSADRES VAN DIE HOUER VAN DIE REGISTRASIESERTIFIKAAT JANSSEN PHARMACEUTICA (Pty) Ltd (Reg. No. 1980/011122/07) Gebou 6, Country Club Estate, Woodlandsrylaan 21, Woodmead, 2191 Tel: +27 (11) DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET Oktober 2015 Page 27 of 28
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