Leaflet PYZCHIVA 130mg concentrate for solution for infusion

Product code:: W70263001
Quantity:: 1
Indicated for:: autoimmune inflammatory diseases
Route of administration:: infusion
Substance:: ustekinumab (monoclonal antibody)
ATC: L04AC05 — Antineoplastic and immunomodulating agents | Immunosuppressants | Immunosuppressants | Interleukin inhibitors

Ustekinumab is a human monoclonal antibody used to treat autoimmune inflammatory diseases such as moderate-to-severe plaque psoriasis, psoriatic arthritis, and inflammatory bowel diseases like Crohn's disease and ulcerative colitis. It works by blocking interleukins IL-12 and IL-23, cytokines involved in inflammatory and autoimmune processes.

By inhibiting these cytokines, ustekinumab reduces inflammation and symptoms associated with these conditions, such as skin lesions, joint pain, diarrhea, and abdominal pain. It is administered as a subcutaneous injection or intravenous infusion, depending on the indication, according to a schedule determined by a healthcare provider.

Common side effects include upper respiratory tract infections, headaches, fatigue, and injection site reactions. Rarely, severe infections, allergic reactions, or an increased risk of certain cancers may occur.

Patients should inform their doctor about any other medical conditions or medications before starting ustekinumab. Regular monitoring is essential to assess the treatment's effectiveness and safety.

General data about PYZCHIVA 130mg

Substance:: ustekinumab
Date of latest medicines list:: 01-10-2026
Product code:: W70263001
Strength:: 130mg
Pharmaceutical form:: concentrate for solution for infusion
Quantity:: 1
Product type:: Generic medicine
Price:: 718.99 RON
Prescription status:: P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:: SAMSUNG BIOEPIS NL B.V. - TARILE DE JOS
Holder:: SAMSUNG BIOEPIS NL B.V. - TARILE DE JOS
Number:: 1801/2024/03
Shelf life:: 18 months-inainte de diluare

Pharmaceutical forms available for ustekinumab

Strengths available for ustekinumab

130mg
45mg/0.5ml
90mg/ml

Official documents

EMA product information (SmPC and leaflet)

Added to database:: 11/06/2024
Source record updated:: 03/07/2026

Warnings:

Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Additional monitoring

This medicine is subject to additional monitoring.

Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning

Use during pregnancy only on medical advice.

Summary of product characteristics for PYZCHIVA 130mg concentrate for solution for infusion

Summary of product characteristics for PYZCHIVA 130mg

1. NAME OF THE MEDICINAL PRODUCT

Pyzchiva 130 mg concentrate for solution for infusion

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each vial contains 130 mg ustekinumab in 26 mL (5 mg/mL).

Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin (IL)-12/23 produced in achinese hamster ovary (CHO) cell line using recombinant DNA technology.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Concentrate for solution for infusion.

The solution is clear, colourless to light yellow, and its formulated at pH 6.0 ± 0.3. The osmolality ofthe solution is 290 ± 30 mOsm/kg.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Adult Crohn’s Disease

Pyzchiva is indicated for the treatment of adult patients with moderately to severely active Crohn’sdisease who have had an inadequate response with, lost response to, or were intolerant to eitherconventional therapy or a TNFα antagonist.

Paediatric Crohn's Disease

Pyzchiva is indicated for the treatment of moderately to severely active Crohn’s disease in paediatricpatients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to eitherconventional or biologic therapy.

4.2 Posology and method of administration

Pyzchiva concentrate for solution for infusion is intended for use under the guidance and supervisionof physicians experienced in the diagnosis and treatment of Crohn's disease.

Pyzchiva concentrate for solution for infusion should only be used for the intravenous induction dose.

Posology

Adult

Crohn’s Disease

Pyzchiva treatment is to be initiated with a single intravenous dose based on body weight. Theinfusion solution is to be composed of the number of vials of Pyzchiva 130 mg as specified in Table 1(see section 6.6 for preparation).

Table 1: Initial intravenous dosing of Pyzchiva

Body weight of patient at the time of Recommended dosea Number of 130 mgdosing Pyzchiva Vials≤ 55 kg 260 mg 2> 55 kg to ≤ 85 kg 390 mg 3> 85 kg 520 mg 4a Approximately 6 mg/kg

The first subcutaneous dose should be given at week 8 following the intravenous dose. For theposology of the subsequent subcutaneous dosing regimen, see section 4.2 of the Pyzchiva solution forinjection (vial) and solution for injection in pre-filled syringe SmPC or pre-filled pen SmPC.

Elderly (≥ 65 years)

No dose adjustment is needed for elderly patients (see section 4.4).

Renal and Hepatic Impairment

Ustekinumab has not been studied in these patient populations. No dose recommendations can bemade.

Paediatric Population

Paediatric Crohn's disease (patients weighing at least 40 kg)

Table 2: Initial intravenous dosing of Pyzchiva

Body weight of patient at the time of Recommended dosea Number of 130 mgdosing Pyzchiva Vials≥ 40 kg to ≤ 55 kg 260 mg 2> 55 kg to ≤ 85 kg 390 mg 3> 85 kg 520 mg 4a Approximately 6 mg/kg

The safety and efficacy of ustekinumab for the treatment of Crohn’s disease in in paediatric patientsweighing less than 40 kg have not yet been established. No data are available.

Method of administration

Pyzchiva 130 mg is for intravenous use only. It should be administered over at least one hour. Forinstructions on dilution of the medicinal product before administration, see section 6.6.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Clinicallyimportant, active infection (e.g. active tuberculosis; see section 4.4).

4.4 Special warnings and precautions for use

Traceability

In order to improve the traceability of biological medicinal products, the tradename and the batchnumber of the administered product should be clearly recorded.

Infections

Ustekinumab may have the potential to increase the risk of infections and reactivate latent infections.

In clinical studies and a post-marketing observational study in patients with psoriasis, serious bacterial,fungal, and viral infections have been observed in patients receiving ustekinumab (see section 4.8).

Opportunistic infections including reactivation of tuberculosis, other opportunistic bacterial infections(including atypical mycobacterial infection, listeria meningitis, pneumonia legionella, andnocardiosis), opportunistic fungal infections, opportunistic viral infections (including encephalitiscaused by herpes simplex 2), and parasitic infections (including ocular toxoplasmosis) have beenreported in patients treated with ustekinumab.

Caution should be exercised when considering the use of ustekinumab in patients with a chronicinfection or a history of recurrent infection (see section 4.3).

Prior to initiating treatment with ustekinumab, patients should be evaluated for tuberculosis infection.

Ustekinumab must not be given to patients with active tuberculosis (see section 4.3). Treatment oflatent tuberculosis infection should be initiated prior to administering ustekinumab. Anti-tuberculosistherapy should also be considered prior to initiation of ustekinumab in patients with a history of latentor active tuberculosis in whom an adequate course of treatment cannot be confirmed. Patientsreceiving ustekinumab should be monitored closely for signs and symptoms of active tuberculosisduring and after treatment.

Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infectionoccur. If a patient develops a serious infection, the patient should be closely monitored andustekinumab should not be administered until the infection resolves.

Malignancies

Immunosuppressants like ustekinumab have the potential to increase the risk of malignancy. Somepatients who received ustekinumab in clinical studies and in a post-marketing observational study inpatients with psoriasis developed cutaneous and non-cutaneous malignancies (see section 4.8). Therisk of malignancy may be higher in psoriasis patients who have been treated with other biologicsduring the course of their disease

No studies have been conducted that include patients with a history of malignancy or that continuetreatment in patients who develop malignancy while receiving ustekinumab. Thus, caution should beexercised when considering the use of ustekinumab in these patients.

All patients, in particular those greater than 60 years of age, patients with a medical history ofprolonged immunosuppressant therapy or those with a history of PUVA treatment, should bemonitored for the appearance of skin cancer (see section 4.8).

Systemic and respiratory hypersensitivity reactions

Systemic

Serious hypersensitivity reactions have been reported in the postmarketing setting, in some casesseveral days after treatment. Anaphylaxis and angioedema have occurred. If an anaphylactic or otherserious hypersensitivity reaction occurs, appropriate therapy should be instituted and administration ofustekinumab should be discontinued (see section 4.8).

Infusion-Related Reactions

Infusion-related reactions were observed in clinical trials (see section 4.8). Serious infusion-relatedreactions including anaphylactic reactions to the infusion have been reported in the post-marketingsetting. If a serious or life-threatening reaction is observed, appropriate therapy should be institutedand ustekinumab should be discontinued.

Respiratory

Cases of allergic alveolitis, eosinophilic pneumonia, and non-infectious organising pneumonia havebeen reported during post-approval use of ustekinumab. Clinical presentations included cough,dyspnoea, and interstitial infiltrates following one to three doses. Serious outcomes have includedrespiratory failure and prolonged hospitalisation. Improvement has been reported after discontinuationof ustekinumab and also, in some cases, administration of corticosteroids. If infection has beenexcluded and diagnosis is confirmed, discontinue ustekinumab and institute appropriate treatment (seesection 4.8).

Cardiovascular events

Cardiovascular events including myocardial infarction and cerebrovascular accident have beenobserved in patients with psoriasis exposed to ustekinumab in a post-marketing observational study.

Risk factors for cardiovascular disease should be regularly assessed during treatment withustekinumab.

Vaccinations

It is recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and Guérin(BCG)) should not be given concurrently with ustekinumab. Specific studies have not been conductedin patients who had recently received live viral or live bacterial vaccines. No data are available on thesecondary transmission of infection by live vaccines in patients receiving ustekinumab. Before liveviral or live bacterial vaccination, treatment with ustekinumab should be withheld for at least 15 weeksafter the last dose and can be resumed at least 2 weeks after vaccination. Prescribers should consult the

Summary of Product Characteristics for the specific vaccine for additional information and guidanceon concomitant use of immunosuppressive agents post-vaccination.

Administration of live vaccines (such as the BCG vaccine) to infants exposed in utero to ustekinumabis not recommended for twelve months following birth or until ustekinumab infant serum levels areundetectable (see sections 4.5 and 4.6). 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 ustekinumabserum 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 topneumococcal polysaccharide or tetanus vaccines (see section 5.1).

Concomitant immunosuppressive therapy

In psoriasis studies, the safety and efficacy of ustekinumab in combination with immunosuppressants,including biologics, or phototherapy have not been evaluated. In psoriatic arthritis studies,concomitant MTX use did not appear to influence the safety or efficacy of ustekinumab. In Crohn’sdisease and ulcerative colitis studies, concomitant use of immunosuppressants or corticosteroids didnot appear to influence the safety or efficacy of ustekinumab. Caution should be exercised whenconsidering concomitant use of other immunosuppressants and ustekinumab or when transitioningfrom other immunosuppressive biologics (see section 4.5).

Immunotherapy

Ustekinumab has not been evaluated in patients who have undergone allergy immunotherapy. It is notknown whether ustekinumab may affect allergy immunotherapy.

Serious skin conditions

In patients with psoriasis, exfoliative dermatitis has been reported following ustekinumab treatment(see section 4.8). Patients with plaque psoriasis may develop erythrodermic psoriasis, with symptomsthat may be clinically indistinguishable from exfoliative dermatitis, as part of the natural course oftheir disease. As part of the monitoring of the patient’s psoriasis, physicians should be alert forsymptoms of erythrodermic psoriasis or exfoliative dermatitis. If these symptoms occur, appropriatetherapy should be instituted. ustekinumab should be discontinued if a drug reaction is suspected.

Lupus-related conditions

Cases of lupus-related conditions have been reported in patients treated with ustekinumab, includingcutaneous lupus erythematosus and lupus-like syndrome. If lesions occur, especially in sun exposedareas of the skin or if accompanied by arthralgia, the patient should seek medical attention promptly. Ifthe diagnosis of a lupus-related condition is confirmed, ustekinumab should be discontinued andappropriate treatment initiated.

Special populations
Elderly

No overall differences in efficacy or safety in patients age 65 and older who received ustekinumabwere observed compared to younger patients in clinical studies in approved indications, however thenumber of patients aged 65 and older is not sufficient to determine whether they respond differentlyfrom younger patients. Because there is a higher incidence of infections in the elderly population ingeneral, caution should be used in treating the elderly.

Sodium content

Ustekinumab contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.ustekinumab is however, diluted in sodium chloride 9 mg/mL (0.9%) solution for infusion. Thisshould be taken into consideration for patients on a controlled sodium diet (see section 6.6).

Polysorbate 80

Ustekinumab contains 10.4 mg of polysorbate 80 (E433) in each dosage unit which is equivalent to0.40 mg/mL. Polysorbates may cause allergic reactions.

4.5 Interaction with other medicinal products and other forms of interaction

Live vaccines should not be given concurrently with ustekinumab.

Administration of live vaccines (such as the BCG vaccine) to infants exposed in utero to ustekinumabis not recommended for twelve months following birth or until ustekinumab infant serum levels areundetectable (see sections 4.4 and 4.6). 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 ustekinumabserum levels are undetectable.

In the population pharmacokinetic analyses of the phase 3 studies, the effect of the most frequentlyused concomitant medicinal products in patients with psoriasis (including paracetamol, ibuprofen,acetylsalicylic acid, metformin, atorvastatin, levothyroxine) on pharmacokinetics of ustekinumab wasexplored. There were no indications of an interaction with these concomitantly administered medicinalproducts. The basis for this analysis was that at least 100 patients (> 5% of the studied population)were treated concomitantly with these medicinal products for at least 90% of the study period. Thepharmacokinetics of ustekinumab was not impacted by concomitant use of MTX, NSAIDs, 6-mercaptopurine, azathioprine and oral corticosteroids in patients with psoriatic arthritis, Crohn’sdisease or ulcerative colitis, or prior exposure to anti-TNFα agents, in patients with psoriatic arthritisor Crohn’s disease or by prior exposure to biologics (i.e. anti-TNFα agents and/or vedolizumab) inpatients with ulcerative colitis.

The results of an in vitro study and a phase 1 study in subjects with active Crohn’s disease do notsuggest the need for dose adjustments in patients who are receiving concomitant CYP450 substrates(see section 5.2).

4.6 Fertility, pregnancy and lactation

Women of childbearing potential

Women of childbearing potential should use effective methods of contraception during treatment andfor at least 15 weeks after treatment.

Pregnancy

Data from a moderate number of prospectively collected pregnancies following exposure toustekinumab with known outcomes, including more than 450 pregnancies exposed during the firsttrimester, do not indicate an increased risk of major congenital malformations in the newborn.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy,embryonic/foetal development, parturition or postnatal development (see section 5.3).

However, the available clinical experience is limited. As a precautionary measure, it is preferable toavoid the use of ustekinumab in pregnancy.

Ustekinumab crosses the placenta and has been detected in the serum of infants born to female patientstreated with ustekinumab during pregnancy. The clinical impact of this is unknown, however, the riskof infection in infants exposed in utero to ustekinumab may be increased after birth. Administration oflive vaccines (such as the BCG vaccine) to infants exposed in utero to ustekinumab is notrecommended for twelve months following birth or until ustekinumab infant serum levels areundetectable (see sections 4.4 and 4.5). 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 ustekinumabserum levels are undetectable.

Breast-feeding

Limited data from published literature suggests that ustekinumab is excreted in human breast milk invery small amounts. It is not known if ustekinumab is absorbed systemically after ingestion. Becauseof the potential for adverse reactions in nursing infants from ustekinumab, a decision on whether todiscontinue breast-feeding during treatment and up to 15 weeks after treatment or to discontinuetherapy with ustekinumab must be made taking into account the benefit of breast-feeding to the childand the benefit of ustekinumab therapy to the woman.

Fertility

The effect of ustekinumab on human fertility has not been evaluated (see section 5.3).

4.7 Effects on ability to drive and use machines

Ustekinumab has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Summary of the safety profile

The most common adverse reactions (> 5%) in controlled periods of the adult psoriasis, psoriaticarthritis, Crohn’s disease and ulcerative colitis clinical studies with ustekinumab were nasopharyngitisand headache. Most were considered to be mild and did not necessitate discontinuation of studytreatment. The most serious adverse reaction that has been reported for ustekinumab is serioushypersensitivity reactions including anaphylaxis (see section 4.4). The overall safety profile wassimilar for patients with psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

Tabulated list of adverse reactions

The safety data described below reflect exposure in adults to ustekinumab in 14 phase 2 and phase 3studies in 6,710 patients (4,135 with psoriasis and/or psoriatic arthritis, 1,749 with Crohn’s disease and826 patients with ulcerative colitis). This includes exposure to ustekinumab in the controlled and non-controlled periods of the clinical studies in patients with psoriasis, psoriatic arthritis, Crohn’s diseaseor ulcerative colitis for at least 6 months (4,577 patients) or at least 1 year (3,648 patients). 2,194patients with psoriasis, Crohn’s disease or ulcerative colitis were exposed for at least 4 years while1,148 patients with psoriasis or Crohn’s disease were exposed for at least 5 years.

Table 3 provides a list of adverse reactions from adult psoriasis, psoriatic arthritis, Crohn’s disease,and ulcerative colitis clinical studies as well as adverse reactions reported from post-marketingexperience. The adverse reactions are classified by System Organ Class and frequency, using thefollowing convention: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to< 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), not known (cannot be estimated fromthe available data). Within each frequency grouping, adverse reactions are presented in order ofdecreasing seriousness

Table 3: List of adverse reactions

System Organ Class Frequency: Adverse reaction

Infections and infestations Common: Upper respiratory tract infection, nasopharyngitis,sinusitis

Uncommon: Cellulitis, dental infections, herpes zoster, lowerrespiratory tract infection, viral upper respiratory tract infection,vulvovaginal mycotic infection

Immune system disorders Uncommon: Hypersensitivity reactions (including rash, urticaria)

Rare: Serious hypersensitivity reactions (including anaphylaxis,angioedema)

Psychiatric disorders Uncommon: Depression

Nervous system disorders Common: Dizziness, headache

Uncommon: Facial palsy

Respiratory, thoracic and Common: Oropharyngeal painmediastinal disorders Uncommon: Nasal congestion

Rare: Allergic alveolitis, eosinophilic pneumonia

Very rare: Organising pneumonia*

Gastrointestinal disorders Common: Diarrhoea, nausea, vomiting

Skin and subcutaneous tissue Common: Pruritusdisorders Uncommon: Pustular psoriasis, skin exfoliation, acne Rare:

Exfoliative dermatitis, hypersensitivity vasculitis Very rare:

Bullous pemphigoid, cutaneous lupus erythematosus

Musculoskeletal and Common: Back pain, myalgia, arthralgiaconnective tissue disorders Very rare: Lupus-like syndrome

General disorders and Common: Fatigue, injection site erythema, injection site painadministration site conditions Uncommon: Injection site reactions (including haemorrhage,haematoma, induration, swelling and pruritus), asthenia

*See section 4.4, Systemic and respiratory hypersensitivity reactions.

Description of selected adverse reactions Infections

In the placebo-controlled studies of patients with psoriasis, psoriatic arthritis, Crohn’s disease andulcerative colitis, the rates of infection or serious infection were similar between ustekinumab-treatedpatients and those treated with placebo. In the placebo-controlled period of these clinical studies, therate of infection was 1.36 per patient-year of follow-up in ustekinumab-treated patients, and 1.34 inplacebo-treated patients. Serious infections occurred at the rate of 0.03 per patient-year of follow-up inustekinumab-treated patients (30 serious infections in 930 patient-years of follow-up) and 0.03 inplacebo-treated patients (15 serious infections in 434 patient-years of follow-up) (see section 4.4).

In the controlled and non-controlled periods of psoriasis, psoriatic arthritis, Crohn’s disease andulcerative colitis clinical studies, representing 15,227 patient-years of ustekinumab exposure in 6,710patients, the median follow-up was 1.2 years; 1.7 years for psoriatic disease studies, 0.6 year for

Crohn’s disease studies, and 2.3 years for ulcerative colitis studies. The rate of infection was 0.85 perpatient-year of follow-up in ustekinumab-treated patients, and the rate of serious infections was 0.02per patient-year of follow-up in ustekinumab-treated patients (289 serious infections in 15,227 patient-years of follow-up) and serious infections reported included pneumonia, anal abscess, cellulitis,diverticulitis, gastroenteritis and viral infections.

In clinical studies, patients with latent tuberculosis who were concurrently treated with isoniazid didnot develop tuberculosis.

Malignancies

In the placebo-controlled period of the psoriasis, psoriatic arthritis, Crohn’s disease and ulcerativecolitis clinical studies, the incidence of malignancies excluding non-melanoma skin cancer was 0.11per 100 patient-years of follow-up for ustekinumab-treated patients (1 patient in 929 patient-years offollow-up) compared with 0.23 for placebo-treated patients (1 patient in 434 patient-years of follow-up). The incidence of non-melanoma skin cancer was 0.43 per 100 patient-years of follow-up forustekinumab-treated patients (4 patients in 929 patient-years of follow-up) compared to 0.46 forplacebo-treated patients (2 patients in 433 patient-years of follow-up).

In the controlled and non-controlled periods of psoriasis, psoriatic arthritis, Crohn’s disease andulcerative colitis clinical studies, representing 15,205 patient-years of ustekinumab exposure in 6,710patients, the median follow-up was 1.2 years; 1.7 years for psoriatic disease studies, 0.6 year for

Crohn’s disease studies and 2.3 years for ulcerative colitis studies. Malignancies excluding non-melanoma skin cancers were reported in 76 patients in 15,205 patient-years of follow-up (incidence of0.50 per 100 patient- years of follow-up for ustekinumab-treated patients). The incidence ofmalignancies reported in ustekinumab-treated patients was comparable to the incidence expected inthe general population (standardised incidence ratio = 0.94 [95% confidence interval: 0.73, 1.18],adjusted for age, gender and race). The most frequently observed malignancies, other than non-melanoma skin cancer, were prostate, melanoma colorectal, and breast cancers. The incidence of non-melanoma skin cancer was 0.46 per 100 patient-years of follow-up for ustekinumab-treated patients(69 patients in 15,165 patient-years of follow-up). The ratio of patients with basal versus squamouscell skin cancers (3:1) is comparable with the ratio expected in the general population (see section4.4).

Hypersensitivity and infusion reactions

In Crohn’s disease and ulcerative colitis intravenous induction studies, no events of anaphylaxis orother serious infusion reactions were reported following the single intravenous dose. In these studies,2.2% of 785 placebo-treated patients and 1.9% of 790 patients treated with the recommended dose ofustekinumab reported adverse events occurring during or within an hour of the infusion. Seriousinfusion-related reactions including anaphylactic reactions to the infusion have been reported in thepost-marketing setting (see section 4.4).

Paediatric population

Paediatric patients 6 years and older with plaque psoriasis

The safety of ustekinumab has been studied in two phase 3 studies of paediatric patients with moderateto severe plaque psoriasis. The first study was in 110 patients from 12 to 17 years of age treated for upto 60 weeks and the second study was in 44 patients from 6 to 11 years of age treated for up to 56weeks. In general, the adverse events reported in these two studies with safety data up to 1 year weresimilar to those seen in previous studies in adults with plaque psoriasis.

Paediatric patients weighing at least 40 kg with Crohn’s disease

The safety of ustekinumab has been studied in one phase 1 and one phase 3 study of paediatric patientswith moderately to severely active Crohn’s disease up to week 240 and week 52, respectively. Ingeneral, the safety profile in this cohort (n = 71) was similar to that seen in previous studies in adultswith Crohn’s disease.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. Itallows continued monitoring of the benefit/risk balance of the medicinal product. Healthcareprofessionals are asked to report any suspected adverse reactions via the national reporting systemlisted in Appendix V.

4.9 Overdose

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 orsymptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

5.2 Pharmacokinetic properties

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Histidine

Histidine hydrochloride monohydrate

Methionine

Disodium edetate

Sucrose

Polysorbate 80 (E 433)

Water for injections

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinalproducts. Pyzchiva should be diluted with sodium chloride 9 mg/mL (0.9%) solution for infusion.

Alternatively, a 250 mL infusion bag containing 0.45% Sodium Chloride Injection, USP may be used.

Pyzchiva should not be administered concomitantly in the same intravenous line with other medicinalproducts.

6.3 Shelf life

Before dilution42 months

Do not freeze.

Individual vials may be stored at room temperature up to 30°C for a maximum single period of up to35 days in the original carton in order to protect from light. Record the date when the vial is firstremoved from the refrigerator in the space provided on the outer carton. At any time before the end ofthis period, the product can be put back in the refrigerator once and kept there until the expiry date.

Discard the vial if not used after the maximum period of 35 days at room temperature storage or by theoriginal expiry date, whichever is earlier.

After dilution

Chemical and physical in-use stability has been demonstrated for up to 72 hours at 30°C. If necessary,the diluted infusion solution may be kept at 2 °C to 8 °C for up to 1 month and at room temperature upto 30°C for an additional 72 hours after removal from refrigeration including the infusion period.

From a microbiological point of view, the infusion solution should be administered immediately. If notused immediately, in-use storage times and conditions prior to use are the responsibility of the userand would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place incontrolled and validated aseptic conditions.

6.4 Special precautions for storage

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the vial in the outer carton in order to protect from light.

For storage conditions after dilution of the medicinal product, see section 6.3.

6.5 Nature and contents of container

26 mL solution in a type I glass 30 mL vial closed with a chlorobutyl rubber stopper. Pyzchiva isavailable in packs of 1 or 3 vials or multipack containing 3 (3 packs of 1) vials.

Not all pack sizes may be marketed

6.6 Special precautions for disposal and other handling

The solution in the Pyzchiva vial should not be shaken. The solution should be visually inspected forparticulate matter or discoloration prior to administration. The solution is clear, colourless to lightyellow. The medicinal product should not be used if the solution is discoloured or cloudy, or if foreignparticulate matter is present.

Dilution

Pyzchiva concentrate for solution for infusion must be diluted and prepared by a healthcareprofessional using aseptic technique.

1. Calculate the dose and the number of Pyzchiva vials needed based on patient weight (seesection 4.2, Table 1). Each 26 mL vial of Pyzchiva contains 130 mg of ustekinumab. Onlyuse complete vials of Pyzchiva.

2. Withdraw and discard a volume of the sodium chloride 9 mg/mL (0.9%) solution fromthe 250 mL infusion bag equal to the volume of Pyzchiva to be added. (discard 26 mLsodium chloride for each vial of Pyzchiva needed, for 2 vials-discard 52 mL, for 3 vials-discard 78 mL, for 4 vials- discard 104 mL). Alternatively, a 250 mL infusion bagcontaining 0.45% Sodium Chloride Injection, USP may be used.

3. Withdraw 26 mL of Pyzchiva from each vial needed and add it to the 250 mL infusionbag. The final volume in the infusion bag should be 250 mL. Gently mix.

4. Visually inspect the diluted solution before administration. Do not use if visiblyopaque particles, discoloration or foreign particles are observed.

5. Administer the diluted solution over a period of at least one hour. Once diluted, the infusionshould be completed within 72 hours at room temperature up to 30°C of the dilution in theinfusion bag. If necessary, the diluted infusion solution may be kept at 2°C to 8°C for up to1 month and at room temperature up to 30°C for an additional 72 hours after removal fromrefrigeration including the infusion period.

6. Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (poresize 0.2 micrometer).

7. Each vial is for single use only and any unused medicinal product should be disposed ofin accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Samsung Bioepis NL B.V.

Olof Palmestraat 102616 LR Delft

The Netherlands

8. MARKETING AUTHORISATION NUMBER(S)

EU/1/24/1801/003

EU/1/24/1801/006

EU/1/24/1801/008

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 19 April 2024

10. DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines

Agency https://www.ema.europa.eu.

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Reimbursement lists for PYZCHIVA 130mg Samsung Bioepis

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