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Wezlana

Wezlana

ustekinumab

Manufacturer:

Amgen

Distributor:

Zuellig
Concise Prescribing Info
Contents
Ustekinumab
Indications/Uses
Moderate to severe plaque psoriasis in adults who failed to respond to, or have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, MTX or PUVA. Alone or in combination w/ MTX for active psoriatic arthritis in adults when response to previous non-biological DMARD therapy has been inadequate.
Dosage/Direction for Use
Initially 45 mg SC, followed by 45-mg dose 4 wk later, & then every 12 wk thereafter. Patient weighing >100 kg Initially 90 mg SC, followed by 90-mg dose 4 wk later, & then every 12 wk thereafter.
Contraindications
Hypersensitivity. Clinically important, active infection (eg, active TB).
Special Precautions
Avoid areas of the skin that show psoriasis as inj sites. Discontinue administration if an anaphylactic or other serious hypersensitivity reaction occurs. Potential to increase risk of infections & reactivate latent infections. Caution in patients w/ chronic infection or history of recurrent infection. Evaluate for TB infection prior to treatment initiation. Consider anti-TB therapy prior to initiation of Wezlana in patients w/ history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor for signs & symptoms of active TB during & after treatment. Potential to increase risk of malignancy. Caution in patients w/ history of malignancy or patients who develop malignancy while receiving ustekinumab. Monitor for appearance of skin cancer, particularly in patients >60 yr, patients w/ medical history of prolonged immunosuppressant therapy or those w/ history of PUVA treatment; systemic & resp hypersensitivity reactions including anaphylaxis, angioedema, alveolitis, eosinophilic pneumonia, & non-infectious organising pneumonia. Regularly assess risk factors for CV disease during treatment. Monitor for symptoms of erythrodermic psoriasis or exfoliative dermatitis. Discontinue treatment if diagnosis of a lupus-related condition is confirmed. Before live viral or live bacterial vaccination, Wezlana treatment should be withheld for at least 15 wk after the last dose & can be resumed at least 2 wk after vaccination. Caution when considering concomitant use w/ other immunosuppressants or when transitioning from other immunosuppressive biologics. Has not been evaluated in patients who have undergone allergy immunotherapy. Has not been studied in patients w/ renal & hepatic impairment. Women of childbearing potential should use effective contraception during treatment & for at least 15 wk after treatment. Preferable to avoid use in pregnancy. Administration of live vaccines to infants exposed in utero to ustekinumab is not recommended for 12 mth following birth or until ustekinumab infant serum levels are undetectable. Discontinue breast-feeding during treatment & up to 15 wk after treatment, or discontinue Wezlana therapy. Safety & efficacy of ustekinumab in childn w/ psoriasis <6 yr or in childn w/ psoriatic arthritis <18 yr have not yet been established.
Adverse Reactions
URTI, nasopharyngitis, sinusitis; dizziness, headache; oropharyngeal pain; diarrhoea, nausea, vomiting; pruritus; back pain, myalgia, arthralgia; fatigue, inj site erythema, inj site pain.
Drug Interactions
Live vaccines should not be given concurrently w/ Wezlana. Safety & efficacy of ustekinumab in combination w/ immunosuppressants, including biologics, or phototherapy have not been evaluated.
MIMS Class
Immunosuppressants
ATC Classification
L04AC05 - ustekinumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Wezlana soln for inj 45 mg/0.5 mL
Packing/Price
1's
Form
Wezlana soln for inj 90 mg/1 mL
Packing/Price
1's
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