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Spevigo

Spevigo

spesolimab

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Concise Prescribing Info
Contents
Spesolimab
Indications/Uses
Generalized pustular psoriasis (GPP) flares in adults.
Dosage/Direction for Use
IV 900 mg infusion over 90 min as a single dose. May administer additional 900 mg 1 wk after initial dose if flare symptoms persist.
Contraindications
Severe or life-threatening hypersensitivity.
Special Precautions
Hypersensitivity & infusion-related reactions may occur. Immediately discontinue use & initiate appropriate treatment if patient develops signs of anaphylaxis or other serious hypersensitivity. Stop treatment & consider appropriate medical therapy (eg, systemic antihistamines &/or corticosteroids) if patient develops mild or moderate infusion-related reaction. May increase risk of infections. Consider potential risks & expected clinical benefits of treatment prior to prescribing in patients w/ chronic infection or history of recurrent infection. Not to be initiated in patients w/ any clinically important active infection until infection resolves or is adequately treated. Evaluate patients for TB infection prior to treatment initiation. Not to be administered to patients w/ active TB infection. Consider anti-TB therapy prior to treatment initiation in patients w/ latent or history of TB in whom adequate treatment course cannot be confirmed; monitor signs & symptoms of active TB after treatment. At least 4 wk interval between live vaccinations & Spevigo initiation. Do not administer live vaccines for at least 16 wk after Spevigo. Potential peripheral neuropathy. Contains Na <1 mmol/900 mg dose. Renal &/or hepatic impairment. Pregnancy & lactation. Childn <18 yr. Elderly ≥65 yr.
Adverse Reactions
UTI, URTI; pruritus; inj site reactions, fatigue.
Drug Interactions
Not to be given concurrently w/ live vaccines.
MIMS Class
Immunosuppressants
ATC Classification
L04AC22 - spesolimab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Spevigo conc for soln for infusion 450 mg/7.5 mL
Packing/Price
2 × 1's
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