Spevigo (specolizumab)

Adult dosage

This medication should be administered as a single intravenous infusion of 900 mg (2 vials of 450 mg/7.5 mL). If exacerbation symptoms persist, an additional 900 mg of this medication may be given one week after the initial dose. This medication must be diluted before use.

This medication should not be used in patients who have had serious allergic reactions to the active ingredient or excipients. It is important not to initiate this medication in patients with active infections until the infection is fully treated. This medication may increase the risk of infections, so patients with a history of chronic or recurrent infections should carefully consider the risks and benefits before treatment. Tuberculosis infection must be evaluated before initiating treatment, and this drug should not be administered to patients with active tuberculosis. Care should be taken as immediate severe allergic reactions such as anaphylaxis or reactions at the injection site, including pain and rash, may occur while using this medication. Injection site reactions are usually mild to moderate, and fatigue is commonly reported as well. This medication can affect the immune system, potentially leading to antibody formation, which may decrease the effectiveness of the drug or result in allergic reactions. Use of this medication is not recommended during pregnancy, and breastfeeding women should consider stopping breastfeeding or discontinuing drug therapy. Safety and efficacy in children under 18 years have not been established. Elderly patients do not typically require special dose adjustments, but data on this group is limited. Generally, patients with impaired renal or liver function do not require adjustments in dosage either. There is no specific experience for overdose treatment; however, adverse reactions should be closely monitored and treated according to symptoms. This drug does not significantly affect driving or operating machinery. When administered, it should be infused slowly intravenously over 90 minutes; if any adverse reactions occur during infusion, it should be stopped immediately and appropriate treatment should be provided. This drug should not be used in conjunction with live vaccines, and it should only be used at least 4 weeks after live vaccine administration, while live vaccine administration should be avoided during treatment. Storage should be in a sealed container to avoid exposure to air. Additionally, it should be stored between 2 to 8 degrees Celsius in a dark place, avoiding direct sunlight. It must not be frozen, as maintaining the correct temperature and environment is crucial for preserving the medication's efficacy.

Serious side effects

Severe or life-threatening hypersensitivity reactions (including anaphylaxis), severe infections (including urinary tract infections), urticaria, severe swelling (edema), chest tightness, difficulty breathing, sweating, pallor, severe allergic reactions, severe skin reactions, severe edema, respiratory issues, systemic hypersensitivity reactions, anaphylactic reactions, severe edema accompanied by elevated blood pressure, drug reactions with systemic symptoms (DRESS)

Mild side effects

Urinary tract infections, upper respiratory infections, pruritus, various injection site reactions (erythema, swelling, pain, induration, warmth, desquamation, papules, itching, rash, urticaria), fatigue, potential for peripheral neuropathy, infusion-related reactions (mild to moderate hypersensitivity reactions)

This medication should be stored in a sealed container to prevent exposure to air. Additionally, it should be kept at a refrigerated temperature between 2 to 8 degrees Celsius and placed in a dark area to protect it from direct light. It must not be frozen, and storing it under proper temperature and environmental conditions is important for maintaining its efficacy.

Appearance

A sterile solution filled in a colorless glass vial, transparent to slightly opaque, with a colorless to slightly yellowish solution.

Package unit

2 vials/box [7.5 mL/1 vial]