Siltuximab for Treating Castleman’s Disease
Siltuximab injection is used to treat patients suffering from multicentric Castleman’s disease (MCD) in which the disease involves multiple lymph nodes or other distant tissues of the body.
Siltuximab must be prescribed only to patients who are having MCD, who are negative for Human Immunodeficiency Virus (HIV) and human herpesvirus-8 (HHV-8) negative.
• If there is an allergy or hypersensitivity to siltuximab.
• Patients who are positive to HIV and HHV-8.
• Pregnant and breastfeeding women.
• History of active infections.
• Children below 18 years of age.
Siltuximab is given in the dose of 11 mg/kg body weight over 1 hour. It is administered every 3 weeks unless there is a confirmation of treatment failure.
Blood tests should be performed regularly up to the first year of siltuximab treatment and thereafter every 3 dosing cycles.
The treatment with siltuximab can be withheld temporarily if any abnormalities in blood count are recorded. However, the dose reduction is not advised.
If a dose of siltuximab is skipped or missed, consult the doctor immediately.
Siltuximab should be given by an intravenous infusion or directly into the vein very slowly over 1 hour.
The dilution and preparation procedure should be done by a trained health care provider in a controlled sterile environment free from micro-organisms.
Siltuximab should be removed from the refrigerator and kept at room temperature for at least 30 minutes before preparing for administration.
Use sterile water for injection for dissolving siltuximab powder and dilute it with dextrose 5% solution. Gently invert the infusion bag for mixing.
Shaking or swirling the infusion bag rigorously should not be done.
It is necessary to inspect the vial and the diluted solution for the presence of any visible particles or discoloration before use.
The reconstituted product should not be kept for more than two hours before adding into the infusion bag.
The infusion should be completed within four hours from the time of dilution.
Do not infuse siltuximab with other agents through the same intravenous (IV) line to avoid unexpected chemical reactions.
•Siltuximab should not be given to patients with severe infections. •Proper antibiotic therapy should be provided and do not give siltuximab until the infection is resolved.
•Live vaccines should not be given to patients on siltuximab treatment because the vaccine may not work properly. •It is advised to have the vaccine immunization before starting the treatment with siltuximab.
•Immediately stop the infusion of siltuximab if a patient develops any allergic reactions.
•The treatment can be resumed at a lower dose and patients can be given allergy treating medications, fever-reducing pills, and steroids.
•Discontinue siltuximab infusion if the allergic reactions are very severe or life-threatening. Do not restart the treatment in such cases.
•Patients can develop stomach ulcer or intestinal bleeding with siltuximab treatment. Therefore, patients must be advised to consult the doctor if severe stomach pain or flatulence occurs to rule out the ulcer.
The most common side effects of siltuximab are weight gain, infection of the airways, skin rashes and pruritus (itching)
The other side effects are :
• Gastrointestinal: Constipation, decreased appetite, stomach pain
• Blood: Low platelet level, fluid accumulation, abnormal blood pressure, high level of uric acid, cholesterol, and triglycerides
• Nervous system: Headache
• Respiratory: Throat pain, cough, sneezing, nasal obstruction
• Others: Dry skin, skin hyperpigmentation, kidney damage
Female of childbearing potential are advised to avoid pregnancy by using an effective contraception during the treatment and continue for 3 months after the last infusion of siltuximab.
Patients must be advised to consult the doctor immediately if any new infection or worsening of the existing medical conditions occur.
It is necessary to evaluate the patient’s health status each time before a treatment cycle is given.
Siltuximab can affect the concentration of certain drugs that may result in either treatment failure or lead to toxicity, therefore should be avoided. The drugs include warfarin, cyclosporine, theophylline, atorvastatin, and oral contraceptives.
Siltuximab vial must be stored in the refrigerator at 2ºC to 8ºC (36ºF to 46ºF).
The vial should be protected from sunlight and excess moisture.
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