Active Ingredient: Rituximab
Rituximab is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 1,000 milligrams rituximab, one dose, over the duration of 2 weeks. Afterwards, intravenous, 1,000 milligrams rituximab, one dose, over the duration of 12 months. Afterwards, intravenous, 500 milligrams rituximab, one dose, over the duration of 6 months. Afterwards, intravenous, 500 milligrams rituximab, one dose.
Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of rituximab.
In patients with pemphigus vulgaris, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to each infusion of rituximab to decrease the incidence and severity of infusion related reactions (IRRs).
Pneumocystis jirovecii pneumonia (PJP) prophylaxis is recommended for adult patients with PV during and following rituximab treatment, as appropriate according to local clinical practice guidelines.
Patients treated with rituximab must be given the patient alert card with each infusion.
The recommended dosage of rituximab for the treatment of pemphigus vulgaris is 1000 mg administered as an intravenous infusion followed two weeks later by a second 1000 mg intravenous infusion in combination with a tapering course of glucocorticoids.
A maintenance infusion of 500 mg intravenous should be administered at months 12 and 18, and then every 6 months thereafter if needed, based on clinical evaluation.
In the event of relapse, patients may receive 1000 mg intravenous. The healthcare provider should also consider resuming or increasing the patient’s glucocorticoid dose based on clinical evaluation.
Subsequent infusions may be administered no sooner than 16 weeks following the previous infusion.
The prepared rituximab solution should be administered as an intravenous infusion through a dedicated line. It should not be administered as an intravenous push or bolus.
Patients should be closely monitored for the onset of cytokine release syndrome. Patients who develop evidence of severe reactions, especially severe dyspnoea, bronchospasm or hypoxia should have the infusion interrupted immediately. The infusion should not be restarted until complete resolution of all symptoms, and normalisation of laboratory values and chest X-ray findings. At this time, the infusion can be initially resumed at not more than one-half the previous rate. If the same severe adverse reactions occur for a second time, the decision to stop the treatment should be seriously considered on a case by case basis.
Mild or moderate infusion-related reactions (IRRs) usually respond to a reduction in the rate of infusion. The infusion rate may be increased upon improvement of symptoms.
The recommended initial rate for infusion is 50 mg/h; after the first 30 minutes, it can be escalated in 50 mg/h increments every 30 minutes, to a maximum of 400 mg/h.
Subsequent doses of rituximab can be infused at an initial rate of 100 mg/h, and increased by 100 mg/h increments at 30 minute intervals, to a maximum of 400 mg/h.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.
