Active Ingredient: Obinutuzumab
Obinutuzumab in combination with mycophenolate mofetil (MMF) is indicated for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis (LN).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 1,000 milligrams obinutuzumab, one dose, over the duration of 2 weeks. Afterwards, intravenous, 1,000 milligrams obinutuzumab, one dose, over the duration of 22 weeks. Afterwards, intravenous, 1,000 milligrams obinutuzumab, one dose, over the duration of 2 weeks. Afterwards, intravenous, 1,000 milligrams obinutuzumab, one dose, over the duration of 6 months. Afterwards, intravenous, 1,000 milligrams obinutuzumab, once every 6 months.
The recommended dosage of obinutuzumab is 1 000 mg administered intravenously. Obinutuzumab should be used in combination with mycophenolate mofetil.
Dose of obinutuzumab for patients with Lupus Nephritis:
| Dose number | Timing of treatment | Dose |
|---|---|---|
| 1 | Initial infusion | 1 000 mg |
| 2 | Week 2 (two weeks after Dose 1) | 1 000 mg |
| 3 | Week 24 | 1 000 mg |
| 4 | Week 26 (two weeks after Dose 3) | 1 000 mg |
| 5* and thereafter | Every 6 months | 1 000 mg |
* Dose 5 should be administered six months after Dose 4
The patient's condition and response should be evaluated at Week 76 and beyond, and an appropriate risk-benefit analysis should be made for continuation of therapy.
If a planned dose of obinutuzumab is missed, it should be administered as soon as possible - do not wait until the next planned dose. The schedule of administration should be adjusted to maintain the appropriate interval between doses.
No dose reductions of obinutuzumab are recommended.
Obinutuzumab should be given as an intravenous infusion through a dedicated line after dilution. Obinutuzumab infusions should not be administered as an intravenous push or bolus.
The initial obinutuzumab infusion should be administered at the standard infusion rate.
Lupus nephritis: Standard infusion rate:
| Dose number | Timing of treatment | Rate of infusion |
|---|---|---|
| 1 | Initial infusion (1 000 mg) | Administer at a rate of 50 mg/hr. The rate of infusion can be escalated in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. For management of IRRs that occur during infusion, refer to Management of IRRs. |
| 2 | Week 2 - two weeks after Dose 1 (1 000 mg) | Administer at a rate of 100 mg/hr. The rate of infusion can be escalated at a rate of 100 mg/hr every 30 minutes to a maximum of 400 mg/hr. |
| 3 | Week 24 (1 000 mg) | |
| 4 | Week 26 - two weeks after Dose 3 (1 000 mg) | |
| 5* and thereafter | Every 6 months (1 000 mg) |
* Dose 5 should be administered six months after Dose 4
Management of IRRs may require temporary interruption, reduction in the rate of infusion, or treatment discontinuations of obinutuzumab as outlined below:
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.