Lumasiran
Generic Name: lumasiran
Brand Names:
Oxlumo
11 DESCRIPTION OXLUMO injection contains lumasiran, a HAO1 -directed double-stranded small interfering ribonucleic acid (siRNA), covalently linked to a ligand containing N- acetylgalactosamine (GalNAc). The structural formula of lumasiran sodium is presented below: The molecular formula of lumasiran sodium is C 530 H 669 F 10 N 173 O 320 P 43 S 6 Na 43 and the molecular weight is 17,286 Da.
Overview
11 DESCRIPTION OXLUMO injection contains lumasiran, a HAO1 -directed double-stranded small interfering ribonucleic acid (siRNA), covalently linked to a ligand containing N- acetylgalactosamine (GalNAc). The structural formula of lumasiran sodium is presented below: The molecular formula of lumasiran sodium is C 530 H 669 F 10 N 173 O 320 P 43 S 6 Na 43 and the molecular weight is 17,286 Da.
Uses
1 INDICATIONS AND USAGE OXLUMO is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients [see Clinical Pharmacology (12.1) , Clinical Studies (14.1 , 14.2 , 14.3) ] . OXLUMO is a HAO1 -directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION The recommended dose of OXLUMO by subcutaneous injection is based on body weight. ( 2.1 ) Body Weight Loading Dose Maintenance Dose less than 10 kg 6 mg/kg once monthly for 3 doses 3 mg/kg once monthly, beginning 1 month after the last loading dose 10 kg to less than 20 kg 6 mg/kg once monthly for 3 doses 6 mg/kg once every 3 months (quarterly), beginning 1 month after the last loading dose 20 kg and above 3 mg/kg once monthly for 3 doses 3 mg/kg once every 3 months (quarterly), beginning 1 month after the last loading dose See Full Prescribing Information for important preparation and administration instructions.
Side Effects
6 ADVERSE REACTIONS The most common adverse reaction (reported in ≥20% of patients) is injection site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alnylam Pharmaceuticals at 1-877-256-9526 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of OXLUMO has been evaluated in a placebo-controlled trial and two single-arm clinical trials. Across these trials, 98 patients with PH1 have been treated with OXLUMO, including 71 pediatric patients and 15 patients on hemodialysis.
Warnings
4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary There are no available data with the use of OXLUMO in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. No adverse effects on pregnancy or embryo-fetal development related to OXLUMO were observed in rats at 45 times and in rabbits at 90 times the maximum recommended human dose in women (see Data ). The estimated background risk of major birth defects and miscarriage in the indicated population is unknown.
Storage
16.2 Storage and Handling Store at 2°C to 25°C [36°F to 77°F]. Store OXLUMO in its original container until ready for use.
Frequently Asked Questions
What is Lumasiran used for?▼
1 INDICATIONS AND USAGE OXLUMO is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients [see Clinical Pharmacology (12.1) , Clinical Studies (14.1 , 14.2 , 14.3) ] . OXLUMO is a HAO1 -directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients. ( 1 )
What are the side effects of Lumasiran?▼
6 ADVERSE REACTIONS The most common adverse reaction (reported in ≥20% of patients) is injection site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alnylam Pharmaceuticals at 1-877-256-9526 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of OXLUMO has been evaluated in a placebo-controlled trial and two single-arm clinical trials. Across these trials, 98 patients with PH1 have been treated with OXLUMO, including 71 pediatric patients and 15 patients on hemodialysis.
Can I take Lumasiran during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data with the use of OXLUMO in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. No adverse effects on pregnancy or embryo-fetal development related to OXLUMO were observed in rats at 45 times and in rabbits at 90 times the maximum recommended human dose in women (see Data ). The estimated background risk of major birth defects and miscarriage in the indicated population is unknown.
What are the important warnings for Lumasiran?▼
4 CONTRAINDICATIONS None. None. ( 4 )
Related Medications
Armodafinil
armodafinil
11 DESCRIPTION Armodafinil tablets are a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is R-(-)-2-[(Diphenylmethyl)sulfinyl]acetamide. The molecular formula is C 15 H 15 NO 2 S and the molecular weight is 273.35.
Azadirachta Indica, Apis Mellifica, Calendula, Echinacea Purpurea, Okoubaka Aubrevillei, Phosphorous, Plantago Major, Strontium, Thuja Occidentalis
azadirachta indica, apis mellifica, calendula, echinacea purpurea, okoubaka aubrevillei, phosphorous, plantago major, strontium, thuja occidentalis
Standardized Insect Venom Allergenic Extract [EPC]
Purpose Active Ingredient Purpose Azadirachta indica Antigingivitis, swelling Apis mellifica Soothing, healing Calendula Antiseptic Echinacea purpurea Antiseptic Okoubaka aubrevillei Soothing, healing Phosphorous Analgesic Plantago major Antiseptic Strontium Analgesic Thuja occidentalis Analgesic, soothing
Supreh Arnica Remedy Plus Bruise Cream
supreh arnica remedy plus bruise cream
Purpose Reduces pain, swelling, and discoloration from bruises
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.