Remsima
Remsima is a biosimilar monoclonal antibody that contains the active substance infliximab. It targets and binds to tumor necrosis factor-alpha (TNF-alpha), a protein involved in inflammation, thereby suppressing the immune response and reducing the symptoms and progression of autoimmune inflammatory diseases.
Dosage by Body Weight
Remsima is prescribed and administered under the supervision of a specialist. Intravenous (IV) dosing is weight-based (usually 3 mg/kg or 5 mg/kg) administered at 0, 2, and 6 weeks, followed by maintenance infusions every 8 weeks. Subcutaneous (SC) dosing is usually a fixed 120 mg injection every 2 weeks after initial IV induction.
- Body Weight
- Below 5 kg
- Dose
- Not recommended
- Frequency
- N/A
- Tracking Notes
- Safety and efficacy have not been established in patients weighing less than 5 kg.
- Body Weight
- 5-7 kg
- Dose
- Not recommended
- Frequency
- N/A
- Tracking Notes
- Typically not recommended for children in this weight bracket unless specifically prescribed by a pediatric specialist for approved indications.
- Body Weight
- 8-10 kg
- Dose
- 24 mg to 50 mg (based on 3-5 mg/kg)
- Frequency
- Weeks 0, 2, and 6, then every 8 weeks
- Tracking Notes
- Administered via intravenous infusion. Primarily indicated for pediatric Crohn's disease or ulcerative colitis in children aged 6 years and older.
- Body Weight
- 11-15 kg
- Dose
- 33 mg to 75 mg (based on 3-5 mg/kg)
- Frequency
- Weeks 0, 2, and 6, then every 8 weeks
- Tracking Notes
- Intravenous infusion administered over approximately 2 hours under medical supervision to monitor for infusion-related reactions.
- Body Weight
- 16-20 kg
- Dose
- 48 mg to 100 mg (based on 3-5 mg/kg)
- Frequency
- Weeks 0, 2, and 6, then every 8 weeks
- Tracking Notes
- Dose must be calculated exactly based on body weight on the day of infusion.
| Body Weight | Dose | Frequency | Tracking Notes |
|---|---|---|---|
| Below 5 kg | Not recommended | N/A | Safety and efficacy have not been established in patients weighing less than 5 kg. |
| 5-7 kg | Not recommended | N/A | Typically not recommended for children in this weight bracket unless specifically prescribed by a pediatric specialist for approved indications. |
| 8-10 kg | 24 mg to 50 mg (based on 3-5 mg/kg) | Weeks 0, 2, and 6, then every 8 weeks | Administered via intravenous infusion. Primarily indicated for pediatric Crohn's disease or ulcerative colitis in children aged 6 years and older. |
| 11-15 kg | 33 mg to 75 mg (based on 3-5 mg/kg) | Weeks 0, 2, and 6, then every 8 weeks | Intravenous infusion administered over approximately 2 hours under medical supervision to monitor for infusion-related reactions. |
| 16-20 kg | 48 mg to 100 mg (based on 3-5 mg/kg) | Weeks 0, 2, and 6, then every 8 weeks | Dose must be calculated exactly based on body weight on the day of infusion. |
Formulation
Purpose
Used to treat inflammatory diseases such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
Generic Name
InfliximabScheduled Drug
Yes. This medicine should be supplied or used only according to applicable prescription and regulatory requirements.