axatilimab-csfr (NIKTIMVO) Sterile Compounding
Immunological Agent | Monoclonal Antibody
Medication Information
| Field | Details |
|---|---|
| Generic Name | Axatilimab-csfr |
| Brand Name | NIKTIMVO™ |
| Dosage Form | Injection, preservative-free |
| Concentration | 50 mg/mL |
| Available Vials | 9 mg/0.18 mL • 22 mg/0.44 mL • 50 mg/mL single-dose vial |
| Route | Intravenous infusion |
| Infusion Time | 30 minutes |
| Dosing Frequency | Every 2 weeks |
| Storage (Undiluted) | Refrigerate 2–8°C (36–46°F); protect from light; Do NOT freeze or shake |
Indication
Chronic graft-versus-host disease (cGVHD) after failure of ≥2 prior systemic therapies in adult and pediatric patients ≥40 kg.
Prescribed Dose
| Parameter | Value |
|---|---|
| Weight (kg) | ______ |
| Dose (0.3 mg/kg) | ______ mg |
| Maximum Dose | 35 mg |
| Final Calculated Dose | ______ mg |
Volume to Withdraw
Each mL contains 50 mg.
| Calculated Volume | ______ mL |
|---|
⚠️ Use 1 mL syringe for precision when volume <1 mL.
Compounding Requirements
Engineering Controls
- ISO Class 5 PEC
- USP <797> compliant environment
Supplies
- NIKTIMVO single-dose vial
- 0.9% Sodium Chloride Injection
- Approved IV bag (PVC, Polyolefin, Polyolefin with polyamide, or EVA)
- 0.2-micron low protein-binding PES filter
- Sterile syringes and needles
- Alcohol pads
- Labels
Aseptic Preparation Procedure
☐ Perform hand hygiene and garbing per USP <797>
☐ Verify drug, dose, and patient
☐ Remove vial from refrigerator
☐ Visually inspect solution
• Slightly opalescent, pale brownish yellow
• Discard if cloudy, discolored, or visible particles
☐ Do NOT shake
☐ Withdraw calculated volume
☐ Inject into IV bag containing 0.9% Sodium Chloride
Final Concentration Requirement
Must be between 0.24 mg/mL to 0.75 mg/mL
☐ Gently invert to mix
☐ Do NOT shake
☐ Discard unused vial contents
Diluent & Final Volume
| Diluent | 0.9% Sodium Chloride Injection ONLY |
|---|---|
| Final Bag Volume | ______ mL |
| Final Concentration | ______ mg/mL |
Stability & Beyond-Use Time
If Used Immediately
- Infuse within 4 hours (includes infusion time)
If Refrigerated (2–8°C)
- Stable up to 24 hours
- Once removed → Must complete infusion within 4 hours
- Do NOT freeze
- Do NOT shake
Administration Instructions
☐ Dedicated IV line
☐ 0.2-micron PES in-line or add-on filter
☐ Infuse over 30 minutes
☐ Do NOT co-administer other medications in same line
☐ Flush with 0.9% Sodium Chloride after infusion
Monitoring Requirements
Baseline and periodic monitoring:
☐ AST
☐ ALT
☐ ALP
☐ CPK
☐ Amylase
☐ Lipase
Monitor every 2 weeks for first month.
Premedication (If Prior Infusion Reaction)
☐ Antihistamine
☐ Antipyretic
Labeling Requirements
Label must include:
- Patient name
- Drug name and dose (mg)
- Final concentration (mg/mL)
- Total volume (mL)
- Route (IV infusion over 30 minutes)
- Beyond-Use Date/Time
- Storage conditions
- “Do Not Shake”
- “Use 0.2-micron PES filter”
Safety Notes
⚠️ Risk of infusion-related reactions
⚠️ Embryo-fetal toxicity risk
⚠️ Single-dose vial — discard unused portion