DOSAGE AND ADMINISTRATION
Recommended Dosage Regimen
- Do not administer as an intravenous push or bolus.
- Premedicate before each infusion [see Dosage and Administration].
- Administer with in-line filter supplied with product.
The recommended dose and schedule is 12 doses administered as follows:
- 300 mg initial dose (Dose 1), followed 1 week later by
- 2,000 mg weekly for 7 doses (Doses 2 through 8), followed 4 weeks later by
- 2,000 mg every 4 weeks for 4 doses (Doses 9 through 12)
Administration
Prepare all doses in 1,000 mL of 0.9% Sodium Chloride Injection, USP [see Dosage and Administration].
- Dose 1: Initiate infusion at a rate of 3.6 mg/hour (12 mL/hour).
- Dose 2: Initiate infusion at a rate of 24 mg/hour (12 mL/hour).
- Doses 3 through 12: Initiate infusion at a rate of 50 mg/hour (25 mL/hour).
In the absence of infusional toxicity, the rate of infusion may be increased every 30 minutes as described in Table 1. Do not exceed the infusion rates in Table 1.
Table 1. Infusion Rates for ARZERRA
|
Interval After Start of Infusion
(min) |
Dose 1a
(mL/hour) |
Dose 2b
(mL/hour) |
Doses 3 - 12b
(mL/hour) |
| 0 - 30 |
12 |
12 |
25 |
| 31 - 60 |
25 |
25 |
50 |
| 61 - 90 |
50 |
50 |
100 |
| 91 - 120 |
100 |
100 |
200 |
| >120 |
200 |
200 |
400 |
|
a Dose 1 = 300 mg (0.3 mg/mL) |
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b Doses 2 and 3 - 12 = 2,000 mg (2 mg/mL) |
Dose Modification
- Interrupt infusion for infusion reactions of any severity [see Warnings and Precautions].
- For Grade 4 infusion reactions, do not resume the infusion.
- For Grade 1, 2, or 3 infusion reaction, if the infusion reaction resolves or remains less than or equal to Grade 2, resume infusion with the following modifications according to the initial Grade of the infusion reaction.
-
Grade 1 or 2: Infuse at one-half of the previous infusion rate.
-
Grade 3: Infuse at a rate of 12 mL/hour.
After resuming the infusion, the infusion rate may be increased according to Table 1 above, based on patient tolerance.
Premedication
- Premedicate 30 minutes to 2 hours prior to each dose with oral acetaminophen 1,000 mg (or equivalent), oral or intravenous antihistamine (cetirizine 10 mg or equivalent), and intravenous corticosteroid (prednisolone 100 mg or equivalent).
- Do not reduce corticosteroid dose for Doses 1, 2, and 9.
- Corticosteroid dose may be reduced as follows for Doses 3 through 8 and 10 through 12:
- Doses 3 through 8: Gradually reduce corticosteroid dose with successive infusions if a Grade 3 or greater infusion reaction did not occur with the preceding dose.
- Doses 10 through 12: Administer prednisolone 50 mg to 100 mg or equivalent if a Grade 3 or greater infusion reaction did not occur with Dose 9.
Preparation and Administration
- Do not shake product.
- Inspect parenteral drug products visually for particulate matter and discoloration prior to administration. ARZERRA should be a colorless solution and may contain a small amount of visible translucent-to-white, amorphous, ofatumumab particles. The solution should not be used if discolored or cloudy, or if foreign particulate matter is present.
Preparation of Solution:
- 300-mg dose: Withdraw and discard 15 mL from a 1,000-mL polyolefin bag of 0.9% Sodium Chloride Injection, USP. Withdraw 5 mL from each of 3 vials of ARZERRA and add to the bag. Mix diluted solution by gentle inversion.
- 2,000-mg dose: Withdraw and discard 100 mL from a 1,000-mL bag of 0.9% Sodium Chloride Injection, USP. Withdraw 5 mL from each of 20 vials of ARZERRA and add to the bag. Mix diluted solution by gentle inversion.
- Store diluted solution between 2° to 8°C (36° to 46°F).
Administration Instructions:
- Do not mix ARZERRA with, or administer as an infusion with, other medicinal products.
- Administer using an infusion pump, the in-line filter provided with the product, and polyvinyl chloride (PVC) administration sets.
- Flush the intravenous line with 0.9% Sodium Chloride Injection, USP before and after each dose.
- Start infusion within 12 hours of preparation.
- Discard prepared solution after 24 hours.
DOSAGE FORMS AND STRENGTHS
100 mg/5 mL single-use vial.
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HOW SUPPLIED/STORAGE AND HANDLING
ARZERRA (ofatumumab) is a sterile, colorless, preservative-free liquid concentrate (20 mg/mL) for dilution and intravenous administration provided in single-use glass vials with a latex-free rubber stopper and an aluminum overseal. Each vial contains 100 mg ofatumumab in 5 mL of solution.
ARZERRA is available as follows:
| Carton Contents |
NDC |
| 3 single-use vials with 2 filters |
NDC 0173-0808-02 |
| 10 single-use vials with 2 filters |
NDC 0173-0808-05 |
Store ARZERRA refrigerated between 2° to 8°C (36° to 46°F). Do not freeze. Vials should be protected from light.
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