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The effectiveness of ARZERRA is based on the demonstration of durable objective responses [see Clinical Studies]. No data demonstrate an improvement in disease-related symptoms or increased survival with ARZERRA.
DOSAGE AND ADMINISTRATION
Recommended Dosage Regimen
- Do not administer as an intravenous push or bolus.
- Premedicate before each infusion.
- Administer with an in-line filter set supplied with product.
The recommended dosage 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)
Administer ARZERRA in an environment where facilities to adequately monitor and treat infusion reactions are available [see WARNINGS AND PRECAUTIONS].
Prepare all doses in 1,000 mL of 0.9% Sodium Chloride Injection, USP.
- 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)|
|aDose 1 = 300 mg (0.3 mg/mL).
bDoses 2 and 3-12 = 2,000 mg (2 mg/mL).
- 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.
- 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 clear to opalescent, 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 bag of 0.9% Sodium Chloride Injection, USP. Withdraw 5 mL from each of 3 single-use 100 mg 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 50 mL from each of 2 single-use 1,000 mg 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).
- No incompatibilities between ARZERRA and polyvinylchloride or polyolefin bags and administration sets have been observed.
- Do not mix ARZERRA with, or administer as an infusion with, other medicinal products.
- Administer using an infusion pump with an administration set and the provided in-line filter set.
- 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.
- 1,000 mg/50 mL single-use vial.
Storage And Handling
ARZERRA (ofatumumab) is a sterile, clear to opalescent, colorless, preservative-free liquid concentrate (20 mg/mL) for dilution and intravenous administration provided in single-use glass vials with a rubber stopper (not made with natural rubber latex) and an aluminum overseal. Each vial contains either 100 mg ofatumumab in 5 mL of solution or 1,000 mg ofatumumab in 50 mL of solution.
ARZERRA is available as follows:
|3 single-use 100 mg/5 mL vials with 2 in-line filter sets||Vial: NDC 0173-0821-02|
|Carton of 3 vials: NDC 0173-0821-33|
|1 single-use 1,000 mg/50 mL vial with 2 in-line filter sets||Vial and Carton: NDC 0173-0821-01|
Store ARZERRA refrigerated between 2° to 8°C (36° to 46°F). Do not freeze. Vials should be protected from light.
Manufactured by: Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom. Distributed by: GlaxoSmithKline Research Triangle Park, NC 27709
Last reviewed on RxList: 10/17/2013
This monograph has been modified to include the generic and brand name in many instances.
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