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ofatumumab (Rx)Brand and Other Names:Arzerra

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 100mg/5mL vial
  • 1000mg/50mL vial
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Chronic Lymphocytic Leukemia

Previously untreated

  • In combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate
  • Cycle 1: 300 mg IV on Day 1 followed 1 week later by 1,000 mg on Day 8, THEN
  • Subsequent 28-day cycles: 1,000 mg on Day 1 for a minimum of 3 cycles until best response or a maximum of 12 cycles

Extended treatment

  • Indicated for extended treatment as a single agent in patients who are in complete or partial response after at least 2 lines of therapy for recurrent or progressive CLL
  • Dose 1: 300 mg IV on Day 1, followed 1 week later by
  • Dose 2: 1,000 mg 1 week on Day 8, followed 7 weeks later by
  • Dose 3 and thereafter: 1,000 mg IV and then q8wk thereafter for up to a maximum of 2 yr

Refractory CLL

  • Indicated for CLL refractory to fludarabine and alemtuzumab
  • Dose 1: 300 mg IV, followed 1 week later by
  • Doses 2-8: 2,000 mg IV qWeek for 7 doses, followed 4 weeks later by
  • Doses 9-12: 2,000 mg IV q4Weeks for 4 doses
  • Regimen totals 12 doses

Safety and efficacy not established

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Adverse Effects

>10%

Neutropenia

Pneumonia

Pyrexia

Cough

Diarrhea

Anemia

Fatigue

Dyspnea

Rash

Nausea

Bronchitis

Upper respiratory tract infections

<10%

Infusion reaction/complication

Cytopenias

Infection (pneumonia, sepsis)

Progressive multifocal leukoencephalopathy

Hepatitis B reactivation

Intestinal obstruction

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Warnings

Black Box Warnings

Progressive multifocal leukoencephalopathy (PML) including fatal PML, can occur in patients receiving obinutuzumab

Hepatitis B virus reactivation

  • Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies
  • Screen all patients for HBV infection before treatment initiation
  • Monitor HBV positive patients during and after treatment
  • Discontinue ofatumumab and concomitant medications in the event of HBV reactivation

Contraindications

Hypersensitivity

Cautions

Increased susceptibility to infection

May increase risk for progressive multifocal leukoencephalopathy (PML)

Fulminant and fatal hepatitis B infection and reactivation reported following treatment; closely monitor HBV carriers for clinical and laboratory signs of active HBV infection during treatment and for 6-12 months following last infusion

Infusion reaction may occur, monitor closely

Neutropenia

Thrombocytopenia

Intestinal obstruction of small intestine

Tumor lysis syndrome (TLS) reported, including the need for hospitalization; patients with high tumor burden and/or high circulating lymphocyte counts (>25 x 10^9/L) are at greater risk; consider TSL prophylaxis with antihyperuricemics and hydration beginning 12-24 hr before infusion

Do not administer live virus vaccines (inability to generate immune response)

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: unknown whether distributed in breast milk; published data suggest neonate/infant does not ingest substantial amount of these maternal antibodies from breast milk, although caution is warranted

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Anti-CD20 human monoclonal antibody that inhibits B-cell activation in early stages

Pharmacokinetics

Half-Life: 14 days (mean between 4th-12th infusions)

Cmax: 63 mcg/mL (after 1st dose); 1482 mcg/mL (after 8th dose); 881 mcg/mL (after 12th dose)

Vdss: 3.2 L (after 1st dose); 5.1 L (after 8th dose); 4.7 L after 12th dose

Clearance: 0.01 L/hr (mean clearance between 4th-12th infusions)

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Administration

IV Compatibilities

Solution: 0.9% NaCl

IV Preparation

Do NOT shake product

IV infusion: Prepare all doses in 1000-mL polyolefin bag of 0.9% NaCl

300 mg dose: Withdraw and discard 15 mL from 1000 mL 0.9% NaCl; add measured dose to IV bag; yields 300 mg/L = 0.3 mg/mL

1,000 mg dose: Withdraw and discard 50 mL from 1000 mL 0.9% NaCl; add measured dose to IV bag; yields 1,000 mg/L = 1 mg/mL

2000 mg dose: Withdraw and discard 100 mL from 1000 mL 0.9% NaCl; add measured dose to IV bag; yields 2000 mg/L = 2 mg/mL

IV Administration

Premedicate with corticosteroid, analgesic, and antihistamine before each infusion to avoid infusion-related reactions

Administer by slow IV infusion and use in-line filter supplied with product via volumetric infusion pump; do NOT administer as IV push or bolus

Previously untreated and extended treatment CLL

  • For initial 300 mg dose: Initiate IV infusion at rate of 3.6 mg/hr (12 mL/hr)
  • For subsequent 1,000 mg doses: Initiate IV infusion at rate of 25 mg/hr (25 mL/hr); initiate infusion at a rate of 12 mg/hr if a ≥grade 3 infusion-related adverse event was experienced during the previous infusion
  • In the absence of an infusion-related adverse event, the rate of infusion may be increased every 30 minutes by 12-25 mL/hr; not to exceed 400 mL/hr

Refractory CLL

  • Dose 1 (300 mg dose): Initiate IV infusion at rate of 3.6 mg/hr (12 mL/hr)
  • Dose 2 (2,000 mg dose): Initiate IV infusion at a rate of 24 mg/hr (12 mL/hr)
  • Doses 3-12 (2,000 mg dose): Initiate IV infusion at a rate of 50 mg/hr (25 mL/hr)
  • In the absence of an infusion-related adverse event, the rate of infusion may be increased every 30 minutes by 12-25 mL/hr; not to exceed 200 mL/hr for doses 1-2, and 400 mL/hr for doses 3-12

Storage

Store undiluted vials refrigerated (between 36-46 degrees F); protect from light

Store diluted solution refrigerated (between 36-46 degrees F)

Start infusion within 12 hr of preparation

Discard prepared solution after 24 hr

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Formulary

FormularyPatient Discounts

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  • View the formulary and any restrictions for each plan.
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  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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