Generic Name and Formulations:
Ofatumumab 20mg/mL; soln for IV infusion after dilution; preservative-free.
Novartis Pharmaceuticals Corp
Indications for ARZERRA:
In combination with chlorambucil in previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate. Extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL. Treatment of CLL refractory to fludarabine and alemtuzumab.
Premedicate with acetaminophen (oral), antihistamine (oral or IV), corticosteroid (IV) 30mins to 2hrs prior to each infusion. Give by IV infusion (rate varies with dose and during infusion); see full labeling. Previously untreated: initially 300mg on Day 1, then 1 week later by 1000mg on Day 8 (Cycle 1), followed by 1000mg on Day 1 of subsequent 28-day cycles for at least 3 cycles until best response or max 12 cycles. Extended treatment: initially 300mg on Day 1, then by 1000mg 1 week later on Day 8, followed by 1000mg 7 weeks later and every 8 weeks thereafter for up to max 2 years. Refractory: initially 300mg on Day 1, then 1 week later by 2000mg weekly for 7 doses, followed 4 weeks later by 2000mg every 4 weeks for 4 doses. Dose modification for infusion reactions: see full labeling.
Hepatitis B virus reactivation. Progressive multifocal leukoencephalopathy.
Increased risk of HBV reactivation. Test/treat HBV infection prior to initiating therapy. Monitor for signs of hepatitis or HBV reactivation during and for several months after therapy; discontinue if HBV reactivation occurs. Monitor CBCs at regular intervals during and after therapy, increase frequency if Grade 3/4 cytopenias develop. Monitor for new onset of or changes in pre-existing neurological signs/symptoms; discontinue and evaluate if progressive multifocal leukoencephalopathy (PML) is suspected. Increased risk of tumor lysis syndrome (TLS) in high tumor burden and/or high circulating lymphocytes; consider prophylaxis with anti-hyperuricemics and hydration beginning 12–24hrs prior to infusion. Pregnancy (Cat.C). Nursing mothers.
CD20-directed cytolytic monoclonal antibody.
Avoid vaccination with live viral vaccines.
Neutropenia, thrombocytopenia, anemia, pneumonia, pyrexia, cough, fatigue, dyspnea, rash, nausea, diarrhea, bronchitis, upper respiratory tract infections; infusion reactions (eg, bronchospasm; laryngeal, pulmonary, or angioedema; flushing, hyper- or hypotension, syncope, cardiac ischemia, back or abdominal pain, fever, urticaria) (interrupt, adjust infusion rate and monitor; permanently discontinue if anaphylaxis occurs), PML, infections (eg, sepsis), hepatotoxicity, TLS.
Single-use vial (5mL)—3; (50mL)—1
Clinical Pain Advisor Articles
- History of Migraine May Be Associated With Higher Risk for Cochlear Disorders
- Radiofrequency Denervation Efficacious in Treating Thoracic Zygapophyseal Joint Pain
- Symptom Severity, Sensory Sensitivity May Indicate Pain Centralization in Chronic Overlapping Pain Conditions
- Stat Consult: Chronic Low Back Pain
- Opioid Misuse May Help Predict Alcohol Dependence Treatment Outcomes
- Consensus Guidelines for the Use of Intravenous Ketamine for Chronic Pain
- Pain Societies Issue Guidelines on Use of Ketamine for the Management of Acute Pain
- Labor Epidural Analgesia Linked to Reduced Likelihood of Successful Breastfeeding
- Novel Oral Treatment Safe, Effective for Migraine Headache Relief
- DFN-02 Nasal Spray Safe, Effective for Acute Treatment of Episodic Migraine
- Chinese Traditional Medicine Showed Effectiveness on Pain, Quality of Life in Advanced Cancer
- International Group Develops Best Practices for Drug Packaging
- New Rules May Constrain Docs' Ability to Treat Chronic Pain
- OnabotulinumtoxinA May Be Effective for Chronic Migraine With Medication Overuse
- FDA Outlines Plan for Increasing Nonprescription Drug Availability