Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 100mg/5mL vial
- 1000mg/50mL vial
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
Relapsed CLL
- Indicated in combination with fludarabine and cyclophosphamide for relapsed CLL
- Dose 1: 300 mg IV, followed 1 week later by
- Dose 2: 1,000 mg IV, followed by
- Dose 3 and thereafter: 1,000 mg on Day 1 of subsequent 28-day cycles for maximum of 6 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
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
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
Progressive multifocal leukoencephalopathy (PML) resulting in death has occurred with therapy; consider PML in any patient with new-onset of or changes in pre-existing neurological signs or symptoms; if PML is suspected, discontinue therapy and initiate evaluation for PML including neurology consultation
The safety of immunization with live viral vaccines during or following administration of the drug has not been studied; do not administer live viral vaccines to patients who have recently received the drug; the ability to generate an immune response to any vaccine following administration of the drug has not been studied
Tumor lysis syndrome
- Tumor lysis syndrome (TLS), including the need for hospitalization, reported; patients with high tumor burden and/or high circulating lymphocyte counts (>25 x 109/L) are at greater risk for developing TLS
- Consider tumor lysis prophylaxis with anti-hyperuricemics and hydration beginning 12 to 24 hours prior to infusion of the drug; for treatment of TLS, administer aggressive intravenous hydration and anti-hyperuricemic agents, correct electrolyte abnormalities, and monitor renal function
Cytopenias
- Severe cytopenias, including neutropenia, thrombocytopenia, and anemia, reported; pancytopenia, agranulocytosis, and fatal neutropenic sepsis have occurred in patients who received the drug in combination with chlorambucil
- Grade 3 or 4 late-onset neutropenia (onset at least 42 days after last treatment dose) and/or prolonged neutropenia (not resolved between 24 and 42 days after last treatment dose) reported in patients who received the drug
- Monitor complete blood counts at regular intervals during and after conclusion of therapy, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias
Infusion reactions
- The drug can cause serious, including fatal, infusion reactions manifesting as bronchospasm, dyspnea, laryngeal edema, pulmonary edema, flushing, hypertension, hypotension, syncope, cardiac events (eg, myocardial ischemia/infarction, acute coronary syndrome, arrhythmia, bradycardia), back pain, abdominal pain, pyrexia, rash, urticaria, angioedema, cytokine release syndrome, and anaphylactoid/anaphylactic reactions
- Infusion reactions occur more frequently with the first 2 infusions; these reactions may result in temporary interruption or withdrawal of treatment
- Pre-medicate with acetaminophen, an antihistamine, and a corticosteroid
- Infusion reactions may occur despite premedication; interrupt infusion with the drug for infusion reactions of any severity; institute medical management for severe infusion reactions including angina or other signs and symptoms of myocardial ischemia
- If an anaphylactic reaction occurs, immediately and permanently discontinue treatment and initiate appropriate medical treatment
Hepatitis B virus infection
- Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred; cases have been reported in patients who are hepatitis B surface antigen (HBsAg) positive and also in patients who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive
- Reactivation also has occurred in patients who appear to have resolved hepatitis B infection (ie, HBsAg negative, anti-HBc positive, and hepatitis B surface antibody [anti-HBs] positive)
- HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive.
- Reactivation of HBV replication is often followed by hepatitis, ie, increase in transaminase levels and, in severe cases, increase in bilirubin levels, liver failure, and death
- Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment; for patients who show evidence of hepatitis B infection (HBsAg positive [regardless of antibody status] or HBsAg negative but anti-HBc positive), consult physicians with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy
- Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following treatment
- HBV reactivation has been reported for at least 12 months following completion of therapy. In patients who develop reactivation of HBV while receiving the drug, immediately discontinue therapy and any concomitant chemotherapy, and institute appropriate treatment
- Resumption of treatment in patients whose HBV reactivation resolves should be discussed with physicians with expertise in managing hepatitis B; insufficient data exist regarding the safety of resuming therapy in patients who develop HBV reactivation
- Fatal infection due to hepatitis B in patients who have not been previously infected reported; monitor patients for clinical and laboratory signs of hepatitis
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.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)
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Arzerra intravenous - | 100 mg/5 mL vial |  | |
| Arzerra intravenous - | 1,000 mg/50 mL vial |  | |
| Arzerra intravenous - | 100 mg/5 mL vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
ofatumumab intravenous
OFATUMUMAB - INJECTION
(oh-fuh-TOO-muh-mab)
COMMON BRAND NAME(S): Arzerra
WARNING: This drug may cause serious (possibly fatal) liver disease. Also, if you have a current or past infection with hepatitis B, this drug may cause the infection to return or worsen. This may occur during treatment or after treatment is finished. Before starting treatment with this medication, your doctor may order a test to see if you have hepatitis B infection. Your doctor may also order blood tests and watch for symptoms of liver disease during treatment and for months after your last dose of this medication. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.Ofatumumab increases your risk of getting a rare but very serious (sometimes fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you develop any signs of PML, including: loss of balance/dizziness, confusion, difficulty walking/talking, seizure, vision changes.
USES: Ofatumumab is used to treat a certain type of cancer (chronic lymphocytic leukemia - CLL). Ofatumumab belongs to a class of drugs known as monoclonal antibodies. This medication works by stopping the growth of cancer cells.
HOW TO USE: This medication is given by slow injection into a vein by a health care professional.The dosage and treatment schedule is based on your medical condition and response to treatment. To lower the chance of side effects, your doctor may prescribe other medications before each treatment, including acetaminophen, an antihistamine (such as diphenhydramine), and a corticosteroid (such as methylprednisolone).This medication may cause very serious (rarely fatal) infusion-related reactions during or up to 24 hours after treatment. These reactions occur more often during the first and second treatments. Your doctor will monitor you closely and increase your dose slowly to reduce the chances of these serious side effects. If you have a reaction, your treatment will be temporarily stopped. Tell your doctor or nurse right away if any of these effects occur: chest pain, flushing, wheezing, trouble breathing, dizziness, fainting, pounding/irregular heartbeat, fever, chills, back/stomach pain, or rash/itching.
SIDE EFFECTS: See also Warning and How to Use section.Nausea, vomiting, diarrhea, tiredness, swelling of hands/ankles/feet, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Your doctor will order blood tests to check for this side effect. It is important to keep all medical/lab test appointments. Tell your doctor right away if you develop any of the following symptoms: easy bruising/bleeding, pale skin, unusual tiredness, signs of infection (such as sore throat that doesn't go away, fever, chills, cough).Ofatumumab sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have ever had a severe reaction to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as chronic obstructive pulmonary disease - COPD, asthma), liver disease (such as hepatitis B), heart disease (such as chest pain, heart attack), immune system problems (such as HIV).This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Ofatumumab can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using ofatumumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown whether this drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Laboratory and/or medical tests (such as complete blood count, platelets, liver/kidney function tests, blood mineral levels, hepatitis B virus) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.Keep all regular medical and laboratory appointments.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised February 2022. Copyright(c) 2022 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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Adding plans allows you to:
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