22 . April , 2018 - Sunday
Check todays hot topics or new products

Find a Drug: Advanced

Please Sign in or Register

All about: Ibritumomab Tiuxetan

Big Image Pronouncation: (EYE-bri-TOOM-oh-mab tye-UX-e-tan)
Class: Monoclonal antibody

Trade Names:
Zevalin
- Injection 3.2 mg

Mechanism of Action

Pharmacology

Ibritumomab is a monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant B lymphocytes. The CD20 antigen is also expressed on more than 90% of B-cell non-Hodgkin lymphomas.

Pharmacokinetics

Absorption

The mean fraction of injected activity in the blood AUC is 39 h.

Elimination

The mean effective t ½ for Y-90 activity in the blood is 30 h. Over 7 days, a median of 7.2% of injected activity is excreted in urine.

Peak

At 4 wk, the median number of circulating B cells is zero (range, 0 to 1,084 cells/mm 3 ).

Duration

B-cell recovery begins at approximately 12 wk following treatment, and the median level of B cells is within the normal range (32 to 341 cells/mm 3 ) by 9 mo after treatment.

Indications and Usage

Treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin lymphoma.

Contraindications

Patients with known type I hypersensitivity or anaphylactic reactions to murine proteins or to any component of the therapeutic regimen.

Dosage and Administration

Adults

IV The therapeutic regimen consists of 2 steps. Step 1 includes a single infusion of rituximab 250 mg/m 2 (not included in the therapeutic kit) preceding a fixed dose of indium-111 (In-111) ibritumomab tiuxetan 5 mCi (1.6 mg total antibody dose) administered as a 10‐min IV push. Step 2 follows step 1 by 7 to 9 days and consists of a second infusion of rituximab 250 mg/m 2 prior to yttrium-90 (Y-90) ibritumomab tiuxetan 0.4 mCi/kg as a 10‐min IV push. Reduce the Y-90 ibritumomab tiuxetan dose to 0.3 mCi/kg (11.1 MBq/kg) for patients with a baseline platelet count between 100,000 and 149,000 cells/mm 3 .

General Advice

  • For IV administration only.
  • Inject In-111 or Y-90 ibritumomab tiuxetan within 4 h following completion of the rituximab dose.
  • Prior to injection of In-111 or Y-90 ibritumomab tiuxetan, a 0.22 micrometer low-protein-binding filter should be in-line between the syringe and the infusion port. After injection, flush the line with at least 10 mL of isotonic sodium chloride solution.
  • Establish a free-flowing IV line prior to Y-90 ibritumomab tiuxetan injection.

Storage/Stability

Store at 36°F to 46°F. Do not freeze. Store In-111 ibritumomab tiuxetan at 36° to 46°F until use and administer within 12 h of radiolabeling. Store Y-90 ibritumomab tiuxetan at 36° to 46°F until use and administer within 8 h of radiolabeling.

Drug Interactions

None well documented. However, because of the frequent occurrence of severe and prolonged thrombocytopenia, the potential benefits of medications that interfere with platelet function or anticoagulation should be weighed against the potential increased risk of bleeding and hemorrhage.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypotension (6%); tachycardia (less than 1%).

CNS

Headache (12%); dizziness (10%); insomnia (5%); anxiety (4%); encephalopathy, subdural hematoma (less than 1%).

Dermatologic

Pruritus (9%); rash (8%); flushing (6%); petechiae, sweats, urticaria (1% to 4%); cutaneous and mucocutaneous events (postmarketing).

EENT

Throat irritation (10%); epistaxis (3%).

GI

Nausea (31%); vomiting (12%); diarrhea (9%); anorexia (8%); abdominal enlargement, constipation (5%); dyspepsia, melena (1% to 4%); GI hemorrhage (1%).

Genitourinary

Vaginal hemorrhage (less than 1%).

Hematologic-Lymphatic

Thrombocytopenia (95%); neutropenia (77%); anemia, platelet count below 50,000 cells/mm 3 (61%); absolute neutrophil count below 1,000 cells/mm 3 (57%); ecchymosis (7%); pancytopenia (2%).

Metabolic-Nutritional

Peripheral edema (8%); angioedema (5%).

Musculoskeletal

Back pain (8%); arthralgia, myalgia (7%); arthritis (less than 1%).

Respiratory

Dyspnea (14%); increased cough (10%); rhinitis (6%); bronchospasm (5%); apnea (1%); lung edema, pulmonary embolus (less than 1%).

Miscellaneous

Asthenia (43%); infection (29%); chills (24%); fever (17%); abdominal pain (16%); pain (13%); allergic reactions, secondary malignancies (2%); tumor pain (1%); hematemesis (less than 1%).

Precautions

Warnings

Fatal infusion reaction

Death within 24 h of rituximab infusion, an essential component of ibritumomab therapeutic regimen, has occurred. These fatalities were associated with an infusion reaction symptom complex that included hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, MI, ventricular fibrillation, and cardiogenic shock. Approximately 80% of fatal infusion reactions occurred in association with the first rituximab infusion.

Cytopenias

Administration of Y-90 ibritumomab tiuxetan results in severe and prolonged cytopenias in most patients.

Cutaneous reactions

Severe cutaneous and mucocutaneous reactions, some fatal, have been reported in association with the ibritumomab tiuxetan treatment regimen.

Special requirements

Only health care providers qualified by training in the safe use and handling of radionuclides should administer In-111 and Y-90 ibritumomab tiuxetan.


Monitor

Obtain platelet and CBC counts weekly following the ibritumomab tiuxetan therapeutic regimen and continue until levels recover. Monitor platelets and CBC more frequently in patients who develop severe cytopenia. Patients receiving medications that interfere with platelet function or coagulation should have more frequent laboratory monitoring for thrombocytopenia.


Pregnancy

Category D .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Biodistribution

Do not administer Y-90 ibritumomab tiuxetan to patients with altered biodistribution of In-111 ibritumomab tiuxetan.

Hypersensitivity

Hypersensitivity reactions, including anaphylaxis, may occur.

Infections

Because this product contains albumin, a derivative of human blood, there is a risk of transmitting infectious agents (eg, viruses), including Creutzfeldt-Jakob disease.

Radionuclide precautions

The ibritumomab tiuxetan kit is not radioactive. However, during and after radiolabeling ibritumomab tiuxetan with In-111 or Y-90, take care to minimize radiation exposure of patients and medical personnel.

Secondary malignancies

Acute myelogenous leukemia and myelodysplastic syndrome have been reported following the ibritumomab tiuxetan therapeutic regimen.

Overdosage

Symptoms

Hematologic toxicity.

Patient Information

  • Advise women to avoid becoming pregnant, and to use effective contraceptive methods during treatment and for up to 12 mo following the ibritumomab tiuxetan therapeutic regimen.

Recent Drug Updates at DrugIndexOnline:





Acetaminophen/Tramadol Acetaminophen/Tramadol
Generic Name: Acetaminophen/Tramadol (a-seet-a-MIN-oh-fen/TRA-ma-dole) Brand Name: UltracetAcetaminophen/Tramadol is used for:Short-term treatment (5 days or less) of pain. Acetaminophen/Tramadol is an analgesic combination. It works in certain areas of the brain and nervous system to decrease more...

aspirin and pseudoephedrine aspirin and pseudoephedrine
Generic Name: aspirin and pseudoephedrine (ASP in and soo doe e FED rin) Brand Names: Ursinus What is aspirin and pseudoephedrine? Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation. Pse more...

Chlor-Al Rel Chlor-Al Rel
Generic Name: chlorpheniramine (klor fen IR a meen) Brand Names: Aller-Chlor, C.P.M., Chlo-Amine, Chlor-Al Rel, Chlor-Mal, Chlor-Phen, Chlor-Phenit, Chlor-Trimeton, Chlorphen, Efidac-24 Chlorpheniramine, Ridramin What is Chlor-Al Rel (chlorpheniramine)? Chlorpheniramine is an antihistam more...

Coricidin HBP Cough/Cold Coricidin HBP Cough/Cold
Generic Name: Chlorpheniramine/Dextromethorphan Tablets (klor-fen-IHR-ah-meen/DEX-troe-meth-OR-fan) Brand Name: Examples include Coricidin HBP Cough/Cold and QC Cough/ColdCoricidin HBP Cough/Cold is used for:Relieving cough and other symptoms such as runny nose and sneezing due to colds, upper more...

Insta-Char Pediatric with Cherry Flavor in a Sorbitol  Base Insta-Char Pediatric with Cherry Flavor in a Sorbitol Base
Some commonly used brand names are: In the U.S.— Actidose-Aqua 1 Actidose with Sorbitol 2 CharcoAid 2 CharcoAid G 1 CharcoAid 2000 1 Insta-Char in an Aqueous Base 1 Insta-Char in an Aqueous Base with Cherry Flavor 1 Insta-Char Pediatric in an Aqueous Base with Cherry Flavor 1 Insta-Char P more...

Meclizine Meclizine
Pronouncation: (MEK-lih-zeen) Class: Anticholinergic Trade Names: Antivert - Tablets 12.5 mg - Tablets 25 mg - Tablets 50 mg Trade Names: Antrizine - Tablets 12.5 mg Trade Names: Dramamine Less Drowsy - Tablets 25 mg Trade Names: Meni-D - Capsules 25 mg Bonamine (Canada) Mechanism of Action Pharmac more...

Oxycodone and Acetaminophen Oxycodone and Acetaminophen
Generic Name: oxycodone hydrochloride and acetaminophen Dosage Form: Tablets, usp CII Rx only Oxycodone and Acetaminophen Description Oxycodone hydrochloride and acetaminophen is supplied in tablet form for oral administration. Each Oxycodone and Acetaminophen tablet, USP 5 mg*/325 mg tablet c more...

Prolixin Oral Concentrate Prolixin Oral Concentrate
Generic Name: fluphenazine hydrochloride Dosage Form: Oral concentrate Prolixin Description Prolixin (fluphenazine hydrochloride) is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. Prolixin Oral Concentrate (Fluphenazine Hydrochloride Oral Solution) contai more...