24 . June , 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:





Acid Jelly Gel Acid Jelly Gel
Generic Name: Acetic Acid Vaginal Gel (a-SEE-tik) Brand Name: Acid JellyAcid Jelly Gel is used for:Restoring and maintaining normal vaginal acidity. Acid Jelly Gel is a buffered vaginal acid jelly. It works by maintaining the pH (acidity) in the vagina through its buffer action. Do NOT use Acid more...

Avalide Avalide
Generic Name: Irbesartan/Hydrochlorothiazide (IR-be-SAR-tan/HYE-droe-KLOR-oh-THYE-a-zide) Brand Name: AvalideAvalide can cause injury or even death to a developing fetus when used after the third month of pregnancy. Contact your doctor immediately if you suspect that you are pregnant. Avalide more...

Etidronate Etidronate
Generic Name: Etidronate (e-ti-DROE-nate) Brand Name: DidronelEtidronate is used for:Treating adults with Paget disease, and preventing and treating abnormal bone growth following hip replacement surgery or spinal cord injury. It may also be used for other conditions as determined by your docto more...

Kytril Injection Kytril Injection
Generic Name: granisetron hydrochloride Dosage Form: Injection Kytril Description Kytril (granisetron hydrochloride) Injection is an antinauseant and antiemetic agent. Chemically it is endo-N-(9-methyl-9-azabicyclo [3.3.1] non-3-yl)-1-methyl-1H-indazole-3-carboxamide hydrochloride with a molecula more...

M-Phen M-Phen
Generic Name: codeine, phenylephrine, and promethazine (KOE deen, phen ill EFF rin, and pro METH ah zeen) Brand Names: M-Phen, Phenergan VC with Codeine What is M-Phen (codeine, phenylephrine, and promethazine)? Codeine is a narcotic. It is a pain reliever and a cough suppressant. Pheny more...

Orudis-E Orudis-E
Some commonly used brand names are: In the U.S.— Actron 9 Advil 7 Advil Caplets 7 Advil, Children's 7 Aleve 14 Anaprox 14 Anaprox DS 14 Ansaid 6 Bayer Select Ibuprofen Pain Relief Formula Caplets 7 Cataflam 1 Clinoril 18 Cotylbutazone 16 Cramp End 7 Daypro 15 Dolgesic 7 Dolobid 2 EC-Napro more...

PanOxyl Aquagel 10 Topical PanOxyl Aquagel 10 Topical
Some commonly used brand names are: In the U.S.— Acne-Aid Vanishing Cream Acne-Aid Aqua Gel Ambi 10 Acne Medication Benoxyl 5 Lotion Benoxyl 10 Lotion Benzac AC 21/2 Gel Benzac AC 5 Gel Benzac AC 10 Gel Benzac AC Wash 21/2 Benzac AC Wash 5 Benzac AC Wash 10 Benzac 5 Gel Benzac 10 Gel Benz more...

paramethadione paramethadione
Generic Name: paramethadione (pare ah meth ah DYE own) Brand Names: Paradione What is paramethadione? Paramethadione is a seizure medication. The exact way that it works is unknown. Paramethadione is used to control absence ("petit mal") seizures. Paramethadione may also be used for purp more...