IBRUTINIB 70MG


Description


Ibrutinib is a generic form of brand name of Imbruvica. Imbruvica 70mg is a small molecule which work as an irreversible potent inhibitor of Burton's tyrosine kinase.
Imbruvica 70mg designated as a targeted covalent drug and it show a very promising activity in B cell malignancies.
Imbruvica 70mg is a prescription drug which is used under the guidance by medical practioners


Indication

The drug Imbruvica 70mg is indicated for adults for the condition as follows :
Chronic graft versus host disease (cGVHD) after failure of ≥1 lines of systemic treatment.
Marginal zone lymphoma (MZL) in patients who require systemic therapy and have administer at least 1 prior anti-CD20-based therapy. All lines of therapy for Waldenström macroglobulinemia (WM), a rare, indolent type of non-Hodgkin lymphoma (B-cell lymphoma); may be needed as a single agent or in combination with rituximab
Mantle cell lymphoma (MCL) in patients who have administer at least 1 previous therapy
Chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL); also indicated for CLL/SLL with 17p deletion; may be needed as a single agent, or in combination with rituximab and bendamustine






Dosage and administration


Dosage for patients with Mantle Cell Lymphoma :
The recommendeddose is 560mg (four 140mg-mg capsules) PO qDay.
Follow until disease progression or undesirable toxicity
Dosage for patients with Waldenström Macroglobulinemia
The recommended dose is 420mg (three 140mg capsules) per oral qDay
When combination with rituximab is 420 mg PO qDay plus rituximab administered weekly for 4 consecutive weeks (weeks 1-4) continued by a second course of weekly rituximab for 4 consecutive weeks (weeks 17-20)
Dosage for patients withChronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma
The recommended dose is 420mg (three 140mg capsules) per oral qDay
While in combination with bendamustine and rituximab the usual dose is 420mg PO qDay administrated q28d for up to 6 cycles until progression or undesirable toxicity
Dosage for patients with Marginal Zone Lymphoma
The recommendeddose is 560mg (four 140mg-mg capsules) PO qDay.
Follow until disease progression or undesirable toxicity
Dosage for patients with Graft vs Host Disease
The recommended dose is 420mg (three 140mg capsules) per oral qDay
Follow until cGVHD progression, recurrence of an underlying malignancy, or undesirable toxicity occurs.

Mechanism Of Action


Burton’s tyrosine kinase (BTK) inhibitor involved in Ibrutinib which forms a covalent bond with a cysteine residue in the BTK active site, leading to prevention of BTK enzymatic activity. Thereby BTK is a signalling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways
BTK’s role in signalling via the B-cell surface receptors reports in activation of pathways necessary for B-cell trafficking, chemotaxis, and adhesion

ADME


Peak plasma concentration of Imbruvica is 1-2 hours and drug taking with food will increases ibrutinib exposure.
Imbruvica has plasma protein level is 97.3% and volume of distribution is 10,000L
Ibrutinib is Metabolized to various metabolites primarily by cytochrome P450 CYP3A, and to a minor extent by CYP2D6
Ibrutinib was excretion through feces 80% and urine 10 %
Half-life of ibrutinib is 4-6 hours

Precautions


Some other malignancies (5-14%) reported involving carcinomas (1-3%); the most frequent second primary malignancy was nonmelanoma skin cancer (4-11%)
Hypertension reported with a median time to onset of 4.6 months; regulate for new onset hypertension or hypertension which is not adequate controlled after starting ibrutinib
Tumor lysis syndrome at times resulted; assess the baseline risk (eg, high tumor burden) and take applicable precautions
Imbruvica 40mg will cause fetal risk when administered to a pregnant woman
lethal and serious cases of kidney failure occur; treatment-emergent have high in creatinine levels up to 1.5 x ULN occurred in 67% (MCL) and 23% (CLL) and from 1.5-3x ULN in 9% (MCL) and 4% (CLL); regularly monitor creatinine and maintain hydration

Drug Interaction


Interaction of Imbruvica 70mg with strong or moderate CYP3A inhibitor will increase ibrutinib plasma concentrations along with have high risk of drug related toxicity
Interaction of Imbruvica 70mg with strong or moderate CYP3A inducers will decrease ibrutinib plasma concentrations.

Side Effects


More common side effects of Imbruvica 70mg :
• Nausea
• Diarrhea
• Reduced neutrophils
• Decreased haemoglobin
• Fatigue
• Bruising
• Low platelets
• Musculoskeletal pain
• Swelling
• Upper respiratory tract infection.
Less common side effects of Imbruvica 70mg :
• Constipation
• Rash
• Sinusitis
• Headache
• Dehydration
• Dyspepsia
• Petechiae
• Arthralgia
• Nosebleeds
• Abdominal pain
• Vomiting
• Decreased appetite
• Cough
• Fever
• Stomatitis
• Dizziness
• Urinary Tract Infection
• Pneumonia
• Skin infections
• Asthenia
• Muscle spasms
• Shortness of breath.

Missed Dose


if dose missed, patients should consult with medical practitioner and follow the instructions given by them.
thereby missed dose should be avoid and follow the regular dosing schedule

Storage


Store the drug at 200C- 250C



Pregnancy


Pregnancy category is D; while taking Imbruvica 70mg avoid becoming pregnancy and for up to 1 month after ending treatment.


Lactation


Avoid breast feeding during treatment with Imbruvica 70mg


Contraindication


Hypersentivity reaction


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