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PRODUCT DETAILS

Brand Name : Imbruvica
Composition : Ibrutinib
Strength availability : 140mg
Manufactured by : Janssen Pharmaceuticals
Pack : 120 capsules
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IMBRUVICA stops a protein in B cells called Bruton’s tyrosine kinase, or BTK. BTK indicating is required for B cells to multiply and survive.
By inhibiting BTK, IMBRUVICA may help progress abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.
Imbruvica is a prescription drug which is used under the guidance by medical practioners

INDICATION

Imbruvica 140mg is indicated for the treatment following condition :
• Mantle cell lymphoma (MCL) who have getting at least one prior treatment
• Chronic lymphocytic leukaemia (CLL)/Small lymphocytic lymphoma (SLL)
• Chronic lymphocytic leukaemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletionv • Waldenström macroglobulinemia (WM)
• Marginal zone lymphoma (MZL) who getting a medicine by mouth or injection (systemic therapy) and have getting a certain type of before treatment
• Chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy

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 Vd 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

DOSAGE

Imbruvica is indicated for the treatment of following conditions;
Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma:
The recommended dose of patient 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
Mantle Cell Lymphoma:
The recommended dose of patientis 560mg (four 140mg-mg capsules) PO qDay.
Follow until disease progression or undesirable toxicity
Waldenström Macroglobulinemia :
The recommended dose of patient 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)
Marginal Zone Lymphoma :
The recommended dose of patientis 560mg (four 140mg-mg capsules) PO qDay.
Follow until disease progression or undesirable toxicity
Graft vs Host Disease:
The recommended dose of patient is 420mg (three 140mg capsules) per oral qDay
Follow until cGVHD progression, recurrence of an underlying malignancy, or undesirable toxicity occurs

MECHANISM

Ibrutinib belongs to type of small-molecule inhibitor of BTK. Ibrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a indicating molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. BTK's role in indicating via the B-cell surface receptors reports in activation of pathways required for B-cell trafficking, chemotaxis, and adhesion. Nonclinical studies revealwhich ibrutinib prohibits malignant B-cell multiplication and survival in vivo as well as cell migration and substrate adhesion in vitro.

PRECAUTION

Other malignancies (5-14%) resulted contains carcinomas (1-3%); the most frequent second primary malignancy was nonmelanoma skin cancer (4-11%)
Hypertension occurs with a median time to onset of 4.6 months; regulate for new onset hypertension or hypertension that is not sufficient controlled after starting ibrutinib
Tumor lysis syndrome intermittentlyresulted; assess the baseline risk (eg, high tumor burden) and take suitable precautions
Based on findings in animals, can cause fetal risk when administered to a pregnant woman
Fatal and severe cases of renal failure resulted; 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


When Co administration of imbruvica 140mg with strong or moderate CYP3A inhibitor will increase ibrutinib plasma concentrations along with have high risk of drug related toxicity
When Co administration of imbruvica 140mg with strong or moderate CYP3A inducers will decrease ibrutinib plasma concentrations.

CONTRAINDICATION

Hypersentivity reaction

MISSED DOSE

If dose is missed, thereby missed dose should be avoid and follow the regular dosing schedule. Patients must consult with medical practitioner and follow the instructions given by them.

SIDE EFFECTS

More common side effects of Imbruvica 140mg :
• Low platelets
• Musculoskeletal pain
• Swelling
• Upper respiratory tract infection
• Nausea
• Diarrhea
• Reduced neutrophils
• Decreased haemoglobin
• Fatigue
• Bruising.
More common side effects of Imbruvica 140mg :
• Skin infections
• Asthenia
• Muscle spasms
• Shortness of breath
• Constipation
• Rash
• Sinusitis
• Headache
• Dehydration
• Dyspepsia
• Abdominal pain
• Vomiting
• Decreased appetite
• Cough
• Feverv
• Stomatitis
• Dizziness
• Urinary Tract Infection
• Pneumonia
• Petechiae
• Arthralgia
• Nosebleeds.

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