Ibrutinib 140mg (Ibrutinib)

Ibrutinib
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Natco Pharma Ltd.

Ibrutinib 140mg (Ibrutinib)

ManufacturerNatco Pharma Ltd.Brand nameImbruvica International trade nameImbruvicaActive substanceIbrutinibStrength140mgCategoryAnti Cancer

Description of Imbruvica 140mg (Ibrutinib 140mg)

Imbruvica 140mg (Ibrutinib 140mg) 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 140mg (Ibrutinib 140mg) may help progress abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.

Imbruvica 140mg (Ibrutinib 140mg) is a prescription medicine which is used under the guidance by medical practioners

Medical use /Indication of Imbruvica 140mg (Ibrutinib 140mg)

Imbruvica 140mg (Ibrutinib 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 deletion 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

Mechanism of Action Imbruvica 140mg (Ibrutinib 140mg)

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 reveal which ibrutinib prohibits malignant B-cell multiplication and survival in vivo as well as cell migration and substrate adhesion in vitro.

Absorption of Imbruvica 140mg (Ibrutinib 140mg)

Peak plasma concentration of Imbruvica 140mg (Ibrutinib 140mg) is 1-2 hours and medicine taking with food will increases ibrutinib exposure.

Distribution of Imbruvica 140mg (Ibrutinib 140mg)

Imbruvica has plasma protein level is 97.3% and Vd is 10,000L Ibrutinib is Metabolized to various

Metabolism of Imbruvica 140mg (Ibrutinib 140mg)

metabolites primarily by cytochrome P450 CYP3A, and to a minor extent by CYP2D6

Excretion of Imbruvica 140mg (Ibrutinib 140mg)

Ibrutinib was excretion through feces 80% and urine 10 % Half-life of ibrutinib is 4-6 hours

Side effects of Imbruvica 140mg (Ibrutinib 140mg)

More common side effects of Imbruvica 140mg (Ibrutinib 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 (Ibrutinib 140mg) Skin infections Asthenia Muscle spasms Shortness of breath Constipation Rash Sinusitis Headache Dehydration Dyspepsia Abdominal pain Vomiting Decreased appetite Cough Fever Stomatitis Dizziness Urinary Tract Infection Pneumonia Petechiae Arthralgia Nosebleeds

Precautions of Imbruvica 140mg (Ibrutinib 140mg)

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 intermittently resulted; 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 of Imbruvica 140mg (Ibrutinib 140mg)

When Co administration of Imbruvica 140mg (Ibrutinib 140mg) with strong or moderate CYP3A inhibitor will increase ibrutinib plasma concentrations along with have high risk of medicine related toxicity When Co administration of Imbruvica 140mg (Ibrutinib 140mg) with strong or moderate CYP3A inducers will decrease ibrutinib plasma concentrations.

Contraindication of Imbruvica 140mg (Ibrutinib 140mg)

Hypersentivity reaction

Pregnancy of Imbruvica 140mg (Ibrutinib 140mg)

Pregnancy category is D; while taking Pregnancy category is D; while taking Imbruvica 140mg (Ibrutinib 140mg) avoid becoming pregnancy and for up to 1 month after ending treatment

Dosage of Imbruvica 140mg (Ibrutinib 140mg)

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

Storage of Imbruvica 140mg (Ibrutinib 140mg)

Store the medicine at 20℃ - 25℃ 

Missed dose of Imbruvica 140mg (Ibrutinib 140mg)

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.

Brand name:
Imbruvica
International trade name:
Imbruvica
Active substance:
Ibrutinib
Strength:
140mg
Category:
Anti Cancer
Manufacturer:
Natco Pharma Ltd
Packaging:
120 Capsules
Product form:
Capsules

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