IMBRUVICA 140MG

Description

Ibrutinib is a generic form of brand name of Imbruvica which is a small molecule drug whichconnects permanently to a protein, Bruton's tyrosine kinase (BTK), which is required in B cells; the drug is necessary to cure B cell cancers like mantle cell lymphoma, chronic lymphocytic leukaemia, and Waldenström's macroglobulinemia

Imbruvica is a prescription drug which is used under the guidance by medical practioners

Indication

Imbruvica is indicated for the treatment of following conditions affect in patients as follows

Chronic lymphocytic leukaemia or small lymphocytic lymphoma

Mantle cell lymphoma

Waldenström Macroglobulinemia

Marginal Zone lymphoma

Graft vs Host Disease

Mechanism of action

Ibrutinib consist of type of tumor growth inhibitor called a tyrosine kinase inhibitor (TKI). 

Tyrosine kinase inhibitors (TKIs) stop chemical messengers (enzymes) known as tyrosine kinases. Tyrosine kinases promote to send growth signals in cells, so preventing them,discontinue the cell growing and dividing.  

ADME Properties

High 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 and administration

Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma

The regular dose of imbruvica 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 regular dose of imbruvica is 560mg (four 140mg-mg capsules) PO qDay.

Extend until disease progression or undesirable toxicity

Waldenström Macroglobulinemia

The regular dose of imbruvica 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 regular dose of imbruvica is 560mg (four 140mg-mg capsules) PO qDay.

Extend until disease progression or undesirable toxicity

Graft vs Host Disease

The regular dose of imbruvica is 420mg (three 140mg capsules) per oral qDay

Extenduntil cGVHD progression, recurrence of an underlying malignancy, or undesirable toxicity occurs

Side effects

More common side effects of Imbruvica 140mg

• Skin infections
• Asthenia
• Muscle spasms
• Shortness of breath
• Constipation
• Rash
• Sinusitis
• Headache
• Dehydration
• Abdominal pain
• Vomiting
• Decreased appetite
• Cough
• Fever
• Stomatitis
• Dizziness
• Urinary Tract Infection
• Pneumonia
• Dyspepsia
• Petechiae
• Arthralgia
• Nosebleeds

More common side effects of Imbruvica 140mg

• Upper respiratory tract infection
• Nausea
• Diarrhea
• Reduced neutrophils
• Decreased haemoglobin
• Fatigue
• Bruising
• Thrombocytopenia
• Musculoskeletal pain
• Swelling

Drug interaction

When interaction of imbruvica 140mg with strong or moderate CYP3A inhibitor will increase ibrutinib plasma concentrations along with have high risk of drug related toxicity

When interaction of imbruvica 140mg with strong or moderate CYP3A inducers will decrease ibrutinib plasma concentrations.

Contraindication

Hypersentivity reaction

Precautions

• While using imbruvica 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 
• While using imbruvicaOther malignancies (5-14%) resulted contains carcinomas (1-3%); the most frequent second primary malignancy was nonmelanoma skin cancer (4-11%)
• Based on findings in animals, can cause fetal risk when administered to a pregnant woman
• While using imbruvica, Fatal and severe cases of renal failure reported; 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

Pregnancy

Pregnancy category is D;

while taking Imbruvica 140mg avoid becoming pregnancy and for up to 1 month after ending treatment.

Lactation

Avoid breast feeding during treatment with Imbruvica 140mg

Storage

Store the drug at 20⁰C- 25⁰C

Missed dose

If missed dose occurs. Have it immediately before next dose time reaches or missed dose should be avoid and follow the regular dosing schedule.

Patients should consult with medical practitioner and follow the instructions given by them