IBRUTINIB 140MG

The drug Imbruvica 140mg is used for adults with chronic graft versus host disease (cGVHD) after failure of ≥1 lines of systemic treatment.
The drug Imbruvica 140mg is used for marginal zone lymphoma (MZL) in patients who require systemic therapy and have administer at least 1 prior anti-CD20-based therapy.
The drug Imbruvica 140mg is used for 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.
The drug Imbruvica 140mg is used for mantle cell lymphoma (MCL) in patients who have administer at least 1 previous therapy The drug Imbruvica 140mg is used for 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.

Ibrutinib

140mg

120 capsules




DESCRIPTION

Ibrutinib is a generic form of brand name of Imbruvica .
Imbruvica is an orally bioavailable, small-molecule inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity.
Imbruvica is a prescription drug which is used under the guidance by medical practioners

Mechanism of action

Ibrutinib belongs to inhibitor of Bruton’s tyrosine kinase (BTK). It develops a covalent bond with a cysteine residue in the active site of BTK (Cys481), causes its inhibition. The prevention of BTK plays a role in the B-cell receptor signalling and thus, the presence of ibrutinib inhibits the phosphorylation of downstream substrates such as PLC-γ.[6]



Pharmacokinetic

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



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ibrutinib-140mg

Ingredients Ibrutinib
Strength 140mg
Pack 120 capsules
Rating

Imbruvica is indicated for the treatment of following conditions :
Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma:
The usual dose is 420mg (three 140mg capsules) per oral qday
While in combination with bendamustine and rituximabthe usual dose is 420mg PO qday administrated q28d for upto 6 cycles until progression or undesirable toxicity
Mantle Cell Lymphoma :
The usual dose is 560mg (four 140mg-mg capsules) PO qday.
Follow until disease progression or undesirable toxicity
Waldenström Macroglobulinemia :
The usual 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)
Marginal Zone Lymphoma :
The usual dose is 560mg (four 140mg-mg capsules) PO qday.
Follow until disease progression or undesirable toxicity
Graft vs Host Disease :
The usual dose is 420mg (three 140mg capsules) per oral qday
Follow until cGVHD progression, recurrence of an underlying malignancy, or undesirable toxicity occurs

Side effects

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

Precautions

Other malignancies (5-14%) resultedcontains 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 – DRUG INTERACTION

  • When concomitant use of Imbruvica 140mg with strong or moderate CYP3A inhibitor will increase ibrutinib plasma concentrations along with have high risk of drug related toxicity
  • When concomitant use of Imbruvica 140mg with strong or moderate CYP3A inducers will decrease ibrutinib plasma concentrations.

Contraindications

Hypersentivity reaction




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

Avoid breast feeding during treatment with Imbruvica 140mg

Store the drug at 20°C - 25°C. Keep away from the children resistances

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


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