Nitib 140mg (Ibrutinib )

DESCRIPTION

Nitib 140mg   is a targeted drug aim to destroy the type of cell which has converted into cancerous orends signals which make cancerous cells develop or multiply. In lymphoma, the type of cell which becomes cancerous is called a ‘lymphocyte’ (a type of white blood cell that fights infection). There are different types of lymphocyte which can become cancerous.

Nitib 140mg   attacks B lymphocytes (B cells) and is therefore necessary to treat B-cell lymphomas.

INDICATION

Nitib 140mg   is an antineoplastic drug which is:

• Indicated for the treatment of Chronic lymphocytic leukaemia or small lymphocytic lymphoma
• Indicated for the treatment of Mantle cell lymphoma
• Indicated for the treatment of Waldenström Macroglobulinemia
• Indicated for the treatment of Marginal Zone lymphoma
• Indicated for the treatment of Graft vs Host Disease

MECHANISM OF ACTION

Ibrutinib prohibits the Bruton's tyrosine kinase (BTK)function. BTK is a basic signaling molecule of the B-cell receptor signaling complex which plays an important role in the endurance of malignant B cells.

Ibrutinib stops signals which prompt malignant B cells to develop and multiply uncontrollably.

PHARMACOKINETICS

 Absorption:
Time to peak plasma concentration of Nitib 140mg  is 1-2 hours and drug taking with food will increases ibrutinib exposure.
Distribution:
Human plasma protein level is 97.3% and Vd is 10,000L
Metabolism:
Metabolized to several metabolites mainly by cytochrome P450 CYP3A, and to a minor extent by CYP2D6
Elimination:
Nitib 140mg  was excretion via feces 80% and urine 10 %
Half-life of Nitib 140mg  is 4-6 hours

DOSAGE MANAGEMENT

Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma :
The usual dose of Nitib 140mg  is 420mg given three 140mg capsules per oral qDay
While in concomitant use with bendamustine and rituximab the prescribed dose is 420mg PO qDay administrated q28d for up to 6 cycles until progression or undesirable toxicity
Mantle Cell Lymphoma :
The usualdose of Nitib 140mg  is 560mg given four 140mg-mg capsules PO qDay.
Extend until disease progression or undesirable toxicity
Waldenström Macroglobulinemia :
The usual dose of Nitib 140mg   is 420mg given three 140mg capsules per oral qDay
When concomitant use 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 of Nitib 140mg  is 560mg given four 140mg-mg capsules PO qDay.
Extend until disease progression or undesirable toxicity
Graft vs Host Disease :
The usual dose of Nitib 140mg  is 420mg given three 140mg capsules per oral qDay
Extenduntil cGVHD development, relapsed of an underlying malignancy, or undesirable toxicity occurs

PRECAUTION

• While on treatment with Nitib 140mg   Hypertension occurs with a median time to onset of 4.6 months; regulate for new onset hypertension or hypertension that is not enough controlled after starting ibrutinib
• While on treatment with Nitib 140mg  , Tumor lysis syndrome intermittently resulted; assess the baseline risk (e.g., high tumor burden) and take suitable precautions
• While on treatment with Nitib 140mg   Other malignancies (5-14%) resulted contains carcinomas (1-3%); the most frequent second primary malignancy was nonmelanoma skin cancer (4-11%)
• When administered to a pregnant woman,based on findings in animals, can cause fetal risk
• While on treatment with Nitib 140mg  , lethal and severe cases of renal failure reported.

SIDE EFFECTS

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

DRUG INTERACTION

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

When combination of Nitib 140mg   with strong or moderate CYP3A inducers will reduces ibrutinib plasma concentrations.

CONTRAINDICATION

Hypersentivity reaction

PREGNANCY

Pregnancy category is D;
While on treatment Nitib 140mg   avoid becoming pregnancy and for up to 1 month after ending treatment.

LACTATION

Avoid breast feeding during treatment with Nitib 140mg   

STORAGE

Store the drug at 20°C- 25°C.

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.
Must consult with doctor and follow the instructions given by them