Ibrutinib

Ibrutinib is developed by Johnson&Johnson and produced by Lucius, with a specification of 140mg*120 tablets.

Ibrutinib was approved by the FDA on November 13, 2013, initially for the treatment of mantle cell lymphoma.

Ibrutinib was initially approved for the treatment of mantle cell lymphoma that had received at least one previous treatment. Ibrutinib inhibits the proliferation and survival of malignant B cells by blocking the B cell receptor signaling pathway.

1.Main components

Ibrutinib

2.Adapt to the population

Ibrutinib is suitable for various hematological diseases such as Chronic Lymphatic Leukemia/Small Lymphatic Lymphoma.

3.Medication for special populations

3.1Pregnancy

Ibrutinib can cause fetal harm based on findings from animal studies. There are no  available data on Ibrutinib use in pregnant women to inform a drug-associated risk of major  birth defects and miscarriage.

3.2Lactation

Because of the potential for  serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment  with Ibrutinib and for 1 week after the last dose.

3.3Females and Males of Reproductive Potential

females

Advise females of reproductive potential to use effective contraception during treatment with  Ibrutinib and for 1 month after the last dose. 

males

Advise males with female partners of reproductive potential to use effective contraception during  treatment with Ibrutinib and for 1 month following the last dose.

3.4Pediatric Use

The safety and effectiveness of Ibrutinib have been established for treatment of cGVHD  after failure of one or more lines of systemic therapy in pediatric patients 1 year of age and older. The safety and effectiveness of Ibrutinib have not been established for this indication in  pediatric patients less than 1 year of age.

3.5Geriatric Use

No overall differences in effectiveness were observed between younger and older  patients.

3.6Hepatic Impairment

Avoid use of Ibrutinib in patients with severe hepatic impairment (Child-Pugh class C). 

3.7Plasmapheresis

Management of hyperviscosity in WM patients may include plasmapheresis before and during  treatment with Ibrutinib. Modifications to Ibrutinib dosing are not required.

4.Drug overdose

There is no specific experience in the management of ibrutinib overdose in patients.

5.Drug storage

Store tablets in original packaging at room temperature 20°C to 25°C (68°F to 77°F). Brief  exposure to 15°C to 30°C (59°F to 86°F) permitted.

6.Pharmacokinetics

Absolute bioavailability of ibrutinib in fasted condition was 2.9% (90% CI: 2.1, 3.9) in healthy  subjects. Ibrutinib is absorbed after oral administration with a median Tmax of 1 hour to 2 hours.

from FDA，2024.05