Ibrutix

Ibrutinib (Eco) instructions

Common name: Ibrutinib

Trade name: Eco

All names: Ibrutinib, Ibrutinib, Eco, Imbruvica, Ibrutin ib, Ibrutix, Ibrunib

Ibrutinib indications:

1. Ibrutinib single agent is suitable for the treatment of patients with mantle cell lymphoma who have received at least one treatment in the past.

2. Ibrutinib single agent is suitable for the treatment of patients with chronic lymphocytic leukemia/small lymphocytic lymphoma who have received at least one treatment in the past.

Ibrutinib specifications:

140mg

Ibrutinib usage and dosage:

Usage:

This product should be administered orally, once a day, and the daily medication time is roughly fixed. Take the entire capsule with water. Do not open, break or chew capsules.

Dosage:

1. Mantle Cell Lymphoma (MCL):

The recommended dose of this product for the treatment of MCL is 560 mg (4 140 mg capsules) once a day until disease progression or unacceptable toxicity occurs.

2. Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL):

The recommended dose of this product for the treatment of CLL/SLL is 420 mg (3 140 mg capsules) once a day until disease progression or unacceptable toxicity occurs.

Dose adjustment in the event of adverse reactions to ibrutinib:

Ibrutinib treatment should be interrupted if any grade ≥ 3 non-hematologic toxicity, grade ≥ 3 neutropenia with infection or fever, or grade 4 hematologic toxicity occurs. When symptoms of toxicity have subsided to Grade 1 or baseline levels (recovery), treatment with the drug can be restarted at the starting dose. If this toxicity recurs, the dose should be reduced by one capsule (140 mg daily). Consider a further 140 mg dose reduction if necessary. If this toxicity persists or recurs after two dose reductions, this product should be discontinued.

Dose adjustment when coadministered with P450 3A (CYP3A) enzyme inhibitors:

Avoid coadministration with strong or moderate CYP3A inhibitors, and consider using alternative drugs with less inhibitory effect on CYP3A.

Concomitant use of strong CYP3A inhibitors that require long-term administration (e.g., ritonavir, indinavir, nelfinavir, saquinavir, boceprevir, telaprevir, nefazodone) is not recommended. During short-term use (treatment duration of 7 days or less) with strong CYP3A inhibitors (e.g., antifungals and antibiotics), consider interrupting treatment with this product until use of the CYP3A inhibitor is no longer required.

If moderate CYP3A inhibitors (e.g., fluconazole, darunavir, erythromycin, diltiazem, atazanavir, aprepitant, amprenavir, fosamprenavir, crizotinib, imatinib, verapamil, and ciprofloxacin) must be used, the dose of this product should be reduced to 140 mg.

Patients receiving concomitant use of strong or moderate CYP3A inhibitors should be more closely monitored for signs of toxicity from this product.

Dose adjustment in patients with hepatic impairment:

The recommended dose in patients with mild hepatic impairment (Child-Pugh Class A) is 140 mg (1 capsule) per day. This product should be avoided in patients with moderate or severe hepatic impairment (Child-Pugh classes B and C).

Missed dose:

If you do not take this product at the planned time, you can take it as soon as possible on the same day and continue to take the medicine at the normally scheduled time the next day. Do not take extra doses to make up for a missed dose.

Eco's medication for special populations:

Liver damage:

Ibrutinib is metabolized in the liver. Data from a liver injury study showed increased exposure to ibrutinib. The AUC after a single dose of ibrutinib was increased 2.7-fold, 8.2-fold, and 9.8-fold, respectively, in patients with mild (Child-Pugh class A), moderate (Child-Pugh class B), and severe (Child-Pugh class C) hepatic impairment compared with patients with normal hepatic function.

The safety of this product has not been evaluated in cancer patients with mild to severe liver impairment according to Child-Pugh score.

Monitor patients for signs of toxicity and adjust dosage as necessary. This product is not recommended for patients with moderate or severe hepatic impairment (Child-Pugh classes B and C) (see Pharmacokinetics).

Women and men of childbearing potential:

Pregnancy test:

Female potential women should confirm their pregnancy status before initiating treatment with this product.

Contraceptive women:

It is recommended that women of childbearing potential avoid pregnancy while taking this product and within 1 month after terminating treatment with this product. Women of childbearing potential must take effective contraceptive measures while using this product. Women who use hormonal birth control methods must also use an additional barrier method. If this product is taken during pregnancy or if pregnancy occurs while taking this product, the patient should be clearly informed that this product may cause harm to the fetus. The time required for safe pregnancy after treatment with this product is not known.

Men:

It is recommended that men avoid childbirth while taking this product and within 3 months after finishing treatment.

Eco adverse reactions:

● Bleeding

● Infection

● Cytopenia

● Interstitial lung disease

● Atrial fibrillation

● Leukostasis

● Hypertension

● Secondary malignant tumors

● Tumor lysis syndrome

Yike Storage:

Store below 30℃.