Nexavar 200mg Bayer treats patients with liver, kidney and thyroid cancer patients (6 blisters x 10 tablets)

Dosage form Box of 6 blisters x 10 tablets
Specifications Sorafenib

Ingredient

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Composition information	Content
Sorafenib	200mg

Uses

indications

Nexavar 200mg drug indicated in the following cases:

Treatment of progressive renal cell carcinoma patients. (C-Craf, Braf and Mutations Braf) and kinase on cell surface (Kit, FLT-3, Ret, Vegfr-1, Vegfr-2, Vegfr-3, and PDGFR- &). Some kinase is thought to be related to tumor cell signal, vascular birth and cell death in the cycle. Sorafenib inhibits the growth of tumor cells in the liver epithelium and kidney cells of the human kidney, the cancer of the differential thyroid disease and some other types of cancer of the micro -grafted person on the mice are damaged by the immune system. The decrease in blood vessels to the tumor and increase the death of tumor cells according to the cycle detected in liver and kidney epithelial cells, and cancer cancer differentiated. In addition, it is also noticed that the phenomenon of reducing the signal of tumor cells in cases of liver carcinoma and thyroid cancer cancer in humans.

extends the range of qt

In a clinical pharmacological study, the QT/QTC range was recorded normally in 31 patients at the beginning (before treatment) and after treatment. After a 28 -day treatment cycle at the maximum concentration of Sorafenib, the QTCB range is 4 ± 19 msec and QTCF by 9 ± 18 msec compared to the original, compared to the placebo group. No patient has a QTCB or QTCF> 500 msec after monitoring with ECG after treatment.

pharmacokinetics

absorption and distribution

After using Sorafenib tablets, relatively average bioavailability is about 38 - 49% compared to oral solution. After drinking, Sorafenib reached the peak concentration of plasma for about 3 hours. When using the same meal with a moderate amount of fat, bioavailability is equivalent to use when hungry. With a high fatty meal, Sorafenib's bioavailability decreases about 29% compared to hunger. On Vitro, the cohesion of Sorafenib with plasma proteins is 99.5%.

Metabolism and elimination

Sorafenib is metabolized mainly in the liver through oxidation and activated by CYP3A4, as well as the glucuronic complex reaction activated by UGT1A9. Combined Sorafenib can be separated in the digestive tract by bacterial glucoronic activity, which allows the reconstruction of drugs in a non -conjugated form. Simultaneous use with Neomycin will affect this process, reducing Sorafenib's average bioavailability by 54%. When taking the 100mg sorafenib solution, 98% of the dose is eliminated from the body within 14 days, with 77% of the dose excreted in the feces and 19% the dose is excreted in the urine in the form of glucuronidate metabolism. Sorafenid is not metabolized, accounting for 51% of the dose, found in feces without urine.

Sorafenib's waste time is from 25 to 48 hours.

Before taking Nexavar 200mg Bayer treats patients with liver, kidney and thyroid cancer patients (6 blisters x 10 tablets)

How to use

Tablets used by oral: Swallowing the tablet with a little water.

Dosage

Sorafenib's daily recommended doses of 400 mg (2 capsules x 200 mg) once, drink 2 times a day, can be taken without food or drink with a meal with low or medium -ratio of fat.

Treatment time

Need to be treated continuously until the patient no longer receives clinical benefits from this therapy or until the occurrence of unacceptable toxicity.

dose, dose adjustment, special recommendations

Dosage reduction for patients with patients with progressive renal cell carcinoma and liver cell carcinoma.

When suspected the adverse effects of the drug may need temporary stop or reduce the dose of Sorafenib. When it is necessary to reduce the dose during the treatment of patients with progressive renal cell carcinoma and liver carcinoma, Sorafenib dose should be reduced to 2 tablets of 200mg orally once a day.

The change of the recommended dose when the skin is toxicity is shown in Table 0.

Table 0: Table of suggestation of adjusting the recommended dose when there is toxicity on the skin of patients with liver epithelial cells and patients with kidney cell carcinoma

level appears Sorafenib dose adjustment Sorafenib.

If the toxicity recovers back to 0 - 1 after reducing the dose, increase the treatment dose at the level of recommended dose after 28 days. 400mg/day for 28 days. mg/day. Until the toxicity recovers to 0 - 1.

When returning to treatment after stopping the drug, maintaining the sorafenib treatment dose of 400mg/day for 28 days. Sorafenib dose, maintenance dose decreased to 400 mg/day.

Monitoring the suspected adverse effects of the drug may require temporary stop and/or reduce the dose of Sorafenib's treatment.

When it is necessary to reduce the dose in the treatment of differential hyperthyroidism, the sorafenib dose can be reduced to 60mg divided twice daily (two 200mg tablets and a 200mg tablet 12 hours apart).

If it is necessary to reduce the dose again, it is possible to reduce the dose of Sorafenib to 1 tablet 200mg twice each

Date, then drop to a 200mg tablet daily. After the improvement of adverse effects is not related to hematology, Sorafenib can be increased.

Table 1: The level of suggestive dose reduction for patients with cancer cancer in differentiated thyroid cancer

Dosage Sorafenib Date)

-1 600mg a day (400 mg and 200mg 12 hours apart, equivalent to 2 tablets and 1 tablet for 12 hours apart-Any dose used before) Date)

-3 200mg a day (200 mg once a day, equivalent to 1 tablet daily)

Levels appears adjust the dose of sorafenib* Sorafenib Density 2 for the first time

Immediately use measures to support and consider reducing the dose of Sorafenib to 600mg per day (400mg and 200mg per drink 12 hours apart).

If not improved, see the adjustment dose below.

does not improve within 7 days or appears a second time

stop using Sorafenib until the toxicity returns to level 0 - 1. When Sorafenib is reused, reducing the dose to a dosage level. Sorafenib is reused, reducing the dose to two levels of dosage. Dose level. Sorafenib

Special patient group:

Children

There is no safety and effectiveness of Sorafenib for a group of children.

The elderly (over 65 years old), gender and weight

Unsurprisingly adjusting the dose for age factors (over 65 years), gender or weight.

Hepatic failure

Unnecessary adjustment of the dose for patients with liver failure at Child-Pough a or b.

There is no study on the use of Sorafenib in patients with hepatic child-pugh c.

kidney failure

Unsurprisingly adjustable dose for patients with mild, medium, severe renal impairment without dialysis. There is no study on the use of Sorafenib in patients with dialysis.

Should monitor water and electrolyte balance in patients at risk of renal dysfunction.

What do

do when overdose? The highest dose of Sorafenib in clinical research is 800mg 2 times/day. The adverse effects are recorded when using this dose is mainly diarrhea and skin reaction. In case of an overdose suspected, Sorafenib should stop and take care of support.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double doses to compensate for missed dose.

Side Effects

The most important serious adverse effects include: myocardial infarction/ ischemia, gastrointestinal perforation, drug -caused hepatitis, hemorrhage and hypertension/ hypertension.

The most common adultery effects include: diarrhea, fatigue, hair loss, infection, reaction on the skin of the hands and feet (corresponding to the skin of the palms of the hand-feet in Meddra), the rash.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

contraindicated

Bivantox 200mg drug contraindicated in the following cases:

Do not use Nexavar for patients with hypersensitivity to Sorafenib or any ingredients of the drug.

Be cautious when using

Pregnant

Women avoid pregnancy during treatment with Sorafenib.

Women of reproductive age need to be notified about the harmful ability of Sorafenib to the fetus, including fetal deformities (monster births), slow development and sterile pregnancy (toxic to embryos).

Do not use Sorafenib during pregnancy. When prescribed, it is necessary to consider if the benefits bring more risk to the fetus.

Stop breastfeeding during treatment with Sorafenib.

Skin toxicity

Reaction on hands and feet (skin redness of the palms) and rash, these symptoms are the most common side effects of Sorafenib.

Rashes and reactions on the skin and feet are usually CTCAE level 1 and 2 (criteria for evaluating the common toxicity of the National Cancer Institute) and generally appears in the first 6 weeks of Sorafenib treatment.

Skin toxic treatment can use topical medications to reduce symptoms, temporary treatment and/or change the dose of sorafenib, or for severe or persistent cases, should stop using Sorafenib.

Hypertension

Increase the rate of hypertension has been recorded in patients using Sorafenib. Hypertension may be mild and medium, appear early in the early stages and easily treat with standard hypertension therapy. In case of necessity to monitor and treat hypertension regularly according to clinical practice standards. In cases of severe or persistent high blood pressure, the use of Sorafenib should be terminated.

Bleeding

Increased risk of bleeding may appear during treatment with Sorafenib. The occurrence of serious bleeding often rarely occurs. Sorafenib should be terminated for any case of bleeding to intervene by medical measures. Due to the risk of bleeding can occur, the intensive gas, bronchial and esophagus should be treated on the spot before taking Sorafenib in patients with differential thyroid cancer.

warfarin

Abnormal bleeding or increasing the Inr ratio has been reported in some patients using warfarin simultaneously with Sorafenib. These patients should be closely monitored to determine the change of prothrombin, Inr and clinical bleeding.

Complications in wound healing phase

No official research has been conducted on the effects of Sorafenib during healing wounds. In patients in the surgical stage, Sorafenib should be temporarily stopped temporarily for serious reasons. There is little clinical experience in reusing this treatment after surgery. Therefore, when deciding to reuse Sorafenib after the surgery on the surgery should be based on clinical assessments suitable for the healing phase.

ischemia and/or myocardial infarction

In the study of 11213, the rate of ischemia and/or myocardial infarction need to be treated in the treatment group with Sorafenib (4.9%) higher than the placebo group (0.4%). In the 100554 study, the rate of ischemia and/or myocardial infarction need to be treated in the treatment group with Sorafenib (2.7%) higher than the placebo group (1.3%). Patients with unstable coronary artery or myocardial infarction have not been chosen to participate in these studies recently.

Should consider stopping temporarily or permanently Sorafenib for patients who develop ischemic and/or myocardial infarction.

extends the range of qt

Nexavar shows that extending QT/QTC, which can lead to an increased risk of ventricular tachycardia. Using Sorafenib cautiously in patients with long -term progression, such as patients with congenital long -term QT syndrome, patients who have treated with high -dose anthracycline, patients treated with many tachycardia drugs or QT can be prolonged, and patients with electrolyte disorders such as hematuria, blood calcium or blood magne. When indicating nexavar for these patients, regular monitoring of ECG and electrolytes (Magne, Potassium, Calcium).

Gastrointestinal tract puncture

Democratic perforation is a rare event and the report only appears at a rate of less than 1% of Sorafenib patients. In some cases this phenomenon is not due to the manifestation of the tumor in the abdominal cavity. Sorafenib therapy can be stopped.

Hepatic failure

There is no data for patients with severe child-pough liver failure C. VI Sorafenib mainly eliminated through the liver, exposure to the drug may increase in patients with severe liver failure.

Lower blood calcium

When using Sorafenib for patients with differential thyroid carcinoma, blood calcium calcium concentration should be closely monitored. In clinical trials, blood calcium reduction is more frequent and worse in patients with differential cancer cancer, especially patients with a history of thyroid disruption, compared to patients with kidney and liver cancer.

Inhibition of TSH in patients with differential cancer cancer

In clinical trials, TSH concentration increased by 0.5mu/I recorded in patients treated with Sorafenib. When using Sorafenib for patients with differential cancer cancer, TSH concentration must be closely monitored.

The effect of drugs on driving and operating machinery

There is no evidence that Sorafenib has an influence on driving and operating machinery.

Use drugs for women during pregnancy and lactation

Pregnant women

There is no sufficient research and no control studies on the use of Sorafenib with pregnant women. Animal studies show that there is a risk of toxicity with fertility including teratogenic. In mice, Sorafenib and its metabolites have been shown to pass through the placenta involved in the inhibition of the embryo blood vessel formation.

Pregnancy should be avoided during Sorafenib treatment. Women of reproductive age should be notified of the risk of embryo, including the ability to deform embryo (monster), underdeveloped fetus and maybe the fetus (embryo poisoning).

Do not use Sorafenib during pregnancy. The prescription doctor should also consider carefully when using the drug, if the benefits of taking the drug beyond the risk of the fetus.

Women of reproductive age

In animals, Sorafenib shows the risk of teratogenic and embryo toxicity. Proper use of contraception should be used during the use of the drug and the next 2 weeks after stopping the drug.

breastfeeding

It is not clear whether Sorafenib has excreted in breast milk. With animals, sorafenib and/or its metabolites are excreted into milk. Because there are many types of excretion of breast milk in humans and due to the influence of Sorafenib on the unclear child emulsion, women should stop breastfeeding during the use of Sorafenib.

Reproduction

Results from animal studies show that Sorafenib can weaken the fertility of both male and female.

Drug interaction

UGT1A1 Road: Be careful when using Sorafenib in combination with drugs that are metabolized/excreted mainly through UGT1A1 road (eg Irinotecan).

Docetaxel: simultaneously use Docetaxel (75 or 100 mg/ m2) and Sorafenib (200 or 400mg 2 times/ day), using the regular dosage of Docetaxel with 3 days of stopping medication, showing the results of AUC (area under the curve) of Docetaxel increased from 36-80%. Caution should be careful when using Sorafenib and Docetaxel simultaneously.

Neomycin: Concomitant use with Neomycin can lead to reduced bioavailability of sorafenib.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

To be out of reach of children, read the user manual carefully before use.

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