Jakavi 15mg Novartis treat patients with bone marrow fiber (4 blisters x 14 tablets)

Dosage form Box of 4 blisters x 14 tablets
Specifications Ruxolitinib

Ingredient

Composition informationContent
Ruxolitinib15mg

Uses

indicated

Jakavi is indicated to treat patients with bone marrow fibrosis, including primary marrow fibers, marrow fibers after being increased in idiopathic red blood cells or marrow fiber after radical platelet growth.

Pharmacokology

Ruxolitinib inhibits Stat3 phosphorylation caused by whole blood cytokine in healthy objects and patients with bone marrow fiber. Ruxolitinib leads to maximum inhibition of Stat3 phosphorylation after 2 -hour medication, returning to the original level at 8 o'clock in both healthy subjects and patients with bone marrow fiber, which shows no initial accumulation or active metabolites.

Initial increase in inflammatory points associated with systemic symptoms such as TNFALPHA, IL-6 and CRP in bone marrow fiber subjects decreased after treatment with Ruxolitinib. Patients with bone marrow fibers are not resistant to the pharmacological effects of Ruxolitinib treatment over time.

In a thorough study of the QT interval in healthy subjects, there is no sign of the effect of extending the QT/QTC range due to Ruxolitinib at single doses up to 200 mg dose exceeding the dose, this shows that Ruxolitinib does not affect the pole of the heart.

Dynamic pharmacokinetics

absorption

Ruxolitinib is a type 1 molecule according to the biological pharmaceutical classification system, high permeability, high solubility and fast solubility properties. In clinical studies, Ruxolitinib is quickly absorbed after oral use with maximum concentrations in plasma (CMAX) reached about 1 hour after taking the drug. Based on the study of mass balance in humans, the absorption of oral Ruxolitinib is 95% or higher. The average CMAX of Ruxolitinib and the total concentration (area under the curve, AUC) increases proportional to the single dose range from 5-200 mg. There is no clinical change in the pharmacokinetics of Ruxolitinib when used with high -fat meals. The average CMAX is moderately reduced (24%) while the average AUC is almost unchanged (up 4%) when taking the drug with a high -fat meal.

distribution

The average distribution volume is in a stable state of about 75 liters in patients with bone marrow fiber. In the concentrations of Ruxolitinib, clinical significance, cohesion to in vitro plasma protein is about 97%, mainly with albumin. A whole body's radiological study in the rat has shown that Ruxolitinib does not absorb through the brain barrier.

Biological/transformation

In vitro studies for CYP3A4 replacement are a major enzyme responsible for the metabolism of Ruxolitinib. The original compound is the main entity in humans, accounting for about 60% of the drug -related substance during the circulation. The two main and active metabolites are determined in the plasma of healthy subjects, representatives of 25% and 11% of the AUC of the original drug. These metabolites have half to 1/5 of the pharmacological activity related to Jak of the original drug.

The total of all active metabolites contributes 18% to the overall ruxolitinib pharmaceutical power. In clinical concentrations, Ruxolitinib does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4 and not a strong CYP1A2, CYP2B6 or CYP3A4 -based drug based on In vitro.

Elimination

After giving healthy adults a single dose of Ruxolitinib single -dose marked radioactive marks [14C], the excretion is mainly through metabolic with 74% radioactive activity excreted in urine and 22% excreted through fertilizer. The unchanged amount of drugs accounts for less than 1% of the total radioactive activity. The average selling time of Ruxolitinib is about 3 hours.

linear/non -linear

Proportional to the dose has been shown in single and multi -dose studies.

Special target groups

Effects of age, gender or race

Based on studies in healthy subjects, do not observe the significant difference of pharmacokinetics of Ruxolitinib in terms of gender and race. In a population pharmacokinetic assessment in patients with bone marrow fiber, there is no clear relationship between the patient's oral clearance and age or race. The clearance is 17.7 liters/hour in women and 22.1 liters/hour in men, with 39% variation between research subjects.

Children

The safety and effectiveness of Jakavi in ​​children have not been determined.

kidney failure

After taking a single -dose of Ruxolitinib 25 mg, the same pharmacokinetics in the subjects with different levels of renal failure and in people with normal kidney function. However, the AUC values ​​of the metabolites of ruxolitinib in plasma tend to increase with the severity of the kidney failure increases and most obvious in the subjects of end -stage kidney disease need hemolysis. Ruxolitinib is not removed by feces. Recommendation of adjusting the dose for patients with severe renal failure (creatinine clearance (CLCR) below 30 ml/minute). For patients with end -stage renal disease, recommend the adjustment of drugs (see the dose and usage).

liver failure

After taking a single -dose of Ruxolitinib 25 mg for patients with different levels of liver failure, pharmacokinetics and Ruxolitinib's pharmacological force have been evaluated. The average AUC of Ruxolitinib increases in mild liver failure patients 87%, in patients with average liver failure is 28%and in patients with severe liver failure is 65%, compared to patients with normal liver function and shows no clear relationship with the level of liver failure based on the Child-Pugh score. The last waste time lasts for patients with liver failure compared to a healthy control group (4.1-5.0 hours compared to 2.8 hours). Recommendations for dosage reduction for patients with hepatic failure (see the dose and usage).

Before taking Jakavi 15mg Novartis treat patients with bone marrow fiber (4 blisters x 14 tablets)

How to use

Jakavi is used orally and can be used or not with food. Dosage

Treatment with Jakavi should only be conducted by a doctor who has experience using cancer medication.

Instructions for monitoring

Total blood formula: must test the total blood formula before the beginning of Jakavi treatment.

Need to monitor the total blood formula every 2-4 weeks until the dose is stable and then clinically indicated (see the warning and cautious section).

starting dose

Jakavi's recommended starting dose is 15 mg, oral 2 times/day for patients with platelets from 100,000 - 200,000/mm3 and 20 mg, 2 times/day for patients with platelets> 200,000/mm3. The information is still limited in the recommendation of the starting dose for patients with platelets from 50,000/mm3 - 100,000/mm3. The maximum starting dose recommended in these patients is 5 mg, 2 times/day and these patients should be carefully adjusted.

dose adjustment

Dosage should be adjusted based on safety and efficiency. Treatment should be temporarily suspended when the number of platelets is below 50,000/mm3 or the absolute neutrophilic amount of less than 500/mm3. After the amount of hemorrhage recovers higher than these levels, it is possible to start taking the drug again at a dose of 5 mg, 2 times/day and gradually increasing based on careful monitoring of total blood counts.

Consider reducing the dose if the number of platelets decreases below 100,000/mm3 for the purpose of avoiding the dose interrupted because of platelet reduction.

If the effect is considered to be unqualified and the amount of full bloody can be increased by a maximum of 5 mg, 2 times/day; Maximum dose of 25 mg, 2 times/day.

Do not increase the starting dose within the first 4 weeks of treatment and then if you need to increase, you must wait at least every 2 weeks to increase once.

Instructions for use

The maximum dose of Jakavi is 25 mg, 2 times/day.

can continue to treat as much as the benefits are more than risk.

Adjust the dose when used simultaneously with strong CYP3A4 or Fluconazole inhibitors :

When Jakavi is used with strong CYP3A4 inhibitors or CYP2C9 and CYP3A4 dual inhibitors (for example, fluconazole), Jakavi's daily daily dose is reduced by about 50% by reducing the dose 2 times/day or reducing the number of drugs to 1 time/day with the corresponding dose when the dose is 2 times/day is not feasible. Avoid simultaneous use of Jakavi and Fluconazole at a dose of more than 200 mg/day (see interaction).

Recommendations are more often monitoring more frequent hematology parameters and clinical signs and symptoms of side effects associated with Jakavi when starting to take a powerful CYP3A4 inhibitor or dual inhibitors CYP2C9 and CYP3A4.

Special patient groups

kidney failure

No special dose adjustment in patients with mild or medium renal failure.

In patients with severe renal failure (creatinine clearance below 30 ml/minute), the recommended starting dose is based on the number of platelets for patients with bone marrow fiber (MF), so it is reduced to about 50%, used 2 times/day. Need to monitor patients need kidneys in safety and effectiveness during treatment with Jakavi.

Data is limited in determining the best dose options for patients with end -stage renal disease (ESRD) being dialysis. The simulation of pharmacokinetics/pharmacokinetics based on existing data in this group of patients shows that the starting dose for patients with bone marrow fibrosis (MF) with end-stage renal disease is being dialysis is a single dose of 15-20 mg or 2 doses of 10 mg used 12 hours apart, used after dialysis and only used on dialysis. Recommendation of a single -dose of 15 mg for patients with bone marrow fiber with a number of platelets from 100,000/mm3 - 200,000/mm3. It is recommended to use a single dose of 20 mg or 2 doses of 10 mg separated by 12 hours apart for patients with bone marrow fiber with a plateletic number> 200,000/mm3. The next dose (single dose or 2 doses of 10 mg used 12 hours apart) should only be used on dialysis days after each dialysis (see clinical pharmacological part).

liver failure

In patients with any level of liver failure, the recommended starting dose is based on the number of platelets should be reduced to about 50%, use 2 times/day. Need to adjust the next dose based on careful monitoring of safety and efficiency. Patients diagnosed with liver failure while treating with Jakavi need to be tested for the whole blood formula, including the ratio of white blood cells, monitoring at least every 1-2 weeks for the first 6 weeks after starting Jakavi treatment and then clinically indicated once the liver function and the amount of hemorrhage have stable. The dose of Jakavi can be adjusted to lower the risk of hemorrhage.

Children

The safety and effectiveness of Jakavi in ​​children have not been determined.

Elderly patients

No additional dose adjustments are recommended for elderly patients.

stop treatment

Can continue treatment as long as the benefits are still greater than the risk. However, the drug should be stopped after 6 months if there is no decrease in the size of the spleen or no improvement of the symptoms from the beginning of treatment.

For patients who show that there are certain clinical improvements, it is recommended to stop treatment with Ruxolitinib if they still have 40% increase in spleen length compared to the original size (nearly equivalent to a 25% increase in spleen volume) and there is no significant improvement in disease -related symptoms.

What do

do when overdose? Single doses of up to 200 mg have been used with acceptable tolerances. The repeated doses are higher than the recommended doses associated with bone marrow inhibition, including leukopenia, anemia and thrombocytopenia. Pre -treatment for appropriate support. Hemonstrology is difficult to increase Jakavi elimination.

What to do when forgetting a dose?

Side Effects

Notice the doctor with unwanted effects when using the drug.

Summary of safety characteristics

Safety assessment is based on a total of 855 patients (bone marrow fiber or another experimental indications) treated with Jakavi in ​​phase studies 2 and phase 3.

During the random treatment period of two key studies Comfort-i and Comfort-II, patients had an average time to use Jakavi of 10.8 months (about 0.3-23.5 months). Most patients (68.4%) have been treated for at least 9 months. Of the 301 patients, 111 patients (36.9%) have the initial number of platelets from 100,000/mm3 - 200,000/mm3 and 190 patients (63.1%) with the number of platelets at first> 200,000/mm3.

In these clinical studies, the drug stopped due to adverse reactions regardless of the causal relationship were observed in 11.3% of patients.

The most commonly reported adverse drug reactions are thrombocytopenia and anemia.

Hematological adverse reactions (any level according to the general term standards for adverse reactions (CTCAE)) include anemia (82.4%), platelet reduction (69.8%) and neutropenia (16.6%).

Anemia, thrombocytopenia and neutropenia are adverse effects related to the dose.

The three most common non -hematological reactions are bruising (21.6%), construction (15.3%) and headache (14.0%).

The three most common non -hematurian tests are hypernamine aminotransferase (27.2%), increased aspartat aminotransferase (19.8%) and hypercholic cholesterol (16.9%).

Long-term safety: As expected with prolonged monitoring time, the frequency of accumulation of a number of adverse reactions increases in the assessment of 3-year monitoring safety data (the time of medical use is 33.4 months in Comfort-i and Comfort-II research for patients who are randomly selected to be treated with Ruxolitinib) from 457 patients with Ruxolitini Randomly and the expansion stage of 2 key phase 3 studies. This assessment includes data from patients who are randomly selected for treatment with Ruxolitinib (n = 301) and patients who were treated with Ruxolitinib after transferring groups from control groups (n = 156). With these updated data, stop treatment due to adverse reactions that have been observed in 21.4% of patients treated with Ruxolitinib.

Describe the side effects of selective drugs

Anemia

In phase 3 clinical studies, the median time leads to the first anemia onset of level 2 or more according to CTCAE is 1.5 months. A patient (0.3%) has stopped treatment due to anemia.

In patients being treated with Jakavi, the average reduction in hemoglobin reaches the lowest level of 15-20 g/l below the initial level after 8-12 weeks of treatment and then gradually recovering to achieve a new stable state of about 10 g/l below the original level. This phenomenon is observed in patients regardless of whether they have blood transfusion during treatment or not.

In a random study, with a placebo (Comfort-I), 59.4% of patients were treated with Jakavi and 37.1% of patients treated with placebo were transmitted red blood cells during treatment. In Comfort-II study, the rate of red blood cell transmission is 51.4% in the group using Jakavi and 38.4% in the best treatment group.

platelet reduction

In phase 3 clinical studies, in patients with platelet reduction of 3 or 4 platelets, the median time leads to an onset of about 8 weeks. Platelets often recover when reducing the dose or temporary suspension of the drug. The median time until the amount of platelets is over 50,000/mm3 is 14 days. Platelet transmission has been used during a random period for 4.5% of patients taking Jakavi and 5.8% of patients are treated for control. Stop treatment due to thrombocytopenia occurs in 0.7% of patients taking Jakavi and 0.9% of patients for control. Patients with platelets 100,000/mm3 - 200,000/mm3 before starting to use Jakavi have a higher frequency of platelet reduction in 3 or 4 higher than those with platelets> 200,000/mm3 (64.2% compared to 35.4%).

Neutral leukopenia

In phase 3 clinical studies, in patients with neutropenia 3 or 4 neutropenia, the median time leads to 12 weeks onset. Temporarily suspend or reduce the dose due to neutropenia during the random stage of the study has been reported in 1.3% of patients and 0.3% of patients have stopped completely due to neutropenia.

Urinary tract infections

In phase 3 clinical studies, urinary tract infections of 3 or 4 have been reported in 1.0% of patients. Hemorrhage infections of urinary origin are reported in 1.0% of patients and kidney infections in 1 patient.

shingles (herpes zoster)

In phase 3 clinical studies, shingles (herpes zoster) level 3 or 4 has been reported in 1 patient.

Warnings

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

contraindicated

hypersensitivity to active ingredients or any excipients of the drug.

Pregnant and lactating women.

Be cautious when using

Read the instructions carefully before use. If you need more information, please consult your doctor.

This drug is only used as prescribed by a doctor.

Reduce the number of blood cells

Jakavi treatment may cause hematological side effects, including platelets, anemia and neutropenia. Total blood formula must be tested before starting Jakavi treatment. Stop treatment in patients with platelets below 50,000/mm3 or absolute neutrophilic amount of less than 500/mm3 (on the frequency of monitoring, see the dosage and usage).

Observed that patients with low platelets ( Ophthalmic reduction is often recovered and usually treated by reducing the dose or suspension of Jakavi use. However, platelets may be required when clinically indicated (see the dose and usage and side effects of the drug).

Patients with anemia may need blood transfusion. It may also be necessary to consider adjusting the dose for patients with anemia.

Patients with hemoglobin less than 10.0 g/dl at the beginning of treatment are at higher risk of hemoglobin reduction below 8.0 g/dl while treatment compared to patients with hemoglobin at the beginning higher (79.3% compared to 30.1%). It is recommended to monitor more frequent hematology parameters, clinical signs and clinical symptoms of adverse adverse reactions related to Jakavi for patients with initial hemoglobin below 10.0 g/dl.

Neutral leukemia (absolute number of neutrophils (ANC)

Need to monitor total blood formula when indicated in clinically and adjust the dose when necessary (see the dose and usage and side effects of the drug).

Infections

It is necessary to assess patients on the risk of bacterial infections, mycobacterium infection and serious virus infection. TB has been reported in patients who are taking Jakavi to treat fibroids. It should be noted about the possibility of hidden tuberculosis or active form. Jakavi treatment should not start until serious infections are resolved. The doctor should carefully monitor patients being treated with Jakavi about the signs and symptoms of the infection and start appropriate treatment immediately (see the side effect of the drug).

There has been an increase in the load of hepatitis B virus (HBV-DNA concentration) increased, and there is no increase with alanin aminotransferase and Aspartat aminotransferase in chronic HBV patients using Jakavi. It is unclear the influence of Jakavi on viral proliferation in patients infected with chronic HBV. Patients infected with chronic HBV should be treated and monitored clinical instructions.

shingles (herpes zoster)

Doctors should educate patients about the early signs and symptoms of shingles (Herpes Zoster) and recommend them to treat as soon as possible.

Multi -naval white brain disease n

Multi -naval white brain disease (PML) has been reported with the treatment of Ruxolitinib. Doctors should be alert to the symptoms of neurological-gods suggesting white brain disease progression.

Skin cancer is not melanoma

Non -melanoma skin cancer (NMSC), including basal cell cancer, scaled cell cancer and Merkel cell carcinoma has been reported in Jakavi patients. Most of these patients have a long history of treatment with hydroxyurea and have previously suffered from NMSC or have malignant skin damage. The causal relationship with Ruxolitinib has not been determined. It is recommended to regularly examine skin for patients at high risk of skin cancer.

Special patient groups

kidney failure

Should reduce the starting dose of Jakavi & patients with severe renal failure. For patients with end -stage kidney disease being secretly divided, the starting dose should be based on the number of platelets. The next dose should only be used for patients on dialysis days after each dialysis. Additional dose adjustment should be based on the safety and effectiveness of the drug (see the dosage and use and clinical pharmacological parts, special patient groups).

liver failure

Should reduce Jakavi's starting dose in patients with liver failure. Additional dose adjustment should be based on the safety and effectiveness of the drug (see the dosage and use and clinical pharmacological parts, special patient groups).

Drug interaction

If Jakavi is simultaneously used with strong CYP3A4 inhibitors or medium -sized dual inhibitors CYP2C9 and CYP3A4 (e.g. Fluconazol), the dose should be reduced by about 50% (on the frequency of monitoring, see the dose and usage and drug interactions).

Effects due to stopping drugs

After stopping treatment, symptoms associated with bone marrow fibrosis are likely to return.

The effect of the drug on driving and operating machinery

has not been conducted.

Use drugs for women during pregnancy and lactation

Women are likely to be pregnant

Pregnant women must take appropriate preventive measures to avoid pregnancy during treatment.

In the case of pregnancy, the risk/benefit assessment must be carried out on the basis of each patient with careful advice on potential risks for pregnancy by using the most updated data.

Pregnant women

There are no complete studies and strict controls about Jakavi in ​​pregnant women.

Studies on embryo development with Ruxolitinib in rats and mice do not show teratogenicity. Ruxolitinib has toxicity for embryos and toxicity for fetuses in rats (increasing embryos after nesting and losing weight of pregnancy) (see section of non -clinical safety data).

It is unclear potential risk to people. Do not recommend using Jakavi during pregnancy.

breastfeeding women

Women who are using Jakavi should not breastfeed.

In breastfeeding rats, Ruxolitinib and/or its metabolites are excreted into milk with a concentration of 13 times higher than plasma concentrations in the mother mouse. It is not clear whether Jakavi will excrete in breast milk.

fertility

There is no data in people on the effect of Ruxolitinib on fertility. In animal studies, there is no harmful effects on fertility or reproductive performance in male or female rats. In a prenatal and postpartum study in rats, fertility in the first generation mice is not affected (see the part of non -clinical safety data).

Drug interaction

Agents that change the Ruxolitinib concentration in plasma

Strong CYP3A4 inhibitors

Strong CYP3A4 inhibitors (including but not limited to: BoCeprevir, Clarithromycin, Indinavir, Itraconazole, Ketoconazol, Lopinavir/Ritonavir, Ritonavir, Mibefradil, Nefazodon, NEFAFINATAR, POSACONAZOL, SAQUINAR, TELAINTVIR, TELACHAVRE, TELACHAVRE, TELACHAVRE telithromycin, voriconazole).

In healthy subjects using Ketoconazole is a strong CYP3A4 inhibitor, at a dose of 200 mg twice a day for 4 days, the area under the curve (AUC) of Jakavi increases 91% and the sale time lasts from 3.7 to 6.0 hours.

When using Jakavi along with strong CYP3A4 inhibitors, Jakavi's daily daily dose should be reduced by about 50%.

Need to closely monitor patients to detect blood cells and should adjust the dose based on safety and effectiveness (see the dose and usage).

mild or medium inhibitors CYP3A4

Mild or medium inhibitors (including but not limited to: ciprofloxacin, erythromycin, Amprenavir, Atazanavir, Diltiazem, Cimetidin).

In healthy objects that are taking erythromycin is the average inhibitor CYP3A4, at a dose of 500 mg twice a day for 4 days, there is an increase of 27% of AUC of Jakavi.

Do not recommend adjusting the dose when Jakavi is simultaneously used with mild or medium inhibitors CYP3A4 (eg erythromycin). Patients should be closely monitored to detect blood cells at the beginning of treatment with an average CYP3A4 inhibitor.

average dual inhibitors CYP2C9 and CYP3A4 (eg fluconazole) : Based on the model on the computer, AUC (area under the curve) of Ruxolitinib is expected to increase 2.9 times and 4.3 times when treated simultaneously with Fluconazol 200 mg or 400 mg, according to the corresponding similar. The 50% dose should be considered for dual inhibitors of CYP2C9 and CYP3A4 enzymes. Avoid simultaneous use Jakavi with fluconazole at a dose greater than 200 mg/day.

CYP3A4 induction drugs

CYP3A4 induction drugs (including but not limited to: Avasimibe, Carbamazepin, Phenobarbital, Phenytoin, Rifabutin, Rifampin (Rifampicin), St. John's Wort (Hypericum Perforatum).

When starting to use a CYP3A4 induction drug, dose adjustment is not recommended. It is possible to gradually increase the dose of Jakavi if the therapeutic effect is reduced during treatment with CYP3A4.

In healthy subjects taking rifampin is a strong CYP3A4 induction drug, at a dose of 600 mg once a day for 10 days, Jakavi's AUC after taking a single dose decreased by 71% and the sale time decreased from 3.3-1.7 hours. The relative quantity of metabolites has an increased activity related to the original compound.

The influence of Ruxolitinib on other drugs

substances transported by P-GLVCoprotein or other shipping substances

Ruxolitinib can inhibit P-Glycoprotein and breast cancer-resistant protein (BCRP). This can lead to increased body concentration of substrates of these transportation such as dabigatran ether, ciclosporin, rosuvastatin and are likely to digoxin. Should monitor the concentration of medication in the blood or clinical monitoring of the affected substance.

It could be the ability to inhibit P-GP and breast cancer protein (BCRP) in the intestine can be minimized if the time between use is far apart as long as possible.

Hematopoietic growth factors

Concomitance the use of hematopoietic growth factors and Jakavi has not been studied. It is unclear whether the inhibition of Janus Associated Kinase (JAK) because Jakavi reduces the effectiveness of hematopoietic growth factors or whether hematopoietic growth factors affect the effectiveness of Jakavi.

Chemical treatment reduces cells

Simultaneous use of cells reducing cells and Jakavi has not been studied. The safety and effectiveness of simultaneous use.

substrate of CYP3A4

A study in healthy objects shows that Ruxolitinib does not inhibit the metabolism of Midazolam oral is the substrate of CYP3A4. Therefore, there is no increase in the concentration of substrates of CYP3A4 used in combination with Jakavi.

Oral contraceptive pills

A study in healthy subjects shows that Jakavi does not affect the pharmacokinetics of oral contraceptives that contain ethinylestradiol and levonorgestrel. Therefore, it is not expected to be the contraceptive effect of this form of combination will be affected by simultaneous use with Ruxolitinib.

Storage

Store in a cool, dry place, at a temperature not exceeding 30 ° C. Keep the drug in the original packaging.

Do not use overdue Jakavi is written "exp" on the packaging.

Must let Jakavi are out of reach and vision of children.

Other drugs

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