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28/11/2018
Like Takeda Pharmaceutical Company Limited (TSE:
4502) announced today that the European Commission
Marketing Authorization for ALUNBRIG (Brigatinib) as monotherapy for the
Treatment of adult patients with anaplastic lymphoma kinase
Advanced Advanced Non-Small Cell Lung Cancer (ALK)
(NSCLC) after treatment with crizotinib. decision
followed a recommendation of the Committee for Medicinal Products for Human Use
(CHMP) of 20 September 2018.
"The introduction of targeted therapies has improved considerably
ALK + NSCLC treatment conducted. Nevertheless, there is about 70 percent
patients with disease progression under crizotinib
with brain metastases show a great need for
Therapeutic Options ", Dr. Enriqueta Felip, M.D., PhD., Head of
Unit of Thoracic Oncology, Department of Oncology, Vall d'Hebron
University Hospital of Barcelona. "The in the ALTA study at the
The survey on data obtained by ALUNBRIG has proved sustainable
results of systemic and intracranial efficacy and
Manageable security profile. The study demonstrated the longest
progression-free survival and longer overall survival in
this connection. With this approval, health professionals from
The European Union, another way to treat patients
with ALK + NSCLC after previous treatment with crizotinib. "
"The decision of the European Commission, ALUNBRIG as therapy
Authorizing ALK + NSCLC patients is a significant advance for
European patients suffering from this deadly disease
suffers, "added Dr. Jesús Gómez-Navarro, MD, Vice President, Head of
Clinical Research and Development in Oncology, Takeda. "This is the first
Time spent to be evaluated by an independent review committee,
median progression-free survival of more than 16 months and one
Overall survival of 34 months after a previous
Cases of crizotinib treatment have been reported, indicating the validity of the
ALTA study data. The approval of ALUNBRIG in the EU highlights
our unwavering commitment to developing innovative solutions
that improve the quality of life of some 40,000 patients worldwide,
who are diagnosed with this disease every year. "
"Many people do not know about ALK + NSCLC and its variants.
It is also not known that young people are often
this type of lung cancer and that he does not smoke
About, "said Stefania Vallone, President of Lung Cancer
Europe. "These young people are often in full life,
have started a family, dedicate themselves to their careers and get involved
in their community. The availability of new
Treatment options that extend their life expectancy without
It is very possible to prolong the progression of the disease
important and can not be underestimated. "
The approval of the European Commission is based on data from the
A global phase 2 study on ALTA in which patients were randomized to a
of two ALUNBRIG dosing regimens: 90 mg once daily
(n = 112) or the recommended dose of 180 mg once daily
an initial seven-day phase with 90 mg once daily (n = 110). the
The results showed that 56% of patients who received the recommended treatment
Dosage pattern, judging by an independent
Review Committee (IRC) showed a confirmed overall response rate (ORR),
during the median duration of the response (DOR) according to the IRC evaluation
Was 15.7 months old. According to the IRC evaluation, ALUNBRIG caused a median loss of
progression-free survival (PFS) of 16.7 months and one
Overall survival of 34.1 months in patients with
Advanced or metastatic ALK-positive NSCLC of which
The disease under crizotinib had progressed.
Among the most common adverse events (≥ 25%) in patients treated with ALUNBRIG
at the recommended dose of 180 mg of treated patients
increase in aspartate aminotransferase (AST), hyperglycemia,
Hyperinsulinemia, anemia, creatine phosphokinase (CPK) elevated, nausea,
increased lipase, decreased lymphocyte count, increased
Alanine aminotransferase (ALT), diarrhea, increased amylase, fatigue,
Cough, headache, increased alkaline phosphatase, hypophosphatemia,
abnormally high activated partial thromboplastin time,
Rash, vomiting, dyspnea, high blood pressure, low blood levels,
Myalgia and peripheral neuropathy. The most common serious undesirable
Answers (≥ 2%) to those recommended with ALUNBRIG in the
Patients treated with the dosage were, in addition to neoplastic
Changes, pneumonia, pneumonia and shortness of breath.
The decision of the European Commission means that ALUNBRIG
now a marketing authorization for this indication in the 28 Member States
the European Union, Norway, Liechtenstein and Iceland.
Additional information on the decision of the European Commission
can be found on the website of the European Medicines Agency: www.ema.europe.eu/ema.
About the ALTA study
The ALTA Phase 2 study (ATLK in TheA G
Cancer Trial of ATP26113) was the basis for
ALUNBRIG approval for the treatment of adults. In this
An open and worldwide multicenter study of 222
Locally advanced or metastatic positive ALK patients
Non-small cell lung cancer included crizotinib treatment
had progressed. Patients received either 90 mg of ALUNBRIG
once daily (n = 112) or 180 mg once daily after one day
initial phase of seven days with 90 mg once daily (n = 110). the
The main outcome of the efficacy study was the
confirmed total response rate (ORR) according to RECIST v1.1 (Response
Evaluation Criteria for Solid Tumors), which was evaluated by the investigator.
Other targets of effectiveness include those of a
Independent Review Committee (IRC)
ORR judged, duration of response (DOR), time without progression
Survival (PFS), the intracranial ORR and the intracranial DOR, the
Security and compatibility.
The results of the ALTA study showed that among patients receiving treatment
Dose schedule of 180 mg received, 56% one
Overall response rate according to the investigator's evaluation and 56% of a ORR
according to the evaluation of the IRC. With the recommended dosage schedule
the median response time was 13.8 months
Evaluation of the investigator and 15.7 months according to the evaluation of the IRC. The median
Progression-free survival was 15.6 months according to the investigator's badessment
and 16.7 months according to the IRC evaluation. In addition, 67% of
Patients with initially measurable brain metastases (n = 18)
total intracranial response rate according to the evaluation of the IRC; the median
The duration of the intracranial response rate was 16.6 months according to
IRC evaluation. The median overall survival rate was 34.1 months.
46% of patients who received the 90 mg regimen received one
ORR according to the evaluation of the investigator and 51% according to the evaluation of the IRC. the
The median duration of response was 12.0 months
Evaluation of the investigator and 16.4 months according to the evaluation of the IRC. The median
Progression-free survival was 9.2 months, both according to the investigator's badessment and according to
IRC evaluation. In addition, 50% of patients presented at the beginning
measurable brain metastases (n = 26) a total intracranial response rate
according to the evaluation of the IRC; the median duration of the intracranial
The response rate was 9.4 months according to the evaluation of the IRC. The median
The overall survival rate was 29.5 months.
About positive NSCLC for ALK
Non-small cell lung cancer
(NSCLC) is the most common form of lung cancer. This represents approximately
85% of the approximately 1.8 million new cases of
Lung cancer, according to the World Health Organization, every year in the world
to be diagnosed. Genetic studies have shown evidence
that in a subgroup of patients with equally chromosomal NSCLC
Rearrangements affecting anaplastic lymphoma kinase (ALK)
play an important role. About three to five percent of patients
with metastatic NSCLC have a rearrangement in the ALK gene.
Takeda pledges to continue research and development
in terms of NSCLC, the quality of life of about 40,000 patients
improve this world where this type of serious and
rare lung cancer is diagnosed every year.
About ALUNBRIG® (Brigatinib)
ALUNBRIG
is a targeted cancer treatment developed by ARIAD
Pharmaceuticals, Inc. was developed in February 2017 by Takeda
acquired companies. ALUNBRIG received the
accelerated approval of the US Food and Drug Administration for treatment
patients with ALK + metastatic NSCLC in progression
during treatment with crizotinib or in case of intolerance
of Crizotinib. The approval of this indication was made in the context
an accelerated approval procedure due to the tumor response rate
and the duration of the answer. Permanent approval for this
The indication may differ from the examination and description of the clinical presentation.
The benefit depends on a confirmatory study. In July 2018 approved
Health Canada ALUNBRIG for the treatment of adult patients with
NSCLC ALK + metastatic during treatment with a
Inhibitors of ALK (crizotinib) showed progression or
Intolerance to crizotinib. Approvals
ALUNBRIG by the FDA and Health Canada were primarily based on
the results of the ALTA Phase 2 pivotal study (ATLK
in TheThe cancer Trial of ATP26113).
ALUNBRIG Receives the Revolutionary Therapy Status of the FDA
(Breaking therapy) in the treatment of patients with
ALK-positive NSCLC whose tumors are resistant to crizotinib.
In addition, the FDA has granted orphan drug status to the drug.
Treatment of ALK-positive and ROS1-positive NSCLC and
NSCLC to EGFR positive.
Brigatinib Clinical Development Program Stresses Again
Takeda continually pursues innovative therapies for
People with ALK-positive NSCLC and the health professionals they
to treat, to develop all over the world. To the complete
The study program includes the following clinical trials:
-
Phase 1/2 safety badessment study, tolerability,
Pharmacokinetics and preliminary antitumor activity of ALUNBRIG -
Phase 2 pivotal test on ALTA to test the effectiveness and
The safety of ALUNBRIG under two dosing regimens in patients with
NSCLC ALK-positive, locally advanced or metastatic, the
showed progression of the disease during treatment with crizotinib -
Phase 3 ALTA-1L, a randomized global trial to test
Efficacy and safety of ALUNBRIG compared to crizotinib
Patients with ALK-positive, locally advanced or
Metastatic NSCLC without pretreatment with ALK inhibitor -
Phase One Multicenter Single Patient Study with Japanese Patients
with ALK-positive NSCLC focusing on patients who have a
Progression of the disease under treatment with alectinib -
One-armed, global phase 2 trial to test ALUNBRIG
Patients with advanced ALK-positive NSCLC who have a
Progression of the disease under treatment with alectinib or ceritinib -
Global Phase 3 Randomized Trial to Test Efficacy and Efficacy
The safety of ALUNBRIG compared to alectinib in patients with
ALK-positive NSCLC, which involves the progression of the disease
Presented a treatment with crizotinib
More information on clinical trials with Brigatinib
You can visit www.clinicaltrials.gov.
ALUNBRIG® (Brigatinib): IMPORTANT
INFORMATION ON SECURITY (EUROPE)
SPECIAL WARNINGS AND USE PRECAUTIONS
pulmonary side effects: heavy,
deadly and fatal pulmonary side effects in the sense of a
Interstitial lung disease (interstitial lung disease) may occur.
Most of the pulmonary side effects were seen during the 7
Days of treatment determined. Side effects at grade 1-2 were after
interruption of treatment or change of dosage
fixed. Ascending age or shorter distance (under 7 years)
Days) between the last dose of crizotinib and the first
The administration of ALUNBRIG was independent of each other
Increased pulmonary side effects badociated. So these are factors
at the beginning of treatment with ALUNBRIG. at
Some patients have had pneumonia at a later date
Treatment with ALUNBRIG on. Patients are in terms of
Reappearance or worsening of breathing difficulties (eg
Respiratory distress, cough, etc.), especially during the first
Week of treatment. In all patients with increased breathing difficulties
a clarification regarding the pneumonia must be made immediately. at
Suspected pneumonia is treatment with ALUNBRIG, suspend and
the patient must be aware of other causes of the symptoms (eg
Pulmonary embolism, tumor progression and infectious pneumonia)
be. The dosage should be adjusted accordingly.
hypertension took place.
Blood pressure is normal during treatment with ALUNBRIG
control. Hypertension complies with standard guidelines for
To control the blood pressure. Heart rate is more common
to control the patient when concomitant use of a
Drug known to cause bradycardia, not avoided
may be. In case of severe hypertension (≥3), treatment with
ALUNBRIG expose up to an improvement in blood pressure to grade 1 or
the initial value occurs. The dosage should be adjusted accordingly.
bradycardia took place.
If ALUNBRIG is co-administered with other drugs,
which is known to cause bradycardia, is caution
displayed. Heart rate and blood pressure should be checked regularly.
For the symptomatic treatment of bradycardia by ALUNBRIG
suspend. Concomitant medication should be checked for active substances that
known to cause bradycardia. The dose of ALUNBRIG is
adjust accordingly after clarification. In danger of death
Bradycardia is ALUNBRIG stopped if no co-leader
Concomitant treatment is found or bradycardia recurs.
If concomitant concomitant medication is determined, then the
Change the dosage accordingly.
blurred vision are at
Treatment with ALUNBRIG took place. Patients must be informed
Report the symptoms of vision. When nine or worse
existing visual problems are an ophthalmological examination and
consider a dose reduction.
Elevations of creatine phosphokinase (CPK)
have been reported. Patients must be reported, inexplicable
Report muscle pain, tenderness or weakness. During the
ALUNBRIG treatment consists of regularly checking the level of CPK. never
the degree of increase in CPK should be interrupted with treatment with ALUNBRIG
and adjust the dosage accordingly.
Increased pancreatic enzymes: amylase
and elevations of lipase have occurred. During treatment with
ALUNBRIG should control the levels of lipase and amylase regularly.
Depending on the degree of deviation of the laboratory values, the treatment with
ALUNBRIG suspend and adjust the dosage accordingly.
hepatotoxicity: increases
hepatic enzymes (aspartate aminotransferase, alanine aminotransferase) and
Bilirubin levels were observed. Liver function, including
AST, ALT and total bilirubin should be taken before starting treatment
ALUNBRIG, then every 2 weeks during the first 3 months of treatment
to be measured. After that, the check should be done regularly
made. Depending on the degree of deviation of the laboratory values, the value of
Treatment with ALUNBRIG in suspension and dosage accordingly
adapt.
hyperglycemia: A raise
Blood sugar in the serum is produced. Before the start of
ALUNBRIG treatment corresponds to fasting blood sugar levels in the serum.
and then monitor it at regular intervals. If necessary
is to initiate treatment with hypoglycemic drugs
or to optimize. If despite adequate optimal treatment
You can not control hyperglycemia, so the
Treatment with ALUNBRIG is suspended until the appropriate control of
Hyperglycemia is reached. After the improvement is a reduction of
The dosage of ALUNBRIG or the definitive discontinuation of ALUNBRIG should be considered.
Interaction with other drugs:
Simultaneous use of ALUNBRIG with a strong
Inhibitors of CYP3A should be avoided. When simultaneous application
a potent inhibitor of CYP3A is inevitable, the
ALUNBRIG dose of 180 mg to 90 mg or 90 mg to 60 mg.
After stopping a potent inhibitor of CYP3A, treatment with
ALUNBRIG with the dose to be restarted before the start of treatment.
Treatment with potent CYP3A inhibitor. the
simultaneous use of ALUNBRIG with strong and moderate
Inducers of CYP3A should be avoided.
fertility: maternity
Women are encouraged to take effective treatment with ALUNBRIG
nonhormonal contraceptive method and use it for at least 4 months
Months after the administration of the last dose. Men with
Female partners of childbearing age are advised during treatment
with ALUNBRIG and at least 3 months after the last dose of ALUNBRIG
use effective methods of contraception.
lactose: ALUNBRIG contains
lactose monohydrate. Patients with rare hereditary diseases
Galactose intolerance, total lactase deficiency or
Glucose-galactose malabsorption should not be this medicine
take.
SIDE EFFECTS
Of the most common adverse reactions
(≥ 25%) in patients receiving ALUNBRIG at the recommended dosage
increase in AST, hyperglycemia, hyperinsulinemia,
Anemia, increased CPK, nausea, increased lipase, decreased
Number of lymphocytes, increase of ALT, diarrhea, increase of amylase, fatigue,
Cough, headache, increased alkaline phosphatase, hypophosphatemia,
increased partial ACT, rash, vomiting, respiratory distress,
Hypertension, decrease in the number of white blood cells, myalgia and
peripheral neuropathy.
The most common serious adverse reactions (≥ 2%) in patients
ALUNBRIG patients treated at the recommended dose were adjacent
Neoplastic changes include pneumonitis, pneumonia and shortness of breath.
SPECIAL POPULATIONS OF PATIENTS
Elderly patients: Limited security data
and efficacy of ALUNBRIG in the treatment of elderly patients
At least 65 years old suggest that an adaptation of the
Dosage is not necessary in the elderly. There is no
Data available for patients over 85 years old.
Limitation of liver function: A dose adjustment is included
Patients with mild hepatic impairment (Child-Pugh
Moderate hepatic impairment or Clbad A insufficiency
(Child-Pugh Clbad B) not required. In patients with severe
Hepatic insufficiency (Child-Pugh clbad C) becomes a
The initial dose of 60 mg daily for the first 7 days of treatment, thereafter
recommended a dose of 120 mg per day.
renal failure: A dose adjustment is in patients with
mild or moderate renal impairment
(estimated glomerular filtration rate (eGFR) ≥ 30 ml / min)
necessary. In patients with severe limitation of
Renal function (eGFR <30 ml / min) is an initial dose of 60 mg once
daily for the first 7 days of treatment, then a dose of 90 mg
recommended once a day. Patients with severe limitations
Kidney function is the new or the
Exacerbation of respiratory symptoms indicative of interstitial lung disease
(shortness of breath, cough, etc.), watch closely,
especially during the first week of treatment.
Children and adolescents: The safety and efficiency of
ALUNBRIG in patients younger than 18 years has not been studied. d & # 39; where
there is no data.
IMPORTANT INFORMATION ON SAFETY (USA)
WARNINGS AND
PRECAUTIONS
Interstitial pneumonitis (interstitial lung disease): heavy,
deadly and fatal pulmonary side effects in the sense of a
Interstitial lung disease (interstitial lung disease) is one of the
The ingestion of ALUNBRIG is produced. In the ALTA study (ALTA) joined a
ILD / pneumonitis in 3.7% of patients in the 90 mg (90 mg
once daily) and 9.1% of patients in the 90 → 180 mg group (180 mg
once a day with a 7-day initiation phase with 90 mg once
everyday). Side effects in the sense of a possible
ILD / pneumonitis occurred early (within 9 days of the start of
Treatment with ALUNBRIG; median start: 2 days) at 6.4% of
Patients with 3rd and 4th degree adverse effects in 2.7%
have been observed. Patients are new or
worsening breathing difficulties (shortness of breath, cough, etc.)
monitor, especially during the first week after the start of
Treatment with ALUNBRIG. Treatment with ALUNBRIG is at all
Patients with new or increased breathing difficulties
suspend, and a clarification regarding ILD / pneumonitis or
other causes of respiratory distress (eg, pulmonary embolism,
Tumor Progression and Infectious Pneumonia) should be promptly performed. at
ILD / 1st or 2nd degree pneumonitis is the treatment with ALUNBRIG after
Basic recovery with dose reduction
take or ALUNBRIG sell permanently. In ILD / pneumonitis 3.
or 4th degree or recurrence of ILD / 1st or 2nd degree pneumopathy
ALUNBRIG installs permanently.
hypertension: In the ALTA study, hypertension was reported in 11% of patients
90 mg patients receiving ALUNBRIG and 21% of patients
Patients in the 90 → 180 mg group were reported. Grade 3 hypertension occurred
in 5.9% of patients. Before starting treatment with
ALUNBRIG requires control of blood pressure. During the
Treatment with ALUNBRIG is blood pressure after 2 weeks and after
monitor at least once a month. When a
Grade 3 hypertension despite optimal antihypertensive treatment is the
Treatment with ALUNBRIG suspend. At normalization of arterial pressure
or the improvement of gravity 1 is a treatment with ALUNBRIG with
take a lower dose. In grade 4 or hypertension
The recurrence of hypertension in the 3rd degree is a definite weaning
consider treatment with ALUNBRIG. During the administration of ALUNBRIG
in combination with antihypertensives at the origin of a bradycardia
Caution is indicated.
bradycardia: In case of ALUNBRIG administration, risk of bradycardia
happen. In the ALTA study, heart rates were below
50 beats per minute in 5.7% of patients in the 90 mg group and
7.6% of patients in the 90 → 180 mg group. Bradycardia in the 2nd degree
in 1 (0.9%) patients in the 90 mg group. During treatment
ALUNBRIG monitors heart rate and blood pressure. May be
simultaneous treatment with a known medication
May cause bradycardia, patients can not avoid it
watch carefully. Symptomatic bradycardia is the
Treatment with ALUNBRIG in suspension and concomitant treatment in combination
Look for known agents to cause bradycardia
can. If a concomitant medication known to be a bradycardia
may cause, recognize and discontinue or adjust dosage
was treated with ALUNBRIG after the subsidence of
symptomatic bradycardia at the same dose.
Otherwise, the dose of ALUNBRIG is symptomatic after the disappearance of the symptom
Reduce bradycardia. Life-threatening bradycardia is
ALUNBRIG stop if no concomitant drug co-responsible
is found.
vision problems: In the ALTA study, adverse effects were reported
Visual impairment, including blurred vision, double vision and denigration
Visual acuity in 7.3% of patients treated with ALUNBRIG resulted in
90 mg group and 10% of patients in the 90 → 180 mg group
reported. Macular edema and 3rd degree cataract occurred respectively
one patient in the 90 → 180 mg group. The patients are on it
advise to report vision problems. When new or appears
Strengthening the existing 2nd or higher degree of vision is the
Treatment with ALUNBRIG suspension and an ophthalmic consultation
catch up. When 2nd or 3rd degree symptoms decrease in degrees
1 or the baseline is the treatment with ALUNBRIG in a
Take the dose. When vision disorders are in fourth grade
stop treatment with ALUNBRIG,
Increased creatine phosphokinase: The ALTA study took place in 27 countries
% of patients treated with ALUNBRIG in the 90 mg and 48%
Patients in the 90 → 180 mg group, increased creatine phosphokinase
(CPK) on. The incidence of CPK elevation in grade 3 or 4 was 2.8.
% in the 90 mg and 12% group in the 90 → 180 mg group. a
Dose reduction due to elevated CPK occurred in 1.8% of patients
the 90 mg and 4.5% group in the 90 → 180 mg group. Patients are
report unexplained muscle pain, tenderness or
weakness During treatment with ALUNBRIG, CPK level
to monitor. Treatment with ALUNBRIG is at CPK 3 elevation.
or 4th degree. When standardization or reduction of
CPK level 1 or initial, the treatment is with
ALUNBRIG at the same dose or at a reduced dose.
Increased pancreatic enzymes: The ALTA study found a
Increase in amylase in 27% of patients in the 90 mg and 39% of patients group
Patients of the group 90 → 180 mg. Elevations of lipase occurred in 21% of patients
Patients in the 90 mg and 45% group of patients
Group 90 → 180 mg. Elevations of amylase at the 3rd or 4th degree were found
in 3.7% of patients in the 90 mg group and in 2.7% of patients
in the group 90 → 180 mg. Grade 3 or 4 lipase elevations occurred
4.6% of patients in the 90 mg group and 5.5% of patients in the group
from group 90 → 180 mg. During treatment with ALUNBRIG,
Monitor the levels of lipase and amylase. Treatment with ALUNBRIG is
Suspend with elevation of pancreatic enzymes in 3rd or 4th degree. at
Normalization or decrease at degree 1 or baseline is the
ALUNBRIG treatment at the same or reduced dose
resume,
hyperglycemia: In the ALTA study, 43% of patients
the ALUNBRIG obtained, the re-emergence or strengthening of the
Hyperglycemia observed. Grade 3 hyperglycemia, determined by
A laboratory test of fasting blood glucose in serum was produced at 3.7%
patients. In 2 out of 20 (10%) patients with diabetes or
The initial glucose intolerance had to be treated with insulin
ALUNBRIG treatment. Before the start of
ALUNBRIG treatment corresponds to fasting blood sugar levels in the serum.
and then monitor it at regular intervals. If necessary
is to initiate treatment with hypoglycemic drugs
or to optimize. If adequate control of hyperglycemia
despite the optimal treatment can not be achieved, then it is
Treatment with ALUNBRIG is suspended until the appropriate control of
Hyperglycemia is reached. A reduction in the dose of ALUNBRIG or a
the definitive stop of ALUNBRIG should be considered.
Embryo-fetal toxicity: The mechanism of action and observations at the
The animals suggest that ALUNBRIG, when it is used in
Pregnancy can harm the unborn baby. There is
No clinical data on the use of ALUNBRIG during pregnancy
before. Pregnant women pose a potential risk to the fetus
to point. Women of childbearing potential are advised during treatment
use ALUNBRIG as an effective non-hormonal contraceptive method
and this for at least 4 months after the last dose
maintain. Men with partners of childbearing age are
recommended during treatment with ALUNBRIG and at least 3 months
after the last dose of ALUNBRIG effective methods for
To use contraception,
ADVERSE REACTIONS
Severe adverse reactions occurred in 38% of patients
Group of 90 mg and 40% of patients in the group 90 → 180 mg. the
The most common serious adverse reactions were pneumonia (5.5%).
in total, 3.7% in the 90 mg and 7.3% group in the 90 → 180 mg group) and
ILD / pneumonitis (4.6% overall, 1.8% in the 90 mg and 7.3% group in
the group 90 → 180 mg). Fatal adverse reactions occurred at 3.7%
included pneumonia (2 patients), more sudden
Death, respiratory distress, respiratory failure, pulmonary embolism, bacterial
Meningitis and urosepsis (1 patient each).
Les réactions indésirables les plus courantes (≥ 25%) dans le groupe 90 mg
nausées (33%), fatigue (29%), maux de tête (28%) et
Essoufflement (27%). Nausées (40%) dans le groupe 90 à 180 mg
Diarrhée (38%), fatigue (36%), toux (34%) et mal de tête (27
%).
INTERACTIONS AVEC D'AUTRES MEDICAMENTS
Les inhibiteurs de CYP3A: Le simultané
L'utilisation d'ALUNBRIG avec des inhibiteurs puissants du CYP3A doit être évitée.
Sur le pamplemousse ou le jus de pamplemousse doit être abandonné, car ceux-ci aussi
Une augmentation du niveau plasmatique de Brigatinib peut entraîner. If the
L’utilisation concomitante d’un puissant inhibiteur du CYP3A est inévitable
est d'abaisser la dose d'ALUNBRIG.
CYP3A inducers: Le simultané
L'utilisation d'ALUNBRIG avec des inducteurs puissants du CYP3A doit être évitée.
des substrats de CYP3A: The commune
Administration d'ALUNBRIG avec des substrats du CYP3A, y compris des médicaments hormonaux
Les contraceptifs peuvent entraîner une baisse des taux et la perte de
Efficacité des substrats du CYP3A.
APPLICATION À DES POPULATIONS PARTICULIÈRES DE PATIENTS
grossesse: ALUNBRIG peut devenir un
Dommage pour la vie à naître. Les femmes en âge de procréer sont sur
indiquer le risque potentiel pour le fœtus.
Allaitement: Il n'y a pas de données à transférer de
Brigatinib in die Muttermilch, zu den Auswirkungen auf den gestillten
Säugling oder die Beeinflussung der Milchproduktion vor. Wegen der
möglichen unerwünschten Reaktionen beim gestillten Säugling ist
stillenden Frauen davon abzuraten, während der Behandlung mit ALUNBRIG
zu stillen.
Gebärfähige Frauen und zeugungsfähige Männer:
Schwangerschaftsverhütung: Gebärfähigen
Frauen ist anzuraten, während der Behandlung mit ALUNBRIG eine wirksame
nicht-hormonelle Verhütungsmethode anzuwenden und diese für mindestens 4
Monate nach Gabe der letzten Dosis beizubehalten. Männern mit
Partnerinnen im gebärfähigen Alter ist anzuraten, während der Behandlung
mit ALUNBRIG und mindestens 3 Monate nach der letzten ALUNBRIG-Dosis
wirksame Methoden zur Schwangerschaftsverhütung anzuwenden.
Infertilität: ALUNBRIG kann bei Männern zu
herabgesetzter Fertilität führen.
Kinder und Jugendliche: Zur Sicherheit und Wirksamkeit von
ALUNBRIG bei pädiatrischen Patienten liegen keine Daten vor.
Ältere Patienten: In die klinischen Studien zu ALUNBRIG wurden
nicht genügend Patienten im Alter von mindestens 65 Jahren aufgenommen,
um einen Unterschied in deren Ansprechen im Vergleich zu jüngeren
Patienten beurteilen zu können. Von den 222 Patienten in der ALTA-Studie
waren 19,4 % in der Altersgruppe 65-74 Jahre und 4,1 % waren mindestens
75 Jahre alt. Es wurden keine klinisch relevanten Unterschiede
hinsichtlich der Sicherheit oder Wirksamkeit zwischen Patienten ≥ 65
Jahre und jüngeren Patienten festgestellt.
Einschränkungen der Leber- oder Nierenfunktion: a
Dosisanpbadung wird bei Patienten mit leichten Einschränkungen der
Leberfunktion oder leichten bis mittelschweren Einschränkungen der
Nierenfunktion nicht empfohlenen. Die Sicherheit von ALUNBRIG bei
Patienten mit mittelschweren bis schweren Einschränkungen der
Leberfunktion oder schweren Einschränkungen der Nierenfunktion wurde
nicht untersucht.
Die vollständigen US-Verschreibungsinformationen zu ALUNBRIG finden
Sie unter www.ALUNBRIG.com
Über die Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited ist ein global tätiges,
forschungs- und entwicklungsorientiertes Pharmaunternehmen, das sich für
bessere Gesundheit und eine bessere Zukunft für Patienten einsetzt,
indem es wissenschaftliche Erkenntnisse in lebensverändernde Medikamente
umwandelt. Takeda konzentriert seine Forschungs- und
Entwicklungsbemühungen auf Onkologie, Gastroenterologie, Impfstoffe und
mit dem Zentralnervensystem zusammenhängende Therapiebereiche sowie
Impfstoffe. Takeda führt sowohl intern als auch über Partner Forschungs-
und Entwicklungsaufgaben aus, um dadurch bei Innovationen an vorderster
Front zu bleiben. Neue innovative Produkte, insbesondere in der
Onkologie und Gastroenterologie, sowie seine Präsenz in Wachstumsmärkten
treiben das Wachstum von Takeda voran. Mehr als 30.000 Mitarbeiter
setzen sich bei Takeda für die Verbesserung der Lebensqualität von
Patienten ein und arbeiten in über 70 Ländern mit Partnern im dortigen
Gesundheitswesen zusammen. Weitere Informationen finden Sie unter http://www.takeda.com/news.
Weitere Informationen über Takeda finden Sie auf der Unternehmenswebsite
unter www.takeda.com.
Weitere Informationen über Takeda Oncology, die Marke für die globale
Onkologie-Sparte von Takeda Pharmaceutical Company Limited, finden Sie
unter www.takedaoncology.com.
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List of live clbades, BSNgine
Stocks on the radar: Valneva . Rosenbauer . Mayr-Melnhof . Zumtobel . RBI . Wienerberger . Telekom Austria . S & T . Petro World Technologies . Semperit . Agrana . Andritz . Palfinger . SBO . Souche Oberbank AG ,
Random partner
OMV
Die OMV fördert und vermarktet Öl und Gas, Energielösungen und petrochemische Produkte. Mit einem Konzernumsatz von 19 Mrd. Euro und einem Mitarbeiterstand von rund 22.500 im Jahr 2016 ist die OMV Aktiengesellschaft eines der größten börsennotierten Industrieunternehmen Österreichs.
>> Visit 64 other partners on boerse-social.com/partner
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