产品介绍:

阿法替尼于2013年7月在美国上市，之后陆续在全球70多个国家获批用于治疗EGFR突变的非小细胞肺癌患者。临床试验数据显示，阿法替尼可明显延长EGFR突变的非小细胞肺癌患者的生存期。

 阿法替尼是第二代EGFR TKI（酪氨酸激酶抑制剂），与第一代可逆的EGFR TKI不同的是，阿法替尼会不可逆地与EGFR结合，从而达到关闭癌细胞信号通路、抑制肿瘤生长的目的。

 阿法替尼是第一个也是唯一一个与最好的化疗方案相比可延长最常见EGFR突变类型肺癌患者生存的TKI7-8，对一线化疗或者第一代TKI治疗（即易瑞沙、凯美纳或特罗凯）治疗失败的病人，能显著改善无进展生存期。

 阿法替尼（中文商品名吉泰瑞）于2017年2月已获中国药管局（CFDA）批准进口。此前，该药在70多个国家被批准用于治疗EGFR突变阳性非小细胞肺癌患者，并在多个国家成为了EGFR靶向药物的首选。

 阿法替尼在2016年分别获得美国FDA和欧盟批准用于治疗铂类化疗时或化疗后病情恶化的晚期肺鳞状细胞癌患者。

 碧康制药生产的Afanix是该药在全球的首仿药，也是迄今为止唯一获得政府监管机构批准合法生产的仿制药。

碧康制药由欧洲财团参与投资，是南亚地区唯一执行欧盟技术规范，并且在孟加拉两大证券交易所主板上市的大型制药企业，产品符合欧洲药典和美国药典标准。

相比其他来源不清晰的所谓同一种仿制药，即使其主要成份含量与碧康产品相接近，但由于不具备严格规范的GMP标准生产场所和政府部门的严格监管，其产品中影响药物吸收率的溶出度和生物利用度也与碧康产品具有很大差异。

 为保证用药安全，敬请谨慎选择！

适应症:

适用于晚期EGFR基因突变非小细胞肺癌的治疗和HER2阳性的晚期乳腺癌患者。阿法替尼是一种口服药物，是表皮生长因子受体(EGFR)和人表皮受体2(HER2)酪氨酸激酶的不可逆抑制剂，是第二代EGFR靶向药物。

适用于用于治疗铂类化疗时或化疗后病情恶化的晚期肺鳞状细胞癌患者。

用法与用量:

阿法替尼的推荐剂量是40mg/天，每天1次，直至疾病进展或患者无较长耐受。 口服，空腹服用，至少餐前1小时或餐后2小时服用。

EVEROLIMUS AFINITOR 10MG TABLETS : 

Everolimus is an immunosuppressant. It works by blocking the action of certain
blood cells in the immune system that may cause the body to reject the
transplanted organ. 

Afinitor 10mg Tablet is utilized as a part of breast cancer,
pancreatic cancer, lung cancer, and kidney cancer. It is likewise used to treat
certain sorts of cutting edge or dynamic cancers of the stomach, digestive
organs, or pancreas. Everolimus is additionally used to treat certain
non-malignant (considerate) cancers of the mind or kidney in individuals with a
specific hereditary condition called tuberous sclerosis complex. 

 

Afinitor 10mg Tablet Uses : 

It is used with other medications (such as cyclosporine) to prevent
rejection of a kidney transplant. Everolimus 10mg Tablet is also used with other
medications (such as tacrolimus) to prevent rejection of a liver transplant.

This drug control gives data about the Afinitor brand of
everolimus. Zortress is another brand used to avoid organ
dismissal after a kidney transplant. 

 

How Afinitor Tablet works : 

Swallow it as an entire. Try not to bite, pound or break it.
Afinitor 10mg Tablet might be taken with or without nourishment, yet it is
smarter to require it at a settled investment.

Everolimus 10mg Tablet smothers the action of the body’s
insusceptible framework and counteracts the dismissal of the transplanted organ. 

 

Side Effects of Everolimus Tablets : 

·    Get crisis therapeutic help in the event that you have any of
these indications of an unfavorably susceptible response: hives; chest pain,
troublesome breathing; swelling of your face, lips, tongue, or throat.

·     Quit utilizing Afinitor and call your specialist without a
moment’s delay in the event that you have genuine symptoms like:

·        
New or exacerbating hack, wheezing, feeling shy of breath;

·        
Cutting chest pain, hack with yellow or green bodily fluid;

·        
Seizure (shakings);

·        
White patches or wounds inside your mouth or on your lips;

·        
Swelling, quick weight pick up, urinating not as much as common or
not under any condition;

·        
Fever, Stomatitis

·        
Renal disappointment

·        
The medicine may cause your cholesterol/triglycerides or blood sugar
to increase.

Precautions and Warnings : 

·        Cooperation with
liquor is obscure. If it’s not too much trouble counsel your specialist.

·        Everolimus 10mg Tablet
is perilous to use during pregnancy.

·      There is certain
confirmation of the human fetal problem, however, the advantages from use in
pregnant women might be satisfactory regardless of the hazard, for instance in
perilous circumstances. If you don’t mind counsel your specialist

·   Afinitor 10mg Tablet
is likely hazardous to use during lactation. Constrained human information recommends
that the medication could speak to a huge hazard to the infant.

·       The medicine may
influence male or female richness; counsel your specialist on the off chance
that you are wanting to have a tyke.

·        Try not to drive
unless you are feeling great. 

·        As weakness is a
typical reaction with Afinitor and this may influence your capacity
to drive

·   The medicine sheltered to use in patients with kidney illness. No measurement
modification of the medicine is prescribed. 

·      This Tablet
ought to be utilized with alert in patients with a liver infection. Dosage
alteration of the tablet might be required. If it’s not too much
trouble counsel your specialist. 

·        Utilization of
Afinitor Tablet isn’t prescribed in patients with extreme liver disease. 

STORAGE REQUIREMENTS : 

Store at room temperature
of 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect
from light; protect from moisture. 

MEDICINE INTERACTIONS : 

Some products that may interact with this drug include: other
drugs that weaken the immune system/increase the risk of infection (such as
natalizumab, rituximab), ACE inhibitors (such as captopril, lisinopril).



Other medications can affect the removal of everolimus from your body, which
may affect how this medicine works. Examples include : 



    azole antifungals (such as itraconazole, ketoconazole),

    boceprevir,

    cobicistat,

    macrolide antibiotics (such as clarithromycin,
erythromycin),

    HIV protease inhibitors (such as atazanavir, ritonavir),

    rifamycins (such as rifabutin, rifampin),

    St. John’s wort, telaprevir, telithromycin, among others. 

ABOUT AFINITOR

AFINITOR is an immunosuppressant. It works by blocking the
action of certain blood cells in the immune system that may cause the body to
reject the transplanted organ.

 

MEDICINAL
USES

AFINITOR is used with other medications (such as
cyclosporine) to prevent rejection of a kidney transplant. Everolimus is also
used with other medications (such as tacrolimus) to prevent rejection of a
liver transplant.

AFINITOR COMMON SIDE EFFECTS:

·        
Constipation, headache, nausea, and sores in the
mouth/throat may occur. If any of these effects persist or worsen, tell your
doctor or pharmacist promptly.

·        
Tell your doctor right away if you have any
serious side effects, including: swelling hands/ankles/feet, wound problems such
as infection, slow wound healing, opening of wound.

·        
Decreased sexual ability (in men), chest
pain/pressure, shortness of breath, unusual bruising/bleeding.

·        
Everolimus may cause your
cholesterol/triglycerides or blood sugar to increase.

AFINITOR PRECAUTIONS:

·        Before taking everolimus, tell your doctor or
pharmacist if you are allergic to it; or to sirolimus or temsirolimus; or if
you have any other allergies. This product may contain inactive ingredients,
which can cause allergic reactions or other problems. Talk to your pharmacist
for more details.

·        Before using this medication, tell your doctor or
pharmacist your medical history, especially of: high cholesterol/triglyceride
levels, any recent/current infections, diabetes, liver disease, certain
hereditary enzyme problems (galactose intolerance, Lapp lactase deficiency,
glucose-galactose malabsorption).

·        Do not have immunizations/vaccinations
without the consent of your doctor. Avoid contact with people who have recently
received live vaccines (such as flu vaccine inhaled through the nose).

·        Since this medication may increase your risk of
skin cancer, avoid prolonged sun exposure, tanning booths, and sunlamps. Use a
sunscreen and wear protective clothing when outdoors.

·        Tell your doctor if you are pregnant or plan to
become pregnant. You should not become pregnant while you are taking
everolimus. Everolimus may harm an unborn baby.

·        
Ask about reliable forms of birth control while
taking this medication and for 8 weeks after stopping treatment. If you become
pregnant, talk to your doctor right away about the risks and benefit of this medication. It is unknown if this medication passes into
breast milk. Because of the possible risk to the infant, breast-feeding while
using this drug and for 2 weeks after stopping treatment is not recommended.
Consult your doctor before breast-feeding.

STORAGE REQUIREMENTS:

Store at room temperature of 25°C (77°F); excursions
permitted to 15°C to 30°C (59°F to 86°F). Protect from light; protect from
moisture.

AFINITOR INTERACTIONS:

Some products that may interact with this drug include: other
drugs that weaken the immune system/increase the risk of infection (such as
natalizumab, rituximab), ACE inhibitors (such as captopril, lisinopril).

Other medications can affect the removal of everolimus from
your body, which may affect how everolimus works. Examples include :

    azole antifungals (such as itraconazole,
ketoconazole),
    boceprevir,
    cobicistat,
    macrolide antibiotics (such as
clarithromycin, erythromycin),
    HIV protease inhibitors (such as
atazanavir, ritonavir),
    rifamycins (such as rifabutin, rifampin),
    St. John’s wort, telaprevir,
telithromycin, among others.

This document does not contain all possible drug
interactions. Keep a list of all the products you use (including
prescription/nonprescription drugs and herbal products) and share it with your
doctor and pharmacist