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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

·        This medicine contains Doxorubicin hydrochloride, which belongs to a group of medicines called cytotoxics used for chemotherapy. This medicine causes cells such as cancer cells that are actively growing, to slow or stop their growth and increases the likelihood that they die. Adriblastina treatment helps to selectively kill the cancer tissue rather than normal, healthy tissue. It can be used in both adults and children.

·        Adriblastina is used to treat a variety of cancers, either alone or in combination with other drugs. The way in which it is used depends upon the type of cancer that is being treated.

·        It has been found to be particularly useful in the treatment of cancers of the breast, bone, ovaries, bladder, thyroid, stomach, nerves, and lung. In addition, this medicine can be given to treat cancers of the blood forming tissues such as malignant lymphomas and leukaemia.

·        You must talk to a doctor if you do not feel better or if you feel worse.


Do not use Adriblastina if you have:

·        If you have an allergy (hypersensitivity) to Adriblastina, other similar medicines called anthracyclines or anthracenediones or any of the other ingredients of this medicine (listed in section 6).

·        If you have low blood cell counts, as it can lower them further.

·        If you have previously been treated with Adriblastina or similar chemotherapy drugs like pharmorubicin, idarubicin, epirubicin or danuorubicin as previous treatment with these similar medicines can increase the risk of side effects with this medicine.

·        If you have suffered from severe heart trouble in the past, or are presently receiving treatment for this.

·        If you have severe liver problems.

 

Warnings and precautions

Talk to your doctor, pharmacist or nurse before being given Adriblastina. Your doctor will assess your health carefully before prescribing this medicine. Make sure your doctor knows before you start taking Adriblastina:

·        If you have or have ever had heart disease, either before or during radiotherapy

·        If you have had or are due to have live or live-attenuated vaccinations.

·        If you are currently taking or have recently taken Trastuzumab (a medicine used in the treatment of certain cancers). Trastuzumab can remain in the body for up to 7 months. As trastuzumab may affect the heart, you should not use doxorubicin for up to 7 months after you have stopped taking trastuzumab. If doxorubicin is used before this time, then your heart function should be carefully monitored.

 

Adriblastina may also cause the following:

·        Decreased blood cells and bone marrow function

·        Abnormal cell growth and infertility

·        Blood found in the urine

·        Severely impaired liver function

·        Damage to body tissue including that of the heart, skin, liver and the thin layer which lines the body cavities and passages

·        Clotting blockages in blood flow

·        High levels of uric acid in the blood

Refer to section 4 for further information.

 

Other Anti-cancer Medicines

Problems are more likely to occur if you have been given other anticancer medicines especially at high doses just before or at the same time as Adriblastina. You will be given time to recover from the effects of the anticancer drug before you begin treatment with this medicine. Your doctor will want to monitor you carefully during and after treatment (see section 3 for more information).

 

Other medicines and Adriblastina

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, particularly any of the following:

·        Some medicines effect the concentration and clinical effect of Adriblastina. (e.g. verapamil, phenobarbital, phenytoin, St. John’s Wort). Please tell your doctor or pharmacist if you are taking any of these medicines.

·        Cyclosporine: which can make the effects of Adriblastina stronger and may result in prolonged decrease in bone marrow and blood cells (coma and seizures have also been described with concomitant administration of cyclosporine and Adriblastina).

·        Calcium Channel Blockers: medicines for your heart.

·        Sorafenib: used to treat inoperable liver cancer and advanced kidney cancer.

·        Paclitaxel: which can make the effects of Adriblastina stronger

 

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before being given this medicine because it may cause birth defects.

If you are sexually active, you are advised to use effective birth control to prevent pregnancy during treatment, whether you are male or female.

 

Breast-feeding

You should stop breast-feeding before starting treatment with this medicine as some of the drug may get into your breast milk and possibly harm your child.

 

Driving and using machines

There are no special precautions and you can drive and operate machinery as long as you feel fully recovered following your hospital treatment.

 

Adriblastina contains sodium

 

Doxorubicin 10mg/5ml, and 50 mg/25 ml contain 17.7 mg, and 88.5 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 0.9%, and 4.43% of the recommended maximum daily dietary intake of sodium for an adult, respectively.


If you are prescribed Adriblastina it will only be given to you by doctors or nurses experienced in giving chemotherapy.

 

This medicine will be given to you by a doctor or nurse through a drip (infusion) into a vein. Your doctor will decide what dose to give and the number of days treatment you will receive depending on your condition.

 

The dose is decided by taking into account the condition you have, your height and weight. From your height and weight the doctor will work out your body surface area; and it is this that your dose is calculated from.

 

While one course of treatment may sometimes be enough, more often your doctor will advise further courses in either one, three or four weeks time. It may take several courses before your illness is under control and you feel better.

 

Regular checks by your doctor during your treatment with Adriblastina solution

 

During treatment your doctor will be making regular checks of your:

·        Blood: To check for low blood cell counts that may need treatment.

·        Heart Function: Heart damage can occur when high doses of Adriblastina are given. This may not be detected for several weeks; so regular tests may be required during this period.

·        Liver: Using blood tests, your doctor will check that this medicine is not affecting the way it functions in a harmful way.

·        Blood uric acid levels: Adriblastina may increase uric acid levels in the blood which might cause gout.  Another medicine may be given if your uric acid levels are too high.

 

If you receive high doses of Adriblastina

High doses can worsen side effects like sores in the mouth or may decrease the number of white blood cells (which fight infection) and platelets (these help the blood to clot) in the blood. Should this happen, you may need antibiotics or blood transfusions. Mouth ulcers can be treated to make them less uncomfortable as they heal.


Like all medicines, this medicine can have side effects although not everybody gets them.

 

Please contact your doctor or nurse immediately if you notice any of the following side effects:

·        Feeling dizzy, feverish, short of breath with a tight chest or throat or have an itchy rash. This type of allergic reaction can be very serious.

·        Anaemia (a low red blood cell count) that can leave you feeling tired and lethargic.

·        White blood cell counts (which fight infection) can also drop, increasing the chance of infections and a raised temperature (fever).

·        Platelets (these are cells that help the blood to clot) can be affected which could make you bruise or bleed more easily. It is important to seek medical advice if this happens. Your doctor should test your blood cell count during treatment.

·        Adriblastina may also cause decreased activity in your bone marrow.

 

Other side effects that may occur are as follows:

Very common: may affect more than 1 in 10 people

·      Infection

·      Lack of appetite.

·      Inflammation in the mouth, diarrhoea, feeling sick (nausea) being sick (vomiting).

·      Reddening, swelling, numbness, pain and tingling in the palms and feet may also occur whilst being treated with Adriblastina.

·      Hair loss is common and may be quite severe. Beard growth may stop in men. Hair normally re-grows when your treatment course ends.

·      Fever, feeling weak, chills.

·      Abnormal ECG (this is an electrical trace of your heart) results.

·      Raised levels of liver enzymes (as detected by a blood test) can determine if the medicine is having an abnormal effect on your liver.

·      Weight increased in patients with early breast cancer.

 

Common: may affect up to 1 in 10 people

·      Blood poisoning.

·      You may notice your heart beating abnormally quickly, with an increase in pulse rate. In some cases, you may notice heart problems several months or years after medication has been completed.

·      Conjunctivitis (usually causing red watery eyes), excess tear production.

·      Heart failure which can be associated with the symptoms of shortness of breath and swelling of the ankles.

·      Increased heart rate, inflammation of the throat and gullet, stomach pain, skin rashes, redness, hives, nails and skin may appear darker than usual.

·      Redness and swelling may develop at site of injection.

 

Uncommon: may affect up to 1 in 100 people

·      Embolism (a blockage in the bloodstream).

 

Not known: (frequency cannot be estimated from the available data)

·      Dehydration, increased uric acid in your urine, inflamed cornea, watery eyes, general discomfort.

·      Increased heart rate, chest pain which could indicate heart problems, shock (low blood pressure and circulation), internal bleeding.

·      Inflammation of veins, blockage of a blood vessel by a clot (thromboembolism), hot flushes.

·      Irritation or bleeding in the intestines, inflammation of the lining of the stomach, heartburn, soreness or ulcers in the mouth, which may not appear until 3-10 days after treatment, discoloration inside the mouth.

·      Increased sensitivity of the skin to the sunlight

·      Inflammation reaction, which could occur soon after treatment or years later, itchy skin and other skin disorders.

·      Reddening of your urine, (which is normal and related to the colour of the medicine). You should inform your doctor if it does not stop in a few days or you think there is blood in your urine. Let your doctor know if you get these symptoms.

·      In women, Adriblastina may cause infertility during the time the drug is taken. Women may also find that their periods stop, but their periods should return to normal after medication is stopped. In some cases early menopause can occur.

·      In men, Adriblastina may cause an absence or decrease in sperm count, but this may return to normal after medication is stopped. Both men and women taking Adriblastina should use effective contraceptive methods.

 

Reporting of side effects

 

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

 

To report any side effect:

 

·        Saudi Arabia

 

National Pharmacovigilance Centre (NPC)

  • SFDA Call center: 19999
  • E-mail: npc.drug@sfda.gov.sa
  • Website: https://ade.sfda.gov.sa/

 

·        Other GCC States

 

-    Please contact the relevant competent authority.

 


·        Stored at between 2° - 8° C (in the refrigerator.) Do not freeze. Protect from light.

·        The unopened vials should be stored in the original container in a fridge until ready for use.

·        Keep out of the sight and reach of children.

·        This medicine should not be used after the expiry date printed on the box and on the vial after EXP. The expiry date refers to the last day of that month. The pharmacist will check this when your medicine is prepared for you. If the solution is cloudy after preparation, the pharmacist will dispose of it safely.

·        In-use shelf-life and in-use storage instructions:

From a microbiological point of view, the product should be used immediately.  If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless reconstitution/dilution (etc) has taken place in controlled and validated aseptic conditions


The active substance is Doxorubicin hydrochloride. The other ingredients are sodium chloride,  water for injections and hydrochloric acid.


Adriblastina solution for injection is a red liquid in single plastic vials containing 2 mg/ml of the active ingredient, Adriblastina hydrochloride.

Marketing Authorisation Holder

Pfizer Australia Pty Ltd, Australia

 

Manufacturer:

Pfizer (Perth) Pty Limited, Bentley, Australia


February 2021
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

·        يحتوي هذا الدواء على هيدروكلوريد دوكسوروبيسين، الذي ينتمي إلى مجموعة من الأدوية تُسمى الأدوية السامة للخلايا وتُستخدم للعلاج الكيميائي. يتسبب هذا الدواء في إبطاء أو إيقاف نمو خلايا مثل الخلايا السرطانية التي تنمو بشكل نشط، ويزيد من احتمال موتها. يساعد علاج أدريبلاستينا على قتل الأنسجة السرطانية بشكل انتقائي بدلًا من الأنسجة الصحية الطبيعية. ويمكن استخدامه في كلٍ من البالغين والأطفال.

·         يُستخدم أدريبلاستينا لعلاج مجموعة متنوعة من السرطانات، إما بمفرده أو بالتزامن مع عقاقير أخرى. وتعتمد الطريقة التي يُستخدم بها على نوع السرطان الذي تتم معالجته.

·         وقد وُجد أنه مفيد بشكل خاص في علاج سرطانات الثدي والرئة. بالإضافة إلى ذلك، يمكن إعطاء هذا الدواء لعلاج السرطانات التي تصيب الأنسجة المكونة للدم مثل سرطانات الغدد الليمفاوية الخبيثة وابيضاض الدم.

·         يجب أن تتحدث إلى أحد الأطباء إذا لم تشعر بتحسن أو إذا ساءت حالتك.

 لا تستخدم أدريبلاستينا إذا كنت مصابًا بما يلي:

·         إذا كنت مصابًا بالحساسية (فرط الحساسية) تجاه أدريبلاستينا أو الأدوية الأخرى المماثلة التي تُسمى مركبات الأنثراسيكلين أو الأنثراسينيديون أو أي من المكونات الأخرى لهذا الدواء (المدرجة في القسم 6).

·         إذا كان لديك انخفاض في تعداد خلايا الدم، لأن الدواء يمكن أن يسبب انخفاضها بشكل أكبر.

·         إذا تم علاجك من قبل بأدريبلاستينا أو عقاقير علاج كيميائي مماثلة مثل فارموروبيسين أو إيداروبيسين أو إبيروبيسين أو دانوروبيسين، حيث أن العلاج السابق بهذه الأدوية المماثلة يمكن أن يزيد من خطر حدوث الآثار الجانبية لهذا الدواء.

·         إذا كنت قد عانيت من مشكلة شديدة في القلب في الماضي، أو كنت تتلقى علاجًا لهذا الأمر الآن.

·         إذا كنت تعاني من مشكلات شديدة في الكبد.

 

 تحذيرات واحتياطات

تحدث مع طبيبك أو الصيدلي أو الممرضة قبل أن يتم إعطاؤك أدريبلاستينا. وسيقوم طبيبك بتقييم حالتك الصحية بعناية قبل وصف هذا الدواء. تأكد من أن طبيبك يعرف الأمور التالية قبل أن تبدأ في تناول أدريبلاستينا:

·        إذا كنت مصابًا أو سبق أن أصبت بمرض في القلب، سواء قبل العلاج الإشعاعي أو أثنائه

·        إذا كنت قد تلقيت أو على وشك تلقي لقاحات حية أو لقاحات حية موهنة.

 

يمكن أن يسبب أدريبلاستينا أيضًا الأمور التالية:

·        انخفاض في عدد خلايا الدم ووظائف نخاع العظم

·        نمو غير طبيعي للخلايا وعقم

·        وجود دم في البول

·        خلل شديد في وظائف الكبد

·        تلف في أنسجة الجسم بما في ذلك أنسجة القلب والجلد والكبد والطبقة الرقيقة التي تبطن مسارات وتجاويف الجسم

·        انسدادات تخثرية في تدفق الدم

·        ارتفاع مستويات حمض اليوريك في الدم

راجع القسم 4 لمزيد من المعلومات.

 

 الأدوية الأخرى المضادة للسرطان

تزيد احتمالية حدوث المشكلات إذا كان قد تم إعطاؤك أدوية أخرى مضادة للسرطان خاصةً إذا كانت الجرعات عالية، قبل إعطائك أدريبلاستينا مباشرةً أو في نفس الوقت. سيتم إعطاؤك وقتًا للتعافي من آثار العقار المضاد للسرطان قبل أن تبدأ العلاج بهذا الدواء. وسيرغب طبيبك في مراقبتك بعناية أثناء العلاج وبعده (انظر القسم 3 لمزيد من المعلومات).

 

 الأدوية الأخرى وأدريبلاستينا

يُرجى إخبار طبيبك أو الصيدلي إذا كنت تأخذ أو أخذت مؤخرًا أو قد تأخذ أي أدوية أخرى، بما في ذلك الأدوية التي تصرف بدون وصفة طبية، وبشكل محدد إذا كنت تأخذ أيًا من الأدوية التالية:

·         بعض الأدوية التي تؤثر على تركيز أدريبلاستينا وتأثيره الإكلينيكي. (مثل فيراباميل، فينوباربيتال، فينيتوين، نبتة سانت جون). لذا يُرجى إبلاغ طبيبك أو الصيدلي إذا كنت تأخذ أيًا من هذه الأدوية.

 

·         سيكلوسبورين: حيث يمكنه أن يجعل تأثيرات أدريبلاستينا أقوى وقد يتسبب في انخفاض نخاع العظم وعدد خلايا الدم لفترة مطولة (تم وصف حدوث غيبوبة ونوبات أيضًا عند الاستعمال المتزامن لسيكلوسبورين وأدريبلاستينا).

·         حاصرات قنوات الكالسيوم: وهي أدوية لعلاج قلبك.

·        سورافينيب: يُستخدم لعلاج سرطان الكبد الذي لا يمكن علاجه جراحيًا وسرطان الكلى المتقدم.

·        باكليتاكسيل: حيث يمكنه أن يجعل تأثيرات أدريبلاستينا أقوى

 

 الحمل

 إذا كنتِ حاملًا أو ترضعين رضاعة طبيعية أو تعتقدين أنكِ قد تكونين حاملًا أو تخططين للحمل، فاستشيري طبيبكِ أو الصيدلي قبل أن يتم إعطاؤكِ هذا الدواء لأنه قد يسبب عيوبًا ولادية.

إذا كنت نشطًا جنسيًا، يُنصح باستخدام وسيلة فعالة لمنع الحمل أثناء العلاج، سواء كنت ذكرًا أو أنثى.

 الرضاعة الطبيعية

 ينبغي عليكِ إيقاف الرضاعة الطبيعية قبل بدء العلاج بهذا الدواء نظرًا لأن بعض العقار قد ينتقل إلى لبن الثدي لديكِ ويمكن أن يؤذي طفلكِ.

 

 القيادة واستخدام الآلات

 ليس هناك احتياطات خاصة ويمكنك القيادة وتشغيل الآلات طالما كنت تشعر بأنك قد تعافيت تمامًا عقب علاجك في المستشفى.

 

 يحتوي أدريبلاستينا على الصوديوم

يحتوي هذا المنتج الدوائي على أقل من 1 مل مول من الصوديوم (23 مجم) لكل جرعة، أي أنه يُعد خاليًا من الصوديوم.

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 إذا تم وصف أدريبلاستينا لك، فسيتم إعطاؤك إياه فقط بواسطة الأطباء أو الممرضات ذوي الخبرة في إعطاء العلاج الكيميائي.

 

 سيقوم أحد الأطباء أو إحدى الممرضات بإعطائك هذا الدواء من خلال التنقيط (التسريب) داخل أحد الأوردة. وسيقرر طبيبك ما الجرعة التي سيعطيها لك وعدد الأيام التي ستتلقى فيها العلاج بناءً على حالتك.

 

 تُحدد الجرعة بالأخذ في الاعتبار حالتك المرضية وطولك ووزنك. سيحدد الطبيب مساحة سطح جسمك عن طريق طولك ووزنك؛ وهذا ما ستُحسب من خلاله الجرعة التي ستتلقاها.

 

 في حين أن دورة علاج واحدة قد تكون كافية في بعض الأوقات، إلا أنه غالبًا ما سينصح طبيبك بدورات علاج إضافية في غضون أسبوع أو ثلاثة أو أربعة أسابيع. وقد يستغرق الأمر عدة دورات علاج قبل أن يصبح مرضك تحت السيطرة وتشعر بالتحسن.

 

 الفحوصات المنتظمة التي يجريها طبيبك أثناء علاجك بمحلول أدريبلاستينا

 

 أثناء فترة علاجك سيجري طبيبك فحوصات منتظمة لـ:

·         دمك: للتحقق من عدم انخفاض تعداد خلايا دمك، الأمر الذي قد يتطلب العلاج.

·         وظائف قلبك: يمكن أن يحدث تلف قلبي عند إعطاء جرعات عالية من أدريبلاستينا. وقد لا يتم اكتشاف هذا لعدة أسابيع؛ لذا قد يلزم إجراء اختبارات منتظمة أثناء هذه الفترة.

·         كبدك: باستخدام فحوصات الدم، سيتحقق طبيبك من أن هذا الدواء لا يؤثر بشكل مؤذٍ على الطريقة التي يعمل بها الكبد.

·         مستويات حمض اليوريك في دمك: يمكن أن يزيد أدريبلاستينا من مستويات حمض اليوريك في الدم مما قد يتسبب في الإصابة بالنقرس.  قد يتم إعطاؤك دواء آخر إذا كانت مستويات حمض اليوريك لديك مرتفعة للغاية.

 

 إذا تلقيت جرعات عالية من أدريبلاستينا

يمكن أن تسبب الجرعات العالية تفاقم الآثار الجانبية مثل التقرحات في الفم أو قد تقلل من عدد خلايا الدم البيضاء (التي تحارب العدوى) والصفيحات الدموية (التي تساعد الدم على التخثر) في الدم. إذا حدث هذا، فقد تحتاج إلى تلقي مضادات حيوية أو عمليات نقل دم. يمكن علاج قرح الفم لجعلها أقل إزعاجًا أثناء التئامها.

كما هو الحال بالنسبة لجميع الأدوية، يمكن أن يكون لهذا الدواء آثار جانبية إلا أنها لا تصيب الجميع.

 

 يُرجى التواصل مع طبيبك أو الممرضة على الفور إذا لاحظت أيًا من الآثار الجانبية التالية:

·         الشعور بالدوار أو الحمى أو ضيق التنفس مع ضيق في الصدر أو الحلق أو الإصابة بطفح جلدي مثير للحكة. يمكن أن يكون هذا النوع من تفاعلات الحساسية خطيرًا للغاية.

·         فقر الدم (انخفاض في تعداد خلايا الدم الحمراء) الذي يمكن أن يتسبب في شعورك بالتعب والخمول.

·         وأيضًا يمكن أن ينخفض تعداد خلايا الدم البيضاء (التي تحارب العدوى)، مما يزيد من فرصة الإصابة بالعدوى وارتفاع درجة الحرارة (الحمى).

·         يمكن أن تتأثر الصفيحات الدموية (وهي خلايا تساعد الدم على التخثر)، والذي قد يجعلك تتكدم أو تنزف بسهولة أكبر. من المهم أن تحصل على استشارة طبية إذا حدث هذا. ينبغي أن يقوم طبيبك باختبار تعداد خلايا الدم لديك أثناء فترة العلاج.

·        يمكن أن يسبب أدريبلاستينا انخفاض النشاط في نخاع عظمك أيضًا.

 

 الآثار الجانبية الأخرى التي قد تحدث هي كما يلي:

شائعة جدًا: قد تصيب أكثر من شخص واحد من بين كل 10 أشخاص

·      العدوى

·      فقدان الشهية.

·      التهاب في الفم، الإسهال، الشعور بالرغبة في التقيؤ (الغثيان)، القيء.

·       يمكن أيضًا أن يحدث احمرار وتورم وشعور بالخدر والألم والوخز في الراحتين والقدمين أثناء العلاج بأدريبلاستينا.

·      تساقط الشعر شائع وقد يكون شديدًا إلى حد كبير. وقد يتوقف نمو اللحية لدى الرجال. عادة ما يعاود الشعر النمو عندما تنتهي دوراتك العلاجية.

·      الحمى، الشعور بالضعف، القشعريرة.

·      نتائج غير طبيعية لاختبار رسم القلب (ECG) (وهو عبارة عن متابعة كهربية لنشاط قلبك).

·      يمكن أن تحدد مستويات إنزيمات الكبد المرتفعة (كما يتم الكشف عنها بواسطة فحص دم) ما إذا كان الدواء يؤثر بشكل غير طبيعي على كبدك أم لا.

·      زيادة الوزن في المرضى المصابين بحالة مبكرة من سرطان الثدي.

 

شائعة: قد تصيب ما يصل إلى شخص واحد من بين كل 10 أشخاص

·      تسمم الدم.

·      قد تلاحظ أن قلبك ينبض بسرعة بشكل غير طبيعي، مع زيادة في معدل النبض. وفي بعض الحالات، قد تلاحظ وجود مشكلات قلبية بعد إكمال العلاج بعدة شهور أو سنوات.

·      التهاب الملتحمة (عادةً ما يسبب احمرار العينين وإدماعهما)، فرط إنتاج الدموع.

·      فشل القلب الذي يمكن أن يكون مرتبطًا بالأعراض الخاصة بضيق التنفس وتورم الكاحلين.

·      زيادة معدل ضربات القلب، التهاب الحلق والمريء، ألم المعدة، الطفح الجلدي، احمرار الجلد، الشرى، يمكن أن يظهر الجلد والأظافر أكثر دكنة من المعتاد.

·      يمكن أن يحدث احمرار وتورم في موضع الحقن.

 

غير شائعة: قد تصيب ما يصل إلى شخص واحد من بين كل 100 شخص

·      الانصمام (انسداد في مجرى الدم).

 

غير معروفة: (لا يمكن تقدير معدل التكرار من البيانات المتاحة)

·      الجفاف، زيادة نسبة حمض اليوريك في بولك، التهاب القرنية، إدماع العينين، شعور بعدم الراحة بشكل عام.

·      زيادة معدل ضربات القلب، ألم الصدر والذي قد يشير إلى وجود مشكلات قلبية، الصدمة (انخفاض في ضغط الدم والدورة الدموية)، النزيف الداخلي.

·      التهاب الأوردة، انسداد الأوعية الدموية بسبب جلطة (الانصمام الخثاري)، هبات الحرارة.

·      تهيج أو نزيف في الأمعاء، التهاب بطانة المعدة، حرقة فم المعدة، وجع أو قرح في الفم والتي قد لا تظهر حتى مرور 3-10 أيام بعد العلاج، تغير اللون داخل الفم.

·      زيادة حساسية الجلد تجاه ضوء الشمس

·       تفاعل التهاب والذي قد يحدث بعد انتهاء العلاج بوقت قصير أو بعد مرور سنوات، حكة الجلد واضطرابات الجلد أخرى.

·        احمرار بولك (وهو أمر طبيعي ويتعلق بلون الدواء). ينبغي عليك إبلاغ طبيبك إذا لم يتوقف هذا خلال أيام قليلة أو إذا كنت تعتقد أن هناك دم في بولك. أخبر طبيبك إذا أصبت بهذه الأعراض.

·        في السيدات، يمكن أن يسبب أدريبلاستينا العقم أثناء فترة تلقي العلاج بالعقار. ويمكن أن تجد السيدات أيضًا أن دوراتهن الشهرية قد توقفت، ولكن من المفترض أن تعود دوراتهن الشهرية إلى حالتها الطبيعية بعد إيقاف الدواء. وفي بعض الحالات يمكن أن يحدث انقطاع مبكر للحيض.

 في الرجال، يمكن أن يسبب أدريبلاستينا غيابًا أو انخفاضًا في تعداد الحيوانات المنوية، ولكن قد يعود هذا إلى الحالة الطبيعية بعد إيقاف الدواء. ينبغي أن يستخدم كلٌ من الرجال والسيدات ممن يأخذون أدريبلاستينا وسائل فعالة لمنع الحمل.

 

 الإبلاغ عن الآثار الجانبية

 

إن الإبلاغ عن التفاعلات الضارة المشتبه بها بعد التصريح بتسويق المنتج الدوائي أمر هام. فهو يسمح بالمراقبة المستمرة للموازنة بين فوائد ومخاطر المنتج الدوائي. يُطلب من متخصصي الرعاية الصحية الإبلاغ عن أي تفاعلات ضارة مشتبه بها وفقًا للمتطلبات المحلية الخاصة بهم.

 

 

 للإبلاغ عن أي أثر جانبي:

 

 

  • المملكة العربية السعودية

 

المركز الوطني للتيقظ والسلامة الدوائية (NPC)

  • الفاكس: +966 11 205 7662
  • اتصل بالمركز الوطني للتيقظ والسلامة الدوائية على رقم +966-11-2038222، تحويلة 2317-2356-2340
  • مركز الاتصال: 19999
  • البريد الإلكتروني: npc.drug@sfda.gov.sa
  • الموقع الإلكتروني: https://ade.sfda.gov.sa/

 

 

·        يحفظ في الثلاجة عند درجة حرارة ما بين 2 إلى 8 درجة مئوية. لا يجمد، ويحفظ بعيداً عن الضوء.

·         ينبغي تخزين القوارير غير المفتوحة في الحاوية الأصلية في الثلاجة حتى تصبح جاهزة للاستخدام.

·         احتفظ بالدواء بعيدًا عن مرأى ومتناول الأطفال.

·         ينبغي عدم استخدام أدريبلاستينا بعد تاريخ انتهاء الصلاحية المطبوع على العبوة وعلى القارورة بعد الرمز "EXP". يشير تاريخ انتهاء الصلاحية إلى آخر يوم من الشهر المذكور. وسيفحص الصيدلي هذا عندما يتم تحضير دوائك لك. إذا كان المحلول عكرًا بعد تحضيره، فسيتخلص منه الصيدلي بشكل آمن.

·        مدة الصلاحية أثناء الاستخدام وتعليمات التخزين أثناء الاستخدام:

من وجهة نظر ميكروبيولوجية، ينبغي استخدام المنتج فورًا. إذا لم يُستخدم فورًا، فإن مسؤولية مدة وظروف تخزين المنتج المحضَر قبل الاستخدام تقع على عاتق المستخدم، وينبغي ألا تزيد هذه المدة في الطبيعي عن 24 ساعة في درجة حرارة تتراوح بين درجتين مئويتين و8 درجات مئوية، إلا إذا كان التحضير/التخفيف (إلخ) قد تم في ظروف تعقيم تم التحكم فيها والتحقق منها

 

المادة الفعالة هي هيدروكلوريد دوكسوروبيسين. والمكونات الأخرى هي ماء مخصص لعمليات الحقن وحمض الهيدروكلوريك.

 

محاليل التخفيف:

كلوريد الصوديوم (بتركيز 0.9 % وزن/حجم) وجلوكوز (بتركيز 5 % وزن/حجم).

 محلول أدريبلاستينا المخصص للحقن هو سائل أحمر معبأ في قوارير فردية بلاستيكية تحتوي على 2 مجم/مل من المكون الفعال وهو هيدروكلوريد أدريبلاستينا.

مالك تصريح التسويق

Pfizer Australia Pty Ltd, West Ryde, Australia

الجهة المصنعة:

 

Pfizer (Perth) Pty Limited, Bentley, Australia

سبتمبر/أيلول 2014
 Read this leaflet carefully before you start using this product as it contains important information for you

Adriblastina 2mg/ml Solution for Injection.

Doxorubicin hydrochloride 2mg/ml. Excipient with known effect: Doxorubicin 10 mg/5 ml Solution for Injection contains 17.7 mg sodium per 5 ml. Doxorubicin 50 mg/25 ml Solution for Injection contains 88.5 mg sodium per 25 ml. For the full list of excipients, see section 6.1.

Solution for intravenous use.

4.1.1 Adjuvant Breast Cancer Doxorubicin Hydrochloride Injection/for

 

Doxorubicin Hydrochloride is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer.

 

4.1.2 Other Cancers

 

Doxorubicin Hydrochloride is indicated for the treatment of

•           acute lymphoblastic leukemia

•           acute myeloblastic leukemia

•           Hodgkin lymphoma

•           non-Hodgkin lymphoma (NHL)

•           metastatic breast cancer

•           metastatic Wilms’ tumor

•           metastatic neuroblastoma

•           metastatic soft tissue sarcoma

•           metastatic bone sarcoma

•           metastatic ovarian carcinoma

•           metastatic transitional cell bladder carcinoma

•           metastatic thyroid carcinoma

•           metastatic gastric carcinoma

•           metastatic bronchogenic carcinoma


The total Adriblastina dose per cycle may differ according to its use within a specific treatment regimen (e.g. given as a single agent or in combination with other cytotoxic drugs) and according to the indication.

 

The solution is given via the tubing of a freely running intravenous infusion, taking not less than 3 minutes and not more than 10 minutes over the injection. This technique minimises the risk of thrombosis or perivenous extravasation which can lead to severe cellulitis, vesication and necrosis. A direct push injection is not recommended due to the risk of extravasation, which may occur even in the presence of adequate blood return upon needle aspiration (see section 4.4).

 

Dosage is usually calculated on the basis of body surface area. As a single agent, the recommended standard starting dose of doxorubicin per cycle in adults is 60-75mg/m2 of body surface area. The total starting dose per cycle may be given as a single dose or divided over 3 successive days or in divided doses given on days 1 and 8. Under conditions of normal recovery from drug-induced toxicity (particularly bone marrow depression and stomatitis), each treatment cycle can be repeated every 3 to 4 weeks. If it is used in combination with other antitumour agents having overlapping toxicity, the dosage of Adriblastina may need to be reduced to 30-60mg/m2 every three weeks.

 

If dosage is calculated on the basis of body weight, it has been shown that giving Adriblastina as a single dose every three weeks greatly reduces the distressing toxic effect, mucositis. However, there are still some who believe that dividing the dose over three successive days (0.4-0.8mg/kg or 20-25mg/m2 on each day) gives greater effectiveness though at the cost of higher toxicity.  If dosage is to be calculated on the basis of body weight, 1.2-2.4 mg/kg should be given as a single dose every three weeks.

 

Administration of Adriblastina in a weekly regimen has been shown to be as effective as the 3-weekly regimen. The recommended dosage is 20mg/m2 weekly, although, objective responses have been seen at 16mg/m2. Weekly administration leads to a reduction in cardiotoxicity.

 

Dosage may also need to be reduced in children, obese patients and the elderly.

 

Lower starting doses or longer intervals between cycles may need to be considered for heavily pre-treated patients, or patients with neoplastic bone marrow infiltration (see section 4.4).

 

Hepatic dysfunction

If hepatic function is impaired, doxorubicin dosage should be reduced according to the following table:

 

Serum Bilirubin Levels

Recommended Dose

 

1.2 – 3.0 mg/100ml

50% Normal dose

> 3.0 mg/100ml

25% Normal dose

 

Adriblastina should not be administered to patients with severe hepatic impairment (see section 4.3).


Hypersensitivity to Adriblastina or to any of the excipients listed in section 6.1, other anthracyclines or anthracenediones. Intravenous (IV) use: • persistent myelosuppression • severe hepatic impairment • severe myocardial insufficiency • recent myocardial infarction • severe arrhythmias • previous treatment with maximum cumulative doses of Adriblasrina, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones (see section 4.4).

Adriblastina should be administered only under the supervision of physicians experienced in the use of cytotoxic therapy.

 

Patients should recover from the acute toxicities of prior cytotoxic treatment (such as stomatitis, neutropenia, thrombocytopenia, and generalized infections) before beginning treatment with doxorubicin.

 

The systemic clearance of Adriblastina is reduced in obese patients (i.e. >130% ideal body weight) (see section 4.2).

 

Cardiac Function

Cardiotoxicity is a risk of anthracycline treatment that may be manifested by early (i.e. acute) or late (i.e. delayed) events.

 

Early (i.e. Acute) Events: Early cardiotoxicity of Adriblastina consists mainly of sinus tachycardia and/or ECG abnormalities such as non-specific ST-T wave changes. Tachyarrhythmias, including premature ventricular contractions and ventricular tachycardia, bradycardia, as well as atrioventricular and bundle-branch block have also been reported.  These effects do not usually predict subsequent development of delayed cardiotoxicity, and are generally not a consideration for discontinuation of doxorubicin treatment.

 

Late (i.e. Delayed) Events: Delayed cardiotoxicity usually develops late in the course of therapy with doxorubicin or within 2 to 3 months after treatment termination, but later events, several months to years after completion of treatment, have also been reported.  Delayed cardiomyopathy is manifested by reduced left ventricular ejection fraction (LVEF) and/or signs and symptoms of congestive heart failure (CHF) such as dyspnoea, pulmonary oedema, dependent oedema, cardiomegaly and hepatomegaly, oliguria, ascites, pleural effusion and gallop rhythm.  Subacute effects such as pericarditis/myocarditis have also been reported.  Life-threatening CHF is the most severe form of anthracycline-induced cardiomyopathy and represents the cumulative dose-limiting toxicity of the drug.

 

Cardiac function should be assessed before patients undergo treatment with Adriblastina and must be monitored throughout therapy to minimize the risk of incurring severe cardiac impairment.  The risk may be decreased through regular monitoring of LVEF during the course of treatment with prompt discontinuation of Adriblastina at the first sign of impaired function.  The appropriate quantitative method for repeated assessment of cardiac function (evaluation of LVEF) includes multi-gated radionuclide angiography (MUGA) or echocardiography (ECHO).  A baseline cardiac evaluation with an ECG and either a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiotoxicity.  Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher, cumulative anthracycline doses.  The technique used for assessment should be consistent throughout follow-up.

The probability of developing CHF, estimated around 1% to 2% at a cumulative dose of 300 mg/m2 slowly increases up to the total cumulative dose of 450-550 mg/m2.  Thereafter, the risk of developing CHF increases steeply and it is recommended not to exceed a maximum cumulative dose of 550 mg/m2.

 

Risk factors for cardiac toxicity include active or dormant cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones and concomitant use of drugs with the ability to suppress cardiac contractility or  of cardiotoxic substances (e.g. trastuzumab) and age over 70 years. Patients receiving anthracyclines after stopping treatment with other cardiotoxic agents, especially those with long half-lives such as trastuzumab, may also be at an increased risk of developing cardiotoxicity. The reported half-life of trastuzumab is variable. Trastuzumab may persist in the circulation for up to 7 months. Therefore, physicians should avoid anthracycline-based therapy for up to 7 months after stopping trastuzumab when possible.  If this is not possible, the patient’s cardiac function should be monitored carefully.  

 

Cardiac function must be carefully monitored in patients receiving high cumulative doses and in those with risk factors. However, cardiotoxicity with Adriblastina may occur at lower cumulative doses whether or not cardiac risk factors are present. 

 

Children and adolescents are at an increased risk for developing delayed cardiotoxicity following Adriblastina administration.  Females may be at greater risk than males.  Follow-up cardiac evaluations are recommended periodically to monitor for this effect.

 

It is probable that the toxicity of Adriblastina and other anthracyclines or anthracenediones is additive.

 

Haematologic Toxicity

Adriblastina may produce myelosuppression.  Haematologic profiles should be assessed before and during each cycle of therapy with Adriblastina, including differential white blood cell (WBC) counts.  A dose-dependent, reversible leucopenia and/or granulocytopenia (neutropenia) is the predominant manifestation of Adriblastina haematologic toxicity and is the most common acute dose-limiting toxicity of this drug.  Leucopenia and neutropenia generally reach the nadir between days 10 and 14 after drug administration; the WBC/neutrophil counts return to normal values in most cases by day 21.  Thrombocytopenia and anaemia may also occur.  Clinical consequences of severe myelosuppression include fever, infections, sepsis/septicaemia, septic shock, haemorrhage, tissue hypoxia or death.

 

Secondary Leukaemia

Secondary leukaemia, with or without a preleukaemic phase, has been reported in patients treated with anthracyclines.  Secondary leukaemia is more common when such drugs are given in combination with DNA-damaging antineoplastic agents, when patients have been heavily pretreated with cytotoxic drugs or when doses of the anthracyclines have been escalated.  These leukaemias can have a 1 to 3 year latency period.

 

Carcinogenesis, Mutagenesis and Impairment of Fertility

Adriblastina was genotoxic and mutagenic in vitro and in vivo tests.

 

In women, Adriblastina may cause infertility during the time of drug administration.  Adriblastina may cause amenorrhoea.  Ovulation and menstruation appear to return after termination of therapy, although premature menopause can occur.

 

Adriblastina is mutagenic and can induce chromosomal damage in human spermatozoa.  Oligospermia or azoospermia may be permanent; however, sperm counts have been reported to return to normospermic levels in some instances.  This may occur several years after the end of therapy.  Men undergoing Adriblastina treatment should use effective contraceptive methods.

 

Liver function

The major route of elimination of Adriblastina is the hepatobiliary system.  Serum total bilirubin should be evaluated before and during treatment with Adriblastina.  Patients with elevated bilirubin may experience slower clearance of the drug with an increase in overall toxicity.  Lower doses are recommended in these patients (see section 4.2).  Patients with severe hepatic impairment should not receive Adriblastina (see section 4.3).

 

Other

Adriblastina may potentiate the toxicity of other anticancer therapies.  Exacerbation of cyclophosphamide-induced haemorrhagic cystitis and enhanced hepatotoxicity of 6-mercaptopurine have been reported.  Radiation-induced toxicities (myocardium, mucosae, skin and liver) have also been reported.

 

As with other cytotoxic agents, thrombophlebitis and thromboembolic phenomena including pulmonary embolism (in some cases fatal) have been coincidentally reported with the use of Adriblastina.

 

Tumour-Lysis Syndrome

Adriblastina may induce hyperuricaemia as a consequence of the extensive purine catabolism that accompanies drug-induced rapid lysis of neoplastic cells (tumour-lysis syndrome).  Blood uric acid levels, potassium, calcium phosphate and creatinine should be evaluated after initial treatment.  Hydration, urine alkalinization, and prophylaxis with allopurinol to prevent hyperuricaemia may minimize potential complications of tumour lysis syndrome.

 

Vaccinations

Administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic agents including Adriblastina, may result in serious or fatal infections.  Vaccination with a live vaccine should be avoided in patients receiving doxorubicin.  Killed or inactivated vaccines may be administered; however, the response to such vaccines may be diminished.

 

Excipient Information

Adriblastina 10 mg/5ml, and 50 mg/25 ml contain 17.7 mg, and 88.5 mg sodium per each vial, equivalent to 0.9%, and 4.43% of the WHO maximum recommended daily intake (RDI) of 2 g sodium for an adult, respectively.


Adriblastina is a major substrate of cytochrome P450 CYP3A4 and CYP2D6, and P‑glycoprotein (P-gp).  Clinically significant interactions have been reported with inhibitors of CYP3A4, CYP2D6, and/or P-gp (e.g, verapamil), resulting in increased concentration and clinical effect of Adriblastina.  Inducers of CYP3A4 (e.g, phenobarbital, phenytoin, St. John’s Wort) and P-gp inducers may decrease the concentration of doxorubicin.

The addition of cyclosporine to Adriblastina may result in increases in area under the concentration-time curve (AUC) for both Adriblastina and doxorubicinol, possibly due to a decrease in clearance of the parent drug and a decrease in metabolism of doxorubicinol. Literature reports suggest that adding cyclosporine to Adriblastina results in more profound and prolonged haematologic toxicity than that observed with Adriblastina alone.  Coma and seizures have also been described with concomitant administration of cyclosporine and Adriblastina.

 

High dose cyclosporine increases the serum levels and myelotoxicity of Adriblastina.

 

Adriblastina is mainly used in combination with other cytotoxic drugs. Additive toxicity may occur especially with regard to bone marrow/haematologic and gastrointestinal effects (see section 4.4). The use of Adriblastina in combination chemotherapy with other potentially cardiotoxic drugs, as well as the concomitant use of other cardioactive compounds (e.g. calcium channel blockers), require monitoring of cardiac function throughout treatment. Changes in hepatic function induced by concomitant therapies may affect Adriblastina metabolism, pharmacokinetics, therapeutic efficacy and/or toxicity.

 

Paclitaxel can cause increased plasma-concentrations of Adriblastina and/or its metabolites when given prior to Adriblastina. Certain data indicate that a smaller increase is observed when Adriblastina is administered prior to paclitaxel.

 

The use of trastuzumab in combination with anthracyclines (such as doxorubicin hydrochloride) is associated with an increased cardiotoxic risk. Trastuzumab and anthracyclines should currently not be used in combination, except for well controlled clinical studies with monitoring of cardiac function (see section 4.4).

 

In a clinical study, an increase in Adriblastina AUC of 21% was observed when given with sorafenib 400 mg twice daily.  The clinical significance of this finding is unknown.


Pregnancy

Adriblastina has harmful pharmacological effects on pregnancy and/or the foetus/newborn child.

 

Due to the embryotoxic potential of Adriblastina, this drug should not be used during pregnancy unless clearly necessary. If a woman receives Adriblastina during pregnancy or becomes pregnant whilst taking the drug, she should be warned of the potential hazard to the foetus. Women of childbearing potential have to use effective contraception during treatment (see section 4.4).

 

Breast-feeding

Adriblastina is secreted into breast milk. Women should not breastfeed while undergoing treatment with Adriblastina.


The effect of Adriblastina on the ability to drive or use machinery has not been systematically evaluated.


Adverse reactions reported in association with Adriblastina therapy are listed below by MedDRA System Organ Class and by frequency. Frequencies are defined as: Very common (≥10%), Common (³1%, <10%), Uncommon (³0.1%, <1%), Rare (≥0.01%, <0.1%), Very rare (<0.01%), and Not known (cannot be estimated from available data).

 

Adverse Reactions Table

Infections and Infestations

Very common

Infection

Common

Sepsis

Neoplasms Benign, Malignant and Unspecified (including cysts and polyps)

Not known

Acute lymphocytic leukaemia, Acute myeloid leukaemia

Blood and Lymphatic System Disorders

Very common

Leukopenia, Neutropenia, Anaemia, Thrombocytopenia

Immune System Disorders

Not known

Anaphylactic reaction

Metabolism and Nutrition Disorders

Very common

Decreased appetite

Not known

Dehydration, Hyperuricaemia

Eye Disorders

Common

Conjunctivitis

Not known

Keratitis, Lacrimation increased

Cardiac Disorders

Common

Cardiac failure congestive, Sinus tachycardia

Not known

Atrioventricular block, Tachyarrhythmia, Bundle branch block

Vascular Disorders

Uncommon

Embolism

Not known

Shock, Haemorrhage, Thrombophlebitis, Phlebitis, Hot flush

Gastrointestinal Disorders

Very common

Mucosal inflammation/Stomatitis, Diarrhoea, Vomiting, Nausea

Common

Oesophagitis, Abdominal pain

Not known

Gastrointestinal haemorrhage, Gastritis erosive, Colitis, Mucosal discolouration

Skin and Subcutaneous Tissue Disorders

Very common

Palmar-plantar erythrodysaesthesia syndrome, Alopecia

Common

Urticaria, Rash, Skin hyperpigmentation, Nail hyperpigmentation

Not known

Photosensitivity reaction, Recall phenomenon, Pruritus, Skin disorder

Renal and Urinary Disorders

Not known

Chromaturiaa

Reproductive System and Breast Disorders

Not known

Amenorrhoea, Azoospermia, Oligospermia

General Disorders and Administration Site Conditions

Very common

Pyrexia, Asthenia, Chills

Common

Infusion site reaction

Not known

Malaise

Investigations

Very common

Ejection fraction decreased, Electrocardiogram abnormal, Transaminases abnormal, Weight increasedb

aFor one to two days after administration

bReported in patients with early breast cancer receiving doxorubicin-containing adjuvant therapy (NSABP B-15 trial)

 

Reporting of suspected adverse reactions
 

Reporting suspected adverse reactions after marketing authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions according to their local requirements.

 

To report any side effect:

 

·        Saudi Arabia

 

National Pharmacovigilance and Drug Safety Centre (NPC)

  • SFDA Call center: 19999
  • E-mail: npc.drug@sfda.gov.sa
  • Website: https://ade.sfda.gov.sa/

 

·        Other GCC States

 

-    Please contact the relevant competent authority.


Single doses of 250mg and 500mg of Adriblastina have proved fatal. Such doses may cause acute myocardial degeneration within 24 hours and severe myelosupression (mainly leucopenia and thromobocytopenia), the effects of which are greatest between 10 and 15 days after administration. Treatment should aim to support the patient during this period and should utilise such measures as blood transfusions and reverse barrier nursing.

 

Acute overdose with Adriblastina will result in gastrointestinal toxic effects (mainly mucositis).  This generally appears early after drug administration, but most patients recover from this within three weeks.

 

Delayed cardiac failure may occur up to six months after the overdosage. Patients should be observed carefully and should signs of cardiac failure arise, be treated along conventional lines.


Pharmacotherapeutic group: Anthracyclines and related substances, ATC code: L01DB01

 

Adriblastina is an antitumour agent.  Tumour cells are probably killed through drug-induced alterations of nucleic acid synthesis although the exact mechanism of action has not yet been clearly elucidated.

 

Proposed mechanism of action include:

 

DNA intercalation (leading to an inhibition of synthesis of DNA, RNA and proteins), formation of highly reactive free-radicals and superoxides, chelation of divalent cations, the inhibition of Na-K ATPase and the binding of Adriblastina to certain constituents of cell membranes (particularly to the membrane lipids, spectrin and cardiolipin).  Highest drug concentrations are attained in the lung, liver, spleen, kidney, heart, small intestine and bone-marrow.  Adriblastina does not cross the blood-brain barrier.


After IV administration, the plasma disappearance curve of Adriblastina is triphasic with half-lives of 12 minutes, 3.3 hours and 30 hours.  The relatively long terminal elimination half-life reflects Adriblastina’s distribution into a deep tissue compartment.  Only about 33 to 50% of fluorescent or tritiated drug (or degradation products), respectively, can be accounted for in urine, bile and faeces for up to 5 days after IV administration.  The remainder of the Adriblastina and degradation products appear to be retained for long periods of time in body tissues.

 

In cancer patients, Adriblastina is reduced to adriamycinol, which is an active cytotoxic agent.  This reduction appears to be catalysed by cytoplasmic and pH-dependent aldo-keto reductases that are found in all tissues and play an important role in determining the overall pharmacokinetics of Adriblastina.

 

Microsomal glycosidases present in most tissues split Adriblastina and adriamycinol into inactive aglycones.  The aglycones may then undergo 0-demethylation, followed by conjugation to sulphate or glucuronide esters, and excretion in the bile.


No information in addition to that presented elsewhere in this Summary of Product Characteristics is available.


Water for Injections

Sodium chloride

Hydrochloric acid

 

            The dilution diluents:

             Sodium Chloride (0.9% w/v) and Glucose (5% w/v).


Adriblastina should not be mixed with heparin as a precipitate may form and it is not recommended that doxorubicin be mixed with other drugs.  Prolonged contact with any solution of an alkaline pH should be avoided as it will result in hydrolysis of the drug.

 

Adriblastina should not be mixed with fluorouracil (e.g. in the same IV infusion bag or at the Y-site of an IV infusion line) since it has been reported that these drugs are incompatible to the extent that a precipitate might form. If concomitant therapy with Adriblastina and fluorouracil is required, it is recommended that the IV line be flushed between the administration of these drugs


2 years Do not use Adriblastina after the expiry date which is stated on the Vial label after EXP: The expiry date refers to the last day of that month. In-use shelf-life and in-use storage instructions: From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless reconstitution/dilution (etc) has taken place in controlled and validated aseptic conditions.

Store refrigerated between 2 - 8°C.

Do not freeze. Protect from light.

Discard any unused solution.


Single glass vials of 5ml (10mg) and 25ml (50mg)

 

Single Cytosafe polypropylene vials of 5ml (10mg) and 25ml (50mg)

 

Not all pack sizes may be marketed.


The following protective recommendations are given due to the toxic nature of this substance:

 

·          Personnel should be trained in good technique for reconstitution and handling.

 

·          Pregnant staff should be excluded from working with this drug.

 

·          Personnel handling doxorubicin should wear protective clothing: goggles, gowns, disposable gloves and masks.

 

·          A designated area should be defined for reconstitution (preferably under a laminar flow system). The work surface should be protected by disposable, plastic-backed and absorbent paper.

 

·          All items for reconstitution, administration or cleaning, including gloves, should be placed in high-risk waste-disposal bags for high temperature incineration.

 

·          Spillage or leakage should be treated with dilute sodium hypochlorite (1% available chlorine)

solution, preferably soaking and then water. 

 

·          All cleaning materials should be disposed of as indicated previously.

 

·          In case of skin contact, thoroughly wash the affected area with soap and water or sodium

·          bicarbonate solution. However, do not graze the skin by using a scrubbing brush.

 

·          In case of contact with eye(s), hold back the eyelid(s) and flush the affected eyes with copious amounts of water for at least 15 minutes. Then seek medical evaluation by a physician.

 

·          Always wash hands after removing gloves.


MARKETING AUTHORISATION HOLDER Pfizer Australia Pty Ltd, Australia MANUFACTURER: Pfizer (Perth) Pty Limited, Bentley, Australia

April 2021
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