盐酸表柔比星注射剂（Epirubicin Hydrochloride）
【中文品名】表柔比星
【药效类别】抗生素>柔红霉素类抗肿瘤药
【通用药名】EPIRUBICIN
【化学名称】 10-[(3-Amino-2,3,6-trideoxy-α-L-arabino-hexopyranosyl)oxy-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-5,12-Naphthacenedione
【CA登记号】[56420-45-2]
【结 构 式】

【分 子 式】C27H29NO11
【分 子 量】543.52
【收录药典】

エピルビシン塩酸塩注射液10mg/5mL「サンド」／エピルビシン塩酸塩注射液50mg/25mL「サンド」

商標名
Epirubicin Hydrochloride Injection
一般名
エピルビシン塩酸塩（Epirubicin Hydrochloride）

化学名
（2S,4S）-4-（3-Amino-2,3,6-trideoxy-α-L-arabino-hexopyranosyloxy）-2,5,12-trihydroxy-2-hydroxyacetyl-7-methoxy-1,2,3,4-tetrahydrotetracene-6,11-dione monohydrochloride

分子式
C27H29NO11・HCl

分子量
579.98

性状
微帯黄赤色～帯褐赤色の粉末である。
水又はメタノールにやや溶けやすく、エタノール（95）に溶けにくく、アセトニトリルにほとんど溶けない。
吸湿性である。

取扱い上の注意
安定性試験3）,4）
最終包装製品を用いた長期保存試験（2～8℃、2年）の結果、エピルビシン塩酸塩注射液10mg/5mL「サンド」及びエピルビシン塩酸塩注射液50mg/25mL「サンド」は通常の市場流通下において2年間安定であることが確認された。 
効能又は効果
下記疾患の自覚的並びに他覚的症状の緩解
急性白血病、悪性リンパ腫、乳癌、卵巣癌、胃癌、肝癌、尿路上皮癌（膀胱癌、腎盂・尿管腫瘍）
以下の悪性腫瘍に対する他の抗悪性腫瘍剤との併用療法
乳癌（手術可能例における術前、あるいは術後化学療法）

用法及び用量
急性白血病の場合
エピルビシン塩酸塩として15mg（力価）/m2（体表面積）を1日1回5～7日間連日静脈内に投与し3週間休薬する。これを1クールとし、必要に応じて2～3クール反復する。
悪性リンパ腫の場合
エピルビシン塩酸塩として40～60mg（力価）/m2（体表面積）を1日1回静脈内に投与し3～4週休薬する。これを1クールとし、通常3～4クール反復する。
乳癌、卵巣癌、胃癌、尿路上皮癌（膀胱癌、腎盂・尿管腫瘍）の場合
エピルビシン塩酸塩として60mg（力価）/m2（体表面積）を1日1回静脈内に投与し3～4週休薬する。これを1クールとし、通常3～4クール反復する。
肝癌の場合
エピルビシン塩酸塩として60mg（力価）/m2（体表面積）を肝動脈内に挿入されたカテーテルより、1日1回肝動脈内に投与し3～4週休薬する。これを1クールとし、通常3～4クール反復する。
膀胱癌（表在性膀胱癌に限る）の場合
エピルビシン塩酸塩として60mg（力価）を1日1回3日間連日膀胱腔内に注入し4日間休薬する。これを1クールとし、通常2～4クール反復する。注入に際しては、ネラトンカテーテルで導尿し十分に膀胱腔内を空にした後、同カテーテルよりエピルビシン塩酸塩溶液を注入し、1～2時間膀胱腔内に把持する。
なお投与量は年齢、症状、副作用により、適宜増減する。
乳癌（手術可能例における術前、あるいは術後化学療法）に対する他の抗悪性腫瘍剤との併用療法の場合
・シクロホスファミド水和物との併用において、標準的なエピルビシン塩酸塩の投与量及び投与方法は、エピルビシン塩酸塩として100mg（力価）/m2（体表面積）を1日1回静脈内に投与後、20日間休薬する。これを1クールとし、通常4～6クール反復する。
・シクロホスファミド水和物、フルオロウラシルとの併用において、標準的なエピルビシン塩酸塩の投与量及び投与方法は、エピルビシン塩酸塩として100mg（力価）/m2（体表面積）を1日1回静脈内に投与後、20日間休薬する。これを1クールとし、通常4～6クール反復する。
なお、投与量は年齢、症状により適宜減量する。

包装
エピルビシン塩酸塩注射液10mg/5mL「サンド」：5バイアル
エピルビシン塩酸塩注射液50mg/25mL「サンド」：1バイアル
製造販売元
サンド株式会社

What epirubicin looks like
Epirubicin is a red fluid.

How it is given
Epirubicin is given by injection or drip (infusion) in one of the following ways:

•through a fine tube (cannula) placed into a vein, usually in the back of the hand
•through a fine plastic tube inserted under the skin into a vein near the collarbone (central line )
•into a fine tube inserted into a vein in the crook of your arm (PICC line ).
Chemotherapy is usually given as a course of several sessions (or cycles) of treatment over a few months. The length of your treatment and the number of cycles you have will depend on the type of cancer for which you are being treated. Your nurse or doctor will discuss your treatment plan with you.

Possible side effects
Each person’s reaction to chemotherapy is different. Some people have very few side effects, while others may experience more. The side effects described in this information won't affect everyone who is given epirubicin, and may be different if you are having more than one chemotherapy drug.

We have outlined the most common side effects and some of the less common ones, so that you can be aware of them if they occur. However, we haven't included those that are very rare and therefore extremely unlikely to affect you. If you notice any effects that are not listed in this information, please discuss them with your doctor or nurse.

Hair loss This usually starts 3-4 weeks after the first dose of epirubicin, although it may happen earlier. Your hair may fall out completely, or it may just thin. You may also have thinning and loss of eyelashes, eyebrows and other body hair. Hair loss| is temporary and all your hair will regrow once the treatment ends. Your nurse can give you advice about coping with hair loss.

To help reduce hair loss, scalp cooling| may be suitable for some people.

Feeling sick (nausea) and being sick (vomiting) This may begin a few hours after the treatment is given and last for up to a day. Your doctor can prescribe very effective anti-sickness (anti-emetic) drugs to prevent or greatly reduce nausea and vomiting| . If the sickness is not controlled, or if it continues, tell your doctor; they can prescribe other anti-sickness drugs which may be more effective. Some anti-sickness drugs can cause constipation. Let your doctor or nurse know if this is a problem.

Lowered resistance to infection Epirubicin can reduce the production of white blood cells by the bone marrow, making you more prone to infection| . This effect can begin seven days after treatment has been given, and your resistance to infection usually reaches its lowest point 10–14 days after chemotherapy. The number of your white blood cells will then increase steadily, and will usually have returned to normal levels before your next course of chemotherapy is due.

Contact your doctor or the hospital straight away if:

•your temperature goes above 38ºC (100.4ºF)
•you suddenly feel unwell (even with a normal temperature).
You will have a blood test before having more chemotherapy, to make sure that your cells have recovered. Occasionally it may be necessary to delay your treatment if the number of blood cells (the blood count) is still low.

Bruising or bleeding  Epirubicin can reduce the production of platelets, which help the blood to clot and stop bleeding. Let your doctor know if you have any unexplained bruising or bleeding, such as nosebleeds, blood spots or rashes on the skin, or bleeding gums.

Anaemia (low number of red blood cells) While having treatment with epirubicin you may become anaemic. This may make you feel tired| and breathless| . Let your doctor or nurse know if these effects are a problem.

Sore mouth and ulcers Your mouth may become sore| , or you may notice small ulcers during this treatment. Drinking plenty of fluids, and cleaning your teeth regularly and gently with a soft toothbrush, can help to reduce the risk of this happening. Tell your nurse or doctor if you have any of these problems, as they can prescribe special mouthwashes and medicines to prevent or clear mouth infections.

Taste changes You may notice that your food tastes different. Normal taste will usually come back after the treatment finishes.

Discoloured urine Your urine may become a pink-red colour. This may last for up to a day after you have had the epirubicin, and is due to the colour of the drug. It is normal.

Skin changes Epirubicin can cause a rash, which may be itchy. Your doctor can prescribe medicine to help with this. Areas which have previously been treated with radiotherapy may become red and sore. Let your doctor know if this happens.

The skin over the vein used for the injection may become discoloured. Your skin may darken due to excess production of pigment. It usually returns to normal a few months after the treatment has finished.

Tiredness and feeling weak You may feel very tired. It is important to allow yourself plenty of time to rest.

Less common side effects
Changes in the way your heart works Higher doses of epirubicin may cause changes in the muscle of the heart. This can affect how the heart works. The effect on the heart depends on the dose given. It's very unusual for the heart to be affected if you have standard doses. Tests to see how well your heart is working may sometimes be carried out before the drug is given.

Diarrhoea This can usually be controlled with medicine, but let your doctor know if it is severe or if it continues. It is important to drink plenty of fluids if you have diarrhoea| .

Changes to nails Your nails may become darker. White lines may appear on them. These changes grow out over a few months once the treatment has finished.

Additional information
Some people have hot flushes when this drug is being given.

Leakage into the tissue If epirubicin leaks into the tissue around the vein it can damage the tissue in that area. If you notice any stinging or burning around the vein while the drug is being given, or any leakage of fluid from the cannula site, it is very important that you tell your doctor or nurse.

If the area around the injection site becomes red or swollen at any time you should tell the doctor or nurse on the ward. If you are at home, ring the clinic or ward and ask to speak to the doctor or nurse.

Risk of blood clots Cancer can increase your risk of developing a blood clot (thrombosis), and having chemotherapy may increase this risk further. A blood clot may cause symptoms such as pain, redness and swelling in a leg, or breathlessness and chest pain. Blood clots can be very serious, so it is important to tell your doctor straightaway if you have any of these symptoms. However, most clots can usually be successfully treated with drugs to thin the blood. Your doctor or nurse can give you more information.

Other medicines  Some medicines, including those you can buy in a shop or chemist, can be harmful to take when you are having chemotherapy. Let your doctor know about any medicines you are taking, including over-the-counter drugs, complementary therapies and herbal drugs.

Fertility Your ability to become pregnant or father a child may be affected by taking this drug. It is important to discuss fertility|  with your doctor before starting treatment.

Contraception It is not advisable to become pregnant or father a child while taking epirubicin, as the developing foetus may be harmed. It is important to use effective contraception while taking this drug, and for at least a few months afterwards. Again, discuss this with your doctor.

References
This section is based on our Epirubicin factsheet which has been compiled using information from a number of reliable sources, including:

•Sweetman et al. Martindale: The Complete Drug Reference. 36th edition. 2009. Pharmaceutical Press.
•The Medicines.org.uk website – www.medicines.org.uk (accessed October 2009).
•British National Formulary. 58th edition. 2009. British Medical Association and Royal Pharmaceutical Society of Great Britain.
•Ed. Perry. Lippincott, Williams and Wilkins The Chemotherapy Source Book. 4th edition. 2007.

完整使用说明附件：http://www.info.pmda.go.jp/go/pack/4235404A1075_1_01/