马法兰,美法仑片说明书ALKERAN(melphalan hydrochloride for Injection)

药店国别

产地国家:香港

处方药:是

所属类别: 50毫克/10毫升/瓶

包装规格: 50毫克/10毫升/瓶

计价单位:瓶

生产厂家中文参考译名

生产厂家英文名:PRIMAL CHEMICAL CO LTD

原产地英文商品名:ALKERAN 50mg/10m/Vial

原产地英文药品名:MELPHALAN

中文参考商品译名:爱克兰 50毫克/10毫升/瓶

中文参考药品译名:美法仑

曾用名:马法兰、 米尔法兰、马尔法兰、美法仑

简介

药品名称

商品名:爱克兰 ( Alkeran)马法兰(美法仑片)

别名: 左旋苯丙氨酸氮芥、米尔法兰、马尔法兰、左旋溶肉瘤素

英文名:Melphalan,L-Sarcolysin,Alkeran,L-PAM

主要成份:美法仑适应症美法仑片适用于治疗多发性骨髓瘤及晚期卵巢腺癌。美法仑片单独应用或与其他药物合用,对于部分晚期乳腺癌病人有显著疗效。美法仑对部分红血球增多症病人有效,美法仑亦曾作为外科治疗乳腺癌的辅助药。用法用法美法仑具有骨髓抑制作用,故在治疗期间内,必需频繁监测血象(血细胞计数),必要时暂缓用药或调整剂量。或遵医嘱。

成年口服用药:口服美法仑的吸收是易变的,为了确保达到可能的治疗水平。应谨慎增加剂量,直到出现出现骨髓抑制作用为止。

多发性骨髓瘤:有多种治疗方案,应详细查阅文献,美法仑与强的松合用,可能比单用美法仑更有效,通常联合用药间歇进行。虽然延长连续用药的优越性仍未证实,但典型的剂量是每日每公斤体重0.15毫克分次服用共四天,六周后重复疗程。对治疗有反应者延长疗程超过一年不会改进疗效。卵巢腺癌:典型的治疗方案是每日每公斤体重0.2毫克共五天,每4~8周或当外周血象恢复时重复疗程;当出现骨髓毒性时应减低剂量。

晚期乳腺癌:口服美法仑每日每公斤体重0.15毫克或每平方米体表面积6毫克,共5日,每六周重复疗程,也可使用美法仑静脉注射治疗。

真性红血球增多症:诱导缓解期,每日用6~10毫克共5~7天,之后可每日2~4毫克直至能满意地控制症状,维持剂量可每周一次用2~6毫克,其间必须对患者仔细谨慎地进行血液学控制,以血细胞计数结果为依据,适当调整剂量。肾功能不全患者:依据目前建立的药动学数据,对中度至重度肾功能不全患者口服美法仑,并非绝对推荐降低剂量,但起始剂量需谨慎地降低。任何疑问,请遵医嘱!不良反应美法仑最常见的不良反应是骨髓抑制,可导致白细胞和血小板减少。高达30%的病人在口服常规剂量美法仑后,出现胃肠道不适,包括恶心和呕吐,使用常规剂量美法仑罕见胃炎发生,而接受高剂量静注美法仑有增加腹泻、呕吐和胃炎发生的可能。有报道称使用环磷酰胺前驱治疗可降低美法仑诱导的胃肠道损伤。偶有患者接受数月以上治疗,出现美法仑过敏反应,例如:荨麻疹、水肿、皮疹和过敏性休克,另有二例出现心脏停顿,但此副作用是否因美法仑引起仍未证实,斑丘疹和搔痒也偶有报道,曾有病例显示,在使用美法仑后,出现肺纤维化和出血性贫血,有脱发的报道,但不普遍

马法兰英文版说明书

Alkeran®Generic name: MelphalanOther names: L-PAM, L-Sarcolysin,
Phenylalanine MustardChemocare.com uses generic names in all descriptions of
drugs. Alkeran is the trade name for Melphalan. L-PAM, L-Sarcolysin, and
Phenylalanine Mustard are other names for Melphalan. In some cases, health care
professionals may use the trade name Alkeran or other names L-PAM, L-Sarcolysin,
and Phenylalanine Mustard when referring to the generic drug name Melphalan.Drug
type: Alkeran is an anti-cancer (“antineoplastic” or “cytotoxic”) chemotherapy
drug. Alkeran is classified as an “alkylating agent.” (For more detail, see “How
this drug works” section
below).—————————————————————————-What
this drug is used for:•Multiple myeloma•Ovarian
cancer•Neuroblastoma•Rhabdomyosarcoma•Breast cancer•Used in some conditioning
regimens prior to bone marrow transplantNote: If a drug has been approved for
one use, physicians may elect to use this same drug for other problems if they
believe it may be
helpful.—————————————————————————-How
this drug is given:•As a pill by mouth. Tablets come in a 2mg size.•Take
medication on an empty stomach (1 hour before to 2 hours after meals).•As an
injection or infusion into the vein (intravenous, IV).•The amount of melphalan
that you will receive depends on many factors, including your height and weight,
your general health or other health problems, and the type of cancer or
condition being treated. Your doctor will determine your dose and
schedule.—————————————————————————-Side
effects:Important things to remember about the side effects of melphalan:•Most
people do not experience all of the side effects listed.•Side effects are often
predictable in terms of their onset and duration.•Side effects are almost always
reversible and will go away after treatment is complete.•There are many options
to help minimize or prevent side effects.•There is no relationship between the
presence or severity of side effects and the effectiveness of the
medication.•The side effects of melphalan and their severity depend on how much
of the drug is given. In other words, high doses may produce more severe side
effects).The following side effects are common (occurring in greater than 30%)
for patients taking melphalan:•Low blood counts. Your white and red blood cells
and platelets may temporarily decrease. This can put you at increased risk for
infection, anemia and/or bleeding. This effect may be prolonged and
cumulative.•Nausea and vomiting. (mild with regular dosing, can be severe with
high-dose therapy)These side effects are less common side effects (occurring in
about 10-29%) of patientsreceiving melphalan:•Allergic reaction. (rare with pill
form, happen in about 10% of patients treated with IV form).•Mouth sores. (mild
with regular dosing, can be severe with high-dose therapy).•Diarrhea. (mild with
regular dosing, can be severe with high-dose therapy).•Loss of fertility.
Meaning, your ability to conceive or father a child may be affected by
melphalan. Discuss this issue with your health care provider.•Hair loss. (rare
with regular dosing, common with high-dose used for bone marrow
transplant).•Nephrotoxicity (see kidney problems): Uncommon with regular doses,
seen when melphalan is given in high-doses used for bone marrow
transplant.•Arrythmias (see heart problems): Uncommon with regular doses, seen
when melphalan is given in high-doses used for bone marrow
transplant.—————————————————————————-Delayed
effects:•There is a slight risk of developing a blood cancer such as leukemia or
myelodysplasia after taking melphalan. Talk to your doctor about this
risk.Nadir: Meaning low point, nadir is the point in time between chemotherapy
cycles in which you experience low blood counts.Onset: 7 daysNadir: 8-10 days
(white blood cells), 27-32 days (platelets).Recovery: 42-50 daysNot all side
effects are listed above. Some that are rare (occurring in less than 10% of
patients) are not listed here. However, you should always inform your health
care provider if you experience any unusual
symptoms.—————————————————————————-When
to contact your doctor or health care provider:Seek emergency help immediately
and notify your health care provider, it you experience the following
symptoms:•Shortness of breath, wheezing, difficulty breathing, closing up of the
throat, swelling of facial features, hives (possible allergic reaction).Contact
your health care provider immediately, day or night, if you should experience
any of the following symptoms:•Fever of 100.5º F (38º C) or higher, chills
(possible signs of infection)The following symptoms require medical attention,
but are not an emergency. Contact your health care provider within 24 hours of
noticing any of the following:•Nausea (interferes with ability to eat and
unrelieved with prescribed medication)•Vomiting (vomiting more than 4-5 times in
a 24 hour period)•Diarrhea (4-6 episodes in a 24-hour period)•Unusual bleeding
or bruising•Black or tarry stools, or blood in your stools or urine•Extreme
fatigue (unable to carry on self-care activities)•Mouth sores (painful redness,
swelling or ulcers)•Yellowing of the skin or eyes.Signs of infection such as
redness or swelling, pain on swallowing, coughing up mucous, or painful
urination.Always inform your health care provider if you experience any unusual
symptoms.—————————————————————————-Precautions:•Before
starting melphalan treatment, make sure you tell your doctor about any other
medications you are taking (including prescription, over-the-counter, vitamins,
herbal remedies, etc.).•Do not receive any kind of immunization or vaccination
without your doctor’s approval while taking melphalan.•Inform your health care
professional if you are pregnant or may be pregnant prior to starting this
treatment. Pregnancy category D (melphalan may be hazardous to the fetus. Women
who are pregnant or become pregnant must be advised of the potential hazard to
the fetus).•For both men and women: Do not conceive a child (get pregnant) while
taking melphalan. Barrier methods of contraception, such as condoms, are
recommended. Discuss with your doctor when you may safely become pregnant or
conceive a child after therapy.•Do not breast feed while taking this
medication.—————————————————————————-Self-care
tips:•If taking melphalan pills take on an empty stomach 1 hour before or 2
hours after meals.•Drink at least two to three quarts of fluid every 24 hours,
unless you are instructed otherwise.•You may be at risk of infection so try to
avoid crowds or people with colds and those not feeling well, and report fever
or any other signs of infection immediately to your health care provider.•Wash
your hands often.•To help treat/prevent mouth sores, use a soft toothbrush, and
rinse three times a day with 1/2 to 1 teaspoon of baking soda and/or 1/2 to 1
teaspoon of salt mixed with 8 ounces of water.•Use an electric razor and a soft
toothbrush to minimize bleeding.•Avoid contact sports or activities that could
cause injury.•This medication when taken as pills causes little nausea. But if
you should experience nausea, take anti-nausea medications as prescribed by your
doctor, and eat small frequent meals. Sucking on lozenges and chewing gum may
also help.•Avoid sun exposure. Wear SPF 15 (or higher) sunblock and protective
clothing.•In general, drinking alcoholic beverages should be kept to a minimum
or avoided completely. You should discuss this with your doctor.•Get plenty of
rest.•Maintain good nutrition.•If you experience symptoms or side effects, be
sure to discuss them with your health care team. They can prescribe medications
and/or offer other suggestions that are effective in managing such
problems.—————————————————————————-Monitoring
and testing:You will be checked regularly by your health care professional while
you are taking melphalan, to monitor side effects and check your response to
therapy. Periodic blood work to monitor your complete blood count (CBC) as well
as the function of other organs (such as your kidneys and liver) will also be
ordered by your
doctor.—————————————————————————-How
this drug works:Cancerous tumors are characterized by cell division, which is no
longer controlled as it is in normal tissue. “Normal” cells stop dividing when
they come into contact with like cells, a mechanism known as contact inhibition.
Cancerous cells lose this ability. Cancer cells no longer have the normal checks
and balances in place that control and limit cell division. The process of cell
division, whether normal or cancerous cells, is through the cell cycle. The cell
cycle goes from the resting phase, through active growing phases, and then to
mitosis (division).The ability of chemotherapy to kill cancer cells depends on
its ability to halt cell division. Usually, the drugs work by damaging the RNA
or DNA that tells the cell how to copy itself in division. If the cells are
unable to divide, they die. The faster the cells are dividing, the more likely
it is that chemotherapy will kill the cells, causing the tumor to shrink. They
also induce cell suicide (self-death or apoptosis).Chemotherapy drugs that
affect cells only when they are dividing are called cell-cycle
specific.Chemotherapy drugs that affect cells when they are at rest are called
cell-cycle non-specific. The scheduling of chemotherapy is set based on the type
of cells, rate at which they divide, and the time at which a given drug is
likely to be effective. This is why chemotherapy is typically given in
cycles.Chemotherapy is most effective at killing cells that are rapidly
dividing. Unfortunately, chemotherapy does not know the difference between the
cancerous cells and the normal cells. The “normal” cells will grow back and be
healthy but in the meantime, side effects occur. The “normal” cells most
commonly affected by chemotherapy are the blood cells, the cells in the mouth,
stomach and bowel, and the hair follicles; resulting in low blood counts, mouth
sores, nausea, diarrhea, and/or hair loss. Different drugs may affect different
parts of the body.Melphalan is classified as an alkylating agent. Alkylating
agents are most active in the resting phase of the cell. These drugs are cell
cycle non-specific. There are several types of alkylating agents:•Mustard gas
derivatives: Mechlorethamine, Cyclophosphamide, Chlorambucil, Melphalan, and
Ifosfamide.•Ethylenimines: Thiotepa and Hexamethylmelamine.•Alkylsulfonates:
Busulfan.•Hydrazines and Triazines: Altretamine, Procarbazine, Dacarbazine and
Temozolomide.•Nitrosureas: Carmustine, Lomustine and Streptozocin. Nitrosureas
are unique because, unlike most chemotherapy, they can cross the blood-brain
barrier. They can be useful in treating brain tumors.•Metal salts: Carboplatin,
Cisplatin, and
Oxaliplatin.—————————————————————————-Note:
We strongly encourage you to talk with your health care professional about your
specific medical condition and treatments. The information contained in this
website is meant to be helpful and educational, but is not a substitute for
medical

 

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