داکاربازین مداک
Dacarbazine (Dtic-Dome)
داکاربازین مداک

نام ژنریک

Dacarbazine

شکل دارویی

اشكال دارويي:


Injection, Powder: 100,200,500mg

موارد مصرف

موارد و مقدار مصرف


توجه: موارد و مقدار مصرف اين دارو ممكن است تغيير يابد. جهت كسب اطلاعات جديد به منابع پزشكي مراجعه كنيد.


الف) ملانوم بدخيم متاستاتيك.


بزرگسالان: مقدار mg/kg/day 5/4-2 يا mg/m2/day 160-70 به مدت 10 روز از راه تزريق وريدي مصرف شده و سپس، بر حسب تحمل بيمار هر چهار هفته تكرار، و يا مقدار mg/m2/day 250 به مدت پنج روز تزريق وريدي شده و اين مقدار هر سه هفته تكرار مي‌شود.


ب) بيماري هوچكين.


بزرگسالان: مقدار mg/m2/day 150 به صورت داخل وريدي (همراه با داروهاي ديگر) به مدت پنج روز مصرف و اين مقدار هر چهار هفته تكرار مي‌شود، و يا مقدار mg/m2/day 375 در روز اول رژيم تركيبي مصرف و سپس، اين مقدار هر 15 روز تكرار مي‌شود (معمولاً‌ در تركيب با داروهاي ديگر مصرف مي‌شود).


ممكن است بروز سميت خوني باعث به تعويق افتادن يا توقف درمان شود.

موارد منع مصرف

موارد منع مصرف و احتياط


موارد منع مصرف: سابقه حساسيت مفرط به اين دارو.


موارد احتياط: در بيماران دچار نقص عملكرد مغز استخوان، مصرف اين دارو با احتياط صورت گيرد.


به دليل وجود احتمال نكروز كبدي، در بيماران دچار نقص عملكرد كبد با احتياط مصرف شود.

عوارض جانبی دارو

عوارض جانبي


اعصاب مرکزي: كانفوزيون، سردرد، پارستزي صورت.


پوست: مسموميت موضعي بر اثر نور، كهير، راش، برافروختگي صورت، آلوپسي.


چشم: تاري ديد.


دستگاه گوارش: تهوع و استفراغ شديد (طي 3-1 ساعت بعد از شروع درمان در حدود 90 درصد از بيماران بروز مي‌كنند و تا 12-1 ساعت ادامه مي‌يابد)، بي‌اشتهايي.


خون: كاهش فعاليت مغز استخوان (به مقدار مصرف بستگي دارد)، لكوپني و ترومبوسيتوپني (تعداد پلاكتها طي 4-3 هفته به حداقل مي‌رسد)، كم‌خوني.


موضعي: درد شديد (در صورت انفيلتره شدن محلول تزريقي يا در صورت غليظ بودن محلول)، آسيب بافتي.


ساير عوارض: آنافيلاكسي، سندرم شبه آنفلوآنزا (تب، احساس كسالت، درد عضلات كه هفت روز بعد از قطع مصرف دارو شروع مي‌شود و احتمالاً 21-7 روز طول مي‌كشد).


توجه: در صورت بروز مسموميت بارز در روند توليد سلولهاي خوني، بايد مصرف دارو قطع شود.


مسموميت و درمان


تظاهرات باليني: سركوب مغز استخوان و اسهال.


درمان: معمولاً حمايتي است و شامل انتقال فرآورده‌هاي خون و پيگيري پارامترهاي خوني مي‌باشد.

موارد قابل توجه

-

تداخل دارویی

تداخل دارويي


مصرف همزمان با باربيتوراتها و فني‌توئين ممكن است موجب افزايش متابوليسم داكاربازين شود و در نتيجه، اثرات اين دارو را از طريق القاي آنزيمهاي ميكروزومي كبدي كاهش و خطر سميت آن را افزايش دهند. مصرف باربيتوراتها و فني‌توئين قبل از شروع درمان با داكاربازين بايد قطع شود و در صورت ادامه مصرف بيمار از نزديك مانيتور شود.


آمفوتريسين مي‌تواند خطر سميت كليوي را افزايش دهد.


داروهاي ضد انعقاد و آسپيرين، در مصرف همزمان، منجر به افزايش خطر خونريزي مي‌شوند و بايد از استفاده همزمان آنها پرهيز شود.


داروهاي سركوب كننده مغز استخوان مي‌توانند منجر به افزايش سميت شوند، در صورت مصرف همزمان اين داروها، بيمار مانيتور گردد.

مکانیزم اثر

تداخل دارويي


مصرف همزمان با باربيتوراتها و فني‌توئين ممكن است موجب افزايش متابوليسم داكاربازين شود و در نتيجه، اثرات اين دارو را از طريق القاي آنزيمهاي ميكروزومي كبدي كاهش و خطر سميت آن را افزايش دهند. مصرف باربيتوراتها و فني‌توئين قبل از شروع درمان با داكاربازين بايد قطع شود و در صورت ادامه مصرف بيمار از نزديك مانيتور شود.


آمفوتريسين مي‌تواند خطر سميت كليوي را افزايش دهد.


داروهاي ضد انعقاد و آسپيرين، در مصرف همزمان، منجر به افزايش خطر خونريزي مي‌شوند و بايد از استفاده همزمان آنها پرهيز شود.


داروهاي سركوب كننده مغز استخوان مي‌توانند منجر به افزايش سميت شوند، در صورت مصرف همزمان اين داروها، بيمار مانيتور گردد.

فارماكوكینتیك

فارماكوكينتيك


جذب: به مقدار بسيار كم از دستگاه گوارش جذب مي‌شود و بنابراين، نمي‌توان آن را به صورت خوراكي مصرف كرد و بايد از راه وريدي مصرف شود.


پخش: در بافتهاي بدن، بخصوص كبد، تجمع مي‌يابد. از سد خوني ـ مغزي به مقدار محدودي عبور مي‌كند. اتصال پروتئيني آن بسيار كم است.


متابوليسم: در كبد به سرعت به چندين تركيب متابوليزه مي‌شود، كه بعضي از آنها ممكن است فعال باشند.


دفع: دفع آن دو مرحله‌اي است؛ در بيماران داراي عملكرد طبيعي كبد و كليه طبيعي نيمه‌‌ عمر مرحلة اول 19 دقيقه و مرحله نهايي پنج ساعت است. حدود 45-30 درصد دوز دارو بدون تغيير از طريق ادرار دفع مي‌شود.

سایر اطلاعات

طبقه‌بندي فارماكولوژيك: تركيب آلكيله كننده (غير اختصاصي چرخه سلولي).


طبقه‌بندي درماني: ضد نئوپلاسم.


طبقه‌بندي مصرف در بارداري: رده C


ملاحظات اختصاصي


علاوه بر ملاحظات مربوط به تمامي داروهاي آلكيله كننده، رعايت موارد زير نيز توصيه مي‌شود:


1- براي تهيه محلول تزريقي داخل وريدي داكاربازين، بايد آب استريل تزريقي به ميزان 9/9 ميلي‌ليتر به ويال 100 ميلي‌گرم، يا 7/19 ميلي‌ليتر به ويال 200 ميلي‌گرم اضافه كرد تا محلول حاوي mg/ml 10 داكاربازين به دست آيد.


2- اين دارو را مي‌توان با دكستروز پنج درصد يا نرمال‌سالين تا حجم
200-100 ميلي‌ليتر رقيق نمود تا از راه انفوزيون وريدي، طي 30 دقيقه، مصرف شود. افزايش حجم دارو يا كاهش سرعت انفوزيون موجب كاهش درد در محل تزريق مي‌شود.


3- دارو ممكن است از راه تزريق وريدي طي 2-1 دقيقه مصرف شود.


4- تغيير رنگ محلول از شيري به صورتي نشانگر تجزيه شدن دارو است. در طي انفوزيون جهت جلوگيري از تخريب دارو نبايد در معرض نور قرار گيرد.


5- در صورت نشت دارو به بافتهاي اطراف رگ، مي‌توان با كمپرس داغ احساس سوزش، درد و تحريك پوستي را برطرف نمود.


6- محلول اين دارو به مدت 72 ساعت در يخچال و هشت ساعت در دماي اتاق قابل نگهداري است.


7- تجويز داكاربازين از راه انفوزيون وريدي و مصرف مايعات زياد (6-4 ساعت قبل از شروع درمان) ممكن است تهوع و استفراغ را به حداقل برساند.


8- لازم است غلظت اسيداوريك پيگيري شود.


9- در صورت مصرف مكرر اين دارو در بيماران مبتلا به اختلال شديد عملكرد كليه، بايد مقدار مصرف دارو كاهش يابد.


10- در موارد نقص عملكرد كليه ياكاهش فعاليت مغز استخوان، مقادير كمتري از اين دارو بايد تجويز شود. CBC بيمار بايستي پيگيري شود. اگر
تعداد گلبولهاي سفيد خون (WBC) تا mm3 /3000 يا تعداد پلاكتها تا mm3 /100000 كاهش يابد، بايد از ادامه مصرف دارو خودداري گردد.


11- حرارت بدن بايد هر روز پيگيري شده و بيمار از نظر بروز علائم و نشانه‌هاي عفونت بررسي شود.


12- اگر تعداد پلاكتها كمتر از mm3/50000 باشد، بايد از تزريق عضلاني تمام داروها خودداري كرد.


13- مصرف داروهاي ضد انعقاد و فرآورده‌هاي حاوي آسپيرين همزمان با داكاربازين، بايد با احتياط همراه باشد. در اين موارد بايد به دقت مراقب علائم خونريزي بود.


نكات قابل توصيه به بيمار


1- تا دو روز بعد از درمان با اين دارو، از قرارگرفتن در زير آفتاب خودداري كنيد. در كل دوره درمان، حتي‌الامكان از در معرض آفتاب قرار گرفتن پرهيز كرده و در غير اين صورت، از محافظت كننده‌ها استفاده كنيد.


2- از تماس با بيماران مبتلا به عفونت خودداري كنيد. هرگونه علائم ناشي از عفونت يا خونريزي ناگهاني و غيرطبيعي را به پزشك اطلاع دهيد.


3- رويش مو 4 تا 8 هفته بعد از پايان درمان مجدداً شروع مي‌شود، ولي معمولاً موها داراي رنگ و جنس متفاوتي خواهد بود.


4- لازم است در طي درمان از باردار شدن پرهيز كرده و در صورت شك به بارداري بلافاصله به پزشك اطلاع دهيد.


5- سندرم شبه آنفلوآنزا را مي‌توان با داروهاي ضد تب ضعيف (مانند استامينوفن) درمان نمود.


6- از مصرف آسپيرين و فرآورده‌هاي حاوي آسپيرين خودداري شود. از علائم و نشانه‌هاي خونريزي آگاه بوده و در صورت بروز اين علائم و نشانه‌ها فوراً به پزشك اطلاع دهيد.


مصرف در شيردهي: ترشح داكاربازين در شير مشخص نيست، ولي به علت خطر عوارض جانبي شديد، موتاژنيك و كارسينوژنيك بودن دارو در شيرخواران، شيردهي در طول درمان با داكاربازين توصيه نمي‌شود.


توجه: براي كسب آگاهي بيشتر دربارة اين دارو به اطلاعات مربوط به
Alkylating Agents مراجعه كنيد.


اثر بر آزمايشهاي تشخيصي


داكاربازين موجب افزايش موقت غلظت‌هاي سرمي كراتي‌نين، BUN، آلانين آمينوترانسفراز (ALT)، آسپارتات آمينوترانسفراز (AST) و آلكالين فسفاتاز مي‌شود. همچنين ممكن است باعث كاهش تعداد WBC، RBC و پلاكتها گردد.

Dacarbazine (Dtic-Dome)

DTIC-Dome®
(dacarbazine) Sterile

WARNING

It is recommended that DTIC-Dome (dacarbazine) be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.

  1. Hemopoietic depression is the most common toxicity with DTlC-Dome (See WARNING).
  2. Hepatic necrosis has been reported (See WARNING).
  3. Studies have demonstrated this agent to have a carcinogenic and teratogenic effect when used in animals.
  4. In treatment of each patient, the physician must weigh carefully the possibility of achieving therapeutic benefit against the risk of toxicity.

DRUG DESCRIPTION

DTlC-Dome Sterile (dacarbazine) is a colorless to an ivory colored solid which is light sensitive. Each vial contains 100 mg of dacarbazine, or 200 mg of dacarbazine (the active ingredient), anhydrous citric acid and mannitol. DTlC-Dome is reconstituted and administered intravenously (pH 3–4). DTlC-Dome is an anticancer agent. Chemically, DTlC-Dome is 5-(3, 3-dimethyl-l-triazeno)-imidazole-4-carboxamide (DTlC) with the following structural formula:

DTIC-Dome® 
  (dacarbazine)  Structural Formula Illustration

What are the possible side effects of dacarbazine (Dtic-Dome)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe or continued vomiting;
  • fever, chills, body aches, flu symptoms;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • nausea, upper stomach pain,...

Read All Potential Side Effects and See Pictures of Dtic-Dome »

What are the precautions when taking dacarbazine (Dtic-Dome)?

Before using dacarbazine, tell your doctor or pharmacist if you are allergic to it; 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: kidney disease, liver disease, blood disorders, decreased bone marrow function, current infections.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received polio vaccine by mouth or flu vaccine inhaled through the nose.

Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the...

Read All Potential Precautions of Dtic-Dome »

Last reviewed on RxList: 11/5/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

DTlC-Dome is indicated in the treatment of metastatic malignant melanoma. In addition, DTlC-Dome is also indicated for Hodgkin's disease as a second-line therapy when used in combination with other effective agents.

DOSAGE AND ADMINISTRATION

MaIignant Melanoma: The recommended dosage is 2 to 4.5mg/kg/day for 10 days. Treatment may be repeated at 4 week intervals.2

An alternate recommended dosage is 250mg/square meter body surface/day I.V. for 5 days. Treatment may be repeated every 3 weeks.3,4

Hodgkin's Disease: The recommended dosage of DTIC-Dome (dacarbazine) in the treatment of Hodgkin's disease is 150mg/square meter body surface/day for 5 days, in combination with other effective drugs. Treatment may be repeated every 4 weeks.5 An alternative recommended dosage is 375mg/square meterbody surface on day 1, in combination with other effective drugs, to be repeated every 15 days.6

DTlC-Dome (dacarbazine) 100mg/vial and 200mg/vial are reconstituted with 9.9 mL and 19.7 mL, respectively, of Sterile Water for Injection, U.S.P. The resulting solution contains 10mg/mL of dacarbazine having a pH of 3.0 to 4.0. The calculated dose of the resulting solution is drawn into a syringe and administered only intravenously.

The reconstituted solution may be further diluted with 5% dextrose injection, U.S.P. or sodium chloride injection, U.S.P. and administered as an intravenous infusion.

After reconstitution and prior to use, the solution in the vial may be stored at 4°C for up to 72 hours or at normal room conditions (temperature and light) for up to 8 hours. If the reconstituted solution is further diluted in 5% dextrose injection. U.S.P. or sodium chloride injection, U.S.P., the resulting solution may be stored at 4°C for up to 24 hours or at normal room conditions for up to 8 hours.

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.7-12 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

HOW SUPPLIED

20 mL vials containing 200 mg of DTlC-Dome as sterile dacarbazine in boxes of 12. Store in a refrigerator 2°C to 8°C (36°F to 46°F).

REFERENCES

2. Nathanson, L., et al.: Characteristics of prognosis and response to an imidazole carboxamide in malignant melanoma. Clinical Pharmacology and Therapeutics 12: 955–962, 1971.

3. Costanza, M.E., et al.: Therapy of malignant melanoma with an imidazole carboxamide and bischloroethyl nitrosourea. Cancer 30: 1457–1461, 1972.

4. Luce, J.K., et al.: Clinical trials with the antitumor agent 5-(3, 3-dimethyl-l-triazeno) imidazole-4-carboxamide (NSC-45388). Cancer Chemotherapy Reports 54: 119–124, 1970.

5. Bonadonna, G., et al.: Combined Chemotherapy (MOPP or ABVD)—radiotherapy approach in advanced Hodgkin's disease. Cancer Treatment Reports 61: 769–777, 1977.

6. Santoro, A., and Bonadonna, G.: Prolonged disease-free survival in MOPP-resistant Hodgkin's disease after treatment with adriamycin, bleomycin, vinblastine and dacarbazine (ABVD). Cancer Chemotherapy Pharmacol. 2: 101–105, 1979.

7. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.

8. AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA, March 15, 1985.

9. National Study Commission on Cytotoxic Exposure—Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, Sc. D., Director of Pharmacy Services, Rhode Island Hospital, 593 Eddy Street, Providence, Rhode Island 02902.

10. Clinical Oncological Society of Australia: Guidelines and recommendations for safe handling of antineoplastic agents, Med. J. Australia 1: 426–428, 1983.

11. Jones, R.B., et al.: Safe handling of chemotherapeutic agents: A report from the Mount Sinai Medical Center, Ca-A Cancer Journal for Clinicians Sept./Oct., 258–263, 1983.

12. American Society of Hospital Pharmacists technical assistance bulletin on handling cytotoxic drugs in hospitals. Am. J. Hosp. Pharm. 42: 131–137, 1985.

Manufactured by: Ben Venue Laboratories, Bedford, Ohio 44146. Distributed by: Bayer Pharmaceuticals Corporation, 400 Morgan Lane, West Haven, CT 06516 USA. FDA Rev date: 9/24/1998

Last reviewed on RxList: 11/5/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Symptoms of anorexia, nausea, and vomiting are the most frequently noted of all toxic reactions. Over 90% of patients are affected with the initial few doses. The vomiting lasts 1–12 hours and is incompletely and unpredictably palliated with phenobarbital and/or prochlorperazine. Rarely, intractable nausea and vomiting have necessitated discontinuance of therapy with DTlC-Dome. Rarely, DTlC-Dome has caused diarrhea. Some helpful suggestions include restricting the patient's oral intake of food for 4–6 hours prior to treatment. The rapid toleration of these symptoms suggests that a central nervous system mechanism may be involved, and usually these symptoms subside after the first 1 or 2 days.

There are a number of minor toxicities that are infrequently noted. Patients have experienced an influenza-like syndrome of fever to 39°C, myalgias and malaise. These symptoms occur usually after large single doses, may last for several days, and they may occur with successive treatments.

Alopecia has been noted as has facial flushing and facial paresthesia. There have been few reports of significant liver or renal function test abnormalities in man. However, these abnormalities have been observed more frequently in animal studies.

Erythematous and urticarial rashes have been observed infrequently after administration of DTIC-Dome (dacarbazine) . Rarely, photosensitivity reactions may occur.

Read the Dtic-Dome (dacarbazine) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 11/5/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Hemopoietic depression is the most common toxicity with DTlC-Dome and involves primarily the leukocytes and platelets, although, anemia may sometimes occur. Leukopenia and thrombocytopenia may be severe enough to cause death. The possible bone marrow depression requires careful monitoring of white blood cells, red blood cells, and platelet levels. Hemopoietic toxicity may warrant temporary suspension or cessation of therapy with DTlC-Dome.

Hepatic toxicity accompanied by hepatic vein thrombosis and hepatocellular necrosis resulting in death, has been reported. The incidence of such reactions has been low; approximately 0.01% of patients treated. This toxicity has been observed mostly when DTIC-Dome (dacarbazine) has been administered concomitantly with other anti-neoplastic drugs; however, it has also been reported in some patients treated with DTlC-Dome alone.

Anaphylaxis can occur following the administration of DTlC-Dome.

PRECAUTIONS

Hospitalization is not always necessary but adequate laboratory study capability must be available. Extravasation of the drug subcutaneously during intravenous administration may result in tissue damage and severe pain. Local pain, burning sensation, and irritation at the site of injectlon may be relieved by locally applied hot packs.

Carcinogenicity of DTlC was studied in rats and mice. Proliferative endocardial lesions, including fibrosarcomas and sarcomas were induced by DTlC in rats. In mice, administration of DTIC resulted in the induction of angiosarcomas of the spleen.

Pregnancy Category C. DTIC-Dome (dacarbazine) has been shown to be teratogenic in rats when given in doses 20 times the human daily dose on day 12 of gestation. DTlC when administered in 10 times the human daily dose to male rats (twice weekly for 9 weeks) did not affect the male libido, although female rats mated to male rats had higher incidence of resorptions than controls. In rabbits, DTlC daily dose 7 times the human daily dose given on Days 6–15 of gestation resulted in fetal skeletal anomalies. There are no adequate and well controlled studies in pregnant women. DTlC-Dome should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for DTIC-Dome (dacarbazine) in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Last reviewed on RxList: 11/5/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Give supportive treatment and monitor blood cell counts.

CONTRAINDICATIONS

DTlC-Dome is contraindicated in patients who have demonstrated a hypersensitivity to it in the past.

Last reviewed on RxList: 11/5/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

After intravenous administration of DTlC-Dome, the volume of distribution exceeds total body water content suggesting localization in some body tissue, probably the liver. Its disappearance from the plasma is biphasic with initial half-life of 19 minutes and a terminal half-life of 5 hours.1 In a patient with renal and hepatic dysfunctions, the half-lives were lengthened to 55 minutes and 7.2 hours.1 The average cumulative excretion of unchanged DTlC in the urine is 40% of the injected dose in 6 hours.1 DTlC is subject to renal tubular secretion rather than glomerular filtration. At therapeutic concentrations DTIC is not appreciably bound to human plasma protein.

In man, DTlC is extensively degraded. Besides unchanged DTlC, 5-aminoimidazole -4 carboxamide (AlC) is a major metabolite of DTlC excreted in the urine. AlC is not derived endogenously but from the injected DTlC, because the administration of radioactive DTlC labeled with 14C in the imidazole portion of the molecule (DTlC-2-14C) gives rise to AIC-2-14C1.

Although the exact mechanism of action of DTIC-Dome (dacarbazine) is not known, three hypotheses have been offered:

  1. inhibition of DNA synthesis by acting as a purine analog
  2. action as an alkylating agent
  3. interaction with SH groups

REFERENCES

1. Loo, T.J., et al.: Mechanism of action and pharmacology studies with DTlC (NSC-45388). Cancer Treatment Reports 60: 149–152, 1976.

Last reviewed on RxList: 11/5/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 11/5/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 11/5/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Dtic-Dome Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

DACARBAZINE - INJECTION

(duh-KAR-buh-zeen)

COMMON BRAND NAME(S): DTIC-Dome

WARNING: This medication may often cause serious blood disorders (decreased bone marrow function leading to a low number of red blood cells, white blood cells, and platelets). These effects can cause anemia, lower your body's ability to fight an infection, and increase your risk of bleeding. Dacarbazine may also cause rare but serious liver problems. These side effects may rarely be life-threatening. Your doctor will monitor you closely while you are receiving this medication.

Tell your doctor immediately if you develop any of the following symptoms: unusual tiredness, pale skin, easy bruising/bleeding, signs of infection (e.g., fever, chills, persistent sore throat), persistent nausea/vomiting, dark urine, yellowing eyes/skin, stomach/abdominal pain.

USES: Dacarbazine is used to treat certain types of cancer, such as skin cancer that has spread (metastatic malignant melanoma) and Hodgkin's disease. It is a cancer chemotherapy drug that is used alone or with other medications to slow or stop cancer cell growth.

HOW TO USE: This medication is given by injection into a vein by a health care professional. It is given on a schedule as directed by your doctor. Dosage is based on your medical condition, body size, and response to treatment.

Disclaimer

Dtic-Dome Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, and loss of appetite commonly occur. Vomiting may last up to 12 hours. Your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating for 4 to 6 hours before treatment, or limiting activity may help lessen these effects. These symptoms usually decrease after 1 to 2 days. Diarrhea, flu-like symptoms (e.g., discomfort, uneasiness, body aches, headache), blurred vision, or flushing/numbness/tingling of the face may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

If this medication leaks out of the vein into the tissue under the skin, it may cause serious tissue damage. Tell your doctor immediately if you experience pain, burning, redness, or swelling at the injection site.

Tell your doctor right away if you have any serious side effects, including: mouth sores, confusion, seizures, sunburn (sun sensitivity).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Dtic-Dome (dacarbazine) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using dacarbazine, tell your doctor or pharmacist if you are allergic to it; 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: kidney disease, liver disease, blood disorders, decreased bone marrow function, current infections.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received polio vaccine by mouth or flu vaccine inhaled through the nose.

Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports.

This drug may infrequently cause blurred vision. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

This medication may rarely make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Due to the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

This medication can affect sperm production in men. Therefore, reliable forms of birth control should be used during treatment and for some time afterwards. Consult your doctor for more details.

Disclaimer

Dtic-Dome Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. 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. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: drugs that may decrease bone marrow function (e.g., azathioprine, trimethoprim/sulfamethoxazole).

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Laboratory and/or medical tests (e.g., complete blood counts) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.

STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised September 2010. Copyright(c) 2010 First Databank, Inc.

Dtic-Dome Patient Information Including Side Effects

Brand Names: Dtic-Dome

Generic Name: dacarbazine (Pronunciation: da CKAR ba zeen)

What is dacarbazine (Dtic-Dome)?

Dacarbazine is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Dacarbazine is used to treat skin cancer (malignant melanoma) and Hodgkin's disease.

Dacarbazine may also be used for purposes not listed in this medication guide.

What are the possible side effects of dacarbazine (Dtic-Dome)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe or continued vomiting;
  • fever, chills, body aches, flu symptoms;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • loss of appetite;
  • diarrhea;
  • temporary hair loss;
  • mild skin rash; or
  • numbness, warmth, redness, or tingly feeling in your face.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Dtic-Dome (dacarbazine) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about dacarbazine (Dtic-Dome)?

Avoid eating anything for 4 to 6 hours before your injection. This may help prevent severe nausea or vomiting.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when dacarbazine is injected.

Dacarbazine can lower blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Your blood may need to be tested often. Visit your doctor regularly.

Do not receive a "live" vaccine while using dacarbazine. The vaccine may not work as well during this time, and may not fully protect you from disease.

Side Effects Centers

Dtic-Dome Patient Information including How Should I Take

What should I discuss with my healthcare provider before receiving dacarbazine (Dtic-Dome)?

You should not use dacarbazine if you are allergic to it.

FDA pregnancy category C. It is not known whether dacarbazine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether dacarbazine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are being treated with dacarbazine.

How is dacarbazine given (Dtic-Dome)?

Dacarbazine is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting.

Avoid eating anything for 4 to 6 hours before your injection. This may help prevent severe nausea or vomiting.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when dacarbazine is injected.

Dacarbazine is sometimes given daily for 5 to 10 days in a row every 3 or 4 weeks. For Hodkin's disease, you may only receive dacarbazine for 1 day every 15 days. Your doctor will determine how long to treat you with dacarbazine.

Dacarbazine can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

To make sure this medication is not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor.

Side Effects Centers

Dtic-Dome Patient Information including If I Miss a Dose

What happens if I miss a dose (Dtic-Dome)?

Call your doctor for instructions if you miss an appointment for your dacarbazine injection.

What happens if I overdose (Dtic-Dome)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving dacarbazine (Dtic-Dome)?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using dacarbazine. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

What other drugs will affect dacarbazine (Dtic-Dome)?

There may be other drugs that can interact with dacarbazine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about dacarbazine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.02. Revision date: 12/15/2010.

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