Dactinomycin for Injection USP 500mcg (0.5mg) Technical Specification:

Product Name:Dactinomycin for Injection USP 500mcg (0.5mg)
Brand Name:Dactinomycin
Strength:500mcg (0.5mg)
Dosage Form:Lyophilized
Dry Powder for Injection
Packing:SINGLE USE VIAL
Route of Administration:For I.V. use only.
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Cancer
Indication: Dactinomycin is used to treat a number of types of cancer. This includes Wilms tumor, rhabdomyosarcoma, Ewing’s sarcoma, trophoblastic neoplasm, testicular cancer, and certain types of ovarian cancer
Storage:Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light and humidity.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Dactinomycin for Injection USP 500mcg (0.5mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Dactinomycin for Injection USP 500mcg (0.5mg)
    Each vial contains:
    Dactinomycin USP…………………….0.5mg
    Mannitol USP……………………………20mg 

THERAPEUTIC INDICATION:

Dactinomycin is used to treat a number of types of cancer. This includes Wilms tumor, rhabdomyosarcoma, Ewing’s sarcoma, trophoblastic neoplasm, testicular cancer, and certain types of ovarian cancer

DIRECTION OF USE:

For Intravenous infusion only.

RECONSTITUTION: Reconstitute dactinomycin for injection by adding 1.1 ml of Sterile Water for Injection (without preservative).

The resulting solution for dactinomycin will contain approximately 500mcg or 0.5mg per ml.

Do not use preservative diluent as precipitation may occur Solution is chemically stable or 24 hr at room temperature. Significant binding of drug occurs with micrometer nitrocellulose filter materials / Standard dilution

IV push: dose/syringe (500 mcg/mL).

The reconstituted solution is clear, gold colored and essentially free from visible particles.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.

WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.

WARNINGS AND PRECAUTIONS
The drug should be administered under the supervision of an experienced cancer chemotherapy physician. If extravasation occurs, it may cause severe soft tissue damage. Contracture of the arms has occurred (rare). Avoid inhalation of vapors or contact with skin mucous membrane or eyes. Handle and dispose agent using appropriate precautions. Avoid exposure during pregnancy.

Contraindications: Hypersensitivity /Active chickenpox or herpes zoster. Caution in hepatic/renal impairment, elderly May cause hepatic sinusoidal obstruction syndrome. Toxic effects may take 1-2 weeks to reach maximum severity following treatment; discontinue treatment if severe diarrhea, myelosuppression, or stomatitis occur. Avoid pregnancy. Avoid use within 2 weeks of radiation treatment for right-sided tumor (may increase risk of hepatotoxicity) Avoid use of concomitant live virus vaccines. Use in myelosuppressive patients not recommended.

ACTINOMYCIN ANTIBIOTIC; INTERCALATES INTO DNA BASE PAIRS PREVENTING RNA, DNA, AND PROTEIN SYNTHESIS

DANGER: Contact poison. Avoid contact with skin, mucous membranes or eyes. Do not inhale the dust or vapor. In case of contact, wash with copious amounts for at least 15 minutes.

Do not give I.M. or S.C.

See PRECAUTIONS and HOW SUPPLIED in accompanying package insert.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard Unused portion.

Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light and humidity.

Dosage: As directed by an Oncologist.

For use in the treatment of gestational trophoblastic neoplasia:
12 mcg/kg intravenously daily for five days as a single agent. Or 500 mcg intravenously on days 1 and 2 as part of a combination regimen with etoposide, methotrexate, folinic acid, vincristine, cyclophosphamide and cisplatin.

Why Taj Pharmaceuticals?

Looking for high-quality Dactinomycin for Injection. Trust Taj Pharma for your healthcare needs. We offer a reliable and trusted source for Dactinomycin, a powerful chemotherapy drug used to treat various cancers. With Taj Pharma, you can count on:

  • Quality Assurance: Our Dactinomycin is manufactured to the highest industry standards, ensuring safety and efficacy for cancer treatment.
  • Affordability: We offer competitive pricing, making life-saving treatments accessible to more patients.
  • Experience: Taj Pharma has a proven track record in the pharmaceutical industry, providing peace of mind to patients and healthcare professionals.
  • Global Reach: Our products are available worldwide, ensuring that patients everywhere have access to essential treatments.

Choose Taj Pharma for your Dactinomycin for Injection needs and experience the difference in quality, affordability, and reliability for your cancer treatment.

What is Dactinomycin for Injection and Its Use?

Dactinomycin for Injection is a medication used in the treatment of certain types of cancer. It is a chemotherapy drug that contains the active ingredient dactinomycin and is administered by injection. Here are some key points about Dactinomycin and its uses:

Active Ingredient: Dactinomycin is an antibiotic derived from Streptomyces bacteria. It is known for its ability to inhibit the growth of cancer cells.

Uses:

  • Wilms Tumor (Nephroblastoma): Dactinomycin is often used in the treatment of Wilms tumor, a type of kidney cancer that primarily affects children. It is typically given as part of a combination therapy along with other cancer-fighting drugs and treatments.
  • Ewing’s Sarcoma: Dactinomycin may also be used in the treatment of Ewing’s sarcoma, a rare type of bone cancer that usually affects children and young adults. It is often combined with other chemotherapy agents and radiation therapy.
  • Rhabdomyosarcoma: This medication can be used to treat rhabdomyosarcoma, a cancer that develops in the soft tissues, such as muscles. It is often used in combination with other treatment modalities.
  • Gestational Trophoblastic Neoplasia: Dactinomycin is occasionally used in the treatment of gestational trophoblastic neoplasia, a group of rare tumors that can develop in the uterus during pregnancy.
  • Other Cancers: In some cases, it may be used in the treatment of other types of cancer, as determined by a healthcare provider.

Dactinomycin works by interfering with the DNA replication process in rapidly dividing cells, which includes cancer cells. By disrupting the growth and division of these cells, it helps to slow down or stop the progression of cancer. However, its use is associated with potential side effects, and the treatment should be closely monitored by healthcare professionals. Dactinomycin should only be used under the supervision of a qualified oncologist or healthcare provider, as it is part of a comprehensive treatment plan for specific types of cancer. Patients should be well-informed about the potential risks and benefits associated with this medication.

How does Dactinomycin for Injection Work?

Dactinomycin for Injection, also known as actinomycin-D or Cosmegen, is a chemotherapy medication used in the treatment of certain types of cancer. It works by interfering with the growth and division of cancer cells. Here’s how Dactinomycin works:

  • Interference with DNA: Dactinomycin is an antibiotic derived from Streptomyces bacteria. It has a unique ability to bind to DNA and disrupt its normal structure and function. Specifically, it intercalates into the DNA double helix, which means it inserts itself between the base pairs of the DNA molecule.
  • Inhibition of DNA Transcription: By binding to DNA, Dactinomycin interferes with the process of transcription. Transcription is the process by which the genetic information encoded in DNA is copied into RNA. This is a critical step in gene expression and the production of proteins.
  • Inhibition of RNA Synthesis: Dactinomycin’s interference with transcription prevents RNA polymerase, the enzyme responsible for creating RNA from DNA, from working properly. This, in turn, inhibits the synthesis of RNA.
  • Disruption of Protein Production: With the inhibition of RNA synthesis, the production of proteins within the cell is compromised. Proteins are essential for many cellular processes, and by disrupting their production, Dactinomycin hampers the normal functioning and growth of the cell.
  • Cytotoxic Effect: The disruption of DNA transcription, RNA synthesis, and protein production ultimately leads to the death of rapidly dividing cancer cells. Dactinomycin is particularly effective against cells that are actively dividing, making it a useful chemotherapy agent for certain types of cancer, such as Wilms tumor, Ewing’s sarcoma, and rhabdomyosarcoma.

It’s important to note that while Dactinomycin targets cancer cells, it may also affect some healthy cells that are actively dividing, leading to potential side effects. The choice to use Dactinomycin and the dosage administered is carefully determined by healthcare professionals to balance its therapeutic benefits against potential side effects.

Dactinomycin is typically used as part of a combination therapy with other chemotherapy drugs, and the treatment plan is tailored to the specific type and stage of cancer being treated. Patients receiving Dactinomycin should be closely monitored by their healthcare team to manage and mitigate any adverse effects.

Benefits of Dactinomycin for Injection:

  • Effective Against Specific Cancers: Dactinomycin is particularly effective in treating certain types of cancer, including Wilms tumor (nephroblastoma), Ewing’s sarcoma, and rhabdomyosarcoma. It is often part of a combination therapy that can improve treatment outcomes for these cancers.
  • Tumor Reduction: Dactinomycin can lead to a reduction in the size of tumors, which can alleviate symptoms and improve the overall prognosis for cancer patients.
  • Curative Potential: In some cases, Dactinomycin, when used as part of a comprehensive treatment plan, can help achieve remission and even cure certain cancers, especially when detected and treated in their early stages.
  • Adjuvant Treatment: Dactinomycin is sometimes used as adjuvant therapy after surgery to destroy any remaining cancer cells, reducing the risk of recurrence.

Side Effects of Dactinomycin for Injection:

  • Nausea and Vomiting: Many patients experience nausea and vomiting during and after treatment with Dactinomycin. Anti-nausea medications can help manage these side effects.
  • Bone Marrow Suppression: Dactinomycin can affect the bone marrow’s ability to produce blood cells, leading to decreased white blood cell counts (neutropenia), red blood cell counts (anemia), and platelet counts (thrombocytopenia). This can increase the risk of infections, fatigue, and bleeding.
  • Hair Loss: Many chemotherapy drugs, including Dactinomycin, can lead to temporary hair loss.
  • Mouth Sores: Some patients may develop mouth sores or ulcers during treatment.
  • Gastrointestinal Issues: Diarrhea and constipation can occur.
  • Skin Reactions: Skin rashes and sensitivity to sunlight (photosensitivity) can be side effects of Dactinomycin.
  • Liver and Kidney Function: Dactinomycin can affect liver and kidney function, so routine blood tests are often required to monitor these organ systems.
  • Infertility: In some cases, Dactinomycin may lead to infertility, so discussions about fertility preservation options should occur before treatment.
  • Cardiac Effects: Dactinomycin can have cardiac effects, so individuals with pre-existing heart conditions should be closely monitored.
  • Long-term Risks: There may be long-term risks, such as an increased risk of secondary cancers, which should be discussed with healthcare providers.

It’s crucial for patients to communicate any side effects they experience to their healthcare team, as supportive care measures can often be employed to manage these effects and improve the patient’s quality of life during treatment. The benefits and risks of Dactinomycin treatment are carefully weighed by healthcare professionals, and the decision to use this medication is made on a case-by-case basis, considering the specific type and stage of cancer and the patient’s overall health.

Frequently asked questions about Dactinomycin for Injection:

  1. What is Dactinomycin for Injection used for?

Dactinomycin is used in the treatment of certain types of cancer, including Wilms tumor, Ewing’s sarcoma, rhabdomyosarcoma, and gestational trophoblastic neoplasia.

  1. How is Dactinomycin administered?

Dactinomycin is typically administered by injection into a vein (intravenously) in a clinical setting, such as a hospital or outpatient infusion center.

  1. Is Dactinomycin a curative treatment for cancer?

Dactinomycin can be curative in certain cases, especially when used as part of a comprehensive treatment plan for specific types and stages of cancer. However, its effectiveness varies depending on individual factors.

  1. What are the potential side effects of Dactinomycin?

Common side effects of Dactinomycin may include nausea, vomiting, bone marrow suppression (leading to low blood cell counts), hair loss, mouth sores, skin sensitivity to sunlight, and more. Your healthcare provider will discuss potential side effects and how to manage them.

  1. How often will I receive Dactinomycin injections?

The frequency of Dactinomycin injections and the duration of treatment will depend on your specific cancer type, stage, and treatment plan. Your healthcare team will provide a schedule.

  1. Can I take other medications or supplements while receiving Dactinomycin?

It’s essential to inform your healthcare provider about all medications, including overthecounter drugs and supplements, as they can interact with Dactinomycin.

  1. Can I become pregnant or father a child while on Dactinomycin?

Dactinomycin can potentially harm a developing fetus. It’s important to discuss contraception or fertility preservation options with your healthcare team if you are of childbearing age.

  1. How will my healthcare team monitor my progress during treatment with Dactinomycin?

Your healthcare team will perform regular blood tests to monitor your blood cell counts and assess the overall impact of the treatment on your body.

  1. Are there any longterm risks associated with Dactinomycin treatment?

Discuss any potential longterm risks, such as an increased risk of secondary cancers, with your healthcare provider.

  1. What should I do if I experience side effects or have concerns during treatment?

If you experience side effects or have any concerns, contact your healthcare team immediately. They can provide guidance on managing side effects and address your concerns.

  1. Can I continue with my daily activities while on Dactinomycin treatment?

Your ability to carry out daily activities may be affected by the side effects of Dactinomycin. It’s important to listen to your body and follow your healthcare provider’s recommendations regarding rest and activity.

As Dactinomycin for Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Dactinomycin for Injection product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Dactinomycin for Injection Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Dactinomycin for Injection, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274

GENERIC NAME OF THE MEDICINAL PRODUCT:

Dactinomycin for Injection USP 500mcg (0.5mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Dactinomycin for Injection USP 500mcg (0.5mg)
Each vial contains:
Dactinomycin USP…………………….0.5mg
Mannitol USP……………………………20mg

THERAPEUTIC INDICATION:

Dactinomycin is used to treat a number of types of cancer. This includes Wilms tumor, rhabdomyosarcoma, Ewing's sarcoma, trophoblastic neoplasm, testicular cancer, and certain types of ovarian cancer

DIRECTION OF USE:

For Intravenous infusion only.
RECONSTITUTION: Reconstitute dactinomycin for injection by adding 1.1 ml of Sterile Water for Injection (without preservative).
The resulting solution for dactinomycin will contain approximately 500mcg or 0.5mg per ml.
Do not use preservative diluent as precipitation may occur Solution is chemically stable or 24 hr at room temperature. Significant binding of drug occurs with micrometer nitrocellulose filter materials / Standard dilution
IV push: dose/syringe (500 mcg/mL).
The reconstituted solution is clear, gold colored and essentially free from visible particles.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
WARNINGS AND PRECAUTIONS
The drug should be administered under the supervision of an experienced cancer chemotherapy physician. If extravasation occurs, it may cause severe soft tissue damage. Contracture of the arms has occurred (rare). Avoid inhalation of vapors or contact with skin mucous membrane or eyes. Handle and dispose agent using appropriate precautions. Avoid exposure during pregnancy.
Contraindications: Hypersensitivity /Active chickenpox or herpes zoster. Caution in hepatic/renal impairment, elderly May cause hepatic sinusoidal obstruction syndrome. Toxic effects may take 1-2 weeks to reach maximum severity following treatment; discontinue treatment if severe diarrhea, myelosuppression, or stomatitis occur. Avoid pregnancy. Avoid use within 2 weeks of radiation treatment for right-sided tumor (may increase risk of hepatotoxicity) Avoid use of concomitant live virus vaccines. Use in myelosuppressive patients not recommended.
ACTINOMYCIN ANTIBIOTIC; INTERCALATES INTO DNA BASE PAIRS PREVENTING RNA, DNA, AND PROTEIN SYNTHESIS
DANGER: Contact poison. Avoid contact with skin, mucous membranes or eyes. Do not inhale the dust or vapor. In case of contact, wash with copious amounts for at least 15 minutes.
Do not give I.M. or S.C.
See PRECAUTIONS and HOW SUPPLIED in accompanying package insert.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light and humidity.
Dosage: As directed by an Oncologist.
For use in the treatment of gestational trophoblastic neoplasia:
12 mcg/kg intravenously daily for five days as a single agent. Or 500 mcg intravenously on days 1 and 2 as part of a combination regimen with etoposide, methotrexate, folinic acid, vincristine, cyclophosphamide and cisplatin.