Order dactinomycin injection and half the paperwork will call it actinomycin D. Both names describe the same cytotoxic antibiotic, supplied as a yellow lyophilized powder in a 0.5 mg vial, and the mismatch catches out buyers comparing tenders and catalogs. Torso Healthcare manufactures the vial for oncology distributors, hospitals, and franchise partners who want it carrying their own brand.

What is dactinomycin injection?

Dactinomycin injection is a cytotoxic antineoplastic antibiotic of the actinomycin group, originally derived from Streptomyces parvullus, supplied as a sterile lyophilized powder and given into a vein by trained oncology staff. Alongside its antitumor action, it carries immunosuppressant properties, which is part of why handling and monitoring matter as much as the dose.

The vial itself is unusual in one respect. It carries 0.5 mg, written as 500 micrograms, of dactinomycin against 20 mg of mannitol, so the bulking agent outweighs the active forty times over. That is the only excipient present, and it is worth checking on a specification sheet next to the rest of our oncology range.

Dactinomycin Mechanism of Action

Dactinomycin binds to double-stranded DNA, slotting between base pairs rather than breaking the strand. Once bound, it blocks the enzyme that reads DNA to build RNA, so transcription stalls and the cell cannot make the proteins it needs to divide. Fast-dividing cells feel that first, which is where both the antitumor effect and the predictable toxicity come from.

Dactinomycin for Injection USP 0.5mg Uses

Approved labeling names the conditions below. They appear here as product information for healthcare professionals and trade buyers rather than as a recommendation for any patient:

• Wilms tumor, as part of a combination or multimodality therapy
• Childhood rhabdomyosarcoma
• Ewing sarcoma
• Metastatic nonseminomatous testicular cancer
• Gestational trophoblastic neoplasia, alone or in combination
• Locally recurrent or locoregionally metastatic melanoma, by regional perfusion with melphalan

Several of those are pediatric indications, which shape demand. Buyers supplying pediatric oncology units order this vial in smaller, steadier quantities than an adult chemotherapy line would suggest.

Why Only Preservative Free Water Reconstitutes This Vial

This is the detail that separates a usable vial from a wasted one, and it appears on almost no supplier listing. Dactinomycin is reconstituted with 1.1 mL of sterile water for injection that contains no preservative, which gives roughly 0.5 mg per mL. Water containing benzyl alcohol or parabens must never be used, because it causes a precipitate to form.

A labeled hypothetical, written as an illustration rather than a case report: a pharmacy technician reaches for the bacteriostatic water sitting next to the preservative-free stock, reconstitutes the vial, and watches a precipitate appear. The vial is finished. On a product priced like this one, that is an expensive reach for the wrong bottle, and it is why the diluent belongs on the carton note rather than buried in the insert.

Two further numbers matter once the vial is open. Dilute only to 10 micrograms per mL or stronger, since weaker solutions lose potency. The prepared solution holds for up to 10 hours at room temperature, or 24 hours refrigerated, and because nothing in the vial preserves it, the remainder is discarded rather than kept.

Dactinomycin Dose and Administration

Dosing is calculated in micrograms and set by the treating oncologist, so no schedule is published here. What the supply side should know is that the calculation basis shifts with the patient. Labeling directs dosing by body surface area for obese or edematous patients rather than by weight, and daily doses carry an upper cap in both adults and children.

Courses run short and repeat after a gap, with a further course starting only once earlier toxicity has resolved. Doses are reduced when the drug runs alongside other chemotherapy or radiotherapy. For direct injection, the two-needle technique is used, one needle to draw up and another to give the dose.

Dactinomycin for Injection USP 0.5mg Side Effects

Myelosuppression leads the list, covering low white cells, low platelets, and pancytopenia, and sepsis has been reported with fatal outcomes. Nausea, vomiting, diarrhea, loss of appetite, and abdominal pain are common, and mucositis with ulceration can follow. Hair loss, rash and dermatitis are frequent, while severe skin reactions including toxic epidermal necrolysis have been reported after marketing.

Timing is worth noting for anyone handling the product. Toxic effects often appear two to four days after a course ends and can peak one to two weeks later, so the quiet period immediately after treatment is not a clear signal.

Three warnings sit above the rest. Hepatic veno-occlusive disease can be fatal, and the risk is highest in children under 48 months. Second primary tumors, including leukemia, have been reported after treatment with this drug alongside other agents or radiation. Given radiotherapy, gastrointestinal toxicity, and marrow suppression both increase; previously irradiated skin can flare, and irradiation of the nasopharynx can bring on severe mucositis.

The product is contraindicated in anyone hypersensitive to dactinomycin or mannitol, and giving it at or near a chickenpox or herpes zoster infection risks severe and potentially fatal disease. Live vaccines are withheld during treatment, and contraception is required during and after treatment for both men and women.

Handling, Extravasation and Storage

Dactinomycin is extremely corrosive to soft tissue. A leak outside the vein can cause severe local damage, and contracture of the arm has been reported, so administration runs through a secure line with staff watching the site. If extravasation happens, the infusion stops, the cannula stays in place while an attempt is made to aspirate the drug, the limb is raised, and a cold compress goes on for about 45 minutes. No antidote is generally accepted, and severe cases may need debridement. Unopened vials sit below 25 degrees C in a dry place, protected from light, handled under the same cytotoxic precautions as the carboplatin 450 mg vial and the rest of the line.

Dactinomycin Brand Name and Own Label Supply

The originator brand is Cosmegen, and Indian suppliers sell the molecule under their own labels, with names such as Dacilon in circulation. Through third-party supply, the 0.5 mg vial goes to market under your brand name, carton, and artwork rather than an existing label, and the brand you build stays with you. Oncology buyers usually order across a list rather than one molecule, so partners pair it with products such as leucovorin calcium.

Dactinomycin for Injection USP 0.5mg Price

The Dactinomycin for Injection USP 0.5mg price is MRP ₹525 per vial. The vial is small, and the fill is only 0.5 mg, so almost none of the volume is the drug itself. Containment, the lyophilization cycle, and release testing carry it instead.

Light and humidity protection in the carton adds to that, because this powder needs both. Order size moves the figure more here than it would on a larger fill, since the fixed cost per vial barely changes with volume. Batch pricing then depends on the number of vials ordered. Send your monthly requirement for dactinomycin injection, with the pack configuration and the destination market, and the team will come back with current rates.

Dactinomycin for Injection USP 0.5mg Manufacturers in India

Torso Healthcare is a WHO GMP-certified manufacturer of injectables in India, running cytotoxic products under dedicated handling alongside the wider oncology list, including gemcitabine 1000 mg. A certificate of analysis travels with every batch, pack, and carton. Options are built around your brand, and dispatch covers domestic and export markets.

Frequently Asked Questions

Is dactinomycin the same as actinomycin D?

Yes. Dactinomycin is the international nonproprietary name, and actinomycin D is the older name still used in protocols, catalogs, and tender documents. Both refer to the same molecule, so a vial labeled either way carries the same active.

Why must preservative-free water be used for reconstitution?

Water for injection containing benzyl alcohol or parabens causes a precipitate to form in the vial, which makes the dose unusable. Labeling specifies 1.1 mL of preservative-free sterile water, giving a solution of about 0.5 mg per mL.

How long does reconstituted dactinomycin stay usable?

Up to 10 hours at room temperature, or 24 hours if refrigerated between 2 and 8 degrees C. The vial contains no antimicrobial preservative, so any remaining solution is discarded rather than held for a later dose.

What happens if dactinomycin leaks outside the vein?

It is extremely corrosive to soft tissue, and extravasation can cause severe local damage. Treatment stops immediately, aspiration is attempted through the cannula, the limb is raised, and a cold compress is applied. There is no generally accepted antidote.

What documentation ships with each batch?

Every consignment carries a certificate of analysis for the batch, along with the pack and carton artwork agreed for your brand. Buyers arranging export can request the additional documentation their market requires when the order is quoted.

Oncology buyers sourcing dactinomycin injection in bulk or under their own label can tell us their quantity and the pack required, and Torso Healthcare will come back with current rates.

Composition, indications, handling, and safety details on this page follow the approved dactinomycin datasheet.

Disclaimer: This page is intended for pharmaceutical businesses, trade buyers, and healthcare professionals as product reference information only. It is not an advertisement to the public, not medical advice, and not a recommendation for treatment. Dactinomycin is a prescription cytotoxic medicine and must be prescribed and administered only under qualified medical supervision.