Aknomid D^® (Solution) Instructions for Use

Marketing Authorization Holder

Adicom LLC (Russia)

Manufactured By

Bryntsalov-A, JSC (Russia)

ATC Code

L01DA01 (Dactinomycin)

Active Substance

Dactinomycin (Rec.INN registered by WHO)

Dosage Form

Aknomid D®

Solution for intravenous administration and perfusion 500 mcg/ml: amp. 1 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous administration and perfusion in the form of a transparent golden-colored liquid.

Excipients: rheopolyglucin, solution for infusion (10% solution of dextran with a molecular weight from 3000 to 4000 in isotonic sodium chloride solution) – up to 1 ml.

1 ml – dark glass ampoules (5) – plastic containers (1) – cardboard packs.
1 ml – dark glass ampoules (10) – plastic containers (1) – cardboard packs.

Clinical-Pharmacological Group

Antineoplastic antibiotic

Pharmacotherapeutic Group

Antineoplastic agent, antibiotic

Pharmacological Action

Antineoplastic agent from the group of actinomycin antibiotics. Inhibits cellular proliferation by forming a stable complex with DNA and disrupting DNA-dependent RNA synthesis. It has an immunosuppressive effect.

Pharmacokinetics

It binds significantly to tissue proteins. It is metabolized weakly. It does not penetrate the blood-brain barrier. The elimination half-life (T_1/2) is 36 hours. It is excreted in bile – 50% unchanged, and by the kidneys – 10% unchanged.

Indications

Wilms’ tumor, rhabdomyosarcoma, choriocarcinoma (including metastatic), metastatic nonseminomatous testicular carcinoma, Kaposi’s sarcoma, Ewing’s sarcoma, melanoma, botryoid sarcoma, ovarian cancer, uterine body cancer (as part of combined and/or complex therapy).

ICD codes

Dosage Regimen

Determine the dosage individually based on the specific malignancy, disease stage, patient’s hematopoietic status, and the chosen antineoplastic therapy protocol.

Administer the solution intravenously only. Avoid intramuscular or subcutaneous injection. Reconstitute the lyophilized powder strictly according to the manufacturer’s instructions using the provided solvent.

For adult patients, the typical single dose is 500 mcg (1 ml of 500 mcg/ml solution) daily for a maximum of five days. Adhere to a minimum interval of three to four weeks between treatment courses, depending on hematological recovery.

For pediatric patients (excluding newborns and infants), calculate the dose based on body surface area. The usual dose is 0.45 mg/m² of body surface area daily for a maximum of five days. Adjust the dose according to the specific pediatric treatment protocol.

Monitor complete blood count (CBC) before each course and regularly during therapy. Withhold treatment if severe myelosuppression is evident. Do not administer if the platelet count is below 100,000/mm³ or the leukocyte count is below 3,000/mm³.

Administer the drug via a running intravenous infusion or as a slow direct intravenous injection over several minutes. Ensure proper intravenous catheter placement to prevent extravasation, which causes severe tissue damage and necrosis.

Assess liver and kidney function before initiation and periodically during treatment. Adjust the dose or discontinue therapy in case of severe hepatic impairment. Monitor plasma uric acid levels, especially in patients with a history of gout or hyperuricemia.

Adverse Reactions

From the digestive system: nausea, vomiting, cheilitis, esophagitis, ulcerative stomatitis, pharyngitis, anorexia, dysphagia, abdominal pain, diarrhea, erosive-ulcerative lesions of the gastrointestinal tract, proctitis.

From the hematopoietic system: anemia (up to aplastic anemia), agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, reticulocytopenia.

From the reproductive system: azoospermia, amenorrhea.

Dermatological reactions: alopecia, skin rash, acne.

Local reactions: tissue necrosis (in case of extravasation).

Other: general malaise, fatigue, lethargy, fever, muscle pain, hypocalcemia, hyperuricemia and nephropathy.

Contraindications

Chickenpox, herpes zoster, severe liver function disorders, pregnancy, hypersensitivity to dactinomycin. Not used in newborns and infants.

Use in Pregnancy and Lactation

Dactinomycin is contraindicated during pregnancy. If it is necessary to use during lactation, breastfeeding should be discontinued.

Women of childbearing potential should use reliable methods of contraception during the period of taking dactinomycin.

Experimental studies have revealed the teratogenic, mutagenic, and embryotoxic effects of dactinomycin.

Use in Hepatic Impairment

Contraindicated in severe liver function disorders. Liver function should be monitored during treatment.

Use in Renal Impairment

During treatment, it is necessary to monitor kidney function and the concentration of uric acid in the blood plasma.

Pediatric Use

Not used in newborns and infants.

Special Precautions

Treatment should be carried out under the strict supervision of a physician experienced in the use of antineoplastic agents.

Dactinomycin should be used with caution in patients with gout or nephrolithiasis (including in the medical history).

During treatment, it is necessary to monitor the degree of myelodepression, as well as liver and kidney function, and the concentration of uric acid in the blood plasma.

There are reports that Dactinomycin may distort the results of biological tests used to determine the concentration of antibacterial drugs in the blood plasma.

Vaccination of the patient and their family members is not recommended during therapy.

When dactinomycin is used concomitantly with radiation therapy, an increase in toxic reactions from the gastrointestinal tract and bone marrow is possible. Particular caution is necessary when prescribing dactinomycin during two-month radiation therapy for right-sided Wilms’ tumor, as hepatomegaly and increased AST activity have been observed in such cases.

Dactinomycin is also used by the method of isolated perfusion and is administered alone or in combination with other antineoplastic drugs either as palliative treatment or as an adjunct to surgical treatment. When administered by perfusion, in some cases Dactinomycin provides more effective temporary improvement than its systemic use.

Drug Interactions

With the simultaneous use of dactinomycin with drugs that have a myelotoxic effect, an increase in the toxic effect is possible.

When used in combination with doxorubicin, an increase in cardiotoxic effects is possible.

With simultaneous use with uricosuric agents, the risk of nephropathy increases.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.