Dactinomycin 0.5mg Inj, 1 Vial

Dactinomycin exerts its cytotoxic effects by intercalating into the minor groove of DNA, primarily at GC-rich regions. This intercalation inhibits DNA-dependent RNA synthesis (transcription) by preventing RNA polymerase movement along the DNA template. It also causes single-strand breaks in DNA and inhibits protein synthesis at high concentrations. Its action is not cell cycle phase-specific.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek immediate medical attention:

Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Bleeding: Vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, gum bleeding, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding.
Liver Problems: Dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellow skin and eyes.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Mouth and Throat Issues: Mouth irritation, mouth sores, or difficulty swallowing.
Severe Skin Reaction (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis): Red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in the mouth, throat, nose, or eyes. This condition can cause severe health problems and may be life-threatening.
Tissue Damage: If the medication leaks from the vein, it can cause tissue damage. Inform your nurse immediately if you experience redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site.

Other Possible Side Effects

Most people taking this medication will not experience severe side effects, but some may occur. If you encounter any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Hair loss
Upset stomach or vomiting
* Fatigue or weakness

This is not an exhaustive list of potential side effects. If you have concerns or questions, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you have recently received a live vaccine.
* If you are breastfeeding. Note that you should not breastfeed while taking this medication and for 2 weeks after your last dose.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Discuss any concerns or questions you may have with your doctor.

This medication can affect the bone marrow's ability to produce essential blood cells, which may lead to bleeding problems, infections, or anemia. In severe cases, these infections can be life-threatening. If you have any questions or concerns, consult your doctor.

You may experience an increased risk of bleeding, so it is crucial to be cautious and avoid injuries. To minimize this risk, use a soft toothbrush and an electric razor.

Additionally, you may be more susceptible to infections. To reduce this risk, wash your hands frequently and avoid close contact with people who have infections, colds, or flu.

There is a potential increased risk of developing certain types of cancer associated with this medication. Discuss this risk with your doctor. If you experience stomach upset, vomiting, diarrhea, or a decrease in appetite, consult your doctor, as there may be ways to alleviate these side effects.

In rare cases, this medication has been linked to severe and potentially life-threatening blood vessel problems in the liver, particularly in children under 4 years old and individuals undergoing radiation treatment. If you have any questions or concerns, discuss them with your doctor.

Before receiving any vaccinations, consult your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

If you have undergone or will be undergoing radiation treatment, inform your doctor, as this medication may exacerbate the side effects of radiation therapy.

This medication can cause harm to an unborn baby. A pregnancy test will be conducted before starting treatment to confirm that you are not pregnant. If you may become pregnant, it is essential to use birth control while taking this medication and for a specified period after the last dose. Consult your doctor to determine the duration of birth control use. If you become pregnant, notify your doctor immediately.

If your partner may become pregnant, it is crucial to use birth control while taking this medication and for a specified period after the last dose. Consult your doctor to determine the duration of birth control use. If your partner becomes pregnant, notify the doctor immediately.

• Live vaccines (due to immunosuppression)

• Other myelosuppressive agents (e.g., other chemotherapies, radiation therapy) - increased risk of severe myelosuppression.
• Hepatotoxic agents (e.g., methotrexate, mercaptopurine) - increased risk of hepatotoxicity.
• Radiation therapy - increased risk of radiation recall phenomenon and enhanced toxicity in irradiated fields.

• Phenytoin - Dactinomycin may decrease phenytoin levels.
• Vitamin K antagonists (e.g., warfarin) - potential for increased bleeding risk due to myelosuppression affecting platelets or direct interaction (monitor INR).

• Signs of infection (fever, chills, sore throat)
• Unusual bleeding or bruising (petechiae, epistaxis, melena)
• Fatigue, weakness
• Nausea, vomiting, diarrhea
• Oral mucositis/stomatitis
• Skin reactions (rash, redness, blistering, especially in previously irradiated areas - radiation recall)
• Alopecia (hair loss)
• Signs of liver dysfunction (yellowing of skin/eyes, dark urine, light-colored stools, abdominal pain)
• Pain, swelling, redness, or blistering at the injection site (extravasation)

Dactinomycin is contraindicated in pregnancy. It can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant during therapy and to use effective contraception during and for a period after treatment.

Lactation is contraindicated during Dactinomycin therapy and for a period after the last dose. It is unknown if Dactinomycin is excreted in human milk, but due to its potential for serious adverse reactions in breastfed infants, 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.

Dactinomycin is commonly used in pediatric oncology, particularly for Wilms' tumor and rhabdomyosarcoma. However, pediatric patients, especially infants, are at increased risk for severe toxicity, including myelosuppression, hepatotoxicity, and gastrointestinal effects. Careful dose calculation based on weight or BSA and close monitoring are crucial. Cumulative dose limits are important to prevent long-term toxicities.

Geriatric patients may be at increased risk for Dactinomycin-induced toxicities, particularly myelosuppression and gastrointestinal side effects, due to decreased organ function, comorbidities, and concomitant medications. Close monitoring of hematologic, hepatic, and renal function is recommended, and dose adjustments may be necessary based on individual tolerance and toxicity.

• Dactinomycin is a vesicant; extreme care must be taken to avoid extravasation. Administer through a free-flowing intravenous infusion, preferably via a central venous catheter. If extravasation occurs, stop the infusion immediately, disconnect the syringe, and aspirate any residual drug. Local injection of hyaluronidase and application of cold compresses may be considered, but evidence is limited.
• Highly emetogenic; prophylactic antiemetics are recommended.
• Can cause 'radiation recall' phenomenon, where skin reactions (erythema, blistering) occur in previously irradiated fields, even months or years after radiation therapy.
• Myelosuppression is dose-limiting and typically occurs 7-10 days after a dose, with nadir around 14-21 days. Recovery usually occurs within 3-4 weeks.
• Oral mucositis and stomatitis are common and can be severe; good oral hygiene is essential.
• Alopecia is common and usually reversible.
• Liver toxicity, including veno-occlusive disease, can occur, especially in children and with higher doses or concomitant hepatotoxic agents.

• Other cytotoxic agents used in pediatric solid tumors: Vincristine, Cyclophosphamide, Doxorubicin, Ifosfamide, Etoposide.
• For specific indications, other agents may be used depending on the tumor type and stage (e.g., cisplatin, carboplatin, irinotecan).

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective use of your medication, never share your prescription with others, and do not take medication that has been prescribed to someone else.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so by a healthcare professional or pharmacist, avoid flushing medications down the toilet or pouring them down the drain. Many communities have drug take-back programs, which your pharmacist can help you locate.

Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will help healthcare providers deliver appropriate care.