Dacihal Injection 1 No's

• Wilms Tumor: A malignant kidney cancer primarily occurring in young children, where it is used alongside other chemotherapy drugs.
• Rhabdomyosarcoma: A tumour arising in soft tissues and skeletal muscles, managed with combination chemotherapy regimens.
• Ewing Sarcoma: An aggressive cancer of the bones and surrounding tissue, managed using a combination of chemotherapy drugs.
• Gestational Trophoblastic Neoplasia (GTN): Rare tumours arising from placental tissues after hydatidiform mole or pregnancy, managed as a single agent in low-risk cases or alongside multi-drug combinations (such as EMA-CO) for high-risk disease.
• Certain Testicular Cancer: Used within multi-drug chemotherapy regimens for certain testicular cancers.
• Locally Recurrent or Regional Solid Tumors: Administered via regional arterial perfusion (hyperthermic limb isolation) to manage localised, recurrent soft tissue sarcomas and melanomas of the limbs.

• Dacihal powder for injection should not be used in patients with a known severe hypersensitivity to dactinomycin or any component of the formulation.
• Patients with severe bone marrow suppression, active serious infection, or significant liver dysfunction require careful assessment because these conditions may increase treatment-related toxicity.
• Pregnancy: Pregnancy is not necessarily listed as an absolute contraindication, but dactinomycin may cause fetal harm and should generally be avoided unless the potential benefit outweighs the potential risk.

• Reduction in white blood cells (neutropenia and leukopenia), leading to dangerous infections
• Low red blood cell levels (anaemia), leading to pale skin, shortness of breath, and chronic weakness
• Low platelet counts (thrombocytopenia), resulting in easy bruising, tiny skin spots, and bleeding
• Nausea, persistent vomiting, loss of appetite, and stomach pain
• Inflammation, redness, and open sores along the mouth and throat (stomatitis and mucositis)
• Frequent loose or watery stools (diarrhoea)
• Temporary loss of hair from the scalp and body (alopecia)
• Severe physical exhaustion, general weakness, and malaise

• Skin breakouts, maculopapular rash, and abnormal darkening of the skin (hyperpigmentation)
• Radiation recall reaction, marked by severe skin inflammation, redness, or peeling on body areas that previously received radiation therapy
• Reversible increases in liver enzymes on routine blood panels
• Dry mouth and altered sense of taste
• Fever (pyrexia)

• Sinusoidal Obstruction Syndrome (SOS / Veno-Occlusive Disease): Severe liver vessel damage marked by yellowing skin or eyes, painful enlargement of the upper right abdomen, fluid building up in the belly, and sudden weight gain.
• Febrile Neutropenia and Systemic Infection: A body temperature of 38°C (100.4°F) or higher accompanied by shaking chills, rapid pulse, or confusion, signaling a medical emergency.
• Extravasation (Tissue Leakage): Sharp burning, stinging, severe local pain, swelling, or blistering around your intravenous injection site.
• Uncontrolled Bleeding: Frequent nosebleeds, bleeding gums, unexpected dark bruised patches, or visible blood in your urine or stool.
• Severe mucocutaneous reactions: Severe skin reactions, including Stevens-Johnson syndrome or toxic epidermal necrolysis, require immediate medical attention and permanent discontinuation of treatment.

• Dacihal powder for injection is administered only by trained healthcare professionals as an intravenous (IV) infusion or slow IV injection in a hospital or oncology setting.
• The administration schedule depends on the cancer type and treatment protocol. The oncologist determines the dose individually based on factors such as body size, blood counts, organ function, and treatment tolerance.
• Dacihal powder for injection is intended only for intravenous use and must never be taken by mouth or handled at home.
• Do not alter, skip, or delay scheduled treatment without speaking with your treating oncologist.

• Store drug vials at controlled room temperature (20°C to 25°C; 68°F to 77°F).
• Keep the vial inside its original cardboard package to shield the powder from direct light.
• Do not freeze the powder or reconstituted solutions.
• Because this medicine is a hazardous cytotoxic substance, clinical staff discard all used vials, IV bags, tubing, and needles exclusively in labelled biohazard waste containers.
• Keep out of reach of children and pets.

• Notify your nurse immediately if you experience pain, burning, or swelling at the intravenous needle site during or after administration.
• Report a temperature of 38°C (100.4°F) or higher urgently, especially when your white blood cell count is low.
• Ensure you use reliable contraception throughout treatment and for the recommended period after the final dose.
• Maintain gentle oral hygiene by using a soft-bristled toothbrush and rinsing with warm salt water as advised by your healthcare team.
• Stay away from crowded public places and people with active illnesses while your white blood cell count remains low.
• Do not miss blood test appointments, including complete blood counts, kidney panels, and liver monitoring.
• Avoid alcohol and do not start any new over-the-counter drugs or supplements without consulting your oncologist.

Overdose

Missed a Dose

Interactions with other medicines

• Avoid live vaccines (such as yellow fever, MMR, BCG, or oral typhoid) during treatment because dactinomycin can suppress the immune system.
• Other bone-marrow-suppressing medicines or radiation therapy may increase the risk of severe low blood-cell counts and other toxicities.
• Concurrent or recent radiation therapy may increase radiation-related toxicity, including radiation recall.
• Medicines that can cause liver or kidney toxicity may require additional monitoring during treatment.
• Always tell your doctor about all prescription and OTC medicines, herbal products, vitamins, and dietary supplements you take before starting treatment.

Interactions with food items

• Because Dacihal powder for injection is administered directly into a vein, food does not affect its absorption or effectiveness.
• Dactinomycin has no specific food interactions.
• If your white blood cell count is low, follow your healthcare team's advice on food safety and avoid raw or unpasteurized foods and undercooked meats.
• Eating small, frequent meals and staying well hydrated may help manage nausea and mouth discomfort during treatment.