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Pegadria 50mg - Doxorubicin Hydrochloride Injection

Pegadria 50mg is a Doxorubicin Hydrochloride injection, an anthracycline chemotherapy agent used in the treatment of various malignancies. It intercalates DNA, inhibits topoisomerase II, and generates free radicals to induce cancer cell death.

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Description Product Details

General Information:

Generic Name: Doxorubicin Hydrochloride

Brand Name: Pegadria

Packing: Single‑use vial

Strength: 50 mg

Manufacturer: Cipla Ltd.

Form: Lyophilized powder for injection (IV)

Category: Anthracycline Antibiotic / Antineoplastic Agent

Product Introduction:

Pegadria 50mg is a vial‑based intravenous chemotherapy formulation of Doxorubicin Hydrochloride. The drug is indicated for a broad spectrum of solid tumors and hematologic cancers. Due to its potent antineoplastic activity and known cardiotoxicity, it requires careful dosing, monitoring, and administration by trained oncology professionals.

Uses of Pegadria 50mg Injection:

Pegadria is indicated for:

Breast Cancer – Adjuvant and metastatic settings.
Ovarian Cancer – Especially platinum‑resistant disease.
Kaposi’s Sarcoma – AIDS‑related.
Acute Leukemias – Both ALL and AML in combination regimens.
Lymphomas – Hodgkin’s and non‑Hodgkin’s (e.g., CHOP protocol).
Bladder Cancer – Advanced or metastatic urothelial carcinoma.
Gastric and Thyroid Cancers – In select combination protocols.

Storage Instructions:

Store refrigerated at 2 °C – 8 °C.
Do not freeze.
Protect from light.
Use immediately after reconstitution per institutional guidelines.

Mechanism of Action:

DNA Intercalation: Inserts between DNA base pairs, disrupting replication.
Topoisomerase II Inhibition: Prevents DNA relegation, causing strand breaks.
Free Radical Generation: Induces oxidative damage to cellular membranes and macromolecules.

Side Effects:

Common:

Nausea, vomiting
Alopecia (hair loss)
Mucositis (oral ulcers)
Myelosuppression (neutropenia, anemia, thrombocytopenia)
Red discoloration of urine
Fatigue

Severe (Rare):

Cardiotoxicity – Cumulative dose–dependent heart failure
Extravasation Injury – Tissue necrosis if leakage occurs
Severe Myelosuppression – Life‑threatening infections or bleeding
Secondary Leukemia – With prolonged use
Infusion Reactions – Fever, chills, hypotension

Dosage (Typical):

Solid Tumors (e.g., breast, lung, bladder): 60–75 mg/m² IV every 21 days
Hematologic Malignancies: 20–30 mg/m² IV on days 1–3 of a 21‑day cycle
Adjust for age, performance status, hepatic function, and blood counts

Method of Administration:

IV infusion over 3–10 minutes (or per protocol) via a central line if possible.
Do not administer intramuscularly or subcutaneously.
Use appropriate PPE when handling.
Monitor vital signs and infusion site; manage extravasation immediately.

Precautions:

Baseline and periodic cardiac assessment (echocardiogram, ECG).
Limit cumulative lifetime dose (~450–550 mg/m²) to reduce heart failure risk.
Dose reduction in hepatic impairment.
Avoid pregnancy and breastfeeding; use effective contraception.
Handle with care to prevent needlestick and extravasation injuries.

Drug Interactions:

Trastuzumab, Cyclophosphamide – ↑ Cardiotoxicity risk
Paclitaxel – Sequence‑dependent toxicity; give Paclitaxel first
Live Vaccines – Contraindicated during treatment
CYP450 modulators – May alter metabolism and toxicity

Allergies (Warnings):

Contraindicated in hypersensitivity to Doxorubicin or anthracyclines.
Monitor for rash, pruritus, bronchospasm, and hypotension during infusion.

Overdose Information:

Symptoms: Severe myelosuppression, mucositis, cardiotoxicity, multiorgan failure
Management: Immediate hospitalization, supportive care (IV fluids, G‑CSF, cardiac monitoring), symptomatic treatment

Missed Dose Instructions:

Do not self‑adjust; contact oncology team to reschedule infusion.
Avoid delays to maintain efficacy, but ensure patient safety.

Additional Notes:

Educate patients on signs of infection, bleeding, and heart failure.
Manage hand–foot syndrome and mucositis proactively.
Monitor CBC, LFTs, and renal function regularly.
Dispose of waste per cytotoxic drug protocols.