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Ujvira (100mg / 160mg) - Trastuzumab Emtansine Injection

Ujvira (100mg / 160mg) - Trastuzumab Emtansine Injection

Ujvira is an antibody-drug conjugate (ADC) combining trastuzumab with a cytotoxic agent (DM1). It is used in the treatment of HER2-positive metastatic breast cancer, particularly in patients previously treated with trastuzumab and a taxane.

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Description Product Details
General Information:
Generic Name: Trastuzumab Emtansine
Brand Name: Ujvira
Strengths Available: 100 mg / 160 mg lyophilized powder for IV infusion
Packing: Single-use vial
Manufacturer: Zydus Cadila
Form: Lyophilized powder for injection
Category: Antibody-drug conjugate, HER2-targeted therapy, Antineoplastic agent
Product Introduction:
Ujvira is a biosimilar formulation of trastuzumab emtansine (also known as T-DM1), developed by Zydus Cadila. It represents a targeted therapy that selectively delivers chemotherapy to HER2-positive cancer cells by combining the HER2-targeting action of trastuzumab with the microtubule inhibitor DM1. This dual-action mechanism enhances efficacy while reducing systemic toxicity.
Uses (Indications):
Ujvira (trastuzumab emtansine) is indicated for the treatment of:
  1. HER2-positive metastatic breast cancer in patients who have received prior trastuzumab and taxane therapy
  2. Progressive HER2-positive breast cancer following prior systemic treatments
  3. Locally advanced or unresectable HER2-positive breast cancer after first-line failure
  4. HER2-positive early breast cancer (eBC) with residual invasive disease after neoadjuvant therapy (in some protocols)
  5. Used in patients intolerant to standard HER2-targeted combinations
Storage Instructions:
  1. Store vials at 2°C to 8°C (refrigerated condition)
  2. Do not freeze the product
  3. Protect from light and moisture
  4. Once reconstituted and diluted, the infusion should be used within 4 hours if stored at room temperature
  5. Follow aseptic techniques during preparation and administration
How It Works (Mechanism of Action):
Ujvira is an antibody-drug conjugate (ADC) consisting of:
  1. Trastuzumab (HER2-targeting monoclonal antibody)
  2. DM1 (emtansine) – a cytotoxic agent derived from maytansine, linked via a stable linker
Mechanism details:
  1. The trastuzumab component binds selectively to HER2 receptors overexpressed on tumor cells.
  2. After binding, the conjugate is internalized into the cancer cell through receptor-mediated endocytosis.
  3. Inside the cell, DM1 is released, disrupting microtubule assembly, leading to cell cycle arrest and apoptosis.
  4. Trastuzumab also retains its ability to inhibit HER2 signaling and mediate antibody-dependent cellular cytotoxicity (ADCC).
This targeted delivery system allows greater cancer cell specificity and limits systemic damage.
Side Effects:
Common Side Effects:
  1. Fatigue
  2. Nausea and vomiting
  3. Headache
  4. Musculoskeletal pain
  5. Constipation
  6. Diarrhea
  7. Elevated liver enzymes (AST, ALT)
Serious Side Effects:
  1. Hepatotoxicity – including severe liver injury and liver failure
  2. Thrombocytopenia – increased risk of bleeding
  3. Left ventricular dysfunction – decreased LVEF
  4. Pulmonary toxicity – interstitial lung disease, pneumonitis
  5. Infusion-related reactions – chills, fever, anaphylaxis
  6. Peripheral neuropathy – due to DM1 component
  7. Severe myelosuppression (rare)
Dosage (Typical Recommended Dose):
  1. Standard Dose: 3.6 mg/kg
  2. Route: Intravenous infusion
  3. Frequency: Once every 3 weeks (21-day cycle)
  4. Duration: Until disease progression or unacceptable toxicity
  5. No dose escalation is recommended; dose adjustments may be made based on tolerability and adverse effects
Method of Administration:
  1. Reconstitute the powder with sterile water for injection
  2. Dilute in 0.9% sodium chloride solution before infusion
  3. Infuse over 90 minutes for the first dose under supervision
  4. If well tolerated, subsequent infusions can be over 30 minutes
  5. Do not administer as a bolus or push injection
  6. Monitor patient for infusion-related reactions during and after administration
Precautions:
  1. Perform baseline and periodic cardiac evaluations (e.g., LVEF)
  2. Monitor platelet counts and liver function tests prior to each dose
  3. Avoid use during pregnancy and lactation – may cause fetal harm
  4. Discontinue permanently if severe pulmonary or hepatic toxicity occurs
  5. Not recommended in patients with severe hepatic impairment
  6. Use with caution in patients with pre-existing neuropathy or cardiac conditions
Drug Interactions:
  1. Strong CYP3A4 inhibitors or inducers (e.g., ketoconazole, rifampicin) may alter DM1 levels
  2. Anticoagulants or antiplatelets may increase bleeding risk due to thrombocytopenia
  3. Avoid combining with other cardiotoxic agents unless closely monitored
  4. No known pharmacokinetic interaction with trastuzumab-based therapies, but monitor closely in polytherapy
Allergies (Warnings for Allergic Reactions):
  1. Hypersensitivity to trastuzumab emtansine, murine proteins, or excipients is a contraindication
  2. Infusion reactions including angioedema, bronchospasm, urticaria, or anaphylaxis may occur
  3. Consider premedication (antihistamines, antipyretics) in patients with prior reactions
  4. Emergency resuscitation equipment must be readily available during infusions
Overdose Information:
  1. Overdose may cause severe myelosuppression, hepatotoxicity, or cardiac dysfunction
  2. No specific antidote exists – manage with supportive care and close monitoring
  3. Monitor platelets, liver enzymes, and cardiac function closely in case of overdose
  4. Discontinue treatment and hospitalize if necessary
Missed Dose Instructions:
  1. If a scheduled dose is missed, it can be administered as soon as possible
  2. Maintain at least 3 weeks between doses
  3. Do not double the dose to make up for the missed one
  4. If the gap is extended beyond guidelines, evaluate patient and resume with caution or after medical advice
Additional Notes:
  1. HER2 positivity must be confirmed using IHC 3+ or FISH+ before initiation
  2. Ujvira offers the efficacy of chemotherapy and targeted therapy in one agent
  3. Compared to traditional regimens, toxicity is more manageable, but monitoring is critical
  4. Patients should be educated on symptoms of liver dysfunction, bleeding, and neuropathy
  5. Long-term survival benefit has been demonstrated in multiple clinical trials (e.g., EMILIA study)
  6. Should only be administered by healthcare professionals trained in oncology and chemotherapy administration

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