Kadcyla
Generic Name
Trastuzumab Emtansine
Manufacturer
Genentech (a member of the Roche Group)
Country
USA/Switzerland
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
kadcyla 100 mg injection | ৳ 131,257.00 | N/A |
kadcyla 160 mg injection | ৳ 224,975.16 | N/A |
Description
Overview of the medicine
Kadcyla (trastuzumab emtansine) is an antibody-drug conjugate indicated for the treatment of HER2-positive breast cancer.
Uses & Indications
Dosage
Adults
3.6 mg/kg intravenously every 3 weeks (21-day cycle).
Elderly
No specific dose adjustment is required for elderly patients.
Renal_impairment
No specific dose adjustment recommended for mild to moderate renal impairment. Data are limited for severe impairment.
How to Take
Administer as an intravenous infusion. Do not administer as an intravenous push or bolus. The initial infusion should be given over 90 minutes. Subsequent infusions can be given over 30 minutes if the previous infusion was well-tolerated.
Mechanism of Action
Trastuzumab emtansine combines the anti-HER2 activity of trastuzumab with the cytotoxic effects of DM1, a microtubule inhibitor. Trastuzumab binds to HER2-positive cancer cells, leading to internalization of the conjugate. DM1 is then released intracellularly, causing cell cycle arrest and apoptosis.
Pharmacokinetics
Onset
Therapeutic effects are observed over multiple cycles of treatment.
Excretion
Mainly through proteolysis, with DM1 metabolites excreted via bile and urine.
Half life
Approximately 4 days for trastuzumab emtansine.
Absorption
Administered intravenously, resulting in 100% bioavailability.
Metabolism
Primarily catabolized via proteolysis. DM1 is metabolized by CYP3A4/5.
Side Effects
Contraindications
- Known hypersensitivity to trastuzumab emtansine or to any excipient.
- Pregnancy.
Drug Interactions
0
Strong CYP3A4 inhibitors (e.g., ketoconazole): May increase DM1 exposure, requiring close monitoring for adverse reactions.
1
Strong CYP3A4 inducers (e.g., rifampicin): May decrease DM1 exposure, potentially reducing efficacy.
Storage
Store unopened vials refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze. Reconstituted solution should be used immediately or stored for up to 24 hours at 2°C to 8°C.
Overdose
No specific antidote. Management involves supportive care and monitoring of vital signs, complete blood count, and liver transaminases.
Pregnancy & Lactation
Contraindicated in pregnancy due to embryo-fetal toxicity. Advise lactating women not to breastfeed during treatment and for 7 months after the last dose due to potential harm to the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 to 3 years when stored as recommended.
Availability
Hospitals, Oncology Centers
Approval Status
FDA Approved
Patent Status
Patented
Clinical Trials
Key trials include EMILIA (for metastatic breast cancer) and KATHERINE (for adjuvant treatment in early breast cancer), demonstrating significant improvements in progression-free survival and invasive disease-free survival respectively.
Lab Monitoring
- Complete blood count (CBC) with platelet count before each dose and as clinically indicated.
- Liver function tests (ALT, AST, bilirubin) before each dose and as clinically indicated.
- Left Ventricular Ejection Fraction (LVEF) assessment before initiation and periodically during treatment.
Doctor Notes
- Perform a thorough baseline cardiac assessment (including LVEF) and monitor periodically during treatment.
- Educate patients on symptoms of liver injury, cardiac dysfunction, and peripheral neuropathy, and advise prompt reporting.
- Consider dose reduction or interruption for significant adverse reactions as per prescribing information.
Patient Guidelines
- Report any signs of liver problems (e.g., jaundice, dark urine, severe abdominal pain).
- Report any new or worsening heart symptoms (e.g., shortness of breath, swelling of ankles/legs).
- Use effective contraception during treatment and for 7 months after the last dose.
Missed Dose Advice
If a dose is missed, administer it as soon as possible. Do not wait until the next planned cycle. Adjust subsequent doses to maintain a 3-week interval between doses.
Driving Precautions
Kadcyla may cause side effects such as fatigue, headache, or visual disturbances that could affect the ability to drive or operate machinery. Advise caution.
Lifestyle Advice
- Maintain a healthy diet and stay well-hydrated.
- Manage fatigue with adequate rest and light physical activity as tolerated.
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