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KADCYLA
Overview
What is KADCYLA?
KADCYLA (ado-trastuzumab emtansine) is a HER2-targeted antibody-drug conjugate (ADC) which contains the humanized anti-HER2 IgG1, trastuzumab, covalently linked to the microtubule inhibitory drug DM1 (a maytansine derivative) via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate). Emtansine refers to the MCC-DM1 complex.
The antibody trastuzumab, is a well characterized recombinant monoclonal antibody product produced by mammalian (Chinese hamster ovary) cells, and the small molecule components (DM1 and MCC) are produced by chemical synthesis. Ado-trastuzumab emtansine contains an average of 3.5 DM1 molecules per antibody. Ado-trastuzumab emtansine has the following chemical structure:
Note: The bracketed structure is DM1 plus MCC which represents the emtansine component. The n is, on average, 3.5 DM1 molecules per trastuzumab (Mab) molecule.
KADCYLA (ado-trastuzumab emtansine) is a sterile, white to off-white preservative free lyophilized powder in single-use vials. Each vial contains 100 mg or 160 mg ado-trastuzumab emtansine. Following reconstitution, each single-use vial contains ado-trastuzumab emtansine (20 mg/mL), polysorbate 20 [0.02% (w/v)], sodium succinate (10 mM), and sucrose [6% (w/v)] with a pH of 5.0 and density of 1.026 g/mL. The resulting solution containing 20 mg/mL ado-trastuzumab emtansine is administered by intravenous infusion following dilution.
What does KADCYLA look like?
What are the available doses of KADCYLA?
Lyophilized powder in single-use vials containing 100 mg per vial or 160 mg per vial. ()
What should I talk to my health care provider before I take KADCYLA?
How should I use KADCYLA?
KADCYLA, as a single agent, is indicated for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either:
The recommended dose of KADCYLA is 3.6 mg/kg given as an intravenous infusion every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.
Closely monitor the infusion site for possible subcutaneous infiltration during drug administration .
First infusion: Administer infusion over 90 minutes. Patients should be observed during the infusion and for at least 90 minutes following the initial dose for fever, chills, or other infusion-related reactions .
Subsequent infusions: Administer over 30 minutes if prior infusions were well tolerated. Patients should be observed during the infusion and for at least 30 minutes after infusion.
What interacts with KADCYLA?
Sorry No Records found
What are the warnings of KADCYLA?
Sorry No Records found
What are the precautions of KADCYLA?
Sorry No Records found
What are the side effects of KADCYLA?
Sorry No records found
What should I look out for while using KADCYLA?
None.
What might happen if I take too much KADCYLA?
There is no known antidote for overdose of KADCYLA. In clinical trials, overdose of KADCYLA has been reported at approximately two times the recommended dose which resulted in Grade 2 thrombocytopenia (resolved 4 days later) and one death. In the fatal case, the patient incorrectly received KADCYLA at 6 mg/kg and died approximately 3 weeks following the overdose; a cause of death and a causal relationship to KADCYLA were not established.
How should I store and handle KADCYLA?
KADCYLA (ado-trastuzumab emtansine) is supplied as:Verapamil hydrochloride extended-release tablets USP, 120 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘292’ debossed on one side and plain on the other side.55700-024-6055700-024-90Verapamil hydrochloride extended-release tablets USP, 180 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘293’ debossed on one side and breakline on the other side.Verapamil hydrochloride extended-release tablets USP, 240 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘G74’ debossed on one side and breakline on the other side.240 mg (brown colored) Bottles of 30 - NDC 68462-260-30 Verapamil hydrochloride extended-release tablets USP, 120 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘292’ debossed on one side and plain on the other side.55700-024-6055700-024-90Verapamil hydrochloride extended-release tablets USP, 180 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘293’ debossed on one side and breakline on the other side.Verapamil hydrochloride extended-release tablets USP, 240 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘G74’ debossed on one side and breakline on the other side.240 mg (brown colored) Bottles of 30 - NDC 68462-260-30 Verapamil hydrochloride extended-release tablets USP, 120 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘292’ debossed on one side and plain on the other side.55700-024-6055700-024-90Verapamil hydrochloride extended-release tablets USP, 180 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘293’ debossed on one side and breakline on the other side.Verapamil hydrochloride extended-release tablets USP, 240 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘G74’ debossed on one side and breakline on the other side.240 mg (brown colored) Bottles of 30 - NDC 68462-260-30 Verapamil hydrochloride extended-release tablets USP, 120 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘292’ debossed on one side and plain on the other side.55700-024-6055700-024-90Verapamil hydrochloride extended-release tablets USP, 180 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘293’ debossed on one side and breakline on the other side.Verapamil hydrochloride extended-release tablets USP, 240 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘G74’ debossed on one side and breakline on the other side.240 mg (brown colored) Bottles of 30 - NDC 68462-260-30 Verapamil hydrochloride extended-release tablets USP, 120 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘292’ debossed on one side and plain on the other side.55700-024-6055700-024-90Verapamil hydrochloride extended-release tablets USP, 180 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘293’ debossed on one side and breakline on the other side.Verapamil hydrochloride extended-release tablets USP, 240 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘G74’ debossed on one side and breakline on the other side.240 mg (brown colored) Bottles of 30 - NDC 68462-260-30 Verapamil hydrochloride extended-release tablets USP, 120 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘292’ debossed on one side and plain on the other side.55700-024-6055700-024-90Verapamil hydrochloride extended-release tablets USP, 180 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘293’ debossed on one side and breakline on the other side.Verapamil hydrochloride extended-release tablets USP, 240 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘G74’ debossed on one side and breakline on the other side.240 mg (brown colored) Bottles of 30 - NDC 68462-260-30
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Ado-trastuzumab emtansine is a HER2-targeted antibody-drug conjugate. The antibody is the humanized anti-HER2 IgG1, trastuzumab. The small molecule cytotoxin, DM1, is a microtubule inhibitor. Upon binding to sub-domain IV of the HER2 receptor, ado-trastuzumab emtansine undergoes receptor-mediated internalization and subsequent lysosomal degradation, resulting in intracellular release of DM1-containing cytotoxic catabolites. Binding of DM1 to tubulin disrupts microtubule networks in the cell, which results in cell cycle arrest and apoptotic cell death. In addition, studies have shown that similar to trastuzumab, ado-trastuzumab emtansine inhibits HER2 receptor signaling, mediates antibody-dependent cell-mediated cytotoxicity and inhibits shedding of the HER2 extracellular domain in human breast cancer cells that overexpress HER2.
Non-Clinical Toxicology
None.HMG-CoA reductase inhibitors:
Co-administration of multiple doses of 10 mg of verapamil with 80 mg simvastatin resulted in exposure to simvastatin 2.5-fold that following simvastatin alone. Limit the dose of simvastatin in patients on verapamil to 10 mg daily. Limit the daily dose of lovastatin to 40 mg. Lower starting and maintenance doses of other CYP3A4 substrates (e.g., atorvastatin) may be required as verapamil may increase the plasma concentration of these drugs.
Ivabradine:
Beta-blockers:
Asymptomatic bradycardia (36 beats/min) with a wandering atrial pacemaker has been observed in a patient receiving concomitant timolol (a beta-adrenergic blocker) eyedrops and oral verapamil.
A decrease in metoprolol and propranolol clearance has been observed when either drug is administered concomitantly with verapamil. A variable effect has been seen when verapamil and atenolol were given together.
Digitalis
Antihypertensive agents
Antiarrhythmic agents:
The electrophysiologic effects of quinidine and verapamil on AV conduction were studied in 8 patients. Verapamil significantly counteracted the effects of quinidine on AV conduction. There has been a report of increased quinidine levels during verapamil therapy.
Other agents:
Hepatotoxicity, predominantly in the form of asymptomatic, transient increases in the concentrations of serum transaminases, has been observed in clinical trials with KADCYLA . Serious hepatobiliary disorders, including at least two fatal cases of severe drug-induced liver injury and associated hepatic encephalopathy, have been reported in clinical trials with KADCYLA. Some of the observed cases may have been confounded by comorbidities and/or concomitant medications with known hepatotoxic potential.
Monitor serum transaminases and bilirubin prior to initiation of KADCYLA treatment and prior to each KADCYLA dose. Patients with known active hepatitis B virus or hepatitis C virus were excluded from Study 1 . Reduce the dose or discontinue KADCYLA as appropriate in cases of increased serum transaminases and/or total bilirubin . Permanently discontinue KADCYLA treatment in patients with serum transaminases > 3 × ULN and concomitant total bilirubin > 2 × ULN. KADCYLA has not been studied in patients with serum transaminases > 2.5 × ULN or bilirubin > 1.5 × ULN prior to the initiation of treatment.
In clinical trials of KADCYLA, cases of nodular regenerative hyperplasia (NRH) of the liver have been identified from liver biopsies (3 cases out of 884 treated patients, one of which was fatal). Two of these three cases of NRH were observed in the randomized trial (Study 1) . NRH is a rare liver condition characterized by widespread benign transformation of hepatic parenchyma into small regenerative nodules; NRH may lead to non-cirrhotic portal hypertension. The diagnosis of NRH can be confirmed only by histopathology. NRH should be considered in all patients with clinical symptoms of portal hypertension and/or cirrhosis-like pattern seen on the computed tomography (CT) scan of the liver but with normal transaminases and no other manifestations of cirrhosis. Upon diagnosis of NRH, KADCYLA treatment must be permanently discontinued.
The following adverse reactions are discussed in greater detail in other sections of the label:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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