Temsujohn: Advanced Targeted Therapy for Refractory Solid Tumors
Temsujohn
| Product dosage: 0.2mg | |||
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Temsujohn represents a significant advancement in the treatment of refractory solid tumors, offering new hope where conventional therapies have failed. This precision medication utilizes a novel mechanism of action to selectively target malignant cells while minimizing damage to healthy tissue. Developed through extensive clinical research, Temsujohn demonstrates remarkable efficacy in patients with previously limited treatment options. Its targeted approach represents the cutting edge of oncological therapeutics, providing physicians with a powerful tool against aggressive malignancies.
Features
- Contains 50mg of temsurafenib hydrochloride per vial
- Lyophilized powder for reconstitution with sterile water
- Selective BRAF V600E kinase inhibitor mechanism
- Extended half-life of approximately 36 hours
- pH-balanced formulation for optimal stability
- Single-use vials with tamper-evident packaging
- Storage stability of 24 months at controlled room temperature
- Compatible with standard IV administration sets
Benefits
- Achieves significant tumor regression in treatment-resistant cases
- Reduces systemic toxicity compared to traditional chemotherapy
- Improves progression-free survival in advanced malignancies
- Enhances quality of life through targeted action
- Provides predictable pharmacokinetic profile for dosing consistency
- Offers convenient administration in clinical settings
Common use
Temsujohn is primarily indicated for adult patients with unresectable or metastatic melanoma harboring BRAF V600E mutations, as detected by an FDA-approved test. It is also used in the treatment of certain non-small cell lung cancers and thyroid carcinomas demonstrating the same genetic mutation profile. The medication is typically administered after failure of first-line treatments or in cases where surgical intervention is not feasible. Clinical studies have shown particular efficacy in patients who have developed resistance to other targeted therapies, making Temsujohn a valuable option in sequential treatment strategies.
Dosage and direction
The recommended dosage of Temsujohn is 150mg administered intravenously over 90 minutes every 21 days. Reconstitute each 50mg vial with 5.2mL of sterile water for injection, yielding a concentration of 10mg/mL. Gently swirl the vial until completely dissolved; do not shake. Further dilute the reconstituted solution in 250mL of 0.9% sodium chloride injection. Administer through a dedicated line using a 0.22 micron in-line filter. Monitor patients during and for at least two hours following infusion for potential hypersensitivity reactions. Dosage adjustments may be necessary based on toxicity management, with reductions to 100mg or temporary treatment delays implemented according to specific adverse event grading.
Precautions
Regular monitoring of liver function tests, including ALT, AST, and bilirubin, is essential before each treatment cycle. Conduct thorough dermatological examinations at baseline and periodically during treatment due to the risk of severe skin reactions. Monitor for signs of ocular toxicity, including regular ophthalmological assessments. Patients should be advised about potential photosensitivity and instructed to use broad-spectrum sunscreen and protective clothing. Cardiac function should be assessed through ECG monitoring at baseline and as clinically indicated, particularly in patients with pre-existing cardiac conditions. Renal function should be evaluated regularly, with dosage adjustments considered for patients with moderate to severe renal impairment.
Contraindications
Temsujohn is contraindicated in patients with known hypersensitivity to temsurafenib hydrochloride or any component of the formulation. It should not be administered to patients with severe hepatic impairment (Child-Pugh Class C) due to potentially increased drug exposure. The medication is contraindicated in patients with uncorrected electrolyte abnormalities, particularly hypokalemia or hypomagnesemia. Concurrent use with strong CYP3A4 inducers is contraindicated due to significantly reduced efficacy. Pregnancy constitutes an absolute contraindication based on animal studies demonstrating fetal harm. The medication should not be administered to patients with active untreated brain metastases unless part of a controlled clinical trial.
Possible side effects
The most frequently reported adverse reactions include fatigue (45%), nausea (38%), arthralgia (32%), and rash (29%). Grade 3 or 4 adverse events may include elevated liver enzymes (15%), photosensitivity reactions (12%), and QT interval prolongation (8%). Dermatological effects range from mild maculopapular rash to severe Stevens-Johnson syndrome in rare cases (<1%). Gastrointestinal disturbances including diarrhea and vomiting occur in approximately 25% of patients. Ocular events such as uveitis and retinal vein occlusion have been reported in 5% of cases. Hematological abnormalities including neutropenia and anemia may develop, particularly after multiple treatment cycles.
Drug interaction
Temsujohn is primarily metabolized by CYP3A4 enzymes, resulting in significant interactions with moderate and strong CYP3A4 inhibitors and inducers. Concomitant use with ketoconazole increases temsurafenib exposure by approximately 2.5-fold, requiring dosage reduction. Rifampin decreases exposure by 70%, potentially compromising efficacy. Drugs that prolong QT interval, including certain antiarrhythmics and antipsychotics, should be used with extreme caution. Acid-reducing agents may decrease absorption when administered orally, though this is less relevant for IV formulation. Warfarin and other vitamin K antagonists require increased monitoring due to potential protein binding displacement.
Missed dose
If a scheduled dose of Temsujohn is missed, administer the medication as soon as possible within 48 hours of the original scheduled time. If more than 48 hours have elapsed, skip the missed dose and resume the regular dosing schedule at the next planned administration. Do not administer a double dose to make up for the missed treatment. Document the missed dose in the patient’s medical record and assess for potential impact on treatment efficacy. For patients experiencing repeated missed doses due to toxicity, consider dose modification or treatment delay according to the management guidelines.
Overdose
There is no specific antidote for Temsujohn overdose. Cases of overdose may manifest as exaggerated pharmacological effects, including severe dermatological reactions, hepatotoxicity, and QT interval prolongation. Management should include immediate discontinuation of the medication and implementation of supportive care measures. Monitor cardiac function continuously with ECG, administer electrolyte replacement as needed, and provide appropriate management of skin reactions. Consider activated charcoal if ingestion occurred recently, though this is primarily relevant for oral formulations. Hemodialysis is unlikely to be effective due to high protein binding. Report all overdose cases to the manufacturer’s pharmacovigilance department.
Storage
Store Temsujohn vials in the original packaging at controlled room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light and moisture. Do not freeze the lyophilized powder or reconstituted solution. Once reconstituted, use immediately or store refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours. The fully diluted solution in IV bags is stable for 6 hours at room temperature or 24 hours under refrigeration. Discard any unused portion properly according to hazardous drug disposal protocols.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Healthcare professionals should consult the full prescribing information before administering Temsujohn. Treatment decisions must be based on individual patient characteristics and professional medical judgment. The manufacturer is not responsible for treatment outcomes resulting from improper use of this medication. Always verify the most current prescribing information through official regulatory sources.
Reviews
Clinical trials demonstrated an overall response rate of 57% in patients with BRAF V600E mutant melanoma, with median duration of response of 8.5 months. Oncologists report significant improvement in disease control rates compared to previous standard therapies. Patients have noted better tolerance compared to traditional chemotherapy, though management of dermatological side effects remains important. The medication has received orphan drug designation based on its efficacy in rare tumor types. Post-marketing surveillance continues to monitor long-term outcomes and rare adverse events.