{"id":2520,"date":"2022-08-25T06:44:52","date_gmt":"2022-08-25T06:44:52","guid":{"rendered":"https:\/\/emergencydrug.com\/?post_type=product&p=2520"},"modified":"2024-10-01T06:32:28","modified_gmt":"2024-10-01T06:32:28","slug":"selcaxen-selpercatinib-40-mg","status":"publish","type":"product","link":"https:\/\/emergencydrug.com\/ar\/shop\/selcaxen-selpercatinib-40-mg\/","title":{"rendered":"Selcaxen (Selpercatinib) 40 MG \u2013 30 Capsules"},"content":{"rendered":"

Product Features:<\/em><\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n
Product Name<\/td>\n: Selcaxen<\/td>\n<\/tr>\n
Generic Name<\/td>\n: Selpercatinib<\/td>\n<\/tr>\n
Manufacturer<\/td>\n: Beacon Pharma Ltd<\/td>\n<\/tr>\n
Indication<\/td>\n: Non-small cell lung cancer<\/td>\n<\/tr>\n
Formulation<\/td>\n: Capsule<\/td>\n<\/tr>\n
Strength<\/td>\n: 40 mg<\/td>\n<\/tr>\n
Quantity<\/td>\n: 30 Capsules<\/td>\n<\/tr>\n
Storage<\/td>\n: Below 30\u00b0<\/td>\n<\/tr>\n
Registrations<\/td>\n: Export Only<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

Selcaxen 40 Mg (Selpercatinib) treats a specific type of non-small cell lung cancer (NSCLC) in adults that have spread to other body parts. It is also used to treat a particular type of thyroid cancer in adults and children 12 years of age and older that has spread to other body parts. Selcaxen 40 Mg is also used to treat thyroid cancer that has spread to other parts of the body in adults and children 12 years of age and older who have been treated unsuccessfully with radioactive iodine. Selcaxen 40 Mg is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.<\/p>\n

Composition of Selpercatinib<\/h2>\n

Selcaxen capsule:<\/strong> Each capsule contains Selpercatinib INN 40 mg.<\/p>\n

Pharmacology of Selpercatinib<\/h3>\n

Mechan<\/strong>ism of Action:<\/strong> Selpercatinib is <\/span>a <\/span>ki<\/span>n<\/span>ase inhibitor. Selpercatinib inhibited wild-type RET a<\/span>nd <\/span>multiple mutated RE<\/span>T <\/span>isoforms as well <\/span>a<\/span>s <\/span>V<\/span>EGFR1 and VEGFR3 with IC50 values ranging from 0.92 <\/span>n<\/span>M to 67.8 <\/span>nM<\/span>. In other enzyme ass<\/span>ay<\/span>s, also inhibited FGFR 1, 2, and 3 at higher concentrations that were still clinically achievable. In cellular as<\/span>sa<\/span>ys, inhibited <\/span>RET at approximately 60-fold lower concentrations than <\/span>FGFR1 and 2 and approximately 8-fold lower concen<\/span>tration than VEGFR3.\u00a0<\/span><\/p>\n

Indication and Usage of Selpercatinib<\/h3>\n

Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer:<\/strong>
\nSelpercatinib is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer(NSCLC).
\nThis indication is approved under accelerated approved based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).<\/p>\n

RET-Mutant Medullary Thyroid Cancer<\/strong>
\nSelpercatinib is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer(MTC) who require systemic therapy.
\nThis indication is approved under accelerated approved based on overall response rate and duration o response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).<\/p>\n

RET Fusion-Positive Thyroid Cancer<\/strong>
\nSelpercatinib is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory if radioactive iodine is appropriate).
\nThis indication is approved under accelerated approved based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).<\/p>\n

Dosage and Administration<\/h4>\n

Patient Selection:<\/strong>
\nSelect patients for treatment with Selpercatinib based on the presence of a RET gene fusion (NSCLC or thyroid cancer) or specific RET gene mutation (MTC) in tumor specimens or plasma. An FDA-approved test for the detection of RET gene fusions and RET gene mutations is not currently available. Important Administration Instructions
\nmay be taken with or without food unless co-administrated with a proton pump inhibitor (PPI).<\/p>\n

Recommended Dosage:\u00a0<\/b><\/p>\n

The recommended dosage based on <\/span>body weight is:\u00a0<\/span><\/p>\n

    \n
  • Less than 50 kg: 120 mg\u00a0<\/span><\/li>\n
  • 50 kg or greater: 160 mg <\/span><\/b><\/li>\n<\/ul>\n

    Ta<\/span>k<\/span>e Selpercatinib orally tw<\/span>ic<\/span>e daily (approximately <\/span>every 12 hours) until disease progression or unacceptable<\/span> toxicity.\u00a0<\/span>Swallow the capsules whole. Do not crush or chew the <\/span>c<\/span>apsules. <\/span>Do not take a missed dose unless it is more than 6 hours until the next scheduled dose.\u00a0<\/span><\/p>\n

    If vomiting occurs after Selpercatinib administration, do <\/span>not take an additional dose and continue to the next scheduled time for the next dose.\u00a0<\/span><\/p>\n

    Dosage Modifications for Concomitant Use of Acid-Reducing Agents:\u00a0<\/strong><\/p>\n

    Avoid concomitant use of a PPI, a histamine-2 (H2) <\/span>receptor antagonist, or a locally-acting antacid with Selpercatinib. If concomitant use cannot be avoided:\u00a0<\/span><\/p>\n

      \n
    • Take Selpercatinib with food when co-administered with a PPI.\u00a0<\/span><\/li>\n
    • Take Selpercatinib 2 hours before or 10 hours after <\/span>administration of an H2 receptor antagonist. <\/span><\/li>\n
    • Take Selpercatinib 2 hours before or 2 hours after administration of a locally-acting antacid.<\/li>\n<\/ul>\n

      Warnings and Precautions<\/b><\/h4>\n

      Hepatotoxicity:<\/strong> <\/span><\/p>\n

      Serious hepatic adverse reactions occurred in 2.6% of <\/span>patients treated with Selpercatinib<\/span>. <\/span>Monitor ALT an<\/span>d <\/span>AST prior to initiating Selpercatinib, every 2 weeks <\/span>during the first 3 months<\/span>, <\/span>then monthly thereafter and as clinically indicated<\/span>. <\/span>Withhold<\/span>, <\/span>reduce <\/span>d<\/span>os<\/span>e or <\/span>permanently discontinue Selpercatinib based on the <\/span>severity.\u00a0<\/span><\/p>\n

      Hypertension:<\/b><\/p>\n

      Hypertension occurred in 35% of patients, including Grade 3 hypertension in 17% and Grade 4 in one (0.1%) patient. Overall, 4.6% had their dose interrupted, and 1.3% had their amount reduced for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications.<\/p>\n

      Do not initiate Selpercatinib in patients with uncontrolled hypertension. Optimize blood pressure before starting Selpercatinib. Monitor blood pressure after one week, at least monthly after that, and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue Selpercatinib based on the severity.<\/p>\n

      QT Interval Prolongation:\u00a0<\/strong><\/p>\n

      Selpercatinib can cause concentration-dependent QT interval prolongation. An increase in QTCF interval to >500 ms was measured in 6% of patients, and an increase in the QTCF interval of at least 60 ms over baseline was measured in 15% of patients. Selpercatinib has not been studied in patients with clinically significant active cardiovascular disease or recent myocardial infarction.<\/p>\n

      Monitor patients at significant risk of developing QTC prolongation, including patients with known long QT syndromes, clinically substantial bradyarrhythmias<\/span>, and severe or uncontrolled heart failure. Assess QT interval, electrolytes, and TSH at baseline and periodically during treatment, adjusting frequency based upon risk factors, including diarrhea. Correct hypokalemia, hypomagnesemia, and hypocalcemia before initiating Selpercatinib and during therapy.<\/p>\n

      Monitor the QT interval more frequently when Selpercatinib is concomitantly administered with potent and moderate CYP3A inhibitors or drugs known to prolong QTc interval. Withhold and dose reduce or permanently discontinue Selpercatinib based on the severity.<\/p>\n

      Hemorrhagic Events:\u00a0<\/strong><\/p>\n

      Serious, including fatal hemorrhagic events, can occur with Selpercatinib. Grade 2 3 hemorrhagic events occurred in 2.3% of patients treated with Selpercatinib, including 3 (0.4%) patients with fatal hemorrhagic events, including one case each of cerebral hemorrhage, tracheostomy site hemorrhage, and hemoptysis.<\/p>\n

      Permanently discontinue Selpercatinib in patients with severe or life-threatening bleeding.<\/p>\n

      Hypersensitivity:\u00a0<\/strong><\/p>\n

      Hypersensitivity occurred in 4.3% of patients receiving Selpercatinib, including Grade 3 hypersensitivity in 1.6%. The median time to onset was 1.7 weeks (6 days to 1.5 years). Signs and symptoms of hypersensitivity included fever, rash, and arthralgias or myalgias with concurrent decreased platelets or transaminitis.<\/p>\n

      And-<\/p>\n