{"id":293,"date":"2026-04-11T17:03:03","date_gmt":"2026-04-11T17:03:03","guid":{"rendered":"https:\/\/luciuspharmacy.com\/?post_type=product&p=293"},"modified":"2026-08-30T03:53:23","modified_gmt":"2026-08-30T03:53:23","slug":"lucisel-selpercatinib-40-mgx120-capsules","status":"publish","type":"product","link":"https:\/\/luciuspharmacy.com\/es\/product\/lucisel-selpercatinib-40-mgx120-capsules\/","title":{"rendered":"LuciSel"},"content":{"rendered":"

HIGHLIGHTS OF PRESCRIBING INFORMATION <\/strong><\/span><\/p>\n

These highlights do not include all the information needed to use LUCISEL safely and effectively. See full prescribing information for LUCISEL.<\/strong><\/span><\/p>\n

 <\/span><\/p>\n

INDICATIONS AND USAGE<\/strong><\/strong><\/span><\/p>\n

LUCISEL is a kinase inhibitor indicated for the treatment of: <\/span><\/p>\n

\u2022 Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test.<\/span><\/p>\n

\u2022 Adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.<\/span><\/p>\n

\u2022 Adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). <\/span><\/p>\n

\u2022 Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.<\/span><\/p>\n

This indication is approved under accelerated approval 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).<\/span><\/p>\n

 <\/span><\/p>\n

DOSAGE AND ADMINISTRATION<\/strong><\/strong><\/span><\/p>\n

\u2022 Select patients for treatment with LUCISEL based on the presence of a RET gene fusion (NSCLC, thyroid, or other solid tumors) or specific RET gene mutation (MTC). <\/span><\/p>\n

\u2022 Adult and adolescent patients 12 years of age or older: <\/span><\/p>\n

the recommended dosage is based on weight: <\/span><\/p>\n

\u2022 Less than 50 kg: 120 mg orally twice daily <\/span><\/p>\n

\u2022 50 kg or greater: 160 mg orally twice daily <\/span><\/p>\n

\u2022 Pediatric patients 2 to less than 12 years of age:  <\/span><\/p>\n

the recommended dosage is based on body surface area (2.3): <\/span><\/p>\n

\u2022 0.33 to 0.65 m2: 40 mg orally three times daily <\/span><\/p>\n

\u2022 0.66 to 1.08 m2: 80 mg orally twice daily <\/span><\/p>\n

\u2022 1.09 to 1.52 m2: 120 mg orally twice daily <\/span><\/p>\n

\u2022 \u22651.53 m2: 160 mg orally twice daily <\/span><\/p>\n

\u2022 Reduce LUCISEL dose in patients with severe hepatic impairment. <\/span><\/p>\n

 <\/span><\/p>\n

DOSAGE FORMS AND STRENGTHS <\/strong><\/strong><\/span><\/p>\n

Capsules: 40 mg\u00d7120 capsules<\/span><\/p>\n

 <\/span><\/p>\n

CONTRAINDICATIONS <\/strong><\/strong><\/span><\/p>\n

None.<\/span><\/p>\n

 <\/span><\/p>\n

WARNINGS AND PRECAUTIONS <\/strong><\/strong><\/span><\/p>\n

\u2022 Hepatotoxicity: Monitor ALT and AST prior to initiating LUCISEL, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce the dose, or permanently discontinue LUCISEL based on severity. <\/span><\/p>\n

\u2022 Interstitial Lung Disease (ILD)\/Pneumonitis: Monitor for new or worsening pulmonary symptoms. Withhold, reduce the dose or permanently discontinue LUCISEL based on severity.<\/span><\/p>\n

\u2022 Hypertension: Do not initiate LUCISEL in patients with uncontrolled hypertension. Optimize blood pressure (BP) prior to initiating LUCISEL. Monitor BP after 1 week, at least monthly thereafter and as clinically indicated. Withhold, reduce the dose, or permanently discontinue LUCISEL based on severity. <\/span><\/p>\n

\u2022 QT Interval Prolongation: Monitor patients who are at significant risk of developing QTc prolongation. Assess QT interval, electrolytes and TSH at baseline and periodically during treatment. Monitor QT interval more frequently when LUCISEL is concomitantly administered with strong and moderate CYP3A inhibitors or drugs known to prolong QTc interval. Withhold and reduce the dose or permanently discontinue LUCISEL based on severity.<\/span><\/p>\n

\u2022 Hemorrhagic Events: Permanently discontinue LUCISEL in patients with severe or life-threatening hemorrhage.<\/span><\/p>\n

\u2022 Hypersensitivity: Withhold LUCISEL and initiate corticosteroids. Upon resolution, resume at a reduced dose and increase dose by 1 dose level each week until reaching the dose taken prior to onset of hypersensitivity. Continue steroids until patient reaches target dose and then taper. <\/span><\/p>\n

\u2022 Tumor Lysis Syndrome: Closely monitor patients at risk and treat as clinically indicated. <\/span><\/p>\n

\u2022 Risk of Impaired Wound Healing: Withhold LUCISEL for at least 7 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of LUCISEL after resolution of wound healing complications has not been established. <\/span><\/p>\n

\u2022 Hypothyroidism: Monitor thyroid function before treatment with LUCISEL and periodically during treatment. Withhold until clinically stable or permanently discontinue based on severity. <\/span><\/p>\n

\u2022 Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the possible risk to a fetus and to use effective contraception.  <\/span><\/p>\n

\u2022 Slipped Capital Femoral Epiphysis\/Slipped Upper Femoral Epiphysis (SCFE\/SUFE) in Pediatric Patients: Monitor patients for symptoms indicative of SCFE\/SUFE and treat as medically and surgically appropriate.<\/span><\/p>\n

 <\/span><\/p>\n

ADVERSE REACTIONS <\/strong><\/strong><\/span><\/p>\n

The most common adverse reactions (\u226525%) include: <\/span><\/p>\n

\u00b7  Adult patients with solid tumors: edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache.<\/span><\/p>\n

\u00b7  Pediatric patients with solid tumors: musculoskeletal pain, diarrhea, headache, nausea, vomiting, coronavirus infection, abdominal pain, fatigue, pyrexia, and hemorrhage.<\/span><\/p>\n

The most common Grade 3 or 4 laboratory abnormalities (\u22655%) include: <\/span><\/p>\n

\u00b7 Adult patients with solid tumors: decreased lymphocytes, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), decreased sodium, and decreased calcium.<\/span><\/p>\n

\u00b7  Pediatric patients with solid tumors: decreased calcium, decreased hemoglobin, and decreased neutrophils.<\/span><\/p>\n

 <\/span><\/p>\n

DRUG INTERACTIONS <\/strong><\/strong><\/span><\/p>\n

\u2022 Acid-Reducing Agents: Avoid coadministration. If coadministration cannot be avoided, take LUCISEL with food (with PPI) or modify its administration time (with H2 receptor antagonist or locally-acting antacid). <\/span><\/p>\n

\u2022 Strong and Moderate CYP3A Inhibitors: Avoid coadministration. If coadministration cannot be avoided, reduce the LUCISEL dose. <\/span><\/p>\n

\u2022 Strong and Moderate CYP3A Inducers: Avoid coadministration. <\/span><\/p>\n

\u2022 CYP2C8 and CYP3A Substrates: Avoid coadministration. If coadministration cannot be avoided, modify the substrate dosage as recommended in its product labeling. <\/span><\/p>\n

\u2022 Certain P-gp Substrates: Avoid coadministration. If coadministration cannot be avoided, modify the substrate dosage as recommended in its product labeling.<\/span><\/p>\n

 <\/span><\/p>\n

USE IN SPECIFIC POPULATIONS <\/strong><\/strong><\/span><\/p>\n

\u2022 Lactation: Advise not to breastfeed.<\/span><\/p>\n

\u2022 Pediatric Use: Monitor open growth plates in pediatric patients. Consider interrupting or discontinuing LUCISEL if abnormalities occur.<\/span><\/p>\n

 <\/span><\/p>\n

Storage <\/strong><\/strong><\/span><\/p>\n

Store at 20\u2103 to 25\u2103 (68\u2109 to 77\u2109), excursions permitted between 15\u2103 and 30\u2103 (59\u2109 and 86\u2109) [see USP Controlled Room Temperature]. Protect from moisture. <\/span><\/p>\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test.<\/p>","protected":false},"featured_media":1963,"comment_status":"open","ping_status":"closed","template":"","meta":{"advanced_seo_description":"","jetpack_seo_html_title":"","jetpack_seo_noindex":false,"jetpack_seo_schema_type":""},"product_brand":[],"product_cat":[19],"product_tag":[],"class_list":["post-293","product","type-product","status-publish","has-post-thumbnail","product_cat-lung-cancer","first","instock","shipping-taxable","purchasable","product-type-simple"],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/luciuspharmacy.com\/es\/wp-json\/wp\/v2\/product\/293","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/luciuspharmacy.com\/es\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/luciuspharmacy.com\/es\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/luciuspharmacy.com\/es\/wp-json\/wp\/v2\/comments?post=293"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/luciuspharmacy.com\/es\/wp-json\/wp\/v2\/media\/1963"}],"wp:attachment":[{"href":"https:\/\/luciuspharmacy.com\/es\/wp-json\/wp\/v2\/media?parent=293"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/luciuspharmacy.com\/es\/wp-json\/wp\/v2\/product_brand?post=293"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/luciuspharmacy.com\/es\/wp-json\/wp\/v2\/product_cat?post=293"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/luciuspharmacy.com\/es\/wp-json\/wp\/v2\/product_tag?post=293"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}