{"id":287,"date":"2026-04-11T10:49:03","date_gmt":"2026-04-11T10:49:03","guid":{"rendered":"https:\/\/luciuspharmacy.com\/?post_type=product&p=287"},"modified":"2026-08-30T03:53:23","modified_gmt":"2026-08-30T03:53:23","slug":"lucipral-pralsetinib-100mgx120-capsules","status":"publish","type":"product","link":"https:\/\/luciuspharmacy.com\/pt\/product\/lucipral-pralsetinib-100mgx120-capsules\/","title":{"rendered":"LuciPral"},"content":{"rendered":"

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

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

 <\/span><\/p>\n

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

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

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

\u2022 Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy.<\/span><\/p>\n

\u2022 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).<\/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

Select patients for treatment with LuciPral based on the presence of a RET gene fusion or gene mutation. <\/span><\/p>\n

The recommended dosage in adults and pediatric patients 12 years and older is 400 mg orally once daily on an empty stomach (no food intake for at least 2 hours before and at least 1 hour after taking LuciPral).<\/span><\/p>\n

 <\/span><\/p>\n

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

Capsules: 100mg\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 Interstitial Lung Disease (ILD)\/Pneumonitis: Withhold LuciPral for Grade 1 or 2 reactions until resolution and then resume at a reduced dose. Permanently discontinue for recurrent ILD\/pneumonitis. Permanently discontinue for Grade 3 or 4 reactions.  <\/span><\/p>\n

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

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

\u2022 Hemorrhagic Events: Permanently discontinue LuciPral in patients with severe or life-threatening hemorrhage. <\/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 LuciPral for at least 5 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 LuciPral after resolution of wound healing complications has not been established.<\/span><\/p>\n

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

 <\/span><\/p>\n

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

The most common adverse reactions (\u226525%) were constipation, hypertension, fatigue, musculoskeletal pain and diarrhea. The most common Grade 3-4 laboratory abnormalities (\u22652%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased calcium (corrected), decreased sodium, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), decreased platelets, and increased alkaline phosphatase.<\/span><\/p>\n

 <\/span><\/p>\n

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

\u2022 Strong CYP3A inhibitors: Avoid coadministration. <\/span><\/p>\n

\u2022 Combined P-gp and Strong CYP3A inhibitors: Avoid coadministration. If coadministration cannot be avoided, reduce the dose of LuciPral. <\/span><\/p>\n

\u2022  Strong CYP3A inducers: Avoid coadministration. If coadministration cannot be avoided, increase the dose of LuciPral. <\/span><\/p>\n

 <\/span><\/p>\n

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

\u2022 Lactation: Advise not to breastfeed. (8.2) <\/span><\/p>\n

\u2022 Pediatric Use: Monitor open growth plates in adolescent patients.   <\/span><\/p>\n

Consider interrupting or discontinuing LuciPral 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":"

dult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC).<\/p>","protected":false},"featured_media":2080,"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-287","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\/pt\/wp-json\/wp\/v2\/product\/287","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/luciuspharmacy.com\/pt\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/luciuspharmacy.com\/pt\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/luciuspharmacy.com\/pt\/wp-json\/wp\/v2\/comments?post=287"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/luciuspharmacy.com\/pt\/wp-json\/wp\/v2\/media\/2080"}],"wp:attachment":[{"href":"https:\/\/luciuspharmacy.com\/pt\/wp-json\/wp\/v2\/media?parent=287"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/luciuspharmacy.com\/pt\/wp-json\/wp\/v2\/product_brand?post=287"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/luciuspharmacy.com\/pt\/wp-json\/wp\/v2\/product_cat?post=287"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/luciuspharmacy.com\/pt\/wp-json\/wp\/v2\/product_tag?post=287"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}