Selpercatinib 40mg capsules 40mg

Product Name: Selpercatinib

Specification: 40 mg * 60 capsules/box

Manufacturer: State Pharmaceutical Factory No. 2, Lao People's Democratic Republic

The anti-cancer drug LOXO-292 (Selpercatinib) is a kinase inhibitor. Selpercatinib (LOXO-292) inhibits wild-type RET and various mutant RET subtypes, as well as VEGFR1 and VEGFR3, with IC50 values ranging from 0.92 nM to 67.8 nM. When using Selpercatinib, patients must selectively undergo treatment based on the presence of RET gene fusions (in NSCLC or thyroid cancer) or specific RET gene mutations (in MTC). For patients with severe hepatic impairment, the dosage of Selpercatinib (LOXO-292) should be appropriately reduced during treatment based on their individual clinical status; however, specific adjustments should ultimately be determined based on a physician's advice. Treatment should continue until the patient no longer derives clinical benefit from the therapy or until drug resistance develops. During this period, patients must not independently increase, decrease, or discontinue Selpercatinib without medical guidance.

[Indications]

1. Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC);

2. Adult and pediatric patients aged ≥12 years with advanced or recurrent RET-mutant medullary thyroid carcinoma (MTC) requiring systemic therapy;

3. Adult and pediatric patients aged ≥12 years with advanced or metastatic RET fusion-positive thyroid cancer requiring systemic therapy and who are refractory to radioactive iodine (if radioactive iodine is appropriate).

[Dosage and Administration]

Recommended dosage based on body weight: ① Less than 50 kg: 120 mg; ② 50 kg or greater: 160 mg.

Administer orally twice daily (approximately every 12 hours) until disease progression or unacceptable toxicity occurs. Swallow the capsules whole; do not crush or chew the capsule shell.

Do not miss any doses unless more than 6 hours have elapsed since the scheduled time for the next dose. If vomiting occurs after taking the medication, do not take a replacement dose; continue with the next scheduled dose according to the original dosing interval.

【Mechanism of Action】

Selpercatinib is a potent, orally administered, highly selective inhibitor of the rearranged during transfection (RET) kinase, indicated for the treatment of patients with cancers harboring RET alterations. The RET gene is a proto-oncogene that undergoes rearrangement during the process of transfection—hence its name—and encodes a cell-surface receptor tyrosine kinase; alterations in this gene serve as rare oncogenic drivers in various types of tumors.

【Side Effects】

Fatigue, edema, thrombocytopenia, dry mouth, diarrhea, rash, hyponatremia, increased creatinine, increased alkaline phosphatase, hypertension, increased total cholesterol, and constipation.

【Precautions】

1. Hemorrhagic Events: This medication may cause severe, including fatal, hemorrhagic events. Patients experiencing severe or life-threatening hemorrhage should permanently discontinue this medication.

2. Hypersensitivity Reactions: Symptoms may include fever, rash, arthritis, and myalgia, accompanied by thrombocytopenia or elevated transaminases. If a hypersensitivity reaction occurs, temporarily withhold the medication and initiate corticosteroid treatment at a dose of 1 mg/kg. Once the hypersensitivity reaction has resolved, reduce the dosage of this medication and re-escalate the dose weekly, based on tolerability, until the dosage administered prior to the onset of the hypersensitivity reaction is reached.

3. Impairment of Wound Healing: This medication possesses anti-angiogenic properties and may impair wound healing. Withhold the medication for at least one week prior to undergoing elective surgery. Do not administer this medication for at least two weeks following major surgery, until the surgical incision has completely healed. The safety of resuming this medication after the resolution of wound-healing complications has not been established.

4. Embryo-Fetal Toxicity: Animal studies have demonstrated that Selpercatinib is embryotoxic and fetotoxic. Patients and their partners should utilize effective contraception during treatment with this medication and for at least one week following its discontinuation. [Manufacturer Introduction]

Pharmaceutical Factory No. 2 of the Lao People's Democratic Republic (PHARMA 2 VIENTIANE)—hereinafter referred to as "Lao Pharma 2"—is a state-owned pharmaceutical enterprise in Laos, operating directly under the supervision of the Lao Ministry of Health. Established in the 1970s, Lao Pharma 2 boasts a history spanning over 40 years. It stands as the largest, oldest, and most comprehensive pharmaceutical manufacturer in Laos, offering the widest range of medicinal products.

Each year, Lao Pharma 2 supplies patients with a diverse portfolio comprising over 160 different types of medicines, including intravenous infusions, injectables, oral tablets, capsules, syrups, and ointments. Keeping pace with the times, Lao Pharma 2 actively engages in exploration and innovation; it continuously introduces advanced foreign technologies and seeks breakthroughs in both manufacturing processes and pharmaceutical R&D to ensure that its research, development, and production capabilities remain aligned with international standards. Currently, Lao Pharma 2 holds ISO 9001:2008 certification for its manufacturing processes. The mission of Lao Pharma 2 is to—through continuous advancement and proactive exploration—provide an ever-growing number of customers and patients with high-quality pharmaceutical products and services that meet international standards. Product Specifications

Product Name: Selpercatinib 40mg (60 capsules/box) | PHOSELP | Retevmo, LOXO-292

Common Name: Selpercatinib

Active Ingredient: Selpercatinib

Dosage Form: Capsules

Specification: 40mg × 60 capsules/box

Manufacturer: PHARMACEUTICAL FACTORY NO.2 (PHARMA 2 VIENTIANE)

Indications:

1. Adult patients with metastatic *RET*-fusion-positive non-small cell lung cancer (NSCLC);

2. Adult and pediatric patients aged ≥12 years with advanced or recurrent *RET*-mutant medullary thyroid cancer (MTC) requiring systemic therapy;

3. Adult and pediatric patients aged ≥12 years with advanced or metastatic *RET*-fusion-positive thyroid cancer requiring systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

Dosage and Administration:

Recommended dosage based on body weight: ① <50 kg: 120 mg; ② ≥50 kg: 160 mg.

Take orally twice daily (approximately every 12 hours) until disease progression or unacceptable toxicity occurs. Swallow the capsules whole; do not crush or chew the capsule shell.

Do not miss a dose unless more than 6 hours have elapsed since the scheduled time for the next dose. If vomiting occurs after taking the medication, do not take a replacement dose; continue with the next scheduled dose at the regular interval.