Platinib instruction manual details

Pralsetinib (Pralsetinib) is a kinase inhibitor. Platinibis specifically indicated for use in adult patients with metastatic rearrangement (RET) fusion-positive non-small cell lung cancer that has occurred during transfection as detected by a U.S. FDA-approved test; in adults and pediatric patients 12 years and older with advanced or metastatic RET-mutant medullary thyroid carcinoma (MTC) requiring systemic therapy or with advanced or metastatic RET that is refractory to radioactive iodine and requiring systemic therapy. Adult and pediatric patients with fusion-positive thyroid cancer (if radioactive iodine is appropriate).

Mechanism of Action: Platinib is a kinase inhibitor of wild-type RET and oncogenic RET fusions and mutations. Certain RET fusion proteins and activating point mutations can drive tumorigenic potential through overactivation of downstream signaling pathways, leading to uncontrolled cell proliferation. Platinib demonstrates antitumor activity in cultured cells and animal tumor implant models harboring oncogenic RET fusions or mutations.

Dosage: Platinib is provided as an oral capsule. The recommended dose is 400 mg taken orally once daily on an empty stomach. You should not eat at least 2 hours before and 1 hour after taking platinib.

SIDE EFFECTS: Get emergency medical help if you have signs of an allergic reaction: hives; trouble breathing; swelling of the face, lips, tongue, or throat.

Platinib may cause serious side effects. Call your doctor right away if you have: fever, chills; new or worsening cough, shortness of breath, or chest pain; severe headache, dizziness, confusion, difficulty speaking; any wound that won't heal; unusual bleeding—bruising, nosebleeds, bleeding gums, unusual vaginal bleeding, any bleeding that doesn't stop; signs of bleeding inside the body—weakness, drowsiness, pink or Brown urine, bloody or tarry stools, coughing up blood, or vomit that looks like coffee grounds; low blood count—Fever, tiredness, sore throat, mouth sores, skin ulcers, pale skin, cold hands and feet, feeling dizzy or short of breath; or liver problems—nausea, vomiting, loss of appetite, stomach pain (upper right side), tiredness, dark urine,Jaundice (yellowing of the skin or eyes). If you experience certain side effects, your cancer treatment may be delayed or permanently stopped.

Common side effects of platinib may include: high blood pressure; low blood counts or other abnormal laboratory tests; muscle or joint pain; feeling tired; or constipation. This is not a complete list of side effects, and other side effects may occur.

PRECAUTIONS: Follow all directions on the drug label and packaging. Tell each of your doctors all of your medical conditions, allergies, and all the medications you take.

Storage: Store at room temperature, away from moisture and heat.