piqray 150 mg

Piqray is an anticancer medicine that contains the active substance Alpelisib. It is a targeted therapy belonging to a class of drugs called “kinase inhibitors.” Specifically, it is a phosphatidylinositol-3-kinase (PI3K) inhibitor. The tablets are light pink, round, and debossed with “L7” on one side and “NVR” on the other.

2. Mechanism of Action:
Piqray works by selectively inhibiting the PI3K alpha enzyme. In cancer cells, the PI3K signaling pathway is often overactive due to mutations in the PIK3CA gene, which promotes tumor growth, metabolism, and survival. By blocking this enzyme, Piqray helps to slow down or stop the growth of cancer cells driven by this specific mutation.

3. Therapeutic Indications (Uses):
Piqray is used in combination with another endocrine therapy medicine called Fulvestrant for the treatment of postmenopausal women and men with:

• Breast Cancer: It is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with a PIK3CA mutation. It is specifically used after progression on or after an endocrine-based regimen.

Important Note: Before starting treatment, a patient must have a tumor tissue or blood test to confirm the presence of the PIK3CA mutation. Piqray is only effective in cancers with this specific mutation.

4. Warnings and Precautions:
Piqray can cause serious side effects. Close monitoring by your healthcare team is essential.

• Severe Allergic Reactions (Hypersensitivity): Serious reactions, including anaphylaxis, can occur. Symptoms may include rash, itching, difficulty breathing, fever, chills, or severe skin reactions. If these occur, treatment should be stopped immediately.

• Severe Skin Reactions: Life-threatening skin reactions such as Stevens-Johnson Syndrome (SJS) and erythema multiforme have been reported. Seek immediate medical attention if you notice a progressive skin rash, blistering, or peeling, especially with mouth sores or fever.

• Hyperglycemia (High Blood Sugar): This is a very common and potentially serious side effect. Piqray can cause significant increases in blood sugar levels, which may require treatment with anti-diabetic medication. Blood sugar levels must be monitored closely before and during treatment. Patients with pre-existing diabetes may require more intensive monitoring and management.

• Pneumonitis (Lung Inflammation): Inflammation of the lungs can occur. Symptoms include new or worsening cough, chest pain, and shortness of breath. Treatment may need to be interrupted if this occurs.

• Diarrhea: Severe diarrhea, leading to dehydration and acute kidney injury, is common. Prompt treatment with anti-diarrheal medication and increased fluid intake is necessary.

• Gastrointestinal Problems: Nausea, vomiting, and decreased appetite are common.

• Liver Problems: Piqray can cause liver injury. Liver function should be monitored through blood tests before and during treatment.

• Fetal Harm (Embryo-Fetal Toxicity): Piqray can cause fetal harm. Women of childbearing potential must use effective contraception during treatment and for at least 1 week after the last dose. Do not breastfeed while taking this medication.

5. Dosage and Administration:

• The recommended dose is 300 mg (two 150 mg tablets) taken orally once daily.

• Piqray should be taken consistently either with food or without food. It should be swallowed whole and not chewed, crushed, or split.

• The tablet is taken in combination with Fulvestrant, which is given as an intramuscular injection on specific days.

• Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.

6. Storage:
Store at room temperature (20°C to 25°C). Keep the bottle tightly closed to protect from moisture.