Lucinav Iptacopan 3mg Tablets 30's

Inavolisib is an oral targeted anticancer medicine. It inhibits the PI3K-alpha signalling pathway and helps suppress cancer-cell growth in selected patients with a specific genetic mutation. Inavolisib targets abnormal signalling associated with mutations in the PIK3CA gene.

It is used in combination with palbociclib and fulvestrant for adults with PIK3CA-mutated, hormone receptor-positive (HR-positive), HER2-negative, locally advanced or metastatic breast cancer that is endocrine-resistant and has recurred during or after adjuvant endocrine therapy.

Inavolisib is used in combination with palbociclib and fulvestrant for:

• PIK3CA-mutated breast cancer: The tumor must have a qualifying PIK3CA mutation.
• HR-positive, HER2-negative breast cancer: The cancer is hormone-receptor positive and HER2 negative.
• Locally advanced or metastatic disease: Cancer that has spread locally or to distant organs.
• Endocrine-resistant disease: Cancer that has recurred during or after adjuvant endocrine therapy, meeting the criteria in the approved indication.

It is not intended for all breast cancers. Treatment suitability depends on the tumor's molecular findings, previous therapy, and the patient's clinical condition.

• Inhibits PI3K-alpha: Blocks signaling driven by abnormal PIK3CA activity.
• Suppresses tumor growth: Helps reduce cancer cell proliferation and survival.
• Combination treatment: Palbociclib inhibits CDK4/6, while fulvestrant blocks estrogen-receptor signaling. Together, the medicines target complementary mechanisms involved in tumor growth.
• Disease control: Clinical-trial evidence supports improved progression-free survival with the combination compared with the study's control regimen.

Treatment response varies. Regular clinical examinations, imaging, and laboratory tests are required to evaluate benefit and toxicity.

• Usual adult dose: 9 mg orally once daily, with or without food.
• Take at approximately the same time every day.
• Swallow tablets whole; do not crush, chew, or split them.
• If a dose is missed, take it within 9 hours of the scheduled time. If more than 9 hours have passed, skip the missed dose and take the next dose at the usual time.
• If vomiting occurs after taking a dose, do not take an additional dose that day; resume the normal schedule the following day.
• Treatment continues until disease progression or unacceptable toxicity, as determined by the oncologist.

Dose adjustments may be necessary because of side effects or kidney impairment. Under the current US prescribing information, the recommended dose is 6 mg daily for moderate renal impairment and 3 mg daily for severe renal impairment. These adjustments must be directed by the treating specialist.

Common:

Reported adverse reactions include the following:

• Increased blood glucose
• Mouth sores or inflammation (stomatitis)
• Diarrhoea
• Nausea
• Fatigue
• Reduced appetite
• Skin rash
• Headache
• Reduced neutrophils, lymphocytes, haemoglobin and platelets
• Changes in kidney-function tests and liver enzymes
• Reduced calcium, potassium, sodium, and magnesium levels

Some laboratory abnormalities may be caused by inavolisib, the combination regimen, or the underlying condition. Regular monitoring is important.

Serious:

Severe hyperglycemia (high blood sugar)

Inavolisib can cause severe or potentially fatal hyperglycemia, including diabetic ketoacidosis. Symptoms may include excessive thirst, frequent urination, blurred vision, nausea, abdominal pain, and unusual weakness or confusion. Severe symptoms require urgent medical attention.

Severe stomatitis

Painful mouth ulcers, difficulty swallowing, or an inability to drink adequately may require treatment interruption and medical care.

Severe diarrhoea and dehydration

Persistent diarrhoea may lead to dehydration and acute kidney injury. Increase oral fluids where appropriate, use anti-diarrheal treatment as instructed by the treating team, and seek medical advice promptly if symptoms are severe.

Low blood-cell counts

Reduced neutrophils can increase infection risk, while low hemoglobin and platelets may cause fatigue, breathlessness, bruising, or bleeding. Report fever or unusual bleeding promptly.

Harm to an unborn baby

Inavolisib can cause fetal harm and should not be used during pregnancy unless specifically assessed under applicable medical guidance.

Inavolisib has the potential to interact with medicines that affect drug-metabolizing enzymes and transport proteins. A pharmacist or oncologist should review the patient's complete medication list before treatment.

• Palbociclib and fulvestrant: These are intended combination partners and must be used according to the prescribed treatment schedule.
• Strong CYP3A inhibitors or inducers: Review medicines such as clarithromycin, itraconazole, rifampicin, and certain anticonvulsants with the oncology team; interaction risk may depend on the specific medicine and regimen.
• Antidiabetic medicines: Blood-glucose-lowering treatment may need to be started or adjusted because inavolisib can cause significant hyperglycemia.
• Other anticancer medicines: Additional therapies should be reviewed for overlapping toxicities and interactions.
• Herbal supplements and non-prescription medicines: Inform the treating team before use.

Do not start, stop, or adjust any medication without professional advice.

• Store at room temperature according to the manufacturer's label.
• Keep tablets in their original packaging and protect them from moisture.
• Keep out of reach of children.
• Do not use expired or damaged tablets.
• Follow the storage instructions supplied with the specific marketed product.

• Confirm the tumor's PIK3CA mutation status using an appropriate validated diagnostic test.
• Check fasting blood glucose and HbA1c before starting treatment; optimize glucose control.
• Monitor blood glucose frequently, particularly during the first weeks of therapy.
• Maintain good oral hygiene and report mouth ulcers early.
• Report diarrhea promptly and maintain hydration as advised.
• Attend scheduled complete blood counts, kidney-function tests, liver-function tests, and electrolyte monitoring.
• Discuss dose interruption or reduction with the oncologist if significant adverse effects develop.
• Do not discontinue or modify treatment independently.