Lucibinim Binimetinib 15mg Tablets 180's

Binimetinib is a targeted anticancer medicine that inhibits MEK1 and MEK2, proteins involved in the MAPK signaling pathway that can drive cancer-cell growth.

It is generally used in combination with encorafenib, rather than as a standalone treatment, for cancers carrying specific BRAF mutations.

A validated test is required to confirm the relevant BRAF mutation before treatment.

BRAF-mutated melanoma:

Binimetinib, together with encorafenib, is used for melanoma that:

• Has spread to other parts of the body, or
• Cannot be completely removed surgically

and has a BRAF V600E or V600K mutation.

BRAF V600E metastatic NSCLC:

The combination is also approved for adults with metastatic non-small-cell lung cancer containing a BRAF V600E mutation.

Binimetinib is a MEK inhibitor.

In many BRAF-mutated cancers, abnormal BRAF signaling activates the MEK → ERK pathway, encouraging cancer cells to grow and survive.

Binimetinib inhibits MEK1/2, thereby reducing downstream signaling and helping to:

• Slow cancer cell proliferation
• Inhibit tumor growth
• Delay disease progression

When combined with encorafenib, the two medicines target different points in the same pathway. The FDA label notes greater antiproliferative and antitumor activity with the combination than with either drug alone in relevant experimental models.

For the FDA-approved indications, the usual recommended binimetinib dose is:

45 mg orally twice daily, approximately 12 hours apart, in combination with encorafenib.

It can be taken:

• With or without food
• At approximately the same times every day
• According to the oncologist's prescription

Missed dose:

If you miss a dose:

• Take it when remembered unless it is within 6 hours of the next scheduled dose.
• If it is within 6 hours, skip the missed dose and take the next dose at the normal time.
• Do not double the dose.

Vomiting after a dose:

• If vomiting occurs after taking binimetinib:
• Do not take an additional dose. Take the next dose at the scheduled time.

Important:

If encorafenib is permanently discontinued, binimetinib should also be discontinued according to the FDA prescribing information.

Common:

• Fatigue
• Nausea
• Diarrhea
• Vomiting
• Abdominal pain
• Constipation
• Rash
• Dizziness
• Visual disturbances
• Peripheral edema
• Fever

The FDA clinical-trial data found fatigue, nausea, diarrhea, vomiting, and abdominal pain among the most common reactions.

For metastatic BRAF V600E NSCLC, commonly reported reactions also include:

• Musculoskeletal pain
• Visual impairment
• Constipation
• Shortness of breath
• Rash
• Cough

Serious:

Some adverse effects require urgent medical attention.

Heart problems / Cardiomyopathy:

Binimetinib can cause reduced heart function.

Possible symptoms include:

• Shortness of breath
• Rapid or pounding heartbeat
• Swelling of ankles or feet
• Dizziness/light-headedness
• Unusual fatigue

Heart function is generally assessed with echocardiography or MUGA scanning before treatment, approximately one month after starting treatment, and subsequently every 2–3 months.

Blood clots:

Venous thromboembolism, including DVT and pulmonary embolism, can occur.

Seek urgent medical attention for:

• Sudden shortness of breath
• Chest pain
• Leg pain
• Swelling of an arm or leg
• Sudden difficulty breathing

Patients should still tell their doctor about all prescription medicines, OTC medicines, vitamins, herbal products, and supplements they take.

Binimetinib is a substrate of P-glycoprotein (P-gp) and BCRP, although clinically important interactions have not been established in the label.

Important practical advice:

Before starting treatment, inform the oncologist particularly about:

• Anticoagulants/blood thinners
• Antiplatelet medicines
• Heart medicines
• Blood-pressure medicines
• Other anticancer medicines
• Herbal supplements
• Vitamins and nutritional supplements

This is especially important because the binimetinib + encorafenib combination can increase the risk of hemorrhage, cardiac problems, and other serious toxicities.

Store binimetinib at:

20°C–25°C (68°F–77°F)

Permitted temperature excursions are:

15°C–30°C (59°F–86°F).

Keep the medicine:

• In its original container
• Tightly closed
• Away from excessive heat and moisture
• Out of reach of children

Binimetinib should generally be considered a specialist oncology medicine, not a routine oral anticancer drug.

Key points for patients:

• Confirm the BRAF mutation before starting therapy.
• Take binimetinib together with encorafenib exactly as prescribed.
• Maintain approximately a 12-hour interval between doses.
• Do not independently change the dose.
• Do not double a missed dose.
• Report any new vision problem immediately.
• Report unexplained breathlessness or cough.
• Report chest pain or leg swelling urgently.
• Attend scheduled heart, eye, and laboratory monitoring.
• Report muscle pain/weakness or dark urine.
• Report unusual bleeding.
• Do not stop treatment without consulting the oncologist.

The FDA specifically recommends monitoring cardiac function, eyes, liver tests, and CPK/creatinine during treatment.