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Palbonix (Ibrance) Palbociclib by Beacon Pharmaceuticals is used to treat breast cancer. It is a chemotherapy drug that works by slowing the growth of cancer cells.

Palbonix 125 is the alternative & generic version of Ibrance by Pfizer. Palbonix is manufactured by Beacon Pharmaceuticals Bangladesh which is the biggest pharmaceutical company in Bangladesh.

Therapeutic Class

Targeted Cancer Therapy

Pharmacology

Treatment of breast cancer cell lines with the combination of palbociclib and antiestrogens leads to decreased retinoblastoma protein (Rb) phosphorylation resulting in reduced E2F expression and signaling and increased growth arrest compared to treatment with each drug alone.

In vitro treatment of ER-positive breast cancer cell lines with the combination of palbociclib and antiestrogens leads to increased cell senescence, which was sustained for up to 6 days following drug removal.

In vivo studies using a patient-derived ER-positive breast cancer xenograft model demonstrated that the combination of palbociclib /Ibrance and letrozole increased the inhibition of Rb phosphorylation, downstream signaling and tumor growth compared to each drug alone.

Palbociclib is an oral, reversible, selective, small-molecule inhibitor of CDK4 and CDK6. CDK4 and CDK6 along with their regulatory partner cyclin D1 play a key role in regulating the G1- to S-phase cell-cycle transition via regulation of phosphorylation of the retinoblastoma (Rb) protein.

Dosage & Administration

Palbociclib / Ibrance capsules are taken orally with food in combination with an aromatase inhibitor or fulvestrant.

• Recommended starting dose: 125 mg once daily taken with food for 21 days followed by 7 days off treatment.

• Dosing interruption and/or dose reductions are recommended based on individual safety and tolerability.

Interaction

CYP3A Inhibitors: Avoid concurrent use of Palbociclib with strong CYP3A inhibitors. If the strong inhibitor cannot be avoided, reduce the Palbociclib /Ibrance dose.

CYP3A Inducers: Avoid concurrent use of Palbociclib with strong CYP3A inducers.

CYP3A Substrates: The dose of sensitive CYP3A4 substrates with narrow therapeutic indices may need to be reduced when given concurrently with Palbociclib.

Contraindications

None

Side Effects

Most common adverse reactions (incidence ≥10%) were neutropenia, infections, leukopenia, fatigue, nausea, stomatitis, anemia, alopecia, diarrhea, thrombocytopenia, rash, vomiting, decreased appetite, asthenia, and pyrexia.

Pregnancy & Lactation

Lactation: Advise not to breastfeed

Precautions & Warnings

Before taking palbociclib / Ibrance, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.

Palbociclib / Ibrance  can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu).

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Ibrance can affect fertility in males. Ask your doctor for more details.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are using palbociclib. Palbociclib / Ibrance may harm an unborn baby.

Women of childbearing age should have a pregnancy test before starting this medication and should ask about reliable forms of birth control while using this medication and for at least 3 weeks after the last dose.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding during treatment and for at least 3 weeks after treatment with this drug is not recommended. Consult your doctor before breast-feeding.