Palbocent 125 | 7 Capsules | 1 Strip

✔️ Common Side Effects

• Hematologic: Neutropenia, leukopenia, anemia, thrombocytopenia
• GI & General: Nausea, vomiting, diarrhea, loss of appetite, fatigue
• Liver Enzymes: Elevated AST/ALT
• Skin & Mucosa: Rash, dry skin, hair thinning/loss, mouth sores
• Other: Fever, infections, weakness

✔️ Dosage & Administration

Recommended Dose: 125 mg orally, once daily for 21 consecutive days, followed by 7 days off (28-day cycle)

With food: Always administer with food

Timing: Same time daily is recommended

For men receiving aromatase inhibitors, concurrent use of an LHRH agonist should be considered.

✔️ Dose Modifications (Adverse Reactions)

• Starting dose: 125 mg/day
• 1st reduction: 100 mg/day
• 2nd reduction: 75 mg/day

Discontinue if further reduction is necessary below 75 mg/day

Not indicated for use in children.

✔️ Drug Interactions

Metabolism:

Primarily metabolized by CYP3A and SULT2A1

Increased Palbocent exposure (avoid coadministration):

Strong CYP3A inhibitors: Itraconazole, Ketoconazole, Clarithromycin, Ritonavir, etc.

Grapefruit or grapefruit juice should also be avoided.

If unavoidable, reduce Palbocent dose.

Decreased Palbocent exposure (avoid coadministration):

Strong CYP3A inducers: Rifampin, Phenytoin, Carbamazepine, Enzalutamide, St. John's Wort

Palbocent as an inhibitor:

May increase plasma levels of sensitive CYP3A substrates (e.g., fentanyl, tacrolimus, cyclosporine), requiring dose adjustments.

✔️ Warnings & Precautions

1. Neutropenia

Reported in up to 80% of patients in clinical trials

Grade 3 neutropenia in ~66% of cases

Monitor CBC at baseline, Day 15 of Cycles 1 and 2, then each cycle

Withhold or reduce dose for Grade 3–4 neutropenia

Febrile neutropenia in ~1.8% of patients

2. Interstitial Lung Disease (ILD)/Pneumonitis

Rare but potentially life-threatening

Monitor for new or worsening cough, dyspnea, or hypoxia

Discontinue permanently if severe or confirmed ILD/pneumonitis is diagnosed

3. Embryo-Fetal Toxicity

Teratogenic risk based on animal studies

Advise effective contraception during treatment and for 3 weeks after the last dose

Discontinue treatment if pregnancy occurs

✔️ Pregnancy & Lactation

Pregnancy Category D: Contraindicated in pregnancy due to risk of fetal harm

Lactation: Unknown if excreted in breast milk; breastfeeding is not recommended

✔️ Storage Conditions

• Store at below 30°C
• Protect from moisture and light
• Keep out of reach of children