PALBOCICLIB SANDOZ CAPSULE 125MG [SIN17007P]

Product Info

PALBOCICLIB SANDOZ CAPSULE 125MG

[SIN17007P]

4.1. Therapeutic indications

Palbociclib is indicated for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:

• an aromatase inhibitor as initial endocrine-based therapy; or

• fulvestrant in patients with disease progression following endocrine therapy.

4.2. Posology and method of administration

The recommended dose of palbociclib is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment (Schedule 3/1) to comprise a complete cycle of 28 days.

When co-administered with palbociclib, the aromatase inhibitor should be administered according to the dose reported in the approved prescribing information.

When co-administered with palbociclib, the recommended dose of fulvestrant is 500 mg administered intramuscularly on Days 1, 15, 29, and once monthly thereafter. Please refer to the full prescribing information of fulvestrant.

Palbociclib should be taken with food. Patients should be encouraged to take their dose at approximately the same time each day. Continue the treatment as long as the patient is deriving clinical benefit from therapy.

If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time. Palbociclib Sandoz capsules should be swallowed whole (do not chew, crush, or open them prior to swallowing). No capsule should be ingested if it is broken, cracked, or otherwise not intact.

Prior to the start of, and throughout treatment, pre/perimenopausal women treated with the combination palbociclib plus aromatase inhibitor/fulvestrant should also be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to local clinical practice.

For men treated with combination palbociclib plus aromatase inhibitor therapy, consider treatment with an LHRH agonist according to current clinical practice standards.

Dose modifications

Dose modification of palbociclib is recommended based on individual safety and tolerability.

Management of some adverse reactions may require temporary dosing interruptions/cycle delays, and/or dose reductions, or permanent discontinuation as per dose reduction schedules provided in Tables 1, 2, and 3 (see Section 4.4 and Section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

No dose modifications are required on the basis of patient’s age, sex or body weight (see Section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Permanently discontinue palbociclib in patients with severe interstitial lung disease (ILD) or pneumonitis (see Section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Special populations

Elderly population: No dose adjustment is necessary in patients ≥65 years of age (see Section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric population: The safety and efficacy of palbociclib in children and adolescents <18 years of age have not been established.

Hepatic impairment: No dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh classes A and B). For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of palbociclib is 75 mg once daily on Schedule 3/1 (see Section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment: No dose adjustment is required for patients with mild, moderate or severe renal impairment (creatinine clearance [CrCl] ≥15 mL/min). Insufficient data are available in patients requiring hemodialysis to provide any dosing recommendation in this patient population (see Section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3. Contraindications

None