Ibrance

PALBOCICLIB

Manufacturer: U.S. Pharmaceuticals

Score: 141.0

Quick Summary

Ibrance (palbociclib) is a kinase inhibitor used in combination with an aromatase inhibitor or fulvestrant for the treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. The recommended dose is 125 mg once daily for 21 consecutive days followed by 7 days off treatment. Key clinical findings indicate that Ibrance has shown efficacy in improving progression-free survival in patients with HR-positive, HER2-negative advanced or metastatic breast cancer. Important safety information includes warnings about neutropenia, interstitial lung disease/pneumonitis, and embryo-fetal toxicity. Contraindications and adverse reactions are also listed. Special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Ibrance is used in combination with an aromatase inhibitor or fulvestrant for the treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer
Ibrance has shown efficacy in improving progression-free survival in patients with HR-positive, HER2-negative advanced or metastatic breast cancer

Important Safety Information

Warning

Neutropenia, interstitial lung disease/pneumonitis, and embryo-fetal toxicity are potential risks associated with Ibrance

Contraindications

None

Adverse Reactions

Neutropenia
Infections
Leukopenia
Fatigue
Nausea
Stomatitis
Anemia
Alopecia
Diarrhea
Thrombocytopenia
Rash
Vomiting
Decreased appetite
Asthenia
Pyrexia

Dosing Recommendations

General Guidance

Dose reductions and interruptions are recommended based on individual safety and tolerability

Hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer

Adult Dose

125 mg once daily for 21 consecutive days followed by 7 days off treatment

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Ibrance can cause fetal harm when administered to a pregnant woman
Advise pregnant women of the potential risk to a fetus

Nursing Mothers

No data available

Pediatric Use

The safety and efficacy of Ibrance in pediatric patients have not been studied
Altered glucose metabolism and associated changes in the pancreas, eye, kidney, and adipose tissue were identified in a 27-week repeat-dose toxicology study in rats

Geriatric Use

No overall differences in safety or effectiveness of Ibrance were observed between older and younger patients
Of 444 patients who received Ibrance in PALOMA-2, 181 patients (41%) were ≥65 years of age and 48 patients (11%) were ≥75 years of age

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